[Federal Register Volume 67, Number 191 (Wednesday, October 2, 2002)]
[Rules and Regulations]
[Pages 61783-61784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25078]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 02F-0042]


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 a mixture of 
peroxyacetic acid, octanoic acid, acetic acid, hydrogen peroxide, 
peroxyoctanoic acid, and 1-hydroxyethylidene-1,1-diphosphonic acid as 
an antimicrobial agent on meat carcasses, parts, trim, and organs. This 
action is in response to a petition filed by Ecolab, Inc.

DATES: This rule is effective October 2, 2002. Submit written or 
electronic objections and requests for a hearing by November 1, 2002.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(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: In a notice published in the Federal 
Register of February 11, 2002 (67 FR 6265), FDA announced that a food 
additive petition (FAP 2A4731) had been filed by Ecolab Inc., Ecolab 
Center, 370 N. Wabasha St., St. Paul, MN 55102, proposing 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 a mixture of peroxyacetic acid, octanoic acid, 
acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-
hydroxyethylidene-1,1-diphosphonic acid as an antimicrobial agent on 
meat parts, trim, and organs.
    The agency has previously approved the use of the subject mixture 
on red meat carcasses (Sec.  173.370(b)(1)) in response to an earlier 
petition submitted by Ecolab, Inc. In the evaluation that led to that 
regulation, the agency considered ``red meat'' to include the species 
cattle, swine, sheep, goats, and equine. The United States Department 
of Agriculture's Food Safety and Inspection Service (FSIS) uses the 
term ``meat'' to refer to these species (9 CFR 301.2). Thus, FDA is 
removing the term ``red'' as a descriptor for ``meat carcasses'' in 
Sec.  173.370(b)(1) to make its terminology consistent with FSIS.
    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 on meat carcasses, parts, 
trim, and organs.
    Therefore, FDA is approving the use of a mixture of peroxyacetic 
acid, octanoic acid, acetic acid, hydrogen peroxide, peroxyoctanoic 
acid, and 1-hydroxyethylidene-1, 1-diphosphonic acid as an 
antimicrobial agent on meat carcasses, parts, trim, and organs. 
Accordingly, Sec.  173.370 is amended as set forth below.
    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 (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.
    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 Dockets 
Management Branch (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.
    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.
    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (see ADDRESSES) 
written or electronic objections. 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 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 Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

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:

[[Page 61784]]

PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR 
HUMAN CONSUMPTION

    1. The authority citation for 21 CFR part 173 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348.

    2. Section 173.370 is amended by revising paragraph (b)(1) to read 
as follows:


Sec.  173.370  Peroxyacids.

* * * * *
    (b)(1) The additive is used as an antimicrobial agent on meat 
carcasses, parts, trim, and organs in accordance with current industry 
practice where the maximum concentration of peroxyacids is 220 parts 
per million (ppm) as peroxyacetic acid, and the maximum concentration 
of hydrogen peroxide is 75 ppm.
* * * * *

    Dated: September 18, 2002.
L. Robert Lake,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 02-25078 Filed 10-1-02; 8:45 am]
BILLING CODE 4160-01-S