[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Rules and Regulations]
[Pages 48645-48648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23244]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 88F-0303]


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 the following 
additives as components of coatings that contact food: meta-
xylylenediamine (1,3-benzenedimethanamine), para-xylylenediamine (1,4-
benzenedimethanamine), 3-diethylaminopropylamine, benzyl alcohol, 
salicylic acid, N-beta-(aminoethyl)-gamma-aminopropyltrimethoxysilane, 
and castor oil, hydrogenated polymer with ethylenediamine, 12-
hydroxyoctadecanoic acid, and sebacic acid. This action responds to a 
petition filed by Sigma Coatings.

DATES: Effective September 20, 1995;written objections and requests for 
a hearing by October 20, 1995.
ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.


[[Page 48646]]

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 November 17, 1988 (53 FR 46505), FDA announced that a food 
additive petition (FAP 8B4067) had been filed by Sigma Coatings, 
Harvey, LA 70059. The petition proposed that Sec. 175.300 Resinous and 
polymeric coatings (21 CFR 175.300) be amended to provide for the safe 
use of the following additives as components of coatings that contact 
food: 1,3-benzenedimethanamine, 1,4-benzenedimethanamine, 3-
diethylaminopropylamine, benzyl alcohol, salicylic acid, N-beta-
(aminoethyl)-gamma-aminopropyltrimethoxysilane, and castor oil, 
hydrogenated polymer with ethylenediamine, 12-hydroxyoctadecanoic acid, 
and sebacic acid.
    FDA has evaluated the data in the petition and other relevant 
material. The agency concludes that the proposed uses for the additives 
in resinous and polymeric coatings in contact with foods are safe and 
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 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.
    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.
    Any person who will be adversely affected by this regulation may at 
any time on or before October 20, 1995, 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 and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 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: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

    2. Section 175.300 is amended in paragraph (b)(3)(viii)(b) and in 
paragraph (b)(3)(xxxiii) by alphabetically adding the following new 
items to read as follows:


Sec. 175.300  Resinous and polymeric coatings.

 * * * * *
    (b) * * *
    (3) * * *
    (viii) * * *
    (b) Catalysts and cross-linking agents for epoxy resins:
 * * * * *
    N-Beta-(aminoethyl)-gamma-aminopropyltrimethoxysilane (CAS Reg. No. 
1760-24-3), for use only in coatings at a level not to exceed 1.3 
percent by weight of the resin when such coatings are intended for 
repeated use in contact with foods only of the types identified in 
paragraph (d) of this section, Table 1, under Types I, II, and III, 
under conditions of use C, D, E, or F as described in Table 2 of 
paragraph (d) of this section; or when such coatings are intended for 
repeated use in contact with foods of the types identified in paragraph 
(d) of this section, Table 1, under Types V, VI, VII, and VIII, under 
conditions of use E or F as described in Table 2 of paragraph (d) of 
this section. Use shall be limited to coatings for tanks of capacity 
greater than 530,000 gallons. 

[[Page 48647]]

    Benzyl alcohol (CAS Reg. No. 100-51-6), for use only in coatings at 
a level not to exceed 4 percent by weight of the resin when such 
coatings are intended for repeated use in contact with foods only of 
the types identified in paragraph (d) of this section, Table 1, under 
Types I, II, and III, under conditions of use C, D, E, or F as 
described in Table 2 of paragraph (d) of this section; or when such 
coatings are intended for repeated use in contact with foods of the 
types identified in paragraph (d) of this section, Table 1, under Types 
V, VI, VII, and VIII, under conditions of use E or F as described in 
Table 2 of paragraph (d) of this section. Use shall be limited to 
coatings for tanks of capacity greater than 530,000 gallons.
 * * * * *
    3-Diethylaminopropylamine (CAS Reg. No. 104-78-9), for use in 
coatings at a level not to exceed 6 percent by weight of the resin when 
such coatings are intended for repeated use in contact with foods only 
of the types identified in paragraph (d) of this section, Table 1, 
under Types I, II, and III, under conditions of use C, D, E, or F as 
described in Table 2 of paragraph (d) of this section; or when such 
coatings are intended for repeated use in contact with foods of the 
types identified in paragraph (d) of this section, Table 1, under Types 
V, VI, VII, and VIII, under conditions of use E or F as described in 
Table 2 of paragraph (d) of this section. Use shall be limited to 
coatings for tanks of capacity greater than 530,000 gallons.
 * * * * *
    Salicylic acid (CAS Reg. No. 69-72-7), for use only in coatings at 
a level not to exceed 0.35 percent by weight of the resin when such 
coatings are intended for repeated use in contact with foods only of 
the types identified in paragraph (d) of this section, Table 1, under 
Types I, II, and III, under conditions of use C, D, E, or F as 
described in Table 2 of paragraph (d) of this section; or when such 
coatings are intended for repeated use in contact with foods of the 
types identified in paragraph (d) of this section, Table 1, under Types 
V, VI, VII, and VIII, under conditions of use E or F as described in 
Table 2 of paragraph (d) of this section. Use shall be limited to 
coatings for tanks of capacity greater than 530,000 gallons.
 * * * * *
    Meta-Xylylenediamine (1,3-benzenedimethanamine, CAS Reg. No. 1477-
55-0), for use only in coatings at a level not to exceed 3 percent by 
weight of the resin when such coatings are intended for repeated use in 
contact with foods only of the types identified in paragraph (d) of 
this section, Table 1, under Types I, II, and III, under conditions of 
use C, D, E or F as described in Table 2 of paragraph (d) of this 
section; or when such coatings are intended for repeated use in contact 
with foods of the types identified in paragraph (d) of this section, 
Table 1, under Types V, VI, VII, and VIII, under conditions of use E or 
F as described in Table 2 of paragraph (d) of this section. Use shall 
be limited to coatings for tanks of capacity greater than 530,000 
gallons.
    Para-Xylylenediamine (1,4 benzenedimethanamine, CAS Reg. No. 539-
48-0), for use only in coatings at a level not to exceed 0.6 percent by 
weight of the resin when such coatings are intended for repeated use in 
contact with foods only of the types identified in paragraph (d) of 
this section, Table 1, under Types I, II, III, under conditions of use 
C, D, E, or F as described in Table 2 of paragraph (d) of this section; 
or when such coatings are intended for repeated use in contact with 
foods of the types identified in paragraph (d) of this section, Table 
1, under Types V, VI, VII, and VIII, under conditions of use E and F as 
described in Table 2 of paragraph (d) of this section. Use shall be 
limited to coatings for tanks of capacity greater than 530,000 gallons.
* * * * *




[[Page 48648]]

    (xxxiii) * * *
 * * * * *
    Castor oil, hydrogenated polymer with ethylenediamine, 12-
hydroxyoctadecanoic acid and sebacic acid (CAS Reg. No. 68604-06-8). 
The condensation product formed by the reaction of hydrogenated castor 
oil with polyamide derived from ethylenediamine, sebacic acid and 12-
hydroxystearic acid, for use only in coatings at a level not to exceed 
3.2 percent by weight of the resin when such coatings are intended for 
repeated use in contact with foods only of the types identified in 
paragraph (d) of this section, Table 1, under Types I, II, and III, 
under conditions of use C, D, E, or F as described in Table 2 of 
paragraph (d) of this section; or when such coatings are intended for 
repeated use in contact with foods of the types identified in paragraph 
(d) of this section, Table 1, under Types V, VI, VII, and VIII, under 
conditions of use E or F as described in Table 2 of paragraph (d) of 
this section. Use shall be limited to coatings for tanks of capacity 
greater than 530,000 gallons.
* * * * *

    Dated: September 6, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-23244 Filed 9-19-95; 8:45 am]
BILLING CODE 4160-01-F