[Federal Register Volume 64, Number 164 (Wednesday, August 25, 1999)]
[Rules and Regulations]
[Pages 46271-46272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21963]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 96F-0176]
Indirect Food Additives: Polymers
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 Nylon 6/12
copolymer resins as nonfood-contact layers of laminated films and rigid
multilaminate constructions with polypropylene outer layers intended
for use in contact with food. This action is in response to a petition
filed by Toray Industries (America) Inc.
DATES: The regulation is effective August 25, 1999; written objections
and requests for a hearing by September 24, 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: Vivian M. Gilliam, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3167.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 27, 1996 (61 FR 44067), FDA announced that a food
additive petition (FAP 6B4505) had been filed by Toray Industries
(America) Inc., c/o Keller and Heckman, 1001 G St. NW., suite 500 West,
Washington, DC 20001. The petition proposed to amend the food additive
regulations in Part 177 Indirect Food Additives: Polymers (21 CFR part
177) to provide for the safe use of Nylon 6/12 copolymers for use as a
non-food contact layer of laminated articles intended for use with
food.
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 as a non-food contact layer of laminated films and
rigid multilaminate constructions where the outer layers are made of
polypropylene is safe, (2) the additive will achieve its intended
technical effect, and (3) the regulations in Secs. 177.1390 and
177.1500 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. 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 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 September 24, 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 177
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 177 is amended as follows:
[[Page 46272]]
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
1. The authority citation for 21 CFR part 177 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
2. Section 177.1390 is amended by revising paragraph (c)(1)(i)(f)
to read as follows:
Sec. 177.1390 Laminate structures for use at temperatures of 250
deg.F and above.
* * * * *
(c) * * *
(1) * * *
(i) * * *
(f) Nylon 6/12 resins (CAS Reg. No. 25191-04-2) complying with item
13.3 of the table in Sec. 177.1500(b), for use as nonfood-contact
layers of laminated films and in rigid multilaminate constructions with
polypropylene outer layers. Laminate structures with authorized food-
contact materials yield no more than 0.15 milligrams of epsilon-
caprolactam and 0.04 milligrams of omega-laurolactam per square inch
when extracted with 95 percent ethanol at 121 deg.C (250 deg.F) for 2
hours.
* * * * *
3. Section 177.1500 is amended in the table in paragraph (b) by
adding item ``13.3'' in numerical order to read as follows:
Sec. 177.1500 Nylon resins.
* * * * *
(b) * * *
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Maximum extractable fraction in selected
solvents (expressed in percent by weight of
Melting point Solubility Viscosity resin)
Nylon Specific (degrees in boiling No. (mL/ -----------------------------------------------
resins gravity Fahrenheit) 4.2N HCl g) 95 percent
Water ethyl Ethyl Benzene
alcohol acetate
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* * * * * * * * *
13.3 Nylon 1.13