[Federal Register Volume 64, Number 178 (Wednesday, September 15, 1999)]
[Rules and Regulations]
[Pages 49981-49982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 99F-0299]


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 raw agricultural 
commodities (RAC's). This action is in response to a petition filed by 
Alcide Corp.

DATES: This regulation is effective September 15, 1999; written 
objections and requests for a hearing by October 15, 1999.
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-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 March 3, 1999 (64 FR 10302), FDA announced that a food 
additive petition (FAP 9A4648) had been filed by Alcide Corp., 8561 
154th Ave. NE., Redmond, WA 98052. The petition proposed to amend the 
food additive regulation in Sec. 173.325 to provide for the safe use of 
aqueous solutions of acidified sodium chlorite as an antimicrobial 
agent on RAC's.
    The petitioner is proposing to limit the use of this additive to 
RAC's in preparing, packing, or holding of such commodities for 
commercial purposes, consistent with section 201(q)(1)(B)(i) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
321(q)(1)(B)(i)), as amended by the Antimicrobial Regulation Technical 
Corrections Act of 1998 (ARTCA) (Public Law 105-324). The petitioner is 
not proposing that the additive be intended for use for any application 
under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or 
(q)(1)(B)(i)(III) of the act, which use would be subject to regulation 
by the Environmental Protection Agency (EPA) as a pesticide chemical. 
The proposed use of the additive is to reduce the microbial 
contamination on RAC's. Under ARTCA, the use of acidified sodium 
chlorite solutions as an antimicrobial agent on RAC's in preparing, 
packing, or holding of such RAC's for commercial purposes, consistent 
with section 201(q)(1)(B)(i) of the act, and not otherwise included 
within the definition of ``pesticide chemical'' under section 
201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III), is subject 
to regulation by FDA as a food additive.
    Although this use of acidified sodium chloride solutions as an 
antimicrobial agent on raw agricultural commodities is regulated under 
section 409 of the act (21 U.S.C. 348) as a food additive, the 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 EPA to determine whether this use 
requires a pesticide registration under FIFRA.

[[Page 49982]]

    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, that the additive 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 October 15, 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 
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.

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 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 (e) as 
paragraph (f) and by adding new paragraph (e) to read as follows:


Sec. 173.325  Acidified sodium chlorite solutions.

* * * * *
    (e) The additive is used as an antimicrobial agent on raw 
agricultural commodities in the preparing, packing, or holding of the 
food for commercial purposes, consistent with section 201(q)(1)(B)(i) 
of the act, and not applied for use under section 201(q)(1)(B)(i)(I), 
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act, in accordance with 
current industry standards of good manufacturing practice. Applied as a 
dip or a spray, the additive is used at levels that result in chlorite 
concentrations of 500 to 1200 parts per million (ppm), in combination 
with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. 
Treatment of the raw agricultural commodities with acidified sodium 
chlorite solutions shall be followed by a potable water rinse, or by 
blanching, cooking, or canning.
* * * * *

    Dated: September 8, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-23969 Filed 9-14-99; 8:45 am]
BILLING CODE 4160-01-F