Indirect Food Additives: Paper and Paperboard Components

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 96F-0242]

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 additional safe use of

perfluoroalkyl substituted phosphate ester acids, ammonium salts formed

by the reaction of 2,2-bis[(,-perfluoroC4-

20alkylthio)methyl]-1,3-propanediol, polyphosphoric acid and ammonium

hydroxide, as an oil and water repellant for paper and paperboard

intended for use in contact with food. This action is in response to a

petition filed by Ciba-Geigy Corp.

DATES: Effective March 7, 1997; written objections and requests for a

hearing by April 7, 1997.

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: 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 July 18, 1996 (61 FR 37483), FDA announced that a food

additive petition (FAP 6B4513) had been filed by Ciba-Geigy Corp., P.O.

Box 18300, Greensboro, NC 27419-8300. 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 additional safe use of perfluoroalkyl substituted

phosphate ester acids, ammonium salts formed by the reaction of 2,2-

bis[(,-perfluoroC4-20alkylthio)methyl]-1,3-

propanediol, polyphosphoric acid and ammonium hydroxide, as an oil and

water repellant for paper and paperboard intended for use in contact

with food.

FDA has evaluated data in the petition and other relevant material.

The agency concludes that the proposed use of the additive in paper and

paperboard products in contact with non-alcoholic foods under condition

of use C through G as described in Table 2 of Sec. 176.170(c) is safe,

that the additive will have the intended technical effect, and,

therefore, that 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. 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. No comments were received during the 30 day comment

period specified in the filing notice for comments on the environmental

assessment submitted with the petition.

Any person who will be adversely affected by this regulation may at

any time on or before April 7, 1997 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 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

revising the entry for ``Perfluoroalkyl substituted phosphate ester

acids, ammonium salts formed by the reaction of 2,2-

bis[(,-perfluoroC4-20alkylthio)methyl]-1,3-

propanediol, polyphosphoric acid and ammonium hydroxide'' under the

heading ``Limitations'' to read as follows:

Sec. 176.170 Components of paper and paperboard in contact with

aqueous and fatty foods.

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(a) * * *

(5) * * *

[[Page 10453]]

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List of Substances Limitations

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Perfluoroalkyl substituted For use only as an oil and water

phosphate ester acids, ammonium repellant at a level not to exceed

salts formed by the reaction of 0.44 percent perfluoroalkyl

2,2-bis[(,- actives by weight of the finished

perfluoroC4-20alkylthio)methyl]- paper and paperboard in contact

1,3-propanediol, polyphosphoric with non-alcoholic foods under

acid and ammonium hydroxide. condition of use H as described in

Table 2 of paragraph (c) of this

section; and in contact with food

of types III, IV-A, V, VII-A, and

IX described in Table 1 of

paragraph (c) of this section

under conditions of use C through

G as described in Table 2 of

paragraph (c) of this section.

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Dated: February 7, 1997.

Fred R. Shank,

Director, Center for Food Safety and Applied Nutrition.

[FR Doc. 97-5558 Filed 3-6-97; 8:45 am]

BILLING CODE 4160-01-F