[Federal Register Volume 64, Number 137 (Monday, July 19, 1999)]
[Rules and Regulations]
[Pages 38563-38565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18300]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 98F-0894]
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, hydrogen peroxide, and 1-hydroxyethylidene-1,1-
diphosphonic acid as an antimicrobial agent on fruits and vegetables
that are not raw agricultural commodities without the requirement of a
potable water rinse following treatment. This action is in response to
a petition filed by Ecolab, Inc.
[[Page 38564]]
DATES: This regulation is effective July 19, 1999; submit written
objections and requests for a hearing by August 18, 1999.
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: Mary E. LaVecchia, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204-0001, 202-418-3072.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of October 20, 1998 (63 FR 56035), FDA announced that a food
additive petition (FAP 8A4622) had been filed by Ecolab, Inc., 370
North Wabasha St., St. Paul, MN 55102. The petition proposed to amend
the food additive regulation in Sec. 173.315 Chemicals used in washing
or to assist in the peeling of fruits and vegetables (21 CFR 173.315)
to provide for the safe use of a mixture of peroxyacetic acid, hydrogen
peroxide, and 1-hydroxyethylidene-1,1-diphosphonic acid as an
antimicrobial agent to wash or assist in the lye peeling of fruits and
vegetables that are not raw agricultural commodities without the
requirement of a potable water rinse following treatment. The use of
peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidene-1,1-
diphosphonic acid is currently approved under Sec. 173.315 provided its
use is followed by a potable water rinse (Sec. 173.315(c)).
The current approval under Sec. 173.315 for the use of peroxyacetic
acid, hydrogen peroxide, and 1-hydroxyethylidene-1,1-diphosphonic acid
is to control the microbial growth in water that contacts fruits and
vegetables that are not raw agricultural commodities (61 FR 46374,
September 3, 1996). This intended technical effect is unchanged by this
regulation. Under the Antimicrobial Regulation Technical Corrections
Act (Pub. L. 105-324), such use in water that comes into contact with
the food in the preparing, packing, or holding of the food for
commercial purposes is subject to regulation by FDA as a food additive
under section 409 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 348) and is not subject to regulation by the Environmental
Protection Agency (EPA) as a pesticide chemical under section 408 of
the act (21 U.S.C. 346a). However, this intended use of peroxyacetic
acid, hydrogen peroxide, and 1-hydroxyethylidene-1,1-diphosphonic acid
may nevertheless be subject to regulation as a pesticide under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Therefore,
manufacturers intending to use this food additive for this intended use
should contact 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 Sec. 173.315
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 previously considered the potential environmental
effects of this rule as announced in the notice of filing for the
petition. 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 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 on or before August 18, 1999, file with the Dockets Management
Branch (address above) written objections thereto. 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
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:
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 173.315 is amended in the table in paragraph (a)(2) by
removing the entries for ``1-Hydroxyethylidene-1, 1-diphosphonic
acid,'' ``Hydrogen Peroxide,'' and ``Peroxyacetic acid'', and by adding
paragraph (a)(5) to read as follows:
Sec. 173.315 Chemicals used in washing or to assist in the peeling of
fruits and vegetables.
* * * * *
(a) * * *
(5) Substances identified in this paragraph (a)(5) for use on
fruits and vegetables that are not raw agricultural commodities and
subject to the limitations provided:
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Substances Limitations
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Hydrogen peroxide.................. Used in combination with acetic
acid to form peroxyacetic acid.
Not to exceed 59 ppm in wash
water.
[[Page 38565]]
1-Hydroxyethylidene-1,1- May be used only with peroxyacetic
diphosphonic acid. acid. Not to exceed 4.8 ppm in
wash water.
Peroxyacetic acid.................. Prepared by reacting acetic acid
with hydrogen peroxide. Not to
exceed 80 ppm in wash water.
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Dated: July 7, 1999.
Janice F. Oliver,
Deputy Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 99-18300 Filed 7-16-99; 8:45 am]
BILLING CODE 4160-01-F