SUPPLIES AND EQUIPMENT

[Title 32 CFR H]
[Code of Federal Regulations (annual edition) - July 1, 2002 Edition]
[Title 32 - NATIONAL DEFENSE]
[Chapter V - DEPARTMENT OF THE ARMY]
[Subchapter H - SUPPLIES AND EQUIPMENT]
[From the U.S. Government Printing Office]

32NATIONAL DEFENSE32002-07-012002-07-01falseSUPPLIES AND EQUIPMENTHSUBCHAPTER HNATIONAL DEFENSEDEPARTMENT OF THE ARMY
SUBCHAPTER H--SUPPLIES AND EQUIPMENT

PART 621--LOAN AND SALE OF PROPERTY--Table of Contents

Sec.
621.1 Loan of Army/Defense Logistics Agency (DLA) owned property for
use at national and State conventions.
621.2 Sales of ordnance property to individuals, non-Federal government
agencies, institutions, and organizations.
621.3 [Reserved]
621.4 Issues, loans, and donations for scouting.

Authority: Pub. L. 81-193; 10 U.S.C. secs. 2574, 4308, 4506, 4507,
4627, and 4655, and Pub. L. 92-249.

Source: 44 FR 5651, Jan. 29, 1979, unless otherwise noted.

Editorial Note: For figures referred to in this part, see 42 FR
43807, Aug. 31, 1977.

Sec. 621.1 Loan of Army/Defense Logistics Agency (DLA) owned property for use at national and State conventions.

(a) General. This section--
(1) Prescribes procedures for loan of Army-owned property to
recognized National Veterans' Organizations for National or State
conventions as authorized by Pub. L. 81-193.
(2) Request for loans for National Youth Athletic or recreation
tournaments sponsored by veterans' organizations listed in the
``Veterans Administration Bulletin 23 (ALPHA),'' will be processed by
parent veterans' organizations.
(3) Loans are not authorized for other types of conventions or
tournaments.
(b) Items authorized for loan. If available, the following items may
be

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loaned for authorized veterans' organizations requirements.
(1) Unoccupied barracks.
(2) Cots.
(3) Mattresses.
(4) Mattress covers.
(5) Blankets.
(6) Pillows.
(7) Chairs, folding.
(8) Tentage, only when unoccupied barracks are not available.
(c) Requests for loan. (1) Requests by authorized veterans'
organizations for loan of authorized Government property will be
submitted to the appropriate CONUS Army Commander of the area in which
the convention will be held or the Commander, Military District of
Washington (MDW) if within his area.
(2) The tenure of loan is limited to 15 days from the date of
delivery, except under unusual circumstances. A narrative explanation
will be provided to support loan requests for more than 15 days
duration.
(3) Loan requests should be submitted by letter at least 45 days
prior to required date, if practicable.
(4) Requests for loans will contain the following information:
(i) Name of veterans' organization requesting the loan.
(ii) Location where the convention will be held.
(iii) Dates of duration of loan.
(iv) Number of individuals to be accommodated.
(v) Type and quantity of equipment required.
(vi) Type of convention, (State or National).
(vii) Complete instructions for delivery of equipment and address of
requesting organizations.
(viii) Other pertinent information necessary to insure prompt
delivery.
(d) Responsibilities. The Army or MDW Commander will:
(1) When the availability of personal and real property is
determined, notify the requesting veterans' organization of the
following:
(i) The items and quantities available for loan and the source of
supply.
(ii) No compensation will be required by the Government for the use
of real property.
(iii) No expense will be incurred by the United States Government in
providing equipment and facilities on loan.
(iv) Costs of packaging, packing, transportation and handling from
source of supply to destination and return will be borne by the
requesting organization.
(v) All charges for utilities (gas, water, heat, and electricity)
based on meter readings or such other methods determined will be paid by
the veterans' organization.
(vi) Charges which may accrue from loan of DLA/GSA material in
accordance with paragraph III, AR 700-49/DSAR 4140.27, and GSA Order
4848.7 and Federal Property Management Regulations, subparagraph 101-
27.5.
(vii) The Army will be reimbursed for any material not returned.
(viii) Costs of renovation and repair of items loaned will be borne
by the requesting organization. Renovation and repair will be
accomplished in accordance with agreement between the Army Commander and
the loanee to assure expeditious return of items.
(ix) Transportation costs in connection with the repair and
renovation of property will also be at the expense of the using
organization.
(x) Assure that sufficient guards and such other personnel necessary
to protect, maintain, and operate the equipment will be provided by the
loanee.
(xi) The period of loan is limited to 15 days from date of delivery,
except as provided for in paragraph (c) of this section.
(xii) Any building or barracks loaned will be utilized in place and
will not be moved.
(xiii) Upon termination of use, the veterans' organization will
vacate the premises, remove its own property therefrom, and turn over
all Government property.
(2) Specify a bond in an amount to insure safe return of real and
personal property in the same condition as when borrowed. (In the case
of personal property, this amount will be equal to the total value of
the items based on current acquisition costs.)
(i) An agreement will be executed between the Army Commander and the
Veterans' Organization if the terms of

[[Page 468]]

the loan are acceptable. A sample loan agreement is shown at figure 7-5
of this subchapter.
(ii) When the agreement has been executed and the bond furnished,
requisitions will be submitted to the appropriate source of supply.
Requisitions will indicate shipping destination furnished by the
veterans' organization. Transportation will be by commercial bills of
lading on a collect basis.
(iii) Appoint a Property Book Officer to maintain accountability for
the Government property furnished under this regulation.
(3) Property Book Officer will:
(i) Assume accountability from the document used in transferring
property to the custody of the veterans' organization.
(ii) Perform a joint inventory with the veterans' organization
representative. Survey any shortage or damages disclosed by the joint
inventory in accordance with AR 735-11.
(iii) Maintain liaison with the veterans' organization during the
period of the loan.
(iv) Prepare, in cooperation with the veterans' organization
representative, an inventory of property being returned. Certify all
copies of the receipt document with the veterans' organization
representative.
(v) Insure the return of all property at the expense of loanee to
the supply source or to repair facilities.
(vi) Obtain a copy of receipted shipping document from the
installation receiving the property.
(vii) Determine cost and make demand on the loanee for:
(A) Items lost, destroyed, or damaged.
(B) Costs of repair or renovation. Estimated costs will be obtained
from the accountable activity.
(C) Comply with instructions contained in AR 700-49/DSAR 4140.27 in
the application of condition A and/or B, C, and T items utilized.
(D) Ascertain that items lost in transit are reconciled prior to
assessing charges. Where the loss is attributable to other than the
loanee, charges should not be borne by the borrower.
(viii) Request payment from the loanee. Checks are to be made
payable to the Treasurer of the United States. Upon receipt of payment,
appropriate fiscal accounts will be credited. The Property Transaction
Record will be closed and the Stock Record Accounts audited.
(ix) Deposit collections in accordance with instructions contained
in AR 37-103. In the event payment is not received within a reasonable
period, Report of Survey Action will be initiated in accordance with AR
735-11.
(x) Reimburse DLA/GSA for the cost of any repair, reconditioning
and/or materiel not returned.

Sec. 621.2 Sales of ordnance property to individuals, non-Federal government agencies, institutions, and organizations.

(a) General. This section--
(1) Cites the statutory authority for, and prescribes the methods
and conditions of sale of certain weapons, ammunition, and related items
as specified herein.
(2) Applies to all sales of weapons and related material to
individuals, organizations, and institutions, when authorized by the US
Army Armament Materiel Readiness Command (ARRCOM), and overseas
commanders.
(3) Provides that sales under this section will be limited to
quantities of an item which authorized purchasers can put to their own
use. It is not intended that property be sold under the provisions of
this section for the purpose or resale or other disposition.
(4) Does not apply to sales of property determined to be surplus.
(See AR 755 series.)
(b) Price. Except as noted below, when sales of the Army property
are made and the title thereto passes from the US Government, the prices
charged will be the standard list price contained in the SC 1305/30
Management Data List series, plus cost of packing, crating, and handling
and administrative charges.
(c) Condition of sale. Provisions apply to sales under this section,
as follows:
(1) Sales will be made without expense to the Government.
(i) All costs incident to sales (including packing, crating,
handling, etc.) will be paid in advance by the purchaser.

[[Page 469]]

(ii) All costs incident to shipment (transportation, parcel post
charges, etc.) will also be paid by the customer.
(iii) Payment for items and charges incident to sale will be made
only by cashier's check, certified check, bank money order, or postal
money order made payable to the Treasurer of the United States.
(iv) For other than items of ammunition and ammunition components,
cash will be acceptable when consignee pickup is authorized or purchase
is made in person.
(2) All financial transactions will be accomplished in accordance
with applicable Department of the Army directives and regulations.
Moneys collected for cost of items, as well as packing, crating, and
handling, will be deposited as an appropriate reimbursement as
prescribed in applicable regulations.
(3) Generally, all sales are final and, normally, the US Government
assumes no obligation or responsibility for repair, replacement, or
exchange, except as provided in AR 920-20. Purchasers will be so advised
prior to making the sale. All weapons sold, however, will be safe for
firing.
(4) Weapons sold at standard price will be supplied with equipment.
Weapons sold at less than standard price will be supplied less
equipment.
(5) Sales of specific items may be suspended at any time by the
direction of CDR, ARRCOM.
(d) Purchasing procedure. (1) Except as provided in paragraph (e) of
this section, all requests originating within CONUS for the purchase of
small arms weapons, repair parts, cleaning, preserving, and target
material will be submitted to the Commander, ARRCOM, Rock Island, IL
61201.
(i) Upon approval, these items will be shipped from Army depots
stocking such material, based upon availability of material. Customers
will be furnished instructions for submission of remittance.
(ii) Upon receipt of proper remittance from eligible customers
ARRCOM will issue the necessary documents directing shipment from an
Army depot where the items are available.
(2) In implementing the subchapter, oversea commands should
designate installations within the oversea command to which requests for
purchase of ammunition and related material will be directed.
(3) Depots shipping weapons to individuals, Director of Civilian
Marksmanship (DCM) affiliated rifle and pistol ``clubs'', museums,
veterans organizations, and other US Government agencies will annotate
shipping documents with the serial number of all the weapons they ship.
Firearms shipped will be reported to Commander, ARRCOM, ATTN: DR SAR-
MMD-D, Rock Island, IL 61202, using DA Form 3535 (Weapons Sales Record),
DA Form 3535 may be obtained from Commander, Letterkenny Army Depot,
ATTN: DRXLE-ATD, Chambersburg, PA 17201.
(i) The transportation officer will ascertain estimated
transportation costs, to include DA transportation security measures
(costs) for shipment to destination. Such information will be
transmitted by letter to consignee with request for acknowledgement that
shipment will be accepted based on costs submitted.
(ii) Shipment will not be made unless consignee agrees to accept
shipments. Refusal to accept shipment shall be reported to ARRCOM.
(4) CDR, ARRCOM is responsible for maintaining a record by serial
number of all weapons reported by depot in accordance with paragraph
(d)(3) of this section. He will establish procedures to screen purchase
requests to insure compliance with any limitations established by this
section.
(e) Sales to individuals, organizations, and institutions. (1) Sales
of small arms weapons and ammunition are limited by statute (10 U.S.C.
4308). Such sales will be made in accordance with the provisions of this
paragraph and with other rules and regulations approved by the Secretary
of the Army.
(2) Sales will be limited to M1 service rifles, either national
match grade or service grade. Only one such rifle and spare parts for it
will be sold to an individual. No ammunition will be sold to
individuals.
(3) Junior marksmanship clubs and junior marksmanship division
affiliated within the Director of Civilian Marksmanship (DCM) pursuant
to AR 920-20 may purchase limited quantities of .22 caliber ammunition.

[[Page 470]]

(4) The DCM will determine the maximum quantity of such ammunition
that clubs will be permitted to purchase in each fiscal year.
(5) Approved, non-profit summer camp organizations that are of a
civic nature are allowed to purchase from the DCM at cost plus shipping
and handling charges, 300 rounds of .22 caliber ammunition for each
junior who is participating in a summer camp marksmanship program.
(6) Requests for purchase of ammunition by marksmanship clubs and
summer camp organizations will be submitted to the DCM for approval. If
he approves, the application will be forwarded to ARRCOM for processing.
If it is disapproved, it is returned to applicant with reason(s) stated
for disapproval.
(f) Eligibility of purchasers. In order to purchase a rifle under
this program, an individual must:
(1) Be a member of a marksmanship club affiliated with the DCM (AR
920-20).
(2) Based upon regular competitive shooting, have an established
status as a marksman as determined by the DCM.
(g) Purchase procedure. (1) Individuals desiring to purchase
National Match Grade M1 service rifles will submit requests to the
Director of Civilian Marksmanship, Department of the Army, Washington,
DC 20314-0110. The request should contain the name and address of the
shooting club with which the purchaser is affiliated and appropriate
evidence of status as a competitive marksman.
(2) Upon receipt of a request, the Director of Civilian Marksmanship
will forward to the individual a Certificate for Purchase of Firearms in
the suggested format at figure 5-1 to be completed, notarized and
returned. When returned with check or arrangements for payment, the
Certificate will be referred for appropriate verification in the records
of US Government agencies and for other investigation as required. This
is done to insure that the sale of a weapon to the applicant is not
likely to result in a violation of law. The Privacy Act Statement for
Certificate of Purchase of Firearms (figure 5-2) will be made available
to the individual supplying data on the Certificate for Purchase of
Firearms (suggested format, figure 5-1). Prior to requesting the
individual to supply data on the Certificate for Purchase of Firearms
(suggested format, figure 5-1) the Privacy Act Statement for Certificate
will be made available to the individual concerned. (The Privacy Act
Statement will be reproduced locally on 8 x 10\1/2\ inch paper.)
(i) A purchase application will be denied if the applicant fails to
meet all the conditions required in the Certificate.
(ii) If an application is denied, the applicant will be informed of
the action and will be given an opportunity to submit additional
information justifying approval of the application.
(iii) If the results of the investigation are favorable, the
application will be forwarded to ARRCOM for processing.
(h) Marksmanship clubs affiliated with the DCM and individuals who
are members of those clubs are authorized to purchase from the Army
targets of types not otherwise available from commercial sources.
Request for such purchases will be submitted to the Director of Civilian
Marksmanship for approval and processing. Individuals who have in the
past purchased rifles from the Army under the authority of 10 U.S.C.
4308(a)(5), may purchase spare parts for those rifles if the parts are
available. Requests for purchase of spare parts will be submitted to the
Director of Civilian Marksmanship for approval. If he/she approves the
application, she/he will forward it to ARRCOM for processing. If he/she
disapproves the application, she/he will return it to the applicant
stating the reasons for disapproval. Current DA transportation security
measures for weapons will be applied under procedures contained in
paragraphs (d)(1) (i) and (ii) of this section.
(i) Cadets, US Military Academy. (1) When approved by the CDR
DARCOM, the Superintendent, US Military Academy may sell to cadets upon
graduation from the Academy those sabers which no longer meet prescribed
standards of appearance and/or serviceability.
(2) Application to purchase sabers under these provisions will be
made in

[[Page 471]]

accordance with procedures established by the Superintendent.
(j) Reserve Officer's Training Corps (ROTC) and National Defense
Cadet Corps (NDCC). Supplies required by educational institution for the
training of units and individuals of the Reserve Officer's Training
Corps and National Defense Cadet Corps, in addition to authorized items
normally furnished to ROTC and NDCC schools, may be sold when available
by the activities listed in paragraph (g) of this section (10 U.S.C.
4627). Such purchases will be in accordance with AR 145-2.
(k) Manufacturers and designers. (1) Under the provisions of 10
U.S.C. 4506, the Secretary of the Army is authorized to sell to
contractors or potential contractors such samples, drawings, and
manufacturing and other information as he considers best for national
defense. Procedures for such sale are contained in APP 13-1502.
(2) Under the provisions of 10, U.S.C. 4507, the Secretary of the
Army may sell to designers who are nationals of the United States,
serviceable ordnance and ordnance stores necessary in the development of
designs for the Armed Forces. Designers will submit application to
purchase to the appropriate Commodity Command.
(3) If any item normally requiring demilitarization pursuant to the
Defense Disposal Manual (DoD 4160.21-M) and the AR 755-series is sold, a
special condition of sale will prohibit further disposition by the
purchaser without prior approval of the Deputy Chief of Staff for
Logistics, Department of the Army.
(l) Sales of individual pieces of U.S. armament for sentimental
reasons. Under the provisions of 10 U.S.C. 2574, individual pieces of
U.S. armament, which are not needed for their historical value and can
be advantageously replaced, may be sold at a price not less than cost
when there exists for such sale sentimental reasons adequate in the
judgment of the Secretary of the Army.
(m) Method of sale. (1) Applications to purchase under the
provisions of this act will be submitted to Deputy Chief of Staff for
Logistics, ATTN: DALO-SMS, Department of the Army, with a complete
identification including serial number, and location of desired item, if
known.
(2) Approved applications for major items will be forwarded through
Commander, U.S. Army Materiel Development and Readiness Command, ATTN:
DRCMM-SP, to the Commander, U.S. Army Armament Materiel Readiness
Command.

[44 FR 5651, Jan. 29, 1979, as amended at 54 FR 48097, Nov. 21, 1989]

Sec. 621.3 [Reserved]

Sec. 621.4 Issues, loans, and donations for scouting.

(a) General. This section provides information relative to issue,
loan or donation of Government property to the Boy Scouts of America and
the Girl Scouts of America.
(b) Guidance. (1) Issues are made under the provisions of the loan
agreement and reimbursement is made for adjusted shortages and damages.
(2) Provisions for donations of surplus property to Scout
organizations, including lists of classes of donable property, are
contained in chapter III, part 3, Defense Disposal Manual (DOD
4160.21M).
(3) The loan of certain Army, Navy, Air Force and DLA equipment and
the provision of transportation and other services for Jamborees is
initially provided for by Pub. L. 92-249. Implementation on a current
basis is made in DOD Directive 7420.1. Army implementation is provided
as follows:
(i) Army stock fund in paragraph 2-6b(4), AR 37-111, Working Capital
Fund-Army Stock Fund Uniform Policies, Principles and Procedures
Governing Army Stock Fund Operations.
(ii) Non-stock fund in paragraph 2-18, AR 310-34, Equipment
Authorization Policies and Criteria, and Common Table of Allowances.
(c) Procedure. Loan agreements are mutually developed preceding the
actual lending of the equipment. Paragraph 1-16, AR 735-5, General
Principles, Policies and Basic Procedures, is used as the guide for
preparation of loan agreements. Authority for commanders to participate
in World and National Jamborees is included in paragraph (d) of this
section; Procedure for Loan of Equipment and Providing

[[Page 472]]

of Transportation and Other Services to the Boy Scouts of America for
World and National Jamborees is included in paragraph (j) of this
section; and sample loan agreement to be executed by area commanders is
included as figure 7-5.
(d) World and National Boy Scout Jamborees. The Act of 10 March 1972
(Pub. L. 92-249; 86 Stat. 62) and (86 Stat. 63) authorized the Secretary
of Defense to lend equipment and provide transportation and other
services to the Boy Scouts of America in support of World and National
Jamborees. The Secretary of Defense has delegated his authority and
responsibility for the support of Jamborees to the Secretary of the
Army. The Commander DARCOM ATTN: DRCMM-SP has been assigned to monitor
the program for the Secretary of the Army.
(e) Group travel and visits. Many Scouts and Leaders will travel in
groups and their itinerary will provide for visits to places of interest
in CONUS en route to and from Jamborees. Such group travel may begin in
June and extend into September and October of the Jamboree year. In
keeping with Department of the Army policies, commanders of Army
installations may extend an invitation to and honor requests from Scout
groups enroute to and from the Jamboree to visit and encamp at their
installation.
(f) Commissary and post privileges. Installation commanders are
authorized to provide commissary and post exchange privileges to Scout
groups en route to and from the Jamboree for food items such as bread,
meat, and dairy products. These privileges will be extended only to
Scout groups which are en route to or from the Jamboree and who are
encamped or quartered at the installation or the Jamboree site.
Commissary and post exchange privileges extended to Scout groups while
encamped at the Jamboree site for supply and food items will only be
honored upon-application by officials of the Boy Scouts of America to
supplement supplies and rations not considered adequate for American
Scouts or Scouters.
(g) Arrangements. Regional Scout Executives have been informed by
the National Headquarters of the contents of this subchapter and that
arrangements pursuant to this subchapter must be made in advance
directly with the installation commanders. However, commanders will
consider factors of extenuation or emergency which may preclude advance
arrangements.
(h) Hospitalization. Boy Scouts and Scout Leaders attending
Jamborees are considered designees of the Secretary of the Army for the
purpose of receiving medical care at US Army Medical facilities. The
reciprocal rate will not be charged. Subsistence charges will be at the
rate of $1.80 per day for hospitalized patients, but will not be
collected locally. Each Boy Scout and Leader participating in Jamborees
and hospitalized in Army medical treatment facilities will be reported
to The Surgeon General, ATTN: DASG-SGRE-SSC, Department of the Army,
Washington, DC 20314, on DD Form 7 (Report of Treatment Furnished Pay
Patients; Hospitalization Furnished (part A)). No local collections are
authorized.
(i) Service coordination. (1) The Departments of the Navy and the
Air Force and the Defense Logistics Agency will assist the Department of
the Army in providing necessary equipment, transportation, and services
in support of the Boy Scouts of America attending Jamborees. The
Secretary of the Army or his designee will maintain liaison, as
appropriate, with such agencies to avoid duplication of effort.
(2) Other departments (agencies) of the Federal Government are
authorized under such regulations as may be prescribed by the Secretary
(Administrator) thereof, to provide to the Boy Scouts of America (BSA),
equipment and other services, under the same conditions and restrictions
prescribed for the Secretary of Defense.
(j) Procedure for loan of equipment and providing of transportation
and other services to the Boy Scouts of America for world and national
jamborees. Preliminary actions. (1) In accordance with the provisions of
Pub. L. 92-249, H.R. 11738, 10 March 1972, and Secretary of Defense Memo
of 17 May 1972, Subject: Loan of Equipment and Providing of
Transportation and Other Services to the Boy Scouts of America for Boy
Scout Jamborees; Memo of 23 January 1973, Subject: Military
Transportation Support for Boy Scout Jamborees; and Memo of

[[Page 473]]

19 August 1974, Subject: Military Transportation Support for Boy Scout
Jamborees, the DOD is authorized to lend certain items and provide
transportation and certain other services to such Jamborees. Prior to
the loan of property and providing transportation and other services, an
appropriate agreement will be executed between the United States of
America and the activity to be supported. A bond (fig. 7-6), in an
amount specified by the Commander, DARCOM, based on statute taken by the
Commander-in-Chief/Commander, Major Army Command (MACOM), and held until
termination of the encampment and final settelment is made for each
Jamboree.
(2) The Commander-in-Chief/Commander, MACOM designated, on behalf of
the Commander, DARCOM, representing the Secretary of Defense will enter
into legal arrangements with the Boy Scouts of America for the loan of
equipment and the providing of transportation and certain other services
for Boy Scouts World and National Jamborees. National Jamborees include
Jamborees conducted by and within the United States and also those
conducted by and within foreign nations.
(3) The Commander-in-Chief/Commander, MACOM, will appoint a Property
Book Officer who will maintain separate stock records in order to
provide for a single final billing to the supported activity (Boy Scouts
of America) for items consumed, lost, damaged or destroyed. The
Department of the Army will not be billed for items obtained from other
than Army sources, except medical supply losses. Bills for medical
supply losses will be submitted to the US Army Area Surgeon for payment.
He will establish liaison with the activity to be supported. The
property book account will be established in accordance with section II,
chapter 2, AR 710-2.
(4) The Commander - in - Chief, MACOM, will task the Army Area
Surgeon for Medical Supply Support to the Jamborees. Each Surgeon
designated should appoint an accountable officer and furnish the name,
location, and routing identifier of a project office wherein medical
supply problems can be resolved.
(5) The Property Book Officer is authorized direct communication
with the source of supply, other military department liaison personnel
and DARCOM ICP's to resolve routine supply problems.
(k) Preparing bills of material. (1) The activity (BSA) will submit
a list of equipment and supplies desired to the Commander-in-Chief/
Commander, MACOM. This list will be edited during and subsequent to
preliminary conferences with representatives of the activity and
furnished to Commander, DARCOM, ATTN: DRCMM-SP.
(2) HQ, DARCOM will convert the informal list to a tentative Bill of
Material and will furnish the respective Commodity Command that part of
the Bill of Material for their items of logistical responsibility. A
suggested format for the Bill of Material is included as figure 7-1.
Local reproduction is authorized. Copies of the entire tentative Bill of
Material will also be furnished to each of the military departments
authorized to participate in the support of the encampments. The Bill of
Material forwarded to the Commander-in-Chief / Commander, MACOM will be
screened to determine inhouse availability prior to placing requisitions
on CONUS supply points.
(3) At such time as item availability information is on hand and the
sources to be used are determined (paragraph (m) of this section, a Bill
of Material (figure 7-1) will be prepared by HQ, DARCOM, and forwarded
to the Commander-in-chief/Commander, MACOM.
(4) The Bill of Material will list, by commodity command (military
department), all items desired, identified by National Stock Number
(NSN) description, quantity desired and required delivery date. The NSN
will provide identification of the items required. Items will be
identified by the Property Book Officer to the responsible commodity
command or military department as indicated below:

------------------------------------------------------------------------
(i) CERCOM......................... 1 US Army Communications and
Electronics Materiel Readiness
Command.
(ii) TSARCOM....................... 2 US Army Troop and Aviation
Materiel Readiness Command.
(iii) ARRCOM....................... 3 US Army Armament Materiel
Readiness Command.
(iv) TARCOM........................ 4 U.S. Army Tank-Automotive
Materiel Readiness Command.
(v) DLA............................ 5 Defense Logistics Agency.
(vi) Navy.......................... N Department of the Navy.

[[Page 474]]

(vii) Air Force.................... F Department of the Air Force.
(viii) Other Installations......... A
------------------------------------------------------------------------

The Bill of Material will be screened to insure that radioactive items
restricted for military use are not included.
(l) Establish property transaction records. (1) A Property
Transaction Record reflecting complete information about each item
loaned to the activity will be established and maintained by the
Property Book Officer (figure 7-2) and the respective commodity command
military department (figure 7-3). Suggested formats for the Property
Transaction Records are found in figures 7-2, 7-3, and 7-4, Local
reproduction is authorized.
(2) The Property Book Officer will also establish and maintain
separate Property Transaction Records for items obtained from supply
sources other than Army commodity commands, i.e., other Army
installations, Department of the Navy, Department of the Air Force
(figure 7-4).
(3) Each entry on the Property Transaction Record will be supported
by appropriate documentation (commodity command: copies of shipping
documents, copies of return documents and copies of surveillance
inspection report--Property Book Officer: Requisition voucher files and
hand receipt cards). This is particularly important for reconciliation
purposes in order that all property received from each source will be
returned to that source upon termination of each encampment.
(m) Locating and obtaining equipment and supplies. (1) The
respective commodity commands (military departments) will screen the
tentative Bill of Material (paragraph (k)(2) of this section) and
determine availability and source of supply identified by Routing
Identifier Code. They will advise HQ, DARCOM, ATTN: DRCMM--SP of
availability, appropriate substitute items when the requested items are
not available in sufficient quantity, and the source of supply for
requisitioning purposes.
(2) Concurrently, the Bill of Material will be screened within the
MACOM to determine those items that can be obtained from assets
available in the command.
(3) The Property Book Officer will requisition equipment and
supplies from the source of supply as indicated by Commander, DARCOM in
accordance with AR 725-50 or other separately furnished instructions.
The requisition number, quantity requisitioned, stock number and source
of supply will be entered in the Property Transaction Record.
Requisitions will cite the appropriate project code assigned and
appropriate activity address code on all requisitions submitted. Project
codes will be assigned by Commander, Logistic Systems Support Activity,
ATTN: DRXLS-LCC, Chambersburg, PA, 17201 and distributed by message to
all interested addressees.
(4) Loan of General Services Administration (GSA) General Supply
Fund Material--The Federal Property and Administrative Services Act of
1949, as amended, authorizes the Administrator, GSA to loan GSA General
Supply Fund Material to the Department of Defense and other federal
agencies. Loan shall be made to the extent that items are readily
available and that such loans will not jeopardize the GSA stock
inventory. The loan of GSA General Supply Fund Material shall normally
be limited to 90 Calendar days. Requisitions for GSA material should be
submitted to the nearest GSA Regional Office by the CINC/CDR MACOM.
(5) Formal accountability for all items shipped to the site of the
activity will be retained by the appropriate accountable activity.
Property and financial accounting will be in accordance with respective
military department regulations governing loans.
(6) The shipping depot or other source will furnish a copy of the
shipping document to the respective commodity command (military
department) where the quantity charged, date shipped, condition of the
property and total value will be posted to the Property Transaction
Record.
(7) Upon receipt of the advance copy of the shipping document, the
commodity command (military department) will post information to his
Transaction Record, by source as in paragraph (l)(1) of this section.
(8) When the shipment is received, the Property Book Officer will
inspect

[[Page 475]]

the property. A narrative statement of condition will be prepared if
condition of the property is other than that indicated on the shipping
document and referenced to the condition entry on the Property
Transaction Record. The source of supply, as appropriate, will be
immediately notified of overages or shortages and verified in condition,
as provided in chapter 8, AR 735-11. The Property Book Officer will
enter on the shipping document the quantity actually received when it
differs from quantity shown as shipped and will post the quantities
received to the property book record.
(9) Discrepancies between the quantity shipped by the depot and that
received by the Property Book Officer and variance in condition will be
reconciled as rapidly as possible and appropriate records will be
brought into agreement. When shortage or damage is not attributable to
the carrier, the Property Book Officer will immediately contact the
responsible source of supply, furnishing the stock number and document
number involved, together with an explanation of the discrepancy.
Reconciliation is particularly important in order to ensure a common
point of departure in determining charges to be assessed upon
termination of the activity. Replacement shipments, when required, will
be covered by appropriate shipping documents.
(10) Special Instructions for Defense Logistics Agency, Clothing and
Textile Items. (See DSAR 4140.27/AR 700-49).
(n) Transportation. (1) Transportation of equipment and supplies--
The responsibility of coordinating movement of equipment and supplies
placed on loan to the Boy Scouts of America during National and World
Jamborees is delegated to the Commander, US Army Materiel Development
and Readiness Command, ATTN: DRCMM-ST.
(2) All requisitions for items in question, will cite the
appropriate project code and will be shipped by commercial bill of
lading on a collect basis to all National Jamborees and World Jamborees
held in the United States.
(3) Shipments to Boy Scout contingents at World Jamborees in foreign
countries will be by Government bills of lading, unless otherwise
specified by the Boy Scouts of America.
(4) All shipments directed to Boy Scout Jamborees will be routed by
the most feasible means as determined by the shipper. Shipments will be
consolidated to the maximum extent possible to assure the lowest charges
available to the Boy Scouts of America.
(5) Separate shipping instructions will be provided for each
Jamboree to assure that correct consignee and railhead addresses are
furnished.
(6) Movement of Boy Scouts, Scouters, and officials living in the
United States of America to a Jamboree within the United States of
America or to a Jamboree in an oversea area shall be the responsibility
of the Boy Scouts of America or the individuals concerned.
(7) No authority exists under Pub. L. 92-249 for the movement of Boy
Scouts, Scouters, and officials via military capabilities other than
those of the Military Airlift Command or the Military Sealift Command.
(o) Transportation by vessels of the Military Sealift Command (MSC).
(1) The MSC does not operate any ships suitable for carriage of
passengers on transoceanic routes. Although pertinent directives and
Pub. L. 92-249 authorize the movement of Boy Scouts on Military Vessels,
the MSC has no capability to provide such transportation.
(2) The MSC is an industrial-funded organization and charges the
military service for sealift services provided in accordance with
established rates. The host command will be responsible to compensate
the MSC for any equipment or material moved on MSC ships. The
limitations inherent in Pub. L. 92-249 stipulate that transportation
support provided will be at no cost to the Government. Under these
directions, Boy Scout equipment or materiel is not authorized movement
on a space available basis without prior approval of the Secretary of
Defense. Such approval is not anticipated.
(3) All billings for transportation provided by MSC will be
forwarded to the appropriate Commander-in-Chief/Commander of the support
major Army command (MACOM). Reimbursement will be requested by the MACOM
Commander from the Boy Scouts of America.

[[Page 476]]

(p) Transportation of oversea based scouts, scouters, and other
authorized personnel by military airlift to national or international
jamborees. (1) Space required reimbursable transportation by Military
Airlift Command (MAC) airlift over established MAC channels is
authorized from points outside the Continental United States (OCONUS) to
aerial ports within CONUS, or to other oversea locations and return.
Such transportation will be provided only to the extent that it does not
interfere with the requirements of military operations, and only to
those Boy Scouts, Scouters, and officials residing overseas and
certified by the Boy Scouts of America (BSA) as representing the BSA at
the Jamboree. Certification by the BSA will be in the form of a letter
identifying each such individual as their authorized representative at
the Jamboree. This letter of authorization must be presented to the
sponsoring overseas command.
(2) Boy Scouts, Scouters, officials and their equipment will be
moved after all space-required traffic, but before any space-available
traffic.
(3) Each passenger is authorized the normal accompanying free
baggage allowance of 66 pounds while traveling on MAC aircraft. It is
not contemplated that any excess baggage allowance will be authorized.
(4) Transportation of Boy Scouts, Scouters, officials, and their
equipment provided by MAC controlled aircraft will be reimbursed at the
common user tariff rates assessed U.S. Government Traffic, as contained
in AFR 76-11.
(5) On the basis of letters of authorization issued by the BSA, the
BSA will monitor services provided by the Department of Defense. One
copy of each BSA letter of authorization will be forwarded to the
Commander, US Army Materiel Development and Readiness Command, ATTN:
DRCMM-SP, 5001 Eisenhower Avenue, Alexandria, VA 22333, for planning
purposes. This letter of authorization should specify whether one way or
round trip transportation is requested.
(6) DACROM responsibilities include the following:
(i) Compiling a passenger forecast to be submitted to MAC in
accordance with AR 59-8/OPNAVINST 4630.18C/AFR 76-38/MCO 4630.6B.
(ii) Providing Military Traffic Management Command (MTMC) an
information copy of the passenger forecast.
(iii) Submitting all passenger requirements for one way and round
trip transportation originating overseas to the appropriate overseas
command.
(7) The responsibilities of the sponsoring overseas command include:
(i) Verifying that Scout passengers are officially authorized
representatives of BSA in accordance with paragraph (p)(1) of this
section.
(ii) Making all necessary passenger reservations with MAC, for
transportation originating overseas, in accordance with AR 55-6/AFR 76-
5/OPNAVINST 4630.23/MCO P4630.11. The oversea command will submit CONUS
outbound return passenger requirements to Commander, Military Traffic
Management Command, ATTN: MTMC-PTO-P, Washington, DC 20315.
(iii) Issuing each passenger a MAC Transportation Authorization (DD
Form 1482) for transportation from the overseas location and return,
when round trip transportation has been requested. The customer
identification code, item (7) of the DD Form 1482, should be designated-
-JBWJ--which was approved by MAC as the permanent CIC for direct billing
purposes to HQ, Boy Scouts of America, North Brunswick, New Jersey,
08902.
(iv) Ensuring that each Scout passenger has a completed DD Form
1381, signed by a parent, guardian or other legally responsible
individual.
(v) Evaluating the use and necessity of military airlift within or
between overseas locations. This evaluation will include such factors as
reasonable travel time, number of connections required, and assurance of
Scout group integrity. Surface transportation will normally be used for
travel within an overseas area.
(8) The responsibilities of the MTMC include:
(i) Evaluating the return outbound passenger requirements and making
the necessary transportation arrangements so as to maintain Scout group
integrity at all times.
(ii) Assisting the BSA in completing required documentation and
insuring

[[Page 477]]

that passengers are ready prior to the return flight.
(iii) Pub. L. 92-249 does not provide authorization for the use of
the Department of Defense transportation by Scouts, Scouters, and
Officials of foreign nations. All requests to transport such persons
should be forwarded through the unified command channels to the Office
of the Assistant Secretary of Defense (Public Affairs). However, DOD
does not contemplate authorization for the use of MAC aircraft for other
than U.S. Scouts, Scouters, and Officials.
(iv) Use of military helicopters in support of medical evacuation,
VIP, press and photo-services--The Director of Army Aviation, the
Department of the Army Staff Judge Advocate, and the Comptroller of the
Army have furnished the general opinion that Pub. L. 92-249 authorizes
the use of Military helicopters in support of the above described
services to the extent they are reasonably available and permits the use
of appropriated funds.
(q) Determination of charges and settlement. (1) All property on
which repair cost is claimed will be held at the depot or post, camp or
station until final charges are determined and a release is given by
CDR, DARCOM, Department of the Army.
(2) The commodity command (military department) will prepare the
following information and statement, and forward them, to CDR, DARCOM,
Department of the Army, for final review:
(i) Complete Property Transaction Record and supporting documents.
(ii) Proper accounts for which reimbursement received for shortages
and repairs are to be deposited.
(iii) The following statement: ``The losses and/or damages indicated
on the Property Transaction Report in the amount of $------ represent
the total claim by (appropriate commodity command or military
department) relative to commodity command or military deparment property
loaned to (Boy Scouts of America). Upon settlement and deposit to the
proper account, the CDR of the commodity command or military department
releases the (Boy Scouts of America) from further obligations.''
(iv) Statements as to the general type of repair (e.g., tentage,
repair tears, insert new panels, replace grommets) will be reported on
separate addendum to the Property Transaction Record for items requiring
repair.
(3) The CINC/CDR, MACOM, will prepare the following information and
statement for property furnished for assets in the command and will
forward this to CDR, DARCOM:
(i) Same as (q)(2)(i) of this section.
(ii) Same as (q)(2)(ii) of this section.
(iii) The following statement: The losses and/or damages indicated
on the Property Transaction Record in the amount of $------ represent
the total claim by (appropriate Army) relative to (appropriate Army)
property loaned to (Boy Scouts of America). Upon settlement and deposit
to the proper account, the CINC/CDR, MACOM releases the (Boy Scouts of
America) from further obligations.
(iv) Same as (q)(2)(iv) of this section.
(4) CDR, DARCOM, will review the charges, inspect property to be
repaired, if necessary, reconcile any discrepancies and determine final
charges to be levied against the supported activity. Approved list of
charges will be forwarded to the CINC/CDR, MACOM, for collection, and
property being held for repair will be released.
(5) The CINC/CDR, MACOM, will prepare and dispatch a letter to the
supporting activity and request payment made payable to the Treasurer of
the United States. Upon receipt of payment, collection documents will be
prepared and appropriate fiscal accounts, as furnished by the commodity
command (military departments) ((q)(2) and (3) of this section)
credited. The MACOM Surgeon will take action to reimburse the DLA stock
fund for expendable medical supply losses reported. The CINC/CDR, MACOM,
will close the Property Transaction Record Account.
(6) The CINC/CDR, MACOM, will advise the CDR, commodity command
(military departments and CDR, DARCOM, DA) that settlement has been
accomplished. Commodity command (military department) Property
Transaction Records will be closed upon receipt of the foregoing advice.

[[Page 478]]

(7) The CDR, DARCOM will advise the CINC/CDR, MACOM, to return the
bond to Boy Scouts of America.
(8) In the event of unsatisfactory settlement, the proceeds of the
bond will be used to satisy the claim. The Power of Attorney executed in
connection with the agreement will be invoked and proceeds collected
from the bond (fig. 7-7).

PART 623--LOAN OF ARMY MATERIEL--Table of Contents

Sec.
623.1 General.
623.2 Loan policies.
623.3 Submission of requests for loan of Army materiel.
623.4 Accounting procedures.
623.5 Loan of arms and accouterments.
623.6 Reimbursement for loan of Army materiel.
623.7 Reports.

Appendix A to Part 623--Explanation of Terms
Appendix B to to Part 623--Approving Authority Addresses/Telephone
Numbers
Appendix C to Part 623--Agreement for Loan of US Army Materiel (DA Form
4881-R)
Appendix D to Part 623--Certificate for Signature by an Alternate (DA
Form 4881-1-R)
Appendix E to Part 623--Surety Bond (DA Form 4881-3-R)
Appendix F to Part 623--Power of Attorney (DA Form 4881-4-R)
Appendix G to Part 623--Continental US Army Boundaries
Appendix H to Part 623--References

Authority: 10 U.S.C. 2571; 31 U.S.C. 686; 10 U.S.C. 2667.

Source: AR 700-131, 45 FR 62038, Sept. 18, 1980, unless otherwise
noted.

Sec. 623.1 General.

(a) Purpose. This part sets forth policies and procedures for loan
of Army materiel. As used in this regulation, the term ``loan'' includes
a lease.
(b) Applicability. (1) This regulation applies to all Department of
the Army (DA) agencies, commands, installations, and activities.
(2) This regulation applies to the Army National Guard (ARNG) only
when the procedure for the loan of equipment under the procedure of
National Guard Regulation (NGR) 735-12 does not apply.
(3) This regulation does not apply to loans governed by the DOD
Military Assistance and Sales Manual, DOD 5105.38-M.
(4) This regulation does not apply to loans governed by the Defense
Acquisition Regulation (DAR).
(c) Scope. This part outlines when loans of Army materiel may be
made. It gives general procedures for requesting and processing loans,
and sets forth responsibilities, including requirements for
reimbursement.
(d) Explanation of terms. (1) The terms ``loan,'' ``lease'' and
``bailment'' are contractual terms and are frequently used
interchangeably. They have no meaning by themselves. It is necessary to
study the statute to see what is required. Usually, a ``loan'' is
thought of as a short-term transfer of property, sometimes with
reimbursement; a ``lease'' is a more formal transfer, often long-term
and requiring a fair monetary rental; and a ``bailment'' is a loosely-
used term, generally reserved for a delivery of property to another in
trust for the purpose of doing something to the property and then
returning the property to the owner. The term ``issue'' is frequently
used in the sense of a transfer of property which will be consumed in
use. The terms ``gift,'' meaning a permanent transfer of property
without reimbursement, and ``sale,'' meaning a permanent transfer with
reimbursement, are outside the scope of this regulation.
(2) For additional definitions, see appendix A.
(3) The words ``he, him, his'' when used in this publication
represent both the masculine and feminine genders, unless otherwise
specifically stated.
(e) Loan restrictions. (1) Army materiel is not normally used for
other than the Army's primary mission; however, under conditions
described herein materiel not immediately needed to support mission
requirements may be loaned to--
(i) Army and other Department of Defense (DOD) elements.
(ii) Non-DOD Federal departments and agencies.
(iii) Civil governments (State and local).
(iv) Special activities, agencies, and others.

[[Page 479]]

(2) Table 2-1 lists various circumstances where loan of Army
materiel might be requested. It identifies the applicable Federal laws
or other authority which would authorize such loans.
(f) Statutory authorities. There are three basic federal laws which
authorize the loan of Army property. There are also numerous specific
statutes which authorize particular types of loans in limited
situations. Unless there is a reason to use the specific statute, one of
the basic statutes will be used.
(1) The following are the basic statutes:
(i) 10 U.S.C. 2571--Authority for loan of property within DOD.
(ii) 31 U.S.C. 686 (The Economy Act)--Authority for loans to other
Federal departments and agencies.
(iii) 10 U.S.C. 2667 (The Leasing Statute)--Authority for loans/
leases, including leases to activities outside the Federal Government.
(2) Following are some of the specific authorizing statutes:
(i) 10 U.S.C. 331--Federal aid for State governments as result of
insurrection.
(ii) 10 U.S.C. 332--Use of militia and Armed Forces to enforce
federal authority.
(iii) 10 U.S.C. 333--Use of militia or Armed Forces to suppress
interference with state and federal law.
(iv) 10 U.S.C. 2541--Loan of equipment and barracks to national
veterans organizations.
(v) 10 U.S.C. 2542--Loan of equipment to the American National Red
Cross for instruction and practice.
(vi) 10 U.S.C. 2543--Loan of equipment to US Presidential Inaugural
Committee.
(vii) 10 U.S.C. 2544--Loan of equipment and services to the Boy
Scouts of America, for national and world jamborees.
(viii) 10 U.S.C. 2572--(See AR 870-20.) Loan of books, manuscripts,
works of art, drawings, plans, models, and condemned or obsolete combat
materiel not needed to--
(A) A municipal corporation.
(B) A soldiers monument association.
(C) A state museum.
(D) A nonprofit incorporated museum.
(E) Posts of Veterans of Foreign Wars of the USA.
(F) American Legion Posts.
(G) A local unit of any other recognized war veterans association.
(H) A post of the Sons of Veterans Reserve.
(ix) 10 U.S.C. 4308--Establishment and support of civilian rifle
ranges.
(x) 10 U.S.C. 4311--Issue of rifles and ammunition for conducting
rifle instruction and practice.
(xi) 10 U.S.C. 4651--Issue of arms, tentage, and equipment to
support educational institutions that do not have ROTC but maintain a
course in military training prescribed by the Secretary of the Army.
(xii) 10 U.S.C. 4652--Loan of rifles and issue ammunition for target
practice to educational institutions having corps of cadets.
(xiii) 10 U.S.C. 4653--Issue of ordnance and ordnance stores to
District of Columbia high schools.
(xiv) 10 U.S.C. 4654--Issue of quartermaster supplies at educational
institutions that maintain a camp for military instruction of its
students.
(xv) 10 U.S.C. 4655--Loan of arms and issue ammunition to other
agencies and departments of the US Government.
(xvi) 10 U.S.C. 4656--Loan of aircraft and ancillary equipment to
accredited aviation schools at which DA or Air Force personnel pursue
courses of instruction.
(xvii) 10 U.S.C. 4683--Loan of obsolete or condemned rifles and
accouterments to local units of recognized national veterans
organizations for certain ceremonial purposes.
(xviii) 10 U.S.C. 4685--Loan of obsolete ordnance to educational
institutions and state soldiers and sailors orphans' homes for purpose
of drill and instruction.
(xix) 32 U.S.C. 702--Issue of supplies to State National Guard.
(xx) 33 U.S.C. 701n (Pub. L. 84-99 as amended)--Flood emergency
preparation; emergency supplies of drinking water.
(xxi) 33 U.S.C. 1251 et seq (Pub. L. 92-500)--Federal Water
Pollution Control Act.

[[Page 480]]

(xxii) 42 U.S.C. 5121 et seq (Pub. L. 93-288)--Disaster Relief Act.
(3) Other statutory guidance:
(i) 10 U.S.C. 4307--Authorizes the establishment of a Director of
Civilian Markmanship (DCM).
(ii) 18 U.S.C. 1385--Unlawful use of Armed Forces in local law
enforcement.
(iii) 18 U.S.C. 3056 (as amended by Pub. L. 91-651)--Powers and
duties of Secret Service.
(g) Responsibilities. (1) The Commanding General (CG), US Army
Materiel Development and Readiness Command (DARCOM), through the
Materiel Readiness Commands' (MRC) commanders, is responsible for loans
of materiel controlled by DARCOM wholesale supply points.
(2) Major Army commands (MACOM) CGs and commanders in chief (CINCs)
of unified commands (UCOMs) are responsible for loans of materiel from
supporting units and installations.
(3) The Director of Military Support, Office of the Deputy Chief of
Staff for Operations (ODCSOPS), is the DOD point of contact for the
Federal Disaster Assistance Administration (FDAA), other Federal
agencies, and the National Red Cross in disaster assistance matters.

Sec. 623.2 Loan policies.

(a) Loan and approval policy--(1) Basic policies. (i) Materiel is
not loaned to non-DOD activities as a routine procedure. However,
materiel in the Army inventory is available for loan for special
purposes if approved. Approving authorities are listed in table 2-1;
their addresses are in appendix B.
(ii) Loans will be approved or disapproved based on the purpose,
duration of the loan, and consideration of the following factors which
can take precedence over any loan.
(A) Military requirements and priorities.
(B) Continuity of military operations, troop survival, and the
rehabilitation of essential military bases.
(C) Stocks and programed Army requirements. This includes
prepositioned mobilization reserve stocks.
(D) Type classification with pending changes.
(E) Minimum diversion of Army stocks.
(F) The adequacy of the borrower's resources. Requesters will be
encouraged to use their own resources.
(iii) Loan requests from civilian authorities or activities will
normally enter Army channels at the installation or MACOM levels. If on-
post or off-post units receive loan requests, they will refer them to
unit's supporting installation commander at once. Emergency loan
requests will be relayed by telephone or electrically transmitted
message.
(iv) When routine handling of a loan request would result in loss of
human life, grave bodily harm, or major destruction of property, and
when the lack of communication facilities prevents use of normal
procedures, loans otherwise permitted by this regulation can be made
with local approval. However, normal policy should be followed to the
extent possible. If procedural requirements cannot be fully complied
with, they must be met as soon as possible after the loan is made.
(v) Army materiel loaned under this part will be delivered to
borrower ``as is, where is'' available.
(vi) Stocks of the least serviceable condition which are still
suitable for the loan's purpose will be used. Logistic control code
``C'' materiel will be loaned before logistic control code ``B''
materiel. Logistic control code ``B'' materiel will be loaned before
logistic control code ``A'' materiel. (Ref chap 9, AR 708-1.)
(vii) Commanders of medical treatment facilities (MTF) are subject
to all the requirements of this regulation, including the requirement
for reimbursement. However, in accordance with AR 360-61 which
implements DOD Instruction 5410.19,
(A) Emergency loans of medical supplies (drugs, vaccines, etc.) may
not be made without reimbursement, but the loan may not exceed 30 days
and the medical supplies must be replaced in kind by the borrowing
agency or activity; and
(B) Emergency loans of medical equipment not to exceed 15 days may
be made without reimbursement if it is the practice in the community for
other hospitals to make such loans.

[[Page 481]]

Equipment loans which exceed 15 days must be approved, in writing, by
the MACOM commander and are subject to all the requirements of 10 U.S.C.
2667, including reimbursement.
(viii) Army property loaned to non-DOD activities will not be
further loaned without approval of the original approving authority.
(ix) There will be no procurement or redistribution of assets to
offset the effects of loans. Material will not be set aside, earmarked,
assembled, or stockpiled to be available for use related to loans.
(x) Army materiel may be recalled from the borrower at any time to
meet Army requirements.
(xi) Stock record accounting and financial transactions for loans
will conform with existing regulations.
(xii) Borrowers are responsible for the care, custody, and proper
use of materiel borrowed. Except as stated in this regulation,
reimbursement will be required for damage, destruction, loss, fair
depreciation in value, and for any Army repair, care, transportation,
preservation, and protection of loaned equipment.
(xiii) Care, renovation, and repair of borrowed materiel will
conform with the loan agreement.
(xiv) As indicated below, borrowers must provide signed loan
agreements, provide surety bonds, and vehicular insurance prior to
receipt of materiel. Loan agreements and bonds will be prepared in
accordance with paragraphs (b) and (c) of this section.

------------------------------------------------------------------------
Loan Vehicular
Borrower agreement Surety bond insurance
required required required
------------------------------------------------------------------------
Army or other DOD activities.. No \1\...... No.......... No.
Non-DOD Federal departments Yes......... No.......... No.
and Agencies.
Civil Authorities (State and Yes......... Yes \2\..... Yes.\2\
Local Governments).
Civilian Activities (veterans' Yes......... Yes......... Yes.
organizations, youth groups,
etc.).
------------------------------------------------------------------------
\1\ A hand receipt or other document assigning responsibility will
suffice.
\2\ In emergency disaster relief cases, bonds and insurance may be
provided after receipt of the materiel. (See paragraph (a)(4) of this
section.)

(2) Loans to DOD organizations. Army materiel may be loaned to DOD
activities for projects, programs, and mission requirements that support
basic functions of the borrowing activity. Examples are field exercises,
maneuvers, training exercises, including annual training (AT) of Reserve
Components, and research development, test, and evaluation (RDTE).
(i) Loans of major end items belonging to MACOMs are approved by
MACOM or UCOM commanders. Loans of materiel other than major end items
are approved at commander/installation level.
(ii) Loans of materiel belonging to DARCOM (wholesale level) are
approved as follows:
(A) Materiels other than major end items. By the director or deputy
director of an MRC.
(B) All other items. By HQ DARCOM or commanders of MRCs unless loan
would interfere with issue against DA Master Priority List (DAMPL)
priorities, then by HQDA ODCSLOG (DALO-SMD).
(3) Loans to federal departments/agencies. Loans to Federal
activities outside the DOD are usually provided under provisions of the
Economy Act, 31 U.S.C. 686. Federal agencies borrowing DOD materiel
using the provisions of this act are responsible for reimbursing the DOD
for all DOD costs incident to the delivery, return, and repair of the
materiel. The borrower is also responsible for reimbursing the DOD for
depreciation if the depreciation cost is significant.
(4) Disaster relief.
(i) CONUS/OCONUS.
(A) In disaster situations local civil authorities must provide
relief from their own resources. If this is not sufficient, and the
American National Red Cross has a team at the disaster, requests for
further assistance should be made to them. If the President has declared
a major disaster or emergency, requests should be made to the regional
director of the Federal Disaster Assistance Administration (FDAA). (See
AR 500-60 for guidance.)
(B) The commanding General, US Army Forces Command (FORSCOM), acting
for the Secretary of the Army (SA), is responsible for Army materiel
support of disaster relief operations

[[Page 482]]

within the United States and the District of Columbia. UCOMs are
responsible for disaster relief operations in US possessions and trust
territories. These commanders are authorized to task DOD agencies and
commands, consistent with defense priorities, to provide materiel in
support of operations. A military representative will be appointed by
the appropriate command to act as the DOD point of contact with the
Housing and Urban Development (HUD) Federal Coordinating Officer (FCO)
when military assistance is required during a Presidential declared
disaster or emergency. When a disaster or emergency is of such
magnitude, the disaster area may be geographically subdivided. A
military representative will then be appointed for each FCO. All
requests for military assistance will be passed through the FCO to the
DOD military representative at the disaster area.
(C) The Director of Military Support (ODCSOPS), HQDA, acts at the
DOD point of contact for the Administrator, FDAA, other Federal
agencies, and the American National Red Cross in all disaster assistance
matters.
(ii) Foreign. (A) The Department of State is responsible for
deciding when emergency foreign disaster relief operations will be
undertaken. This authority is delegated to Chiefs of Diplomatic Missions
for disaster relief operations whose total costs will not exceed
$25,000.
(B) Send queries on foreign disaster relief to HQDA (DAMO-ODS) (para
4, app B).
(5) Civil disturbances. The maintenance of law and order is
primarily the responsibility of local and state authorities. In civil
disturbance situations, a basic goal of the Federal Government is to
minimize the involvement of active military forces. One of the most
effective means of keeping Federal forces off the streets is to loan US
Army civil disturbance type equipment to Federal, State, and local law
enforcement agencies and also to the National Guard. (For specific
guidance see AR 500-50.)
(i) Requests for loan of Army materiel during or for expected civil
disturbances are of three types with approval authority as follows:
(A) Group one. Arms, ammunition, tank-automotive equipment, and
aircraft. Loans will be approved by the SA or his designee.
(B) Group two. Riot control agents, concertina wire, and similar
military equipment which is not included in group one. Loans will be
approved by the SA (or his designee), or by an Army task force commander
employed at an objective are during a civil disturbance.
(C) Group three. Protective equipment such as masks and helmets;
body armor vests; other equipment not included in group one or two such
as clothing, communications equipment, and searchlights; and the use of
DOD facilities. Such loans will be approved by the SA (or his designee);
by MACOMs; by the CGs of CONUS armies, MDW, and by commanders of UCOMs
outside CONUS as applicable. (NOTE: Firefighting equipment will not be
used for riot control).
(ii) Queries concerning loans in support of civil disturbances will
be forwarded to the Director of Military Support, HQDA(DAMO-ODS), WASH
DC 20310. (See app B.)
(6) Terrorism. (i) The Department of the Army is the DOD Executive
Agent for support to the FBI in combating terrorism. Existing civil
disturbance loan procedures, including categories of equipment, apply to
equipment loans to the FBI for combating terrorism. Military resources
will be provided only upon request of the Director, FBI, or the Senior
FBI official present at the scene of a terrorist incident. It may be
difficult in some situations to determine whether a practical incident
fits the definition of terrrorism. In these cases, commanders are
authorized to accept the judgment of the FBI official making the request
if it is supported by the available facts. (See para 3, table 2-1.)
(ii) For requests from the FBI in connection with terrorist
incidents, any commander in the chain of command down to and including
commanders of military installations are authorized to approve loans of
group two and group three resources. (See paragraphs (a)(4)(1) (B) and
(C) of this section.) Requests for equipment which involve

[[Page 483]]

technical/operating personnel, excluding fire-fighting equipment and
explosive ordnance disposal, will be processed as a group one resource.
For example, approval authority is retained by the DOD Executive Agent.
(7) Aircraft piracy. Assistance to other federal agencies in the
protection of airways is provided through loans under guidance in
paragraph 3, table 2-1. Specific limitations on such support are covered
in AR 500-1.
(8) Loan/lease to activities outside the Federal Government. Title
10, U.S.C. 2667, authorizes the lease of Army materiel to non-DOD
departments, agencies, activities, or individuals when it is determined
that the materiel is not, for the period of the lease, needed for public
use, is not excess property, and that the loan will promote the national
defense or be in the public interest, (See AR 360-61.) Such a lease must
not be for more than 1 year (or be renewed/extended for a total period
of more than 5 years); it must provide that the lessee will pay a fair
monetary rental. The fair monetary rental will be determined on the
basis of prevailing commercial rates or computed according to sound
commercial accounting practices for the fixing of rental on such
property. This will include a return on capital investment and
administrative cost as well as depreciation. The delegation of authority
to lease is SAOSA-71-6, paragraph 1-5103, ADARS, the prescribed lease
agreement is at paragraph 16-553, ADARS.
(b) Loan agreements. (1) Upon approval of a loan request and before
shipment or issue of the materiel, the approving authority will complete
a written loan agreement, DA Form 4881-R. In all cases, the statutory
basis for the loan will be cited. The approving authority is acting for
the DOD on loans to other Federal agencies, and for the United States on
loans to civil authorities and special activities. The agreement will be
signed by the approving authority and the borrowing activity. When
emergency loans have been made as authorized by this AR, follow-up
action will be taken at once to formalize the loan by completing a loan
agreement.
(2) Loan agreements are mutually developed by the approving
authority and the chief of the borrowing activity (or their designees).
The agreements identify the responsibilities of all parties. They
include terms and conditions of the loan. Appendix C illustrates a
sample loan agreement, DA Form 4881-R (Agreement for the Loan of US Army
Materiel), and specifies what the loan agreements will stipulate and
contain. Also illustrated at appendix C is DA Form 4881-2-R, which will
be completed and appended to the loan agreement as ``Exhibit I.''
(3) Loan agreements will be held by the approving authority until
termination and final settlement of each loan.
(4) If the loan agreement is signed by someone other than the chief
borrowing official, than a Certificate for Signature by an Alternate
will be completed. (See appendix D for DA Form 4881-1-R.) It will be
attached to the signed (by the borrower) copy of the agreement that is
retained by the approving authority. DA Forms 4881-R, 4881-1-R, and
4881-2-R are reproduced locally on 8\1/2\ by 11-inch paper.
(c) Surety bonds. (1) Some borrowers of Army materiel must post a
surety bond. (See table 2-1 and DA Form 4881-3-R at app E.) Bonds ensure
safe return of the borrowed materiel or reimbursement for any loss of or
damage to the materiel. The bond will consist of --
(i) A properly executed surety bond with a certified bank check,
cash, or negotiable US Treasury bonds, or
(ii) Notice of bond by a reputable bonding company deposited with
the approving authority for the loan. Bonds will equal the total price
of the borrowed items as shown in exhibit I to the loan agreement (app
C, DA Form 4881-R). A ``double'' bond (bond equal to twice the value of
the borrowed item(s)) will be required--
(A) For Army materiel loaned to the Red Cross for instruction and
practice to aid the Army, Navy, or Air Force in time of war (10 U.S.C.
2542).
(B) For ordnance and ordnance stores loaned to high schools in the
District of Columbia (10 U.S.C. 4653).
(2) The bond need not be posted by the borrowing agency itself. The
source or originating agency for the bond is immaterial if the bond is
valid. For example, to secure a loan, a State may

[[Page 484]]

post bond on behalf of a city, county, or other governmental body or
authority within the State.
(3) In an emergency, when posting a bond would delay approval of an
urgent loan request and when the total price is less than $1,000, the
approval authority may approve the request. The approval is on the
condition that the bond be posted within 5 days.
(4) Bond forfeitures or exceptions to mandatory forfeitures can only
be made with the concurrence of the Secretary of the Army. Forfeitures
will be based on actual expense incurred. Forfeitures do not release the
borrowing agency from returning borrowed materiel or affect ownership.
Bonds are normally forfeited under the following conditions:
(i) Materiel is not returned at the termination of a loan period or
when return has been directed by the Army.
(ii) The borrowing agent refuses to pay for damages or other Army
expenses.
(5) Surety bonds will be held by the approving authority until the
loan is terminated and final settlement is made. At that time, the bond
will be returned to the borrower.
(6) If US treasury bonds are posted as surety bond, the borrower
must execute a power of attorney (DA Form 4481-4-R, app F). This will
enable cashing of the treasury bonds if some forfeiture is required. DA
Form 4881-3-R (Surety Bond) and DA Form 4881-4-R (Power of Attorney)
will be reproduced locally on 8\1/2\ by 11-inch paper.
(d) Loan duration. (1) Loan periods and extensions will be shown in
table 2-2.
(2) Materiel will be loaned only for the number of days needed for
the specific purpose for which borrowed. Loan extensions must be
justified. The reason(s) why other means or other than Army materiel
cannot be used must be included. Approval of loan extensions will be
based on the merit of the reasons given.
(3) Loan extensions authorized beyond 1 year will not be approved
unless the lender of the loaned materiel has inspected and inventoried
the materiel to insure completeness and serviceability.
(e) Types of DA materiel available for loan. Examples of types of
items that may be loaned, and examples of the types of organizations
that may borrow Army materiel, are listed in table 2-1. Most loans will
be nonexpendable items or expendable items not forecast to be consumed
(durable items). Expendable items (e.g., expendability code X) will not
be loaned unless approved as an exception.

[[Page 485]]

Table 2-1--Loan Authority and Purpose
[See footnotes at end of table]
----------------------------------------------------------------------------------------------------------------
Examples of materiel
Requester Authority and guidance Normal approving authority authorized
----------------------------------------------------------------------------------------------------------------
1. DOD Activities........... 10 U.S.C. 2571.......... Secretary of the Army (or Materiel, supplies, and
designee). equipment.
2. Department of Agriculture 31 U.S.C. 686; Memo of Secretary of the Army (or Communications,
(U.S. Forest Service) Understanding (MOU), designee). earthmoving, and
protection against wildfire Apr. 24, 1975; AR 500- vehicular equipment.
\2\ (see AR 500-60 for 60.
guidance) \3\.
Avalanche Control \3\... 10 U.S.C. 4655; 31 Secretary of the Army (or Communications,
U.S.C. 686; AR 735-5; designee). howitzers, etc.
MOU Nov. 29, 1973.
3. Department of Justice 10 U.S.C. 331; 10 U.S.C. .............................. Transport aircraft,\1\
(FBI). 332; 10 U.S.C. 333. helicopters, flares,
parachutes,
communications
equipment, arms,
vehicles, etc.
Aircraft Piracy \1\ (see 10 U.S.C. 4655; 18 DOD General Counsel \1\ or
AR 500-1 for guidance). U.S.C. 1385; 31 U.S.C. designee; in urgent cases,
686; DODD 3025.12; AR Deputy Director for
500-1. Operations, NMCC.
Terrorism \2\............. AR 500-50............... See item 7 below for \2\ See item 8 below for \2\
approval authority by classification
equipment classification. equipment.
Drug Enforcement Agency 31 U.S.C. 686; AR 735-5, Asst SECDEF (or designee)..... Same as above.
\1\. par. 1-16; CSR 1-25.
4. Treasury Department (U.S. 18 U.S.C. 3056; 31 Asst SECDEF (or designee); Mil Same as above.
Custom Service) (U.S. U.S.C. 686; AR 735-5, Asst to the President;
Secret Service) \1\. par. 1-16; DODD followed by the Spec Asst to
3025.13; DODI 5030.34; the SECDEF; (overseas) CINC,
AR 1-4. UCOM's.
5. National Guard Equipment AR 735-5; 10 U.S.C. 2571 Secretary of the Army HQDA; CG Material, supplies, and
(loan to NG). FORSCOM; DARCOM. equipment.
6. Other Federal agencies 31 U.S.C. 686; AR 735-5; Spec Asst SECDEF; Secretary of Material, supplies, and
emergency support \1\ to AR 1-35; AR 500-60; the Army. equipment for flood
Federal agencies (see AR 1- DODD 4000.19. fighting, rescue
35 and AR 500-60 for operations, repair/
guidance). restoration of flood
control works, or
hurricane flood
protection works.
Support to FPA/GSA AR 15-17; DODD 5100.74; HQDA; CG FORSCOM; CG CONUSA... Transportation,
Regional Field Boards \2\ OEP Civ 8500.6. emergency power and
(see AR 15-17 for fuel.
guidance).
Support to Inaugural 10 U.S.C. 2543.......... SECDEF........................ Tents, flags, litters,
Committee. ambulances, drivers,
hospital furniture,
camp appliances.
7. Support for Search and AR 500-2; FM 20-150; AR CG FORSCOM; GC CONUSA......... Search craft and crews.
Rescue. 525-90.

[[Page 486]]

8. Civil Authorities Civil 42 U.S.C. 5121 et seq.; Group One: DOD Executive Agent Group One: Arms,
Disturbance \2\ (see AR 500- 10 U.S.C. 331; DODD or designee. ammunition, tank-
50 for guidance). 3025.12; AR 500-50; AR automotive equipment,
350-7; DACD Plan; and aircraft.
Garden Plot.
Group Two: DOD Executive Agent Group Two: Riot control
or designee, or task force agents, concertina
command at objective area wire, and other like
during the civil disturbance. military equipment to
be employed in control
of civil disturbances.
...................... Group Three: DOD Executive Group Three:
Agent or designee; CG MDW; CG Firefighting resources,
CONUSA; and CINC's UCOM's, equipment of a
OCONUS. protective nature
(masks, helmets, body
armor vests) and use of
Army facilities.
Disaster Relief \2\....... 42 U.S.C. 5121 et seq.; CG FORSCOM; CG DARCOM for Same as 6 above.
DODD 3025.1; AR 500-60 DARCOM stocks; and CINC's,
and AR 930-5; DODD UCOM's, OCONUS.
5100.46.
Civil Defense............. DODD 3025.10; AR 500-70. CG FORSCOM.................... Personnel, facilities,
equipment, supplies,
and services.
American National Red MOU between DOD and HQDA; The Adjutant General Personnel, equipment,
Cross for support of Army ANRC, June 24, 1975. (DAAG-ASO-R). office space,
units in support of local equipment, supplies;
civil government disaster and custodial, utility,
relief. maintenance, and
communication services.
9. Environmental Protection 33 U.S.C. 1251 et seq.; Same as disaster relief....... Personnel, facilities,
Agency and U.S. Coast Guard DODD 5030-41; AR 500-60. supplies, equipment,
(oil and hazardous and transportation.
substances pollution
spills).
10. Boy and Girl Scouts of 10 U.S.C. 2544; AR 725- MACOM CG on behalf of CG Bedding, cots, chairs,
America (world or national 1, ch. 7. DARCOM. vehicles, buildings,
jamborees) \3\. etc.
11. Civilian Marksmanship 10 U.S.C. 4308, 4311, Secretary of the Army (or Arms and accouterments.
Program (Clubs and Schools) 4651, 4652, 4653, 4685; designee).
\3\. AR 920-15; AR 920-20.
12. Community Relations and AR 28-19; AR 360-61; 42 Installation commanders....... Equipment or buildings
Domestic Action Programs U.S.C. 2701. which may aid in
\1\ (Youth Conservation instruction to the
Corps). disadvantaged.
13. Veterans Organizations 10 U.S.C. 2541.......... MACOM CG and CG CONUSA........ Cots, bedding, chairs,
(State and National tents, mattresses,
Conventions) \3\. pillows, unoccupied
barracks, etc.

[[Page 487]]

Burial Ceremonies......... 10 U.S.C. 4683.......... Secretary of the Army......... Obsolete rifles.
14. Armies of the United 10 U.S.C. 2667; AR 34-1. CG DARCOM (those for equip Equipment.
Kingdom, Canada, and valued over $100,000 and
Australia (Standardization those not favorably
Program). considered by DARCOM will be
referred to the DCSRDA, HQDA,
for approval).
15. Aid to District of DODD 5030.46; CSR 500-4. Secretary of the Army (or Communications,
Columbia Government in designee). vehicles, aircraft,
Combating Crime \2\. arms, etc.
16. Departments, agencies, 10 U.S.C. 2667; SAOSA-71- Heads of Procuring Activity... Army property, not
municipalities, 6, par. 1-5103, ADARS. excess requirements,
organizations, activities, but not needed for
and individuals. period of lease. (See
delegation of
authority.)
17. Red Cross (Aid to DOD in 10 U.S.C. 2602; AR 930-5 DAAG.......................... Office space, supplies
time of war). and equipment;
uniforms.
18. Army Flying Clubs....... AR 230-1; DODD 1330.2... DAAG; CG FORSCOM.............. Army aircraft.
19. Civilian Activities..... 10 U.S.C. 2572; AR 870- Chief, Military History....... Historical properties
15; AR 870-20. and military art.
20. Civilian Educational 10 U.S.C. 4654.......... Secretary of the Army......... Quartermaster supplies.
Institutions.
----------------------------------------------------------------------------------------------------------------
\1\ DA DCSOPS, Director of Military Support, has responsibility for these staff functions.
\2\ DA DCSOPS, Director of Military Support, has responsibility for these executive agent functions. (See app. A
for definition of this term.)
\3\ DA DCSLOG, Director of Supply and Maintenance, has responsibility for these staff functions.

Table 2-2--Loan Periods
----------------------------------------------------------------------------------------------------------------
Loan periods \1\
Borrower/purpose Initial extension
----------------------------------------------------------------------------------------------------------------
1. DOD Activities............... As needed for mission accomplishment.................. As needed for mission
accomplishment.
2. Army National Guard (loan of For minimum essential period as determined by For minimum essential
equipment). requirements. period as determined
by requirements.
3. Department of Agriculture 90 days............................................... 90 days.
(U.S. Forest Service)
(protection against wildfire).
4. Department of Justice (FBI) For minimum essential period.......................... For minimum essential
(Aircraft piracy). period.
(Drug Enforcement Agency)..... 1 year or less as determined by requirements.......... 1 year or less.
5. Treasury Department (U.S. 1 year or less as determined by requirements.......... 1 year or less.
Customs Service).
(U.S. Secret Service)......... For minimum essential period as determined by For minimum essential
requirements. period as determined
by requirements.
6. Environmental Protection For duration of requirements..........................
Agency/U.S. Coast Guard.

[[Page 488]]

7. Other Federal Agencies....... For minimum essential period.......................... 1 year.
8. Civil Agencies (Civil 15 days during actual disorder........................ 15 days.
disturbances) Type I.
Type II....................... 90 days in anticipation of a disorder................. 90 days.
(Disaster relief)............. For minimum essential period, no extension for use
during rehabilitation unless requested by the FDAA.
9. Boy and Girl Scouts of For duration of ``Jamboree'' plus period en route to
America (World or National or return from Jamborees.
Jamborees).
10. Civilian Marksmanship (Clubs 1 year................................................ 1 year.
and Schools).
11. Civilian Community As justified by local requesters......................
(Relations and Domestic Action
Programs).
12. American National Red Cross Same as above for duration of requirements (office Same as above.
for support of Army units in equipment).
support of local civil
Government disaster relief.
13. Veterans' Organizations..... 15 days............................................... 15 days.
14. To Armies of the United 1 year or less as determined by requirements.......... As negotiated.
Kingdom, Canada, and Australia
(Standardization Program).
15. Civilian Organizations:
a. Arms and accouterments..... 1 year or less as determined by requirements.......... 1 year.
b. DLA stock fund items....... 120 days.............................................. 30 days.
c. Medical equipment.......... 15 days............................................... As negotiated.
d. Medical supplies (drugs, 30 days............................................... As negotiated.
vaccines, etc. must be
replaced in kind).
e. All other items............ Requester justification............................... As negotiated.
16. DA materiel provided under 1 year................................................ 1 year.
10 U.S.C. 2667.
----------------------------------------------------------------------------------------------------------------
\1\ All extensions or loan renewals which extends the overall loan period beyond 1 year must be approved by the
Secretary of the Army (or designee).

[[Page 489]]

Sec. 623.3 Submission of requests for loan of Army materiel.

(a) General. (1) Loan requests will be expedited according to the
situation's urgency. A situation may be so serious that waiting for
instructions or approval from a higher authority is unwarranted.
Commanders will then take action as required to save human life, prevent
human suffering, or reduce property damage or destruction. (See
Sec. 623.2(b)(1).) Such emergency actions will be reported at once to
higher authority according to Sec. 623.7.
(2) Requests to the US Army for loan, or loan extension, will be
promptly sent by the Army element that received the request through
channels to the approving authority shown in table 2-1 or as specified
in appropriate regulations.
(3) Loan requests will be made by the head of the Federal agency,
civil authority, or civilian activity desiring the materiel. An
exception is that requests from the Federal Disaster Assistance
Administration (FDAA) will normally be initiated by an FDAA regional
director rather than by the administrator. The requests should be made
directly to the approving authorities shown in table 2-1.
(b) The Army National Guard (ARNG). Loan requests for property
belonging to ARNG will be made under National Guard Regulation 735-12.
(See para 5, table 2-1.)
(c) General Procedures. (1) DOD activities. DOD activities will
borrow Army materiel as follows:
(i) Requests will be made in writing citing--
(A) Detailed justification for loan to include urgency of need.
(B) Duration of loan.
(C) Funds to defray transportation and handling.
(D) Serviceability requirements.
(ii) Approving authority involved will--
(A) Forward a loan agreement to requester. Loan agreements within
DOD will often consist of letter requests, approving endorsements, and
materiel issue document (DD 1348-1) transferring temporary
accountability. Between units and activities, a hand receipt may be used
as the loan agreement.
(B) Furnish positive identification of item to be loaned.
(C) Provide instructions for delivery of equipment.
(iii) DOD recipient of loaned Army materiel will--
(A) Forward accepted loan agreement to approving authority (all
actions can be accomplished by electrically transmitted messages).
(B) Provide geographic location of equipment and specific activity
that is responsible for care and preservation of loaned equipment.
(C) Return equipment to Army in condition received with normal
allowance for fair wear and tear.
(2) Non-DOD activities. Non-DOD activities, including Federal
agencies will request loan of Army materiel as follows:
(i) Non-DOD activities, and agencies, will send routine requests by
letter 45 days before the materiel is required. Federal agencies may use
Standard Form 344 (Multiuse Standard Requisitioning/Issue System
Document). Requests will include the following:
(A) The DA approving authority. See table 2-1.
(B) Date request is submitted.
(C) Title of requesting agency and/or person authorized to receive
or pick up the borrowed materiel. Be specific; e.g., Special Agent in
Charge John Doe, FBI, Anytown, USA, (telephone number with area code)
123-456-7890.
(D) Type of loan; e.g., Boy Scout National Jamboree, American Legion
Convention, etc. (with a short summary of circumstances).
(E) Statement that none of the requested materiel is internally
available to the requesting activity.
(F) Statement that this support is not reasonably available from
local government or commercial sources.
(G) Authority for the loan (if known); e.g., public law, US code,
executive order, etc. See table 2-1.
(H) Positive identification of the type and quantity of items
required. If national stock numbers and nomenclature are not available,
identify the items needed by type, model, size, capacity, caliber, etc.
(I) Geographic location where the materiel will be located and used.
(J) Proposed duration of the loan.

[[Page 490]]

(K) Statement that the agency has, or will ensure capability to
properly operate, maintain, secure, and care for the borrowed materiel.
(L) If firearms are requested, a statement that adequate facilities
are available to secure the arms. See Sec. 623.5(a)(4).
(M) A statement that the borrowing activity will assume all
responsibilities, liabilities, and costs related to the movement, use,
care, security, loss, damage, and repair of the loaned materiel.
(N) Citation of funds to cover reimbursable costs. Also, a statement
that an adequate bond will be provided, if required.
(O) A statement that the loan agreement prepared by the Army will be
signed by the ``responsible official'' of the borrowing activity (or
designee).
(P) Name, address, and telephone number of the person who will serve
as the point of contact for the requesting agency, authority, or
activity.
(Q) Complete instructions for delivery of the equipment to ensure
that shipping instructions in the request are consistent with the
urgency of the situation. State whether a small quantity shipped by air,
express, or other fast means will satisfy immediate needs until bulk
shipments can arrive. Also state quantity immediately required.
(R) If applicable, the number of persons to be accommodated.
(ii) Urgent requests may be made to meet expected or actual
emergencies. Such requests may be made by telephone or by electrically
transmitted message. Include information required in paragraphs
(c)(2)(i) (A) through (R) of this section to the extent possible. The
request will be presented to the approving authority. The borrower will
then send a complete written request to formalize the emergency request.
(iii) If approval of the loan is granted, approving authorities will
contact accountable property officers at CONUS installations (equivalent
level overseas), or MRC item managers to determine which items are
available. Installation requests to MRCs will state that the
installation resources could not meet the loan requirements.
Availability decisions will be based on normal management criteria
including past and anticipated demand, asset balances, order-ship time,
repair rate and repair cycles, and procurement schedules. If requested
items are available and approved for issue, the approving authority (or
designee) will--
(A) Negotiate and agreement;
(B) Obtain surety bond from the borrower when required;
(C) Provide reproduced copies of the signed documents to the
appropriate accountable property office along with authorization to make
the loan.
(iv) Approving authorities will maintain a system of numerical
control for all loans. The accountable property officer will enter this
number on all transaction documents related to each specific loan to
include requisition, issue, shipping, turn-in, and financial documents.
(3) The US Secret Service (USSS).
(i) Army regulation 1-4 provides policies and procedures for Army
support to the Secret Service. Support will be provided only on the
request of the Director, United States Secret Service or his authorized
representative. It will be provided only to assist the United State
Secret Service in performance of its statutory protective functions.
(ii) Routine requests are sent by the United States Secret Service
direct to the Office of the Special Assistant to the SECDEF for
approval. Approved requests involving Army resources are tasked through
HQDA (DAMO-ODS) to the proper command. Approved requests for resources
of other Services are tasked direct to the proper Service.
(iii) Approved requests for resources to be used in oversea areas
(regardless of Service) will be passed from the Office of the Special
Assistant to the SECDEF to the Joint Chiefs of Staff (JCS) for tasking
of the proper unified command.
(iv) In urgent situations, the United States Secret Service may
request military resources from the nearest military commander who is
authorized to take action consistent with the urgency. As soon as
possible, they will seek guidance/approval through command channels to
the approval authority (Spec Asst to the SECDEF).
(4) Drug and narcotics interdiction activities. All non-DOD Federal
agencies requesting DOD resource in support of

[[Page 491]]

drug or narcotics interdiction activities should send requests through
their headquarters to DOD, ATTN: Deputy Assistant SECDEF (Program
Management), WASH DC 20314. Concurrently, information pertaining to the
request should be sent to HQDA (DAMO-ODS) (para 4, app B), or relayed by
telephone (AUTOVON 225-2003 or the Army Operations Center 851-1800
during nonduty hours). The Deputy Assistant SECDEF will pass approved
request to HQDA (DAMO-ODS), through the Office, Under Secretary of the
Army, for determination of availability and readiness impact. If
approved by the Under Secretary of the Army, ODCSOPS (DAMO-ODS) will
task the proper MACOM to provide support. Requests for extension or
changes to agreements will be processed as noted in tables 2-1, 2-2 and
paragraph (a)(2) of this section.
(5) The Federal Bureau of Investigation. (i) Requests for aircraft
piracy assistance, received from Federal authorities by Army field
commands or activities, will be forwarded through command channels by
telephone (confirmed by electrically transmitted message) to the
Military Support Division, ODCSOPS (DAMO-ODS), AUTOVON 255-3848/7433/
2003 (WATS 202-695-2003). These requests will be approved by the DOD
General Counsel (or designee).
(ii) The requests will then be sent to the National Military Command
Center (NMCC). It will coordinate between the lending accountable
property officer and the borrower.
(iii) In urgent cases, the Deputy Director for Operations, NMCC, may
approve requests upon his or her own responsibility. This is subject to
a later report to the chairman of the Joint Chiefs of Staff and the DOD
General Counsel.
(iv) Approved requirements will be passed to the Secretary of the
Army by telephone and confirmed by electrically transmitted message. The
Secretary of the Army will then assign the requirement to the proper
command (or staff agency) which will contact the designated Federal
civil official and confirm the details of the request. Modification of
the requirement to better perform the mission is authorized if the
Federal official agrees.
(6) Enviromental Protection Agency (EPA), US Coast Guard (USCG), or
National Response Team (NRT). Non-DOD Federal agency requests for loan
of materiel to combat oil and hazardous substance pollution spills will
be made directly to the Commanding General, FORSCOM. Requests will be
made by an ``On Scene Coordinator'' (OSC) of the EPA, or by the USCG
acting for the Department of Transportation. The pollution spill NRT may
also initiate requests. Approval authority is shown in table 2-1.
(d) Civil Authorities. Loans of materiel to civil authorities for
use during civil disturbances and disasters will be made as follows:
(1) Civil disturbances. Requests for Army materiel in anticipation
of (or during) civil disturbances will be promptly sent through command
channels to the approving authority (UCOM commanders will coordinate
requests originating from areas outside CONUS) as follows:
(i) Requests for resources that require Secretary of the Army
approval will be sent through channels to HQDA (DAMO-ODS) (para 4, app
B).
(ii) Requests for group three resources (Sec. 623.2(a)(5)) that are
not available to commanders having the approval authority will be sent
through channels to HQDA (DAMO-ODS). Intermediate commands may approve
and make available the requested resources.
(iii) Requests received by other DOD agencies will be referred to
local Army installation commanders for processing.
(2) Disaster relief. Requests for loan of materiel to support
disaster relief will be handled as follows:
(i) Valid requests for disaster relief assistance (see
Sec. 623.2(a)(4) for decisionmaking process) will be given to the DOD
liaison (a military officer) assigned to the disaster; or forwarded to
the CONUS Army commander in which the disaster occurs. (See appendix G.)
If no Federal Disaster Assistance Administration (FDAA) official (HUD
Federal Coordinating Officer (FCO)) is present at the disaster scene,
requests may be received from the Red Cross.

[[Page 492]]

(ii) HUD Regional Directors for FDAA, or FCOs, will send requests
for loan of materiel to the Commanding General, FORSCOM, or to the
proper CONUS Army commander. (Requests for Defense Civil Preparedness
Agency (DCPA) resources will be sent to DCPA regional offices.)
(e) Civilian Activities. (1) Veterans' Organizations. Loan requests
by authorized veterans' organizations (as listed in VA Bulletin 23A)
will be sent to the commander of the CONUS Army area (or Commander,
MDW), for the area where the materiel will be required. (See appendix
G.)
(2) Scouting Loans. National and regional scout executives will send
requests (restricted to DOD support of national and world jamborees)
according to chapter 7, AR 725-1. (See Sec. 621.4 of this title.)
(3) Loans/Leases Under the Provisions of Title 10 U.S.C. 2667.
Requests for loans from other civil activities and organizations may
come into the DOD through various channels; e.g., telephone call to
local installation commander, letter to Congressmen, or directly to the
Secretary of Defense or Army. Each request will be forwarded to the
authority having the item and having the authority to approve the
request. (See appendix B and table 2-1.) In cases where approval is
questionable, the request may be submitted through channels to HQDA
(DALO-SMD) WASH DC 20310 (para 2, app B) recommending approval/
disapproval action.
(f) Loans to the United Kingdom (UK), Canada, and Australia. All
requests for loans (restricted to materiel for use in the
``Standardization Program'') to the UK, Canada, or Australia will be
sent to Commander, DARCOM, ATTN DRC-IRD for approval. AR 795-204
addresses loans to other allied governments. (See DOD Military
Assistance and Sales Manual, DOD 5105.38-M.)
(g) Special Materiel Requests.
(1) Loan of Communications Security (COMSEC) Equipment. Subject to
provisions of this regulation, requests for loan of COMSEC equipment
will be sent to the Commander, US Army Communications Security Logistics
Agency (para 24, app B) for approval, loan action, and establishment of
loan records. All loans of Army COMSEC equipment to civilian authorities
or activities will be according to Technical Bulletin 380-41. Standard
Form 153 will be annotated to show purpose of the loan, expected date of
return, and authority for the loan. A copy will be sent to the Director,
National Security Agency (NSA), ATTN: S3, Fort George G. Meade, MD
20755.
(2) Loan of arms and accouterments. Requests for loan of arms and
accouterments will be sent by requesting agencies directly to the
Secretary of the Army, Military Support Division, HQDA (DAMO-ODS) (para
4, app B). Requests received out of this channel will be returned to the
originator for resubmission. The Secretary of the Army (or designee) is
the approval authority. See Sec. 623.5 for procedures.
(3) War reserves and operational project stocks. Regulatory guidance
with respect to loan of war reserves and operational project stocks to
DOD organizations is found in chapter 8, AR 710-1. Loans of war reserves
and operational project stocks to non-DOD activities will be according
to this regulation and must be approved by HQDA (DALO-SMW) (para 3, app
B).
(4) Loan of historical property and art. Requests for loans of Army
historical property and military art will be sent to the Commander, US
Army Center of Military History (para 4, app B). Specific information on
such loans is found in AR 870-15 and AR 870-20.

Sec. 623.4 Accounting procedures.

(a) Loan Document Format. (1) When the lending accountable property
officer receives copies of the loan request, loan agreement, surety bond
(if required), and written loan authorization from the approving
authority, the loan request will be converted to Military Standard
Requisitioning and Issue Procedures requisition formal (DD Form 1348) as
follows: (NOTE: In emergencies, authorization may be made by telephone.
The format request, agreement, bond, and authorization will follow.
Informal records should be also maintained.)

------------------------------------------------------------------------
Card columns Code or data
------------------------------------------------------------------------
1-3............................... ``AOE''.
4-6............................... RIC of NICP (lender).

[[Page 493]]

7................................. Media and status code.
8-22.............................. National stock number.
23-24............................. Unit of issue.
25-29............................. Quantity.
30-43............................. Document number.
(30-35)........................... DODAAC of the requisitioner, if
applicable, otherwise DODAAC of
accountable property officer
(lender).
(36-39)........................... Julian date.
(40-43)........................... Serial number.
44................................ ``N'' for nonrecurring demand.
45-50............................. Supplemental address (loanee DODAAC)
for DOD units. For non-DOD
activities enter the shipping
destination.
(45).............................. ``Y''.
(46-49)........................... Julian date of receipt of loan
request.
(50).............................. Alphabetic (except I or O)
indicating which loan of the day is
first; e.g., A-first, B-second,
etc.
51................................ ``M''.
52-53............................. ``G4'' for loans to nonresearch and
development activities. ``G6'' for
loans to research and development
activities.
54-56............................. Blank.
57-59............................. Project code if applicable. Note:
This will be the same for all
loans. Project codes will be
assigned by Chief, Logistic Systems
Support Activity, ATTN: DRXLS-LCC,
Chambersburg, PA 17201. It will be
sent by message to all interested
addresses.
60-61............................. Priority.
62-64............................. RDD.
65-66............................. Blank.
67-69............................. Depot RIC.
70................................ Purpose code.
71................................ Condition code.
72................................ Management code.
73-80............................. Blank.
------------------------------------------------------------------------

(2) Loaned property will be kept on the accountable records of the
owning property account. The entry showing the quantities loaned will be
supported by DD Form 1348-1 (receipt document), and copies of the loan
agreement and surety bond (if required). The receipt document must be
signed by the responsible official of the borrowing activity. It is then
returned to the accountable property officer as a valid hand receipt for
property accounting purposes.
(3) Loans will be processed by accountable property officers
according to normal supply procedures except as modified by this
regulation.
(4) Accountable property officers will keep loan files with enough
documentation to provide an audit trail for loan transactions and a
single source of accounting and billing for reimbursement. No separate
property book accounts will be set up for these loans. Items, with dates
shipped, will be identified by use of ``loan control numbers'' in loan
jacket files and in supporting documentation. The files will include
copies of--
(i) The loan request. If the request was made by telephone (urgent),
a copy of the Memorandum for Record prepared to summarize the call will
be used.
(ii) The loan agreement.
(iii) The surety bond (with cash, certified check, US treasury
bonds, or adequate bond from a bonding company).
(iv) The approving authorization to make the loan.
(v) DD Form 1348-1 used for shipping the items.
(vi) A master loan register with the loan control number and
shipping document number.
(b) Shipment of Loaned Materiel. (1) Loaned Army materiel will be
shipped only to the chief of the borrowing activity or to a designee
authorized to receive and sign for the materiel. To keep the materiel
out of unauthorized hands, consignees (receivers) will be advised of the
items and quantities to be loaned; the source of supply; whether the
items are to be picked up or shipped; and of shipments made.
(2) All shipments of loaned equipment will be documented on DOD
single line item ``release or receipt'' document (DD Form 1348-1). These
will be initiated by the lending accountable property officer. Packing,
crating, handling, estimated transportation costs, and serial numbers
(if applicable) of items shipped will be shown on all copies. The
consignee will be given advance copies of the DD Form 1348-1 as notice
of shipment, and a list of DD Form 1348-1 document numbers. For loans to
non-DOD activities two copies of the certificate below will be prepared
by the accountable property officer (see fig. 1). It will accompany the
DD Forms 1348-1.
``I certify receipt of and assume responsibility for the Army
materiel listed on DD Form 1348-1. Control numbers on DD Form 1348-1
follow. The items were received in good condition except as noted on the
DD Form 1348-1. Serial numbers have been verified (omit if not
applicable).''

________________________________________________________________________
Signature of responsible officer
________________________________________________________________________

[[Page 494]]

Typed name of responsible officer
________________________________________________________________________
Address of responsible officer
________________________________________________________________________
Date certificate was signed

Figure 1. Sample receipt certificate

(3) One copy of each signed DD Form 1348-1 (for non-DOD activities,
one copy of the signed certificate) will be returned to the accountable
property officer. Also, one copy of each will be kept in the borrower's
file.
(4) The installation or depot transportation officer is responsible
for coordinating movement of the items that must be shipped.
(5) Shipments, including those to foreign countries, will be made on
commercial bills of lading (CBL). Freight charges will be paid by the
borrower. The CBL will cite proper project codes. NOTE: In emergencies
where use of CBL would delay shipment, government bills of lading (GBL)
may be used subject to later reimbursement. Shipments to Boy Scout World
Jamborees in foreign countries will be by GBL unless otherwise specified
by the Boy Scouts.
(6) Shipments will be consolidated to the maximum to get the lowest
charges available.
(7) Separate shipping instructions will be provided for each
recipient, convention, jamboree, etc., to ensure correct consignee and
railhead addresses.
(8) Transportation will be at no expense to the government. The
Defense Transportation Services (Military Sealift Command, Military
Airlift Command, and Military Traffic Management Command) will send all
billings for such transportation costs to the US Army Finance and
Accounting Center (USAFAC). The USAFAC will then bill the fiscal station
servicing the accountable property office that made the loan. This
fiscal station will then bill the borrower for these transportation
costs. Army materiel loaned to non-DOD activities is not authorized for
oversea movement on a space available basis by MSC or MAC without their
prior approval.
(c) Receipt of Borrowed Property. (1) The person authorized to
receive the materiel (whether shipped or picked up) will check the
quantities received against the quantities shown on the DD Form 1348-1.
This person will also verify the condition of the materiel. Any
variation in quantity or condition must be resolved at once. If the
shortage or damage is not due to a common carrier, the borrower will
give the accountable property officer the National Stock Number,
document number, and an explanation of the variation at once. This
establishes a basis for assessing charges on termination of the loan.
Replacement shipments, when required, will be covered by a DD Form 1348-
1. All variations will be noted on the reverse side of the bill of
lading.
(2) When a DD Form 1348-1 has not been received by the borrower and
does not accompany the shipment, an informal report will be made to the
accountable property officer at once. It will include the nomenclature,
quantities, condition, and if applicable, the model numbers and serial
number of all material received.
(3) When shipment has been verified, the borrower (or designee) will
enter the quantity received on two copies of the DD Form 1348-1. Serial
numbers will also be entered for serial numbered items. The completed
copies of the DD Form 1348-1 will be signed by the authorized person.
One copy of the DD Form 1348-1 and one copy of the signed certificate
(receipt of the materiel) will be returned to the accountable property
officer.
(4) If shipments are received damaged or short, take action
described in Sec. 623.4(g).
(d) Accounting by Borrower. Non-DOD borrowing activities should
maintain a system of jacket files. This should include copies of all
documents that authorize the loan of materiel and relate to loan
transactions. Such files will insure return of materiel within the
approved loan period. Files should be retained for audit or any other
purpose as required. These files may be destroyed upon turn in of the
borrowed materiel, final completion of accounting, and reimbursement for
Army costs related to the loan. DOD borrowers will conform to the
requirements contained in existing regulations.
(e) Return of Borrowed Materiel--(1) General. (i) Borrowed materiel
will be returned to the Army in the condition received, less fair wear
and tear, unless

[[Page 495]]

the terms of agreement specify otherwise.
(ii) Property for which repair cost is claimed will be held at the
Army depot or installation until final charges are determined and a
release is given by respective property officers.
(iii) Return of materiel loaned to rifle clubs and schools will
conform with Sec. 623.5.
(2) Accountable property officer actions.
(i) At the end of a loan period, recall, or upon notice by the
borrower that the loaned materiel is no longer needed, the accountable
property officer will send a letter of instruction to the borrower for
return of the materiel. He will verify or modify the turn-in
instructions provided in the loan agreement.
(ii) These procedures will be used by accountable property officers
to terminate loans:
(A) For loans up to 30 days no specific termination action is
necessary except when materiel is not returned by the loan due date.
Then, a written loan termination notice will be sent to the borrower. A
follow-up notice will be sent every 15 days until the materiel is
returned or other settlement is made.
(B) For all other loans 15 days before the loan is due, a loan
termination notice will be sent by the lending activity to the borrower
verifying (or modifying) the turn-in instructions.
(C) Follow-up of loan termination notice will be made every 15 days
until the materiel is returned or other settlement is made.
(iii) After receiving inspection reports (Sec. 623.4(e)(3)) and
final shipment receipts, the accountable property officer will clear the
loan records.
(iv) The accountable property officer will then advise the borrower
of the transaction completion by furnishing receipted copies of the
receiving document(s).
(v) The accountable property officer will notify the servicing
finance and accounting office (FAO) of any reimbursement required.
(3) Actions by the receiving installation, depot, or arsenal. (i)
The installation, depot, or arsenal receiving activities will inspect
returned materiel.
(A) If the quantity received differs from the quantity shipped, the
actual quantity received will be entered on the DD Form 1348-1.
(B) If the condition of the property differs from that noted on the
DD Form 1348-1, the variation will be stated.
(ii) Loaned materiel returned in an unserviceable condition will be
inspected by qualified technical inspectors at installation level and by
quality assurance activities at depots to determine condition code.
(A) If the condition of returned materiel is the same as noted on
the receipt document or the prepositioned materiel receipt card, the
item will be processed as a normal receipt.
(B) If there is a discrepancy in the actual condition of the item or
in the assigned code on the receipt document, obtain an estimate of
repair cost and continue normal receipt documentation processing.
(C) The receiving depot or installation will prepare an Inspection
and Surveillance Report for each returned item that needs repair. Cards
will also be prepared for shortages. The cards will include the cost of
equipment repair or the value of shortage. A minimum of two copies of
each report will be sent to the proper acountable property officer.
(f) Loan Inventories. (1) If a loan has been approved or extended
(by the SA) for a period longer than 1 year, the accountable property
officer will inspect and reconcile loan accounts with the borrower at
the end of each 12-month period.
(2) If no discrepancies are noted, the accountable property officer
will file the signed annual inventory form in the borrower's memorandum
receipt jacket file.
(3) If the inventory shows that amounts and kinds of Army materiel
for which the borrower is responsible differ from that actually in his
possession, the accountable property officer will--
(i) For overages, assume accountability for the overages noted on
the annual inventory form. Use a copy of the annual inventory form as a
debit voucher to the account. No approval of this voucher is needed.

[[Page 496]]

(ii) For shortages, act to obtain reimbursement for the value of the
missing property or to adjust the discrepancy by report of survey.
(g) Lost, Damaged, and Destroyed Materiel. (1) When loss or damage
occurs during shipment, DOD and Federal agencies will refer to AR 55-38
for specific instructions.
(2) Damage or loss which is the fault of the carrier will be billed
to the carrier after reconciliaton.
(3) Army materiel lost, damaged, or destroyed while in the
possession of rifle clubs or schools will be handled as described in
Sec. 623.5.
(4) Any Army materiel loaned at the request of an FDAA Regional
Director which is not returned according to instructions in this chapter
will be reported to the borrower and to the FDAA Regional Director. The
latter will arrange for proper reconciliaton and reimbursement.

Sec. 623.5 Loan of arms and accouterments.

(a) General. (1) Loan of arms and accouterments requires special
processing and handling. Loans to DOD and non-DOD activities will be
handled as a normal loan according to instructions in this section with
the added requirement of maintaining serial number visibility. Loans of
arms and accouterments as included herein are not applicable to Army
National Guard (ARNG).
(2) The Commanding General, Armament Readiness Command (ARRCOM)
(ATTN: DRSAR-MMS) has been designated by Commanding General, Materiel
Development and Readiness Command (DARCOM), as being responsible for
keeping a centralized serial number visibility record for all small arms
made for the Army. ARRCOM maintains accountable property records for
loans to organizations such as the Director of Civilian Marksmanship
(DCM); and for loans to non-DOD activities such as the Federal Bureau of
Investigation (FBI), United States Secret Service (USSS), United States
Customer Service (USCS); or rifle clubs, educational institutions, and
veterans' organizations.
(3) Requests for loan of arms which are type classified standard
(logistics control code A or B) will be filled with the lowest type
classified items available.
(4) Borrowers of Army arms will be fully responsible for the care,
custody, and proper use of loaned materiel. Physical security measures
must be equal to or greater than the minimum requirements set forth in
Army Regulation 190-11 and Army Regulation 190-49.
(5) If borrowed arms are lost, stolen, or unaccounted for, the
borrower must inform the lender (accountable property officer), the
local police, and the FBI within 24 hours after discovery.
(6) This regulation does not apply to arms issued to Reserve
Officers Training Corps units under the National Defense Act. Army
Regulation 710-2 is applicable.
(b) Loans to Civilian Activities (Other Than Rifle Clubs and
Educational Institutions). (1) Arms and accouterments may be loaned by
the Army to civilian authorities and to civilian activities as follows:
(Sec. 623.5(c) covers rifle clubs and institutions.)
(i) For use in protection of public money and property (10 U.S.C.
4655).
(ii) Obsolete or condemed rifles (not more than 10), slings, and
cartridge belts may be loaned to local units of any national veteran's
organization for use by that unit in ceremonies. (For example, a funeral
for a former member of the armed forces.) The organization must be
recognized by the Veterans' Administration (VA) (10 U.S.C. 4683).
(iii) Arms and accouterments loaned to organizations listed in
Sec. 623.5(c)(1) for a period of 1 year or less will be accounted for by
ARRCOM. Loans of items that exceed 1 year will be accounted for by the
DCM under Sec. 623.5(c).
(2) Requests for loan (or extension of loan) of Army arms and
accouterments will be sent by requesting agencies through HQDA (DALO-
SMD), (para 2, app B) to the Secretary of the Army. Requests received
outside of this channel will be returned to the originator for direct
submission to the address above.
(3) Requests approved by the Secretary of the Army (or Under
Secretary) will be sent to ARRCOM, (para 12 app B) Rock Island, IL
61299, for

[[Page 497]]

completion of a formal loan agreement and issue of items.
(4) Requisitioning, accounting, and reimbursement procedures are
given in Sec. 623.4. However, upon receipt of signed copies of DD Form
1348-1 with the listing of verified serial numbers from the consignee,
the ARRCOM Arms and Accouterments Property Officer will send the
required transaction data to the DOD Small Arms Serialization Program
(DODSASP) at ARRCOM. These data will indicate that the small arms on
loan to other Government agencies are accounted for under DOD Activity
Address Code W52P41.
(5) Shipment and returns are described in Sec. 623.4 except as
follows:
(i) The responsible property officer for materiel or loan will
request disposition instructions from the accountable property officer
when loaned materiel is no longer needed or at the end of the loan
period. Loaned materiel may be withdrawn from the borrowing activity at
any time to satisfy military requirements.
(ii) The accountable property officer will:
(A) Issue shipping instructions for the return of property to a
designated installation. The letter of instruction will contain a
MILSTRIP document number (AR 725-50) for each line item scheduled for
return to be used for the shipment. The shipper will be directed to cite
this document number on the shipping document.
(B) Prepare and submit to the receiving installation a prepositioned
materiel receipt card (DOD Materiel Receipt Document (DD Form 1486))
(Document Identifier DWC) as advance notice of the shipment.
(1) Exception data will be annotated as follows: ``Return of Loan
from Other Government Agency--Report Receipt of Arms and Accouterments
Accountable Property Officer, ATTN: DRSAR-MMD.''
(2) A copy of the letter of shipping instructions (paragraph
(b)(5)(ii) of this section) will be inclosed with the prepositioned
materiel receipt card for information.
(iii) Upon receipt at the receiving installation, property will be
inspected immediately. Cost of repairing unserviceable items and cost of
replacement, if irreparable, will be determined at time of inspection.
The MILSTRIP receipt card will be mailed to the accountable property
officer with estimated damage cost and detailed materiel condition as
exception data.
(iv) Upon notification of materiel receipt, the accountable property
officer will:
(A) Clear the loan record with a credit entry and process the
receipt to the inventory records as an increase on hand to asset
balance.
(B) Furnish receipted copies of the receiving document to the
consignor and the responsible property officer closing the transaction.
(c) Loans to Rifle Clubs and Educational Institutions--(1)
Authorization. Arms and accouterments may be loaned to rifle clubs and
educational institutions for periods established in table 2-2 under the
following conditions:
(i) Rifled arms may be loaned to civilian rifle clubs for promotion
of marksmanship training among able-bodied US citizens (10 U.S.C. 4308).
(ii) Arms, tentage, and equipment, as the Secretary of the Army
deems necessary, may be loaned to an educational institution to provide
proper military training where there is no ROTC, but there is a course
in military training prescribed by the Secretary of the Army and there
are at least 100 physically fit males over 14 years of age (10 U.S.C.
4651).
(iii) Magazine rifles and appendages may be loaned to schools having
a uniformed corps of cadets of sufficient number for target practice.
Models loaned must not be in use at the time, or needed for a proper
reserve supply (10 U.S.C. 4652).
(iv) Ordnance and ordnance stores may be loaned to Washington, DC,
high schools for military instruction and practice (10 U.S.C. 4653).
(v) Obsolete ordnance and ordnance stores may be loaned to
educational institutions and to State soldiers', sailors', and orphans'
homes for drill and instruction if recommended by the Governor of the
state or territory concerned (10 U.S.C. 4685).
(2) Director of Civilian Marksmanship (DCM). The President may
detail an officer of the Army or Marine Corps as

[[Page 498]]

Director of Civilian Marksmanship (10 U.S.C. 4307). The DCM is
responsible for--
(i) Control and accountability of Army materiel issued to civilian
rifle clubs;
(ii) Policies and procedures for the issue of arms and ammunition to
civilian rifle clubs; and
(iii) Ensuring proper bonding of clubs before issue of Army
materiel. The Secretary of the Army has further made the DCM similarly
responsible for loans to institutions (schools).
(3) Property transactions. US Army Armament Materiel Readiness
Command (ARRCOM) will transfer accountability for materiel shipped to
civilian rifle clubs and institutions to the DCM. The DCM will keep a
mission stock record account for these items as shown in Army Regulation
710-2. In addition, the account will note all property transactions
between the DCM and civilian rifle clubs and institutions as follows:
(i) Loan and return of arms and accouterments to (from) civilian
rifle clubs and institutions will not be posted to the accountable
record as loss or gain vouchers. They will be posted as ``loan
transactions'' with the DCM retaining accountability. In addition to
debit, credit, and adjustment voucher files, the DCM accountable
property officer will keep a ``loan voucher'' file in two sections;
e.g., ``active'' and ``terminated.''
(A) The active section (suspense for items on loan) will contain DD
Form 1348-1 or a letter acknowledging receipt of the items. (The
signature of the borrower will be according to paragraph (4) (v) or (vi)
of this section.) This section will contain a folder for each activity
serviced by the DCM. The active loan vouchers will be filed in National
Stock Number and voucher number sequence. This section serves as the DCM
loan record.
(B) The terminated section (for items no longer on loan) will
contain the original loan shipping document (loan voucher). The return
receipt document which terminates the loan will be attached. The receipt
document will contain the original shipping document number and the
return advice code ``IQ.''
(ii) Shipments of expendable items (e.g., ammunition, targets, etc.)
will be posted as a credit to the accountable record. Accountability
will be dropped (These items are deemed to have been consumed at the
time of issue).
(iii) Expendable items returned by rifle clubs and institutions will
be posted to the accountable record as a debit voucher. The DCM will
determine disposition of these items.
(4) Requisition procedures. (i) The DCM will prepare requisitions
based on information from the rifle clubs or institutions. DA Form 1273
(Requisition for Articles Authorized for Issue to Civilian Rifle Clubs)
will be used. Two completed copies of the requisition will be sent to
the requester.
(ii) The rifle club or institution will complete the form and return
one signed copy to the DCM, HQDA, Secretary Field Directorate
Marksmanship (SFDM), (para 7, app B) and keep one copy for file.
(iii) On receipt of the signed copy of DA Form 1273, the DCM will
take proper issue action. When more arms are required by the DCM, a DD
Form 1348 will be prepared and sent to the Secretary of the Army for
approval (AR 725-50).
(iv) The supply source responsible for the loan will ship the
materiel directly to the rifle club or school.
(v) DD Forms 1348-1 received with the shipment or by mail, will be
annotated and signed by the person authorized to receive and sign for
property for the rifle club or school. The quantity and condition of the
items received will be entered thereon. This entry will be based on a
physical check and inspection of the materiel. Serial numbers of items
received (if applicable and not noted) will also be entered. Two of the
completed copies will be signed by the person authorized to sign for the
club or institution. They will be mailed to the DCM, HQDA Secretary
Field Directorate Marksmanship (SFDM). The third completed copy will be
kept in the unit's file.
(vi) If a DD Form 1348-1 is not received with the shipment or is not
received by mail, a receipt letter will be sent to the DCM. It will set
forth the nomenclature, quantities, condition, and serial numbers (of
serial-numbered

[[Page 499]]

items) of all property received. This letter will be sent as soon as
possible after receipt of the property. The receipt letter will be used
by the DCM as a loan voucher. One copy will be recorded in the voucher
register and placed in the voucher file. The loan action will be posted
to the DCM stock record account.
(5) Property returns. When property is returned by civilian rifle
clubs or institutions, the DCM will prepare seven copies of the DD Form
1348-1. Five copies will be mailed to the rifle club or institution; one
will be kept in suspense in the club's or institution's jacket file; and
one will be sent to the US Army Management Systems Support Agency
(USAMSSA), Wash., DC 20310, to update the ``rifles intransit program.''
The rifle club or institution will enter on the five copies the shipment
date, how shipped, the quantity shipped, and other necessary data not
entered by the DCM and distribute the five copies as follows:
(i) Two copies to the consignee (receiving depot, arsenal, or
installation). One copy of the DD Form 1348-1 received by the consignee
will be used to tally the shipment and to account for property received.
The other copy will be signed by the accountable property officer (or
representative) and will be sent to the DCM to terminate the open
receipt in the loan voucher file.
(ii) One copy with the shipment.
(iii) One copy to the DCM, HQDA (SFDM), accompanied by the bill of
lading (where available).
(iv) One copy retained by the rifle club or institution.
(6) Lost, damaged, or destroyed property. Loss, damage, or
destruction of property in the possession of a rifle club or institution
will be reported within 24 hours by telephone to the DCM (202-693-6460),
the local police, and the FBI. All public and local laws must be
complied with. Rifles and other equipment (except ammunition) that
becomes unserviceable will be reported to the DCM by the club or
institution. The DCM will give instructions for return of the equipment
without expense to the government. Any equipment damage or loss that is
the fault of the club or institution will be determined by a report of
survey (AR 735-11). The club or institution must then reimburse the DCM.
The DCM may replace damaged equipment after reimbursement. Government
property lost or destroyed without fault or neglect on the club's part
will be replaced, if replacements are available. The club will pay only
shipping and handling charges.

[AR 700-131, 45 FR 62038, Sept. 18, 1980; AR 700-131, 61 FR 45890, Aug.
30, 1996]

Sec. 623.6 Reimbursement for loan of Army materiel.

(a) Reimbursement Policies and Procedures. (1) Policies. (i) DA
elements do not program for costs related to loan of Army materiel.
(ii) Loans to non-DOD Federal activities are made on the basis that
there will be no extra cost to the Army. Costs that are in addition to
normal Army operating expenses will be reimbursed by the borrower. This
provision will be a part of the loan agreement.
(iii) In cases of aircraft piracy, civil disturbance, disaster
relief, or protection of the President or visiting dignitaries,
emergency support will not be withheld for lack of a formal
reimbursement agreement. In these cases, the supporting Army element
will absorb initial costs (within existing fund availability).
Reimbursement will be coordinated later.
(iv) Loans made under the provisions of Title 10 U.S.C. 2667 will
provide that the borrower must pay a fair monetary rental. The fair
monetary rental will be determined on the basis of prevailing commercial
rates or computed by sound commercial accounting practices including a
return on capital investment and administrative cost as well as
depreciation. Leases made under this code section will include a
provision establishing the rental cost of the materiel and method of
payment.
(v) The Army National Guard (ARNG) is responsible for reimbursement
of costs, over and above normal DA operating expenses, related to the
borrowed Army materiel.
(vi) Support to the United States Secret Service (USSS) will be on a
reimbursable basis except for costs directly related to protection of
the President

[[Page 500]]

or Vice President. Requests for reimbursement for all other support for
USSS will be according to AR 37-27.
(vii) The cost of emergency support will be billed directly to the
recipient.
(2) Procedures. (i) The Army accountable property officer handling
the loan of DLA stock fund items will coordinate DLA billings and
borrower reimbursement. The borrower can make payment directly to the
Defense Stock Fund.
(ii) Installation financial accounting for ``accounts receivable''
will conform with Army Regulation 37-108.
(iii) The finance and accounting office (FAO) supporting the
supplying accountable property officer will record all charges,
including accounts receivable of Army Stock Fund offices (or branch
offices), in separate ledger accounts for each borrower.
(iv) Charges and collections recorded in each loan account will be
reported per Army regulations and directives prescribing the reporting
of the fund status in any current fiscal year.
(v) Billing will be initiated on Standard Form 1080, and sent to the
borrower within 30 days of turn-in of materiel and loan termination. For
loans of arms and accouterments and issue of ammunition pursuant to 10
U.S.C. 4655, the Standard Form 1080 will be annotated to show that
collections are to reimburse DA appropriations.
(vi) Special appropriations established to support disaster relief
will be used promptly by Army commanders concerned to ensure that all
direct expenses are charged to the special appropriation. Exclude those
charges subject to reimbursement by the American National Red Cross
(ANRC). ANRC reimburses for supplies, materiel, and services for which
they are responsible in the disaster area.
(b) Reimbursable Costs. Unless specifically stated, borrowing
agencies, authorities, and activities will reimburse the Army for all
costs related to loan of Army materiel to include but not limited to the
following:
(1) Any overtime pay and pay of additional civilian personnel
required to accompany, operate, maintain, or safeguard borrowed
equipment.
(2) Travel and per diem expenses of Army personnel (military and
civilian).
(3) Packing, crating, handling, and shipping from supply source to
destination and return. This includes port loading and off loading.
(4) All transportation including return for repair or renovation.
(5) Hourly rate for the use of Army aircraft.
(6) Petroleum, oil, and lubricants (POL) (including aviation fuel).
(7) The cost of materiel lost, destroyed, or damaged beyond
economical repair except for Army aircraft, motor vehicles, or motor
craft used in connection with aircraft piracy.
(8) Utilities (gas, water, heat, and electricity). Charges will be
based on meter readings or other fair method.
(9) Any modification or rehabilitation of Army real property which
affects its future use by DA. In such cases the borrower will also bear
the cost of restoring the facility to its original form.
(10) Repair/overhaul of returned materiel. Renovation and repair
will conform with agreement between the Army and the borrower. (See
paragraph (e)(1) of this section.)
(11) Repair parts used in maintenance or renovation.
(12) Price decline of borrowed stock fund materiel at which returned
property can be sold.
(c) Nonreimbursable Costs. The following costs are normal operating
expenses of the Army for which no reimbursement is required:
(1) Regular pay and allowances of Army personnel (except travel) and
per diem costs.
(2) Administrative overhead costs.
(3) Annual and sick leave, retirement, and other military or
civilian benefits except as provided in certain cases; e.g., Army
Industrial Fund regulations.
(4) Telephone, telegram, or other electrical means used to
requisition items, replenish depot stocks, or coordinate the loan.
(5) Charges for the use of Army motor vehicles and watercraft except
POL and per diem costs (paragraph (b) of this section).
(6) The use of real property (except as required for utilities,
modification, etc.).

[[Page 501]]

(d) Funding Records. (1) Records of all costs (other than normal
operating expenses), related to loans of Army materiel, will be kept at
the accountable property officer level by the supporting finance and
accounting office. This will be done within existing Army financial
accounting systems.
(2) Separate subsidiary general ledger accounts and/or files of
documents showing the total value of all issues and materiel returned
for credit, and supporting documentation will be set up by the finance
and accounting office. The accounts will be kept current for each loan
action so reports may be made as prescribed; and so that accounts
receivable can be processed for billing and collection action.
(e) Determination of Charges and Settlement. (1) Returned materiel
will be promptly classified by a qualified inspector with action as
follows:
(i) Materiel classified as unserviceable, uneconomically reparable
will be billed at 100 percent of value.
(ii) Materiel classified as unserviceable, economically reparable
will be billed for reduced utility (if appropriate) as well as for
repair/overhaul costs.
(iii) The depreciation of borrowed materiel will be determined by
technical inspectors according to Army Regulation 735-11. When qualified
inspectors are not available, returned property will be received with
``condition'' shown as ``subject to final classification by DA.''
Accountable property officers will complete classification promptly so
charges and billing can be made within 30 days of return of materiel.
(2) All returned property which needs repair will be examined by a
technical inspector to find cost of repair. Then the accountable
property officer will prepare a property transaction record with
supporting documents. These records will be sent to the proper MACOM
commander or CINC of UCOM for final review. They will include--
(i) A statement on the transaction record identifying the financial
account to which the reimbursement money is to be deposited.
(ii) A statement on the transaction record (if appropriate) as
follows: ``The losses and/or damages shown on the Property Transaction
Record in the amount of $------ represent the total claim by the US Army
for property loaned to ----------------. Upon settlement and deposit to
the proper account, lender releases the ---------------- from further
obligations.''
(iii) A description of the type and degree of repair (separate
addendum).
(3) After the final review, an approved list of charges will be sent
to the servicing finance office for collection. The property will be
released for repair and returned to stock.
(4) The finance office will send a letter to the borrower requesting
payment (payable to the Treasurer of the United States). Upon payment,
collection documents will be prepared and fiscal accounts credited. The
MACOM or UCOM Surgeon will ensure the stock fund is reimbursed for
expendable medical supply losses reported.
(5) The finance office will advise the loaning accountable property
officer that settlement has been made. Property transaction records will
be closed.
(6) The approving authority will then return the bond to the
borrower.
(7) The value of supplies and equipment returned to the Army will be
credited to the account originally debited at the time of issue. FDAA
Regional Directors may find that it is not in the public interest to
return borrowed materiel that has not been consumed, lost, or damaged.
They will negotiate with the CONUS Army concerned for proper
reimbursement for the borrowed materiel not returned.
(f) Delinquent and Uncollectable Accounts. (1) In cases of
unsatisfactory settlement, bond proceeds will be used to satisfy the
claim.
(2) If this does not settle the account, then 6 months after the
final report and after all collection efforts have failed--
(i) Servicing finance offices will send delinquent ``accounts
receivable'' reports to commanders of CONUS Armies and DARCOM readiness
commands, and to CINCs of UCOMs, by forwarding--
(A) Duplicate copies of Standard Form 1080 billing documents showing
complete accounting classification to which reimbursement is to be
credited.

[[Page 502]]

(B) Duplicate copies of all supporting documents.
(C) One copy of any correspondence showing the reason(s) for
nonpayment of the account.
(ii) The CONUS Army Commanding General, CINC of UCOM, or Commanding
Generals of DARCOM Materiel Readiness Commands, will also try to collect
for these delinquent accounts. If all efforts fail, these accounts,
(with any delinquent accounts applicable to billings initiated within
their own headquarters) will be sent to the Director of Comproller
Systems, HQDA (DACA-BUS). (Para 1, app B). The letter of transmittal
will state that the accounts are transferred according to this
regulation. A copy will be sent to the FAO handling the accounts. The
FAO will then transfer the account to inactive status. A Standard Form
1017G (Journal Voucher) will be prepared showing a debit to account 3052
(Transfer of Accounts Receivable) and a credit to the proper accounts
receivable.
(iii) Appropriations available to the accountable property officer
or installation will be used for reimbursing; e.g., the Army Stock Fund
or Army Industrial Fund accounts. Any later reimbursements received will
be credited to the Army appropriation from which payment was made.
(3) Upon receipt of the accounts included in paragraph (f)(2) of
this section, the Comptroller, HQDA (DACA-BUS), will take further
collecton action under normal operating procedures. All later collection
action is the responsibility of the Comptroller. Accounting records and
reports will conform with normal procedures. When further collection
effort by the Comptroller fails, these accounts will be dropped from
receivable balances of the Army. They will be referred to the General
Accounting Office (GAO).

Sec. 623.7 Reports.

(a) General. Reports of Army materiel loaned to non-DOD activities
must be forwarded as described below.
(b) Aircraft Piracy. (1) Commands and agencies providing aircraft
piracy support will initially report through command channels by
telephone to the HQDA, (DAMO-ODS). (Para 4, app B.) Confirmation will be
made by electrically transmitted message to HQDA, ATTN: DAMO-ODS. These
reports are exempt from reports control under Army Regulation 335-15.
Initial reports will include all available details. Following is a guide
for content of reports.
(i) Supporting unit.
(ii) Home station of supporting unit.
(iii) Support provided and duration of requirement.
(iv) Changes, if any, in support requested or duration of
requirement as made by the Federal civil official in charge.
(v) Additional remarks.
(2) A final report noting termination of support will be made.
(c) Civilian Rifle Clubs and Schools. (1) Each affiliated club and
institution (schools) must file an annual report (DA Form 1277, Annual
Statistical Report of Civilian Rifle Club) on the anniversary date of
the loan with the DCM.
(2) A roster of club members will list each member required to fire
annually. It will include the full name, address, and age; the DCM
course; score; and the date the member fired for record.
(3) A description of the club's procedures and facilities for
safekeeping arms and ammunition will be appended to the roster of club
members.
(d) Civil Disturbances. (1) Requests to meet civil disturbances are
of two types:
(i) Type I--Requests to meet an urgent need during an actual
disorder.
(ii) Type II--Requests in anticipation of an imminent civil
disorder.
(2) Approving authorities, other than the Secretary of the Army,
will prepare reports (RCS DD-A(AR)1112) on all requests for loan of Army
materiel to support civil disturbances. The reports will be sent within
2 working days after receipt of the request. They will be prepared in
the format shown in Army Regulation 500-60. They will also serve as
``the request'' when no other written request is available.
(3) The reports will be sent to the (HQDA (DAMO-ODS)). When reports
are received from unified or specified commands, ODCSOPS will send an
information copy to the Joint Chiefs of Staff (JCS) National Military
Command Center (NMCC).

[[Page 503]]

(4) The Secretary of the Army will send information copies of civil
disorder reports to the DOD General Counsel and the US Deputy Attorney
General.
(5) Reports of civil disturbance operation costs (RCS DD-A(AR)1112)
also will be prepared as shown in Army Regulation 500-60.
(e) Disaster Assistance. When Army materiel is loaned in support of
disaster assistance, CONUS Army Commanding Generals and UCOM CINCs will
send reports as follows:
(1) Initial reports. Initial reports will be made by telephone to
the Commanding General, FORSCOM (AUTOVON 588-3912), who will, in turn,
telephone the report to the Military Support Division, ODCSOPS, AUTOVON
225-2003 or 7045). This will be followed within 12 hours by a Tempest
Rapid Materiel Report in message form and sent electrically. The message
report will be prepared according to Army Regulation 500-60.
(2) Daily message reports. Tempest Rapid Daily Materiel Reports of
Army materiel loaned to support disaster relief will also be sent by
electrically transmitted message. The reports will cover the 24-hour
period from 0601Z to 0600Z. The reports must arrive at the HQDA (DAMO-
ODS), no later than 1100Z the same day. Daily reports will be sent
according to the format in Army Regulation 500-60 except that part III
will not be included. Also, ``no change reports'' may be made by
telephone. On the day of the last daily message report include the words
FINAL DAILY REPORT in the subject line.
(3) Final reports. In addition to the final Tempest Rapid Daily
Materiel Report, a final report on military assistance provided will be
sent within 45 working days of termination of disaster assistance. The
CONUS Army Commanding General will send the report by 1st Class Mail
through the Commanding General, FORSCOM, to the HQDA (DAMO-ODS). The
final report will include--
(i) An historic account of the disaster.
(ii) Cumulative totals of support given.
(iii) A statement of accomplishments.
(iv) Actual or estimated expenses excluding costs incurred by the
Corps of Engineers under Pub. L. 84-99. Costs will be reported by
Service by appropriation, using three columns to identify normal costs,
incremental costs, and total costs.
(v) The status of reimbursements requested from borrowing Federal
agencies, and civilian authorities and activities. If reimbursement has
not been completed by the date of the final report, a separate cost
report will be sent upon final reimbursement payment.
(vi) Lessons learned.
(4) Information copies. Information copies of all reports will be
sent to the proper HUD Regional Directors for FDAA and DCPA Regional
Offices.
(5) Additional information. Additional information may be needed by
Federal officials. Normally, such requests will be telephoned by ODC
SOPS Military Support Division to the Commanding General, FORSCOM.
(6) Pollution spills. The Commanding General, FORSCOM, will report
committal of Army resources to the HQDA (DAMO-ODS), by the fastest
means. Daily and final Tempest Rapid Materiel Reports will be sent with
``not applicable'' shown in paragraphs 8, 9, and 10 of the report.
(f) Drugs and Narcotics Interdiction Program. (1) Army staff
agencies will submit monthly status reports of actions that support this
program. The reports will be as of the last day of June and December,
respectively. Reports will be sent to HQDA (DAMO-ODS), 4 working days
after the end of the designated months. Reports will summarize all
support during the period to include pending or terminated support plus
estimated cost of items.
(2) Based on information received in these reports, ODCSOPS will
prepare a report of the drug and narcotics interdiction assistance given
by the Army. This report will be sent through the Army Chief of Staff to
the Secretary of the Army.
(g) United States Secret Service (USSS). Army commands and agencies
providing materiel support (routine or urgent) to the USSS will report
any significant problems or deviation from

[[Page 504]]

the approved request at once. Reports will be telephoned through command
channels.
(h) Other Reports. Active Army accountable property officers will
make semiannual reports on open loans. The reports will be prepared as
of the last day of July and December. They will be sent by the 15th day
of the following month. These reports will include the items on loan,
quantity, dollar value, and duration of the loans. The reports will be
sent to the approving authority.

Appendix A to Part 623--Explanation of Terms

As used in this regulation, the following explanation of terms apply:
Accouterments. Equipment that is associated with small arms
characterized as personal and individual that is available
from Army stocks.
Approving authority. The person (or designee) authorized to approve
specific types of loans of Army materiel. (See table 2-1 and
app B.)
Arms. Weapons for use in war.
Civil authorities. Those elected and appointed public officials and
employees who govern the 50 States, District of Columbia,
Commonwealth of Puerto Rico, US possessions and territories,
and governmental subdivisions thereof.
Civil defense. All those activities and measures designed or undertaken
to:
a. Minimize the effects upon the civilian population caused, or
which would be caused, by an enemy attack upon the United States.
b. Deal with immediate emergency conditions which would be created
by any such attack.
c. Effect emergency repairs to, or the emergency restoration of,
vital utilities and facilities destroyed or damaged by any such attack
(JCS Pub 1).
Community relations program. A program of action, to earn public
understanding and acceptance, conducted at all levels of
military command wherever stationed. The program includes
participation in public events, humane acts, and cooperation
with public officials and civil leaders (AR 360-61).
Defense Civil Preparedness Agency (DCPA). A defense department agency
responsible for plans and preparations for civil defense and
assistance to local governments in disaster relief planning.
Department of Housing and Urban Development (HUD). The Federal
department responsible for directing and coordinating Federal
assistance for major disasters on behalf of the President.
Domestic action program. A program of assistance to local, State, and
Federal agencies for the continued improvement and development
of society (AR 28-19 and para 4-10, AR 360-61).
Emergency. Any catastrophe in any of the United States which in the
determination of the President requires Federal supplementary
emergency assistance.
Emergency medical treatment. The immediate application of medical
procedures to wounded, injured, or sick, by trained
professional medical personnel.
Executive agent. That individual or his designee authorized to act as
the US Government's agent in making certain loans of
government materiel. The President of the United States has
delegated to the Secretary of the Army (or to his designee,
the Under Secretary of the Army) authority, as Executive
Agent, to approve certain loans of DOD materiel to non-DOD
activities. (See table 2-1.) Other ``approving authorities''
act as ``Executive Agents'' for the US Government, but do not
have that title.
Federal agency. Any department, independent establishment, government
corporation, or other agency of the executive branch of the
Federal Government, except the ANRC.
Federal Coordinating Officer (FCO). The person appointed by the
President to operate under the HUD Regional Director for
Federal Disaster Assistance Administration to coordinate
Federal assistance in Presidentially declared emergency or
major disaster.
Federal Disaster Assistance Administration (FDAA). The agency within HUD
delegated the disaster relief responsibilities previously
assigned to the Office of Emergency Preparedness.
Federal function. Any function, operation, or action carried out under
the laws of the United States by any department, agency, or
instrumentality of the United States or by an officer or
employee thereof.
Federal property. That property which is owned, leased, possessed, or
occupied by the Federal Government.
Imminent serious condition. Any disaster or civil disturbance which is
of such severity that immediate assistance is required to save
human life, prevent immediate human suffering, or reduce
destruction or damage to property.
Local government. Any county, parish, city, village, town, district,
Indian tribe or authorized tribal organization, Alaska native
village or organization, or other political subdivision of any
State.
Major disaster. Any hurricane, tornado, storm, flood, high water, wind-
driven water, tidal wave, earth-quake, drought, fire, or other
catastrophe which, in the

[[Page 505]]

determination of the President, is or threatens to be off
sufficient severity and magnitude to warrant disaster
assistance by the Federal Government. This assistance
supplements the efforts and available resources of States,
local governments, and relief organization in alleviating the
damage, loss, hardship, or suffering caused thereby.
Objective area. A specific geographical location where a civil
disturbance or disaster is occurring or is anticipated.
Routine requests. Requests resulting from situations which are
reasonably predictable or do not require immediate action to
prevent or reduce loss of life, property, or essential
services. Reduced efficiency of the requester's operation is
not in itself grounds for classifying a request higher than
routine.
Small arms. Hand and shoulder weapons for use in war.
Surety bond. A bond, including dollar deposit, guaranteeing performance
of a contract or obligations.
Terrorist incident. A form of civil disturbance which is a distinct
criminal act committed or threatened to be committed by a
group or single individual in order to advance a political or
other objective, thus endangering safety of individuals or
property. This definition does not include aircraft piracy
emergencies.
Threatened major disaster. Any hurricane, tornado, storm, flood, high
water, wind-driven water, tidal wave, earthquake, drought,
fire, or other catastrophe which, in the determination of the
Administrator, FDAA, threatens to be of severity and magnitude
sufficient to warrant disaster assistance by the Federal
Government. This assistance will be used to avert or lessen
the effects of such disaster before its actual occurrence.
Urgent requests. Those resulting from unforeseeable circumstances, civil
disturbances, civil defense needs, aircraft piracy, secret
service requirements, and disasters when immediate action is
necessary to prevent loss of life, physical injury,
destruction of property, or disruption of essential functions.
Youth groups. Youth groups are groups such as the Boy Scouts of America;
Girl Scouts of the United States of America; Civil Air Patrol;
Camp Fire Girls, Incorporated; The Boy's Club of America;
Young Men's Christian Association; Young Women's Christian
Association; Four H Clubs; and similar groups.

Appendix B to Part 623--Approving Authority Addresses/Telephone Numbers
*

B-1. HQDA (DACA-BUS), WASH DC 20310, Telephone: AUTOVON 225-6336, WATS
202-695-6336;
---------------------------------------------------------------------------

* Telephone numbers are provided for principal loan approving
authorities and agencies responsible for specific loans IAW table 2-1.
---------------------------------------------------------------------------

B-2. HQDA (DALO-SMD), WASH DC 20310, Telephone: AUTOVON 227-5960, WATS
202-697-5960;
B-3. HQDA (DALO-SMW), WASH DC 20310, Telephone: AUTOVON 227-3159, WATS
202-697-3159;
B-4. HQDA (DAMO-ODS), WASH DC 20310, Telephone: AUTOVON 225-2003, WATS
202-695-2003;
B-5. HQDA (NGB-ZA), WASH DC 20310, Telephone: AUTOVON 227-2430, WATS
202-697-2430;
B-6. HQDA (DASG-HCL), WASH DC 20310, Telephone: AUTOVON 227-8286, WATS
202-697-8286;
B-7. Director, Civilian Marksmanship (SFNB) Room 1E-OM3, West Forrestal
Building, 1000 Independence Avenue, SW., Telephone: AUTOVON 223-6460,
WATS 202-693-6460;
B-8. Commander in Chief, US Army, Europe and Seventh Army, APO New York
09403;
B-9. Commander, First US Army, Fort George G. Meade, MD 20755,
Telephone: AUTOVON 923-7500, WATS 301-677-7500;
B-10. Commander, Fifth US Army, Fort Sam Houston, TX 78234, Telephone:
AUTOVON 471-4707, WATS 512-221-4707;
B-11. Commander, Sixth US Army, Presidio of San Francisco, CA 94129,
Telephone: AUTOVON 486-4110, WATS 415-561-4110;
B-12. Commander, US Army Armament Materiel Readiness Command, ATTN:
DRSAR-MMS, Rock Island, IL 61229;
B-13. Commander, US Army Armament Research and Development Command,
Dover, NJ 07801;
B-14. Commander, US Army Aviation Research and Development Command, PO
Box 209, St. Louis, MO 63177;
B-15. Commander, US Army Communications and Electronics Materiel
Readiness Command, Fort Monmouth, NJ 07703;
B-16. Commander, US Army Communications Research and Development
Command, Fort Monmouth, NJ 07703;
B-17. Commander, US Army Communications Security, Logistics Agency,
ATTN: SELCL-NICP-IM, Fort Huachuca, AZ 86513;

[[Page 506]]

B-18. Commander, US Army Forces Command, Fort McPherson, GA 30330,
Telephone: AUTOVON 588-2694, WATS 404-752-2694;
B-19. Commander, US Army Health Services Command, Fort Sam Houston, TX
78234;
B-20. HQDA (DAMH-HS), WASH DC 20314;
B-21. Commander, US Army Military District of Washington, Fort Leslie J.
McNair, Washington, DC 20319;
B-22. Commander, US Army Missile Materiel Readiness Command, Redstone
Arsenal, AL 35809;
B-23. Commander, US Army Missile Research and Development Command,
Redstone Arsenal, AL 35809;
B-24. Commander, US Army Security Assistance Center, ATTN: DRSAC, 5001
Eisenhower Avenue, Alexandria, VA 22333, Telephone: AUTOVON 284-9638,
WATS 202-274-9638;
B-25. Commander, US Army Tank-Automotive Materiel Readiness Command,
Warren, MI 48090;
B-26. Commander, US Army Tank-Automotive Research and Development
Command, Warren, MI 48090;
B-27. Commander, US Army Test and Evaluation Command, Aberdeen Proving
Ground, MD 21005;
B-28. Commander, US Army Training and Doctrine Command, Fort Monroe, VA
23651, Telephone: AUTOVON 680-3112, WATS 804-727-3112;
B-29. Commander, US Army Troop Support and Aviation, Materiel Readiness
Command, 4300 Goodfellow Boulevard, St. Louis, MO 63120.

Appendix C to Part 623--Agreement for Loan of US Army Materiel (DA Form
4881-R)

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Appendix D to Part 623--Certificate for Signature by an Alternate (DA
Form 4881-1-R)
[GRAPHIC] [TIFF OMITTED] TC24OC91.019

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Appendix E to Part 623--Surety Bond (DA Form 4881-3-R)

[[Page 514]]

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[GRAPHIC] [TIFF OMITTED] TC24OC91.022

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[GRAPHIC] [TIFF OMITTED] TC24OC91.023

Appendix F to Part 623--Power of Attorney (DA Form 4881-4-R)

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[GRAPHIC] [TIFF OMITTED] TC24OC91.024

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[GRAPHIC] [TIFF OMITTED] TC24OC91.025

Appendix G to Part 623--Continental US Army Boundaries

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[GRAPHIC] [TIFF OMITTED] TC24OC91.026

Appendix H to Part 623--References

AR 1-4 Deployment of DA Resources in Support of the US Secret Service.
AR 15-17 Army Representation on Office of Preparedness; General Service
Administration (OP/GSA) Regional Field Boards in Crisis
Management Operations.
AR 28-19 Department of the Army Domestic Action Program.
AR 34-1 United States Army Participation in International Military
Rationalization/Standardization/Interoperability (RSI)
Programs.
AR 37-27 Accounting Policy and Procedures for Intragovernment,
Intradefense; and Intra-Army Transactions.
AR 37-44 Accounting Procedures for Guaranteed Loans.
AR 37-48 Accounting and Reporting for Materiel, Services, and
Facilities Furnished Allied Governments and International
Organizations Under Emergency or Combat Conditions.

[[Page 520]]

AR 37-60 Pricing for Materiel and Services.
AR 37-111 Working Capital Funds--Army Stock Fund; Uniform Policies,
Principles, and Procedures Governing Army Stock Fund
Operations.
AR 58-1 Management acquisition and use of administration use motor
vehicles.
AR 130-44 Logistical Policies for Support.
AR 190-11 Physical Security of Weapons, Ammunition, and Explosives.
AR 190-49 Physical Security of Arms, Ammunition, and Explosives In-
Transit.
AR 210-55 Funding Support for Morale, Welfare and Recreational
Programs, and Facilities.
AR 230-1 The Nonappropriated Fund System.
AR 350-7 Training and Evaluation of Forces for Civil Disturbances.
AR 360-61 Army Information--Community Relations.
AR 500-1 Aircraft Piracy Emergencies.
AR 500-2 Search and Rescue (SAR) Operations.
AR 500-50 Civil Disturbances.
AR 500-60 Disaster Relief.
AR 500-70 Military Support of Civil Defense.
AR 525-90 Wartime Search and Rescue (SAR) Procedures.
AR 700-32 Logistic Support of US Nongovernmental, Nonmilitary Agencies,
and Individuals in Oversea Military Commands.
AR 700-49 Loan of DSA Stock Fund Materiel.
AR 700-83 Army Support of United Seamen's Service.
AR 710-1 Centralized Inventory Management of the Army Supply System.
AR 710-2 Materiel Management for Using Units, Support Units, and
Installations.
AR 725-1 Requisition and Issue of Supplies and Equipment--Special
Authorization and Procedures for Issues, Sales, and Loans.
AR 725-50 Requisitioning, Receipt, and Issue System.
AR 735-5 Property Accountability--General Principles, Policies, and
Basic Procedures.
AR 735-11 Accounting for Lost, Damaged, and Destroyed Property.
AR 795-25 Policies, Responsibilities, and Principles for Supply Support
Arrangements.
AR 795-204 Policies and Procedures for Furnishing Defense Articles and
Services on a Sale or Loan Basis.
AR 870-15 Historical Activities, Army Art Collection.
AR 870-20 Historical Activities, Historical Properties and Museums.
AR 920-15 National Board for the Promotion of Rifle Practice and Office
of Director of Civilian Marksmanship.
AR 920-20 Civilian Marksmanship--Promotion of Practice with Rifled
Arms.
AR 920-25 Rifles M14M and M14N for Civilian Marksmanship Use.
AR 930-5 Service Organizations--American National Red Cross Service
Program and Army Utilization.
FM 20-150 Combatives.
MOU, 25 Apr 75, between DOD and Department of Agriculture and the
Interior.
MOU, 24 Jun 75, between DOD and the American National Red Cross for
Military Support.

PART 625--SURFACE TRANSPORTATION--ADMINISTRATIVE VEHICLE MANAGEMENT--Table of Contents

Sec.
625.1 Purpose.
625.2 Applicability.
625.3 References.
625.4 OCE policy.
625.5 General.

Appendix A to Part 625--Dependent Travel Waiver of Liability

Authority: Comptroller General Decision, B-190440, 20 January 1978.

Source: 44 FR 63099, Nov. 2, 1979, unless otherwise noted.

Sec. 625.1 Purpose.

This regulation provides guidance, and authorizes dependents to
accompany a Corps employee on Temporary Duty (TDY) in a Government-owned
or leased motor vehicle.

Sec. 625.2 Applicability.

This regulation is applicable to all field operating agencies
authorized to operate or lease Administrative Use Motor Vehicles.

Sec. 625.3 References.

(a) Title 31, U.S. Code, section 638.
(b) Comptroller General Decision, 25 Comp. Gen. 844(1946) B-57732.
(c) Comptroller General Decision, 54 Comp. Gen. 855(1975) B-178342.
(d) Comptroller General Decision, B-190440, 20 January 1978.
(e) DOD Regulation 4500.36-R June 1977.

Sec. 625.4 OCE policy.

Pursuant to the authorities, penalties and interpretations cited in
the preceding references, Commanders/Directors of field operating
agencies may authorize dependents to accompany a

[[Page 521]]

Corps of Engineers employee during official travel when using a
Government-owned or leased motor vehicle, providing the following
procedures and restrictions are adhered to:
(a) The Commanders/Directors of field operating agencies must make a
Determination that transportation of the dependent is in ``the interest
of the Government''.
(b) A determination of ``the interest of the Government'' is a
matter of administrative discretion, taking into consideration the
following limitations:
(1) The use of motor vehicles shall be restricted to the ``official
use'' of the vehicles, and any questions concerning ``official use''
shall be resolved in favor of strict compliance with statutory
provisions and policies of this and other pertinent regulations.
(2) When the travel of the dependent is in ``the interest of the
Government'' and incidentally provides a convenience to the employee,
then there can be no objection to the employee's enjoyment of that
convenience. However, the convenience of itself, provides no
justification to authorize dependent travel.
(3) Dependent travel will not be provided or authorized when
justification is based on reasons of rank or prestige.
(4) Transportation to, from and between locations for the purpose of
conducting personal business or engaging in other activities of a
personal nature by military personnel, civilian officials and employees,
members of their families or others is prohibited.
(c) Increased travel time (rest stops) and operational inefficiency
(added weight) occasioned by the number of dependents to be transported
will also be considered.
(d) Dependents must understand and agree never to operate the motor
vehicle consigned to the employee for official travel.
(e) Neither the seating capacity nor the size of the motor vehicle
will be changed or increased to accommodate dependent travel.
(f) Motor vehicles as used in this regulation applies to all types
of motor vehicles, owned, consigned to or leased by the Corps of
Engineers.

Sec. 625.5 General.

(a) In view of the potential liability the Government could incur by
allowing dependents to accompany an employee in a government-owned,
consigned or leased motor vehicle, a Dependent Travel Waiver of
Liability will be obtained prior to each and every trip. Suggested
language for such waiver is set forth in appendix A.
(b) When dependents are to be transported in a GSA rented vehicle,
an extra signed copy of the Dependent Travel Waiver will be furnished
the GSA Interagency Motor Pool from which the vehicle is acquired.

Appendix A to Part 625--Dependent Travel Waiver of Liability

``I ------------------------------------------
(Name of dependent)
will be accompanying ----------,

(Name of employee)
who is my ----------------------------------
(Relationship)
and who is an employee of ----------,

(Agency, division)

on official Government business in or while using a Government vehicle.
Dates of travel are from ---------- to ---------- 19----. I do hereby
knowingly, freely and voluntarily waive any right or cause of action of
any kind whatsoever, against the United States, arising as a result of
such activity from which any liability may or could accrue while
accompanying the above employee in or while using said Government
vehicle.''

Signature of dependent

Notary Public

Date

PART 626--BIOLOGICAL DEFENSE SAFETY PROGRAM--Table of Contents

Subpart A--Introduction

Sec.
626.1 Purpose.
626.2 References.
626.3 Explanation of abbreviations and terms.
626.4 Responsibilities.

[[Page 522]]

Subpart B--Biological Defense Safety Policy and Procedures

626.5 Policy.
626.6 Mishap reporting and investigation.
626.7 Administrative and work practice controls.
626.8 Etiologic agent containment.
626.9 Inspections.
626.10 Transportaton of BDP etiologic agents.
626.11 General construction plans.
626.12 Maximum credible event (MCE).
626.13 Controls.
626.14 Waivers and exemptions.

Subpart C--BDP Contractors

626.15 Written procedures for contractor review.
626.16 Contracting agencies.
626.17 Contractor changes.
626.18 BDP contract requirements.

Subpart D--BDP Studies and Reviews

626.19 Assuring maximum safety.
626.20 Special studies.

Appendix A to Part 626--References
Appendix B to Part 626--Glossary Abbreviations

Authority: 5 U.S.C. 102, 10 U.S.C. 21, 111, 151-158, 42 U.S.C. 216,
50 U.S.C. 1431; Pub. L. 101-510, 104 Stat. 1516.

Source: 57 FR 11368, Apr. 2, 1992, unless otherwise noted.

Subpart A--Introduction

Sec. 626.1 Purpose.

(a) This regulation prescribes Department of the Army (DA) safety
policy, responsibilities, and procedures for biological defense
research, development, test, and evaluation (RDTE) operations.
(b) DA Pam 385-69 prescribes the minimum safety criteria and
technical requirements for the Army biological defense safety program
and will be used in conjunction with this regulation to establish and
implement the biological defense safety program.

Sec. 626.2 References.

Required and related publications are listed in appendix A of this
part.

Sec. 626.3 Explanation of abbreviations and terms.

Abbreviations and special terms used in this regulation are
explained in the appendix B of this part.

Sec. 626.4 Responsibilities.

(a) The Assistant Secretary of the Army (Installations, Logistics,
and Environment) (ASA(IL&E)) establishes overall Army occupational
safety and health policy and maintains oversight of the following--
(1) All aspects of environment, safety, and occupational health
statutory compliance.
(2) Safe biological defense RDTE operations.
(b) The Assistant Secretary of the Army (Research, Development, and
Acquisition) (ASA(RDA)). Establishes overall Army RDA policy and will--
(1) Integrate, coordinate, and manage Army efforts to increase
effectiveness of biological defense technologies, materiel research, and
the development and acquisition program.
(2) Review and validate all future biological defense RDTE facility
construction or renovation requirements before any organization
initiates these construction or renovation programs.
(c) The Director of Army Safety (DASAF), Office of the Chief of
Staff, Army (OCSA), administers and directs the Army Safety Program as
specified in AR 385-10. The DASAF will--
(1) Manage Army-wide safety policy and guidance for biological
defense RDTA programs as a part of the Army Safety Program.
(2) Approve all actions that imply or establish a DA safety position
for biological defense RDTE covered by this part.
(3) Represent DA on all biological defense RDTE safety studies and
reviews.
(4) Develop safety policy and standards for biological defense RDTE
operations.
(5) Develop Army level safety program guidance.
(6) Conduct an annual management review of the biological defense
occupational safety and health programs of commands with Biological
Defense

[[Page 523]]

Program (BDP) operations and responsibilities, to ensure consistency
with DA policy.
(7) Conduct biological defense safety evaluation visits, and advise
the Army Staff (ARSTAF) of concerns, trends, and needed corrective
actions.
(8) Develop policies and provide guidance for executing the
Biological Defense Safety Program.
(9) Conduct the review of general construction plans for biological
defense RDTE facilities.
(10) Establish procedures to investigate biological defense related
mishaps, referenced in AR 385-40.
(11) Serve as proponent for Army biological safety training.
(d) The Commanding General, United States Army Corps of Engineers,
(CG, USACE) will establish procedures to ensure that biological defense
RDTE facilities are designed, constructed, and acquired in accordance
with current Federal, State, Department of Defense (DOD), and DA
regulatory standards.
(e) The Surgeon General (TSG) will--
(1) Develop occupational health standards and medical support
policies for the BDP.
(2) Provide advice and guidance for health hazard assessments and
medical surveillance in accordance with current directives and policies.
(3) Provide medical guidance for selecting appropriate protective
equipment for use in the BDP.
(4) Provide a representative to each BDP special safety study group.
(5) Provide occupational health support to the DASAF for conduct of
annual management reviews (Sec. 624.4(c)(6)).
(f) The Commander, United States Army Medical Research and
Development Command (USAMRDC), in addition to major Army commands
(MACOMs) responsibilities, will--
(1) Conduct safety site assistance visits at BDP Army research
facilities, on a periodic basis as determined necessary by the DASAF,
and advise the ARSTAF of findings and recommendations.
(2) Provide a group member for all other studies and reviews.
(3) Assist Headquarters, Department of the Army (HQDA) in its
oversight role of monitoring biological defense RDTE activities
throughout the Army and advise HQDA on concerns, trends, and corrective
actions required.
(4) Assist the DASAF in performing biological defense safety program
mishap investigations.
(5) Assist the DASAF in developing biological defense safety policy
and recommend changes to policies and procedures.
(6) Serve as the proponent for the BDP Special Immunization Program.
(g) MACOM Commanders with a BDP mission will--(1) Establish and
operate an effective safety program.
(2) Publish a command program to implement HQDA biological safety
standards and to identify responsibilities for all subordinate
organizations that maintain, store, handle, use, transport, or dispose
of etiologic agents used in the BDP.
(3) Supervise subordinate organizations to ensure that an effective
safety program, which complies with this regulation, DA Pam 385-69, and
AR 385-10 is implemented and maintained.
(4) Ensure that biological defense safety programs comply with the
provisions of this regulation and DA Pam 385-69.
(5) Appoint a safety and health manager per AR 385-10, who is
occupationally qualified under Office of Personnel Management standards
and has special knowledge of biological safety and health requirements.
This safety and health manager should be the single point of contact for
all aspects of the BDP Safety Program.
(6) Review standing operating procedures (SOPs) for biological
defense RDTE operations.
(7) Develop and submit general construction plans for approval
through command channels to HQDA, Army Safety Office, DACS-SF, WASH DC
20310-0200.
(8) Approve or disapprove individual access to etiologic agent
restricted areas.
(9) Implement a Chemical Hygiene Plan, as appropriate, which meets
the requirement of 29 CFR 1910.1450.

[[Page 524]]

Subpart B--Biological Defense Safety Policy and Procedures

Sec. 626.5 Policy.

(a) This regulation applies to BDP RDTE operations involving
etiologic agents being investigated by DA for biological defense
purposes.
(b) Specific biological safety requirements and guidance are
contained in DA Pam 385-69.

Sec. 626.6 Mishap reporting and investigation.

Biological defense RDTE related mishaps will be reported and
investigated per AR 385-40 and AR 40-400. Med 16 Report will be used to
report only personnel exposure or illness related to the BDP.

Sec. 626.7 Administrative and work practice controls.

(a) The cardinal principle for safety in BDP operations is to
minimize the potential exposure of personnel to etiologic agents. In
practice, this means conducting RDTE activities using the appropriate
facilities, equipment, and procedures for the biosafety level (BL), and
requiring only the minimum number of appropriately trained personnel,
the minimum period of time, and minimum amount of the material,
consistent with program objectives and safe operations.
(b) Open air testing under the BDP is restricted to use of simulants
only, unless the Secretary of Defense determines that testing is
necessary for national security in accordance with section 409, Public
Law 91-121, 83 Stat. 204, signed November 18, 1967. Also, for RDTE
involving protective equipment or detection devices, the least hazardous
etiologic agent consistent with mission objectives will be employed. All
testing of such equipment employing etiologic agents will be in
appropriate biosafety level containment laboratories.
(c) A hazard analysis, to determine safety precautions, necessary
personnel protection and engineering features, and procedures to prevent
exposure, will be completed for--
(1) All BDP operations involving etiologic agents.
(2) A change in process or control measures that may increase
potential contact or concentrations of biological material.
(d) An SOP is required for all biological defense RDTE operations.
The SOP will--
(1) Describe in detail all necessary operational and safety
requirements.
(2) Describe in detail actions to take in the event of mishap.
(3) Describe in detail the location of required emergency response
equipment.
(4) Be available at the work site.
(5) Forbid concurrent unrelated work during biological defense RDTE
operations within a laboratory area or suite.
(6) Be approved by the commander or the safety officer and signed by
workers involved in the operation.
(7) Provide names and telephone numbers of responsible personnel.
(e) Training and information. All personnel who work directly with
etiologic agents in the BDP, or who otherwise have a potential for
exposure, will receive appropriate training to enable them to work
safely and to understand the relative significance of agent exposures.
(1) This training will include signs and symptoms of etiologic agent
exposure, information on sources of exposure, possible adverse health
affects, and practices and controls used to limit exposures. The
environmental and medical monitoring procedures in use, their purposes,
worker responsibilities in health protection programs, and handling of
laboratory mishaps will also be presented.
(2) Workers will be required to demonstrate proficiency before
performing potentially hazardous operations. Refresher training will be
repeated at least annually.
(3) Initial and refresher training will be documented and kept on
file as a permanent record.
(f) Medical surveillance. A medical surveillance program (see AR 40-
5) will be established for all personnel (military and civilian) who may
be potentially exposed to etiologic agents.

[[Page 525]]

(1) Placement, periodic medical surveillance examinations, and
termination examinations shall be conducted for each worker, to
establish a baseline health record and to provide periodic job-related
assessments of the worker's health status. Preassignment, periodic, and
termination health assessments will include a work history, a medical
history, physical examinations, indicated clinical laboratory sutdies
and, when available, examinations or tests specific to the etiologic
agent in question.
(2) Medical officers responsible for treating BDP etiologic agent
exposures and conducting medical surveillance for BDP workers shall
receive specialized training on the unique hazards of etiologic agents
and recommended medical therapies.
(3) Special immunizations will be given to personnel handling
specific etiologic agents as required.
(4) Records documenting the above will be maintained permanently.
(g) Emergency preparedness: (1) SOPs will address emergency
procedures related to any mishap involving BDP etiologic agents.
Notification and evacuation procedures will be covered in detail, as
well as measures to contain the contamination.
(2) Local, regional, State, or Federal emergency support and
coordinating agencies, such as law enforcement, fire departments, health
departments, and governments will be informed of BDP activities and the
appropriate support necessary, to include any equipment and training
necessary, to provide effective emergency response and ensure compliance
with community ``right-to-know'' statutes and regulations. Agreements
with external agencies must be formalized.
(3) If a mishap with a BDP etiologic agent results in personnel
exposure, approved emergency procedures will be immediately initiated to
protect personnel and the environment and to constrain the spread of
contamination. All personnel except those responsible for emergency
operations will evacuate the immediate area.
(4) Special medical surveillance will be started as soon as possible
for all workers present in the potentially affected area at the time of
the mishap.
(h) Labeling and posting of hazards:
(1) Hazard warning signs which incorporate the universal biohazard
symbol will be posted on the access door to the work area. (See DA PAM
385-69, para 3-5a(1).) The sign will be covered or removed if the
organizational safety officer certifies that the area has been
decontaminated.
(2) For areas irradiated with ultraviolet light, a caution sign
reading ``Ultraviolet Light, Wear Eye Protection'' will be posted.
(i) Disposal controls. Etiologic agents used in the BDP must be
decontaminated before disposal of infectious or hazardous wastes and
must not violate any Army, Federal, State, local, or host nation
environmental standards. Procedures for decontamination are described in
DA Pam 385-69.
(1) The preferred methods of decontamination of etiologic agents are
autoclaving or chemical inactivation with appropriate biocidal
solutions. (See chap 5, DA Pam 385-69.)
(2) Etiologic agents awaiting decontamination will be contained at
the appropriate biosafety level.
(j) Maintenance controls. A continuing program for equipment and
facility maintenance will be implemented for each BDP operation.
(k) Protective equipment. Guidance concerning protective equipment
is contained in DA Pam 385-69.

Sec. 626.8 Etiologic agent containment.

(a) Facility engineering controls and appropriate biocontainment
equipment will be used, in conjunction with special practices and
procedures, to minimize potential exposure of personnel and the
environment to etiologic agents used in BDP operations. Engineering and
equipment controls will be implemented to the maximum extent feasible
and verified as effective. Protective clothing will not be used in lieu
of engineering controls. Engineering controls will be the prime means of
biocontainment. Personal protective equipment such as respirators are to
be used only after feasible engineering controls have been shown unable
to control the environment fully.
(b) Before beginning any etiologic agent operation, a determination
will be made that the hazards associated

[[Page 526]]

with the operation are under positive control as defined in the
applicable SOP and that the operation complies with the criteria of this
regulation and DA Pam 385-69.

Sec. 626.9 Inspections.

(a) Biosafety laboratories require periodic (at least quarterly for
BL-1 and BL-2 and monthly for BL-3 and BL-4 laboratories), inspections
by safety and health professionals. Safety officials will document the
inspections, assure that deviations from safe practices are recorded,
and that recommended corrective actions are taken. If deviations are
life threatening, this area will be restricted until corrective actions
are accomplished. New RDTE efforts involving etiologic agents will be
evaluated and inspected prior to start-up to assure equipment,
facilities, employee training, and procedures are in place and adequate
for the introduction of BDP material. Safety officials will maintain
such records for 3 years and will review the records at least annually
for trends requiring corrective actions.
(b) Supervisors shall inspect work areas frequently (at least
weekly) and take corrective actions promptly.

Sec. 626.10 Transportation of BDP etiologic agents.

(a) Etiologic agents utilized in the BDP shall be packed, labeled,
marked, prepared for shipment, and shipped in accordance with applicable
Federal, State, and local laws and regulations, to include 42 CFR part
72, ``Interstate Shipment of Etiologic Agents,'' 49 CFR parts 172 and
173 (Department of Transportation), 9 CFR part 122 (USDA Restricted
Animal Pathogens), and DA Pam 385-69.
(b) Etiologic agents shipped to support the BDP will use secondary
shipping containers which are sealed with a crimped lid (see app D, DA
Pam 385-69).
(c) BDP organizations and contractors who provide etiologic agents
will ship all etiologic agents by private carrier. The United States
Postal Service will not be used to transport etiologic agents required
for the BDP.
(d) In addition to the above requirements, shipments of BL-4
etiologic agents will be hand carried by Government courier or under the
immediate supervision of a responsible party. This individual must be
knowledgeable about the potential hazards of the materials and be able
to monitor all aspects of the shipment to ensure that required transfers
have been completed and documented and final receipt has been
accomplished and acknowledged.
(e) Audit trails of all BDP etiologic agent shipments and receipts
of such agents shall be established and maintained for at least 3 years.
Such audit trails shall identify date of shipment, carrier, addresses of
the shipper and recipient, and agent(s) shipped and received.

Sec. 626.11 General construction plans.

General construction plans for BDP facilities, as well as for
changes in use of facilities, will be submitted through the chain of
command to HQDA, Army Safety Office, DACS-SF, WASH DC 20310-0200 for
safety review and approval. Plans shall be forwarded for new
construction or major modifications of facilities used in the BDP. The
facility system safety requirements of AR 385-16 and AR 415-15 shall be
followed. Simultaneously, RDTE requirements that necessitate such
renovation, modification, or construction shall be submitted through the
chain of command to HQDA, OASA(RDA), SARD-ZT, WASH DC 20310-0103 for
review and approval.

Sec. 626.12 Maximum credible event (MCE).

(a) Because of the complexity of the RDTE conducted in the BDP, the
range of potential consequences that could be associated with a mishap
must be considered. MCE is a risk analysis technique which provides a
useful tool for estimating the effectiveness of existing safeguards. The
potential for events must be carefully analyzed to determine the MCE
that could occur and cause a mishap. All hazard analysis and general
construction plans mentioned in Sec. 626.11 will include a consideration
of an MCE.
(b) The term MCE, as used herein, is analogous to a realistic worst-
case analysis. The best available credible information will be applied
to estimate

[[Page 527]]

the results of various MCEs. Those assumptions that yield the potential
for more severe consequences, as opposed to assumptions that operational
and safety controls will always perform as designed, will be used. The
rule of reason will be applied to confine the MCE to realistic or
believable occurrences.
(c) When considering an MCE, consider the redundancy of safety
systems engineered into the facilities and the equipment used, depending
on containment level required to make them as fail-safe as practical.
The MCE for containment laboratories must be considered in terms of
physical containment for both toxins and biological organisms.
Therefore, both toxin and biological MCEs will be considered.
(d) Because aerosols of etiologic agents represent the most
significant potential hazard for exposure of workers or the environment,
a hazard analysis (to include MCE) of proposed BDP RDTE activities will
be performed to determine the procedures, engineering controls, and
facility design required to mitigate potential significant hazards.

Sec. 626.13 Controls.

(a) Personnel who are not needed to operate a BDP laboratory, will
not be allowed to enter potentially hazardous areas.
(b) Written procedures to control access and ensure that personnel
can be evacuated or protected from exposure may be used in place of
absolute personnel exclusion.

Sec. 626.14 Waivers and exemptions.

(a) The goal of the biological defense safety program is strict
adherence to safety standards and the elimination of all waivers and
exemptions.
(b) Waiver authority. (1) The Chief of Staff, Army (CSA) is the
controlling authority for granting waivers of biological defense safety
standards. This authority is redelegated by this regulation to
commanders of MACOMs and the commander of the USAMRDC.
(2) Waiver authority will not be subdelegated.
(3) Commanders with waiver authority will--
(i) Ensure the existence of necessary and compelling reasons before
granting waivers.
(ii) Grant waivers to standards for installations and activities
within their areas of authority.
(c) Waiver requests: (1) Commanders of installations and activities
will submit a request for waiver when compliance with these standards
cannot be achieved. When such waivers affect on other commands,
initiating activities will coordinate requests with those commands.
(2) Requests for waivers will contain the following information:
(i) Description of conditions. State the mission requirements and
compelling reasons which make the waiver essential and the impact if not
approved, and describe all affected sites or facilities and the quantity
and type of BDP required.
(ii) The safety regulations, including specific safety requirements
or conditions cited by paragraph, from which the waiver is requested,
and the reasons for the waiver.
(iii) Specific time period for which the waiver is requested.
(iv) A hazard analysis which identifies actual and potential hazards
which can result from the waived requirements or conditions.
(v) A risk assessment that provides information on the risk being
assumed because of the waiver. The assessment will include those safety
precautions and compensatory measures in force during the waiver period.
(vi) A waiver abatement plan to include milestones, resources, and
actions planned to eliminate the need for the waiver.
(3) Requests for waivers will be forwarded through command channels
to the MACOM or CG, USAMRDC, as appropriate, for approval. MACOM or
USAMRDC safety officials will forward a copy of approved waivers to
HQDA, DACS-SF, WASH DC 20310-0200. Copies of all waivers will be
maintained at the installation and MACOM or USAMRDC Safety Offices for
up to 3 years after the waiver is terminated.
(4) Time limitations: (i) Waivers are normally limited to 1 year or
less, and will be considered rescinded after 1 year, unless reviewed.
The activity or

[[Page 528]]

installation commander forwarding a request for waiver will allow time
to permit investigation, evaluation, and reply.
(ii) Waivers may be renewed each year by the commander originally
granting the waiver for a waiver period not to exceed 5 years. Prior
renewal, commanders will review the need for the waiver to ensure that
circumstances requiring the waiver have not changed. Results of this
review (and a progress report regarding milestones that have been
completed) will be forwarded through command channels to the commander
originally granting the waiver.
(iii) A request for amendment will be initiated when factors or
circumstances requiring a change to the original waiver are identified.
(iv) When factors or circumstances prevent correction of the waiver
condition within 5 years of the initial approval of the waiver, such
condition becomes a candidate for an exemption.
(d) Exemptions. (1) Exemptions are relatively long-term exceptions
to otherwise mandatory standards. Exemptions will be granted only under
the following conditions:
(i) If corrective measures are impractical.
(ii) If impairment of the overall defense posture would result.
(iii) If positive programs to eliminate of the need for the
exemption are being pursued.
(2) Exemptions can be approved only by the Secretary of the Army.
(i) Requests for exemptions will be sent through command channels to
HQDA, DACS-SF, WASH DC 20310-0200.
(ii) Exemption requests will include the information required in
paragraph(c)(2) of this section.
(iii) Copies of exemption requests will be maintained at the
installation and MACOM or USAMRDC Safety Offices.

Subpart C--BDP Contractors

Sec. 626.15 Written procedures for contractor review.

The contracting agency will prepare written procedures for reviewing
contractor capability to safely perform BDP work with etiologic agents.
The written procedures will describe the criteria and guidelines for
preparing the facilities description, safety requirements, special
procedures and techniques, inspection procedures, and MCE scenarios.
These written procedures will be submitted to the contracting agency
MACOM for review and approval.

Sec. 626.16 Contracting agencies.

Contracting agencies, in coordination with their respective Command
safety offices will monitor contractor performance in meeting safety
requirements.
(a) The contracting agency will establish an inspection program and
schedule for all BDP contractors who perform contract work with BL-3 or
BL-4. Inspections will be conducted by safety and health personnel. The
schedule will include, as a minimum, the following:
(1) A pre-award inspection on site, prior to contact award, for
initial contracts for BDP work requiring BL-3 or BL-4 operations. If
during a pre-award inspection, major corrective measures are required, a
reinspection is required prior to the beginning of contract operations.
(2) A pre-award inspection of follow-on BL-3 and BL-4 contracts.
(3) A pre-operational inspection if a major change in procedures,
facilities, or equipment is made after the pre-award survey.
(4) Annual inspection of BL-3 and seminannual inspection of BL-4
contractor facilities, equipment, and operations.
(b) Pre-award surveys and annual inspections of contractors
performing work requiring BL-3 or BL-4 will be conducted by safety and
health professionals trained in BDP operational safety requirements.
Pre-award surveys and annual inspections of BL-1 and BL-2 contractors
will be conducted by safety and health professionals or contracting
agency representatives who are trained in biological safety inspection
techniques. The Safety Inspection Checklist in DA Pam 385-69 will be
used.
(c) The contracting agency will require each BDP contractor whose
contract requires the use of etiologic

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agents to prepare a facility safety program plan based on the criteria
below and submit the plan to the contracting agency for review prior to
beginning BDP contract operations. The plan will describe the contractor
organization, and procedures for meeting DOD, Army, and contracting
Command safety requirements as specified in the contract.
(1) A safety training program for all individuals working with
etiologic agents must be documented by the contractor and include, as a
minimum, the requirements in Sec. 626.7(e). Appropriate safety training
will be provided to scientists, other laboratory personnel, and
unrelated personnel such as technicians, clerical, and maintenance
workers. This training will be documented.
(2) The contractor must designate a qualified individual to be
responsible for the entire safety program with full authority to develop
and enforce contractor safety policies. Regular safety inspections will
be conducted and inspection reports will be provided to the contracting
agency upon request.
(3) Policies for storing, handling, and moving etiologic agents
within the contractor facility shall be included in the plan.
(4) Policies and procedures for disposal of any etiologic agent
waste must be identified. Disposal must comply with Federal, State, and
local regulations as well as DOD and Army requirements.
(5) An SOP must be established for each area where BDP etiologic
agents are stored, transferred, or used. In addition, an SOP must be
prepared for operations unique to any specific contract. The contractor
will provide the SOP to contracting agency personnel upon request for
review.
(6) For contracts requiring BL-3 or BL-4, the contractor will
provide (upon request) facility engineering drawings and specifications
for the relevant etiologic agent containment areas, associated
ventilation systems, and local approving authority. Also to be included
is test data verifying that all systems adequately meet the DOD and Army
safety requirements, as well as test methods for periodic
recertification of the system.
(7) MCE scenarios that ensure that all realistic threats are
considered at contractor sites, see Sec. 626.12 of this part.

Sec. 626.17 Contractor changes.

The contractor will submit proposed changes to the original safety
documentation to the contracting agency for review prior to
implementation. Requests will include justification and test data
verifying that adequate safety will be maintained.

Sec. 626.18 BDP contract requirements.

(a) Contractors performing work with BL-3 and BL-4 material must
prepare a plan detailing procedures for controlling laboratory mishaps
involving etiologic agents.
(1) The contractor shall have the necessary equipment and trained
personnel for controlling the mishap.
(2) In the event of an incidental release of a BDP etiologic agent
from appropriate laboratory biocontainment that may result in personnel
exposure, approved emergency procedures will be initiated immediately to
effectively protect personnel and the environment and to constrain the
spread of contamination. The affected areas will be decontaminated
before normal operations are resumed.
(3) Special medical surveillance will be started as soon as possible
for all workers present in the potentially affected area at the time of
the mishap.
(4) Local emergency support agencies, such as law enforcement, fire
departments, health departments, and governments will be informed of BDP
activities and the appropriate support necessary, to include any
equipment and training to provide effective emergency response.
Agreements with external agencies must be formalized.
(5) The contractor shall be required to review the plan annually and
consult external agencies if there is an agreement for them to provide
assistance. This should be done in coordination with the contracting
agency.
(b) [Reserved]

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Subpart D--BDP Studies and Reviews

Sec. 626.19 Assuring maximum safety.

(a) Safety studies and reviews are conducted to assure that maximum
safety and health measures are being taken to prevent mishaps involving
BDP etiologic agents in any amount or under any conditions that may
cause incapacitation, illness, or death to any person, or adverse
effects on the public or to the environment.
(b) The system safety requirements of AR 385-16 will be followed
during all BDP safety studies and reviews.

Sec. 626.20 Special studies.

Any HQDA agency may recommend a special study or review of an
etiologic agent or system when it becomes necessary to investigate the
condition or changes described below. The responsbile HQDA agency will
determine the scope and conduct the study or review. Special study
activities will be coordinated with HQDA, DACS-SF, WASH DC 20310-0200.
(a) Conditions or practices which may affect safety.
(b) Major system modifications including both design and physical
configuration changes.
(c) Significant changes to safety, health, and environmental
protection standards and requirements that affect BDP operations.

Appendix A to Part 626--References

These publications can be obtained from the National Technical
Information Services, U.S. Department of Commerce, 5285 Port Royal Road,
Springfield, Virginia 22161.

Required Publications

AR 40-5--Preventive Medicine. (Cited Sec. 626.7(f) introductory text)
AR 40-400--Patient Administration. (Cited in Sec. 626.6)
AR 385-10--Army Safety Program. (Cited in Secs. 626.4(c) introductory
text, 626.4(g)(3), and 626.4(g)(5))
AR 385-16--System Safety Engineering and Management. (Cited in
Secs. 626.11, and 626.19)
AR 385-40--Accident Reporting and Records. (Cited in Secs. 626.4(c)(10)
and 626.6)
AR 415-15--Military Construction, Army (MCA) Program Development. (Cited
in Sec. 626.11)
DA Pam 385-69--Biological Defense Safety Program. (Cited in
Secs. 626.1(b), 626.4(g)(3), 626.4(g)(4), 626.5(b), 626.7(h)(1),
626.7(i) intro text, 626.7(i)(1), 626.7(k), 626.8(b), 626.10(a),
626.10(b), and 626.16(b))
Med 16 Report. (Cited in Sec. 626.6)

Related Publications

A related publication is merely a source of additional information.
The user does not have to read it to understand this regulation.

AR 40-10--Health Hazard Assessment Program in Support of the Army
Material Acquisition Decision Process
AR 70-1--Systems Acquisition Policy and Procedures
AR 70-10--Test and Evaluation During Development and Acquisition of
Materiel
AR 70-18--The Use of Animals in DOD Programs
AR 70-25--Use of Volunteers as Subjects of Research
AR 70-65--Management of Controlled Substances, Ethyl Alcohol, and
Hazardous Biological Substances in Army Research, Development, Test, and
Evaluation Facilities
AR 200-1--Environmental Protection and Enhancement
AR 200-2--Environmental Effects of Army Actions
AR 405-90--Disposal of Real Estate

Appendix B to Part 626--Glossary Abbreviations

AMC--United States Army Materiel Command
AR--Army regulation
ARSTAF--Army Staff
ASA (IL&E)--Assistant Secretary of the Army (Installations, Logistics
and Environment)
ASA (RDA)--Assistant Secretary of the Army (Research, Development, and
Acquisition)
BDP--Biological Defense Program
BL--Biosafety level
CG--commanding general
CSA--Chief of Staff, United States Army
DA--Department of the Army
DA Pam--Department of the Army Pamphlet
DASAF--Director of Army Safety
DCSOPS--Deputy Chief of Staff for Operations and Plans
DOD--Department of Defense
HEPA--high efficiency particulate air
HQDA--Headquarters, Department of Army
IPR--in process reviews
MACOM--major Army command
MCA--Military Construction, Army
MCE--maximum credible event
OCSA--Office of the Chief of Staff, United States Army
R&D--research and development
RDTE--research, development, test, and evaluation
RCRA--Resource Conservation Recovery Act

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SOP--standing operating procedure
TSG--The Surgeon General, Army
USACE--United States Army Corps of Engineers
USAMRDC--United States Army Medical, Research and Development Command

Terms

Biological Defense Mishap

An event in which the failure of laboratory facilities, equipment,
or procedures appropriate to the level of potential pathogenicity or
toxicity of a given etiologic agent (organism or toxin) may allow the
unintentional, potential exposure of humans or the laboratory
environment to that agent. Mishaps can be categorized into those
resulting in confirmed exposures and those resulting in potential
exposures. A confirmed accidental exposure is any mishap in which there
was direct evidence of an exposure, such as a measurable rise in
specific antibody titer to the etiologic agent in question, or a
confirmed diagnosis of intoxication or disease. A potential exposure is
any mishap in which there was reason to believe that anyone working with
an etiologic agent may have been exposed to that agent, yet no
measurable rise in specific antibody titer or diagnosis of illness or
disease can be found. However, there is reason to believe in such a case
that the possibility existed for introduction of an etiologic agent
through mucous membranes, the respiratory tract, broken skin, or the
circulatory system as a direct result of the incident or injury.

Biocontainment Area

An area which meets the requirements for a BL-3 or BL-4 facility.
The area may be an entire building, a suite of rooms, a single room
within a building, or a biological safety cabinet.

Biological Safety Cabinets

Engineering controls designed to enable laboratory workers to handle
infectious etiologic agents and to provide primary containment of any
resultant aerosol. There are three major classes of cabinets (I, II, and
III) and several sub-classes of class II cabinets. Each type of cabinet
provides a different degree of protection to personnel and to the
products handled inside them.

Biosafety Level

A combination of facilities, equipment, and procedures used in
handling etiologic agents to protect the worker, environment, and the
community. This combination is proportional to the potential hazard of
the etiologic agent in question.

Biosafety Level 1

The facilities, equipment, and procedures suitable for work
involving agents of no known or of minimal potential hazard to
laboratory personnel and the environment.

Biosafety Level 2

The facilities, equipment, and procedures applicable to clinical,
diagnostic, or teaching laboratories, suitable for work involving
indigenous agents of moderate potential hazard to personnel and the
environment. It differs from BL-1 in that (1) laboratory personnel have
specific training in handling pathogenic agents, (2) the laboratory is
directed by scientists with experience in the handling of specific
agents, (3) access to the laboratory is limited when work is being
conducted, and (4) certain procedures in which infectious aerosols could
be created are conducted in biological safety cabinets or other physical
containment equipment. Personnel must be trained. Strict adherence to
recommended practices is as important in attaining the maximum
containment capability as is the mechanical performance of the equipment
itself.

Biosafety Level 3

The facilities, equipment, and procedures applicable to clinical,
diagnostic, research, or production facilities in which work is
performed with indigenous or exotic agents where there is potential for
infection by aerosol and the disease may have serious or lethal
consequences. It differs from BL-2 in that (1) more extensive training
in handling pathogenic and potentially lethal agents is necessary for
laboratory personnel, (2) all procedures involving the manipulation of
infectious material are conducted within biological safety cabinets, or
by other physical containment devices, (3) the laboratory has special
engineering and design features, including access zones, sealed
penetrations, and directional airflow, and (4) any modification of BL-3
recommendations must be made only by the commander.

Biosafety Level 4

The facilities, equipment, and procedures required for work with
dangerous and exotic agents which pose a high individual risk of life-
threatening disease. It differs from BL-3 in that (1) members of the
laboratory staff have specific and thorough training in handling
extremely hazardous infectious agents, (2) laboratory personnel
understand the primary and secondary containment functions of the
standard and special practices, containment equipment, and laboratory
design characteristics, (3) access to the laboratory is strictly
controlled by the commander, (4) the facility is either in a separate
building or in a controlled area within a building, which

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is completely isolated from all other areas of the building, (5) a
specific facility operations manual is prepared or adopted, (6) within
work areas of the facility, all activities are confined to Class III
biological safety cabinets or Class I or Class II biological safety
cabinets used in conjunction with one-piece positive pressure personnel
suits ventilated by a life support system, and (7) the maximum
containment laboratory has special engineering and design features to
prevent microorganisms from being disseminated to the environment.

Building

A structure that contains the requisite components necessary to
support a facility that is designed according to the required biosafety
level. The building can contain one or more facilities conforming to one
or more biosafety levels.

Confirmed Exposure

Any mishap with a BDP agent in which there was direct evidence of an
actual exposure such as: A measurable raise in antibody titer to the
agent, or a confirmed diagnosis of intoxication or disease.

Decontamination

The physical or chemical processes by which an object or area,
contaminated with a harmful or potentially harmful etiologic agent, is
made safe for handling or use. Such processes include physical removal
of all contaminants, thermal destruction of biological activity
(sterilization), chemical inactivation (biocidal process), or a
combination of these methods.

Etiologic Agent

A viable microorganism, or its toxin which causes or may cause human
disease, and includes those agents listed in 42 CFR 72.3 of the
Department of Health and Human Services regulations, and any material of
biological origin that poses a degree of hazard similar to those
organisms.

Exemption

A permanent written exemption approved by HQDA for a requirement
imposed by this regulation. An exemption is based on a determination
that conformity to the established standard is impossible, highly
impracticable, unnecessary, or not in the best interest of the United
States Government.

First Aid

Any one-time treatment, and any follow-up visit for the purpose of
observation of minor scratches, cuts, burns, splinters, and so forth,
which do not ordinarily require medical care. Such one-time treatment,
and follow-up visit for observation, is considered first aid, even
through provided by a physician or registered medical professional
personnel.

High efficiency particulate air (HEPA) filter

A filter which removes particulate matter down to sub-micron sized
particles from the air passed through it with a minimum efficiency of
99.97 percent. HEPA filters remove particulate matter with great
efficiency while vapors and gases (for example from volatile chemicals)
are not removed and pass through unrestricted. HEPA filters are used as
the primary means of removing infectious agents from air exhausted from
engineering controls and facilities.

Institute Director

The commander of an Army activity conducting RDTE with BDP etiologic
agents, or the equivalent at a research organization under contract to
the BDP.

Institution

An organization such as an Army RDTE activity (institute, agency,
center, or similar facility) or a contract organization such as a school
of medicine or research institute that conducts RDTE with BDP etiologic
agents.

Laboratory

An individual room or rooms within a facility that provides space in
which work with etiologic agents may be performed. It contains all of
the appropriate engineering features and equipment required at a given
biosafety level to protect personnel working in the laboratory and the
environment external to the facility.

Potential Accidental Exposure

Any mishap in which there was reason to believe that anyone working
with a BDP material may have been exposed to that material, yet no
measurable rise in antibody titer or diagnosis of intoxication or
disease was made. However, the high probability existed for introduction
of an agent through mucous membranes, ingestion, respiratory tract,
broken skin, or circulatory system as a direct result of the accident,
injury, or incident.

Resource Conservation Recovery Act (RCRA) Listed Hazardous Waste

The waste materials listed by Environmental Protection Agency under
authority of the RCRA for which the disposal is regulated by the
Environmental Protection Agency. A description and listing of these
wastes is located in 40 CFR part 261.

Sterilization

The complete destruction of all forms of microbial life.

[[Page 533]]

Suite

An area consisting of more than one room, and designed to be a
functional unit in which laboratory operations can be conducted. Suites
may contain a combination of laboratories and animal holding rooms or
both and associated support areas within a facility that are designed to
conform to a particular biosafety level. There may be one or more suites
within a facility.

Toxin

Toxic material of biologic origin that has been isolated from the
parent organism. The toxic material of plants, animals, or
microorganisms.

Waiver

A temporary (1 year or less) written relief from a requirement
imposed by this regulation, pending accomplishment of actions or
programs which will result in conformance to the required standards.
Waivers will not be extended beyond 5 years.

PART 627--THE BIOLOGICAL DEFENSE SAFETY PROGRAM, TECHNICAL SAFETY REQUIREMENTS (DA PAMPHLET 385-69)--Table of Contents

Subpart A--Introduction

Sec.
627.1 Purpose.
627.2 Background.
627.3 Scope.
627.4 References.
627.5 Abbreviations and terms.

Subpart B--Administration

627.6 Safety administration.
627.7 Goal of a laboratory safety program.
627.8 Occupational health.
627.9 Medical records.

Subpart C--Operational Requirements

627.10 Personnel prerequisites.
627.11 Operational prerequisites.
627.12 General laboratory techniques.
627.13 Biosafety level 1.
627.14 Biosafety level 2.
627.15 Biosafety level 3.
627.16 Biosafety level 4.
627.17 Toxins.
627.18 Emergencies.
627.19 Large-scale operations.
627.20 Operations with radioactive material.

Subpart D--Personal Protective Equipment

627.21 Introduction.
627.22 Minimum laboratory attire for use of etiologic agents.
627.23 Biosafety level 1.
627.24 Biosafety level 2.
627.25 Biosafety level 3.
627.26 Biosafety level 4.
627.27 Large-scale (LS) operations.
627.28 Solutions of toxins and dry forms of toxins in closed
containers.
627.29 Dry forms of toxins handled in open containers.
627.30 Situations specified in Sec. 627.18(e).
627.31 Specific requirements for individual PPE items.

Subpart E--Decontamination and Disposal

627.32 Introduction.
627.33 Methods of decontamination.
627.34 Disposal.

Subpart F--Importation, Shipment, and Transport of Etiologic Agents

627.35 Introduction.
627.36 Administration.
627.37 Importation directives.
627.38 Shipment directives.
627.39 Transportation directives.
627.40 Additional requirements.
627.41 Sources for further information on shipment of etiologic agents.

Subpart G--Facilities

627.42 Introduction.
627.43 Biosafety level 1.
627.44 Biosafety level 2.
627.45 Biosafety level 3.
627.46 Biosafety level 4.
627.47 Large-scale facilities.
627.48 Toxins.

Subpart H--Engineering Controls

627.49 Introduction.
627.50 Class I biological safety cabinet.
627.51 Class II biological safety cabinet.
627.52 Class III biological safety cabinet.
627.53 Fume hood.
627.54 Glove box.
627.55 Ventilated balance enclosures.
627.56 Ventilated cage enclosures.
627.57 Ventilated cage areas.

Appendix A to Part 627--References
Appendix B to Part 627--Resource List for Immunoprophylaxis of Personnel
at Risk
Appendix C to Part 627--Laboratory Safety Inspection Checklist
Appendix D to Part 627--Packaging and Labeling Requirements for Shipment
of Etiologic Agents
Appendix E to Part 627--Permits for Importation and Shipment of
Etiologic Agents
Appendix F to Part 627--Drawings, Biological Safety Cabinets
Appendix G to Part 627--Glossary

[[Page 534]]

Authority: 5 U.S.C. 102, 21 U.S.C. 111, 151-158; 42 U.S.C. 216; sec.
361, 58 Stat. 703 and 264; 49 U.S.C. App. 1803, 1804, 1807, and 1808; 50
U.S.C. 1431, 29 CFR 1910. 1450(e) and Public Law 101-510, 104 Stat.
1516.

Source: 57 FR 12604, Apr. 10, 1992, unless otherwise noted.

Subpart A--Introduction

Sec. 627.1 Purpose.

This pamphlet prescribes the technical safety requirements for the
use, handling, shipment, storage, and disposal of etiologic agents used
in research, development, test, and evaluation (RDTE) for the Biological
Defense Program (BDP)

Sec. 627.2 Background.

The United States Army BDP, on behalf of the Department of Defense,
supports RDTE efforts to maintain and develop defensive measures and
materiel to meet potential biological warfare threats. The program's
objectives are to develop measures for identification, detection,
treatment, protection against, and decontamination of these threats. To
meet the program objectives, etiologic agents are used to conduct the
necessary handling, storage, shipment, and disposal of etiologic agents.
This pamphlet describes requirements based on Centers for Disease
Control-National Institute of Health (CDC) (NIH) guidelines, Biosafety
in Microbiological and Biomedical Laboratories, and establishes
guidelines for toxins.

Sec. 627.3 Scope.

The requirements stated in this pamphlet apply to all elements of
the Army to include the ARNG and the USAR and its contractors and
subcontractors who use, produce, store, handle, or ship etiologic agents
in support of the BDP, regardless of the source of the agent(s).

Sec. 627.4 References.

Required and related publications are listed in appendix A of this
part.

Sec. 627.5 Abbreviations and terms.

Abbreviations and special terms used in this part are explained in
appendix F of this part.

Subpart B--Administration

Sec. 627.6 Safety administration.

Each BDP institution must have a safety program that complies with
AR 385-10, AR 385-69, and this pamphlet. In addition, the safety program
must be designed to ensure compliance with--
(a) Occupational Safety and Health Administration (OSHA)
requirements for health and safety.
(b) Environmental Protection Agency (EPA) regulations designed to
implement the Resource Conservation and Recovery Act (RCRA) and the
National Environmental Policy Act (NEPA).
(c) Nuclear Regulatory Commission (NRC) requirements for safe
handling of radioactive isotopes (when applicable).
(d) NIH Guidelines for Research Involving Recombinant
Deoxyribonucleic Acid (DNA) Molecules.
(e) Relevant national, State, and local regulations.
(f) Any requirements of applicable accrediting bodies.

Sec. 627.7 Goal of a laboratory safety program.

The goals of the laboratory safety program are to protect those
working in the laboratory, others who may potentially be exposed to
hazards in the laboratory, and the environment. In addition, a
laboratory safety program should ensure that hazardous materials will be
handled and disposed of in such a way that people, other living
organisms, and the environment are protected from harm. Safety awareness
must be a part of everyone's habits, and can only be achieved if all
senior and responsible staff have a sincere, visible, and continuing
interest in preventing injuries and occupational illnesses. Laboratory
personnel, for their part, must carry out their work in a way that
protects themselves and their fellow workers.
(a) Laboratory safety. The safety program will be carried out as
stated in AR 385-69. Additionally, the program will contain the
following elements--
(1) The commander or institute director, along with all personnel,
must have a continuing, observable, and known commitment to the safety
program.

[[Page 535]]

(2) An effective institutional safety program requires a safety
officer appropriately trained in relevant safety technology. This
individual, besides supplying advice and recommendations, will ensure
that records are kept showing that the institution's physical facilities
and safety rules are internally consistent and compatible with potential
risks, as well as in compliance with all applicable laws, regulations,
and guidelines.
(3) The commander ensures safety in every department or other
equivalent administrative unit of the institution. Ensuring safe
operations is an integral function of each level of management through
the first line supervisor. The safety office staff must work closely
with administrators and investigators to develop and implement written
policies and practices that promote safe laboratory work. Collectively,
this group routinely must monitor current operations and practices, see
that appropriate audits are maintained, and continue to seek ways to
improve the safety program.
(4) Safety is a critical job element for each member of the
scientific and technical staff. Each individual working in the
laboratory must perform his or her job in a manner consistent with
safety policy and training.
(5) If laboratory goals dictate operations or substances not suited
to the existing facilities or equipment, the laboratory supervisor will,
assisted by the safety officer, advise and assist the laboratory worker
in developing or obtaining adequate facilities or equipment and
designing appropriate work procedures.
(6) The supervisor will authorize each specific operation, delineate
appropriate safety procedures, and instruct those who carry out the
operation.
(7) Potential hazards will be identified before work with etiologic
agents begins, and actions necessary to avoid accidents and illnesses
will be implemented. This practice, called a job safety analysis,
consists of breaking a job down into its logical steps, analyzing each
for its hazard potential, and deciding the safe procedures to use. The
process will be designed by a project director with input from
employees, and each step with potential for exposure or other incidents
must be described in writing in a standing operating procedure (SOP).
All such SOPs will be approved by, at a minimum, the commander or
institute director and the safety officer.
(8) The job safety analysis will include a consideration of health
hazards identified in AR 40-10 and of maximum credible events as
described in paragraph 2-8, AR 385-69.
(b) Safety plans. Clearly defined, published safety rules and
monitoring procedures for compliance must be established. These rules
will be readily available, in writing, for all involved in laboratory
operations. This goal may be accomplished by preparing or modifying a
facility safety plan, laboratory safety manual, occupational safety and
health program or equivalent. This plan will--
(1) Be coordinated with institutional and Federal, State, and local
emergency services.
(2) Be practiced with the emergency groups whose services are part
of that plan prior to any need for their services, so that they can
become familiar with any potential problem areas that may be encountered
when they are called upon for assistance.
(3) Describe the method of rapid communication (for telephone,
alarms, and so forth) that will be used during an emergency.
(4) Describe the institution's etiologic agent labeling system.
(5) Describe the institution's requirements for testing engineering
controls (for example, biological safety cabinets and high efficiency
particulate air (HEPA) filters) and essential safety equipment (for
example, autoclaves) that are used to conduct RDTE funded by the BDP.
(6) Appoint and train personnel responsible for handling an
emergency.
(7) Require that emergency telephone numbers be posted, so that
emergency service personnel know whom to contact at all times of the day
or night.
(8) Describe the institution's rules that have been established and
are practiced to limit access to the facilities where etiologic agents
under the sponsorship of the BDP are handled. The rules will include the
following requirements:

[[Page 536]]

(i) Access to biosafety level (BL)-1 and BL-1 large-scale (LS)
laboratories is limited or restricted at the discretion of the commander
or institute director when experiments are in progress.
(ii) Access to areas classified as BL-2, BL-2 LS, or where work with
toxins is conducted, is limited by the commander or institute director
when work with etiologic agents is in progress. Individuals who are at
increased risk of acquiring infection or for whom infection may be
unusually hazardous are not allowed in the laboratory. Only persons who
have been advised of the potential hazard and meet any specific entry
requirements (for example, immunization) may enter the individual
laboratory or animal rooms. The commander or institute director must
assess each circumstance and determine who may enter or work in the
laboratory.
(iii) Access to areas classified as BL-3 or BL-3 LS is limited as
stated in Sec. 627.7(b)(8)(ii), and is restricted to those persons whose
presence in the facility or individual laboratory rooms is required for
program or support purposes. Individuals under 18 years of age may not
enter the controlled area.
(iv) Access to BL-4 facilities is limited as stated in
Sec. 627.7(b)(8) (ii) and (iii). This is done with secure, locked doors
with access controlled by the commander or institute director, safety
officer, or other person responsible for the physical security of the
facility. Before entry, all persons will be advised as to the
appropriate safeguards for ensuring their safety. Authorized persons
must comply with these instructions and all other applicable entry and
exit procedures. A logbook will be maintained for all personnel to
indicate the date and time of each entry and exit. A card-key activated
computer record (or other electronic entry device) may be used if it
indicates the date and time of both entry and exit.
(9) Describe the system that is developed and is operational for the
reporting of accidents and exposures, employee absenteeism, and for the
medical surveillance of potential laboratory-associated illnesses.
(c) Safety meetings and safety committees. In effective safety
programs, everyone associated with the laboratory becomes involved. This
is done by ensuring maximum participation in planning and by conducting
group safety meetings.
(1) A staff safety committee, consisting of the commander or
institute director or his or her designated representative, research
supervisors, managers, medical personnel, employees, and the safety
officer, will be established. This group leads the safety effort,
reviews mishaps, and recommends changes in policies, safety program, or
equipment as needed to improve safety.
(2) Safety committees will meet at least quarterly and minutes will
be prepared and maintained for at least 3 years.
(3) When work with recombinant DNA molecules is undertaken, an
institutional biosafety committee (IBC) for review of such work will be
established and will function as stated in the NIH Guidelines for
Research Involving Recombinant DNA Molecules (see appendix A to this
part).
(d) SOPs. Besides the documented safety program that will be in
effect, each institution will require that an SOP be established for
each unique biological defense RDTE operation. The SOPs will meet the
criteria stated in AR 385-69 and be reviewed and updated annually. A
copy of the SOP will be maintained in the work area. In addition, SOPs
will address the following issues--
(1) The unique hazards introduced by the activity in the work area.
(2) The methods of controlling these hazards.
(3) Any unique procedures and requirements needed that are not
described as universally required in the safety plan (for example,
signs, waste disposal, immunizations, emergency procedures, and
personnel monitoring).
(4) Specialized orientation or training of personnel beyond that
required in the safety plan.
(5) Ways of ensuring that the unique procedures are followed.
(6) Emergency procedures.
(e) Safety communications. Safety communications alert people to
newly recognized hazards, remind them of

[[Page 537]]

basic biological safety principles, and instill positive attitudes
toward safety. Training requirements are also found in Sec. 627.10(b). A
system of communication will be established to--
(1) Implement a biological safety training program for all personnel
working with hazardous biological or chemical materials.
(2) Publish information addressing useful biological safety advice
and accounts of laboratory accidents, along with the lessons to be
learned from them.
(3) Make reference books and regulations concerning laboratory
hazards, occupational health, and proper laboratory practices readily
available.
(4) Assure that material safety data sheets (MSDS) for hazardous
chemicals used in the laboratory are readily available to all employees.
(f) Safety audits. One of the essential elements of a good safety
program is the conduct of periodic audits of the safety performance in a
laboratory. Observing individual safety practices and checking the
operability of safety equipment and compliance with safety rules must be
part of the audit.
(1) An individual and an alternate will be appointed for each
laboratory or room where BDP work is conducted. On a daily basis he or
she will monitor the conduct of personnel within their room(s) and
maintenance of the room to see that they comply with the safety program
and SOPs.
(2) Supervisors will ensure that their projects comply with
applicable safety requirements and will audit their areas at least
weekly to ensure compliance.
(3) The safety officer or his or her qualified designee will inspect
the institution's BL-1, BL-2, and toxin laboratories quarterly. BL-3 and
BL-4 laboratories and those in which dry forms of highly potent toxins
are handled will be inspected monthly by safety and health
professionals. These inspections will be announced and include coverage
of general safety practices as well as features specific to a particular
biosafety level.
(i) Reports of deficiencies or procedures that create a potentially
life-threatening situation will be made directly to supervisory
personnel and the commander or institute director and actions will be
taken immediately to correct the situation. The operation will not
continue until every deficiency is corrected.
(ii) Reports of deficiencies for other than life-threatening
situations will be made as soon as possible to the appropriate
supervisor, with copies furnished to the commander or institute
director. If a problem is widespread, all affected personnel will be
notified.
(4) Supervisory personnel notified of safety deficiencies by the
safety officer will ensure that the people directly concerned are
contacted and that the deficiencies are remedied before operations are
resumed.
(5) Malfunctioning equipment must be reported to the appropriate
individuals, labeled to indicate that it should not be used, and
repaired promptly.
(6) As a minimum, the audits conducted by the safety officer or his
or her qualified designee will cover the items listed in appendix C to
this part.
(g) Documentation. Records, documenting the following items, will be
maintained for 3 years:
(1) Safety audits and the corrective measures.
(2) Risk assessments for proposed new laboratory procedures.
(3) Annual reviews of established SOPs.
(4) Training.
(5) Engineering controls and protective equipment certifications and
tests.
(6) Safety committee meeting minutes and recommendations.
(7) Any outside auditor comments and responses.

Sec. 627.8 Occupational health.

An occupational health program will be implemented per AR 40-5,
chapter 5, for all employees whose employment requires that they conduct
duties in a BDP etiologic agent area. Essential elements of the program
will include--
(a) Medical surveillance examinations. Medical examinations by a
licensed medical doctor will be given prior to employment, at least
every 3 years thereafter, and upon termination of duties requiring
access to laboratories where etiologic agents are used. When full
medical examinations are not given annually, health professionals will
perform annual health screening.

[[Page 538]]

Safety and health professionals will ensure that medical examiners are
made aware of all hazardous substances each employee works with at the
time of the medical examination. The physician's findings will include
assessment of whether an employee has any health condition that would
preclude work with etiologic agents. If any of the findings obtained
during the examination are outside the normal range, the employee's
supervisor and the employee will be notified and counseled on the
courses of action available. In addition, a safety and health audit will
be conducted to identify any potential occupational causes for the
abnormalities, and corrective measures will be taken if applicable.
(b) Serum samples. When appropriate, considering the agent(s)
handled, baseline serum samples for laboratory and other at-risk
personnel will be collected and stored for their biologically useful
lifetime, but not longer than 40 years. Additional serum specimens will
be collected periodically, based upon the agents handled, or as required
by participation in a special immunizations program. SOPs will be
written detailing the collection procedures and periods if serum
sampling is deemed necessary.
(c) Assignment of personnel. Personnel assigned duties in work areas
where etiologic agents are used will be evaluated to determine their
suitability for their assigned tasks by the installation medical
authority. Only personnel who are physically and mentally capable of
working in biocontainment areas (BL-3 and BL-4) or with toxins will be
assigned to these duties.
(d) Immunization of at-risk personnel. The guidelines for
immunizations in the latest edition of the American College of
Physicians' Guide for Adult Immunizations and recommendations of Health
and Human Services (HHS) in publication number (NIH) 88-8395 shall be
followed. A resource list for available immunizations for personnel at
risk is given in appendix B of this part.
(e) Reporting exposures. Spills and mishaps which result in
observable, known or potential exposures to etiologic agents will be
immediately reported to the supervisor, the safety officer, the
responsible medical personnel, and the commander. Appropriate medical
evaluation, surveillance, and treatment will be provided and written
records of these occurrences will be maintained for 40 years. A Med-16
report will be initiated (see AR 40-400).
(f) Quarantine. When etiologic agents designated as BL-4 by the CDC-
NIH in HHS publication no. (NIH) 88-8395, (or most recent edition) are
handled, a facility for the quarantine, isolation, and medical care of
personnel with potential or known laboratory-associated exposures will
be available.

Sec. 627.9 Medical records.

Army activities will maintain medical records in accordance with AR
40-66 and FPM 293-31 for all military and Department of the Army (DA)
civilian employees who work with etiologic agents under sponsorship of
the BDP.

Subpart C--Operational Requirements

Sec. 627.10 Personnel prerequisites.

(a) Medical. Before to assignment to work with etiologic agents,
personnel will be evaluated by the appropriate medical personnel with
respect to their assignment and will be evaluated in the medical
surveillance program described in Sec. 627.8.
(b) Training. All personnel directly or indirectly involved with
containment or handling of known and potentially biohazardous material
shall receive instruction that adequately prepares them for their
assigned duties. Training will be given by occupationally qualified
personnel as determined by the commander. This training will be
documented and will include--
(1) General training--
(i) Personal hygiene related to laboratory work.
(ii) Laboratory practices.
(iii) Personal protective equipment.
(iv) Effective use of engineering controls.
(v) Packaging, transportation, and shipment of etiologic agents
(when applicable).
(vi) Hazardous and infectious waste disposal, handling, and
minimization procedures.

[[Page 539]]

(2) Training conducted specifically for the facilities that the
individual will be working in, including--
(i) Procedures for the facility.
(ii) Reporting incidents and accidents.
(iii) Labeling and posting of signs.
(iv) Biohazardous waste handling, approaches to minimizing the
volume of waste, decontamination, packaging, and disposal.
(v) Emergency procedures.
(3) Additional general training required for work in facilities
where viable etiologic agents are present.
(i) Aseptic technique and procedures to include hands-on instruction
and demonstration of proficiency.
(ii) Concept and definition of biosafety levels.
(iii) Disinfection and sterilization.
(iv) Safe use of workplace equipment, for example autoclave and
centrifuge.
(v) Monitoring and auditing requirements.
(vi) Precautions for handling blood, tissues, and body fluids (when
applicable).
(vii) The infectivity, pathogenicity, mode(s) of transmission, and
medical surveillance requirements of specific agents.
(viii) Training for all new employees will include a period of
supervised orientation in the facilities by a scientist or technician
with specific training in the procedures and properties of the etiologic
agents in use. During the training period, new laboratory personnel will
be under the constant supervision of appropriately trained personnel.
(ix) Personnel who are assigned tasks in BL-2, BL-3, or BL-4
facilities will also have specific training in handling pathogens.
(x) Personnel assigned duties in a BL-4 facility will also have
specific and thorough training in handling extremely hazardous
infectious agents, the primary and secondary containment functions of
standard and special practices, use of personal protective equipment,
containment equipment, and laboratory design characteristics.
(4) Additional general training for handling toxins will include
relevant items from Sec. 627.10 plus--
(i) The availability of reference material on the hazards and safe
handling of toxic substances.
(ii) The biological effects of the toxin(s) in use.

Sec. 627.11 Operational prerequisites.

(a) Evaluation of the risks. The risk assessment of laboratory
activities involving the use of etiologic agents is ultimately a
subjective process. Those risks associated with the agent, as well as
with any adjunct elements of the activity to be conducted, (chemicals,
radioisotopes, end-products, and so forth) must be considered in the
assessment. The appropriate biosafety level for work with a particular
agent or animal study depends on the virulence, pathogenicity,
biological stability, route of transmission, and communicability of the
agent; the nature of the laboratory; the procedures and manipulations to
be used; the quantity and concentration of the agent; and the
availability of effective vaccines or therapeutic measures.
(b) The characteristics of etiologic agents, primary laboratory
hazards of working with the agent, and recommended biosafety levels are
described by CDC-NIH (HHS publication No. (NIH) 88-8395), the
considerations for recombinant DNA molecules are described by NIH, and
those for oncogenic viruses are described by NCI-NIH (sources listed
below). The commander or institute director will assign work with given
etiologic agents to the appropriate biosafety level. A risk assessment
should take into account not only the NIH Guidelines for Research
Involving Recombinant DNA Molecules, but also potential hazards
associated with the organism and the product of the experimentation.
(1) When established guidelines exist, these will be followed. The
primary source guidelines are--
(i) HHS Publication No. (NIH) 88-8395, Biosafety in Microbiological
and Biomedical Laboratories, as amended, and updates published in
Morbidity and Mortality Weekly Report.
(ii) NIH Guidelines for Research Involving Recombinant DNA Molecules
(FR 51: 16958-16985 and updates).

[[Page 540]]

(iii) The publication by the American Committee on Arthropod-Borne
Viruses Subcommittee on Arbovirus Laboratory Safety (SALS) entitled
Laboratory Safety for Arboviruses and Certain Other Viruses of
Vertebrates in the American Journal of Tropical Medicine and Hygiene,
29(6), 1980, pp. 1359-1381.
(iv) The Department of Health and Human Services Publication No.
(NIH) 76-1165 by the National Cancer Institute (NCI) entitled Biological
Safety Manual for Research Involving Oncogenic Viruses.
(2) When samples with unidentified viable agents are obtained, a
knowledgeable and qualified scientist will evaluate the risks and make
recommendations to the safety officer, who will add recommendations for
review and approval by the commander or institute director. When
guidelines for a specific organism are not established, in addition to
these steps, the CDC or SALS or both will be consulted. Their
recommendations will be documented and provided to the commander or
institute director before approval.
(c) Selection of facilities. The facility requirements identified by
the risk assessment will be adhered to. Any variations and compensatory
measures will be approved by the IBC (when recombinant DNA molecules are
involved), the safety officer, and the commander or institute director
before a request for an exception or waiver is submitted as stated in AR
385-69.
(d) Policies and procedures. Policies in the form of a laboratory
safety manual, regulations, memorandums, or SOPs are required for work
with etiologic agents in the BDP. Before beginning a new procedure, the
policies and procedures will be reviewed to ascertain that the intended
operations are described and to determine the requirements that apply to
the operation. If procedures exist for the intended operation, personnel
will be trained to follow them; if procedures do not exist, then a
detailed SOP will be written, reviewed, and approved before beginning
the operation. SOPs will conform to the requirements stated in
Sec. 627.7(d), and be signed by all personnel who are required to follow
the procedures, thus acknowledging that they have read and understood
the contents. All SOPs that pertain to a specific area (room,
laboratory, or suite) will be available at the worksite.

Sec. 627.12 General laboratory techniques.

The general requirements for use of etiologic agents are composed of
two sets of requirements, with the requirements for toxins being a
subset of the requirements for handling viable etiologic agents. These
requirements are as follows--
(a) General techniques applicable to etiologic agents.
(1) A fully fastened long-sleeved laboratory coat, gown, uniform, or
coveralls will be worn in laboratories or animal rooms.
(2) Eating, drinking, smoking, and applying cosmetics are not
permitted in the work areas.
(3) Personnel must wash their hands after they handle etiologic
agents or animals, and before leaving the laboratory area.
(4) Mouth pipetting is strictly prohibited. Mechanical pipetting
aids must be used.
(5) Gloves--(i) Will be worn when manipulating etiologic agents and
handling containers of etiologic agents. Gloves are not required when
materials are packaged appropriately for shipment.
(ii) Will be selected based on the hazards.
(iii) Will be changed frequently (or decontaminated frequently), and
will be decontaminated or discarded into a labeled biohazard container
after each use and immediately upon observable direct contact with an
etiologic agent.
(iv) Will be removed at the work-space (workbench or hood) after
handling etiologic agents to ensure that doorknobs and other surfaces
are not contaminated.
(6) Good housekeeping will be maintained. This includes--
(i) Work areas free of clutter.
(ii) Work environment free of tripping hazards, with adequate access
to exits, emergency equipment, controls, and such.
(iii) Benches and general work areas will be cleaned regularly using
a wet

[[Page 541]]

sponge or similar method with disinfectant as appropriate. Methods that
stir up dust such as sweeping or using vacuum cleaners, (except for
HEPA-filtered vacuum cleaners) are unacceptable.
(iv) Specific work areas will be cleaned and decontaminated
immediately following each use of an etiologic agent (at least once a
day) and after any spill of viable material.
(v) Hallways and stairways will not be used for storage.
(7) All solutions, reagents, and chemicals will be labeled.
(8) All contaminated liquid or solid wastes will be inactivated
before disposal.
(9) Work will be conducted over spill trays or plastic-backed
absorbent paper. The paper will be removed, decontaminated, or
disinfected, and the general area wiped with decontaminant at the end of
each day or at the end of the experiment, whichever occurs first.
(10) Etiologic agents will be kept in closed containers when not in
use. Cultures, solutions, or dried etiologic agents in glass vessels
transported or incubated within a room or suite will be handled in
nonbreakable, leak-proof pans, trays, pails, carboys, or other secondary
containers large enough to contain all the material, if the glass vessel
leaks or breaks. Etiologic agents removed from a room or suite for
transport to another approved area within the same building will be
placed in a closed unbreakable secondary container before removal from
the laboratory. The secondary container will be labeled on the exterior
with a biohazard symbol and identification of the contents, including
the required biosafety level, the scientific name, the concentration (if
applicable), and the responsible individual. The secondary containers
will be wiped with suitable disinfectant before removal from the
laboratory or area.
(11) Working stocks of etiologic agents will be stored in double
containers. The primary and secondary containers will provide a positive
seal and the secondary container will be unbreakable. The secondary
container will be labeled as stated in Sec. 627.12 (a)(10) and with the
date stored.
(12) Storage units (for example, freezers, refrigerators, cabinets,
and hoods) will be labeled with the universal biohazard sign and
indicate the classes of etiologic agents contained in them. Storage
units will be secured when not in use.
(13) All contaminated materials, containers, spills, and solutions
will be decontaminated or disinfected by approved methods before
disposal.
(14) After injection of an etiologic agent into animals, the site of
injection will be swabbed with a decontaminant.
(15) Syringes. (i) Reusable or disposable syringes will be of the
fixed needle or LUER-LOK type (or equivalent) to assure that the needle
cannot separate during use.
(ii) After use, nondisposable glass syringes with attached needles
contaminated with etiologic agents will be submerged in a container of
decontaminant. Disposable syringes will be discarded with needles
attached in puncture-proof rigid containers. Needles will not be
recapped after use.
(iii) Sterilized or decontaminated containers marked ``Syringes and/
or Needles'' may be deposited in appropriate refuse containers after
proper packaging and destruction of the contents.
[Note: Many States, especially those on the Eastern seaboard, have
implemented strict requirements for the disposal of medical wastes. For
example, Maryland has designated all waste from a microbiological
laboratory as hazardous waste with licensing requirements for generators
of 50 kilograms per month or more of waste, while all medical waste
released for transport off-site must be manifested to a State licensed
medical waste hauler with the destination specified. Additionally, in
some cases, the local government (for example, a city) regulates the
disposal of these wastes. These requirements will be identified and
followed.]

Needles or syringes may not be destroyed by clipping. A mechanical shear
may be used to smash or sheer needles after or concurrently with
sterilization or decontamination.
(16) Refrigerators, deep freezers, and dry ice chests should be
checked, cleaned out, and defrosted periodically to remove any ampules,
tubes, and so forth, containing etiologic agents that may have broken
during storage. Rubber gloves and respiratory protection

[[Page 542]]

appropriate to the materials in storage should be worn during cleaning.
Do not store flammable solutions in nonexplosion proof refrigerators.
(b) Additional techniques applicable to work with viable etiologic
agents. The major objective of these techniques is to assist in
protection against laboratory acquired infections. Air sampling studies
have shown that aerosols are generated from most of the manipulations of
bacterial and viral cultures common to research laboratories. The
generation of aerosols during routine laboratory manipulations must be
considered when evaluating the individual degree of risk, keeping in
mind the four main factors governing infection: dosage, virulence of the
organism, route of infection (for example, skin, eyes, mouth, lungs),
and host susceptibility (for example, state of health, natural
resistance, previous infection, response to vaccines and toxoids). The
requirements stated below are minimum handling requirements to prevent
accidental infection created by incidental aerosols.
(1) All procedures are performed carefully to minimize the creation
of aerosols.
(2) No infectious mixtures will be prepared by bubbling air through
a liquid.
(3) Pipettes.
(i) No infectious material will be forcibly ejected from pipettes.
Only to deliver (TD) pipettes will be used.
(ii) Pipettes used with infectious or toxic materials will be
plugged with cotton unless they are used exclusively in a gas-tight
cabinet system.
(iii) Contaminated pipettes will be placed horizontally in a rigid
container containing enough disinfectant for complete immersion.
Cylinders used for vertical discard are not recommended. The container
and pipettes must be autoclaved as a unit and replaced by a clean
container containing fresh disinfectant.
(iv) Pipetting devices must be used. Under no circumstances is mouth
pipetting permitted.
(4) Syringes. (i) Using syringes and needles for making dilutions of
etiologic agents is not recommended.
(ii) When removing a syringe and needle from a rubber stopper bottle
containing viable etiologic agents, an alcohol soaked pledget around the
stopper and needle will be used.
(iii) Excess fluid and bubbles should be expelled from syringes
vertically into a cotton pledget soaked with disinfectant or into a
small bottle containing disinfectant-soaked cotton.
(iv) The site of injection of an animal will be swabbed with a
disinfectant before and after injection.
(v) After use, syringes contaminated with residual infectious fluid
will be submerged in a container of disinfectant in a safety cabinet
prior to removal for autoclaving. To minimize accidental injection of
infectious material, the removable needles should remain on such
syringes until after autoclaving. When possible, syringes with attached
needles should be placed in a pan separate from that holding other
discarded materials.
(vi) Caps will not be placed over needles until after disinfection.
During recapping, procedures to prevent personal injuries will be used.
(5) Centrifuges and shakers. (i) Before centrifuging, tubes, rotors,
seals, and gaskets will be checked for cleanliness and integrity. In low
speed clinical-type centrifuges, a germicidal solution may be added
between the tube and trunnion cup to disinfect the outer surfaces of
both and to cushion against shocks that might break the tube. Metal or
plastic tubes (other than nitro-cellulose) will be used.
(ii) Decanting from centrifuge tubes will be avoided. If decanting
is necessary, the outer rim will be wiped with a disinfectant after
decanting so that material on the lip cannot spin off as an aerosol.
Centrifuge tubes will not be filled byond the level the manufacturer
recommends.
(iii) Broth cultures will be shaken in a manner that avoids wetting
the plug or cap.
(6) Water baths in which viable etiologic agents are incubated must
contain a disinfectant. For cold water baths, 70 percent propylene
glycol is recommended. The disinfectant should be changed frequently.
(7) When a laboratory vacuum is used to manipulate viable etiologic
agents, a secondary reservoir containing disinfectant and a HEPA filter
must be employed to ensure that the laboratory

[[Page 543]]

vacuum lines do not become contaminated.
(8) Test tubes. (i) Tubes containing viable etiologic agents should
be manipulated with extreme care. Studies have shown that simple
procedures, such as removing a tube cap or transferring an inoculum, can
create a potentially hazardous aerosol.
(ii) Manipulation of biohazardous test tubes will be conducted in
biological safety cabinets. Tubes and racks of tubes containing
biohazardous material should be clearly marked. The individual employee
must ensure that tubes containing biohazardous material are properly
sterilized prior to disposal or glassware washing. Safety test tube
trays should be used in place of conventional test tube racks to
minimize spillage from broken tubes. When safety test tube trays are not
used, the conventional test tube racks will be placed in a tray large
enough to contain any potential spill. A safety test tube tray is one
having a solid bottom and sides deep enough to hold all liquids, should
a test tube break.
(9) Care should be exercised when using membrane filters to obtain
sterile filtrates of viable etiologic agents. Due to the fragility of
the membranes and other factors, such filtrates cannot be considered
noninfectious until laboratory culture or other tests have proven their
sterility.
(10) The preparation, handling, and use of dry powders of viable
etiologic agents in open containers presents unusual hazards. The
slightest manipulation of such powders can cause the generation of
aerosols containing a high concentration of etiologic agents. Therefore,
work with dry powders of etiologic agents in open containers should be
carried out in gas-tight biological safety cabinets.

Sec. 627.13 Biosafety level 1.

(a) Requirements beyond those for all etiologic agents. BL-1
operations follow the general techniques described in Secs. 627.12(a)
and 617.12(b).
(b) Additional laboratory requirement. Contaminated materials that
are to be decontaminated at a site away from the laboratory are placed
in a durable leak-proof container which is closed before being removed
from the laboratory. Examples of suitable containers are metal tubs with
lids or plastic bags that are sealed and then placed inside a rigid
container for transport.
(c) Additional animal requirements. (1) Bedding materials from
animal cages will be removed in such a manner as to minimize the
creation of aerosols and disposed of in compliance with applicable
institutional or local requirements.
(2) Cages are washed manually or in a cagewasher. Temperature of
final rinse water will be a minimum of 180 deg.F.
(3) Laboratory coats, gowns, or uniforms worn in animal rooms shall
not be worn in other areas.

Sec. 627.14 Biosafety level 2.

(a) Additional requirements. In addition to the general
microbiological techniques stated in Sec. 627.13, BL-2 operations
include the following requirements:
(1) When etiologic agents are in use, a hazard warning sign
incorporating the universal biohazard symbol is posted on the access
door of the work area. The hazard warning sign identifies the etiologic
agent, lists the name and telephone number of the institute director or
other responsible person(s), and indicates the special requirement(s)
for entering the laboratory.
(2) Animals not involved in the work being performed are not
permitted in the laboratory.
(3) Special care is taken to avoid skin contamination with the
etiologic agents; gloves will be worn when handling etiologic agents or
infected animals.
(4) All wastes from laboratories and animal rooms are decontaminated
before disposal.
(5) Hypodermic needles and syringes are used only for parenteral
injection and aspiration of fluids from laboratory animals and diaphragm
bottles.
(6) Spills and accidents which result in a potential exposure to
etiologic agents will be reported immediately to the safety officer, the
project leader, and the institute director.
(7) Biological safety cabinets (Class I or II) will be used when:
(i) Procedures with a high potential for creating infectious
aerosols are conducted.

[[Page 544]]

(ii) High concentrations or large volumes of etiologic agents are
used.
(8) Laboratory coats, gowns, smocks, or uniforms will be removed
before leaving the animal facility or laboratory area.
(b) Additional animal requirements.
(1) Cages must be decontaminated, preferably by autoclaving, before
they are cleaned and washed.
(2) Approved molded masks are worn by all personnel entering animal
rooms housing nonhuman primates.
(3) If floor drains are provided, the drain traps will be kept
filled with water or a suitable disinfectant.

Sec. 627.15 Biosafety level 3.

(a) Additional requirements. In addition to the requirements stated
in Secs. 627.13 and 627.14, the following requirements apply--
(1) Approved molded masks or respirators with HEPA filters are worn
by all personnel in rooms housing infected animals.
(2) Protective clothing worn in a laboratory or animal room will be
removed before exiting the laboratory or animal room.
(3) Clothing worn in laboratories and animal areas to protect street
clothing will be decontaminated before being laundered.
(b) Additional laboratory requirements. (1) Laboratory doors will be
kept closed.
(2) All activities involving etiologic agents will be conducted in
biological safety cabinets (Class I, II, or III) or other physical
containment devices within the containment module. No work in open
vessels is conducted outside a biological safety cabinet.
(3) The work surfaces of biological safety cabinets and other
containment equipment will be decontaminated after work with etiologic
agents. Plastic-backed paper toweling should be used on nonperforated
work surfaces within biological safety cabinets to facilitate clean-up.
(c) Additional animal requirements. (1) Cages are autoclaved before
bedding is removed and before they are cleaned and washed.
(2) Gloves are removed aseptically and autoclaved with other wastes
before being disposed of or reused.
(3) Boots, shoe covers, or other protective footwear and
disinfectant foot baths must be available and used when indicated.
(4) Personal protective clothing and equipment and other physical
containment devices are used for all procedures and manipulations of
etiologic agents or infected animals. The risk of infectious aerosols
from infected animals or their bedding shall be reduced by housing
animals in partial containment caging systems as described in
Sec. 627.56.
(d) Work with BL-3 etiologic agents that require additional
secondary containment. Facilities in which work with certain viruses,
for example, Rift Valley fever, yellow fever, and Venezuelan equine
encephalitis, is conducted require HEPA filtration of Xallexhaust air
prior to discharge from the laboratory. All persons working with those
agents for which a vaccine is available should be immunized.

Sec. 627.16 Biosafety level 4.

Laboratory work at BL-4 must follow the requirements stated in
Secs. 627.13, 627.14 and 627.15 as well as the following:
(a) All activities are conducted in Class III biological safety
cabinets or in Class I or II biological safety cabinets in conjunction
with a one-piece positive pressure personnel suit ventilated by a life-
support system.
(b) Biological materials to be removed from the Class III cabinet or
from the maximum containment laboratory in a viable or intact state must
be transferred to a sealed nonbreakable primary container, enclosed in a
nonbreakable sealed secondary container, and removed from the facility
through a disinfectant dunk tank, fumigation chamber, or an airlock
designed for this purpose.
(c) No materials, except for biological materials that are to remain
in a viable or intact state, are removed from the maximum containment
laboratory unless they have been autoclaved or decontaminated before
they leave the facility. Equipment or material which might be damaged by

[[Page 545]]

high temperature or steam is decontaminated by gaseous or vapor methods
in an airlock or chamber designed for this purpose.
(d) Personnel may enter and leave the facility only through the
clothing change and shower rooms. Personnel must shower each time they
leave the facility. Personnel may use the airlocks to enter or leave the
laboratory only in an emergency.
(e) Street clothing must be removed in the outer clothing change
room and kept there. Complete laboratory clothing, including
undergarments, pants and shirts or jumpsuits, shoes, and gloves, will be
provided and must be used by all personnel entering the facility. Head
covers are provided for personnel who do not wash their hair during the
shower. When leaving the laboratory and before proceeding into the
shower area, personnel must remove their laboratory clothing and store
it in a locker or hamper in the inner change room.
(f) When etiologic agents or infected animals are present in the
laboratory or animal rooms, a hazard warning sign incorporating the
universal biohazard symbol must be posted on all access doors. The sign
must identify the agent, list the name of the commander or institute
director or other responsible person(s), and indicate any special
requirements for entering the area (for example, the need for
immunizations or respirators).
(g) Supplies and materials needed in the facility are brought in by
way of the double-doored autoclave, fumigation chamber, or airlock which
is appropriately decontaminated after each use. After securing the outer
doors, personnel within the facility retrieve materials by opening the
interior doors of the autoclave, fumigation chamber, or airlock. These
doors are secured after materials are brought into the facility.
(h) Materials (for example, animals and clothing) not related to the
experiment being conducted are not permitted in the facility.
(i) Whenever possible, avoid using any glass items.

Sec. 627.17 Toxins.

The laboratory facilities, equipment, and procedures appropriate for
work with toxins of biological origin must reflect the intrinsic level
of hazard posed by a particular toxin as well as the potential risks
inherent in the operations performed. All toxins must be considered to
pose a hazard in an aerosol form. However, most toxins exert their
effects only after parenteral exposure or ingestion, and a few toxins
present a dermal hazard. In general, toxins of biological origin are not
intrinsically volatile. Thus, the laboratory safety precautions
appropriate for handling these materials closely parallel those for
handling infectious organisms. The requirements in this section for the
laboratory use of toxins of biological origin include the requirements
in Sec. 627.12(a) and the following:
(a) Vacuum lines. When vacuum lines are used with systems containing
toxins, they will be protected with a HEPA filter to prevent entry of
toxins into the lines (or sink drains when water aspirators are used).
(b) Preparation of concentrated stock solutions and handling closed
primary containers of dry toxins. Preparation of primary containers of
toxin stock solutions and manipulations of closed primary containers of
dry forms of toxins will be conducted--
(1) In a chemical fume hood, a glove box, or a biological safety
cabinet or equivalent containment system approved by the safety officer.
(2) While wearing eye protection if using an open-fronted
containment system.
(3) Ensuring that gloves worn when handling toxins will be disposed
of as toxin waste, with decontamination if required.
(4) With the room door closed and posted with a universal biohazard
sign, or other sign, indicating that toxin work is in progress.
Extraneous personnel shall not be permitted in the room during
operations.
(5) Ensuring that toxins removed from hoods or biological safety
cabinets are double-contained during transport.
(6) After verification of hood or biological safety cabinet inward
airflow is

[[Page 546]]

made by the user before initiating work.
(7) Within the operationally effective zone of the hood or
biological safety cabinet.
(8) Ensuring that nondisposable laboratory clothing is
decontaminated before release for laundering.
(9) Ensuring that all individuals who handle toxins wash their hands
upon each exit from the laboratory.
(10) With two knowledgeable individuals present whenever more than
an estimated human lethal dose is handled in a syringe with a needle.
Each must be familiar with the applicable procedures, maintain visual
contact with the other, and be ready to assist in the event of an
accident.
(c) Manipulations with open containers of dry forms of toxins.
Handling dry forms of toxins in uncovered containers (for example,
during weighing) will be performed following the requirements stated in
Secs. 627.12(a), 627.17 (a) and (b), and the following:
(1) Manipulations will be conducted in a HEPA filtered chemical fume
hood, glove box, or biological safety cabinet. In addition the exhaust
may be charcoal filtered if the material is volatile.
(2) When using an open-fronted fume hood or biological safety
cabinet, protective clothing, including gloves and a disposable long-
sleeved body covering (gown, laboratory coat, smock, coverall, or
similar garment) will be worn so that hands and arms are completely
covered. Eye and approved respiratory protection is also required. The
protective clothing will not be worn outside of the laboratory and will
be disposed of as solid toxin waste.
(3) Before containers are removed from the hood, cabinet, or glove
box, the exterior of the closed primary container will be decontaminated
and placed in a clean secondary container.
(4) When toxins are in use, the room will be posted to indicate
``Toxins in Use--Authorized Personnel Only.'' Any special entry
requirements will be posted on the entrance(s) to the room.
(5) All operations will be conducted with two knowledgeable
individuals present. Each must be familiar with the applicable
procedures, maintain visual contact with the other, and be ready to
assist in the event of an accident.
(6) Individuals handling toxins will wash their hands upon leaving
the laboratory.
(d) Additional considerations of specific toxin properties. The
following requirements are in addition to the requirements stated in the
paragraphs above. Determine whether the material fits Sec. 627.17 (b) or
(c), and complies with the appropriate section and the following when
applicable:
(1) When handling dry forms of toxins that are electrostatic--
(i) Do not wear gloves (such as latex) that help to generate static
electricity.
(ii) Use glove bag within a hood or biological safety cabinet, a
glove box, or a class III biological safety cabinet.
(2) When handling toxins that are percutaneous hazards (irritants,
necrotic to tissue, or extremely toxic from dermal exposure)--
(i) Gloves will be selected that are known to be impervious to the
toxin and the diluent (when applicable) for the duration of the
manipulations.
(ii) Disposable laboratory clothing will be worn, left in the
laboratory upon exit, and disposed of as solid toxin waste.
(e) Aerosol exposures. The requirements found in Sec. 627.17 (a) and
(b) will be complied with plus the following:
(1) Chambers, nose-only exposure apparatus, and generation system
must be placed inside a fume hood, glove box, or a Class III biological
safety cabinet. Glove boxes and Class III biological safety cabinets
will have HEPA filters on both inlet and outlet air ports.
(2) The atmosphere from within the exposure chamber will be HEPA
filtered before release inside the hood, glove box, or cabinet.
(3) All items inside the hood, glove box, or Class III biological
safety cabinet will be decontaminated upon removal. Materials such as
experimental samples that cannot be decontaminated directly will be
placed in a closed secondary container, the exterior of which will be
decontaminated and labeled appropriately. Animals will have any areas
exposed to toxin wiped clean after removal from the exposure apparatus.

[[Page 547]]

(4) The interior of the hood, glove box, or cabinet containing the
chamber and all items will be decontaminated periodically, for example,
at the end of a series of related experiments. Until decontamintated,
the hood, box, or cabinet will be posted to indicate that toxins are in
use, and access to the equipment and apparatus restricted to necessary,
authorized personnel.

Sec. 627.18 Emergencies.

(a) Introduction. All laboratories will establish specific emergency
plans for their facilities. Plans will include liaison through proper
channels with local emergency groups and with community officials. These
plans will include both the building and the individual laboratories.
For the building, the plan must describe evacuation routes, facilities
for medical treatment, and procedures for reporting accidents and
emergencies. The plans will be reinforced by drills. Emergency groups
and community officials must be informed of emergency plans in advance
of any call for assistance. See AR 385-69.
(b) General emergency procedures. The following emergency procedures
will be followed for laboratory accidents or incidents--
(1) Using appropriate personal protection, assist persons involved,
remove contaminated clothing if necessary, decontaminate affected areas,
and remove personnel from exposure to further injury if necessary; do
not move an injured person not in danger of further harm. Render
immediate first aid if necessary.
(2) Warn personnel in adjacent areas of any potential hazards to
their safety.
(3) In case of fire or explosion, call the fire department or
community fire brigade immediately. Follow local rules for dealing with
incipient fire. Portable fire extinguishers will be made available with
instructions for their use. Fire fighters responding to the fire scene
will be advised to wear a self-contained positive pressure breathing
appartus to protect themselves from toxic combustion by-products.
(4) Laboratories must be prepared for problems resulting from severe
weather or loss of a utility service. In the event of the latter, most
ventilation systems not supplied with emergency power will become
inoperative. All potentially hazardous laboratory work must stop until
service has been restored and appropriate action has been taken to
prevent personnel exposure to etiologic agents.
(5) In a medical emergency, summon medical help immediately.
Laboratories without a medical staff must have personnel trained in
first aid available during working hours.
(6) For small-scale laboratory accidents, secure the laboratory,
leave the area, and call for assistance.
(7) When handling mixed hazards (for example, a substance or mixture
that may be infectious and radioactive, or infectious and chemically
toxic), respond with procedures addressing the greater hazard first, and
then follow through with those for the lesser hazards to ensure that all
appropriate steps have been taken.
(c) Evacuation procedures. Building and laboratory evacuation
procedures will be established and communicated to all personnel.
(1) Emergency alarm system. (i) There will be a system to alert
personnel of an emergency that requires evacuation of the laboratory or
building. Laboratory personnel must be familiar with the location and
operation of alarm equipment.
(ii) Isolated areas (for example, cold, warm, or sterile rooms) will
be equipped with an alarm or communication system that can be used to
alert others outside to the presence of a worker inside, or to warn
workers inside of an emergency that requires evacuation.
(2) Evacuation routes will be established and an outside assembly
area for evacuated personnel must be designated. All individuals should
be accounted for.
(3) Shut-down and start-up procedures.
(i) Guidelines for shutting down operations during an emergency
evacuation will be available in writing. Those guidelines will include
procedures for handling any power failure emergency.
(ii) Written procedures will also be provided to ensure that
personnel do not return to the laboratory until the emergency is ended.
Those procedures

[[Page 548]]

must also contain start-up operations for the laboratory.
(iii) All shut-down and start-up procedures will be available to
personnel and reviewed semiannually.
(4) All aspects of the building evacuation procedur will be tested
semiannually with practice drills.
(d) Spills. (1) All areas where work with etiologic agents is
performed will have designated personnel to respond to a spill and
provide protective apparel, safety equipment, and materials necessary to
contain and clean up the spill. Protective clothing requirements are
described in Sec. 627.21. Also, there will be supplies on hand to deal
with the spill consistent with the hazard and quantities of the spilled
substance.
(2) The safety officer will be notified immediately of all spills.
The first line supervisor will ensure that proper clean-up techniques
are employed.
(3) Etiologic agents. (i) A program for responding to spills of
etiologic agents will be developed and implemented. This program will
contain emergency response procedures for a biological spill, which will
be tailored to the potential hazard of the material being used, the
associated laboratory reagents involved, the volume of material, and the
location of the materials within the laboratory. Generally, the spill
should be confined to a small area while minimizing the substance's
conversion to an aerosol. The spill will be chemically decontaminated or
neutralized, followed by a cleanup with careful disposal of the residue.
If the spilled material is volatile and noninfectious, it may be allowed
to evaporate but must be exhausted by a chemical hood or ventilation
system.
(ii) When a mishap occurs that may generate an aerosol of etiologic
agents requiring BL-2 (or higher) containment, the room must be
evacuated immediately, the doors closed, and all clothing
decontaminated, unless the spill occurs in a class II or class III
biological safety cabinet. Sufficient time must be allowed for the
droplets to settle and the aerosols to be reduced by the air changes of
the ventilation system before decontaminating the area. The area will
then be decontaminated to prevent exposure to the infectious agents or
toxic substances. Reentry procedures to perform the decontamination will
conform to Sec. 627.18(e).
(iii) A spill of biohazardous material within a biological safety
cabinet requires a special response and cleanup procedure. Cleanup will
be initiated while the cabinet continues to operate, using an effective
chemical decontaminating agent. Aerosol generation during
decontamination and the escape of contaminants from the cabinet must be
prevented. Caution must be exercised in choosing the decontaminant,
keeping in mind that fumes from flammable organic solvents, such as
alcohol, can reach dangerous concentrations within a biological safety
cabinet.
(4) Combined radioactive and biological spills. (i) Both the
radiation protection officer (RPO) and the safety officer must be
notified immediately whenever there is a spill of radioactive biological
material, regardless of its size. Laboratory personnel may be expected
to clean up the spill. The RPO will direct the cleanup, in accordance
with the NRC license for the facility.
(ii) The spill will be cleaned up in a way that minimizes the
generation of aerosols and spread of contamination. All items used in
cleaning up the spill must be disposed of as radioactive waste.
(iii) Following cleanup, the area, affected protective clothing, and
all affected equipment and supplies must be surveyed for residual
radioactive contamination. All potentially affected areas and items that
are not disposable will be wipe-tested to verify that unfixed
radioactive contamination has been removed. If fixed contamination is
found, the RPO will determine the requirements for additional cleanup.
(e) Reentry procedures. This section applies when reentry is
necessary to clean up a spill outside of a hood or biological safety
cabinet, or to decontaminate or service engineering controls that have
failed or malfunctioned so that they do not provide the required
containment.
(1) When agents requiring BL-1 or BL-1 LS containment are involved,
the clothing requirements stated in Sec. 627.30

[[Page 549]]

(a) or (b) as appropriate will be followed. Individuals will remove the
required protective clothing when finished and wash their hands before
proceeding to other tasks.
(2) When agents requiring BL-2, BL-2 LS, or toxin procedures and
containment are involved, personnel will be required to wear the
clothing described in Sec. 627.30 (c) or (d) as appropriate. Outer
protective clothing will be removed and left in the room before exiting
and personnel will wash their hands before proceeding on to other
activities.
(3) When agents requiring BL-3, or BL-3 LS containment are involved,
containers for sealing up inner protective clothing and decontaminant
will be placed at the room exit. Personnel will be required to wear the
clothing described in paragraph 4-10e. When exiting the area after
decontamination procedures, individuals will remove their outer layer of
protective clothing just before exiting the room. Once outside the room,
the inner layer of protective clothing (for example, coverall) will be
removed and placed in the container and the inner gloves will be
decontaminated before being removed and placed in the container.
Personnel will proceed directly to the shower facility to take a
complete shower before exiting the facility.
(4) When agents requiring BL-4 containment are involved, the
following applies as appropriate to the type of BL-4 facility:
(i) When a spill requiring clean-up is in an area designed for use
with personal positive pressure suits, the entry and exit procedures
will be those normally required to enter or exit the area.
(ii) When entering a nonsuit area where a spill of etiologic agent
has occurred outside the containment of a Class III biological safety
cabinet, personnel will wear the clothing as described in
Sec. 627.30(f). Before entry, decontamination areas will be established.
To accomplish this, two step-in decontamination pans with the
appropriate disinfectant will be set up [one just inside the room (where
the contamination exists) and the second immediately outside the room].
Immediately outside the room, there will also be a sealable container
suitable for sealing up the suit and any air lines (if used).
(iii) When exiting the room, suited individuals will place all
equipment and other items in autoclaves or disinfectant, step into the
disinfectant pan, and wash down the exterior of their suits with
appropriate disinfectant. When completed, the door to the room will be
opened and the individual will step through the doorway into the second
disinfectant pan. The suit will be thoroughly rinsed with disinfectant
again before moving toward the exit from the facility. The suit (but not
the respirator) will be placed in the provided container. The individual
will proceed through another doorway before removing the respirator and
placing it in a closed container for decontamination. The individual
will then proceed directly to the shower area and take a full shower
before exiting the area. In case they are needed, personnel will be
standing by ready to render assistance. Suited individuals will be
visually observed, if possible. When visual observation is not possible,
a communications system is required.
(f) Mishap reports and investigations. (1) Each institution must
have a defined system for reporting laboratory injuries, illnesses, and
mishaps, as well as for investigating them. These events will be
documented and reported to the appropriate safety, supervisory, and
occupational health personnel. Those organizations subject to the
regulations promulgated by the OSHA will follow the specific
requirements for reporting injuries in the work place contained in those
regulations. The requirements stated in AR 385-69, State, and local
government requirements for similar reporting will be followed.
(2) Form(s) for recording mishaps will be available and completed
for all laboratory mishaps. Those reports must include a description of
the mishap and any factors contributing to it. In addition, a
description of any first aid or other health care given to the employee
will be included. Responsibility for completing these forms must be
clearly defined in the facility safety

[[Page 550]]

manual. Mishaps will be reviewed periodically by the safety officer, the
safety committee, the employee health unit, or other appropriate
personnel. Individual reports or a summary must be sent, along with
recommended changes in laboratory procedure or policy, to the commander
or institute director. Policy or procedural changes must be implemented
if deemed necessary by the commander or institute director.
(3) Any mishaps with etiologic agents used under sponsorship of the
BDP that result in sero-conversion or a laboratory-acquired illness will
be reported.

Sec. 627.19 Large-scale operations.

(a) Large-scale. In addition to the requirements stated in
Sec. 627.13, the following applies to research or production activities
involving viable etiologic agents in quantities greater than 10 liters:
(1) All large-scale operations will be conducted in facilities
described in Sec. 627.47.
(2) Cultures will be handled in a closed system.
(3) Sample collection, the addition of materials, and the transfer
of culture fluids shall be done in a manner which minimizes the release
of aerosols or contamination of exposed surfaces.
(4) A closed system or other primary containment equipment that has
contained viable organisms shall not be opened for maintenance or other
purposes unless it has been sterilized.
(5) SOPs will include a section describing and requiring a
validation of the process equipment's proper function.
(6) Scientists, technicians, equipment workers, and support
personnel with access to the large-scale production area during its
operation will be included in the medical surveillance program.
(b) BL-2--LS. In addition to the requirements stated in
Secs. 627.19(a) and 627.14, the following procedures will be employed
for BL-2--LS:
(1) Rotating seals and other mechanical devices directly associated
with the closed system used for the propagation and growth of viable
organisms shall be designed to prevent leakage or shall be fully
enclosed in ventilated housings that are exhausted through filters which
have efficiencies equivalent to HEPA filters or through other equivalent
treatment devices.
(2) A closed system used for the propagation and growth of viable
organisms and other primary containment equipment used to contain
operations involving viable organisms shall include monitoring or
sensing devices that monitor the integrity of containment during
operations.
(3) Systems used to propagate and grow viable organisms shall be
permanently identified. This identification shall be used in all records
reflecting testing, operation, and maintenance and in all documentation
relating to the use of this equipment.
(c) BL-3--LS. In addition to the requirements stated in
Secs. 627.19(a) and 617.14, the following procedures apply:
(1) Personnel entry into the controlled area shall be through the
entry area specified in Sec. 627.47(c)(1).
(2) Persons entering the controlled area shall exchange or cover
their personal clothing with work garments such as jumpsuits, long
sleeved laboratory coats, pants and shirts, head cover, and shoes or
shoe covers. On exit from the controlled area, the work clothing may be
stored in a locker separate from that used for personal clothing, or
discarded for laundering. Clothing shall be decontaminated before
laundering.
(3) Entry into the controlled area during periods when work is in
progress shall be restricted to those persons required to meet program
support needs.
(4) Prior to entry, all persons shall be informed of the operating
practices, emergency procedures, and the nature of the work conducted.
(5) The universal biohazard sign shall be posted on entry doors to
the controlled area and all internal doors. The sign posted on the entry
doors to the controlled area shall include a statement of agents in use
and personnel authorized to enter.
(6) Equipment and materials required for the management of accidents
involving viable organisms shall be available in the controlled area.
(d) BL-4--LS. Guidelines for these operations are not established.
If these

[[Page 551]]

are needed, they must be established by the United States Army Surgeon
General or the NIH on an individual basis.

Sec. 627.20 Operations with radioactive material.

Operations that combine etiologic agents with radioactive material
present unique problems. When this is the case, the following apply:
(a) Radiation program. A radiation program meeting the requirements
of AR 385-11 and NRC licensing that allows the particular isotope and
its use are required. The requirements for acquisition, handling
procedures, labeling, storage, training, monitoring, and disposal will
be described in an organization policy document.
(b) Procedure approval. In addition to the required approvals for
work with etiologic agents, the RPO will approve all SOPs involving the
use of radioactive materials. Laboratory operators must be fully
trained, with annual training updates as required by the existing
license.
(c) Special situations. (1) The laboratory waste must be segregated
as radioactive waste and disposed of as such after it has been
decontaminated. Do not mix nonradioactive waste with radioactive waste
as the disposal of radioactive waste is much more complex and expensive.
When RCRA-listed chemicals are mixed with radioactive waste, it becomes
``mixed waste'' for which there is currently no means of disposal.
(2) Activities conducted with radioisotopes should be confined to
the smallest number of areas or rooms consistent with requirements.
(3) Decontamination methods specific to etiologic agents will not
always remove radioactivity. Other methods, such as specialized
detergents and solvents designed for this use, should be employed to
remove residual radioactivity.

Subpart D--Personal Protective Equipment

Sec. 627.21 Introduction.

Personal protective equipment (PPE) includes clothing and equipment
used to protect the laboratory worker from contact with infectious,
toxic, and corrosive agents, as well as excessive heat, fire, and other
physical hazards. The appropriate PPE for any activity depends upon the
proposed operations and the potential hazards associated with them.
While PPE is an important item of personal protection, it serves as only
a secondary line of protection against hazards in the workplace.
Engineering controls (subpart H), combined with common sense, good
laboratory techniques, and adherence to SOPs, are the primary barriers
to exposure. There are some situations, however, in which it is either
impractical or impossible to rely exclusively on engineering controls.
In these cases, PPE may form the primary barrier between personnel and
the hazardous or infectious materials.

Sec. 627.22 Minimum laboratory attire for use of etiologic agents.

Individuals required to wear PPE will be trained in its proper use.
The PPE listed below is the minimum required when etiologic agents are
handled at any biosafety level. Research with etiologic agents usually
involves hazards other than those presented by the agents themselves.
When PPE is selected, the hazards presented by these other factors must
be considered regardless of the biosafety level used. For example, toxic
chemicals are commonly used in research involving etiologic agents. The
processes may expose personnel to physical hazards, such as heat or
animal bites, and the decontamination process may involve the handling
of toxic or corrosive materials. When the PPE required to mitigate these
hazards exceeds that of the minimum requirements, the necessary PPE will
be selected considering all the hazards. Information regarding the
additional appropriate PPE worn to protect against these hazards will be
available from one of the following sources: MSDS, SOP for the
operation, or the safety officer. Deviations from the standards stated
in approved SOPs must be approved by the safety officer. All laboratory
coats worn to protect the individual should be left in the laboratory
when that individual leaves. In each case, the minimum attire will be--

[[Page 552]]

(a) Laboratory workers. Street attire is permissible in the
laboratory, but must include closed-toe shoes. A full-length, long
sleeved, fully fastened laboratory coat, gown, or smock will be worn
over the street attire in the laboratory at all times. The laboratory
clothing will be removed and left in the laboratory when leaving to
enter nonlaboratory use areas.
(b) Animal caretakers. In addition to the clothing requirements in
Sec. 627.22(a), animal handlers will be provided with safety shoes or
safety boots. The requirements of Sec. 627.22(b) should also apply.
(c) Nonhuman primate rooms. Personnel entering rooms housing
nonhuman primates will wear the clothing stated in Sec. 627.22(a) and,
if applicable, Sec. 627.22(b) in addition to a molded mask or HEPA
filtered respirator, latex or vinyl gloves, and eye protection.

Sec. 627.23 Biosafety level 1.

This level requires only the minimum attire described in
Sec. 626.22.

Sec. 627.24 Biosafety level 2.

This level requires the following additions to the minimum clothing
specified in Sec. 627.22:
(a) Laboratory. Gloves (type dependent on the application) will be
worn when handling etiologic agents or containers of etiologic agents
and when handling infected animals.
(b) Animal rooms. (1) Protective clothing will be changed completely
every day. One- or two-piece laboratory suits or solid-front gowns and
wrap-around smocks are preferable. Full-length, long-sleeved, fully
fastened laboratory coats are allowed.
(2) Eye protection must be worn when handling nonhuman primates.
(3) Appropriate gloves must be worn.
(4) Molded masks or HEPA filtered respirators will be worn in rooms
housing nonhuman primates.

Sec. 627.25 Biosafety level 3.

The outer clothing worn in these facilities must never be worn
outside the facility. Color-coded clothing that is worn only in the
facility is recommended to remind individuals not to wear it outside.
The minimum clothing includes--
(a) Laboratory. (1) Long-sleeved, solid front, or wraparound gowns,
scrub suits, or coveralls over street attire which includes closed-toe
shoes. Dedicated shoes, boots, or shoe covers will be worn in the
facility.
(2) Appropriate gloves.
(b) Animal rooms. (1) A complete change of protective clothing on a
daily basis. Long-sleeved one- or two-piece solid front uniforms, solid-
front gown, wrap-around smocks, or solid front coveralls.
(2) Eye protection must be worn when handling nonhuman primates.
(3) Molded masks or HEPA filtered respirators will be worn in rooms
housing infected animals.
(4) Shoe covers will be worn and removed before exiting the room;
alternatively, disinfectant footbaths will be used for each exit from
the room when infected animals are present.

Sec. 627.26 Biosafety level 4.

Street clothing must be removed in an outer clothing change room and
kept there. Clothing worn in the facility will be removed in an inner
change room and a shower taken before replacing the street clothing. Two
distinct PPE requirements exist for BL-4 operations:
(a) Class III biological safety cabinet containment. Clothing
requirements when all etiologic agents and infected animals are housed
and manipulated in Class III biological safety cabinets will include--
(1) Complete change of clothing and wet shower upon exit. This
includes undergarments, pants and shirts or jump-suits, and shoes. While
it is preferred that the shower include washing the hair, head covers
will be worn by those who do not wash their hair on each exit.
(2) Appropriate inner gloves. The inner gloves will be donned in the
change room.
(b) Class I or II biological safety cabinet containment. Clothing
requirements for this level when etiologic agents are contained in Class
I or II biological safety cabinets of equivalent partial-

[[Page 553]]

containment caging systems (for infected animals) (See Secs. 627.56 and
627.57) include--
(1) Complete change of clothing and wet shower upon exit. This
includes undergarments, pants and shirts or jump-suits, and shoes. While
the shower should include washing the hair, head covers will be worn by
those who do not wash their hair on each exit.
(2) Appropriate inner gloves will be donned in the change room.
(3) A one-piece positive pressure suit described in Sec. 627.31(g).
(4) Impervious boots fitted over the suit.

Sec. 627.27 Large-scale (LS) operations.

The clothing requirements for these are the same as for the
corresponding biosafety levels for laboratory operations.

Sec. 627.28 Solutions of toxins and dry forms of toxins in closed containers.

In addition to the minimum clothing specified in Sec. 627.22,
disposable gloves or gloves designed to protect against the diluent will
be worn when handling these materials.

Sec. 627.29 Dry forms of toxins handled in open containers.

In addition to the requirements stated in Sec. 627.28, the
requirements stated in Sec. 627.18(c) apply.

Sec. 627.30 Situations specified in Sec. 627.18(e).

The clothing requirements for this section are for the emergency
procedures specified in Sec. 627.18(e). Because situations can occur and
there is no feasible or available means to mitigate the potential hazard
adequately by engineering controls, the clothing requirements exceed
those required for a properly conducted laboratory operation at an
equivalent biosafety level. The protective equipment required will be
selected based upon an assessment of the potential hazards that could be
encountered. The following clothing requirements are given as a guide.
The selection of PPE will be based upon the highest possible level of
contamination that could exist in the room. This will be based upon what
is known about the operations that were conducted in the room during and
prior to the current incident. In each situation, the aerosols will be
allowed to dissipate or settle before entry (approximately 30 minutes).
The following clothing requirements apply to these situations:
(a) BL-1. (1) Gloves.
(2) Outer complete covering such as a pair of coveralls.
(3) Shoe covers, provided shoes, or safety shoes or boots.
(4) Eye protection (maintenance only).
(b) BL-1 LS. The same as described in section 627.30(a) with the
following additions:
(1) An impervious apron.
(2) Impervious boots.
(c) BL-2 and toxins. (1) Gloves.
(2) Full outer covering such as a coverall.
(3) Shoe covers, provided shoes, or safety shoes or boots
(maintenance).
(4) An approved half-face or full-face respirator with HEPA filters
(worn).
(5) Eye protection.
(6) An impervious apron (not required for entry only).
(d) BL-2 LS. The same as Sec. 627.30(c) with the addition of
impervious boots.
(e) BL-3 and BL-3 LS. (1) A complete change of clothing.
(2) Gloves.
(3) An approved full-face HEPA or HEPA plus charcoal filtered
respirator.
(4) An impervious apron (not required for entry only).
(5) Impervious boots.
(6) Head cover.
(f) BL-4.
(1) A full change of inner clothing.
(2) An inner pair of gloves.
(3) A one-piece positive pressure suit as described in
Sec. 627.31(g), or a one-piece Xsuit with an approved positive pressure
self-contained breathing apparatus (SCBA) and a supplied-air respirator
(SAR) or both (see Sec. 627.31(f)).
(4) Appropriate gloves fitted to the suit.
(5) Impervious boots fitted over the suit.

Sec. 627.31 Specific requirements for individual PPE items.

(a) Aprons. Simple plastic or rubber aprons.
(b) Boots. When boots must be worn with an apron, the apron should
cover

[[Page 554]]

the boot tops sufficiently so that liquids splashed on the apron will
not run into the boots.
(c) Eye and face protection. Eye protection will meet or exceed the
requirements of OSHA found in the 29 CFR 1910.133 and will be worn at
all times when required. Special eye wear may be required around
ultraviolet (UV) light source.
(d) Gloves. (1) No one glove will be satisfactory for all
applications. Gloves are fabricated in a wide assortment of materials.
The type of glove selected will depend upon the specific activity. The
various activities in biocontainment facilities call for gloves to
protect against etiologic agents in situations where micro-manipulations
are required and excellent tactile feed-back through gloves is
important, gloves for handling hot glassware and cryogenic materials,
and gloves to protect against animal bites, toxic substances, chemical
carcinogens, solvents, acids, and caustics. Many of these requirements
call for gloves distinctly different from gloves suitable for the other
hazards. As a result, the SOP for each operation should address these
hazards and specify the appropriate glove required for each operation.
Consult MSDSs, manufacturer glove charts, and the safety officer to
determine the correct glove type needed.
(2) Before donning a pair of gloves, examine them closely to
ascertain that they are in serviceable condition. Check for rips and pin
holes. Gloves should over-wrap the cuff and lower sleeve of the
laboratory garment.
(3) Operations in open-front biological safety cabinets should be
planned so that once the operator has inserted gloved hands into the
cabinet, he or she does not have to withdraw them from the cabinet until
the work has been completed. If gloves become visibly contaminated, they
will be removed and decontaminated. Additional gloves should be
available so that work can continue. When wearing gloves for an extended
period, change them periodically or decontaminate them. Individual SOPs
will designate the appropriate period based upon the hazards.
(4) Gloves will be removed before going from one level of
containment to another (remove gloves in a safety cabinet before
removing your hands from the cabinet). Take care to ensure that skin is
not touched with the outer surface of contaminated or potentially
contaminated gloves when they are removed. Gloves will be placed in
suitable decontaminant when they are removed. Disposable gloves will be
placed in a covered container for decontamination or disposal.
(5) Gloves that are a part of a biological safety cabinet system
will be examined initially, after each sterilization of the biological
safety cabinet system, and at least annually for leaks using the soap
bubble test, followed by the halo-carbon test. Gloves will be tested
while still attached to the cabinet.
(6) Sterilization of nondisposable gloves either before use or
before reuse is usually done with ethylene oxide or formaldehyde gas.
Sterilized gloves must be aerated in flowing sterile (filtered) air at
21 deg.C or higher for a minimum of 24 hours prior to use to prevent
skin burns and irritation from residual decontaminants.
(e) Laboratory clothing. Users will check clothing before wearing
it, to ensure that it is free from defects that would compromise its
usefulness. Laboratory clothing (except BL-1) will be decontaminated
before being released for laundering by untrained or unprotected
personnel. Protective laboratory clothing that requires the wearer to
pull it over the head will not be used. Laboratory clothing will meet
OSHA requirements found in the 29 CFR 1910.132.
(f) One-piece suits. One-piece suits with a respirator under the
suit are not used to any great extent except in certain emergencies. The
respirators used with these are supplied air by an approved positive
pressure SCBA or SAR. Respirators will be of the pressure-demand or
constant flow type. The air provided will meet OSHA requirements found
in the 29 CFR 1910.134, the requirements of Grade D breathing air as
specified in the Compressed Gas Association pamphlet G-7.1 and American
National Standards Institute (ANSI) Z86.1-1973. When used in an area
that

[[Page 555]]

does not have a chemical shower to decontaminate the suit, a
decontamination station will be set up for this purpose. Suits
maintained for emergency use will be inspected at least quarterly and
respiratory equipment will be inspected monthly.
(g) One-piece positive pressure suits. A life-support system will be
provided with alarms and emergency backup breathing tanks. The air
provided will be HEPA-filtered meeting OSHA requirements found in the 29
CFR 1910.134, the requirements of Grade D breathing air as specified in
the Compressed Gas Association pamphlet G-7.1 and ANSI Z86.1-1973. A
HEPA-filter will be in-line between the disconnect on the suit and the
breathing space in the suit. When these are used in other than an
emergency situation, a chemical shower must be provided to decontaminate
the surfaces of the suit as the worker leaves the containment area.
Suits will be inspected before each use to check for indications of
significant wear or leakage. The suits will be worn with impervious
boots over the foot area of the suit and the outer gloves will be
attached over the hand portion.
(h) Respiratory protection equipment. (1) Respirators and their use
will be approved by the safety officer. The selection will be based on
the conditions of the activities and the risks involved. In general,
National Institute for Occupational Safety and Health (NIOSH) approved
respirators that use aerosol filters for dusts and fumes having a
Threshold Limit Value (TLV) of less than 0.05 mg/m³ have been
found acceptable for use in microbiological laboratories. Alternatively,
the Army M-17 or M-9 masks may be used. Air-supplied hoods are used in
situations where greater respiratory protection is required without the
need for body protection. One-piece suits are used when total body and
respiratory protection are required.
(2) When respirators are used, a respirator protection program will
be established that conforms to AR 11-34 and OSHA standards in the 29
CFR 1910.134. In general, a medical authority will designate who is to
wear respirators, they will be fitted by individuals trained in their
use and limitations, and wearers will be responsible for the proper
storage and regular inspection of their assigned respirators. Air-
purifying respirators will not be worn in oxygen deficient environments.
(3) Reusable respirators that have been worn in a contaminated area
will be decontaminated before reuse. At the end of each workday when a
respirator has been worn in an area where it was required, the wearer
will wipe it down with an appropriate liquid decontaminant. A damp cloth
soaked in the decontaminant, with the excess liquid squeezed out, will
be used for the wipe-down process, taking care to ensure that all
crevices are reached. The respirator will be rinsed with clean, warm
water. Visibly contaminated respirators will be decontaminated and
discarded.
(4) Respirator programs will comply with AR 385-10 and AR 11-34.
(i) Shoes. All shoes specially issued for use in controlled access
areas should be identified so that they can be segregated from other
areas. Safety shoes or boots meeting OSHA requirements stated in the 29
CFR 1910.134 will be issued wherever heavy items or corrosive chemicals
are handled. These will be sterilized appropriately after visible
contamination. In certain situations (excluding BL-4 operations), it is
desirable to wear disposable booties over street shoes, especially when
product protection is required.

Subpart E--Decontamination and Disposal

Sec. 627.32 Introduction.

All material or equipment that is potentially contaminated with
etiologic agents must be rendered nonhazardous before disposal. This
chapter describes the acceptable physical and chemical decontamination
methods and the general applicability of each. In general, all
infectious materials and all contaminated equipment or apparatus will be
sterilized before being washed and stored or discarded.

Sec. 627.33 Methods of decontamination.

(a) Autoclave. The use of wet heat is the most dependable procedure
for destroying all forms of microbial life. An autoclave employs
saturated steam under a pressure of approximately 15

[[Page 556]]

pounds per square inch (psi) to achieve a chamber temperature of at
least 121 deg.C for a minimum of 15 minutes. The time is measured after
the temperature of the material being sterilized reaches 121 deg.C.
Other combinations of temperature and pressure (some of which are
dependent on the equipment used) can be used to accomplish sterilization
provided that the efficacy of sterilization is validated as described
below. The most critical factor in ensuring the reliability of this
sterilization method, other than proper temperature, is preventing
entrapped air that is not replaced by stem. Material to be autoclaved
must come in contact with steam and heat and, as a result, it may be
necessary to add water to a load of waste to aid in the formation and
penetration of steam. Autoclaves use either a steam-activated exhaust
valve that reamins open during the replacement of air by live steam
until the steam triggers the valve to close, or a pre-cycle vacuum to
remove air prior to steam introduction.
(b) Sterilization will be verified using biological indicators (for
example, Bacillus stearothermophilus spores) at locations throughout the
autocalve, to include placement in the center of test loads, when the
autoclave is first put into service, and after any maintenance or
repairs. The primary means of verifying routine sterilization will be
through using chemical indicators (for example, autoclave tape or
labels) at locations throughout the autoclave. In addition each
autoclave will be equipped with a permanent means to record time and the
temperature of each operational event as a means of ensuring
sterilization. The type of materials being handled must be reviewed and
standard conditions for sterilization of each established. As a guide,
the manufacturer's manual for the autoclaves will be consulted as a
starting point in establishing these conditions. Treatment conditions to
achieve sterility will vary in relation to the volume of material
treated, the contamination level, the moisture content, and other
factors that should be considered and which may cause the times to
lengthen. In each case, the conditions will be established based on
tests which verify that the conditions selected are effective. In
addition to being effective from viable agents, autoclaving effectively
inactivates most protein toxins.
(c) Dry heat. Dry heat requires longer times or higher temperatures
or both than does wet heat. If used, the specific sterilization times
and temperatures must be determined for each type of material being
sterilized. In general, sterilization by dry heat can be accomplished at
169-170 deg.C for periods of 2 to 4 hours. Higher temperatures reduce
the time requirements. The heat transfer properties and spatial relation
or arrangement of materials in the load are critical in ensuring
effective sterilization.
(d) Liquid disinfectants. Liquid disinfectants may be used in
surface treatment, in dip tanks, and, at sufficient concentration, as
sterilants of liquid waste for final disposal. If liquid disinfectants
are used, they must have been shown to be effective against the
organisms present. Important considerations include: temperature, time
of contact, the negative logarithm of hydrogen ion concentration (pH),
concentration and state of dispersion, penetrability, and reactivity of
organic material at the site of application. Small variations in these
factors may make large differences in the effectiveness of disinfection,
so complete reliance should not be placed on liquid disinfectants when
the end result must be sterility. If evidence of efficacy under the
proposed procedures has not been reported previously, preliminary
studies to verify the efficacy of liquid disinfectants must be
conducted. Such studies may include attempts to recover and quantitate
the agent in question from liquid or swab samples, or sealed patches, by
animal inoculation, plaque assay, agar or broth cultivation, and similar
methods, following controlled decontamination under the same
experimental conditions envisioned for the proposed studies.
(1) Alcohol. Ethyl or isopropyl alcohol at the concentration of 70-
85 percent by weight will denature proteins but is slow in its
germicidal action. Alcohols are effective disinfectants for lipid-
containing viruses. These alcohols exhibit no activity against bacterial
spores.

[[Page 557]]

(2) Phenolic compounds. These are effective disinfectants against
vegetative bacteria, including Mycobacterium tuberculosis, fungi, and
lipid-containing viruses. The phenolics are not effective against
bacterial spores or non-lipid-containing viruses. The concentrations
used will be in accordance with the manufacturer's recommendations.
(3) Formaldehyde solutions. Formaldehyde in solution at a
concentration of 8 percent (formalin) is effective against vegetative
bacteria, spores, and viruses. It loses considerable disinfectant
activity below room temperature. Due to the toxic properties of
formaldehyde, the use of formalin is restricted to surfaces or materials
that are contained within appropriate engineering controls.
(4) Quaternary ammonium compounds. These cationic detergents are
strongly surface-active. They lose effectiveness in the presence of
proteins and are neutralized by anionic detergents, such as soap. At low
concentrations, they are bacteriostatic, tuberculostatic, sporostatic,
fungistatic, and algistatic. At medium concentration, they are
bactericidal, fungicidal, algicidal, and virucidal against lipophilic
viruses. They are not tuberculocidal, sporicidal, or virucidal against
hydrophilic viruses, even at high concentrations. The manufacturer's
recommended dilution will be used.
(5) Chlorine. Sodium hypochlorite is normally used as a base for
chlorine disinfectants. Free available chlorine is the active ingredient
and, at concentrations of at least 2,500 parts per million (ppm) (0.25
percent), is a disinfectant that is active against most microorganisms
and bacterial spores. Chlorine solutions at 2.5 percent free available
chlorine are effective against most toxins. Chlorine solutions lose
strength if exposed to air, so fresh solutions must be prepared whenever
the free chlorine content falls below desired minimums.
(6) Iodine. The characteristics of chlorine and iodine are similar.
Iodophor compounds with 1,600 ppm free available iodine provide a
relatively rapid inactivation of all microorganisms, including some
bacterial spores. A commonly available iodophor is Wescodyne. The
manufacturer of Wescodyne recommends a range of dilution form 1 to 3
ounces per 5 gallons of water, giving a solution containing from 25 to
75 ppm of free iodine. At these concentrations, available iodine may be
rapidly taken up by any extraneous protein present and will not be an
effective sporocide. A solution providing 1,600 ppm iodine is
recommended for hand washing or for use as a sporocide.
(7) Mercurials. Although the mercurials exhibit good activity
against viruses, they are toxic and are not recommended for general use.
They have poor activity against vegetative bacteria and are totally
ineffective sporicides. The dilution recommendations stated by the
manufacturer will be followed.
(e) Vapors and gases. Formaldehyde, ethylene oxide, peracetic acid,
beta-propiolactone, methyl bromide, and glutaraldehyde have all been
used successfully as space sterilants where they can be employed in
closed systems and with controlled conditions of temperature and
humidity. Of these, methyl bromide, beta-propiolactone, and
glutaraldehyde are not recommended because of their toxic properties.
Peracetic acid can readily decompose with explosive violence in a
concentrated state and must be used only in a diluted state and with
extreme care. Formaldehyde and ethylene oxide are both regulated by OSHA
for their potential human carcinogenicity, but do have permissible
exposure levels (unlike beta-propiolactone, for example) and can be used
safely under controlled conditions.
(1) Formaldehyde. Formaldehyde gas is, in general, the chemical of
choice for space disinfection. Biological safety cabinets and associated
effluent air-handling systems and air filters, incubators, laboratory
rooms, buildings, or other enclosed spaces can be disinfected with
formaldehyde. The procedures found in appendix E of the National
Sanitation Foundation Standard Number 49 will be followed for the
disinfection of biological safety cabinets. Other enclosures or areas
will be disinfected by following the same principles. To disinfect
rooms, the generation of formaldehyde gas from heating powdered or flake
paraformaldehyde is

[[Page 558]]

the preferred method. When area decontamination is performed, use 0.3
grams of paraformaldehyde for each cubic foot of space to be treated.
The room or area must be above 70 deg.F, the relative humidity above 70
percent, and the exposure time at least 2 hours (overnight is
preferred). After the required time for disinfection, the room must be
cleared of the formaldehyde gas (a small room with nonporous surfaces
and no materials or equipment in the room can be cleared of all
detectable formaldehyde by aeration for one hour, while larger areas
with equipment in them may take a full day). Before formaldehyde is used
as a space disinfectant, the area to be treated must be surveyed to
ensure that there are no open containers of any acidic solution
containing chloride ion in order to prevent the possible formation of
bis (chloromethyl)ether, a human carcinogen. Specific OSHA requirements
for posting of rooms and equipment, personnel protection, and other
requirements are found in 29 CFR 1910.1048.
(2) Ethylene oxide (EtO). EtO sterilization will only be conducted
in a sterilizer designed for that purpose and designed to maintain
potential exposure levels below the current OSHA standard. EtO is
effective against all microorganisms, including spores, molds,
pathogenic fungi, and highly resistant thermophilic bacteria. All
materials to be used in contact with human skin (for example, clothing,
shoes, masks, adhesive tape) must be aerated for at least 24 hours after
sterilization and prior to use. Concentrations of 500 to 1000 ppm are
required for sterilization. Specific OSHA requirements for the use of
ethylene oxide are found in 29 CFR 1910.1047.
(f) UV Radiation. UV radiation at a wave length of 253.7 nanometers
is a practical method for inactivating airborne virsuses, mycoplasma,
bacteria, and fungi. The usefulness of UV radiation on exposed surfaces
is limited by its low penetrating power. UV radiation shall only be
relied upon to sterilize surfaces when conventional methods, such as
autoclaving or the use of liquid disinfectants, would make the product
unusable. An example is data sheets that must be brought out of a
biocontainment facility. The UV intensity must be at least 40
microwatts/cm ³ on the surface to be treated. Single sheets
of paper may be treated by exposing them to this radiation for a minimum
of 15 minutes. A calibrated photoelectric UV intensity meter, capable of
measuring UV radiation at a wave length of 253.7 nanometers, will be
used whenever a new UV source is installed, and quarterly thereafter, to
ensure the UV source is providing at least 40 microwatts/cm ³
at the work surface. Bulbs should be cleaned routinely to remove any
accumulated dust and prolong bulb performance and assure proper energy
output. Protective eye wear and clothing may be necessary when working
around UV radiation.

Sec. 627.34 Disposal.

Inactivation is the first step in the disposal of etiologic agents
or materials that are potentially contaminated with them. All
contaminated or potentially contaminated materials must be effectively
disinfected or sterilized by an approved procedure discussed in
Sec. 627.33. After decontamination, reusable items, such as clothing or
glassware, may be washed with other uncontaminated or decontaminated
items.
(a) Combustible items. Combustible disposable items should be bagged
and incinerated in an appropriate approved incinerator or otherwise
disposed of in accordance with State and local regulations.
(b) Noncombustible disposable items. Items will be packaged as
stated in Sec. 626.34(e) and disposed of by a licensed waste hauler.
(c) Equipment. Equipment that cannot be autoclaved will be
decontaminated by gaseous sterilization or with a suitable liquid
disinfectant. Such equipment will be certified as decontaminated by the
safety officer.
(d) Waste. Materials generated, such as solvents, acids, chemical
carcinogens, radioactive isotopes, medical waste, or dead animals must
be decontaminated, packaged, and then disposed of in accordance with
EPA, NRC, local, State, and Federal regulations.

[[Page 559]]

(e) Mixed waste. When two or more hazardous materials are mixed
together, the mixture will be decontaminated and disposed of in
accordance with EPA, NRC, State, and Federal regulations for the
mixture, or for the most hazardous material.
(f) Packaging. Solid waste will be placed in cans, sturdy bags, or
boxes. Rigid, puncture-resistant, sealable containers will be used for
packaging ``sharps.'' When wet materials are packaged for disposal, the
materials will be placed in a leak-proof container. Heavy waste will be
placed in rigid containers ensuring that the burst strength of the
container is not exceeded.
(g) Labeling. A method of verifying that all items prepared for
disposal have been decontaminated will be established for etiologic
agent wastes. Mixed waste will be labeled as appropriate to indicate the
hazards that must be addressed after decontamination.
(h) Recordkeeping. A manifest will be initiated and maintained,
where required, to record the disposition and transfer of waste.
Applicable Federal, State, and local ordnances will be followed.

Subpart F--Importation, Shipment, and Transport of Etiologic Agents

Sec. 627.35 Introduction.

The CDC of the Public Health Service (PHS), the United States
Department of Agriculture (USDA), the Food and Drug Administration
(FDA), the Department of Transportation (DOT), the United States Postal
Service and the International Air Transport Association (IATA) regulate
the importation, shipment, and transportation of etiologic agents. This
chapter outlines the minimum administrative requirements the commander
or institute director are to follow and gives sources for information on
the requirements for importation, packaging, labeling, and shipment of
etiologic agents.

Sec. 627.36 Administration.

The commander or institute director will establish the following
controls to ensure that etiologic agents are transported with proper
authorization, controls, and procedures:
(a) Institute policies will be established in writing to ensure that
before etiologic agents are acquired or shipped--
(1) The division chief responsible for the area where work with
etiologic agents is to be conducted approves all acquisitions or
shipments.
(2) The safety officer is informed in writing of the type and amount
of any BL-4 or USDA-restricted etiologic agent (listed in HHS
publication No. (NIH) 88-8395 or current edition) being received, and
the estimated date of arrival.
(3) The recipient of all etiologic agents shipped from an institute
will be documented.
(4) The commander or institute director approves all acquisitions
and shipments of BL-4 or USDA-restricted etiologic agents.
(5) The commander or institute director approves all requests for
shipments to or from foreign countries and to individuals not affiliated
with an institution or agency (for example, physicians in private
practice).
(6) The Office of The Surgeon General, United States Army, or the
Commander, United States Army Materiel Command (AMC) approves the
initial acquisition and use of all reference stocks of etiologic agents
and transfers between Army RDTE activities in accordance with AR 70-65.
(7) There is full compliance with the regulatory requirements
referenced in Secs. 627.37, 627.38, 627.39 and 627.40.
(8) The following information regarding the recipient and the
intended use of BL-4 and USDA-restricted animal pathogens, will be kept
on file for 10 years. This information will also be kept for all
shipments to or from foreign countries and to individuals not affiliated
with an institution or agency (for example, physicians in private
practice).
(i) The requester's name and address.
(ii) The type and amount of the etiologic agent to be sent.
(iii) The qualifications of the recipient of the etiologic agent.
(iv) The intended use of the etiologic agent.

[[Page 560]]

(v) A statement indicating that the agent is not for human use.
(b) Etiologic agents assigned to biosafety level 1, 2, or 3,
approved for shipment, and properly labeled and packaged may be shipped
by commercial cargo carriers.
(c) All etiologic agents assigned to BL-4 or USDA-restricted animal
pathogens approved for shipment and properly packaged, will be
accompanied by a designated courier, or under close supervision of a
responsible party who will monitor aspects of the shipment, ensuring
that required transfers have been completed and documented and final
receipt has been accomplished and acknowledged.

Sec. 627.37 Importation directives.

Importation of etiologic agents is subject to the Public Health
Service Foreign Quarantine Regulations (42 CFR 71.156). Examples of
permits authorizing the importation or receipt of regulated materials
and specifying conditions under which the etiologic agent is shipped,
handled, and used are contained in appendix E to this part.

Sec. 627.38 Shipment directives.

Shipping unmarked and unidentified etiologic agents is prohibited.
Etiologic agents will be packaged, labeled, and shipped according to the
requirements found in the Interstate Shipment of Etiologic Agents
Regulations (42 CFR part 72) and its amendments. The USDA regulations in
9 CFR parts 102 through 104, 122 and the FDA regulations in 21 CFR parts
312 and 600 through 680 will also be followed as applicable. Packaging
and labeling requirements for interstate shipment of etiologic agents
are summarized and illustrated in appendix D. Permits authorizing the
shipment of regulated materials and specifying conditions under which
the etiologic agent is shipped, handled, and used are contained in
appendix E to this part.

Sec. 627.39 Transportation directives.

The packaging and labeling requirements cited above must be followed
for the local transport of etiologic agents and diagnostic specimens by
courier or by other delivery services. Similar requirements and
restrictions applicable to the transport of etiologic agents, diagnostic
specimens, and biological products by all modes of transportation (that
is, air, motor, rail, and water) are imposed by the Department of
Transportation (49 CFR part 173), IATA ``Dangerous Goods Regulations,''
the Air Transport Association ``Restricted Articles Tariff 6-D,'' the
International Civil Aviation Organization (ICAO), Postal Bulletin No.
21246 ``International Mail-Hazardous Materials,'' 39 CFR, and, the
Domestic Mail Manual. When shipments exceed 4 liters, the requirements
found in AR 740-32 will be followed.

Sec. 627.40 Additional requirements.

Additional requirements for importation, shipment, and
transportation of infectious agents and hazardous materials that must be
followed are contained in the following directives:
(a) AR 40-12, Medical and Agricultural Foreign and Domestic
Quarantine Regulations for Vessels, Aircraft, and Other Transports of
the Armed Forces.
(b) AR 70-65, Management of Controlled Substances, Ethyl Alcohol,
and Hazardous Biological Substances in Army Research, Development, Test,
and Evaluation Facilities.

Sec. 627.41 Sources for further information on shipment of etiologic agents.

(a) Guide for Transportation of Hazardous Materials, Vol. 4(1),
February 10, 1975. Copies are obtainable from the Office of Research
Grants Inquiries, NIH, Department of Health and Human Services, 5333
Westbard Avenue, Bethesda, MD 20205.
(b) The CDC, Office of Biosafety, 1600 Clifton Road N.E., Atlanta,
Georgia 30333. Telephone (404) 639-3883, or FTS: 236-3883.
(c) The American Type Culture Collection (ATCC), Packaging and
Shipping of Biological Materials at ATCC. Copies may be obtained from
the ATCC, 12301 Parklawn Drive, Rockville, MD 20852. Phone (301) 881-
2600.
(d) National Committee for Clinical Laboratory Standards (NCCLS),
Procedures for the Domestic Handling and Transport of Diagnostic
Specimens and

[[Page 561]]

Etiologic Agents, (H5-A2), Second edition. Vol. 5, No. 1. Copies are
obtainable from the NCCLS, 771 East Lancaster Avenue, Villanova, PA
19085.

Subpart G--Facilities

Sec. 627.42 Introduction.

The design of the facility is important in providing a secondary
barrier to protect individuals inside and outside the facility. Because
the hazards presented by various organisms and materials vary, the
requirements for the facility will vary accordingly. The minimum
facility requirements for the various biosafety levels and toxins are
described below. The biosafety levels correspond to those described in
the HHS Publication Biosafety in Microbiological and Biomedical
Laboratories (HHS No. (NIH) 88-8395), while the large-scale biosafety
levels were adapted from those described in the NIH Guidelines for
Research Involving Recombinant DNA Molecules.

Sec. 627.43 Biosafety level 1.

(a) Laboratories. Each laboratory used for this level will, as a
minimum, have the following features:
(1) A sink for handwashing.
(2) Work surfaces that are impervious to water and resistant to
acids, alkalis, organic solvents, and moderate heat.
(3) Fly screens on any windows that can be opened.
(4) Furnishings and surfaces that are sturdy and designed to be
easily cleaned.
(5) Spaces between furnishings and equipment that are accessible for
cleaning.
(b) Animal facilities. Each room will have the following features:
(1) Design and construction to facilitate cleaning and housekeeping.
(2) A sink for handwashing within the facility.
(3) Fly screens on any windows that can be opened.
(4) Ventilation designed so that the direction of airflow in the
animal facility is inward, with the exhausted air discharged to the
outside without being recirculated.
(5) Self-closing doors that open inward.

Sec. 627.44 Biosafety level 2.

(a) Laboratories. Each laboratory used for this level of hazard will
have, in addition to the requirements stated in Sec. 627.43(a), the
following:
(1) An autoclave available.
(2) Containment equipment necessary for the operations unless the
safety officer approves the use of a compensatory level of personal
protective equipment.
(3) An eyewash available near the laboratory.
(b) Animal facilities. In addition to the requirements stated in
Sec. 627.43(b), facilities will include--
(1) A sink for handwashing in each room where animals are housed.
(2) An autoclave available in the building.
(3) Appropriate containment equipment unless the safety officer
approves the use of a compensatory level of personal protective
equipment.

Sec. 627.45 Biosafety level 3.

(a) General requirements. Each suite used as a laboratory or in
which infected animals are housed will, as a minimum, have the following
features:
(1) Physical separation from areas which are open to unrestricted
traffic.
(2) All entrances to each laboratory or animal room from the
nonlaboratory access corridors will be through two sets of doors. A
change room or airlock may be incorporated between the doors.
(3) The interior surfaces of walls, floors, and ceilings will be
water resistant so that they may be easily cleaned.
(4) All penetrations into the walls, floors, and ceilings should be
sealed or capable of being sealed to facilitate decontamination.
(5) A foot, elbow, or automatically operated sink will be located
near the exit door to each laboratory or animal room.
(6) An autoclave should be in each laboratory or animal room and
will be available to the facility.
(7) A ventilation system that will--
(i) Create directional airflow that draws air into the laboratory
through the entry areas.
(ii) Not recirculate laboratory air.

[[Page 562]]

(iii) Discharge the exhaust air from the laboratory to the outside
and disperse the exhaust air away from occupied areas and air intakes.
(iv) Exhaust the HEPA-filtered air from Class I or II biological
safety cabinets or other primary containment devices directly to the
exterior of the laboratory or through the building exhaust system.
Exhaust air from the cabinets may be recirculated within the laboratory
if the cabinet is tested and certified at least every 12 months. If the
filtered cabinet exhaust is discharged through the building exhaust
system, it will be connected to this system in a manner (for example,
thimble unit connection) that avoids any interference with the air
balance of the cabinets or the building exhaust system.
(8) All windows to the facility will be sealed shut.
(9) Appropriate biological safety cabinets or other specialized
containment equipment will be provided.
(10) Any vacuum line in the facility will have a HEPA filter and
liquid disinfectant trap.
(11) Bench tops that are impervious to water and resistant to acids,
alkalis, organic solvents, and moderate heat.
(12) Furnishings that are sturdy and spaces between benches,
cabinets, and equipment that are accessible for cleaning.
(13) An eyewash available in or near the laboratory.
(b) Additional animal facility requirements. In addition to the
requirements given in Sec. 627.44(b) and 627.45(a), all doors to the
animal rooms will open inward and be self-closing.

Sec. 627.46 Biosafety level 4.

The engineering controls within the facility must provide absolute
biological containment. All procedures with etiologic agents requiring
this biosafety level of facilities, equipment, and procedures must be
conducted either in Class III biological safety cabinets, or in a
facility that is designed for the use of a personal positive pressure
suit as described in Sec. 627.46(b) in conjunction with Class I or II
biological safety cabinets.
(a) General requirements. The facility will have the following
features:
(1) A separate building or a clearly demarcated and isolated area
within a building which incorporates positive personnel control for
access.
(2) All entrances from access corridors incorporate an inner and
outer change room.
(3) Inner and outer change rooms separated by a shower facility.
(4) A double-doored autoclave, fumigation chamber, or ventilated
airlock for passage of all items which do not enter the facility through
the change room.
(5) Interior surfaces of walls, floors, and ceilings resistant to
water and chemicals to facilitate cleaning and disinfecting.
(6) Walls, floors, and ceilings of the facility constructed to form
a sealed internal shell which facilitates fumigation and is animal and
insect proof.
(7) All penetrations into the walls, floors, and ceilings sealed.
(8) All liquid drains in the facility connected directly to a liquid
waste decontamination system.
(i) Holding tanks collecting waste from sinks, biological safety
cabinets, floors, and autoclave chambers provide decontamination by heat
treatment.
(ii) Holding tanks collecting waste from shower rooms and toilets
provide decontamination by heat or chemical disinfectant methods.
(9) Sewer and other ventilation vents contain in-line HEPA filters.
(10) Internal facility appurtenances (for example, light fixtures,
air ducts, and utility pipes) arranged to minimize the horizontal
surface area on which dust can settle.
(11) A foot, elbow, or automatically operated handwashing sink
located near the exit door to each laboratory or animal room.
(12) Self-closing and lockable access doors.
(13) A ventilation system that--
(i) Is dedicated to the facility and provides fresh air meeting
American Society of Heating, Refrigerating, and Air Condition Engineers,
Inc. (ASHRAE) Standard 62.
(ii) Maintains a negative pressure differential and assures flow
inward from areas outside of the facility toward areas of highest
potential risk.

[[Page 563]]

(iii) Has manometers or magnehelic gauges to provide, sense, and
display pressure differentials between adjacent areas maintained at
different pressure levels. An alarm will sound when the pressures fall
below acceptable levels.
(iv) Has the air supply and exhaust interlocked to ensure that
exhaust failure or reduction will not allow the air pressure in the area
to become positive to the adjacent areas.
(v) Does not recirculate exhaust air.
(vi) Is HEPA-filtered and discharged to the outside, dispersing the
exhaust air away from occupied areas and air intakes.
(vii) Has the HEPA filters on the exhaust located as near to the
rooms as is practicable.
(viii) Has the filter chambers designed to allow in-place
decontamination before the filters are removed and to facilitate
certification testing.
(ix) Contains prefilters and HEPA filters in the air supply system
to protect the supply air system should air pressures become unbalanced.
(x) Exhausts the HEPA-filtered air from Class I or II biological
safety cabinets directly into the laboratory or to the exterior of the
building. If the HEPA-filtered exhaust from these cabinets is
recirculated, the cabinets are tested and certified every 6 months. If
the filtered cabinet exhaust is discharged through the building exhaust
system, it will be connected to this system in a manner (for example,
thimble unit connection) that avoids any interference with the air
balance of the cabinets or the building exhaust system.
(xi) Passes the treated exhaust air from Class III biological safety
cabinets through two sets of HEPA filters in series to the exterior of
the facility through the laboratory exhaust air system.
(14) Windows (if present) sealed shut and breakage resistant.
(15) Has a double-doored autoclave for decontaminating materials
passing out of the facility. The autoclave door that opens to the area
external to the facility is sealed to the outer wall and automatically
controlled so that it can only be opened after the autoclave
sterilization cycle has been completed.
(16) Has a pass-through dunk tank, fumigation chamber, or an
equivalent decontamination method for materials and equipment that
cannot be autoclaved.
(17) Has central vacuum systems (if present) that--
(i) Do not serve areas outside the facility.
(ii) Have an in-line HEPA filter placed as near as practicable to
each use point or service cock.
(iii) Have filters designed to allow in-place decontamination and
replacement.
(18) Liquid and gas services to the facility provided with
protective devices that prevent backflow.
(b) Additional requirements for personal positive pressure suit
areas. If personal positive pressure suits are worn in lieu of using
Class III biological safety cabinets for containment, a special suit
area will be provided. The suit area will provide the following, in
addition to the requirements stated in Sec. 627.46(a):
(1) An exhaust system dedicated to that area that provides
filtration by two sets of HEPA filters installed in series. This system
will be backed up by a duplicate filtration unit, exhaust fan, and an
automatically starting emergency power source. The ventilation system
will maintain the suit area under negative pressure relative to the
surrounding areas.
(2) An entry area consisting of an airlock fitted with airtight
doors.
(3) A chemical shower to decontaminate the surface of the personal
positive pressure suit upon exit.
(4) An air supply and distribution system to support the life
support system of the personal positive pressure suits.
(5) Emergency lighting and communications systems.
(6) Sealed penetrations into the internal shell of the area.
(7) A double-doored autoclave to decontaminate waste materials to be
removed from the suit area.
(c) Additional laboratory requirements. In addition to those given
in Sec. 627.45, if water fountains are provided, they will be foot
operated and located in the facility corridors outside the laboratory.

[[Page 564]]

(d) Additional animal facility requirements. In addition to those
requirements given in Sec. 627.45, all animal facility external doors
will be self-locking.

Sec. 627.47 Large-scale facilities.

The following requirements apply to facilities in which an
individual culture of viable etiologic agents exceed 10 liters:
(a) BL-1 LS. In addition to the laboratory requirements stated
Sec. 627.43(a), the exhaust gases removed from a closed system or other
primary containment equipment shall be treated by filters which have
efficiencies equivalent to HEPA filters or by other equivalent
procedures (for example, incineration) to minimize the release of viable
organisms.
(b) BL-2 LS. In addition to the requirements stated in
Secs. 627.44(a) and 627.47(a), these facilities will have--
(1) Rotating seals and other mechanical devices directly associated
with a closed system used to contain viable organisms shall be designed
to prevent leakage or shall be fully enclosed in ventilated housings
that are exhausted through filters which have efficiencies equivalent to
HEPA filters or through equivalent treatment devices.
(2) A closed system used to propagate and grow viable organisms
shall include monitoring or sensing devices that monitor the integrity
of containment during operations.
(3) Closed systems used for the propagation and growth of viable
organisms shall be tested operationally for integrity of the containment
features. The containment will be rechecked following modification or
replacement of essential containment features. Procedures and methods
used in the testing shall be appropriate for the equipment design and
for recovery and demonstration of the test organism. Records of tests
and results shall be maintained on file.
(c) BL-3 LS. The requirements stated in Secs. 627.45 and 627.57(b)
apply, and all closed systems and other primary containment equipment
used in handling cultures of viable organisms shall be located within a
controlled area which meets the requirements of a BL-3 facility plus the
following requirements:
(1) All utilities and service or process piping or wiring entering
the controlled area shall be protected against contamination.
(2) A shower facility shall be provided. This facility shall be
located near the controlled area.
(3) The controlled area shall be designed to preclude release of
culture fluids outside in the event of an accidental spill or release
from the closed systems or other primary containment equipment.
(4) The controlled area shall have a ventilation system capable of
controlling air movement. The movement of air shall be from areas of
lower contamination potential to areas of higher contamination
potential. If the ventilation system provides positive pressure supply
air, the system shall operate so as to prevent the reversal of air
movement or shall be equipped with an alarm that would be actuated if
reversal in the direction of air movement were to occur. The exhaust air
from the controlled area shall not be recirculated to other areas of the
facility. The exhaust air from the controlled area may be discharged to
the outdoors after filtration or other means of effectively reducing an
accidental aerosol burden, and dispersed clear of occupied buildings and
air intakes.

Sec. 627.48 Toxins.

General requirements for all facilities in which toxins are used are
as follows. Such facilities will--
(a) Have a ventilation system that provides three to six air changes
per hour, and that provides a directional airflow inward relative to the
access halls.
(b) Have a sink for handwashing.
(c) Have an eyewash available.
(d) Have bench tops that are impervious to water and resistant to
acids, alkalis, organic solvents, and moderate heat.
(e) Have furniture, furnishings, and surfaces that are sturdy and
designed to be easily cleaned.
(f) Be arranged so that items are accessible for cleaning.
(g) Have a quick-drench shower available within the facility.

[[Page 565]]

(h) A fume hood, biological safety cabinet, glove box, or equivalent
engineering control equipped with HEPA filters and with charcoal filters
if volatile materials are being used.

Subpart H--Engineering Controls

Sec. 627.49 Introduction.

As required by the OSHA and recommended by the American Industrial
Hygiene Association (AIHA) and the CDC, engineering controls and proper
microbiological techniques are the primary means of protecting personnel
who work with potentially hazardous biological materials. In situations
of potentially higher hazard, these engineering controls are
supplemented by personal protective clothing and equipment. Thus, the
engineering controls discussed in this chapter will be the primary means
of personnel and environmental protection when working with etiologic
agents. Because of the importance of these engineering controls, this
chapter contains not only requirements for the engineering and
construction of these controls, but also requirements for their
certification and continuous satisfactory performance. These will be
described for each engineering control.

Sec. 627.50 Class I biological safety cabinet.

(a) Description. The Class I biological safety cabinet (figure H-I
in appendix F to this part) is a ventilated cabinet for personnel
protection only. The cabinet provides an uncirculated inward flow of air
away from the operator. The exhaust is passed through a HEPA filter. It
may be discharged into the laboratory or vented out of the laboratory
and dispersed away from occupied spaces or air intakes. When the exhaust
is recirculated in a BL-2 or BL-3 facility, the cabinet must be tested
and certified annually. In a BL-4 facility, if the exhaust is
recirculated, the cabinet must be tested and certified semiannually.
(b) Uses. These cabinets are used if personnel protection against
the microorganisms is required; for modest quantities of volatile,
toxic, or radioactive chemicals (in concentrations and quantities
associated with biological systems) if vented to the outside; and when
sterility is not required. They are commonly used for housing tabletop
centrifuges, in the necropsy of small animals, and for changing animal
bedding.
(c) Prohibitions. This class of cabinet is not to be used when
sterility must be maintained. In addition, volatile, toxic, or
radioactive materials can not be used in this class of cabinet when the
exhaust air is not exhausted to the exterior.
(d) Certifications and requirements. (1) The inward air velocity on
these cabinets will be an average of 100 plus or minus 20 linear feet
per minute (lfpm). Each cabinet must be certified before use and
semiannually thereafter by a face velocity test. Additionally, smoke
tests will be performed annually to verify containment.
(2) The exhaust system will have a HEPA filter, which will be tested
initially upon installation, after repair or replacement, and every 2
years thereafter (except when required more often). Filters will be
certified to be 99.97 percent effective in capturing particulate matter
by a leakage test using mineral oil or other appropriate aerosol
dispersed as 0.3 micron droplets.

Sec. 627.51 Class II biological safety cabinet.

All Class II biological safety cabinets (figure H-II in appendix F
to this part) are ventilated cabinets for personnel and product
protection, having an open front with inward air flow for personnel
protection.
(a) Operating standards. (1) All of these cabinets must conform and
be certified to meet National Sanitation Foundation (NSF) Standard No.
49 revised, June 1987, for the applicable type of cabinet.
(2) After installation and before use, and annually thereafter, the
cabinets will be tested in accordance with NSF Standard No. 49 (latest
revision June 1987) as follows:
(i) Primary (required) tests--
(A) Velocity profile test.
(B) Work access opening airflow (face velocity) test.
(C) HEPA filter leak test.

[[Page 566]]

(D) Cabinet integrity test (soap bubble test) for cabinets with
positive pressure internal plenums.
(ii) Secondary (optional) tests--
(A) Vibration test.
(B) Electrical leakage and ground circuit resistance tests.
(C) Noise level test.
(D) Lighting intensity test.
(E) UV light intensity test.
(3) After repairs or alterations to the cabinetry or ventilation
system that affect the cabinet, the tests listed in Sec. 627.51(a)(2)
will be performed for the relevant parameters.
(4) The work access opening airflow (face velocity) test, as
specified in NSF Standard No. 49 (latest revision, June 1987), will be
performed to check that the cabinet is within specifications on an
annual basis for BL-1 and BL-2 and toxin use. This test will be
performed semiannually on cabinets used for BL-3 and BL-4 as well as for
work with dry forms of toxins.
(5) When the exhaust is recirculated in a BL-4 facility, the cabinet
must be tested and certified semiannually.
(b) Class IIA biological safety cabinets.--(1) Description. A Class
IIA biological safety cabinet is one in which typically 70 percent of
the air is recirculated within the cabinet and the exhaust passes
through a HEPA filter before discharge. The exhaust may be exhausted
into the room and positive-pressure contaminated ducts and plenums
within the cabinet are allowed. Type A cabinets shall have a minimum
calculated face velocity of 75 feet per minute (fmp).
(2) Uses. These cabinets are for working with low-to-moderate risk
biological samples and for protecting personnel against biological
material while providing a sterile atmosphere in which to handle the
material.
(3) Prohibitions. Materials that are toxic or volatile must not be
used in these cabinets.
(c) Class IIB1 biological safety cabinets.--(1)
Description. A Class IIB1 biological safety cabinet is one
that maintains a minimum average inflow of air of 100 plus or minus 20
lfpm and in which typically 30 percent of the air is recirculated. All
recirculated and exhausted air passes through two HEPA filters in
series. All contaminated internal ducts and plenums are under negative
pressure. Type B cabinets shall have a minimum calculated face velocity
of 100 fpm.
(2) Uses. When ultra-sterility is needed, these are the cabinets of
choice. The double filtration achieves a cleaner atmosphere. Minute
quantities of volatile, toxic, or volatile radioactive materials
coincidental to use in biological systems may also be used in these
cabinets.
(3) Prohibitions. More than minute quantities of toxic, volatile, or
radioactive materials must not be used in these cabinets.
(4) Additional certifications or requirements. None.
(d) Class IIB2 biological safety cabinets.--(1)
Description. A Class IIB2 biological safety cabinet is one
that maintains a minimum average of 100 plus or minus 20 lfpm inward
flow and in which all air is exhausted directly from the cabinet through
a HEPA filter without recirculation within the cabinet. All contaminated
ducts and plenums are under negative pressure. Type B cabinets shall
have a minimum calculated face velocity of 100 fpm.
(2) Uses. These cabinets are recommended when small quantities of
volatile, flammable, or toxic chemicals must be used coincidentally with
items requiring sterility.
(3) Prohibitions. While these cabinets do offer the greatest degree
of safety for volatile, toxic, and flammable chemical handling in a
sterile environment, they are not to be used in place of a fume hood to
prepare stock solutions of hazardous chemicals.
(e) Class IIB3 biological safety cabinets.--(1)
Description. A Class IIB3 biological safety cabinet is one
that meets all of the requirements of a Class IIB2 biological
safety cabinet except that it recirculates most (typically 70 percent)
of the air inside the cabinet. Type B cabinets shall have a minimum
calculated face velocity of 100 fpm.
(2) Uses. Minute amounts of nonflammable chemicals can be used
coincidentally with low-to-moderate risk biological agents.
(3) Prohibitions. Flammable materials and more than minute amounts
of toxic, radioactive, or volatile chemicals must not be used in these
cabinets.

[[Page 567]]

(4) Additional certifications or requirements. None.

Sec. 627.52 Class III biological safety cabinet.

(a) Description. These cabinets (figure H-III in appendix F to this
part) are totally enclosed, ventilated cabinets of gas-tight
construction. Operations are conducted through attached rubber gloves.
The supply of air is drawn into the cabinet through HEPA filters. The
exhaust air is treated by double HEPA filtration, or by HEPA filtration
followed by incineration, and is not allowed to recirculate within the
room.
(b) Uses. These cabinets provide the ultimate protection for
personnel. They are suitable for low, moderate, and high-risk etiologic
agents.
(c) Prohibitions. More than minute amounts of flammables must not be
used in these cabinets.
(d) Certifications and requirements. (1) These cabinets will have a
manometer or magnehelic gauge that indicates the negative pressure that
is maintained inside the cabinet. The pressure inside the cabinet should
be a minimum of 0.5 inches water gauge negative to the surrounding room.
(2) These cabinets will be pressure tested by the soap bubble or
halogen leak test as prescribed in NSF Standard No. 49, appendix B1
(latest revision, June 1987), and certified, when the HEPA filter units
are serviced.

Sec. 627.53 Fume hood.

Fume hoods in which etiologic agents are handled must use proven
technologies to provide optimal containment. Fume hood placement,
design, and capture testing requirements for use in designing new
laboratories can be found in the latest edition of Industrial
Ventilation, A Manual of Recommended Practices, published by the
American Conference of Governmental Industrial Hygienists.
(a) Description. Fume hoods are common chemical laboratory
furnishings designed to capture fumes from chemicals that are used
within them. Air is drawn through the opening and vented to the exterior
without recirculation.
(b) Uses. Fume hoods provide excellent containment for handling
hazardous chemicals.
(c) Prohibitions. Moderate risk biologicals and open containers of
dry forms of toxins must not be used in a fume hood without HEPA
filtration. Fume hoods should never be used when sterility is required.
(d) Certification and requirements. (1) Inward air flow will be an
average of 100 plus or minus 20 lfpm as measured at the face of the fume
hood. Proper function of laboratory hoods is not only a function of face
velocity. An evaluation of the total operating environment is necessary.
(2) When filters are required, they will be certified by the mineral
oil droplet (HEPA) or Freon (Charcoal) leak test as appropriate. Leakage
through the filters will be less than 0.05 percent for Freon and 0.03
percent for oil droplets when initially installed.
(3) Fume hoods will be provided with indicator devices to give a
warning should the ventilation system fail or if the hood face velocity
falls below an average of 80 lfpm
(4) Hood air flow will be certified when installed, when maintenance
is performed on the ventilation system, and semiannually thereafter.

Sec. 627.54 Glove box.

(a) Description. A glove box is an enclosure that provides a
positive barrier from liquids, solids, and chemical vapors. A glove box
has viewing ports and glove ports for access. The box maintains
personnel protection through solid barriers and maintenance of a
negative pressure relative to its surroundings.
(b) Uses. Glove boxes are used when extreme containment is needed
for highly toxic chemicals, especially for dry chemicals that can be
swept out of containers by the airflow in hoods.
(c) Prohibitions. Unventilated boxes must not be used with volatile
flammable materials and should be used with volatile toxic materials
unless dilution ventilation is provided.
(d) Additional certifications and requirements. (1) The glove box
will be maintained at a pressure of at least 0.25 inches water guage
less than its surroundings.
(2) The pressure differential will be indicated by a manometer or
magnehelic guage. Indicator devices

[[Page 568]]

will display a loss of pressure below 0.25 inches water guage.
(3) Gloves will be changed at appropriate intervals (dependent on
the box contents) to ensure they provide the protection needed.
(4) Inlets that provide dilution air will be protected by HEPA
filters.

Sec. 627.55 Ventilated balance enclosures.

(a) Description. A ventilated balance enclosure is a box that
surrounds a balance and has a small open area for access and handling
material in the front. Air is exhausted out the rear of the enclosure.
(b) Uses. A ventilated balance enclosure is used when containment of
a balance is required to weigh hazardous materials that have a low vapor
pressure (such as toxins). These enclosures are also used when it is
best to use the balance in other than a fume hood (due to the turbulence
and vibration) and when biological safety cabinets or glove boxes are
inappropriate or unavailable. Dry forms of toxins may be weighed in
these enclosures.
(c) Prohibitions. Very volatile or highly toxic volatile materials
must not be handled in ventilated balance enclosures unless they are
placed in closed containers in a properly functioning fume hood before
being transferred to the balance enclosure.
(d) Additional certifications or requirements. (1) The flow through
the openings in the enclosure will be at least 60 lfpm and must average
between 60 and 80 lfpm.
(2) Containment will be certified prior to first use and annually
thereafter by smoke tubes.
(3) The air flow will be certified initially and semiannually by
averaging readings taken from the face of the opening.

Sec. 627.56 Ventilated cage enclosures.

There are a number of cage-ventilated enclosures in which infected
animals may be housed at levels corresponding to the various classes of
biological safety cabinets. A brief description of four different types
of animal ventilated cages is given below. This is not a complete
description of all the different animal ventilated cages available. The
proper functioning of these will be tested initially, upon each
connection to exhaust sources, and at least annually. The inward flow
rates on the partial containment systems and pressure checks on the
total containment cages will be performed. Prior to selecting such
equipment, an evaluation of the function and the equipment should be
made, and the methods for testing and decontamination should be analyzed
and documented.
(a) Filter-top cages. Small laboratory animal polystyrene or
polycarbonate cage bottoms are fitted with a dome shaped glass fiber or
polyester filter cage cover. The dome shaped filters help reduce the
dissemination of aerosols, and the spread of infectious agents. Adequate
ventilation around cages fitted with a dome shaped filter is essential
since they may contain elevated ammonia and carbon dioxide levels, and
high temperature and humidity. Ventilation recommendations in the NIH
publication 86-23, 1985 ``Guide for the Care and Use of Laboratory
Animals'' will be followed.
(b) Forced ventilation cages. This is a small HEPA-filtered cage
connected to a centralized exhaust system. A minimum airflow of 0.03
m\3\ /min per cage is required. Ventilation rates may vary with the size
of the cage, and the number and type of animals being housed.
(c) Cubicle-type isolation cage. This is a partial containment unit
which holds several animal cages. This unit is a negative pressure HEPA-
filtered stainless steel cage. A minimum airflow of 0.3 m\3\ /min per
cage is required for a 0.24 m\3\ unit. Ventilation rates may vary with
the size of the cage and the number and type of animals being housed.
(d) Total containment cage. This unit is a negative pressure or
positive pressure HEPA-filtered stainless steel cage which has the
filters incorporated into the design. It is halogen gas-leak tight and
can be considered a Class III biological safety cabinet. A minimum
airflow of 0.3 m\3\ /min per cage is required for a 0.24 m\3\ unit.
Ventilation rates may vary with the size of the cage, and the number and
type of animals being housed.

[[Page 569]]

Sec. 627.57 Ventilated cage areas.

Ventilated cage areas within a room that are solid-walled and
bottomed areas for containing multiple cages housing infected animals.
The containment for these areas is equivalent to the Class I biological
safety cabinet. For testing purposes, they will be treated the same as a
Class I biological safety cabinet.

Appendix A to Part 627--References

Publications referenced in this part can be obtained from the
National Technical Information Services, U.S. Department of Commerce,
5285 Port Royal Road, Springfield, VA 22161.

Required Publications

AR 11-34

Army Respiratory Protection Program. (Cited in Secs. 627.31(h)(2)
and 627.31(h)(4).)

AR 40-5

Preventive Medicine. (Cited in Sec. 627.8.)

AR 40-10

Health Hazard Assessment Program in Support of the Army Materiel
Acquisition Decision Process. (Cited in Sec. 627.7(a)(8).)

AR 40-12

Medical and Agricultural Foreign and Domestic Quarantine Regulations
for Vessels, Aircraft, and Other Transports of the Armed Forces. (Cited
in Sec. 627.40(a).)

AR 40-66

Medical Records and Quality Assurance Administration. (Cited in
Sec. 627.9.)

AR 40-400

Patient Administration. (Cited in Sec. 627.8(e).)

AR 70-65

Management of Controlled Substances, Ethyl Alcohol, and Hazardous
Biological Substances in Army Research, Development, Test, and
Evaluation Facilities. (Cited in Secs. 627.36(a)(6) and 627.40(b).)

AR 385-10

Army Safety Program. (Cited in Secs. 627.6 and 627.31(h)(4).)

AR 385-69

Biological Defense Safety Program. (Cited in Secs. 627.6, 627.7(a),
627.7(a)(8), 627.7(d), 627.11(c), 627.18(a) and 627.18(f)(1).)

AR 740-32

Responsibilities for Technical Escort of Dangerous Materials. (Cited
in Sec. 627.39.)

Related Publications

A related publication is merely a source of additional information.
The user does not have to read it to understand this pamphlet.

AR 40-14

Control and Recording Procedures for Exposure to Ionizing Radiation
and Radioactive Materials.

ANSI Z86.1-1973

Breathing Air

ASHRAE Standard 62

Bacterial Toxins: A Table of Lethal Amounts, Gill, D.M.,
Microbiological Reviews, Volume 46, Number 1; March 1982, pages 86-94.

Biohazards Reference Manual

American Industrial Hygiene Association, 1985, Clinical Medicine
Branch, Division of Host Factors, Center for Infectious Disease, Centers
for Disease Control, Atlanta, GA 30333, telephone: (404) 639-3356,
Compressed Gas Association Pamphlet G-7.1

Grade D Breathing Air

Dangerous Goods Regulations, International Air Transport Association
(IATA), Publications Section, 2000 Peel Street, Montreal, Quebec, Canada
H3A 2R4, Tel (514) 844-6311. DHEW Pub. No. (NIH) 76-1165
Biological Safety Manual for Research Involving Oncogenic Viruses,
Executive Order 12196
Safety and Health Programs for Federal Employees, 26 February 1980
Guide for Adult Immunizations, Published by the American College of
Physicians, Guide for Transportation of Hazardous Materials, Vol. 4(1)
February 10, 1975. (Copies may be obtained from the Office of Research
Grants Inquiries, NIH, Department of Health and Human Services, 5333
Westbard Avenue, Bethesda, MD 20205.)
Guidelines for Laboratory Design, Health and Safety Considerations,
L. DiBerardinis, et al., John Wiley and Sons, 1987
Guidelines for Prevention of Herpesvirus Simiae (B Virus) Infection
in Monkey Handlers, Kaplan, J.E., et al., Mortality and Morbidity Weekly
Report, Volume 36, Number 41; October 23, 1987, pages 680-689.
HHS Publication No. (NIH) 88-8395, Biosafety in Microbiological and
Biomedical Laboratories
Industrial Ventilation, A Manual of Recommended Practice Published
by the American Conference of Governmental Industrial Hygienists.

[[Page 570]]

Laboratory Safety for Arboviruses and Certain Other Viruses of
Vertebrates, The American Journal of Tropical Medicine and Hygiene,
29:1359-1381, 1980.
NIH Guidelines for Research involving Recombinant DNA Molecules (51
FR 16958, May 7, 1986).
NIH publication 86-23, Guide for the Care and Use of Laboratory
Animals
NSF Standard 49, National Sanitation Foundation Standard
Number 49, Class II (Laminar Flow) Biohazard Cabinetry
Packaging and Shipping of Biological Materials at ATCC, The American
Type Culture Collection (ATCC). (Copies may be obtained from the ATCC,
12301 Parklawn Drive, Rockville, MD 20852. Telephone (301) 881-2600.)
Postal Bulletin No. 21246, International Mail-Hazardous Materials
Procedures for the Domestic Handling and Transport of Diagnostic
Specimens and Etiologic Agents, National Committee for Clinical
Laboratory Standards (NCCLS), (H5-A2), Second edition. Vol. 5, No. 1.
(Copies may be obtained from the NCCLS, 771 East Lancaster Avenue,
Villanova, PA 19085.)
Restricted Articles Tariff 6-D, Air Transport Association
Technical Instructions for the Safe Transport of Dangerous Goods by
Air, International Civil Aviation Organization (ICAO) Intereg Group,
5724 Pulaski Road, Chicago, IL 60646, Tel. (312) 478-0900.
The Centers for Disease Control, Office of Biosafety, 1600 Clifton
Road NE., Atlanta, Georgia 30333. Telephone (404) 639-3883, or FTS: 236-
3883.

9 CFR Parts 102 Through 104, 122

Animals and Animal products.

10 CFR Chapter 1

Nuclear Regulatory Commission.

21 CFR Parts 312, 600 Through 680

Food and drugs.

29 CFR Part 1910

Occupational Health and Safety Administration Safety and Health
Standards.

39 CFR Part 111

Postal Service.

40 CFR Parts 1500 Through 1508

Protection of environment.

42 CFR Parts 71 and 72

Public Health Service Foreign Quarantine Regulations.

49 CFR Parts 172 and 173

The Department of Transportation.

[[Page 571]]

Appendix B to Part 627--Resource List for Immunoprophylaxis of Personnel
at Risk

B-1. Recommendations for Immunoprophylaxis of Personnel at Risk
----------------------------------------------------------------------------------------------------------------
Description of disease Product Recommended for use in Source of product
----------------------------------------------------------------------------------------------------------------
Anthrax.......................... Inactivated vaccine. Personnel working regularly with USAMRIID.\1\
cultures, diagnostic materials,
or infected animals.
Botulism......................... Pentavalent toxoid Personnel working regularly with CDC.\3\
(A,B,C,D,E) cultures or toxin.
(IND).\2\.
Cholera.......................... Inactivated vaccine. Personnel working regularly with Commercially
large volumes or high available.
concentrations of infectious
materials.
Diphtheria Tetanus (Adult)....... Combined toxoid..... All laboratory and animal care Commercially
personnel irrespective of agents available.
handled.
Eastern equine encephalitis (EEE) Inactivated vaccine Personnel who work directly and USAMRIID.\1\
(IND) \2\. regularly with EEE in the
laboratory.
Hepatitis A...................... Immune Serum Animal care personnel working Commercially
Globulin [ISG directly with chimpanzees available.
(Human)]. naturally or experimentally
infected with Hepatitis A virus.
Hepatitis B...................... Serum-derived or Personnel working regularly with Commercially
recombinant vaccine. human blood and blood components. available.
Influenza........................ Inactivated vaccine. (Vaccines prepared from earlier Commercially
isolated strains may be of little available.
value in personnel working with
recent isolates from humans or
animals).
Japanese Encephalitis............ Inactivated vaccine Personnel who work directly and CDC.\3\
(IND) \2\. regularly with JE virus in the
laboratory.
Measles.......................... Live attenuated Measles-susceptible personnel Commercially
virus vaccine. working with the agent or available.
potentially infectious clinical
materials.
Meningococcal Meningitis......... Purified Personnel working regularly with Commercially
polysaccharide large volumes or high available.
vaccine. concentrations of infectious
materials (does not protect
against infection with group B
meningococcus).
Plague........................... Inactivated vaccine. Personnel working regularly with Commercially
cultures of Yersinia pestis or available.
infected rodents or fleas.
Poliomyelitis.................... Inactivated (IPV) Polio-susceptible personnel Commercially
and live attenuated working with the virus or available.
(OPV) vaccines. entering laboratories or animal
rooms where the virus is in use.
Pox viruses (Vaccinia, Cowpox, or Live (lyophilized) Personnel working with orthopox CDC.\3\
Monkey Pox viruses). vaccinia virus. viruses transmissible to humans,
with animals infected with these
agents, and persons entering
areas where these viruses are in
use.
Q Fever (Phase II) vaccine....... Inactivated (IND) Personnel who have no demonstrable USAMRIID.\1\
\2\. sensitivity to Q fever antigen
and who are at high risk of
exposure to infectious materials
or animals.
Rabies........................... Human diploid line Personnel working with all strains Commercially
cell inactivated of rabies virus, with infected available.
vaccine. animals, or persons entering
areas where these activities are
conducted.
Rift Valley Fever................ Inactivated virus All laboratory and animal care USAMRIID.\1\
vaccine (IND) \2\. personnel working with the agent
or infected animals and all
personnel entering laboratories
or animal rooms when the agent is
in use.
Rubella.......................... Live attenuated Rubella-susceptible personnel, Commercially
virus vaccine. especially women, working with available.
``wild'' strains or in areas
where these viruses are in use.
Tuberculosis..................... Live, attenuated BCG vaccine ordinarily is not used Commercially
(BCG) bacterial in laboratory personnel in the available.
vaccine. U.S.
Tularemia........................ Live attenuated Personnel working regularly with USAMRIID.\1\
bacterial vaccine cultures or infected animals or
(IND).\2\. persons entering areas where the
agent of infected animals are in
use.
Typhoid.......................... Inactivated vaccine. Personnel who have no demonstrated Commercially
sensitivity to the vaccine and available.
who work regularly with cultures.
Venezuelan equine (VEE) Live attenuated Personnel working with VEE and the USAMRIID.\1\
encephalitis. (TC83) viral Equine Cabassou, Everglades,
vaccine (IND).\2\. Mucambo, and Tonate viruses, or
who enter areas where these
viruses are in use.

[[Page 572]]

Western equine encephalitis (WEE) Inactivated vaccine Personnel who work directly and USAMRIID.\1\
(IND) \2\ with WEE regularly in the laboratory.
virus.
Yellow Fever..................... Live attenuated Personnel working with virulent Commercially
(17D) virus vaccine. and avirulent strains of Yellow available.
Fever virus.
----------------------------------------------------------------------------------------------------------------
\1\ For information, contact: United States Army Medical Materiel Development Activity, Fort Detrick, Frederick,
MD 21701, telephone: (301) 663-7661.
\2\ Investigational New Drug (IND).
\3\ Clinical Medicine Branch, Division of Host Factors, Center for Infectious Disease, Centers for Disease
Control, Atlanta, GA 30333, telephone: (404) 639-3356.

Source: Adapted from recommendations of the PHS Immunization Practices Advisory Committee and Biosafety in
Microbiological and Biomedical Laboratories.

[[Page 573]]

Appendix C to Part 627--Laboratory Safety Inspection Checklist

C-1. The checklist that follows is not an exhaustive list of the
items to consider when inspecting facilities where etiologic agents are
used. It does provide some basic guidelines to remind safety and
nonsafety professionals of the things that need to be considered in the
laboratories they manage. The checklist should be used as follows: All
area should be inspected using the general list in C-2. Certain items
are optional, such as radiation safety. If no radioactive material is
present in the room, then this would not be applicable. For BL-1
facilities the list in C-2 is adequate, while BL-2, BL-3, and BL-4
facilities must use the list in C-2 together with the appropriate list
in C-3 to C-5.

C-2. Basic checklist

(a) Housekeeping
(1) Is the room free of clutter?
(2) Are all aisles from the work areas to the available exits
maintained clear of obstructions?
(3) Are all safety equipment items unobstructed and ready for use?
(4) Is the room clean?
(b) Fire safety
(1) Is the fire extinguisher hung in its proper place, ready for
use, and unobstructed?
(2) Are there excess flammables located outside National Fire
Protection Association (NFPA) approved cabinetry?
(3) Are all Class IA flammables that are in breakable containers in
pint or smaller containers?
(4) Are all Class IB flammables that are in breakable containers in
liter or smaller containers?
(c) Chemical safety
(1) Are the chemicals stored with compatible materials?
(2) Have the chemical fume hoods been certified in the last 6
months?
(3) Are the eyewash and deluge shower unobstructed and ready for
use?
(4) Is the eyewash and deluge shower tested regularly to document
proper operation?
(5) Is the organic waste container maintained in a closed position?
(6) Are all reagents and solutions properly labeled?
(7) Is a spill kit within a reasonable distance from the work areas?
(8) Is appropriate protective clothing available for the chemical
hazards present?
(9) Is there a written hazard communication program?
(10) Have the personnel in the laboratory been trained in the
provisions and principles of the hazard communication program?
(11) Are MSDSs located where they are available to the laboratory
workers?
(12) Is there a written chemical hygiene plan?
(d) Radiation safety
(1) Are the radioactive materials stored double-contained?
(2) Is the containment for the radiation waste container adequate to
preclude the spread of radiation?
(3) Are all containers appropriately labeled with radiation labels?
(4) Are all entrances to the room appropriately labeled?
(e) Electrical safety
(1) Are excess extension cords being utilized?
(2) Are there any frayed cords in the room?
(3) Are there any cords on the floor across normal traffic patterns
in the room?
(f) General laboratory safety
(1) Are sharps discarded and destroyed in a safe manner?
(2) Are work surfaces decontaminated daily and after a spill?
(3) Is the appropriate attire worn by everyone in the room?
(4) Is there evidence that personnel eat, drink, smoke, or store
food, drinks, or tobacco in the room?
(5) Was mouth pipetting observed?
(6) Are all gas cylinders secured and are all cylinders not in use
capped?
(7) Are cylinders of oxidizers stored at least 20 feet from
cylinders of flammable gases in the same room?
(8) Are the contents of the cylinders clearly labeled?
(9) Are the cylinders transported on appropriate dollies or hand
trucks?
(10) Is there a written respiratory protection program where
respirators are used?
(g) Etiologic agents
(1) Are all containers of etiologic agents appropriately labeled?
(i) Are freezers, refrigerators, and similar storage units labeled
with the biohazard warning sign?
(ii) Are the storage and shipping containers adequate and properly
labeled?
(2) Have all personnel been adequately trained in general
microbiological techniques?
(3) Are laboratory doors kept closed when experiments are in
progress?
(4) Are all operations conducted over plastic-backed absorbent paper
or spill trays?

C-3. Biosafety level 2 supplemental checklist

(a) Are all floor drains filled with water or suitable disinfectant?
(b) Is the SOP for an etiologic agent spill signed by all personnel
who work with etiologic agents in the room?
(c) If biological safety cabinets are used, have they been certified
within the last year?
(d) Are the appropriate decontaminants available?
(e) Are all entrances to the laboratory posted with--

[[Page 574]]

(1) The appropriate special provisions for entry?
(2) The universal biohazard symbol?
(3) The name and telephone number of the laboratory director or
other responsible person?
(f) Is entry limited and restricted?
(g) Are gloves being worn when handling infected animals or
infectious or toxic materials?
(h) Is eye and respiratory protection being worn in rooms where
nonhuman primates are present?
(i) If materials are being transported off-site for decontamination,
is the containment adequate?

C-4. Biosafety level 3 supplemental checklist

(a) Is laboratory clothing decontaminated before being sent to the
laundry?
(b) Are all windows and penetrations through the walls and ceilings
sealed?
(c) If biological safety cabinets are used, have they been certified
within the last year?
(d) Are the appropriate decontaminants available?
(e) Are all entrances to the facility posted with--
(1) The appropriate special provisions for entry?
(2) The universal biohazard symbol?
(3) The name and telephone number of the laboratory director or
other responsible person?
(f) Is entry limited and restricted?
(g) Are gloves being worn when handling infected animals or
infectious or toxic materials?
(h) Is eye and respiratory protection being worn in rooms where
nonhuman primates are present?
(i) Do the monitors indicate that the room is under negative
pressure relative to all entrances?
(j) Are all vacuum lines protected with HEPA filters and liquid
disinfectant traps?
(k) Is the autoclave being properly maintained and certified?
(l) Is the foot, elbow, or automatic handwash sink operating
properly?
(m) Are all operations with etiologic agents being conducted inside
biological safety cabinets or other approved engineering controls?
(n) Are all infected animals housed using appropriate primary
containment systems?
(o) Do all personnel who enter rooms housing infected animals wear
appropriate respiratory protection?
(p) Do personnel who exit rooms having infected animals leave their
protective clothing in the animal and laboratory rooms?
(q) If available, has the UV pass box ouput been certified within
the last 3 months?

C-5. Biosafety level 4 supplemental inspection checklist

(a) Precautions for all areas.
(1) Are all penetrations through the walls and ceilings sealed?
(2) Are the appropriate decontaminants available and used properly?
(3) Are all entrances to the facility posted with--
(i) The appropriate special provisions for entry?
(ii) The universal biohazard symbol?
(iii) The name and telephone number of the laboratory director or
other responsible person?
(4) Is access to the laboratory controlled strictly and documented?
(5) Do the monitors indicate that the room is under negative
pressure relative to all entrances?
(6) Are all vacuum lines protected with HEPA filters and liquid
disinfectant traps?
(7) Is the autoclave being properly maintained and certified?
(8) Is the foot, elbow, or automatic handwash sink operating
properly?
(9) Do the self-closing doors to the facility operate properly?
(10) Do personnel completely exchange street clothing for laboratory
clothing before entry and shower upon exiting?
(11) Is the dunk tank disinfectant fresh and appropriate for the
agents in use?
(b) Suit areas.
(1) Are all operations with etiologic agents conducted in Class I or
II biological safety cabinets?
(2) Do the procedures in place ensure that, as much as possible, the
contamination remains inside the cabinets (such as ensuring that
everything removed from within the cabinets, such as gloves being worn,
instruments, glassware, or similar items, are decontaminated or properly
packaged first)?
(3) Are the Class I or II cabinets in the facility certified every 6
months?
(4) Does the suit decontamination shower have adequate appropriate
decontaminant available?
(5) Has the suit decontamination shower been used or tested in the
last month?
(6) Is the ventilated suit air supply and emergency air supply
adequate and working properly?
(7) Is the emergency alarm system working properly?
(8) Are all of the one-piece positive pressure suits available for
use in serviceable condition?
(9) Are infected animals housed in appropriate primary containment
systems?
(10) Is the static pressure in the suit area negative to all
surrounding areas?
(c) Nonsuit areas.
(1) Are all operations with etiologic agents conducted inside Class
III biological safety cabinets?

[[Page 575]]

(2) Were the Class III biological safety cabinets certified before
initiating the current operation?
(3) Are all infected animals housed in Class III cabinet containment
caging systems?

Appendix D to Part 627--Packaging and Labeling Requirements for Shipment
of Etiologic Agents

D-1. Packaging and Labeling of Etiologic Agents, from HHS publication
No. (NIH) 88-8395.
D-2. Guidelines for the Air Shipment of Diagnostic Specimens, from the
Air Transport Association of America, Cargo Services Division, 1709 New
York Ave., NW., Washington, DC 20006.

Appendix E to Part 627--Permits for Importation and Shipment of
Etiologic Agents

E-1. Permit Application to Import or Transport Agents or Vectors of
Human Disease. Department of Health, Education and Welfare, PHS, CDC,
Office of Biosafety, Atlanta, Georgia 30333.
E-2. Permit Application to Import Controlled Material; Import or
Transport Organisms or Vectors. U.S. Department of Agriculture, Animal
and Plant Health Inspection Service, Veterinary Services, Federal
Building, Hyattsville, Maryland 20782.

Appendix F to Part 627--Drawings, Biological Safety Cabinets

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Appendix G to Part 627--Glossary

Abbreviations
AIHA American Industrial Hygiene Association
AMC United States Army Materiel Command
ANSI American National Standards Institute
AR Army Regulation
ATCC American Type Culture Collection
ASHRAE American Society of Heating, Refrigerating, and
Air Condition Engineers, Inc.
BDP Biological Defense Program
BL biosafety level
CDC Centers for Disease Control
CFR Code of Federal Regulations
DA PAM Department of Army Pamphlet
DHEW Department of Health, Education, and Welfare
DOD Department of Defense
DOT Department of Transportation
DNA deoxyribonucleic acid
EPA Environmental Protection Agency
EtO ethylene oxide
FDA Food and Drug Administration
fpm feet per minute
HEPA high efficiency particulate air

[[Page 579]]

HHS Health and Human Services
IATA International Air Transport Association
IBC Institutional Biosafety Committee
ICAO International Civil Aviation Organization
lfpm linear feet per minute
LS large-scale
m meter
min minute
MSDS Material Safety Data Sheets
MSHA Mine Safety and Health Administration
NCCLS National Committee for Clinical Laboratory
Standards
NCI National Cancer Institute
NEPA National Environmental Policy Act
NFPA National Fire Protection Association
NIH National Institutes of Health
NIOSH National Institute for Occupational Safety and
Health
NRC Nuclear Regulatory Commission
NSF National Sanitation Foundation
OSHA Occupational Safety and Health Administration
pH the negative logarithm of hydrogen ion
concentration
PHS Public Health Service
PPE personal protective equipment
ppm parts per million
psi pounds per square inch
RCRA-Listed Resource Conservation Recovery Act of 1976
Listed Hazardous Waste
RDTE research, development, test, and evaluation
RPO Radiation Protection Officer
SALS Subcommittee on Arbovirus Laboratory Safety
SAR supplied-air respirator
SCBA self-contained breathing apparatus
SOP Standing Operating Procedure
TD to deliver
TLV threshold limit value
USDA United States Department of Agriculture
UV ultraviolet

Terms

Approved respiratory protection

Equipment which is tested and listed as satisfactory according to
standards established by a competent authority (such as NIOSH, Mine
Safety and Health Administration (MSHA), or host country agency) to
provide respiratory protection against the particular hazard for which
it is designed. For military agent protection, DA and Department of
Defense (DOD) are the approval authorities. (Approval authority may be
specified by law.)

Biocontainment area

An area which meets the requirements for a BL-3 or BL-4 facility.
The area may be an entire building or a single room within a building.
See subpart G for details.

Biological Safety Cabinets

Engineering controls designed to enable laboratory workers to handle
infectious etiologic agents and to provide primary containment of any
resultant aerosol. There are three major classes of cabinets (I, II, and
III) and several subclasses of class II cabinets. Each type of cabinet
provides a different degree of protection to personnel and to the
products handled inside them. The various classes of cabinets are
described in detail in subpart H.

Biosafety Level 1

The facilities, equipment, and procedures suitable for work
involving agents of no known or of minimal potential hazard to
laboratory personnel and the environment.

Biosafety Level 2

The facilities, equipment, and procedures applicable to clinical,
diagnostic, or teaching laboratories, and suitable for work involving
indigenous agents of moderate potential hazard to personnel and the
environment. It differs from BL-1 in that (1) laboratory personnel have
specific training in handling pathogenic agents, (2) the laboratory is
directed by scientists with experience in the handling of specific
agents, (3) access to the laboratory is limited when work is being
conducted, and (4) certain procedures in which infectious aerosols could
be created are conducted in biological safety cabinets or other physical
containment equipment.

Biosafety Level 3

The facilities, equipment, and procedures applicable to clinical,
diagnostic, research, or production facilities in which work is
performed with indigenous or exotic agents where potential exists for
infection by aerosol, and the disease may have serious or lethal
consequences. It differs from BL-2 in that (1) more extensive training
in handling pathogenic and potentially lethal agents is necessary for
laboratory personnel; (2) all procedures involving the manipulation of
infectious material are conducted within biological safety cabinets,
other physical containment devices, or by personnel wearing appropriate
personal protective clothing and devices; (3) the laboratory has special
engineering and design features, including access zones, sealed
penetrations, and directional airflow; and (4) any modification of BL-3
recommendations must be made only by the commander.

Biosafety Level 4

The facilities, equipment, and procedures required for work with
dangerous and exotic agents which pose a high individual risk of life-
threatening disease. It differs from BL-3 in that (1) members of the
laboratory staff have specific and thorough training in handling
extremely hazardous infectious agents; (2) laboratory personnel
understand the primary and secondary containment functions of the
standard and special practices, containment equipment, and laboratory
design characteristics; (3) access to the laboratory is strictly
controlled by the institute director; (4) the facility is either in a
separate

[[Page 580]]

building or in a controlled area within a building, completely isolated
from all other areas of the building; (5) a specific facility operations
manual is prepared or adopted; (6) within work areas of the facility,
all activities are confined to Class III biological safety cabinets or
Class I or Class II biological safety cabinets used in conjunction with
one-piece positive pressure personnel suits ventilated by a life support
system; and (7) the maximum containment laboratory has special
engineering and design features to prevent microorganisms from being
disseminated to the environment.

Building

Confirmed Exposure

Any mishap with a BDP agent in which there was direct evidence of an
actual exposure such as a measurable rise in antibody titer to the agent
or a confirmed diagnosis of intoxication or disease.

Etiologic Agents

Any viable microorganism, or its toxin which causes or may cause
human disease, including those agents listed in 42 CFR 72.3 of the
Department of Health and Human Services regulations, and any agent of
biological origin that poses a degree of hazard similar to those agents.

Facility

An area within a building that provides appropriate protective
barriers for persons working in the facility and the environment
external to the facility, and outside of the building.

HEPA Filter

A filter which removes particulate matter down to submicron sized
particles from the air passed through it with a minimum efficiency of
99.97 percent. While the filters remove particulate matter with great
efficiency, vapors and gases (for example, from volatile chemicals) are
passed through without restriction. HEPA filters are used as the primary
means of removing infectious agents from air exhausted from engineering
controls and facilities.

Human Lethal Dose

The estimated quantity of a toxin that is a minimum lethal dose for
a 70 kilogram individual based upon published data or upon estimates
extrapolated from animal toxicity data.

Commander or Institute Director

The commander or institute director of an Army activity conducting
RDTE with BDP etiologic agents, or the equivalent, at a research
organization under contract to the BDP.

Institution

An organization such as an Army RDTE activity (institute, agency,
center, and so forth) or a contract organization such as a school of
medicine, or research institute that conducts RDTE with BDP etiologic
agents.

Laboratory

An individual room or rooms within a facility that provide space in
which work with etiologic agents can be performed. It contains all of
the appropriate engineering features and equipment required at a given
biosafety level to protect personnel working in it and the environment
external to the facility.

Large-Scale Operations

Research or production involving viable etiologic agents in
quantities greater than 10 liters of culture.

Maximum Containment Area

An area which meets the requirements for a BL-4 facility. The area
may be an entire building or a single room within the building. See
chapter 7 for details.

Molded Masks

Formed masks that fit snugly around the mouth and nose and are
designed to protect against a nontoxic nuisance level of dusts and
powders. These do not require approval by NIOSH or MSHA. Masks made of
gauze do not qualify.

Potential Accidental Exposure

Any accident in which there was reason to believe that anyone
working with a BDP agent may have been exposed to that agent, yet no
measurable rise in antibody titer or diagnosis of intoxication or
disease was made. However, the high probability existed for introduction
of an agent through mucous membranes, respiratory tract, broken skin, or
the circulatory system as a direct result of the accident, injury, or
incident.

Resource Conservation Recovery Act of 1976 Listed Hazardous Waste

The waste materials listed by the Environmental Protection Agency
under authority of the RCRA for which the agency regulates disposal. A
description and listing of these wastes is located in 40 CFR part 261.

[[Page 581]]

Suite

An area consisting of more than one room, designed to be a
functional unit in which entire operations can be facilitated. Suites
may contain a combination of laboratories or animal holding rooms and
associated support areas within a facility that are designed to conform
to a particular biosafety level. There may be one or more suites within
a facility.

Toxin

Toxic material of etiologic origin that has been isolated from the
parent organism.\1\
---------------------------------------------------------------------------

\1\ The publication ``Bacterial Toxins: a Table of Lethal Amounts,''
(Gill, D.M. (1982) Microbiological Reviews, 46:86-94) contains a useful
table of mammalian toxicities of numerous toxins.