[Federal Register Volume 64, Number 1 (Monday, January 4, 1999)]
[Rules and Regulations]
[Pages 34-35]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34734]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 97F-0504]
Indirect Food Additives: Adjuvants, Production Aids, and
Sanitizers
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 expanded safe use of the
butylated reaction product of p-cresol and dicyclopentadiene for use as
an antioxidant in acrylonitrile/butadiene/styrene copolymers in contact
with food. This action is in response to a petition filed by The
Goodyear Tire and Rubber Co.
DATES: The regulation is effective January 4, 1999; submit written
objections and request for a hearing by February 3, 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: Hortense S. Macon, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3086.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of December 10, 1997 (62 FR 65084), FDA announced that a food
additive petition (FAP 8B4561) had been filed by The Goodyear Tire and
Rubber Co., 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 Sec. 178.2010 Antioxidants and/or stabilizers (21 CFR
178.2010) to provide for the expanded safe use of butylated reaction
product of p-cresol and dicyclopentadiene for use as an antioxidant in
acrylonitrile/butadiene/styrene copolymers in contact with food.
In the notice of filing for this additive, FDA announced that it
had determined under Sec. 25.32(i) (21 CFR 25.32(i)) that this action
was of a type that did not individually or cumulatively have a
significant effect on the human environment. Subsequently, during FDA's
indepth review of the petition, the agency determined that the proposed
use of the subject additive was for both single service food-packaging
materials and repeat use articles. Therefore, at the agency's request,
the petitioner provided an amended claim of categorical exclusion from
the requirement to prepare an environmental assessment under both
Sec. 25.32(i) (single service food packaging) and (j) (repeated use
articles).
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that: (1) The proposed
use of the additive is safe, (2) the additive will achieve its intended
technical effect, and (3) the regulations in Sec. 178.2010 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 determined under Sec. 25.32(i) and (j) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
This final rule contains no collections 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 February 3, 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 178
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 178 is amended as follows:
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
1. The authority citation for 21 CFR part 178 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
2. Section 178.2010 is amended in the table in paragraph (b) in the
entry for ``Butylated reaction product of p-cresol and
dicyclopentadiene * * *'' by revising the entry under the heading
``Limitations'' to read as follows:
Sec. 178.2010 Antioxidants and/or stabilizers for polymers.
* * * * *
(b) * * *
[[Page 35]]
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Substances Limitations
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* * * * * *
*
Butylated reaction product of p-cresol and For use only:
dicylopentadiene produced by reacting p-cresol and 1. As components of nonfood articles complying with
dicyclopentadiene in an approximate mole ratio of 1.5 Secs. 175.105 and 177.2600(c)(4)(iii) of this
to 1, respectively, followed by alkylation with chapter.
isobutylene so that the butyl content of the final 2. At levels not to exceed 1.0 percent by weight of
product is not less than 18 percent. acrylonitrile/butadiene/styrene copolymers. The
finished copolymers may be used in contact with food
of Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII
under conditions of use B through H, as described in
tables 1 and 2 of Sec. 176.170(c) of this chapter,
and with food of Types III, IV-A, V, VI-C, VII-A, and
IX under conditions of use C through G as described in
tables 1 and 2 of Sec. 176. 170(c) of this chapter.
* * * * * *
*
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Dated: December 21, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-34734 Filed 12-31-98; 8:45 am]
BILLING CODE 4160-01-F