[Federal Register Volume 66, Number 123 (Tuesday, June 26, 2001)]
[Rules and Regulations]
[Pages 33829-33830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 00F-1482]


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 ozone in gaseous 
and aqueous phases as an antimicrobial agent on food, including meat 
and poultry. This action is in response to a petition filed by the 
Electric Power Research Institute, Agriculture and Food Technology 
Alliance.

DATES: This rule is effective June 26, 2001. Submit written objections 
and requests for a hearing by July 26, 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 listed in Sec. 173.368(c), effective as of June 26, 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 September 13, 2000 (65 FR 55264), FDA announced that a food 
additive petition (FAP 0A4721) had been filed by the Electric Power 
Research Institute, Agriculture and Food Technology Alliance, 2747 
Hutchinson Ct., Walnut Creek, CA 94598. The petition proposed to amend 
the food additive regulations in part 173 (21 CFR part 173) to provide 
for the safe use of ozone in gaseous and aqueous phases as an 
antimicrobial agent for the treatment, storage, and processing of 
foods.
    The proposed use would include the use of this additive on raw 
agricultural commodities (RACs) in the preparing, packing, or holding 
of such commodities for commercial purposes, consistent with section 
201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 321(q)(1)(B)(i)), as amended by the Antimicrobial Regulation 
Technical Corrections Act of 1998 (ARTCA) (Public Law 105-324). The 
petitioner is not proposing that the additive be intended for use for 
any application under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or 
(q)(1)(B)(i)(III) of the act, which use would be subject to regulation 
by the Environmental Protection Agency (EPA) as a pesticide chemical. 
The proposed use of the additive includes the use to reduce the 
microbial contamination on RACs. Under ARTCA, the use of ozone as an 
antimicrobial agent on RACs in the preparing, packing, or holding of 
such RACs for commercial purposes, consistent with section 
201(q)(1)(B)(i) of the act, and not otherwise included within the 
definition of ``pesticide chemical'' under section 201(q)(1)(B)(i)(I), 
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) is subject to regulation by FDA 
as a food additive.
    Although this use of ozone as an antimicrobial agent on RACs is 
regulated under section 409 of the act (21 U.S.C. 348) as a food 
additive, the intended use may nevertheless be subject to regulation as 
a pesticide under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA). Therefore, manufacturers intending to market ozone for 
such use should contact the EPA to determine whether this use requires 
a pesticide registration under FIFRA.
    FDA has evaluated data in the petition and other relevant material.

[[Page 33830]]

 Based on this information, the agency concludes that the proposed use 
of the additive is safe, that the additive will achieve its intended 
technical effect, and therefore, that the regulation in part 173 should 
be 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 
information 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.
    The agency has carefully considered the potential environmental 
effects of this rule as announced in the notice of filing for FAP 
0A4721. No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.
    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 July 26, 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 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 173.368 is added to subpart D to read as follows:


Sec. 173.368  Ozone.

    Ozone (CAS Reg. No. 10028-15-6) may be safely used in the 
treatment, storage, and processing of foods, including meat and poultry 
(unless such use is precluded by standards of identity in 9 CFR part 
319), in accordance with the following prescribed conditions:
    (a) The additive is an unstable, colorless gas with a pungent, 
characteristic odor, which occurs freely in nature. It is produced 
commercially by passing electrical discharges or ionizing radiation 
through air or oxygen.
    (b) The additive is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter.
    (c) The additive meets the specifications for ozone in the Food 
Chemicals Codex, 4th ed. (1996), p. 277, 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. Copies are available from the National Academy Press, 
2101 Constitution Ave. NW., Washington, DC 20055, or may be examined at 
the Office of Premarket Approval (HFS-200), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC, and the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC.
    (d) The additive is used in contact with food, including meat and 
poultry (unless such use is precluded by standards of identity in 9 CFR 
part 319), in the gaseous or aqueous phase in accordance with current 
industry standards of good manufacturing practice.
    (e) When used on raw agricultural commodities, the use is 
consistent with section 201(q)(1)(B)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) and not applied for use under section 
201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act.

    Dated: June 15, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 01-15963 Filed 6-25-01; 8:45 am]
BILLING CODE 4160-01-S