[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
