[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
