[Federal Register Volume 59, Number 97 (Friday, May 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12429]
[[Page Unknown]]
[Federal Register: May 20, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 177
[Docket No. 91F-0254]
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 petroleum
hydrocarbon resins (cyclopentadiene-type), hydrogenated, as an adjuvant
in the manufacture of polypropylene homopolymer or a copolymer of
propylene and ethylene containing not less than 94 weight percent
propylene for use in contact with food. This action is in response to a
petition filed by Exxon Chemical Co.
DATES: Effective on May 20, 1994; written objections and requests for a
hearing by June 20, 1994. The Director of the Office of the Federal
Register approves the incorporations by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21 CFR
177.1520(b), effective on May 20, 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: Julius Smith, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-254-9500.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 1, 1991 (56 FR 36814), FDA announced that a food
additive petition (FAP 1B4267) had been filed by Exxon Chemical Co.,
P.O. Box 241, Baton Rouge, LA 70821. The petition proposed that the
food additive regulations be amended to provide for the safe use of
hydrogenated cyclodiene resins for use as a component of polypropylene
film intended to contact food.
Upon thorough review of the petition, the agency noted that the
petitioner requested use of the additive in copolymers of propylene and
ethylene containing not less than 94 weight percent propylene, in
addition to its use in polypropylene films. Therefore, in the Federal
Register of December 1, 1993 (58 FR 63381), FDA amended the filing
notice of August 1, 1991, to state that the petitioner requested that
the food additive regulations be amended to provide for the safe use of
petroleum hydrocarbon resins (cyclopentadiene-type), hydrogenated, as a
component of polypropylene or a copolymer of propylene and ethylene
containing not less than 94 weight percent propylene for use in contact
with food. This final rule is in response to both filing notices.
FDA, in its safety evaluation, 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 may contain minute amounts of
polynuclear aromatic hydrocarbons (PAH's), carcinogenic impurities
resulting from the manufacture of the additive.
Residual amounts of reactants, manufacturing aids, and their
constituent impurities, such as polynuclear aromatic hydrocarbons in
this instance, 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,'' a food additive cannot be approved for a particular use
unless a fair evaluation of the evidence 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 food additives 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 constituents of 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 the Petitioned Use of the Additive
FDA estimates that the petitioned use of the additive, petroleum
hydrocarbon resins (cyclopentadiene-type), hydrogenated, will result in
levels of exposure to the additive no greater than 40 parts per billion
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 and subchronic 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. The agency has also used
risk assessment procedures to estimate the upper-bound limit of risk
presented by polynuclear aromatic hydrocarbons that may be present as
impurities in the additive. This risk evaluation of polynuclear
aromatic hydrocarbons 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. Polynuclear Aromatic Hydrocarbons
FDA has estimated the hypothetical worst-case exposure to
polynuclear aromatic hydrocarbons from the petitioned use of the
additive in the manufacture of polypropylene film to be 0.7 nanograms
per person per day (ng/person/day), based on a polynuclear aromatic
hydrocarbon dietary concentration of 4.9 parts per trillion and a daily
diet of 3 kilograms of food per person per day (Ref. 1).
The agency used data from a carcinogenesis bioassay on
benzo[a]pyrene, conducted by Brune, H. et al., to estimate the upper-
bound limit of lifetime human risk from exposure to this chemical
stemming from the proposed use of petroleum hydrocarbon resins
(cyclopentadiene-type), hydrogenated (Ref. 3). The results of the
bioassay on polynuclear aromatic hydrocarbons demonstrated that the
material was carcinogenic for Sprague-Dawley rats under the conditions
of the study. The test material induced treatment-related benign
forestomach tumors or esophageal tumors in male rats.
Based on a potential exposure of 0.7 ng/person/day, FDA estimates
that the upper-bound limit of individual lifetime risk from the
potential exposure to polynuclear aromatic hydrocarbons from the use of
the subject additive is 2.1x10-8, or less than 1 in 50 million
(Ref. 4). Because of the numerous conservative assumptions used in
calculating the exposure estimate, actual lifetime averaged individual
exposure to polynuclear aromatic hydrocarbons 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 of no harm from the
exposure to polynuclear aromatic hydrocarbons that might result from
the proposed use of the additive.
B. Need for Specifications
The agency has also considered whether specifications are necessary
to control the amount of polynuclear aromatic hydrocarbon impurity in
the food additive. The agency finds that specifications are not
necessary for the following reasons: (1) Because of the low level at
which polynuclear aromatic hydrocarbons may be expected to remain as
impurities following production of the additive, the agency would not
expect PAH's to become components of food at other than extremely low
levels; and (2) the upper-bound limit of lifetime risk from exposure to
polynuclear aromatic hydrocarbons, even under worst-case assumptions,
is very low, less than 1 in 50 million.
C. Conclusions on Safety
FDA has evaluated the data in the petition and other relevant
material. The agency concludes that the proposed uses for the additive
in polypropylene homopolymer films and propylene/ethylene copolymer
films in contact with nonfatty foods are safe. Based on this
information, the agency has also concluded that the additive will have
the intended technical effect and therefore 21 CFR 177.1520 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 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 June 20, 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 to the Indirect
Additives Branch, FDA, concerning ``FAP 1B4267--Exxon Chemical
Company. Submission dated 5-4-93. Hydrogenated Cyclodiene Resins as
an Adjuvant in Polypropylene Film,'' June 25, 1993.
2. Kokoski, C. J., ``Regulatory Food Additive Toxicology,'' in
Chemical Safety Regulation and Compliance, edited by Homburger, F.,
J. K. Marquis, and S. Karger, New York, NY, pp. 24-33, 1985.
3. Brune, H., R. P. Deutsch-Wenzel, M. Habs, S. Ivankovis, and
D. Schmahl, ``Investigation of the Tumorigenic Response to
Benzo(a)pyrine in Aqueous Caffine Solution Applied Orally to
Sprague-Dawley Rats,'' Journal of Cancer Research and Clinical
Oncology, 102:153-157, 1981.
4. Memorandum from Julius Smith, Indirect Additive Branch, to
Sara H. Henry, Quantitative Risk Assessment Committee, on
``Estimation of the Upper Bound Lifetime Risk From Polynuclear
Aromatic Hydrocarbons (PAH's) in Hydrogenated Cyclodiene Resin, the
Subject of Food Additive Petition No. 1B4267 (Exxon Chemical
Company),'' August 6, 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 177.1520 is amended in the table in paragraph (b) by
alphabetically adding a new entry under the headings ``Substance'' and
``Limitations'' to read as follows:
Sec. 177.1520 Olefin polymers.
* * * * *
(b) * * *
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Substance Limitations
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Petroleum hydrocarbon resins For use only as an adjuvant at
(cyclopentadiene-type), hydrogenated levels not to exceed 30 percent
(CAS Reg. No. 68132-00-3) produced by weight in blends with: (1)
by the thermal polymerization of Polypropylene complying with
dicyclopentadiene and cyclodiene paragraph (c), item 1.1 of this
codimers (consisting of a mixture of section, or (2) a copolymer of
cyclopentadiene, methyl propylene and ethylene
cyclopentadiene, and C4-C5 acyclic containing not less than 94
dienes), followed by hydrogenation weight percent propylene and
and having a ring-and-ball softening complying with paragraph (c),
point of 119 deg.C minimum as item 3.2 of this section. The
determined by ASTM Method E 28-67 average thickness of the food-
(Reapproved 1982), ``Standard Test contact film is not to exceed
Method for Softening Point by Ring- 0.1 millimeter (0.004 inch). The
and-Ball Apparatus,'' and a minimum finished polymer may be used in
viscosity of 3,000 cubic centimeters contact with food types I, II,
per second, measured at 160 deg.C, IV-B, VI-A, VI-B, VII-B, and
as determined by ASTM Method D 3236- VIII identified in Table 1 of
88, ``Standard Test Method for Sec. 176.170(c) of this chapter
Apparent Viscosity of Hot Melt and under conditions of use C
Adhesives and Coating Materials,'' through G described in Table 2
both of which are incorporated by of Sec. 176.170(c) of this
reference in accordance with 5 chapter.
U.S.C. 552(a) and 1 CFR part 51.
Copies are available from the
American Society for Testing and
Materials, 1916 Race St.,
Philadelphia, PA 19103, or from the
Division of Petition Control, Center
For Food Safety and Applied
Nutrition (HFS-216), 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.
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* * * * *
Dated: May 16, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-12429 Filed 5-19-94; 8:45 am]
BILLING CODE 4160-01-F
