[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