[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