[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