[Federal Register Volume 61, Number 223 (Monday, November 18, 1996)]
[Rules and Regulations]
[Pages 58628-58629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29393]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 176
[Docket No. 94F-0257]
Indirect Food Additives: Paper and Paperboard Components
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 the copolymer of
the sodium salt of acrylic acid with polyethyleneglycol allyl ether in
paper mill boilers. This action is in response to a petition filed by
Betz Laboratories, Inc.
DATES: Effective November 18, 1996; written objections and requests for
a hearing by December 18, 1996.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: John R. Bryce, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3023.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 19, 1994 (59 FR 42837), FDA announced that a food
additive petition (FAP 4B4426) had been filed by Betz Laboratories,
Inc., 4636 Somerton Rd., Trevose, PA 19053-6783. The petition proposed
to amend the food additive regulations in Sec. 176.170 Components of
paper and paperboard in contact with aqueous and fatty foods (21 CFR
176.170) to provide for the safe use of the copolymer of the sodium
salt of acrylic acid with polyethyleneglycol allyl ether in paper mill
boilers.
FDA has evaluated the data and information in the petition and
other relevant material. The agency concludes that the proposed use of
the additive as an anticorrosion agent in paper mill boilers is safe,
that it will achieve its intended technical effect, and that the
regulations in Sec. 176.170 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
information 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.
The agency has carefully considered the potential environmental
effects of this action. In the August 19, 1994, notice of filing, the
agency announced that it was placing the petitioner's environmental
assessment on public display and provided 30 days for comments on that
assessment. FDA received no comments on the assessment. Based upon the
information available, 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.
Any person who will be adversely affected by this regulation may at
any time on or before December 18, 1996, 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
[[Page 58629]]
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 176
Food additives, Food packaging.
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 176 is amended as follows:
PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
1. The authority citation for 21 CFR part 176 continues to read as
follows:
Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).
2. Section 176.170 is amended in the table in paragraph (a)(5) by
alphabetically adding a new entry under the headings ``List of
Substances'' and ``Limitations'' to read as follows:
Sec. 176.170 Components of paper and paperboard in contact with
aqueous and fatty foods.
* * * * *
(a) * * *
(5) * * *
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List of Substances Limitations
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* * *
Acrylic acid, sodium salt copolymer For use only in paper mill
with polyethyleneglycol allyl ether boilers.
(CAS Reg. No. 86830-15-1).
* * * *
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Dated: October 25, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-29393 Filed 11-15-96; 8:45 am]
BILLING CODE 4160-01-F