[Federal Register: December 30, 2004 (Volume 69, Number 250)]
[Rules and Regulations]               
[Page 78303-78305]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de04-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 2003F-0128]

 
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 sodium 
chlorite solutions as an antimicrobial agent on finfish and 
crustaceans. This action is in response to a petition filed by Alcide 
Corp.

DATES: The regulation is effective December 30, 2004. Submit written or 
electronic objections and requests for a hearing by January 31, 2005. 
See section VI of this document for information on the filing of 
objections.

ADDRESSES: You may submit written objections and requests for a hearing 
identified by Docket No. 2003F-0128, by any of the following methods:
     Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting comments on the agency Web site.
     E-mail: fdadockets@oc.fda.gov. Include Docket No. 2003F-
0128 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All objections received will be 
posted without change to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, 

including any personal information provided. For detailed instructions 
on submitting objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm 

and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mical E. Honigfort, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1278.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of April 10, 2003 (68 
FR 17656), FDA announced that a food additive petition (FAP 3A4743) had 
been filed by Alcide Corp., 8561 154th Ave. NE., Redmond, WA 98052-
3557. The petition proposed to amend the food additive regulations in 
Sec.  173.325

[[Page 78304]]

Acidified sodium chlorite solutions (21 CFR 173.325) to expand the 
permitted use concentration and to expand the pH range for acidified 
sodium chlorite solutions as an antimicrobial agent in water and ice 
intended for use on seafood (fresh or saltwater).
    Under the Antimicrobial Regulation Technical Corrections Act of 
1998 (ARTCA) (Public Law 105-324), the use of acidified sodium chlorite 
solutions as an antimicrobial agent on seafood is subject to regulation 
by FDA as a food additive. Such solutions are to be used on 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, 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; this 
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 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 seafood 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 acidified sodium chlorite solutions as an 
antimicrobial agent on 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 sodium chlorite solutions 
for such use should contact the Environmental Protection Agency to 
determine whether this use requires a pesticide registration under 
FIFRA.

II. Conclusion

    In consultation with the agency, the petitioner agreed to limit the 
proposed use of the additive to a concentration of 1,200 parts per 
million (ppm) and pH ranging from 2.3 to 2.9 as an antimicrobial agent 
to reduce pathogenic bacteria on finfish and crustaceans. FDA has 
evaluated data in the petition and other relevant material. Based on 
this information, the agency concludes that the proposed use of the 
additive is safe and the additive will achieve its intended technical 
effect. Therefore, 21 CFR part 173 is amended as set forth in this 
document.
    The agency is including as a condition of use that seafood treated 
with acidified sodium chlorite solutions at a concentration of 1,200 
ppm must be cooked prior to consumption to ensure that there are no 
detectable residues on the treated products (Ref. 1).

III. Public Disclosure

    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 in this document. 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.

IV. Environmental Impact

    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 Division 
of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Paperwork Reduction Act of 1995

    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.

VI. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) written or 
electronic objections. 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 are to be submitted and are to 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 Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

VII. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Memorandum from the Chemistry Review Group to the Regulatory 
Review Group II, ``Acidified solutions of sodium chlorite in 
processing waters intended for use on seafood or freshwater fish,'' 
June 21, 2004.

List of Subjects in 21 CFR Part 173

    Food additives.

0
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

0
1. The authority citation for 21 CFR part 173 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348.

0
2. Section 173.325 is amended by redesignating paragraph (d) as 
paragraph

[[Page 78305]]

(d)(1) and by adding new paragraph (d)(2) to read as follows:


Sec.  173.325  Acidified sodium chlorite solutions.

* * * * *
    (d)(1) * * *
    (2) The additive is used as a single application in processing 
facilities as an antimicrobial agent to reduce pathogenic bacteria due 
to cross-contamination during the harvesting, handling, heading, 
evisceration, butchering, storing, holding, packing, or packaging of 
finfish and crustaceans; or following the filleting of finfish; in 
accordance with current industry standards of good manufacturing 
practice. Applied as a dip or spray, the additive is used at levels 
that result in a sodium chlorite concentration of 1,200 ppm, in 
combination with any GRAS acid at levels sufficient to achieve a pH of 
2.3 to 2.9. Treated seafood shall be cooked prior to consumption.
* * * * *

    Dated: December 21, 2004.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 04-28577 Filed 12-29-04; 8:45 am]

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