Food Additives Permitted in Feed and Drinking Water of Animals; Poly(2-vinylpyridine-co-styrene)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

21 CFR Part 573

[Docket No. 94F-0282]

Food Additives Permitted in Feed and Drinking Water of Animals;

Poly(2-vinylpyridine-co-styrene)

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 (animal use) to provide for the safe use of the

food additive poly(2-vinylpyridine-co-styrene) as a coating agent in

the preparation of rumen-stable, abomasum-dispersible nutrient products

for dairy cattle. This action is in response to a food additive

petition filed by Rhone-Poulenc Animal Nutrition.

DATES: Effective March 21, 1996; written objections and request for

hearing by April 22, 1996.

ADDRESSES: Submit written objections and requests for hearing to the

Dockets Management Branch (HFA-305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Sharon A. Benz, Center for Veterinary

Medicine (HFV-226), Food and Drug Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301-594-1729.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal

Register of August 11, 1994 (59 FR 41326), FDA announced that a food

additive petition (animal use) (FAP 2231) had been filed by Rhone-

Poulenc Animal Nutrition, 42, Avenue Aristide Briand, B.P. 100, 92164

Antony Cedex, France. The petition proposed to amend the food additive

regulations in Sec. 573.870 (21 CFR 573.870) to provide for the safe

use of poly(2-vinylpyridine-co-styrene) as a coating agent in the

preparation of rumen-stable, abomasum-dispersible nutrient products for

dairy cattle and dairy replacement heifers. The additive is currently

listed in Sec. 573.870 as safe for use as a nutrient protectant in feed

for beef cattle.

The notice of filing provided for a 75-day comment period. One

comment has been received in response to the notice and is on file in

the Dockets Management Branch (address above). The comment raised

several questions concerning the fate and effects of poly(2-

vinylpyridine-co-styrene) and its components released into the

environment. Questions concerned the degradation rate when applied to

the land as manure fertilizer, and degradation endpoint products. The

comment also questioned whether the polymer or its monomers (styrene

and 2-vinylpyridine) resulted in bioaccumulation, movement into

groundwater, and/ or pollutant uptake by animals and plants.

FDA has reviewed the environmental assessment and supporting

studies for use of poly(2-vinylpyridine-co-styrene) in dairy cattle

feed. The amount expected to enter the soil environment from a typical

consumption of 10 to 25 grams of rumen protected amino acid per head

per day via manure from treated animals is 1.06 parts per million. The

polymer is expected to be strongly adsorbed by soil and to have a low

mobility. Therefore, it is not expected to move in significant

quantities to surface or groundwater due to agricultural runoff. The

environmental assessment states that no more than trace quantities are

likely to enter the aquatic environment and no subsequent

bioconcentration is expected. The environmental assessment demonstrates

that 1.31 pounds of each of the monomers are expected to enter the

environment each year resulting in soil concentrations of 0.21 parts

per trillion (ppt) and air point source concentrations of 60 ppt.

Therefore, the two monomers are not expected to have a significant

effect on the environment. The information in the environmental

assessment is sufficient to address the questions raised in the comment

and adequate to conclude that significant environmental impacts are not

expected to occur.

FDA has evaluated the data in the petition and other relevant

material and concluded that use of poly(2-vinylpyridine-co-styrene) for

dairy cattle (including replacement dairy heifers) in addition to the

use for beef cattle as a nutrient protectant in feed is safe.

Therefore, Sec. 573.870 is amended as set forth below.

In accordance with Sec. 571.1(h) (21 CFR 571.1(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 Veterinary Medicine by appointment with the information

contact person listed above. As provided in 21 CFR 571.1(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

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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 April 22, 1996, 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 573

Animal feeds, Food additives.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs and

redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is

amended as follows:

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF

ANIMALS

1. The authority citation for 21 CFR part 573 continues to read as

follows:

Authority: Secs. 201, 402, 409 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 342, 348).

Sec. 573.870 [Amended]

2. Section 573.870 Poly(2-vinylpyridine-co-styrene) is amended in

the introductory text and in paragraph (b) by adding the phrase ``and

dairy cattle and replacement dairy heifers'' after the phrase ``beef

cattle''.

Dated: March 6, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96-6738 Filed 3-20-96; 8:45 am]

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