[Federal Register Volume 66, Number 182 (Wednesday, September 19, 2001)]
[Rules and Regulations]
[Pages 48208-48209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23263]



[[Page 48208]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 01F-0142]


Secondary Direct Food Additives Permitted in Food for Human 
Consumption

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 poultry carcasses, poultry parts, and organs. 
This action is in response to a petition filed by Ecolab, Inc.

DATES: This rule is effective September 19, 2001. Submit written 
objections and requests for a hearing by October 19, 2001. 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 a 
certain publication in Sec. 173.370 as of September 19, 2001.

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 March 30, 2001 (66 FR 17430), FDA announced that a food 
additive petition (FAP 1A4728) 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 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 
poultry carcasses, poultry parts, and organs.
    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 poultry carcasses, 
poultry parts, and organs. Therefore, 21 CFR 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 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 collections 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 October 19, 2001. 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 shall be 
submitted and shall 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 Dockets Management Branch 
(address above) 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 amended by revising paragraphs (b) and (c) to 
read as follows:


Sec. 173.370  Peroxyacids.

* * * * *
    (b)(1) 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.
    (2) The additive is used as an antimicrobial agent on poultry 
carcasses, poultry parts, and organs in accordance with current 
industry standards of good manufacturing practice (unless precluded by 
the U.S. Department of Agriculture's standards of identity in 9 CFR 
part 381, subpart P) where the maximum concentration of peroxyacids is 
220 parts per million (ppm) as peroxyacetic acid, the maximum 
concentration of hydrogen peroxide is 110 ppm, and the maximum 
concentration of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) is 13 
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,'' July 26, 2000, developed by 
Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The 
concentration of 1-hydroxyethylidene-

[[Page 48209]]

1,1-diphosphonic acid is determined by a method entitled 
``Determination of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) 
Peroxyacid/Peroxide-Containing Solutions,'' August 21, 2001, developed 
by Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The 
Director of the Office of the Federal Register approves these 
incorporations by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain copies of these methods from the Division 
of Petition Review, 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: September 6, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 01-23263 Filed 9-18-01; 8:45 am]
BILLING CODE 4160-01-S