Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Rules and Regulations 2111

4D02A ‘‘Software’’ specially

designed or modified to support

‘‘technology’’ controlled by 4E01 or

4E02.

Requirements

Validated License Required:

QSTVWYZ.

Unit: $ value.

Reason For Control: NS, MT, NP, FP

(see Notes).

GTDR: Yes, except MT, FP, and for

‘‘software’’ for computers that require a

validated license, see Notes.

GTDU: No.

Notes: 1. MT controls apply to ‘‘software’’

specially designed or modified to support

technology for the ‘‘development,’’

‘‘production’’ or ‘‘use’’ of equipment

controlled for MT by 4A01, 4A02 and 4A03.

2. FP and NP controls apply to all

destinations, except:

a. Countries listed in § 776.10(d) of this

subchapter (Computer Tier 1),

b. Countries listed in § 776.10(e) of this

subchapter (Computer Tier 2), for

—software— for computers with a CTP equal

to or less than 10,000 MTOPS; and

c. Countries listed in § 776.10(f) of this

subchapter (Computer Tier 3), for computers

with a CTP equal to or less than 2,000

MTOPS to all end-users/uses or a CTP equal

to or less than 7,000 MTOPS to end-users/

uses that are not military end-users and enduses and are not nuclear, chemical,

biological, and missile end-users and enduses defined in part 778 of this subchapter.

3. FP controls apply to all destinations

except Australia, Japan, New Zealand and

members of NATO, for ‘‘software’’ specially

designed or modified for the ‘‘development’’,

‘‘production’’, or ‘‘use’’ of computers for

computerized fingerprint equipment.

4D94F ‘‘Software’’ specially designed

for the ‘‘development’’, ‘‘production’’,

or ‘‘use’’ of ‘‘digital computers’’,

‘‘assemblies’’ and related equipment

therefor controlled by 4A94F.

Requirements

Validated License Required: SZ, Iran,

Sudan, Syria.

Unit: $ value.

Reason For Control: FP.

GTDR: No.

GTDU: No.

4E01A Technology, according the

General Technology Note, for the

‘‘development’’, ‘‘production’’ or ‘‘use’’

of equipment controlled by 4A01, 4A02,

4A03, or 4A04, or ‘‘software’’

controlled by 4D01, 4D02, or 4D03.

Requirements

Validated License Required:

QSTVWYZ.

Reason for Control: NS, MT, NP, FP

(see Notes).

GTDR: Yes, except MT, FP, and

‘‘technology’’ required for computers

with a CTP greater than 2,000 MTOPs.

GTDU: No.

Notes: 1. MT controls apply to certain

items controlled by 4A01, 4A02, 4A03, 4D01,

or 4D02. See Reason for Control paragraphs

in these entries to determine which items are

subject to MT controls.

2. FP and NP controls apply to all

destinations.

3. FP controls apply, for all destinations

except Australia, Japan, New Zealand, and

members of NATO, to technology for the

‘‘development’’, ‘‘production’’, or ‘‘use’’ of

computers controlled by 4A03 for

computerized fingerprint equipment.

4E94F Technology for the

‘‘development’’, ‘‘production’’, or ‘‘use’’

of ‘‘digital computers’’, ‘‘assemblies’’

and related equipment therefor

controlled by 4A94F.

Requirements

Validated License Required: SZ, Iran,

Sudan, and Syria.

Reason for Control: FP.

GTDR: No.

GTDU: No.

Dated: January 4, 1996.

Sue E. Eckert,

Assistant Secretary for Export

Administration.

[FR Doc. 96–293 Filed 1–22–96; 2:52 pm]

BILLING CODE 3510–DT–P

TENNESSEE VALLEY AUTHORITY

18 CFR Part 1301

Privacy Act Regulations;

Implementation

AGENCY: Tennessee Valley Authority.

ACTION: Final rule.

SUMMARY: The Tennessee Valley

Authority (TVA) is amending its

regulations implementing the Privacy

Act of 1974 (the Act), 5 U.S.C. 552a. The

amendment modifies existing TVA

regulations (18 CFR 1301.24) exempting

the system of records known as OIG

Investigative Records—TVA (TVA–31)

from certain provisions of the Act and

corresponding agency regulations.

EFFECTIVE DATE: January 25, 1996.

FOR FURTHER INFORMATION CONTACT:

Wilma H. McCauley, TVA, 1101 Market

St. (CST 13B), Chattanooga, TN 37402–

2801, telephone number: (423) 751–

2523.

SUPPLEMENTARY INFORMATION: On

October 28, 1993, (58 FR 57972–57974)

TVA gave notice as required by the

Privacy Act of its intention to amend the

system of records known as OIG

Investigative Records—TVA (TVA–31)

from certain provisions of the Act and

corresponding agency regulations. No

comments were received. TVA is

therefore updating its regulations at 18

CFR part 1301 to reflect this

amendment.

List of Subjects in 18 CFR Part 1301

Administrative practice and

procedure, Freedom of Information,

Privacy Act, Sunshine Act.

For the reasons set forth in the

preamble, TVA is amending 18 CFR,

chapter XIII, part 1301, as follows:

PART 1301—PROCEDURES

1. The authority citation for part 1301

continues to read as follows:

Authority: 16 U.S.C. 831–831dd, 5 U.S.C.

552a.

2. Section 1301.24(d) is revised to

read as follows:

§ 1301.24 Specific exemptions.

* * * * *

(d) The TVA system OIG Investigative

Records is exempt from subsections

(c)(3), (d), (e)(1), (e)(4), (G), (H), and (I)

and (f) of 5 U.S.C. 552a (section 3 of the

Privacy Act) and corresponding sections

of these rules pursuant to 5 U.S.C.

552a(k)(2). The TVA system OIG

Investigative Records is exempt from

subsections (c)(3), (d), (e)(1), (e)(2),

(e)(3), (e)(4)(G), (H), and (I), (e)(5), (e)(8),

and (g) pursuant to 5 U.S.C. 552a(j)(2).

This system is exempt because

application of these provisions might

alert investigation subjects to the

existence or scope of investigations,

lead to suppression, alteration,

fabrication, or destruction of evidence,

disclose investigative techniques or

procedures, reduce the cooperativeness

or safety of witnesses, or otherwise

impair investigations.

* * * * *

William S. Moore,

Senior Manager, Administrative Services.

[FR Doc. 96–1191 Filed 1–24–96; 8:45 am]

BILLING CODE 8120–08–W

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 94F–0381]

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
2112 Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Rules and Regulations

food additive regulations to provide for

the safe use of glyceryl

polyoxypropylene triol;α,α′,α′′-1,2,3-

propanetriyltris[ωhydroxypoly(oxypropylene)], minimum

average molecular weight 250, as a

reactant in the preparation of polyester

and polyurethane resins used as

components of adhesives for foodcontact articles. This action is in

response to a petition filed by the Dow

Chemical Co.

DATES: Effective January 25, 1996;

written objections and requests for a

hearing by February 26, 1996.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

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 23, 1994 (59 FR 60363), FDA

announced that a food additive petition

(FAP 4B4435) had been filed by the

Dow Chemical Co., 1803 Bldg.,

Midland, MI 48674–1803. The petition

proposed to amend the food additive

regulations in § 175.105 Adhesives (21

CFR 175.105) to provide for the safe use

of glyceryl polyoxypropylene

triol;α,α′,α′′-1,2,3-propanetriyltris[ωhydroxypoly(oxypropylene)], minimum

average molecular weight 250, as a

reactant in the preparation of polyester

and polyurethane resins used as

components of adhesives for foodcontact articles.

The chemical, glyceryl

polyoxypropylene triol;α,α′,α′′-1,2,3-

propanetriyltris[ωhydroxypoly(oxypropylene)] is

currently listed in 21 CFR 175.105

under the synonym, glyceryl

polyoxypropylene triol. Therefore, for

consistency, the subject additive is

being listed by its synonym in this final

rule.

In its evaluation of the safety of this

additive, 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 the

additive itself has not been shown to

cause cancer, it has been found to

contain minute amounts of unreacted

propylene oxide, a carcinogenic

impurity, resulting from the

manufacture of the additive. Residual

amounts of reactants and manufacturing

aids, such as propylene oxide, are

commonly found as contaminants in

chemical products, including food

additives.

I. Determination of Safety

Under section 409(c)(3)(A) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 348(c)(3)(A), the socalled ‘‘general safety clause’’ of the

statute, a food additive cannot be

approved for a particular use unless a

fair evaluation of the data available to

FDA establishes that the additive is safe

for that use. FDA’s food additive

regulations (21 CFR 170.3(i)) define safe

as ‘‘a reasonable certainty in the minds

of competent scientists that the

substance is not harmful under the

intended conditions of use.’’

The food additives anticancer or

Delaney clause (section 409(c)(3)(A) of

the act) further provides that no food

additive shall be deemed safe if it is

found to induce cancer when ingested

by man or animal. Importantly,

however, the Delaney clause applies to

the additive itself and not to the

impurities in the additive. That is,

where an additive itself has not been

shown to cause cancer, but contains a

carcinogenic impurity, the additive is

properly evaluated under the general

safety clause using risk assessment

procedures to determine whether there

is a reasonable certainty that no harm

will result from the proposed use of the

additive, Scott v. FDA, 728 F.2d 322

(6th Cir. 1984).

II. Safety of Petitioned Use of the

Additive

FDA estimates that the petitioned use

of the additive, glyceryl

polyoxypropylene triol (also known as

glyceryl polyoxypropylene triol;α,α′,α′′-

1,2,3-propanetriyltris[ωhydroxypoly(oxypropylene)], minimum

average molecular weight 250, will

result in exposure to the additive of no

greater than 7 parts per billion in the

daily diet (Ref. 1).

FDA does not ordinarily consider

chronic toxicological testing to be

necessary to determine the safety of an

additive whose use will result in such

low exposure levels (Ref. 2), and the

agency has not required such testing

here. However, the agency has reviewed

the available toxicological data from

acute toxicity studies on the additive.

No adverse effects were reported in

these studies.

FDA has evaluated the safety of this

additive under the general safety clause,

considering all available data and using

risk assessment procedures to estimate

the upper-bound limit of risk presented

by the carcinogenic chemical that may

be present as an impurity in the

additive, propylene oxide. This risk

evaluation of propylene oxide has two

aspects: (1) Assessment of the worstcase exposure to the impurity from the

proposed use of the additive; and (2)

extrapolation of the risk observed in the

animal bioassays to the conditions of

probable exposure to humans.

A. Propylene Oxide

FDA has estimated the hypothetical

worst-case exposure to propylene oxide

from the petitioned use of the additive

in the manufacture of adhesives to be 7

parts per quadrillion of the daily diet or

21 picogram (pg)/person/day (Ref. 1).

The agency used data from a

carcinogenesis bioassay on propylene

oxide, conducted for the Institute of

Hygiene, University of Mainz, Germany,

to estimate the upper-bound lifetime

human risk from exposure to this

chemical stemming from the proposed

use of the additive (Ref. 3). The results

of the bioassay on propylene oxide

demonstrated that the material was

carcinogenic for female rats under the

conditions of the study. The test

material caused carcinomas and

papillomas in the squamous epithelium

of the forestomach.

Based on the estimated worst-case

exposure of 21 pg/person/day, FDA

estimates that the upper-bound limit of

individual lifetime risk arising from

likely exposure to propylene oxide

resulting from the use of the subject

additive is in the range of 3.2 × 10-12 (or

3.2 in 1 trillion) to 1.5 × 10-11 (or 1.5 in

100 billion) (Ref. 4). The range in FDA’s

estimate results from the agency’s

evaluation of complex tumor data in an

oral toxicity study using rats. Because of

the numerous conservative assumptions

used in calculating the exposure

estimate, the actual lifetime averaged

individual exposure to propylene oxide

is expected to be substantially less than

the worst-case exposure, and therefore,

the calculated upper-bound limit of risk

would be less. Thus, the agency

concludes that there is a reasonable

certainty that no harm from exposure to

propylene oxide would result from the

proposed use of the additive.

B. Need for Specifications

The agency has also considered

whether specification are necessary to

control the amount of propylene oxide

as an impurity in the additive. The

agency finds that specifications are not

necessary for the following reasons: (1)

Because of the low level at which

propylene oxide may be expected to

remain as an impurity following

production of the additive, the agency

would not expect the impurity to

become a component of food at other

than extremely small levels; and (2) the
Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Rules and Regulations 2113

upper-bound limits of lifetime risk from

exposure to the impurity, even under

worst-case assumptions, is very low, in

the range of less than 3.2 in 1 trillion to

1.5 in 100 billion.

III. Conclusion

FDA has evaluated data in the

petition and other relevant material and

concludes that the proposed use of the

additive in adhesives is safe. Based on

this information, the agency has also

concluded that the additive will have

the intended technical effect. Therefore,

§ 175.105 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 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.

IV. Environmental Impact

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.

V. 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. Memorandum from the Chemistry

Review Branch (HFS–247), Center for Food

Safety and Applied Nutrition (CFSAN), FDA,

to the Indirect Additives Branch (HFS–216),

CFSAN, FDA, concerning FAP 4B4435—Dow

Chemical Co.—exposure to the food additive

and its component, propylene oxide, dated

March 1, 1995.

2. Kokoski, C. J., ‘‘Regulatory Food

Additive Toxicology,’’ in Chemical Safety

Regulation and Compliance, edited by F.

Homburger and J. K. Marquis, S. Karger, New

York, NY, pp. 24–33, 1985.

3. Dunkelberg, H., ‘‘Carcinogenicity of

Ethylene Oxide and 1,2-Propylene Oxide

Upon Intragastric Administration to Rats,’’

British Journal of Cancer, 46: 924, 1982.

4. Memorandum, ‘‘Report of the

Quantitative Risk Assessment Committee,’’

CFSAN, FDA, dated April 20, 1995.

VI. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before February 26, 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.

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 175.105 is amended in

paragraph (c)(5) in the table by

alphabetically adding a new entry under

the headings ‘‘Substances’’ and

‘‘Limitations’’ to read as follows:

§ 175.105 Adhesives.

* * * * *

(c) * * *

(5) * * *

Substances Limitations

* * * * * * *

Glycerol polyoxypropylene triol, minimum average

molecular weight 250 (CAS Reg. No. 25791–96–2).

For use only in the preparation of polyester and polyurethane resins in adhesives.

* * * * * * *

Dated: January 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–1143 Filed 1–24–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 178

[Docket No. 93F–0243]

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 4,5,6,7-tetrachloro-2-[2-

(4,5,6,7-tetrachloro-2,3-dihydro-1,3-

dioxo-1H-inden-2-yl)-8-quinolinyl]-1Hisoindole-1,3(2H)-dione (C. I. Pigment

Yellow 138), as a colorant for all foodcontact polymers. This action is in

response to a petition filed by BASF

Corp.