[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]


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

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.

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

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:

 
------------------------------------------------------------------------
             Substances                          Limitations
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

* * * * *

    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