[Federal Register: July 20, 1998 (Volume 63, Number 138)]
[Rules and Regulations]
[Page 38746-38747]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jy98-5]
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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