[Federal Register Volume 64, Number 156 (Friday, August 13, 1999)]
[Rules and Regulations]
[Pages 44122-44123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20890]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 98F-0014]
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 acidified solutions
of sodium chlorite as an antimicrobial agent in processing water and
ice intended for use in contact with seafood. This action is in
response to a petition filed by Bio-Cide International, Inc.
DATES: The regulation is effective August 13, 1999; written objections
and requests for a hearing by September 13, 1999. The Director of the
Office of the Federal Register approves the incorporation by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain
publications in Sec. 173.325(e) (21 CFR 173.325(e)), effective August
13, 1999.
ADDRESSES: Written objections may be sent 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-215), 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 January 26, 1998 (63 FR 3749), FDA announced that a food
additive petition (FAP 8A4568) had been filed by Bio-Cide
International, Inc., c/o Keller and Heckman LLP, 1001 G St. NW., suite
500 West, Washington, DC 20001. The petition proposed to amend the food
additive regulations in 21 CFR part 173 to provide for the safe use of
acidified sodium chlorite solutions in processing water and ice
intended for use in contact with seafood. In its evaluation of the
petition, the agency has concluded that the microbial population of the
water and ice is reduced, as long as a residual level of available
acidified solution of sodium chlorite is maintained.
Under the Antimicrobial Regulation Technical Corrections Act of
1998 (ARTCA) (Public Law 105-324), the use of an acidified solution of
sodium chlorite used as an antimicrobial agent in water and ice that
are used to rinse, wash, thaw, transport, or store seafood is subject
to regulation by FDA as a food additive. Such solutions are to be used
``in water that comes in contact with the food in the preparing,
packing, or holding of the food for commercial purposes,'' and
therefore, such use is exempt from the definition of the term
``pesticide chemical'' (21 U.S.C. 321(q)(1)(B)(i)). Moreover, as stated
in the ``Legal and Policy Interpretation of the Jurisdiction Under the
Federal Food, Drug, and Cosmetic Act of the Food and Drug
Administration and the Environmental Protection Agency Over the Use of
Certain Antimicrobial Substances'' (63 FR 54532 at 54541, October 9,
1998), FDA discussed, in the context of its jurisdiction over
antimicrobial substances, what constitutes ``processing'' of seafood,
which interpretation is unchanged by ARTCA. FDA stated that fish that
is harvested is ``processed.'' Consequently, activities done
postharvest to seafood, such as handling, storing, preparing, heading,
eviscerating, shucking, or holding, would be activities done to
``processed food,'' not raw agricultural
[[Page 44123]]
commodities. Therefore, under ARTCA, fish processing operations and
commercial fishing vessels would not be considered a ``field'' or a
``treatment facility where raw agricultural commodities are the only
food treated'' (21 U.S.C. 321(q)(1)(B)(i)), and thus, an antimicrobial
applied to water to which seafood is added at such locations would not
be subject to regulation as a ``pesticide chemical,'' but instead would
be subject to regulation as a ``food additive'' under the Federal Food,
Drug, and Cosmetic Act (the act).
Although the use of an acidified solution of sodium chlorite as an
antimicrobial agent in water and ice that are used to rinse, wash,
thaw, transport, or store seafood is regulated under section 409 of the
act (21 U.S.C. 348) as a food additive, this intended use may
nevertheless be subject to regulation as a pesticide under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Therefore,
manufacturers intending to market acidified solutions of sodium
chlorite for such use should contact the Environmental Protection
Agency to determine whether this use requires a pesticide registration
under FIFRA.
FDA has evaluated data in the petition and other relevant
material. The agency concludes that the proposed use of the additive to
reduce the microbial contamination of water and ice that are used to
rinse, wash, thaw, transport, or store seafood is safe, will achieve
its intended technical effect, and therefore, that the regulation in
Sec. 173.325 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
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.
This final rule contains no collection 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 September 13, 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
(address above) between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 173
Food additives, Incorporation by reference.
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 173.325 is amended by redesignating paragraph (d) as
paragraph (e), and by adding new paragraph (d) to read as follows:
Sec. 173.325 Acidified sodium chlorite solutions.
* * * * *
(d) The additive is used as an antimicrobial agent in water and
ice that are used to rinse, wash, thaw, transport, or store seafood in
accordance with current industry standards of good manufacturing
practice. The additive is produced by mixing an aqueous solution of
sodium chlorite with any GRAS acid to achieve a pH in the range of 2.5
to 2.9 and diluting this solution with water to achieve an actual use
concentration of 40 to 50 parts per million (ppm) sodium chlorite. Any
seafood that is intended to be consumed raw shall be subjected to a
potable water rinse prior to consumption.
* * * * *
Dated: August 5, 1999.
Janice F. Oliver,
Deputy Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 99-20890 Filed 8-12-99; 8:45 am]
BILLING CODE 4160-01-F