[Federal Register Volume 61, Number 171 (Tuesday, September 3, 1996)]
[Rules and Regulations]
[Pages 46374-46376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22286]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 95F-0160]


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, 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. Elsewhere in 
this issue of the Federal Register, FDA is publishing a document that 
provides for the safe use of a mixture of peroxyacetic acid, acetic 
acid, and hydrogen peroxide

[[Page 46375]]

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 5A4460) 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, hydrogen peroxide and 1-hydroxyethylidene-1,1-diphosphonic acid 
(HEDP) 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. 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). 
Lastly, the comment stated that one of the components of the mixture 
contained phosphoric acid, which needed to be declared as an 
ingredient.
    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. 
FDA notes that this formulation is presently approved for use as a 
sanitizing solution, under Sec. 178.1010(b)(30). However, 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. 
To the extent that the comment suggests that the solution should be 
regulated as a sanitizing solution under Sec. 178.1010, the comment is 
meaningless because the solution is already approved for such use 
(Sec. 178.1010(b)(30)).
    Finally, the agency disagrees with the comment to the extent that 
it asserts that one of the components of the mixture contains 
phosphoric acid, which should be considered an ingredient. Importantly, 
there is no phosphoric acid in the formulation and thus there is no 
need to consider it as an ingredient. Commercial HEDP does contain a 
low level (approximately 3 percent by weight) of phosphorous acid, not 
phosphoric acid (Ref. 1), which is used as a reactant in the 
preparation of HEDP. The agency has evaluated the level of phosphorous 
acid in HEDP and concludes that essentially no residue of phosphorous 
acid would remain on treated produce and that this use of HEDP is safe. 
Because this antimicrobial solution contains no phosphoric acid, FDA 
finds no merit in the comment stating that phosphoric acid needs to be 
disclosed as an ingredient.
    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

[[Page 46376]]

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.

Reference

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Monsanto Material Safety Data Sheet for Monsanto Product Name 
DEQUEST 2010 DEFLOCCULANT and SEQUESTRANT.

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 a new entry 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) * * *

                                                                                                                
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                   Substances                                               Limitations                         
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
1-Hydroxyethylidene-1,1-diphosphonic acid.        May be used only with peroxyacetic acid. Not to exceed 4.8 ppm
                                                   in wash water. Limited to use on fruits and vegetables that  
                                                   are not raw agricultural commodities.                        
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    Dated: August 26, 1996.
Fred A. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-22286 Filed 8-30-96; 8:45 am]
BILLING CODE 4160-01-F