[Federal Register Volume 74, Number 51 (Wednesday, March 18, 2009)]
[Rules and Regulations]
[Pages 11476-11478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5852]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2005-F-0505] (formerly Docket No. 2005F-0138)
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Silver Nitrate and Hydrogen Peroxide
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of an aqueous solution
of silver nitrate and hydrogen peroxide as an antimicrobial agent in
bottled water. This action is in response to a petition filed by Kareem
I. Batarseh.
DATES: This final rule is effective March 18, 2009. Submit written or
electronic objections and requests for a hearing by April 17, 2009. See
section VIII of this document for information on the filing of
objections. The Director of the Federal Register approves the
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51 of certain publications in 21 CFR 172.167 as of March 18, 2009.
ADDRESSES: You may submit written or electronic objections and requests
for a hearing identified by Docket No. FDA-2005-F-0505 (formerly Docket
No. 2005F-0138) by any of the following methods:
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written objections in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of objections, FDA is no longer
accepting objections submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic objections by using the Federal
eRulemaking Portal, as described in the Electronic Submissions portion
of this paragraph.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All objections received will be
posted without change to http://www.regulations.gov, including any
personal information provided. For detailed instructions on submitting
objections, see the ``Objections'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Mical E. Honigfort, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1278.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of April 18, 2005 (70
FR 20145), FDA announced that a food additive petition (FAP 5A4759) had
been filed by Kareem I. Batarseh, P.O. Box 8, College Park, MD 20741-
0008. The petition proposed to amend the food additive regulations in
part 172, Food Additives Permitted for Direct Addition to Food for
Human Consumption (21 CFR part 172), to provide for the safe use of an
aqueous solution of silver nitrate and hydrogen peroxide as an
antimicrobial agent in bottled drinking water at a level not to exceed
17 micrograms per kilogram (microg/kg) of silver and 23 milligrams per
kilogram (mg/kg) of hydrogen peroxide in the treated bottled water.
II. Evaluation of Safety
Under the general safety standard in section 409 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348), a food additive
cannot be approved for a particular use unless a fair evaluation of the
data available to
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FDA establishes that the additive is safe for that use. FDA's food
additive regulations (21 CFR 170.3(i)) define safe as ``a reasonable
certainty in the minds of competent scientists that the substance is
not harmful under the intended conditions of use.''
To establish with reasonable certainty that a food additive is not
harmful under its intended conditions of use, FDA considers the
estimated human dietary intake of the additive, the additive's
toxicological data, and other relevant information (such as published
literature) available to the agency. FDA compares an individual's
estimated daily intake (EDI) of the additive to an acceptable intake
level established by toxicological data. The EDI is determined by
projections based on the amount of the additive proposed for use in
particular foods and on data regarding the amount consumed from all
sources of the additive. The agency commonly uses the EDI for the 90th
percentile consumer of a food additive as a measure of high chronic
dietary intake.
FDA estimates the EDI of silver from the petitioned use in bottled
water to be 26 micrograms per person per day (microg/p/d) for the 90th
percentile consumer aged 2 years or more (Ref. 1). Currently, silver is
permitted as a component of an antimicrobial agent in water filters
(the subject of effective food contact substance notification number
351 (Ref. 2)). The EDI from this filter use is 27 microg/p/d for the
90th percentile consumer. The petitioner has proposed as a condition of
safe use that the subject additive not be used in bottled water that
has been or is intended to be filtered with a silver-containing water
filter. Consequently, bottled water containing the subject additive
will generally be consumed as a substitute for, rather than in addition
to, bottled water that has been filtered with a silver-containing
filter. Thus, the use of the subject additive in bottled water will not
increase consumer exposure to silver. Because there is no increase in
the intake of silver beyond a level that has already been established
as safe, FDA has no concerns regarding the petitioned use of silver as
a component of this additive.
Regarding exposure to nitrate from use of the subject additive, FDA
estimates that the maximum level of nitrate in bottled drinking water
treated with the subject additive would result in a worst-case intake
of 15 microg/p/d at the 90th percentile (Ref. 1), which is equivalent
to 0.25 micrograms per kilogram body weight per day (microg/kg-bw/d) in
a 60 kg adult. FDA has no safety concerns because the intake of nitrate
in bottled drinking water treated with the subject additive is
significantly lower than the chronic oral reference dose of 1,600
microg/kg-bw/d for nitrate that was established by the Environmental
Protection Agency (Ref. 3).
FDA also has no safety concerns regarding the use of hydrogen
peroxide as a component of this additive as it will rapidly break down
to water and oxygen after addition to the bottled water. Consequently,
the dietary exposure to hydrogen peroxide from the petitioned use of
the subject additive is essentially zero (Ref. 1).
III. Conclusion
FDA reviewed data in the petition and other available relevant
material to evaluate the safety of the use of a mixture of silver
nitrate and hydrogen peroxide as an antimicrobial agent in bottled
water. Based on this information, the agency concludes that the
proposed use of the additive is safe and the additive will achieve its
intended technical effect as an antimicrobial agent under the proposed
conditions of use. Therefore, the regulations in part 172 should be
amended as set forth in this document.
To ensure that food grade hydrogen peroxide is used in food, the
additive must meet the specifications for hydrogen peroxide set forth
in this regulation.
FDA notes that bottled water must meet the quality standards for
bottled water in Sec. 165.110(b)(2) through (b)(5) (21 CFR
165.110(b)(2) through (b)(5)), including the limits specified for total
silver and nitrate, unless the water bears a label statement of
substandard quality, as provided for under Sec. 165.110(c) (21 CFR
165.110(c)). Furthermore, bottled water containing a substance at a
level considered injurious to health under section 402(a)(1) of the act
(21 U.S.C. 342(a)(1)) is deemed adulterated, regardless of whether or
not the water bears a label statement of substandard quality, Sec.
165.110(d) (21 CFR 165.110(d)).
IV. Public Disclosure
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition will be made available for inspection
at the Center for Food Safety and Applied Nutrition by appointment with
the information contact person (see FOR FURTHER INFORMATION CONTACT).
As provided in Sec. 171.1(h), the agency will delete from the
documents any materials that are not available for public disclosure
before making the documents available for inspection.
V. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 5A4759. No new
information or comments have been received that would affect the
agency's previous determination that there is no significant impact on
the human environment and that an environmental impact statement is not
required.
VI. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
FDA's review of this petition was limited to section 409 of the
act. This final rule is not a statement regarding compliance with other
sections of the act. For example, the Food and Drug Administration
Amendments Act of 2007, which was signed into law on September 27,
2007, amended the act to, among other things, add section 301(ll) (21
U.S.C. 301(ll)). Section 301(ll) of the act prohibits the introduction
or delivery for introduction into interstate commerce of any food that
contains a drug approved under section 505 of the act (21 U.S.C. 355),
a biological product licensed under section 351 of the Public Health
Service Act (42 U.S.C. 262), or a drug or biological product for which
substantial clinical investigations have been instituted and their
existence has been made public, unless one of the exceptions in 21
U.S.C. 301(ll)(1) to (ll)(4) applies. In our review of this petition,
FDA did not consider whether section 301(ll) or any of its exemptions
apply to food containing this additive. Accordingly, this final rule
should not be construed to be a statement that a food containing this
additive, if introduced or delivered for introduction into interstate
commerce, would not violate section 301(ll). Furthermore, this language
is included in all food additive final rules and therefore should not
be construed to be a statement of the likelihood that section 301(ll)
applies.
VIII. Objections
Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) written or
electronic objections. Each objection shall be separately numbered, and
each numbered objection shall specify with
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particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. Three copies of all documents are to be
submitted and are to be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
IX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum from D. Doell, Division of Petition Review, CFSAN,
FDA to M. Honigfort, Division of Petition Review, CFSAN, FDA, June
14, 2005.
2. FDA, Inventory of Effective Food Contact Substance (FCS)
Notifications, Food Contact Substance Notification Number 351
(http://www.cfsan.fda.gov/~dms/opa-fcn.html).
3. Environmental Protection Agency, Integrated Risk Information
System: Nitrate (CASRN 14797-55-8) (http://www.epa.gov/ncea/iris/subst/0076.htm). (FDA has verified the Web site address, but FDA is
not responsible for any subsequent changes to the Web site after
this document publishes in the Federal Register).
List of Subjects in 21 CFR Part 172
Food additives, Incorporation by reference, Reporting and
recordkeeping requirements.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 172 is amended as follows:
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION
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1. The authority citation for 21 CFR part 172 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
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2. Section 172.167 is added to subpart B to read as follows:
Sec. 172.167 Silver nitrate and hydrogen peroxide solution.
An aqueous solution containing a mixture of silver nitrate and
hydrogen peroxide may be safely used in accordance with the following
prescribed conditions:
(a) The additive is used as an antimicrobial agent in bottled
water.
(b) Hydrogen peroxide meets the specifications of the ``Food
Chemicals Codex,'' 6th ed. (2008), pp. 463 and 464, which is
incorporated by reference. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain copies from the United States
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852
(Internet address http://www.usp.org). Copies may be examined at the
Center for Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2163, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030 or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(c) The amount of silver added will not exceed 17 micrograms per
kilogram in the treated bottled water, and the amount of hydrogen
peroxide will not exceed 23 milligrams per kilogram in the treated
bottled water. Analyses for silver and hydrogen peroxide shall be
conducted on samples of treated bottled water at the site of bottling,
using samples of the water intended for treatment for the blank
determination.
(d)(1) The amount of silver in the treated bottled water is
determined using the method for silver designated in 21 CFR
165.110(b)(4)(iii)(G)(2)(i).
(2) The amount of hydrogen peroxide in the treated bottled water is
determined using a Hydrogen Peroxide Test Kit from the HACH Co., or
equivalent. The manual from the Hydrogen Peroxide Test Kit, Model HYP-
1, Catalog Number 22917-00, 1991, is incorporated by reference. The
Director of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain copies of the test kit manual from the HACH Co., P.O. Box 389,
Loveland CO, 80359 (1-800-227-4224), Model HYP-1, Catalog Number 22917-
00. Copies may be examined at the Center for Food Safety and Applied
Nutrition's Library, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-436-2163, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
http://www.archives.gov/federal_register/code_of_ federal_
regulations/ibr_locations.html.
(e) Substances generally recognized as safe in or on food may be
used to stabilize the additive to ensure that the additive will perform
its intended technical effect.
(f) The additive may not be added to bottled water that has been
filtered or is intended to be filtered through a silver-containing
water filter.
(g) Bottled water must meet the quality standards for bottled water
in Sec. 165.110(b)(2) through (b)(5) of this chapter, including the
limits specified for total silver and nitrate, unless the water bears a
label statement of substandard quality, as provided for under Sec.
165.110(c) of this chapter.
Dated: March 12, 2009.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and
Applied Nutrition.
[FR Doc. E9-5852 Filed 3-17-09; 8:45 am]
BILLING CODE 4160-01-S