[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