Federal Register / Vol. 61, No. 99 / Tuesday, May 21, 1996 / Rules and Regulations 25395

* * * * *

Dated: May 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–12762 Filed 5–20–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 178

[Docket No. 93F–0385]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

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 formaldehyde, polymer

with 1-naphthylenol, as a release agent,

applied on the internal parts of reactors

employed in the production of

polyvinyl chloride and acrylic

copolymers intended for food-contact

applications. This action is in response

to a petition filed by Compagnia Italiana

di Ricerca e Sviluppo, srl (CIRS).

DATES: Effective May 21, 1996; written

objections and requests for a hearing by

June 20, 1996.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–216), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

November 18, 1993 (58 FR 60859), FDA

announced that a food additive petition

(FAP 3B4380) had been filed by

Compagnia Italiana di Ricerca e

Sviluppo, srl (CIRS),

c/o AAC Consulting Group, 1730 Rhode

Island Ave. NW., Washington, DC

20036. The petition proposed to amend

the food additive regulations in part 178

(21 CFR part 178) to provide for the safe

use of formaldehyde, polymer with 1-

naphthylenol, as an antiscaling agent,

applied on the internal parts of reactors

employed in the production of

polyvinyl chloride and acrylic

copolymers intended for food-contact

applications. During its review, the

agency determined that the use of the

additive as an antiscaling agent has

essentially the same technical effect as

that of a release agent. This final rule

reflects this conclusion and therefore

FDA is listing the additive in § 178.3860

Release agents.

FDA has evaluated data in the

petition and other relevant material. The

agency concludes that the proposed use

of the additive is safe and that the

regulations in § 178.3860 should be

amended as set forth below.

FDA’s review of the petition indicates

that the additive may contain trace

amounts of formaldehyde as an

impurity. The potential carcinogenicity

of formaldehyde was reviewed by the

Cancer Assessment Committee (the

Committee) of FDA’s Center for Food

Safety and Applied Nutrition. The

Committee noted that for many years,

formaldehyde has been known to be a

carcinogen by the inhalation route, but

it concluded that these inhalation

studies are not appropriate for assessing

the potential carcinogenicity of

formaldehyde in food. The Committee’s

conclusion was based on the fact that

the route of administration (inhalation)

is not relevant to the safety of

formaldehyde residues in food and the

fact that tumors were observed only

locally at the portal of entry (nasal

turbinates). In addition, the agency has

received literature reports of two

drinking water studies on

formaldehyde: (1) A preliminary report

of a carcinogenicity study purported to

be positive by Soffritti et al. (1989),

conducted in Bologna, Italy (Ref. 1); and

(2) a negative study by Til et al. (1989),

conducted in The Netherlands (Ref. 2).

The Committee reviewed both studies

and concluded that data concerning the

Soffritti study reported, ‘‘* * * were

unreliable and could not be used in the

assessment of the oral carcinogenicity of

formaldehyde’’ (Ref. 3). This conclusion

is based on a lack of critical details in

the study, questionable

histopathological conclusions, and the

use of unusual nomenclature to describe

the tumors. Based on the Committee’s

evaluation, the agency has determined

that there is no basis to conclude that

formaldehyde is a carcinogen when

ingested.

In accordance with § 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 June 20, 1996, 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.

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. Soffritti, M., F. Maltoni, and R. Biagi,

‘‘Formaldehyde: An Experimental

Multipotential Carcinogen,’’ Toxicology and

Industrial Health, vol. 5, No. 5:699–730,

1989.

2. Til, H. P., R. A. Woutersen, V. J. Feron,

V. H. M. Hollanders, H. E. Falke, and J. J.

Clary, ‘‘Two-Year Drinking Water Study of

Formaldehyde in Rats,’’ Food Chemical

Toxicology, vol. 27, No. 2, pp. 77–87, 1989.

3. Memorandum of conference concerning

‘‘formaldehyde;’’ meeting of the Cancer

Assessment Committee, FDA; April 24, 1991,

and March 4, 1993.
25396 Federal Register / Vol. 61, No. 99 / Tuesday, May 21, 1996 / Rules and Regulations

List of Subjects in 21 CFR Part 178

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 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 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 178.3860 is amended in the

table in paragraph (b) by alphabetically

adding a new entry under the headings

‘‘List of substances’’ and ‘‘Limitations’’

to read as follows:

§ 178.3860 Release agents.

* * * * *

(b) * * *

List of substances Limitations

* * * * * * *

Formaldehyde, polymer with 1-naphthylenol (CAS Reg. No. 25359–91–

5).

For use only as an antiscaling or release agent, applied on the internal

parts of reactors employed in the production of polyvinyl chloride

and acrylic copolymers, provided that the residual levels of the additive in the polymer do not exceed 4 parts per million.

* * * * * * *

Dated: May 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–12761 Filed 5–20–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Departmental Offices

31 CFR Part 12

Sale and Distribution of Tobacco

Products

AGENCY: Departmental Offices,

Department of the Treasury.

ACTION: Final rule.

SUMMARY: Section 636 of the Department

of the Treasury’s Appropriations Act,

Pub. L. 104–52, requires the Secretary of

the Treasury to promulgate regulations

that restrict the sale of tobacco products

in vending machines and the

distribution of free samples of tobacco

products in any Federal building under

the jurisdiction of the Secretary of the

Treasury. Section 636 permits the

Secretary to designate areas not subject

to these prohibitions, if such areas also

prohibit the presence of minors.

EFFECTIVE DATE: May 21, 1996.

FOR FURTHER INFORMATION CONTACT:

Robert T. Harper, (202) 622–0500.

SUPPLEMENTARY INFORMATION: The

Department of the Treasury has

determined that this rule is not a

significant regulatory action for the

purposes of Executive Order 12866.

Pursuant to 5 U.S.C. sec. 553(a)(2), this

rule is not required to be published for

notice and comment. Therefore, the

Regulatory Flexibility Act does not

apply.

List of Subjects in 31 CFR Part 12

Concessions, Federal buildings and

facilities, Vending machines.

For the reasons set forth in the

preamble, 31 CFR part 12 is added as

follows:

PART 12—RESTRICTION OF SALE

AND DISTRIBUTION OF TOBACCO

PRODUCTS

Sec.

12.1 Purpose.

12.2 Definitions.

12.3 Sale of tobacco products in vending

machines prohibited.

12.4 Distribution of free samples of tobacco

products prohibited.

12.5 Prohibitions not applicable in areas

designated by the Secretary of the

Treasury.

Authority: Sec. 636, Pub. L. 104–52, 109

Stat. 507.

§ 12.1 Purpose.

This part contains regulations

implementing the ‘‘Prohibition of

Cigarette Sales to Minors in Federal

Buildings Act,’’ Public Law 104–52,

Section 636, with respect to buildings

under the jurisdiction of the Department

of the Treasury.

§ 12.2 Definitions.

As used in this part—

(1) the term Federal building under

the jurisdiction of the Secretary of the

Treasury includes the real property on

which such building is located;

(2) the term minor means an

individual under the age of 18 years;

and

(3) the term tobacco product means

cigarettes, cigars, little cigars, pipe

tobacco, smokeless tobacco, snuff, and

chewing tobacco.

§ 12.3 Sale of tobacco products in vending

machines prohibited.

The sale of tobacco products in

vending machines located in or around

any Federal building under the

jurisdiction of the Secretary of the

Treasury is prohibited, except in areas

designated pursuant to § 12.5 of this

part.

§ 12.4 Distribution of free samples of

tobacco products prohibited.

The distribution of free samples of

tobacco products in or around any

Federal building under the jurisdiction

of the Secretary of the Treasury is

prohibited, except in areas designated

pursuant to § 12.5 of this part.

§ 12.5 Prohibitions not applicable in areas

designated by the Secretary of the

Treasury.

The prohibitions set forth in this part

shall not apply in areas designated by

the Secretary as exempt from the

prohibitions, but all designated areas

must prohibit the presence of minors.

George Mun ̃ oz,

Assistant Secretary for Management and

Chief Financial Officer.

[FR Doc. 96–12273 Filed 5–20–96; 8:45 am]

BILLING CODE 4810–25–P