[Federal Register Volume 63, Number 200 (Friday, October 16, 1998)]
[Proposed Rules]
[Pages 55565-55571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27707]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[OPP-300734; FRL-6035-7]
RIN 2070-AB78
Pesticides Tolerance Reassessment Actions; 4-Amino-6-(1,1-
dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-one [Metribuzin],
Dichlobenil, Diphenylamine, O-Ethyl O-[4-(methylthio) phenyl] S-propyl
phosphorodithioate [Sulprofos], Pendimethalin, and Terbacil
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document announces the proposed revocation of tolerances
for the herbicides 4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-
triazin-5(4H)-one [Metribuzin], dichlobenil, pendimethalin, and
terbacil; and the insecticide O-ethyl O-[4-(methylthio) phenyl] S-
propyl phosphorodithioate [Sulprofos]. EPA expects to determine whether
any individuals or groups want to support these tolerances. Also, this
document is proposing the establishment and revision of tolerances for
4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-one
(metribuzin), dichlobenil, pendimethalin, terbacil, and the plant
growth regulator diphenylamine. In addition, EPA is also proposing to
revise commodity terminology for 4-amino-6-(1,1-dimethylethyl)-3-
(methylthio)-1,2,4-triazin-5(4H)-one [Metribuzin], diphenylamine, and
pendimethalin to conform to current practice. The regulatory actions in
this notice are part of the Agency's reregistration program under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the
tolerance reassessment requirements of the Federal Food, Drug, and
Cosmetic Act (FFDCA). By law, EPA is required to reassess 33% of the
tolerances in existence on August 2, 1996, by August 1999, or about
3,200 tolerances.
DATES: Comments must be received on or before December 15, 1998.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit IV of the ``SUPPLEMENTARY INFORMATION'' section of
this document. Be sure to identify the appropriate docket number [OPP-
300734].
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Joseph Nevola, Special Review Branch, (7508C), Special Review and
Reregistration Division, Office of Pesticide Programs, U.S.
Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460.
Office location: Special Review Branch, Crystal Mall #2, 6th floor,
1921 Jefferson Davis Hwy., Arlington, VA. Telephone: (703) 308-8037; e-
mail: nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
I. What is the progress of tolerance reassessment?
By law, EPA is required to reassess 33% of the tolerances in
existence on August 2, 1996, by August 1999, or about 3,200 tolerances.
The regulatory actions proposed in this document pertain to the
provosed revocation of 29 tolerances and/or exemptions, which count
toward the August, 1999 review deadline of FIFRA, as amended by the
Food Quality Protection Act (FQPA) of 1996.
II. Does this notice apply to me?
You may be affected by this notice if you sell, distribute,
manufacture, or use pesticides for agricultural applications, process
food, distribute or sell food, or implement governmental pesticide
regulations. Pesticide reregistration and other actions [see FIFRA
section 4(g)(2)] include tolerance and exemption reassessment under
FFDCA section 408. In this notice, the tolerance actions are proposed
in coordination with the cancellation of associated registrations.
Potentially affected categories and entities may include, but are not
limited to:
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Examples of Potentially
Category Affected Entities
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Agricultural Stakeholders................. Growers/Agricultural Workers
Contractors [Certified/
Commercial Applicators,
Handlers, Advisors, etc.]
Commercial Processors
Pesticide Manufacturers
User Groups
Food Consumers
Food Distributors......................... Wholesale Contractors
Retail Vendors
Commercial Traders/Importers
Intergovernmental Stakeholders............ State, Local, and/or Tribal
Government Agencies
Foreign Entities.......................... Governments, Growers, Trade
Groups
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this table could also be
affected. If you have any questions regarding the applicability of this
action to a particular entity, you can consult with the technical
person listed in the ``FOR FURTHER INFORMATION CONTACT'' section.
III. How can I get additional information or copies of this or
other support documents?
A. Electronically
You may obtain electronic copies of this document and various
support documents from the EPA Internet Home Page at http://
www.epa.gov/. On the Home Page select ``Laws and Regulations'' and then
look up the entry for this document under ``Federal Register -
Environmental Documents.'' You can also go directly to the ``Federal
Register'' listings at http://www.epa.gov/homepage/fedrgstr/.
B. In Person or by Phone
If you have any questions or need additional information about this
action, please contact the technical person identified in the ``FOR
FURTHER INFORMATION CONTACT'' section. In addition, the official record
for this notice, including the public version, has been established
under docket control number [OPP-300734], (including comments and data
submitted electronically as described below). A public version of this
record, including printed, paper versions of any electronic comments,
which does not include any information claimed as Confidential Business
Information (CBI), is available for inspection in Room 119, Crystal
Mall
[[Page 55566]]
#2, 1921 Jefferson Davis Hwy., Arlington VA, from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Public Information
and Records Integrity Branch telephone number is 703-305-5805.
IV. How can I respond to this notice?
A. How and to whom do I submit comments to?
You may submit comments through the mail, in person, or
electronically. Be sure to identify the appropriate docket control
number (i.e., [OPP-300734]) in your correspondence.
1. By mail. Submit written comments, identified by the docket
control number [OPP-300734], to: Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, U.S. Environmental Protection Agency, 401
M St., S.W., Washington, DC 20460.
2. In person or by courier. Deliver written comments, identified by
the docket control number [OPP-300734], to: Public Information and
Records Integrity Branch, Office of Pesticide Programs, U.S.
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA.
3. Electronically. Submit your comments and/or data electronically
by E-mail to: oppt.ncic@epa.gov. Do not submit any information
electronically that you consider to be CBI. Submit electronic comments
in ASCII file format avoiding the use of special characters and any
form of encryption. Comment and data will also be accepted on standard
computer disks in WordPerfect 5.1/6.1 or ASCII file format. All
comments and data in electronic form must be identified by the
appropriate docket control number [OPP-300734]. You may also file
electronic comments and data online at many Federal Depository
Libraries.
B. How should I handle CBI information in my comments?
You may claim information that you submit in response to this
document as CBI by marking any part or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the comment that does
not contain CBI must be submitted for inclusion in the public record.
Information not marked confidential will be included in the public
docket by EPA without prior notice. If you have any questions about CBI
or the procedures for claiming CBI, please consult with the technical
person identified in the ``FOR FURTHER INFORMATION CONTACT'' section.
V. What is a `tolerance''?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals in or on raw agricultural commodities and processed
foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as amended by the
FQPA of 1996, Pub.L. 104-170, authorizes the establishment of
tolerances (maximum residue levels), exemptions from the requirement of
a tolerance, modifications in tolerances, and revocation of tolerances
for residues of pesticide chemicals in or on raw agricultural
commodities and processed foods. 21 U.S.C. 346(a). Without a tolerance
or exemption, food containing pesticide residues is considered to be
unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA.
If food containing pesticide residues is considered to be
``adulterated,'' you can not distribute the product in interstate
commerce (21 U.S.C. 331(a) and 342(a)). For a food-use pesticide to be
sold and distributed, the pesticide must not only have appropriate
tolerances under the FFDCA, but also must be registered under section 3
of FIFRA (7 U.S.C. et seq.).
VI. Why is EPA proposing the tolerance actions discussed below?
EPA has issued a Reregistration Eligibility Decision (RED) for each
of the pesticides subject to this notice, except for sulprofos, which
during the RED process was voluntarily canceled by the registrant. The
RED contains the Agency's evaluation of the database for a pesticide,
including requirements for additional data on the active ingredients to
confirm the potential human health and environmental risk assessments
associated with current product uses, and the Agency's decisions and
conditions under which these uses and products will be eligible for
reregistration. The safety findings for pesticide tolerances can be
found in those RED documents. Printed copies of the RED may be obtained
from EPA's National Center for Environmental Publications and
Information (EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-2419,
telephone 1-800-490-9198; fax 513-489-8695 and from the National
Technical Information Service (NTIS), 5285 Port Royal Road,
Springfield, VA 22161, telephone 703-487-4650. Electronic copies of the
RED are available on the internet at http://www.epa.gov/REDs.
It is EPA's general practice to propose revocation of tolerances
for residues of pesticide active ingredients for which FIFRA
registrations no longer exist. EPA has historically expressed a concern
that retention of tolerances that are not necessary to cover residues
in or on legally treated foods has the potential to encourage misuse of
pesticides within the United States. However, in accordance with FFDCA
section 408, EPA will not revoke any tolerance or exemption proposed
for revocation if any person demonstrates a need for the retention of
the tolerance, and if retention of the tolerance will meet the
tolerance standard established under FQPA. Generally, interested
parties support the retention of such tolerances in order to permit
treated commodities to be legally imported into the United States,
since raw agricultural commodities or processed food or feed
commodities containing pesticide residues not covered by a tolerance or
exemption are considered to be adulterated.
Tolerances and exemptions established for pesticide chemicals with
FIFRA registrations cover residues in or on both domestic and imported
commodities. To retain these tolerances and exemptions, EPA must make a
finding that the tolerances and exemptions are safe. To make this
safety finding, EPA needs data and information indicating that there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide residues covered by the tolerances and exemptions.
For tolerances without U.S. registrations, EPA has the same
toxicology and residue chemistry data requirements as are needed to
support U.S. food-use registrations. For import tolerances, EPA applies
these data requirements on a case-by-case basis to account for specific
growing conditions in foreign countries. (See 40 CFR part 158 for EPA's
data requirements to support domestic use of a pesticide and the
establishment and maintenance of a tolerance. EPA is developing a
guidance concerning submissions for import tolerance support. This
guidance will be made available to interested stakeholders.) In most
cases, EPA also requires residue chemistry data (crop field trials)
that are representative of growing conditions in exporting countries in
the same manner that EPA requires representative residue chemistry data
from different U.S. regions to support domestic use of a pesticide and
any resulting tolerance(s) or exemption(s). Good Laboratory Practice
(GLP) requirements for studies submitted in support of tolerances and
exemptions for import purposes only are the same as for domestic
purposes; i.e., the studies are required to either
[[Page 55567]]
fully meet GLP standards, or have sufficient justification presented to
show that deviations from GLP requirements do not significantly affect
the results of the studies.
Monitoring and enforcement of pesticide tolerances and exemptions
are carried out by the U.S. Food and Drug Administration (FDA) and the
U.S. Department of Agriculture (USDA). This includes monitoring for
pesticide residues in or on commodities imported into the United
States.
VII. Which pesticides are covered by this action?
4-Amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-
one [Metribuzin, trade name Sencor] is an herbicide used on a wide
range of crop and non-crop sites, including alfalfa, asparagus, barley,
carrots, field corn, garbanzo beans, lentils, peas, potatoes, soybean,
sugarcane, tomatoes, wheat, fallow land and turfgrasses, to selectively
control broadleaf and grassy weed species. It is manufactured by Bayer
Corporation.
Dichlobenil (trade names Casoron, Norosac) is a selective herbicide
registered for use on cranberry bogs, dichondra, ornamentals;
blackberry, raspberry, and blueberry fields; apple, pear, filbert, and
cherry orchards; vineyards, and hybrid poplar-cottonwood plantations.
It is manufactured by Uniroyal Chemical.
Diphenylamine is a plant growth regulator used post-harvest on
apples to control storage scald. Elf Atochem and Pace International are
the manufacturers of the chemical.
O-Ethyl O-[4-(methylthio) phenyl] S-propyl phosphorodithioate
[Sulprofos] is an insecticide once used on cotton. It was manufactured
by Bayer Corporation.
Pendimethalin (trade names Prowl, Squadron) is a selective
herbicide used to control broadleaf weeds and grassy weed species on a
number of crop and noncrop areas and on residential lawns and
ornamentals. It is manufactured by American Cyanamid Corporation.
Terbacil (3-tert-butyl-5-chloro-6-methyluracil, trade name Sinbar)
is an herbicide used to control barnyardgrass, broadleaf weeds,
chickweed, clover, crabgrass, dandelion, foxtail, peppergrass, pigweed,
quackgrass, ragweed, and ryegrass. It is manufactured by E. I. Du Pont
de Nemours and Co., Incorporated.
VIII. What action is being taken?
This notice proposes revocation of FFDCA tolerances for residues of
the herbicides 4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-
triazin-5(4H)-one [Metribuzin], dichlobenil, pendimethalin, and
terbacil; and the insecticide O-Ethyl O-[4-(methylthio) phenyl] S-
propyl phosphorodithioate [Sulprofos] in or on commodities listed in
the regulatory text because these pesticides are not registered under
FIFRA for uses on the commodities. The registrations for these
pesticide chemicals were canceled because the registrant failed to pay
the required maintenance fee and/or the registrant voluntarily canceled
one or more registered uses of the pesticide. It is EPA's general
practice to propose revocation of those tolerances for residues of
pesticide chemicals for which there are no active registrations under
FIFRA, unless any person in comments on the proposal demonstrates a
need for the tolerance to cover residues in or on imported commodities
or domestic commodities legally treated.
Changes in the commodity terminology and definitions are proposed
in accordance with the revised Crop Group Regulation (40 CFR 180.41)
and the updated Table I ``Raw Agricultural and Processed Commodities
and Feedstuffs Derived from Crops' (August, 1996) in the Residue
Chemistry Test Guidelines: OPPTS 860.1000 (EPA 721-C-96-169). Table I
contains data on both crops and livestock diets, and lists feed
commodities considered significant in livestock diets. Significant
feedstuffs account for more than 99% of the available annual tonnage
(on-a dry-matter basis) of feedstuffs used in the domestic production
of more than 95 percent of beef and dairy cattle, poultry, swine, milk,
and eggs. EPA has devised criteria to include or exclude feedstuffs
from Table I and sets tolerances for significant feedstuffs. Tolerances
are not set for feedstuffs which are neither significant nor a human
food. Pesticide residues on such feedstuffs are governed by tolerances
on the commodity from which they are derived (December 17, 1997, 62 FR
66020) (FRL-5753-1). These changes are technical in nature and have no
effect on the scope of the tolerance.
This notice also proposes to establish and revise tolerances as
given in the regulatory text. A determination of safety by EPA includes
consideration of (a) potential cumulative effects with pesticides that
have a common mode of toxicity, (b) aggregate risks resulting from
exposure to residues in food and drinking water and exposure occuring
due to pesticide application in residential settings, and (c) special
sensitivity to children. FFDCA section 408(b)(2)(C) requires that when
determining appropriate tolerances EPA apply an additional ten-fold
safety factor for infants and children to take into account potential
pre- and post-natal toxicity and the completeness of data on toxicity
and exposure unless a different margin of safety, on the basis of
reliable data, will be safe for infants and children. Retention,
reduction, or removal of the ten-fold safety factor is based on a
weight-of-evidence evaluation of all applicable data. Through the
Reregistration Eligibility Decision (RED) process, EPA has determined
that each of the amended tolerances meet the safety standards under
FQPA for each of the following active ingredients. This safety finding
determination is found in detail in the RED for the active ingredient.
Each RED concerning an active ingredient is publically available as
described in Unit VI of this proposed rule and by contacting the
Pesticide Docket, Public Information and Records Integrity Branch,
Information Resources and Services (7502C), Office of Pesticide
Programs (OPP), U.S. EPA, Washington, DC 20460, telephone 703-305-5805.
4-Amino-6(1,1-dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-one
[Metribuzin]
The tolerance for lentils, vine hay in 40 CFR 180.332 is being
proposed for revocation. Lentils, vine hay is no longer considered a
significant livestock feed commodity. Contrary to the RED, a registered
use now exists for sweet corn, as conveyed by EPA in a letter to the
Bayer Corporation as of August, 1997. Therefore, the tolerance for
corn, fresh (inc. sweet K + CWHR) will not be revoked. Tolerances for
both barley, hay and wheat, hay are proposed to be established at 7
ppm. Tolerances for both asparagus and soybeans should be increased
from 0.05 to 0.1 and from 0.1 to 0.3 ppm, respectively. The tolerance
for peas, vine hay is proposed to be increased from 0.05 to 4 ppm
(along with a proposed terminology revision to peas, field, hay); and
the tolerance for sugarcane molasses was listed incorrectly as 0.3 ppm,
it should be revised to reflect the correct tolerance of 2 ppm (August
24, 1978, 43 FR 35915), along with a proposed terminology revision to
sugarcane, molasses. Other terminology changes are given in the
regulatory text.
Dichlobenil
The tolerances listed under 40 CFR 180.231 are for the combined
negligible residues of the herbicide dichlobenil (2,6-
dichlorobenzonitrile) and its metabolite 2,6-dichlorobenzoic acid (2,6-
DCBA). The Agency has determined that the metabolite 2,6-
[[Page 55568]]
Dichlorobenzamide (BAM) should be added to the tolerance expression and
the metabolite 2,6-DCBA should be deleted from the tolerance
expression. Tolerances for almond hulls; avocados; citrus; figs; and
mangoes in 40 CFR 180.231 are being proposed for revocation because no
registered uses exist. The tolerance for nuts in 40 CFR 180.231 is
proposed for revocation and a tolerance for filberts is being proposed
to be established at 0.1 parts per million, since the use of
dichlobenil on all other nuts has been canceled. Based upon the
available residue data and to reflect the combined residues of
dichlobenil and BAM, tolerances for apples and pears should be
increased from 0.15 to 0.5 ppm, and tolerances for blackberries,
cranberries, and raspberries should be decreased from 0.15 to 0.10 ppm.
Diphenylamine
This notice proposes to establish tolerances of 0.01 ppm for
residues in milk and meat, fat, and mbyp (excluding liver) of cattle,
goats, horses, and sheep. Separate tolerances are proposed to be
established at 0.1 ppm for residues of diphenylamine in liver of
cattle, goats, horses, and sheep. A tolerance of 30 ppm is proposed to
be established for diphenylamine residues in wet apple pomace. Also,
this notice proposes to increase milk and meat tolerances for
diphenylamine residues from 0 to 0.01 ppm based on adequate ruminant
data. Terminology changes are given in the regulatory text.
O-Ethyl O-[4-(methylthio) phenyl] S-propyl phosphorodithioate
[Sulprofos]
The tolerance for cottonseed oil in 40 CFR 185.3000 is being
proposed for revocation because the registrant voluntarily canceled its
registered use.
Pendimethalin
The tolerance for peanut, forage in 40 CFR 180.361(a) is being
proposed for revocation because it is no longer considered a
significant livestock feed commodity; therefore, a tolerance is not
necessary. This notice proposes to establish a tolerance of 0.1 ppm for
residues in or on rice, straw; and to raise the tolerance on rice grain
from 0.05 to 0.1 ppm based on available field trial data and to reflect
the analytical method's limit of quantitation for the combined residues
of pendimethalin and its regulated metabolite. EPA also proposes to
combine the tolerance for garlic, listed under 180.361(c) Tolerances
with regional registrations, with tolerances 180.361(a), which lists
tolerances for registrations without regional restriction, since EPA
has data that supports a national registration and tolerance for garlic
at the same level (0.1 ppm). Terminology changes are given in the
regulatory text.
Terbacil
Tolerances for pears; pecans; sainfoin, forage; and sainfoin hay in
40 CFR 180.209(a) are being proposed for revocation because no
registered uses exist. Tolerances for cattle, fat; cattle, mybp;
cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs,
mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; milk, fat;
sheep, fat; sheep, mbyp; and sheep, meat in 40 CFR 180.209(a) are being
proposed for revocation because there is no reasonable expectation of
finite terbacil residues in animal commodities since available data
support the establishment of lower alfalfa tolerances [40 CFR
180.6(a)(3)]. For further information, consult the RED for Terbacil.
EPA is proposing that the tolerance expressions be unified to include
terbacil (3-tert-butyl-5-chloro-6-methyluracil) and its metabolites [3-
tert-butyl-5-chloro-6-hydroxymethyl-uracil], [6-chloro-2,3-dihydro-7-
hydroxymethyl 3,3-dimethyl-5H-oxazolo (3,2-a) pyrimidin-5-one], and [6-
chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo (3,2-a) pyrimidin-5-one],
calculated as terbacil. In accordance, 40 CFR 180.209 sections (a)(1)
and (a)(2) should be combined. To reflect the combined limit of
detection for terbacil and its three regulated metabolites, this
document proposes to raise the tolerances for terbacil residues in or
on peaches from 0.1 to 0.2 ppm, blueberries from 0.1 to 0.2 ppm, and
caneberries from 0.1 to 0.2 ppm. Based upon available residue data,
tolerances should be increased for apples from 0.1 to 0.3 ppm,
asparagus from 0.2 to 0.4 ppm, and sugarcane from 0.1 to 0.4 ppm;
however, tolerances should be decreased for alfalfa, forage; from 5.0
to 1.0 ppm, and alfalfa, hay; from 5.0 to 2.0 ppm.
IX. When do these actions become effective?
EPA proposes that these actions become effective 90 days following
publication of a final rule in the Federal Register. EPA has delayed
the effectiveness of these revocations for 90 days following
publication of a final rule to ensure that all affected parties receive
notice of EPA's action. For this particular proposed rule, the actions
will affect uses which have been canceled for more than a year. This
should ensure that commodities have cleared the channels of trade. If
you have comments regarding existing stocks, please submit comments as
described in Unit IV of this preamble.
Any commodities listed in the regulatory text of this notice that
are treated with the pesticides subject to this notice, and that are in
the channels of trade following the tolerance revocations, shall be
subject to FFDCA section 408(1)(5), as established by FQPA. Under this
section, any residue of these pesticides in or on such food shall not
render the food adulterated so long as it is shown to the satisfaction
of FDA that, (1) the residue is present as the result of an application
or use of the pesticide at a time and in a manner that was lawful under
FIFRA, and (2) the residue does not exceed the level that was
authorized at the time of the application or use to be present on the
food under a tolerance or exemption from tolerance. Evidence to show
that food was lawfully treated may include records that verify the
dates that the pesticide was applied to such food.
X. What can I do if I wish the Agency to maintain a tolerance that
the Agency proposes to revoke?
In addition to submitting comments in response to this notice, you
may also submit an objection. EPA subsequently issues a final rule
after considering the comments that are submitted in response to this
notice. If you fail to file an objection to the final rule within the
time period specified, you will have waived the right to raise any
issues resolved in the final rule. After the specified time, the issues
resolved in the final rule cannot be raised again in any subsequent
proceedings.
This proposal provides 60 days for any interested person to
demonstrate a need for retaining a tolerance, if retention of the
tolerance will meet the tolerance standard established under FQPA. If
EPA receives a comment to that effect, EPA will not proceed to revoke
the tolerance immediately. However, EPA will take steps to ensure the
submission of any needed supporting data and will issue an order in the
Federal Register under FFDCA section 408(f) if needed. The order would
specify the data needed, the time frames for its submission, and would
require that within 90 days some person or persons notify EPA that they
will submit the data. If the data are not submitted as required in the
order, EPA will take appropriate action under FIFRA or FFDCA.
[[Page 55569]]
XI. How do the regulatory assessment requirements apply to this
action?
A. Is this a ``significant regulatory action''?
No. Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), this action is not a
``significant regulatory action.'' The Office of Management and Budget
(OMB) has determined that tolerance actions, in general, are not
``significant'' unless the action involves the revocation of a
tolerance that may result in a substantial adverse and material affect
on the economy. In addition, this action is not subject to Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997), because this
action is not an economically significant regulatory action as defined
by Executive Order 12866. Nonetheless, environmental health and safety
risks to children are considered by the Agency when determining
appropriate tolerances. Under FQPA, EPA is required to apply an
additional 10-fold safety factor to risk assessments in order to ensure
the protection of infants and children unless reliable data supports a
different safety factor.
B. Does this action contain any reporting or recordkeeping
requirements?
No. This action does not impose any information collection
requirements subject to OMB review or approval pursuant to the
Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
C. Does this action involve any ``unfunded mandates''?
No. This action does not impose any enforceable duty, or contain
any ``unfunded mandates'' as described in Title II of the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
D. Do Executive Orders 12875 and 13084 require EPA to consult with
States and Indian Tribal Governments prior to taking the action in this
notice?
No. Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to the Office of Management and Budget (OMB) a description
of the extent of EPA's prior consultation with representatives of
affected State, local and tribal governments, the nature of their
concerns, copies of any written communications from the governments,
and a statement supporting the need to issue the regulation. In
addition, Executive Order 12875 requires EPA to develop an effective
process permitting elected officials and other representatives of
State, local and tribal governments ``to provide meaningful and timely
input in the development of regulatory proposals containing significant
unfunded mandates.''
Today's proposed rule does not create an unfunded federal mandate
on State, local or tribal governments. The rule does not impose any
enforceable duties on these entities. Accordingly, the requirements of
section 1(a) of Executive Order 12875 do not apply to this proposed
rule.
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governmen (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected and other representatives of Indian tribal governments ``to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities.''
Today's proposed rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian Tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this proposed rule.
E. Does this action involve any environmental justice issues?
No. This action is not expected to have any potential impacts on
minorities and low income communities. Special consideration of
environmental justice issues is not required under Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
F. Does this action have a potentially significant impact on a
substantial number of small entities?
No. Pursuant to section 605(b) of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.), the Agency hereby certifies that tolerance
actions, including these specific tolerance actions, will not result in
a significant economic impact on a substantial number of small
entities. Because similar tolerance actions are expected to have the
same general impact from chemical to chemical, this certification is
applicable to all tolerance actions. Unless a particular tolerance
action is expected to have impacts different than those used for the
analysis, this determination will also serve as a ``generic''
certification for the promulgation of any pesticide tolerance action,
and EPA will incorporate it by reference in future individual tolerance
actions. This ``generic'' certification (46 FR 24950, May 4, 1981) and
the rationale presented below has been provided to the Chief Counsel
for Advocacy of the Small Business Administration. Technical changes
such as changing the individual commodity name or crop group definition
will have no impact on the crop itself or residue requirements.
Therefore, I certify that these types of administrative changes will
not have an economic impact or cause significant adverse effects on a
substantial number of small entities.
EPA has determined that the revocation of a tolerance after the use
of the pesticide becomes illegal in this country, will not have a
significant impact on a substantial number of small entities, because
such revocations do not have a significant impact on affected entities
in general, regardless of the size of the entity. Since small entities
are not disproportionally impacted, EPA considered the impacts on
domestic growers and domestic importers of food products that could be
affected by the revocation of the tolerance.
In the case of domestically grown food, the tolerances revoked by
this notice will have no economic impact. Since the uses are no longer
registered, uses have already been deleted from the pesticide product
labels. U.S. growers may no longer purchase the pesticides in question
for use on such crops and EPA believes that no existing stocks
[[Page 55570]]
remain of the pesticides in question labeled for the deleted uses. In
these circumstances, revoking the tolerances after deletion of the uses
should have no impact on food grown in the United States. However, food
legally treated under FIFRA before the use deletions occurred will not
be considered adulterated if the residue level complies with the
tolerance in effect at the time of treatment [see FFDCA section
408(l)(5)].
Revocation may have an effect on domestic importers of foreign-
grown food to the extent their foreign suppliers use pesticides in ways
that result in residues no longer allowed in the United States. If
foreign growers use a pesticide on crops for which there is no
tolerance or exemption from the requirement of a tolerance, the food
they grow will be considered adulterated and subject to detention and
regulatory action if residues of the pesticide are found in or on the
food when offered for import or imported into the United States.
Nevertheless, the effect on U.S. importers is expected to be minimal
regardless of their size.
In the absence of extraordinary circumstances, the revocation of a
particular tolerance is unlikely to have a significant impact on the
price of a commodity on the international market. Transaction costs may
occur as a result of having to find alternative suppliers of food
untreated with pesticides for which tolerances were revoked. Affected
importers, however, would have the options of finding other suppliers
in the same country or in other countries, or inducing the same
supplier to switch to alternative pest controls. Given the existence of
these options, EPA expects any price increases or transaction costs
resulting from revocations to be minor. Given the overall minimal
impact anticipated, revocations are not expected to have a significant
impact on those affected, including small entities.
As to the pesticide uses involved in this action, EPA has reviewed
its available data on imported food and foreign pesticide usage and
concludes that there is a reasonable international supply of food not
treated with the pesticides having tolerances that are proposed for
revocation, generally within the same countries from which the relevant
commodities are currently imported.
G. Does this action involve technical standards?
No. This tolerance action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Pub. L. 104-113, Section 12(d) (15
U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus
standards in its regulatory activities unless to do so would be
inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, business practices,
etc.) that are developed or adopted by voluntary consensus standards
bodies. The NTTAA requires EPA to provide Congress, through OMB,
explanations when the Agency decides not to use available and
applicable voluntary consensus standards. EPA invites public comment on
this conclusion.
H. Are there any international trade issues raised by this action?
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. When possible, EPA seeks
to harmonize U.S. tolerances with Codex MRLs. EPA may establish a
tolerance that is different from a Codex MRL, however FFDCA section
408(b)(4) requires that EPA explain in a Federal Register notice the
reasons for departing from the Codex level. EPA's effort to harmonize
with Codex MRLs is summarized in the tolerance reassessment section of
individual REDs. The U.S. EPA is developing a guidance concerning
submissions for import tolerance support. This guidance will be made
available to interested stakeholders.
I. Is this action subject to review under the Congressional Review Act?
No. This action is not a final rule. Under 5 U.S.C. 801(a)(1)(A) of
the Administrative Procedure Act (APA) as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-
121, 110 Stat. 847), only final rules must be submitted to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication in the Federal Register.
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and record
keeping requirements.
40 CFR Part 185
Environmental protection, Food additives, Pesticides and pests.
Dated: September 28, 1998.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR parts 180 and 185 be amended
to read as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. Section 180.190 is revised to read as follows:
Sec. 180.190 Diphenylamine; tolerances for residues.
(a) General. Tolerances for residues of the plant regulator
diphenylamine are established in or on the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apple, pomace, wet........................ 30
Apples from preharvest or postharvest use 10
(including use of impregnated wraps).
Cattle, fat............................... 0.01
Cattle, liver............................. 0.1
Cattle, mbyp (excluding liver)............ 0.01
Cattle, meat.............................. 0.01
Goat, fat................................. 0.01
Goat, liver............................... 0.1
Goat, mbyp (excluding liver).............. 0.01
Goat, meat................................ 0.01
Horse, fat................................ 0.01
Horse, liver.............................. 0.1
Horse, mbyp (excluding liver)............. 0.01
Horse, meat............................... 0.01
Milk...................................... 0.01
Sheep, fat................................ 0.01
Sheep, liver.............................. 0.1
Sheep, mbyp (excluding liver)............. 0.01
Sheep, meat............................... 0.01
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[[Page 55571]]
c. In Sec. 180.209, by alphabeticaly adding the entries in the
table in paragraph (a)(1) to the table in paragraph (a)(2), by removing
paragraph (a)(1), by redesignating paragraph (a)(2) as paragraph (a),
and revising newly designated paragraph (a) to read as follows:
Sec. 180.209 Terbacil; tolerances for residues.
(a) General. Tolerances are established for combined residues of
the herbicide terbacil (3-tert-butyl-5-chloro-6-methyluracil) and its
metabolites [3-tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro-
2,3-dihydro-7-hydroxymethyl 3,3-dimethyl-5H-oxazolo (3,2-a) pyrimidin-
5-one], and [6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo (3,2-a)
pyrimidin-5-one], calculated as terbacil, in or on raw agricultural
commodities as follows:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa, forage........................... 1.0
Alfalfa, hay.............................. 2.0
Apple..................................... 0.3
Asparagus................................. 0.4
Blueberry................................. 0.2
Caneberry (blackberry, boysenberry, 0.2
dewberry, loganberry, raspberry, and
youngberry, and varieties and/or hybrids
of these).
Citrus fruits............................. 0.1
Mint hay (peppermint and spearmint)....... 2.0
Peach..................................... 0.2
Strawberry................................ 0.1
Sugarcane................................. 0.4
------------------------------------------------------------------------
* * * * *
d. Section 180.231 is revised to read as follows:
Sec. 180.231 Dichlobenil; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of the herbicide dichlobenil (2,6-dichlorobenzonitrile) and its
metabolite 2,6-dichlorobenzamide in or on the following raw
agricultural commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apple..................................... 0.5
Blackberry................................ 0.1
Blueberry................................. 0.15
Cranberry................................. 0.1
Filbert................................... 0.1
Grape..................................... 0.15
Pear...................................... 0.5
Raspberry................................. 0.1
Stone fruits group........................ 0.15
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registration. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
e. In Sec. 180.332, paragraph (a) the table is revised to read as
follows:
Sec. 180.332 4-Amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-
triazin-5(4H)-one; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa, green............................ 2
Alfalfa, hay.............................. 7
Asparagus................................. 0.1
Barley, grain............................. 0.75
Barley, hay............................... 7
Barley, milled fractions (exceept flour).. 3
Barley, straw............................. 1
Carrots................................... 0.3
Cattle, fat............................... 0.7
Cattle, mbyp.............................. 0.7
Cattle, meat.............................. 0.7
Corn, field, stover....................... 0.1
Corn, field, forage....................... 0.1
Corn, fresh (inc. sweet K+CWHR)........... 0.05
Corn, grain (inc. popcorn)................ 0.05
Eggs...................................... 0.01
Goats, fat................................ 0.7
Goats, mbyp............................... 0.7
Goats, meat............................... 0.7
Grass, forage............................. 2
Grass, hay................................ 7
Hogs, fat................................. 0.7
Hogs, mbyp................................ 0.7
Hogs, meat................................ 0.7
Horses, fat............................... 0.7
Horses, mbyp.............................. 0.7
Horses, meat.............................. 0.7
Lentil.................................... 0.5
Milk...................................... 0.05
Peas, field, hay.......................... 4
Pea, field, vine.......................... 0.5
Pea, seed................................. 0.05
Pea, succulent............................ 0.1
Potato, processed potato waste............ 3
Potatoes.................................. 0.6
Poultry, fat.............................. 0.7
Poultry, mbyp............................. 0.7
Poultry, meat............................. 0.7
Sainfoin, forage.......................... 2
Sainfoin, hay............................. 7
Sheep, fat................................ 0.7
Sheep, mbyp............................... 0.7
Sheep, meat............................... 0.7
Soybean, seed............................. 0.3
Soybeans, forage.......................... 4
Soybeans, hay............................. 4
Sugarcane................................. 0.1
Sugarcane, molasses....................... 2
Tomatoes.................................. 0.1
Wheat, forage............................. 2
Wheat, hay................................ 7
Wheat, grain.............................. 0.75
Wheat, milled fractions (except flour).... 3
Wheat, straw.............................. 1
------------------------------------------------------------------------
* * * * *
f. In Sec. 180.361, paragraph (a), the table is revised to read as
follows:
Sec. 180.361 Pendimethalin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Bean, succulent and bean, seed............ 0.1
Beans, forage............................. 0.1
Beans, hay................................ 0.1
Corn, field, stover....................... 0.1
Corn, forage.............................. 0.1
Corn, sweet (K+CWHR)...................... 0.1
Corn, field, grain........................ 0.1
Corn, pop, grain.......................... 0.1
Cotton, undelinted seed................... 0.1
Onions, dry bulb.......................... 0.1
Peanuts................................... 0.1
Peanut, hay............................... 0.1
Peas (except field peas).................. 0.1
Potatoes.................................. 0.1
Rice, grain............................... 0.1
Rice, straw............................... 0.1
Sorghum, stover........................... 0.1
Sorghum, forage........................... 0.1
Sorghum, grain............................ 0.1
Soybeans.................................. 0.1
Soybeans, forage.......................... 0.1
Soybeans, hay............................. 0.1
Sugarcane................................. 0.1
Sunflower, seeds.......................... 0.1
------------------------------------------------------------------------
* * * * *
g. In Sec. 180.361, paragraph (c), the entry for ``garlic'' is
alphabetically added to the table in paragraph (a).
PART 185-- [AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 348.
Sec. 185.3000 [Removed]
b. By removing Sec. 185.3000.
[FR Doc. 98-27707 Filed 10-15-98; 8:45 am]
BILLING CODE 6560-50-F