[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