[Federal Register Volume 59, Number 172 (Wednesday, September 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21900]
[[Page Unknown]]
[Federal Register: September 7, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 91F-0449]
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 hydrogenated
butadiene/acrylonitrile copolymers in repeated use food-contact
articles. This action is in response to a petition filed by Polysar
Rubber Corp.
DATES: Effective September 7, 1994; written objections and requests for
a hearing by October 7, 1994. The Director of the Office of the Federal
Register approves the incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51 of a certain publication in 21 CFR
177.2600(c)(4)(i), effective September 7, 1994.
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 December 19, 1991 (56 FR 65907), FDA announced that a food
additive petition (FAP 2B4299) had been filed by Polysar Rubber Corp.,
1265 South Vidal St., Sarnia, Ontario, Canada N7T 7MI. The petition
proposed that the food additive regulations be amended in Sec. 177.2600
Rubber articles intended for repeated use (21 CFR 177.2600) to provide
for the safe use of hydrogenated butadiene/acrylonitrile copolymers in
repeated use food-contact articles.
FDA, in its evaluation of the safety of this additive, reviewed the
safety of the additive and the chemical impurities that may be present
in the additive resulting from its manufacturing process. Although the
additive itself has not been shown to cause cancer, it has been found
to contain minute amounts of unreacted acrylonitrile, a carcinogenic
reactant used in the manufacture of the additive. Residual amounts of
reactants and manufacturing aids, such as acrylonitrile, are commonly
found as contaminants in chemical products, including food additives.
I. Determination of Safety
Under section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 348(c)(3)(A), the so-called ``general safety
clause'' of the statute, a food additive cannot be approved for a
particular use unless a fair evaluation of the data available to FDA
establishes that the additive is safe for that use. FDA's food additive
regulations (21 CFR 170.3(i)) define ``safe'' as ``a reasonable
certainty in the minds of competent scientists that the substance is
not harmful under the intended conditions of use.''
The anticancer or Delaney clause (section 409(c)(3)(A) of the act)
further provides that no food additive shall be deemed safe if it is
found to induce cancer when ingested by man or animal. Importantly,
however, the Delaney clause applies to the additive itself and not to
the impurities in the additive. That is, where an additive itself has
not been shown to cause cancer, but contains a carcinogenic impurity,
the additive is properly evaluated under the general safety clause
using risk assessment procedures to determine whether there is a
reasonable certainty that no harm will result from the proposed use of
the additive (Scott v. FDA 728 F.2d 322 (6th Cir. 1984)).
II. Safety of Petitioned Use of the Additive
FDA estimates that the petitioned use of the additive,
hydrogenated butadiene/acrylonitrile copolymer, will result in exposure
to the additive of no greater than 7 parts per trillion (ppt) in the
daily diet (Ref. 1).
FDA does not ordinarily consider chronic toxicological testing to
be necessary to determine the safety of an additive whose use will
result in such low exposure levels (Ref. 2), and the agency has not
required such testing here. However, the agency has reviewed the
available toxicological data from acute toxicity studies on the
additive. No adverse effects were reported in these studies.
FDA has evaluated the safety of this additive under the general
safety clause, considering all available data and using risk assessment
procedures to estimate the upper-bound limit of risk presented by
acrylonitrile, a carcinogenic chemical that may be present as an
impurity in the additive. This risk evaluation of acrylonitrile has two
aspects: (1) Assessment of the exposure to the impurity from the
proposed use of the additive; and (2) extrapolation of the risk
observed in the animal bioassays to the conditions of probable exposure
to humans.
A. Acrylonitrile
FDA has estimated the worst-case exposure to acrylonitrile from the
petitioned use of the additive in the manufacture of repeated use food-
contact articles to be 0.02 ppt of the daily diet (3 kilograms) or 0.06
nanogram (ng) per person per day (Ref. 1). The agency used data from
two carcinogenicity studies on acrylonitrile monomer fed to rats to
estimate the upper-bound limit of lifetime human risk from exposure to
this chemical stemming from the proposed use of hydrogenated butadiene/
acrylonitrile copolymers and the level of acrylonitrile that may be
present in the additive (Ref. 3). The results of the bioassays on
acrylonitrile monomer demonstrated that the material was carcinogenic
for rats under the conditions of the studies. The test material caused
significantly increased incidences of carcinogenic tumors at many
tissue sites.
Based on the estimated worst-case exposure of 0.06 ng per person
per day, FDA estimates that the upper-bound limit of individual
lifetime risk from the use of the hydrogenated butadiene/acrylonitrile
copolymers is 8 x 10-11 or 8 in 100 billion (Ref. 4). Because of
the numerous conservative assumptions used in calculating the exposure
estimate, the actual lifetime averaged individual daily exposure to
acrylonitrile is expected to be substantially less than the worst-case
exposure, and therefore, the calculated upper-bound limit of risk would
be less. Thus, the agency concludes that there is a reasonable
certainty that no harm from exposure to acrylonitrile would result from
the proposed use of hydrogenated butadiene/acrylonitrile copolymers.
B. Conclusion on Safety
FDA has evaluated data in the petition and other relevant material
and concludes that the proposed use of the additive in repeated use
food-contact articles is safe. Based on this information, the agency
has also concluded that the additive will have the intended technical
effect. Therefore, Sec. 177.2600 should be amended as set forth below.
C. Need for Specifications
The agency has also considered whether a specification is
necessary to control the amount of acrylonitrile impurity in the food
additive. The agency finds that a specification is not necessary for
the following reasons: (1) Because of the low level at which
acrylonitrile may be expected to remain as an impurity following
production of the additive, the agency would not expect this impurity
to become a component of food at other than extremely small levels; and
(2) the upper-bound limit of lifetime risk from exposure to this
impurity, even under worst-case assumptions, is very low, less than 8
in 100 billion.
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.
III. Environmental Impact
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.
IV. Objections
Any person who will be adversely affected by this regulation may at
any time on or before October 7, 1994, 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.
V. 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. Memorandum from the Chemistry Review Branch (HFS-247) to the
Indirect Additives Branch, FDA (HFS-216), concerning FAP 2B4299
(Polysar Rubber Corp.) and exposure to the food additive and its
component (acrylonitrile), November 24, 1992.
2. Kokoski, C. J., ``Regulatory Food Additive Toxicology,'' in
Chemical Safety Regulation and Compliance, edited by F. Homburger,
J. K. Marquis, and S. Karger, New York, NY, pp.24-33, 1985.
3. Memorandum of the Cancer Assessment Committee, Center for
Food Safety and Applied Nutrition, FDA, on ``Acrylonitrile Risk
Assessment,'' dated November 24, 1981.
4. Memorandum from the Quantitative Risk Assessment Committee,
Center for Food Safety and Applied Nutrition, FDA, concerning
acrylonitrile (FAP 2B4299), dated April 19, 1993.
List of Subjects in 21 CFR Part 177
Food additives, Food packaging, Incorporation by reference.
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 177.2600 is amended in paragraph (c)(4)(i) by
alphabetically adding a new entry to read as follows:
Sec. 177.2600 Rubber articles intended for repeated use.
* * * * *
(c) * * *
(4) * * *
(i) * * *
Hydrogenated butadiene/acrylonitrile copolymers (CAS Reg. No.
88254-10-8) produced when acrylonitrile/butadiene copolymers are
modified by hydrogenation of the olefinic unsaturation to leave not
more than 10 percent trans olefinic unsaturation and no
,-olefinic unsaturation as determined by a method
entitled ``Determination of Residual ,-Olefinic and
Trans Olefinic Unsaturation Levels in HNBR,'' developed October 1,
1991, by Polysar Rubber Corp., 1256 South Vidal St., Sarnia, Ontario,
Canada N7T 7MI, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the
Division of Petition Control, Center for Food Safety and Applied
Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, or may be examined at the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
* * * * *
Dated: August 24, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-21900 Filed 9-6-94; 8:45 am]
BILLING CODE 4160-01-F