Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations 12669

§ 1262.307 Decision.

(a) The adjudicative officer shall issue

an initial decision on the application

with 90 calendar days after completion

of proceedings on the application. The

decision shall include written findings

and conclusions on such of the

following as are relevant to the decision:

* * * * *

§ 1262.309 [Amended]

6. In section 1262.309, last sentence,

the word ‘‘amont’’ is revised to read

‘‘amount’’.

Dated: March 3, 1995.

Daniel S. Goldin,

Administrator.

[FR Doc. 95–5669 Filed 3–7–95; 8:45 am]

BILLING CODE 7510–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket Nos. 89F–0011 and 93F–0384]

Irradiation in the Production,

Processing, and Handling of Food

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 sources of radiation to

irradiate frozen, packaged meats for use

in the National Aeronautics and Space

Administration (NASA) space flight

programs. FDA is also amending the

food additive regulations to permit the

use of packaging materials that are not

otherwise listed in the regulations

regarding food irradiation in the

irradiation of frozen, packaged meats for

use in the NASA space flight programs.

This action is in response to two

petitions filed by NASA.

DATES: Effective March 8, 1995; written

objections and requests for a hearing by

April 7, 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.

FOR FURTHER INFORMATION CONTACT:

Patricia A. Hansen, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

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

202–418–3098.

SUPPLEMENTARY INFORMATION:

I. Introduction

In a notice published in the Federal

Register of February 6, 1989 (54 FR

5679), FDA announced that a food

additive petition (FAP 9M4125) had

been filed by NASA, Washington, DC

20546, proposing that the food additive

regulations be amended to provide for

the safe use of sources of radiation to

process beefsteaks for use in space flight

programs.

In a tentative final rule published in

the Federal Register of December 8,

1993 (58 FR 64526), FDA announced its

tentative decision to amend the food

additive regulations to provide for the

safe use of sources of radiation to

irradiate frozen, packaged beefsteak for

use in NASA’s space flight programs.

FDA also announced its tentative final

decision to amend the food additive

regulations to permit the use of

packaging materials that are not listed in

the regulations regarding food

irradiation in the irradiation of frozen,

packaged beefsteak for use in the NASA

space flight programs. The agency

published a tentative final rule before

proceeding to final action because it was

including provisions regarding the

packaging materials to be used with the

beefsteaks that it had not announced in

the notice of filing for the petition (FAP

9M4125). Interested persons were given

the opportunity to comment on FDA’s

tentative decision. FDA did not receive

any comments in response to this

tentative final rule.

In the meantime, in a notice

published in the Federal Register of

November 19, 1993 (58 FR 61093), FDA

announced that a food additive petition

(FAP 3M4394) had been filed by NASA,

Lyndon B. Johnson Space Center,

Houston, TX 77058, proposing that the

food additive regulations be amended to

provide for the safe use of sources of

radiation to process certain prepackaged

meats for use in NASA space flight

programs and to permit the use of

packaging materials that are not listed in

the regulations regarding food

irradiation in the irradiation of the

meats for use in NASA space flight

programs. Interested persons were given

the opportunity to comment on the

environmental assessment submitted in

the petition. No comments were

received.

The amendment to the food additive

regulations proposed in FAP 9M4125 is

encompassed by that proposed in FAP

3M4394. This rule is the agency’s final

decision with respect to both FAP

3M4394 and FAP 9M4125.

II. Evaluation of Safety

In assessing the safety of food

additives, including the use of

irradiation in the processing of food, the

agency usually considers the effects of

lifetime daily exposure to the additive.

The requested use, however, is limited

to NASA’s space flight programs. The

amount of irradiated meat that could be

consumed by individuals in the

programs would constitute an extremely

small fraction of their diets when

considered over a lifetime. Because of

this factor, questions regarding acute

hazards, including those resulting from

pathogenic organisms that could be

present in the food, are more significant

in evaluating this petitioned use of a

source of radiation than they would

ordinarily be in deciding whether to list

a food additive. The petitions have

requested that FDA authorize the use of

irradiation processing only under

conditions that ensure the microbial

sterility of the product and the integrity

of the product packaging. NASA has

stated that it will ensure these qualities

of sterility and packaging integrity by

requiring adherence to an irradiation

processing protocol (scheduled process)

that it submitted with both petitions

(Ref. 1). NASA’s protocol specifies a

minimum dose of 44 kiloGrays (kGy) in

order to ensure sterility of the treated

meat (Ref. 1).

Having evaluated the data in the

petitions and other relevant material in

its files, the agency finds that radiationsterilized meats will be at least as

nutritious as those sterilized by

conventional means. FDA also finds that

the total amount of radiolytic products

that are produced in the meats during

irradiation processing, and that will be

consumed by individuals in the space

flight programs, will be too small to be

of any toxicological significance.

Likewise, FDA finds that the total

amount of radiolytic products that could

be formed in the packaging materials

during irradiation processing, and then

migrate to the food and subsequently be

consumed by individuals in the space

flight programs, is too small to be of any

toxicological significance (Refs. 2 and

3).

Section 179.25(c) (21 CFR 179.25(c))

restricts packaging materials used in the

irradiation of prepackaged foods to

those materials listed in § 179.45 (21

CFR 179.45), namely, those that have

been demonstrated to be safe for use

during irradiation of prepackaged foods,

assuming that those foods would be

consumed daily over a lifetime. The

agency finds that this restriction is

unnecessary for packaging that is to be

used only in space flight programs. The
12670 Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations

final regulation set forth below,

therefore, exempts this packaging from

the requirement in § 179.25(c) that

packaging materials be restricted to

those listed in § 179.45, provided that

FDA has listed the packaging as safe for

holding food in the applicable

regulations ((parts 174 through 186) (21

CFR parts 174 through 186)).

III. Conclusions

The agency finds that meats irradiated

at a minimum dose of 44 kGy and

handled in accordance with the

provisions of § 179.25(d) will meet

current standards for commercial

sterility and nutritional adequacy. The

protocol submitted by NASA (Ref. 1) in

its petitions is a scheduled process that

satisfies the requirements of § 179.25(d)

because, among other things, it sets

forth procedures that will ensure that

the minimum dose will be delivered.

The agency concludes, therefore, that

the proposed use of sources of radiation

is safe, and that § 179.26 of the

regulations should be amended as set

forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petitions and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petitions 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. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before April 7, 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.

VI. 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. U.S. Army Natick RD & E Center, ‘‘Space

Food Prototype, Production Guide No. 60–

C,’’ April 13, 1993.

2. Memorandum from M. DiNovi,

Chemistry Review Branch, CFSAN, FDA, to

P. Hansen, Biotechnology Policy Branch,

CFSAN, FDA, dated April 29, 1994.

3. Memorandum from H. Irausquin,

Division of Health Effects Evaluation,

CFSAN, FDA, to P. Hansen, Biotechnology

Policy Branch, CFSAN, FDA, dated

November 9, 1994.

List of Subjects in 21 CFR Part 179

Food additives, Food labeling, Food

packaging, Radiation protection,

Reporting and recordkeeping

requirements, Signs and symbols.

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 179 is

amended as follows:

PART 179—IRRADIATION IN THE

PRODUCTION, PROCESSING AND

HANDLING OF FOOD

1. The authority citation for 21 CFR

part 179 continues to read as follows:

Authority: Secs. 201, 402, 403, 409, 703,

704 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 342, 343, 348, 373, 374).

2. Section 179.26 is amended in the

table in paragraph (b) by adding a new

entry ‘‘7.’’ under the headings ‘‘Use’’

and ‘‘Limitations’’ to read as follows:

§ 179.26 Ionizing radiation for the

treatment of food.

* * * * *

(b) * * *

Use Limitations

* * * * *

7. For the sterilization of

frozen, packaged

meats used solely in

the National Aeronautics and Space Administration space

flight programs.

Minimum dose 44

kGy (4.4 Mrad).

Packaging materials used

need not comply

with § 179.25(c)

provided that

their use is otherwise permitted

by applicable

regulations in

parts 174

through 186 of

this chapter.

* * * * *

Dated: February 26, 1995.

Janice F. Oliver,

Deputy Director for Systems and Support,

Center for Food Safety and Applied Nutrition.

[FR Doc. 95–5672 Filed 3–7–95; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 9 and 63

[AD–FRL–5165–3]

RIN 2060–AD97

National Emission Standards for

Hazardous Air Pollutants Final

Standards for Epoxy Resins

Production and Non-Nylon Polyamides

Production

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This action promulgates final

standards that limit emissions of

hazardous air pollutants (HAP) from

existing and new epoxy resins and nonnylon polyamides production

operations that are located at major

sources. The EPA is in the process of

developing standards for a wide range of

types of polymer and resin production

facilities. The polymers and resins

covered by this rule use

epichlorohydrin as a feedstock. This

rulemaking would affect epoxy resin

manufacturers that produce basic liquid

epoxy resin, which is often used to

produce a cured resin with desired