[Federal Register: June 26, 2001 (Volume 66, Number 123)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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
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 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
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
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.
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
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
1. The authority citation for 21 CFR part 173 continues to read as
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
[FR Doc. 01-15963 Filed 6-25-01; 8:45 am]
BILLING CODE 4160-01-S