[Federal Register Volume 63, Number 138 (Monday, July 20, 1998)]
[Rules and Regulations]
[Pages 38746-38747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19314]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 94F-0040]


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 chlorine dioxide as 
an antimicrobial agent in water used to wash certain fruits and 
vegetables. This action is in response to a petition filed by the 
National Food Processors Association.

DATES: The regulation is effective July 20, 1998; written objections 
and requests for a hearing by August 19, 1998.
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-217), 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 March 24, 1994 (59 FR 13970), FDA announced that a food 
additive petition (FAP 4A4415) had been filed by the National Food 
Processors Association, 1401 New York Ave. NW., Washington, DC 20005. 
The petition proposed that the food additive regulations be amended to 
provide for the safe use of chlorine dioxide to disinfect waters in 
contact with fresh fruits and vegetables intended for human 
consumption. In its evaluation of the petition, the agency has 
concluded that the water is not disinfected, but the microbial 
contamination of the water is reduced.
    An antimicrobial added to water used to wash fruits and vegetables 
may be 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 
may be subject to regulation as a pesticide chemical under section 408 
of the act (21 U.S.C. 346a), depending upon the status of the fruit or 
vegetable which is washed with the antimicrobial solution. FDA 
regulates antimicrobials added to water used in food and for food 
processing.\1\ An antimicrobial substance added to water used to wash 
fruits and vegetables that are not raw agricultural commodities\2\ is 
an antimicrobial ``used in food and for food processing.'' EPA 
regulates, as pesticides under FIFRA (7 U.S.C. 136(u)) and as pesticide 
chemicals under section 201(q) of the act, antimicrobial substances 
directed against microbes in water used to wash raw agricultural 
commodities.
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    \1\ This is consistent with the memorandum of understanding 
(MOU) between FDA and the Environmental Protection Agency (EPA) on 
the jurisdiction over substances in drinking water (44 FR 42775, 
July 20, 1979). Moreover, an antimicrobial that is added to water 
used in food and for food processing is an antimicrobial that is 
used in or on a ``processed food.'' The use of an antimicrobial in 
or on processed food is subject to FDA's regulatory authority as a 
food additive under section 409 of the act. Such use is not a 
pesticide use because pests that are in or on processed food are 
excepted from the definition of fungus in 7 U.S.C. 136(k) and from 
the definition of pest in 40 CFR 152.5. Therefore, such an 
antimicrobial is neither a ``pesticide'' under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 
136(u)) nor a ``pesticide chemical'' under section 201(q) of the act 
(21 U.S.C. 321(q)).
    \2\ Such nonraw agricultural commodities include, for example, 
those that are cut, peeled, sliced, chopped, ground, irradiated, or 
cooked.
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    The petition proposed the use of chlorine dioxide in water for 
contact with fresh fruits and vegetables, regardless of whether such 
fruits and vegetables are raw agricultural commodities or processed 
food. This proposed use would include uses subject to EPA regulatory 
authority, as well as FDA jurisdiction. Because FDA can act only to 
approve those uses subject to its jurisdiction, the approval set out in 
this final rule is limited to the use of chlorine dioxide in water used 
to wash fruits and vegetables that are not raw agricultural 
commodities. Any person who wishes to request an approval for the use 
of chlorine dioxide in water used to wash raw agricultural commodities 
should consult with EPA to ascertain whether a FIFRA pesticide 
registration and a section 408 of the act tolerance or exemption from 
the requirement for such tolerance would be required by EPA.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that the proposed use 
of chlorine dioxide to reduce the microbial contamination of water used 
to wash fruits and vegetables, other than raw agricultural commodities, 
is safe and that the additive will achieve its intended technical 
effect. FDA has also considered the safety of chlorine dioxide 
breakdown products, i.e., chlorite and chlorate, and concludes

[[Page 38747]]

that residues of these compounds would be removed from the treated 
produce if the treatment with chlorine dioxide is followed by a potable 
water rinse or by blanching, cooking or canning. Therefore, the agency 
is including in the regulation the requirement that treatment of fruits 
and vegetables with chlorine dioxide shall be followed by a potable 
water rinse or by blanching, cooking or canning. Based on the agency's 
conclusions concerning this proposed use, the regulations in 21 CFR 
173.300 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.
    In the notice of filing, FDA gave interested parties an opportunity 
to submit comments on the petitioner's environmental assessment. FDA 
received no comments in response to that notice. 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 August 19, 1998, 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.
    This final rule contains no collections of information. Therefore, 
clearance of the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

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, 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 173.300 is amended by revising paragraph (b) to read as 
follows:

Sec. 173.300  Chlorine dioxide.

* * * * *
    (b)(1) The additive may be used as an antimicrobial agent in water 
used in poultry processing in an amount not to exceed 3 parts per 
million (ppm) residual chlorine dioxide as determined by Method 4500-
ClO2 E, referenced in paragraph (a) of this section, or an 
equivalent method.
    (2) The additive may be used as an antimicrobial agent in water 
used to wash fruits and vegetables that are not raw agricultural 
commodities in an amount not to exceed 3 ppm residual chlorine dioxide 
as determined by Method 4500-ClO2 E, referenced in paragraph 
(a) of this section, or an equivalent method. Treatment of the fruits 
and vegetables with chlorine dioxide shall be followed by a potable 
water rinse or by blanching, cooking, or canning.

    Dated: July 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-19314 Filed 7-17-98; 8:45 am]
BILLING CODE 4160-01-F