[Federal Register Volume 65, Number 228 (Monday, November 27, 2000)]
[Rules and Regulations]
[Pages 70660-70661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 00F-1332]


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 red meat carcasses. This action is in 
response to a petition filed by Ecolab, Inc.

DATES: This rule is effective November 27, 2000. Submit written 
objections and requests for a hearing by December 27, 2000. 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 173.370, as of November 27, 
2000.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert L. Martin, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204-0001, 202-418-3074.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 13, 2000 (65 FR 37155), FDA announced that a food 
additive petition (FAP 0A4720) had been filed by Ecolab Inc., Ecolab 
Center, 370 Wabasha St., St. Paul, MN 55102. The petition proposed to 
amend the food additive regulations in part 173 (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 
red meat carcasses.
    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 red meat carcasses. The 
agency also concludes that the regulation approving the additive should 
be entitled ``Peroxyacids.'' Reaction of hydrogen peroxide with acetic 
acid and octanoic acid results in partial conversion to peroxyacetic 
acid and peroxyoctanoic acid, respectively. Therefore, part 173 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 listed above. 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 (address above) 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 (address above) 
written objections by December 27, 2000. 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. 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, Incorporation by reference.

    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

    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 added to subpart D to read as follows:


Sec. 173.370  Peroxyacids.

    Peroxyacids may be safely used in accordance with the following 
prescribed conditions:
    (a) The additive is a mixture of peroxyacetic acid, octanoic acid, 
acetic

[[Page 70661]]

acid, hydrogen peroxide, peroxyoctanoic acid, and 1-hydroxyethylidene-
1,1-diphosphonic acid.
    (b) The additive is used as an antimicrobial agent on red meat 
carcasses 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.
    (c) The concentrations of peroxyacids and hydrogen peroxide in the 
additive are determined by a method entitled ``Hydrogen Peroxide and 
Peracid (as Peracetic Acid) Content,'' dated July 26, 2000, developed 
by Ecolab, Inc., 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 of this method from the Division of Petition Control 
(HFS-215), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204-0001, or you may 
examine a copy at the Center for Food Safety and Applied Nutrition's 
Library, 200 C St. SW., rm. 3321, Washington, DC, or at the Office of 
the Federal Register, 800 North Capitol St. NW., suite 700, Washington, 
DC.

    Dated: November 14, 2000.
L. Robert Lake,
Director of Regulations Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-30050 Filed 11-24-00; 8:45 am]
BILLING CODE 4160-01-F