[Federal Register Volume 65, Number 78 (Friday, April 21, 2000)]
[Rules and Regulations]
[Pages 21311-21312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 98F-0675]


Indirect Food Additives: Adhesives and Components of Coatings

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 
polyethylenepolyamines as cross-linking agents for epoxy resins in 
coatings intended for use in contact with food. This action responds to 
a petition filed by the Dow Chemical Co.

DATES: This rule is effective April 21, 2000; submit written objections 
and requests for a hearing by May 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: Hortense S. Macon, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3086.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 24, 1998 (63 FR 45073), FDA announced that a food 
additive petition (FAP 8B4606) had been filed by The Dow Chemical Co., 
2030 Dow Center, Midland, MI 48674. The petition proposed to amend the 
food additive regulations in Sec. 175.300 Resinous and polymeric 
coatings (21 CFR 175.300) to provide for the safe use of 
polyethylenepolyamines (PEPA's) as cross-linking agents for epoxy 
resins in coatings intended for use in contact with food.
    In its evaluation of the safety of PEPA's, 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 PEPA's have not been shown to cause cancer, they could contain 
minute amounts of unreacted starting material, ethylene dichloride 
(1,2-dichloroethane), a carcinogenic impurity. However, FDA concludes 
that 1, 2-dichloroethane is not likely to be present in the final food 
contact material in an amount that could present a safety concern for 
the

[[Page 21312]]

following reasons. Based on the low boiling point of 1,2-dichloroethane 
relative to PEPA's, residual 1,2-dichloroethane would be expected to be 
removed during any purification process of PEPA's. Any residual 1,2-
dichloroethane in PEPA's would also be expected to be removed on curing 
of epoxy resins with PEPA's. In addition, because epoxy resins cured 
with PEPA's will be allowed only for repeat-use applications, any 1,2-
dichloroethane that could be present in food would be minimized by 
evaporation and washing of the surface before food is added and by the 
large volume of food in contact with the cured resin over its service 
lifetime. Based on this information, the agency concludes that the 
proposed use of the additive is safe, and that the additive will 
achieve its intended technical effect. Therefore, the agency concludes 
that the regulations in Sec. 175.300 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.
    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 8B4606 (63 FR 
45073). No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.
    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.
    Any person who will be adversely affected by this regulation may at 
any time on or before May 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 Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 175

    Adhesives, 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 
175 is amended as follows:

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF 
COATINGS

    1. The authority citation for 21 CFR part 175 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.
    2. Section 175.300 is amended in paragraph (b)(3)(viii)(b) by 
alphabetically adding an entry to read as follows:


Sec. 175.300  Resinous and polymeric coatings.

* * * * *
    (b) * * *
    (3) * * *
    (viii) * * *
    (b) * * *
    Polyethylenepolyamine (CAS Reg. No. 68131-73-7), for use only in 
coatings intended for repeated use in contact with food, at 
temperatures not to exceed 180  deg.F (82  deg.C).
* * * * *

    Dated: April 14, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-9941 Filed 4-20-00; 8:45 am]
BILLING CODE 4160-01-F