[Federal Register Volume 64, Number 96 (Wednesday, May 19, 1999)]
[Rules and Regulations]
[Pages 27177-27179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12531]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 95F-0191]


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 polyestercarbonate 
resins produced by the condensation of 4,4'-isopropylidenediphenol, 
carbonyl chloride, terephthaloyl chloride, and isophthaloyl chloride. 
The finished resins are composed of 45 to 85 mole percent ester, of 
which up to 55 mole percent is the terephthaloyl isomer, as articles or 
components of articles in contact with food. This action responds to a 
petition filed by the General Electric Co.

DATES: This regulation is effective May 19, 1999; written objections 
and requests for a hearing by June 18, 1999.
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 31, 1995 (60 FR 39000), FDA announced that a food 
additive petition (FAP 5B4470) had been filed by the General Electric 
Co., 1 Lexan Lane, Mt. Vernon, IN 47620-9364. The petition proposed to 
amend the food additive regulations in Sec. 177.1585 Polyestercarbonate 
resins (21 CFR 177.1585) to provide for the safe use of 
polyestercarbonate resins produced by the condensation of 4,4'-
isopropylidenediphenol, carbonyl chloride, terephthaloyl chloride, and 
isophthaloyl chloride. The finished resins are composed of 45 to 85 
percent ester, of which up to 55 percent is the terephthaloyl isomer, 
as articles or components of articles in contact with food. (The agency 
will subsequently use mole-percent to describe these resins because 
this term better describes the resin composition.)
    In its evaluation of the safety of this food additive, FDA has 
reviewed the safety of the additive itself, the starting materials 
used, 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 methylene chloride, which has been shown to cause 
cancer in test animals. Residual amounts of reactants and manufacturing 
aids, such as methylene chloride, are commonly found as contaminants in 
chemical products, including food additives.

I. Determination of Safety

    Under the general safety standard of section 409(c)(3)(A) 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 
(409(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 the 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 Petitioned Use of the Additive

    FDA estimates that the petitioned use of the additive, 
polyestercarbonate resins, as food packaging, will not significantly 
increase the overall exposure to polyestercarbonate oligomers, 
monomers, p-cumylphenol, and methylene chloride above the exposure from 
the currently regulated uses of these polyestercarbonate resins (Ref. 
1).
    FDA does not ordinarily consider chronic toxicological studies to 
be necessary to determine the safety of an additive use of which 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 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 methylene chloride, the carcinogenic chemical 
that may be present as an impurity in the additive. This risk 
evaluation of methylene chloride 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. Methylene Chloride

    FDA has estimated the exposure to methylene chloride from the 
petitioned and regulated uses of polyestercarbonate resins as articles 
intended to contact food to be no more than 4.9 parts per billion in 
the daily diet (3 kilogram), or 15 micrograms per person per day (Ref. 
1). The agency used data in the National Toxicology Program Report No. 
306 (January 1986), on inhalation studies in F344/N rats and 
B6C3F1 mice to estimate the upper-bound limit of lifetime 
human risk from exposure to this chemical resulting from the petitioned 
and regulated uses of the additive (Ref. 3). The authors reported that 
the test material caused an increased incidence of liver cell neoplasms 
and lung neoplasms in both male and female B6C3F1 mice.
    Based on the agency's estimate that exposure to methylene chloride 
will not exceed 15 micrograms/person/day, FDA estimates that the upper-
bound limit of lifetime human risk from the regulated and petitioned 
uses of the polyestercarbonate resins is 1 x 10-7 or 1 in 10 
million (Ref. 4). Because of numerous conservative assumptions used in 
calculating the exposure estimate, the actual lifetime-averaged 
individual exposure to methylene chloride 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

[[Page 27178]]

agency concludes that there is reasonable certainty that no harm from 
exposure to methylene chloride would result from the petitioned use of 
the additive.

B. Need for Specifications

    The agency has also considered whether specifications are necessary 
to control the amount of methylene chloride present as an impurity in 
the additive. The agency finds that the specification currently in 
Sec. 177.1585 is adequate to insure that the risk from methylene 
chloride resulting from the petitioned use of the polyestercarbonate 
resins in contact with food is insignificant and that use of the resins 
is safe.

III. Conclusion on Safety

    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that the 
proposed uses for the food additive in food-contact articles are safe, 
that the food additive will achieve its intended technical effect, and 
that the regulations in Sec. 177.1585 should be amended as set forth in 
the codified of this document.
    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 previously. As provided in 
Sec. 171.1(h)(2), 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 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. 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 June 18, 1999, file with the Dockets Management 
Branch (address above) written objections thereto and may make a 
written request for a public hearing on the stated objections and the 
grounds for the objection. Each objection shall be separately numbered, 
and each numbered objection shall specify with particularity the 
provision 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.

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 dated April 25, 1996, from the Chemistry Review 
Branch (HFS-247), to the Indirect Additives Branch (HFS-216) 
entitled ``FAP 5B4470 (MATS 825, M2.0 and 2.1--General 
Electric Company (GE) Polyestercarbonate (PEC) resins. Submission 
dated 6-1-95.''
    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. 24-33, 1985.
    3. ``Toxicology and Carcinogenesis Studies of Dichloromethane 
(Methylene Chloride) (CAS Reg. No. 75-09-2) in F344/N Rats and 
B6C3F1  Mice (Inhalation Studies),'' National Toxicology 
Program Technical Report Series, No. 306 (January 1986).
    4. Memorandum, dated June 4, 1996, from the Indirect Additives 
Branch, (HFS-216), to Executive Secretary, Quantitative Risk 
Assessment Committee (QRAC), (HFS-308), entitled ``Estimation of 
Upper-bound Lifetime Human Risk from Methylene Chloride in 
Polyestercarbonate Resins, the Subject of FAP 5B4470 (General 
Electric Co.).''

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, 379e.
    2. Section 177.1585 is amended by revising paragraphs (a) and 
(c)(1) to read as follows:


Sec.  177.1585  Polyestercarbonate resins.

 * * * * *
    (a) Polyestercarbonate resins (CAS Reg. No. 71519-80-7) are 
produced by the condensation of 4,4'-isopropylidenediphenol, carbonyl 
chloride, terephthaloyl chloride, and isophthaloyl chloride such that 
the finished resins are composed of 45 to 85 molepercent ester, of 
which up to 55 mole-percent is the terephthaloyl isomer. The resins are 
manufactured using a phthaloyl chloride/carbonyl chloride mole ratio of 
0.81 to 5.7/1 and isophthaloyl chloride/terephthaloyl chloride mole 
ratio of 0.81/1 or greater. The resins are also properly identified by 
CAS Reg. No. 114096-64-9 when produced with the use of greater than 2 
but not greater than 5 weight percent p-cumylphenol (CAS Reg. No. 599-
64-4), as an optional adjuvant substance in accordance with paragraph 
(b)(2) of this section.
 * * * * *
    (c) * * *
    (1) Specifications. Polyestercarbonate resins identified in 
paragraph (a) of this section can be identified by their characteristic 
infrared spectrum. The resins shall comply with either or both of the 
following specifications:
    (i) The solution intrinsic viscosity of the polyestercarbonate 
resins shall be a minimum of 0.44 deciliter per gram, as determined by 
a method entitled ``Intrinsic Viscosity (IV) of Lexan 
Polyestercarbonate Resin by a Single Point Method Using Dichloromethane 
as the Solvent,'' developed by the General Electric Co., September 20, 
1985, which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies are available from the Office of 
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
215), Food and Drug

[[Page 27179]]

Administration, 200 C St. SW., Washington, DC 20204, or may be examined 
at the Center for Food Safety and Applied Nutrition's Library, Food and 
Drug Administration, 200 C St. SW., rm. 3321, Washington, DC, or at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC; or
    (ii) A minimum weight-average molecular weight of 27,000, as 
determined by gel permeation chromatography using polystyrene 
standards.
 * * * * *

    Dated: May 10, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-12531 Filed 5-18-99; 8:45 am]
BILLING CODE 4160-01-F