[Federal Register Volume 61, Number 56 (Thursday, March 21, 1996)]
[Rules and Regulations]
[Pages 11546-11547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6738]



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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

[[Page 11547]]
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]
BILLING CODE 4160-01-F