[Federal Register: April 2, 2004 (Volume 69, Number 64)]
[Rules and Regulations]
[Page 17297-17298]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap04-4]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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