[Federal Register Volume 61, Number 108 (Tuesday, June 4, 1996)]
[Rules and Regulations]
[Pages 28048-28051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13983]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 177
[Docket No. 94F-0022]
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 films and copolymer
films of propylene and ethylene containing not less than 94 weight
percent propylene for use in contact with fatty and alcoholic foods.
This action responds to a petition filed by Exxon Chemical Co. The
agency is also correcting a technical error in the current listing for
petroleum hydrocarbon resins.
DATES: Effective June 4, 1996; written objections and requests for a
hearing by July 5, 1996.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
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, 202-418-3091.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of March 10, 1994 (59 FR 11278), FDA announced that a petition
(FAP 4B4411) had been filed by Exxon Chemical Co., P.O. Box 241, Baton
Rouge, LA 70821. (The address of the petitioner has been changed to
P.O. Box 5200, Baytown, TX 77522-5200.) The petition proposed to amend
the food additive regulations in Sec. 177.1520 Olefin polymers (21 CFR
177.1520) to provide for the safe use of hydrogenated cyclodiene resins
as a component of polypropylene homopolymer or a copolymer of propylene
and ethylene containing not less than 94 weight percent propylene for
use in contact with food. -
In its evaluation of this additive, FDA has determined that the
additive is more accurately described as petroleum hydrocarbon resins
(cyclopentadiene-type), hydrogenated, and is approved for other food
additive uses under this name in Sec. 177.1520. Therefore, the additive
will be identified with this name in the remainder of this document.
The agency has also 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 the so-called ``general safety clause'' of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 348(c)(3)(A), 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 anticancer or Delaney clause of the act 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 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, petroleum
hydrocarbon resins (cyclopentadiene-type), hydrogenated, will result in
levels of exposure to the additive no greater than 0.77 parts per
million (ppm) in the daily diet (Ref. 1).
FDA does not ordinarily consider chronic toxicological studies 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 and using risk assessment
procedures to estimate the upper-bound limit of lifetime human 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 worse-case
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 (PAH's) from the petitioned uses of
the additive to be 0.3 nanograms per person per day (ng/person/day),
based on a PAH dietary concentration of 4.9 parts per trillion and a
daily diet of 3 kilograms of food per person per day (Ref. 1).
PAH's occur as a mixture of compounds; the toxicity of these
compounds varies, and some members of the family have been shown to be
carcinogenic in animal studies. For this risk estimate, FDA has made
the ``worst-case'' assumption that the PAH's in the additive consist
entirely of benzo[a]pyrene, the member of the PAH family which current
data indicate to be one of the more potent carcinogens.
Therefore, the agency used data from a carcinogenesis bioassay on
benzo[a]pyrene, conducted by H. Brune et al., to estimate the upper-
bound limit of lifetime human risk from exposure to this chemical
resulting from the proposed use of petroleum hydrocarbon resins
(cyclopentadiene-type), hydrogenated (Ref. 3). The results of the
bioassay on benzo[a]pyrene 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 0.3 ng/person/day, FDA estimates
that the upper-bound limit of lifetime human risk from the potential
exposure to PAH's from the use of the subject additive is 8.8 x
10-9, or less than 1 in 100 million (Ref. 4). Because of numerous
conservative assumptions used in calculating the exposure estimate and
the carcinogenic potency of PAH's in the additive, the actual lifetime
averaged individual exposure to PAH's is expected to be substantially
[[Page 28050]]
less than the potential exposure, and therefore, the upper-bound limit
of human risk would be less. Thus, the agency concludes that there is a
reasonable certainty of no harm from the exposure to PAH's that might
result from the proposed use of the additive.
B. Need for Specifications
The agency has also considered whether a specification is
necessary to control the amount of PAH's present as impurities in the
additive. The agency finds that a specification is not necessary for
the following reasons: (1) Because of the low level at which PAH's may
be expected to remain as impurities following production of the
additive, the agency would not expect these impurities to become
components of food at other than extremely low levels; and (2) the
upper-bound limit of lifetime human risk from exposure to the PAH's,
even under worst-case assumptions, is very low, less than 1 in 100
million.
III. Conclusion on Safety
FDA has evaluated the data in the petition and other relevant
material and concludes that the proposed uses of the additive in
polypropylene homopolymer films and propylene/ethylene copolymer films
in contact with fatty and alcoholic foods are safe. The agency also
concludes that the additive will have its intended technical effect.
The agency is also amending the current listing for the additive to
correct a technical error by changing ``cubic centimeters'' to read
``centipoise.'' Therefore, Sec. 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.
IV. Environmental Impact
In the notice of filing for this petition that published in the
Federal Register of March 10, 1994 (59 FR 11278), FDA gave interested
parties an opportunity to submit comments on the petitioner's
environmental assessment by April 11, 1994, to the Dockets Management
Branch (address above). FDA received no comments in response to that
notice.
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.
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, FDA, to the
Indirect Additives Branch, FDA, concerning ``FAP 4B4411 (MATS 754
M2.1): Hydrogenated Cyclodiene Resins--Use in Polypropylene Films in
Contact With Fatty and Alcoholic Food--Exxon Chemical Co.--
Submission of 1/3/94,'' dated June 8, 1994.
-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 to 33, 1985.
-3. Brune, H., R. P. Deutsch-Wenzel, M. Habs, S. Ivankovis, and
D. Schmahl, ``Investigation of the Tumorigenic Response to
Benzo(a)pyrene in Aqueous Caffeine Solution Applied Orally to
Sprague-Dawley Rats,'' Journal of Cancer Research and Clinical
Oncology, 102:153 to 157, 1981.
-4. Memorandum from the Indirect Additives Branch, FDA, to the
Executive Secretary, Quantitative Risk Assessment Committee, FDA,
concerning, ``Estimation of the Upper Bound Lifetime Risk from
Polynuclear Aromatic Hydrocarbons (PAH's) in Hydrogenated Cyclodiene
Resin, the subject of Food Additive Petition No. 4B4411 (Exxon
Chemical Co.),'' dated May 11, 1995.
VI.- Objections
Any person who will be adversely affected by this regulation may at
any time on or before July 5, 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 177
-Food additives, Food packaging.
-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: Sec. 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) for
the item ``Petroleum hydrocarbon resins (cyclopentadiene-type) * * *''
under the heading ``Substance'' by removing the phrase ``cubic
centimeters'' and replacing it with ``centipoise'' and under the
heading ``Limitations'' by revising the entry 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) * * *. levels not to exceed 30
percent by weight in blends
with: (1) Polypropylene
complying with paragraph (c),
item 1.1 of this section, or
(2) a copolymer of propylene
and ethylene containing not
less than 94 weight percent
propylene and complying with
paragraph (c), item 3.2 of
this section. The average
thickness of the food-contact
film is not to exceed 0.1
millimeter (0.004 inch). The
finished polymer may be used
in contact with (1) Food types
I, II, IV-B, VI-A, VI-B, VII-
B, and VIII identified in
Table 1 of Sec. 176.170(c) of
this chapter and under
conditions of use C through G
described in Table 2 of Sec.
176.170(c) of this chapter;
and (2) food types III, IV-A,
V, VI-C, VII-A, and IX
identified in Table 1 of Sec.
176.170(c) of this chapter and
under conditions of use D
through G described in Table 2
of Sec. 176.170(c) of this
chapter.
* * * *
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Dated: May 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-13983 Filed 6-3-96; 8:45 am]
BILLING CODE 4160-01-F
