[Federal Register Volume 69, Number 64 (Friday, April 2, 2004)]
[Rules and Regulations]
[Pages 17297-17298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7399]



[[Page 17297]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 2002F-0181]


Secondary Direct Food Additives Permitted in Food for Human 
Consumption

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 cetylpyridinium 
chloride as an antimicrobial agent in poultry processing. This action 
is in response to a petition filed by Safe Foods Corp.

DATES: This rule is effective April 2, 2004. Submit written or 
electronic objections and requests for a hearing by May 3, 2004. The 
Director of the Office 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 173.375 as of April 2, 2004.

ADDRESSES: Submit written objections and requests for hearing to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
objections to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Andrew D. Laumbach, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 202-418-3071.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of May 7, 2002 (67 FR 
30716), FDA announced that a food additive petition (FAP 2A4736) had 
been filed by Safe Foods Corp., c/o Keller and Heckman LLP, 1001 G St. 
NW., Washington, DC 20001. The petition proposed to amend the food 
additive regulations in part 173 (21 CFR part 173) to provide for the 
safe use of cetylpyridinium chloride as an antimicrobial agent in 
poultry processing.

II. Conclusion

    FDA has evaluated data in the petition and other relevant material. 
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 in poultry processing. 
Therefore, part 173 is amended as set forth in this document.
    The agency is including as a condition of use in this regulation 
the requirement that cetylpyridinium chloride be captured and recycled 
during poultry processing. Because byproducts resulting from poultry 
processing are typically recycled back into animal feed, the additive 
could also become a component of animal feed unless controls to prevent 
such a situation are established. In situations where human food 
additives become components of animal feed, possibly in substantially 
higher amounts than in human food, FDA estimates the amount of additive 
likely to be consumed by the animals and assesses the safety of such 
additives for the animals themselves and of the human food that may be 
produced by such animals. To mitigate any potential concerns associated 
with the possibility of the additive becoming a component of animal 
feed, the petitioner proposed a system which ensures capture and 
recycling of the additive and disposal of residual cetylpyridinium 
chloride in an appropriate manner. The agency agrees with this 
approach. Therefore, as stated in paragraph (c) in the codified section 
of this document, the agency is requiring use of a capture and recycle 
technology to limit the potential for bioaccumulation of 
cetylpyridinium chloride in animal feed and thus to avoid the 
possibility of additional exposure to humans who consume poultry.
    The petitioner proposes to apply cetylpyridinium chloride as an 
aqueous solution at a level not to exceed 0.3 gram of cetylpyridinium 
chloride per pound of poultry. As a further condition of use, the 
regulation provides that the applied solution contain propylene glycol 
at a level 1.5 times that of cetylpyridinium chloride. The propylene 
glycol is included as part of the applied solution in order to: (1) 
Maintain the solubility and stability of the cetylpyridinium chloride 
solution, and (2) reduce the absorption of cetylridinium chloride on 
the treated poultry (Ref. 1).

III. 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 are available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
contact person listed in this document (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.

IV. Environmental Impact

    In the notice of filing, FDA gave interested parties an opportunity 
to submit comments on the petitioner's environmental assessment. FDA 
received no comments in response to that notice.
    The agency 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. The agency'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.

V. 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.

VI. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may at 
any time file with the Division of Dockets Management (see ADDRESSES) 
written or electronic objections (see DATES). Each objection shall be 
separately numbered, and each numbered objection shall specify with 
particularity the provisions of the regulation to which the objection 
is made and the grounds for the objection. Each numbered objection on 
which a hearing is requested must state that a hearing is requested. 
Failure to request a hearing for any particular objection will 
constitute a waiver of the right to a hearing on that objection. Each 
numbered objection for which a hearing is requested must 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 must be 
submitted and must be identified with the docket number found in the 
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.

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VII. References

    The following reference has 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 the Chemistry Review Group to the Regulatory 
Group II, ``Cetylpyridinium Chloride (CPC) For Use as an 
Antimicrobial Treatment for Use on Poultry,'' dated November 19, 
2002.

List of Subjects in 21 CFR Part 173

    Food additives, Incorporation by reference.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 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 173.375 is added to read as follows:


Sec.  173.375  Cetylpyridinium chloride.

    Cetylpyridinium chloride (CAS Reg. No. 123-03-5) may be safely used 
in food in accordance with the following prescribed conditions:
    (a) The additive meets the specifications of the United States 
Pharmacopeia (USP)/National Formulary (NF) methods described in USP 24/
NF 19, p. 370, January 2000, which is incorporated by reference. The 
Director of the Office 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, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, or you 
may examine a copy at the Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (b) The additive is used in food as an antimicrobial agent as 
defined in Sec.  170.3(o)(2) of this chapter to treat the surface of 
raw poultry carcasses. The additive is applied as a fine mist spray of 
an ambient temperature aqueous solution to raw poultry carcasses prior 
to immersion in a chiller, at a level not to exceed 0.3 gram 
cetylpyridinium chloride per pound of raw poultry carcass. The aqueous 
solution shall also contain propylene glycol (CAS Reg. No. 57-55-6) 
complying with Sec.  184.1666 of this chapter, at a concentration of 
1.5 times that of the cetylpyridinium chloride.
    (c) The additive shall be used in systems that collect and recycle 
solution that is not carried out of the system with the treated poultry 
carcasses.

    Dated: March 26, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-7399 Filed 4-1-04; 8:45 am]
BILLING CODE 4160-01-S