Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Rules and Regulations 43075

Dated: July 10, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–21156 Filed 8-11-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 92F–0261]

Indirect Food Additives: Adhesives

and Components of Coatings

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 3-pentadecenyl phenol

mixture (obtained from cashew nutshell

liquid) reacted with formaldehyde and

ethylenediamine in a ratio of 1:2:2 as an

epoxy curing agent in resins and

coatings intended for contact with food.

This action is in response to a petition

filed by Cardolite Corp.

DATES: The regulation is effective

August 12, 1997. Submit written

objections and requests for a hearing by

september 11, 1997.

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:

Ellen M. Waldron, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3089.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 21, 1992 (57 FR 32226), FDA

announced that a food additive petition

(FAP 2B4326) had been filed by

Cardolite Corp., c/o 1414 Fenwick Lane,

Silver Spring, MD 20910 (now c/o

Regulatory Assistance Corp., 17

Clearview Circle, Hopewell Junction, NJ

12533). The petition proposed to amend

the food additive regulations in

§ 175.300 Resinous and polymeric

coatings (21 CFR 175.300) to provide for

the safe use of 3-pentadecenyl phenol

mixture (obtained from cashew nutshell

liquid) reacted with formaldehyde and

ethylenediamine in a ratio of 1:2:2 (CAS

Reg. No. 68413–28–5) as an epoxy

curing agent in resins and coatings

intended for contact with food.

FDA’s review of the subject petition

indicates that the additive may contain

trace amounts of formaldehyde and

ethylenediamine as impurities. The

potential carcinogenicity of

formaldehyde and ethylenediamine 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, concerning the Soffritti

study, ‘‘ * * * that the data 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 histopathologic

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.

The Committee also evaluated the

results of a 2-year study submitted by

the petitioner on ethylenediamine

dihydrochloride (EDA•2HCl) in Fisher

344 rats (Ref. 4). The committee

concluded that data from this study do

not demonstrate carcinogenic potential

for (EDA•2HCl) in Fisher 344 rats (Ref.

5). Based on the Committee’s

evaluation, the agency has determined

that based upon the available data and

information, there is no basis to

conclude that ethylenediamine is a

carcinogen.

FDA has evaluated data in the

petition and other relevant material. The

agency concludes that the proposed use

of the additive is safe, that the additive

will have its intended technical effect,

and therefore, that the regulations in

§ 175.300 should be amended as set

forth below.

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 § 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 September 11, 1997,

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
43076 Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Rules and Regulations

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Soffritti, M., C. Maltoni, F. Maffei, and

R. Biagi, ‘‘Formaldehyde: An Experimental

Multipotential Carcinogen,’’ Toxicology and

Industrial Health, vol. 5, No. 5, pp. 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.

4. Bushy Run Research Center,

‘‘Ethylenediamine Dihydrochloride TwoYear Feeding Study in the Rat; Report 46–

27,’’ Mellon Institute-Union Carbide Corp.,

Export, PA.

5. Memorandum of conference concerning

‘‘Ethylenediamine Dihydrochloride

(EDA•2HCl);’’ meeting of the Cancer

Assessment Committee, FDA; June 7, 1996.

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: 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) by

alphabetically adding a new entry to

read as follows:

§ 175.300 Resinous and polymeric

coatings.

* * * * *

(b) * * *

(3) * * *

(viii) * * *

(b) * * *

* * * * *

3-Pentadecenyl phenol mixture

(obtained from cashew nutshell liquid)

reacted with formaldehyde and

ethylenediamine in a ratio of 1:2:2 (CAS

Reg. No. 68413–28–5).

* * * * *

Dated: August 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–21292 Filed 8–11–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Minerals Management Service

30 CFR Parts 227, 228, and 229

RIN 1010–AC25

Delegation of Royalty Management

Functions to States

AGENCY: Minerals Management Service,

Interior.

ACTION: Final rulemaking.

SUMMARY: The Minerals Management

Service (MMS) is adding new rules

authorizing the delegation of several

Federal royalty management functions

to States. These rules implement

recently-enacted legislation.

EFFECTIVE DATE: September 11, 1997.

FOR FURTHER INFORMATION CONTACT:

David Guzy, Chief, Rules and

Publications Staff, Royalty Management

Program, Minerals Management Service,

telephone (303) 231–3432, Fax (303)

231–3385, e-Mail

DavidlGuzy@mms.gov.

SUPPLEMENTARY INFORMATION: The

principal authors of this final

rulemaking are Larry Cobb, Harry

Corley, Jim Detlefs, Clare Onstad, Robert

Prael, Todd McCutcheon, Dave Steiber,

Cecelia Williams, and Sam Wilson,

MMS; and Peter Schaumberg and Sarah

Inderbitzin of the Office of the Solicitor.

I. General

On August 13, 1996, Congress enacted

the Federal Oil and Gas Royalty

Simplification and Fairness Act of 1996,

Pub. L. 104–185, as corrected by Pub. L.

104–200 (RSFA). The RSFA amends

portions of the Federal Oil and Gas

Royalty Management Act of 1982

(FOGRMA), 30 U.S.C. 1701 et seq. Prior

to the RSFA enactment, section 205 of

FOGRMA, 30 U.S.C. 1735, provided for

the delegation of only audits,

inspections, and investigations to the

States. The RSFA amendments to

section 205 now provide that the

Minerals Management Service (MMS)

may delegate other Federal royalty

management functions to requesting

States for Federal oil and gas leases

onshore.

The royalty management functions

MMS may delegate under the RSFA

amendments are:

(1) Conducting audits and

investigations;

(2) Receiving and processing

production and royalty reports;

(3) Correcting erroneous report data;

(4) Performing automated verification;

and

(5) Issuing demands, subpoenas,

orders to perform restructured

accounting, and related tolling

agreements and notices to lessees or

their designees.

The RSFA amendments to section

205(d) also provide that within 12

months after the date of enactment, after

consultation with the States, the

Secretary must issue standards and

regulations pertaining to delegable

functions and other relevant

responsibilities, including:

(1) Audits to be performed;

(2) Records and accounts to be

maintained;

(3) Reporting procedures to be

required by the States under this

section;

(4) Receipt and processing of

production and royalty reports;

(5) Correction of erroneous report

data;

(6) Performance of automated

verification;

(7) Issuance of standards and

guidelines in order to avoid duplication

of effort;

(8) Transmission of report data to the

Secretary; and

(9) Issuance of demands, subpoenas,

and orders to perform restructured

accounting, for royalty accounting

purposes.

In response to the section 205 RSFA

amendments, MMS formed the 205

Consultation Team, comprised of MMS,

interested States, representatives from

State associations, and a representative

of the Bureau of Land Management to

discuss how to implement the

delegation provisions of the RSFA.

MMS proposed rules implementing

the section 205 RSFA amendments (62

FR 19967 April 24, 1997. As part of that

proposed rulemaking, MMS explained

that it would develop MMS Standards

for Delegation (Standards) which would

contain further information States

would need to perform delegated

functions. MMS held several outreach

meetings in June of 1997 at various

locations to discuss the MMS Standards

for Delegation (Standards) document

with States and industry attendees.

II. Indian Lands

In the proposed rule, MMS proposed

to amend 30 CFR parts 228 and 229 to

remove references to cooperative

agreements and delegations for Federal

lands under those parts since delegation

for Federal lands are now covered under

new part 227. MMS also proposed to

amend those parts to conform to the

principles of ‘‘Plain English.’’ Because

MMS is not under a statutory deadline

to publish parts 228 and 229 like it is

for part 227, MMS is not removing the

references to Federal lands in, or

making the ‘‘Plain English’’ changes to