[Federal Register Volume 61, Number 171 (Tuesday, September 3, 1996)]
[Rules and Regulations]
[Pages 46376-46378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22287]


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


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 173

[Docket No. 95F-0161]


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, acetic acid, and hydrogen peroxide to reduce the 
microbial load in water used to wash certain fruits and vegetables. 
Elsewhere in this issue of the Federal Register, FDA is also publishing 
a document that provides for the safe use of a mixture of peroxyacetic 
acid, acetic acid, hydrogen peroxide, and 1-hydroxyethylidene-1,1-
diphosphonic acid (HEDP) to reduce the microbial load in water used to 
wash certain fruits and vegetables. This action is in response to a 
petition filed by Ecolab Inc.

DATES: Effective September 3, 1996; written objections and requests for 
a hearing by October 3, 1996.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Mary E. LaVecchia, Center for Food 
Safety and Applied Nutrition (HFS-217), 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 July 13, 1995 (60 FR 36150), FDA announced that a food 
additive petition (FAP 5A4459) had been filed by Ecolab Inc., 370 North 
Wabasha St., St. Paul, MN 55102. The petition proposed to amend the 
food additive regulations in Sec. 173.315 Chemicals used in washing or 
to assist in the lye peeling of fruits and vegetables (21 CFR 173.315) 
to provide for the safe use of a mixture of peroxyacetic acid, acetic 
acid and hydrogen peroxide to control microbial growth in water 
contacting fruits and vegetables.
    An antimicrobial solution used to wash fruits and vegetables is 
potentially subject to regulation as a food additive under section 409 
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348), 
or as a pesticide chemical under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA) (7 U.S.C. 136(u)), depending upon the 
status of the fruit or vegetable. FDA regulates antimicrobial solutions 
as food additives under the act when such solutions are used on 
processed food.

[[Page 46377]]

The Environmental Protection Agency (EPA) regulates antimicrobial 
solutions as pesticide chemicals under FIFRA when the solutions are 
used on raw agricultural commodities.
    Under section 201(q)(1) of the act (21 U.S.C. 321(q)(1)), as 
amended by the Food Quality Protection Act of 1996, the term 
``pesticide chemical'' means a pesticide as defined in FIFRA. Under 
FIFRA's regulatory scheme, an antimicrobial solution used on or in 
processed food does not come within the definition of the term 
pesticide. FIFRA defines a pesticide as any substance intended for 
preventing, destroying, repelling, or mitigating any pest (7 U.S.C. 
136(u)); the definition of pest includes ``fungus'' (7 U.S.C. 136(t)). 
However, excluded from the definition of fungus are rust, smut, mildew, 
mold, yeast, and bacteria on or in processed food (7 U.S.C. 136(k)). 
Therefore, by definition, an antimicrobial solution used on or in 
processed food is not a pesticide because it does not prevent, destroy, 
repel, or mitigate a ``pest,'' within the meaning of that term (7 
U.S.C. 136(t)). Thus, such a solution is not a pesticide chemical under 
the act.
    FDA received one comment in response to the notice of filing of 
this petition. The comment expressed concern that the chemical mixture 
appeared to be a biocide and may require FIFRA pesticide registration. 
The comment also stated that the preparation would be regulated more 
accurately under Sec. 178.1010 Sanitizing solutions (21 CFR 178.1010).
    As noted above, an antimicrobial formulation used on raw 
agricultural commodities is regulated as a pesticide chemical and thus, 
may require registration under FIFRA, as well as a tolerance 
established under section 408 of the act (21 U.S.C. 346a). Similarly, 
FDA has jurisdiction over antimicrobial solutions used on processed 
foods. Thus, consistent with FDA's jurisdiction, FDA's approval of this 
formulation is limited to its use in washing fruits and vegetables 
other than those that are raw agricultural commodities. This approval 
is consistent with the division of responsibility between FDA and EPA 
over solutions of this type. FDA has, however, referred the petitioner 
to EPA in order to ascertain whether FIFRA pesticide registration and a 
tolerance under section 408 of the act are required for any uses not 
regulated by FDA. Thus, FDA's decision in this final rule takes into 
consideration the jurisdictional question between FDA and EPA raised by 
the comment.
    FDA disagrees with the comment to the extent that it suggests that 
the solution in question should be regulated as a sanitizing solution. 
The petitioned use for this formulation is to reduce the microbial load 
in water used to wash fruits and vegetables, consistent with the 
technical effect listed in 21 CFR 170.3(o)(2). This use is different 
from its use as a sanitizing solution. Because the petitioned 
conditions of use differ from those for a sanitizing solution, approval 
under Sec. 173.315 is necessary and appropriate. The point of this 
comment is not entirely clear. To the extent that this comment suggests 
that the solution is not safe for use as a washing solution for fruits 
and vegetables, the agency has determined that the petitioned use is 
safe.
    FDA has evaluated data in the petition and other relevant material. 
As part of its review, FDA evaluated the safety of each of the 
components of the antimicrobial solution. Based on this information, 
the agency concludes that the proposed use of the additive is safe, 
that it will achieve its intended technical effect of reducing the 
microbial load in water used to wash fruits and vegetables, and that 
therefore, the regulations 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 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.
    Any person who will be adversely affected by this regulation may at 
any time on or before October 3, 1996, 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 
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: Secs. 201, 402, 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348).

    2. Section 173.315 is amended in the table in paragraph (a)(2) by 
alphabetically adding two new entries under the headings ``Substances'' 
and ``Limitations'' to read as follows:


Sec. 173.315  Chemicals used in washing or to assist in the lye peeling 
of fruits and vegetables.

 * * * * *
    (a) * * *
    (2) * * *

[[Page 46378]]



                                                                                                                
----------------------------------------------------------------------------------------------------------------
                   Substances                                              Limitations                          
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Hydrogen peroxide.                               Used in combination with acetic acid to form peroxyacetic acid.
                                                  Not to exceed 59 ppm in wash water. Limited to use on fruits  
                                                  and vegetables that are not raw agricultural commodities.     
Peroxyacetic acid.                               Prepared by reacting acetic acid with hydrogen peroxide. Not to
                                                  exceed 80 ppm in wash water. Limited to use on fruits and     
                                                  vegetables that are not raw agricultural commodities.         
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: August 26, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-22287 Filed 8-30-96; 8:45 am]
BILLING CODE 4160-01-F