[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Rules and Regulations]
[Pages 71695-71697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29279]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. FDA-2011-F-0853]
Secondary Direct Food Additives Permitted in Food for Human
Consumption; Sodium Dodecylbenzenesulfonate
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 sodium
dodecylbenzenesulfonate (CAS No. 25155-30-0) as an antimicrobial agent
for use in wash water for fruits and vegetables without the requirement
of a potable water rinse. This action is in response to a petition
filed by Ecolab, Inc.
DATES: This rule is effective December 4, 2012. Submit either
electronic or written objections and requests for a hearing by January
3, 2013. See section VII of this document for information on the filing
of objections.
ADDRESSES: You may submit either electronic or written objections and
requests for a hearing, identified by Docket No. FDA-2011-F-0853, 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 or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-F-0853 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, 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: Molly Harry, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-1075.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of February 2, 2012
(77 FR 5201), FDA announced that a food additive petition (FAP 2A4785)
had been filed by Ecolab, Inc., 370 North Wabasha St., St. Paul, MN
55102-1390. The petition proposed to amend the food additive
regulations in part 173, ``Secondary Direct Food Additives Permitted in
Food for Human Consumption'' (21 CFR part 173), to provide for the safe
use of sodium dodecylbenzenesulfonate (SDBS) as an antimicrobial agent
used as a component of an antimicrobial formulation added to wash water
for fruits and vegetables (e.g., whole fruits and vegetables as well as
fruits, vegetables, and herbs that have been chopped, sliced, cut, or
peeled) to reduce microorganisms in wash water
[[Page 71696]]
and on the surfaces of treated fruits and vegetables. Fruits and
vegetables treated by the additive do not require a potable water
rinse. The petition requested that the additive be considered for use
only in certain food service facilities. The additive may be used at a
level not to exceed 111 milligrams per kilogram of the wash water.
The use of SDBS is currently approved in washing or to assist in
the peeling of fruits and vegetables under Sec. 173.315 provided its
use is followed by a potable water rinse. In addition, FDA food
additive regulations permit the use of SDBS as an indirect food
additive for use as a component of single and repeated use food contact
substances (21 CFR 177.1010, 177.1200, 177.1630, 177.2600, and
177.2800), in sanitizing solutions (21 CFR 178.1010), and in the
production of animal glue (21 CFR 178.3120).
The definition of ``pesticide chemical'' under section
201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 321(q)(1)(B)(i)), excludes an antimicrobial added to
water that comes into contact with food, in the preparing, packing, or
holding of the food for commercial purposes. This exclusion applies
whether the water is to contact raw agricultural commodities or
processed food. Consequently, such an antimicrobial is a ``food
additive'' under section 201(s) of the FD&C Act and subject to the
requirements in section 409 of the FD&C Act (21 U.S.C. 348). The
petitioned use of SDBS as an antimicrobial agent in processing water is
for a food additive use in certain food service facilities. Although
the petitioned use of SDBS is regulated under section 409 of the FD&C
Act as a food additive, this intended use of SDBS may nevertheless be
subject to regulation as a pesticide under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Therefore, manufacturers
intending to use this food additive for this intended use should
contact the Environmental Protection Agency to determine whether this
use requires a pesticide registration under FIFRA.
II. Evaluation of Safety
Under the general safety standard in section 409 of the FD&C Act, a
food additive cannot be approved for a particular use unless a fair
evaluation of the data available to 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
projected human dietary intake of the additive, the additive's
toxicological data, and other relevant information (such as published
literature) available to FDA. As part of FDA's safety evaluation, FDA
reviewed data from published studies in animals on the safety of SDBS,
including a 2-year carcinogenicity study in rats and a multigeneration
reproductive study with rats. Based on the results from these studies
and FDA's estimated dietary intake to SDBS from current and the
proposed food uses, FDA concludes that there is a reasonable certainty
of no harm and the petitioned use of SDBS is safe within the meaning of
section 409 of the FD&C Act.
III. Conclusion
FDA reviewed data in the petition and other available relevant
material to evaluate the safety of SDBS as an antimicrobial agent for
use in wash water for fruits and vegetables without the requirement of
a potable water rinse. Based on this information, FDA 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 173
should be amended as set forth in this document.
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), FDA will delete from the documents any
materials that are not available for public disclosure before making
the documents available for inspection.
V. Environmental Impact
FDA has carefully considered the potential environmental effects of
this action. FDA has concluded that the action will not have a
significant impact on the human environment, and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through
Friday.
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. Objections
Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) either
electronic or written objections. Each objection shall be separately
numbered, and each numbered objection shall specify with 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.
It is only necessary to send only one set of documents. Identify
documents 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.
VIII. Section 301(ll) of the FD&C Act
FDA's review of this petition was limited to section 409 of the
FD&C Act. This final rule is not a statement regarding compliance with
other sections of the FD&C Act. For example, the Food and Drug
Administration Amendments Act of 2007, which was signed into law on
September 27, 2007, amended the FD&C Act to, among other things, add
section 301(ll) (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act
prohibits the introduction or delivery for introduction into interstate
commerce of any food that contains a drug approved under section 505 of
the FD&C 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
[[Page 71697]]
exemptions in section 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) of the FD&C
Act. 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) of the FD&C Act applies.
List of Subjects in 21 CFR Part 173
Food additives.
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 173 is amended as follows:
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION
0
1. The authority citation for 21 CFR part 173 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
0
2. Section 173.405 is added to subpart D to read as follows:
Sec. 173.405 Sodium dodecylbenzenesulfonate.
Sodium dodecylbenzenesulfonate (CAS No. 25155-30-0) may be safely
used in accordance with the following prescribed conditions:
(a) The additive is an antimicrobial agent used in wash water for
fruits and vegetables. The additive may be used at a level not to
exceed 111 milligrams per kilogram in the wash water. Fruits and
vegetables treated by the additive do not require a potable water
rinse.
(b) The additive is limited to use in commissaries, cafeterias,
restaurants, retail food establishments, nonprofit food establishments,
and other food service operations in which food is prepared for or
served directly to the consumer.
(c) To assure safe use of the additive, the label or labeling of
the additive container shall bear, in addition to the other information
required by the Federal Food, Drug, and Cosmetic Act, adequate
directions to assure use in compliance with the provisions of this
section.
Dated: November 28, 2012.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2012-29279 Filed 12-3-12; 8:45 am]
BILLING CODE 4160-01-P