[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]



-----------------------------------------------------------------------

[[Page 28049]]


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.

-----------------------------------------------------------------------

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) * * *

[[Page 28051]]



                                                                        
------------------------------------------------------------------------
               Substance                           Limitations          
------------------------------------------------------------------------
  *                    *                    *                    *      
             *                    *                    *     -- -- -- --
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.                      
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

* * * * *

    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