[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Rules and Regulations]
[Pages 54425-54426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26268]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 177

[Docket No. 91F-0371]


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 ultra-filtration 
membranes that consist of a microporous poly(vinylidene fluoride) 
membrane with a hydrophilic surface modifier consisting of 
hydroxypropyl acrylate/tetraethylene glycol diacrylate copolymer for 
processing foods. This action is in response to a petition filed by 
Keller and Heckman.


[[Page 54426]]

DATES: Effective October 24, 1995; written objections and requests for 
a hearing by November 24, 1995.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of October 15, 1991 (56 FR 51719), FDA announced that a food 
additive petition (FAP 1B4287) had been filed by Keller and Heckman, 
1001 G St. NW., suite 500 West (formerly, 1150 17th St. NW.), 
Washington, DC 20001. The petition proposed that the food additive 
regulations be amended in Sec. 177.2910 Ultra-filtration membranes (21 
CFR 177.2910) to provide for the safe use of ultra-filtration membranes 
that consist of a microporous poly(vinylidene fluoride) membrane with a 
hydrophilic surface modifier consisting of hydroxypropyl acrylate/
tetraethylene glycol diacrylate copolymer for processing foods.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the food additive is safe 
and that Sec. 177.2910 should be amended as set forth below.
     Information in the petition indicates that one of the components 
of the surface modifier for the ultra-filtration membrane, 
tetraethylene glycol diacrylate (TEGDA), may be a weak rodent 
carcinogen when applied to the skin (Ref. 1). FDA evaluated this study 
and has concluded that the evidence that TEGDA may be a weak dermal 
carcinogen in rodents does not preclude a conclusion that the 
petitioned use of the food additive is safe.
     First, in the dermal rodent study, there was evidence of systemic 
exposure to the test compound and an assessment of TEGDA's ability to 
induce tumors at sites distant from the dermal application. The study 
reported that an examination of several sentinel tissues, including 
heart, lung, spleen, kidney, bladder, thyroid, adrenal, testes, 
prostate, and stomach provided no evidence that TEGDA causes tumors 
systemically. Second, dermal carcinogenicity is not highly predictive 
of carcinogenicity by other routes of exposure (Ref. 2). These 
observations support the agency's view that there is no evidence that 
suggests that TEGDA is likely to be a carcinogen when orally ingested, 
which is the route of exposure most directly relevant to the safety 
assessment of food additives.
    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 21 CFR 
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.
    Any person who will be adversely affected by this regulation may at 
any time on or before November 24, 1995, 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.

References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
     1. Barkley, W., and L. Klaus Stemman, ``Chronic Mouse Dermal 
Toxicity Study,'' revised May 1986, submitted to Keith A. Bearson by 
Department of Environmental Health, University of Cincinnati Medical 
Center, Cincinnati, OH, (unpublished), submitted in Food Additive 
Petition No. 1B4287, p. 430, 1991.
    2. Tobin, Paul S. et al., ``An Evaluation of Skin Painting 
Studies as Determinants of Tumorigenesis Potential Following Skin 
Contact With Carcinogens,'' Regulatory Toxicology and Pharmacology, 
vol. 2, 22-37, 1982.

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, 21 CFR 
part 177 is amended as follows:

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

     1. The authority citation for 21 CFR part 177 continues to read as 
follows:

     Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

     2. Section 177.2910 is amended by revising the introductory text, 
by adding new paragraph (a)(4), by redesignating paragraphs (e) and (f) 
as paragraphs (f) and (g), and by adding a new paragraph (e) to read as 
follows:


Sec. 177.2910  Ultra-filtration membranes.

    Ultra-filtration membranes identified in paragraphs (a)(1), (a)(2), 
(a)(3), and (a)(4) of this section may be safely used in the processing 
of food, under the following prescribed conditions;
    (a) * * *
    (4) Ultrafiltration membranes that consist of a microporous 
poly(vinylidene fluoride) membrane with a hydrophilic surface modifier 
consisting of hydroxypropyl acrylate/tetraethylene glycol diacrylate 
copolymer.
* * * * *
    (e) Ultrafiltration membranes identified in paragraph (a)(4) may be 
used to filter aqueous or acidic foods containing up to 13 percent of 
alcohol at temperatures not to exceed 21 deg.C (70 deg.F).
 * * * * *

    Dated: October 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-26268 Filed 10-23-95; 8:45 am]
BILLING CODE 4160-01-F