[Federal Register Volume 65, Number 14 (Friday, January 21, 2000)]
[Rules and Regulations]
[Pages 3384-3386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1408]



[[Page 3384]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 98F-0569]


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 ethylene-norbornene 
copolymers as articles or components of articles in contact with dry 
food. This action responds to a petition filed by Ticona.

DATES:  This regulation is effective January 21, 2000. Submit written 
objections and requests for a hearing by February 22, 2000.

ADDRESSES:  Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Julius Smith, Center for Food Safety 
and Applied Nutrition (HFS-215), 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 July 23, 1998 (63 FR 39583), FDA announced that a food 
additive petition (FAP 8B4597) had been filed by Ticona, c/o Keller and 
Heckman, 1001 G St. NW., suite 500 West, Washington, DC 20001. 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 ethylene-norbornene copolymers as articles or components of 
articles in contact with dry foods.
    In its evaluation of the safety of this additive, FDA has reviewed 
the safety of the additive itself 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 residual amounts of benzene, a carcinogenic 
impurity resulting from the manufacture of the additive. Residual 
amounts of reactants and manufacturing aids, such as benzene, are 
commonly found as contaminants in chemical products, including food 
additives.

I. Determination of Safety

    Under the general safety standard 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 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 food additives anticancer, or Delaney, clause of the act (21 
U.S.C. 348 (c)(3)(A)) 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 
standard using risk assessment procedures to determine whether there is 
a reasonable certainty that no harm will result from the intended 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, ethylene-
norbornene copolymers, will result in exposure to no greater than 2.5 
parts per billion of the additive in the daily diet (3 kilograms (kg)) 
or an estimated daily intake of 7.5 micrograms per person per day 
(Refs. 1 and 2).
    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. 3), and the agency has not 
required such testing here. However, the agency has reviewed the 
available toxicological data on the additive and concludes that the 
estimated small dietary exposure resulting from the petitioned use of 
this additive is safe.
    FDA has evaluated the safety of this additive under the general 
safety standard, considering all available data and using risk 
assessment procedures to estimate the upper-bound limit of lifetime 
human risk presented by benzene, the carcinogenic chemical that may be 
present as an impurity in the additive. The risk evaluation of benzene 
has two aspects: (1) Assessment of exposure to the impurity from the 
petitioned use of the additive, and (2) extrapolation of the risk 
observed in the animal bioassay to the conditions of probable exposure 
to humans.

A. Benzene

    FDA has estimated the exposure to benzene from the petitioned use 
of the additive to be no more than 15 parts per trillion in the daily 
diet (3 kg) or 50 nanograms/person/day (ng/p/d) (Ref. 1). The agency 
used data from a carcinogenesis bioassay of benzene using B6C3F1 hybrid 
mice (Ref. 4), sponsored by the National Toxicology Program, to 
estimate the upper-bound limit of lifetime human risk from exposure to 
this chemical resulting from the petitioned use of the additive. The 
authors reported that there were significantly increased incidences of 
mice with neoplasms at several organ sites associated with the 
administration of benzene by the oral route.
    Based on the agency's estimate that exposure to benzene will not 
exceed 50 ng/p/d, FDA estimates that the upper-bound limit of lifetime 
human risk from the petitioned use of the subject additive is 3.6  x  
10<SUP>-8</SUP>, or 3.6 in 100 million (Refs. 1 and 5). Because of the 
numerous conservative assumptions used in calculating the exposure 
estimate, the actual lifetime-averaged individual exposure to benzene 
is likely to be substantially less than the estimated exposure, and 
therefore, the probable lifetime human risk would be less than the 
upper-bound limit of lifetime human risk. Thus, the agency concludes 
that there is reasonable certainty that no harm from exposure to 
benzene would result from the petitioned use of the additive.

B. Need for Specifications

    The agency also has considered whether specifications are necessary 
to control the amount of benzene present as an impurity in the 
additive. The agency finds that specifications are not necessary for 
the following reasons: (1) Because of the low level at which benzene 
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 low levels; and (2) the 
upper-bound limit of lifetime risk from exposure to benzene from the 
petitioned use is very low, 3.6 in 100 million.

III. Conclusion

    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that: (1) The 
proposed use of the additive is safe, (2) the additive will achieve its 
intended technical effect,

[[Page 3385]]

and therefore, (3) the regulations in 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 Sec. 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

    The agency has carefully considered the 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. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VI. Objections

    Any person who will be adversely affected by this regulation may at 
any time on or before February 22, 2000, 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 office above between 9 
a.m. and 4 p.m., Monday through Friday.

VII. 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 Division of Product Manufacture and Use, 
Chemistry Review Team (HFS-246), to the Division of Petition Control 
(HFS-215), entitled ``FAP 8B4597 (MATS# 974, M2.0 & 2.1): Ticona 
Submission, Through Their Agent Keller and Heckman, Dated 5-8-98. 
Ethylene-Norbornene Copolymers for Use in Contact With Dry Food,'' 
February 16, 1999.
    2. Memorandum from the Division of Product Manufacture and Use, 
Chemistry Review Team (HFS-246), to the Division of Petition Control 
(HFS-215), entitled ``FAP 8B4597 (MATS# 974, M2.2): Ticona 
Submission, Through Their Agent Keller and Heckman, Dated 5-8-98. 
Ethylene-Norbornene Copolymers for Use in Contact With Dry Food,'' 
June 15, 1999.
    3. Kokoski, C. J., ``Regulatory Food Additive Toxicology,'' 
Chemical Safety Regulation and Compliance, edited by F. Homburger, 
J. K. Marquis, published by S. Karger, New York, NY, pp. 24-33, 
1985.
    4. ``Toxicology And Carcinogenesis Studies of Benzene (CAS No. 
71-43-2) in F344/N Rats And B6C3F1 Mice (Gavage Studies),'' National 
Toxicology Program Technical Report Series, No. 289, April 1986.
    5. Memorandum from the Division of Petition Control (HFS-215), 
to Executive Secretary, Quantitative Risk Assessment Committee 
(QRAC) (HFS-308), entitled ``Estimation of the Upper-Bound Lifetime 
Risk From Benzene, an Impurity in Ethylene-Norbornene Copolymers, 
the Subject of Food Additive Petition 8B4597 (Ticona Co.),'' March 
23, 1999.

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:  21 U.S.C. 321, 342, 348, 379(e).

    2. Section 177.1520 is amended by adding paragraph (a)(3)(vii), and 
by amending paragraph (c) in the table by adding item 3.9 to read as 
follows:


Sec. 177.1520  Olefin polymers.

    (a) * * *
    (3) * * *
    (vii) Ethylene and 2-norbornene (CAS Reg. No. 26007-43-2) 
copolymers that shall contain not less than 30 and not more than 70 
mole percent of polymer units derived from 2-norbornene.
* * * * *
    (c) * * *

 
----------------------------------------------------------------------------------------------------------------
                                                                       Maximum extractable     Maximum soluble
                                                Melting Point (MP)    fraction (expressed    fraction (expressed
                                                or softening point    as percent by weight  as percent by weight
    Olefin Polymers            Density            (SP) (Degrees      of the polymer) in N-     of polymer) in
                                                   Centigrade)        hexane at specified    xylene at specified
                                                                         temperatures.          temperatures
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *
                                                             *
 3.9 Olefin             Not less than 1.0
 copolymers described
 in paragraph
 (a)(3)(vii) of this
 section may only be
 used in contact with
 dry foods, Type
 VIII, as identified
 in Sec.  176.170(c)
 of this chapter,
 Table 1.
  *                    *                    *                    *                    *                    *
                                                             *
----------------------------------------------------------------------------------------------------------------


[[Page 3386]]

* * * * *

    Dated: January 11, 2000.
Margaret M. Dotzel,
Acting Associate for Commissioner for Policy.
[FR Doc. 00-1408 Filed 1-20-00; 8:45 am]
BILLING CODE 4160-01-F