Federal Register / Vol. 65, No. 210 / Monday, October 30, 2000 / Rules and Regulations 64605

in § 172.841 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.

On June 1, 1998, the President

directed all Federal agencies to use

‘‘plain language’’ in all new documents.

In compliance with this directive, FDA

has drafted its amendment to § 172.841

using the principles of ‘‘plain language’’

set forth by the President. In amending

the regulation, the agency is also making

an editorial change by alphabetizing the

list of regulated uses of polydextrose.

III. Environmental Impact

In the notice of filing, FDA gave

interested parties an opportunity to

submit comments on the petitioner’s

environmental assessment. The agency

received no comments in response to

that notice.

The agency has carefully considered

the potential environmental effects of

this rule. 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.

IV. Paperwork Reduction Act of 1995

This final rule contains no collection

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

V. Objections

Any person who will be adversely

affected by this regulation may at any

time file with the Dockets Management

Branch (address above) written

objections by November 29, 2000. 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

are to be submitted and are to 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. Reference

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 dated December 2, 1992,

from the Division of Product Manufacture

and Use to the Division of Petition Control,

‘‘FAP 2A4332: Pfizer, Inc., Polydextrose in

Tablespreads, Technologically Self-limiting

Level, Submission of 11–12–92.’’

2. Memorandum dated September 30,

1992, from the Division of Product

Manufacture and Use to the Division of

Petition Control, ‘‘FAP 2A4332 (MATS #658):

Pfizer, Inc., Polydextrose as a Bulking Agent/

Texturizer in Tablespreads, Submission of 6–

22–92.’’

List of Subjects in 21 CFR Part 172

Food additives, Reporting and

recordkeeping requirements.

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 172 is

amended as follows:

PART 172—FOOD ADDITIVES

PERMITTED FOR DIRECT ADDITION

TO FOOD FOR HUMAN

CONSUMPTION

1. The authority citation for 21 CFR

part 172 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 348,

371, 379e.

2. Section 172.841 is amended by

revising paragraph (c) to read as follows:

§ 172.841 Polydextrose.

* * * * *

(c) Polydextrose is used in accordance

with current good manufacturing

practice as a bulking agent, formulation

aid, humectant, and texturizer in the

following foods when standards of

identity established under section 401

of the act do not preclude such use:

(1) Baked goods and baking mixes

(restricted to fruit, custard, and

pudding-filled pies; cakes; cookies; and

similar baked products);

(2) Chewing gum;

(3) Confections and frostings;

dressings for salads;

(4) Film coatings on single and

multiple vitamin and mineral

supplement tablets;

(5) Frozen dairy desserts and mixes;

(6) Fruit spreads;

(7) Gelatins, puddings and fillings;

(8) Hard and soft candy;

(9) Peanut spread;

(10) Sweet sauces, toppings, and

syrups; and

(11) Tablespreads.

* * * * *

Dated: October 20, 2000.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 00–27734 Filed 10–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 99F–673]

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 ionizing radiation to

control microbial pathogens in seeds for

sprouting. This action is in response to

a petition filed by Caudill Seed Co., Inc.

DATES: This regulation is effective

October 30, 2000. Submit written

objections and requests for a hearing by

November 29, 2000.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Lane A. Highbarger, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

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

202–418–3032.

64606 Federal Register / Vol. 65, No. 210 / Monday, October 30, 2000 / Rules and Regulations

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal

Register of August 16, 1999 (64 FR

44530), FDA announced that a food

additive petition (FAP 9M4673) had

been filed by Caudill Seed Co., Inc.,

1402 West Main St., Louisville, KY

40203. The petitioner proposed that the

food additive regulations in part 179

Irradiation in the Production, Processing

and Handling of Food (21 CFR part 179)

be amended to provide for the safe use

of sources of ionizing radiation to

control microbial pathogens in alfalfa

and other sprouting seeds.

II. Safety Evaluation

Under section 201(s) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

321(s)), a source of radiation used to

treat food is defined as a food additive.

The additive is not, literally, added to

food. Instead, a source of radiation is

used to process or treat food such that,

analogous to other food processes, its

use can affect the characteristics of the

food. In the subject petition, the

intended technical effect is a change in

the microbial load of the food,

specifically, a reduction in the number

of microbial pathogens in or on seeds

for sprouting.

The petitioner submitted published

articles and other study reports

containing data and information related

to seeds for sprouting and other kinds

of food in the areas of radiation

chemistry, nutrition, toxicology, and

microbiology. FDA has fully considered

the data and studies submitted in the

petition as well as other information in

its files relevant to the safety and

nutritional adequacy of seeds treated

with ionizing radiation prior to

sprouting.

The effects of ionizing radiation on

the characteristics of treated foods are a

direct result of the chemical reactions

induced by the absorbed radiation.

Scientists have compiled a large body of

data regarding the effects of ionizing

radiation on different foods under

various conditions of irradiation.

Research has established that the types

and amounts of products generated by

radiation-induced chemical reactions

(‘‘radiolysis products’’) depend on the

chemical constituents of the food and

on the conditions of irradiation.

Furthermore, the principles of radiation

chemistry govern the extent of changes,

if any, both in the nutrient levels and in

the microbial load of irradiated foods.

Key factors include the specific nutrient

or microorganism of interest, the food,

and the conditions of irradiation. See

the agency’s final rule permitting the

irradiation of meat for FDA’s discussion

of radiation chemistry, nutrition,

toxicology, and microbiology related to

irradiation of foods under various

conditions of use (62 FR 64107,

December 3, 1997).

FDA has reviewed the relevant data

and information submitted in the

petition regarding radiation chemistry

as it applies to seeds for sprouting, as

well as data readily available and in the

agency’s files. FDA has concluded that

the concentrations and types of

radiolysis products formed by the

irradiation of seeds for sprouting will be

comparable to those products produced

by the irradiation of foods of similar

composition (Ref. 1). Most of these

radiolysis products are formed in very

small amounts and are either the same

as, or structurally similar to, compounds

found in foods that have not been

irradiated. Thus, the chemical

composition of sprouts grown from

irradiated seeds will not differ in any

significant manner from sprouts grown

from seeds that have not been

irradiated.

This petition contained no toxicity

studies on the sprouts grown from

irradiated seeds. Nonetheless, a review

of the agency’s data base and submitted

published references of toxicological

studies related to irradiated foods,

combined with the fact that only

negligible amounts of radiolysis

products are expected to be present in

the sprouts that are grown from

irradiated seeds for sprouting, show that

the estimated exposure of an individual

to these radiolytic products will be

negligible. Therefore, FDA has

determined that no toxicity concerns are

raised from the petitioned use of

irradiation on seeds for sprouting (Ref.

2).

The purported technical effect of

irradiating seeds for sprouting is to

control the level of microbial pathogens.

FDA evaluated data on the relation

between various doses of radiation and

the reduction of detectable levels of

coliforms generally, and Escherichia

coli 0157:H7 and Salmonella serotype

Stanley specifically. The petitioner

found that, depending on the pathogen

and other factors, between 3 and 5

KiloGray (kGy) of irradiation would

reduce the amount of pathogens to

below detectable levels (Ref. 3). To

accommodate the uncertainty of

irradiation treatment and dose variation

due to absorption by the target, the

petitioner requested a maximum

irradiation dose of 8 kGy. The agency

has determined that irradiation of seeds

for sprouting at levels up to 8 kGy will

have the desired effect of controlling the

levels of microbial pathogens on seeds

for sprouting (Ref. 3).

Regarding the nutritional aspects of

irradiating seeds for sprouting, it is well

documented that protein, fat, and

minerals are not significantly altered by

irradiation within the given dose range

requested in this petition (Ref. 2). The

petitioner evaluated the potential loss of

vitamins from irradiation of seeds for

sprouting. Although there was a great

deal of variability in vitamin levels of

the seeds tested (e.g., in studies

submitted by the petitioner, vitamin A

content of sprouts grown from control

seeds was actually lower than that for

sprouts grown from irradiated seeds),

researchers did not observe any

significant losses of any of the vitamins

in the resultant sprouts (up to 6 kGy)

when compared to nonirradiated

controls. Any loss of vitamins, even if

it occurs, is expected to be

inconsequential when compared to total

dietary nutrient consumption (Ref. 2).

FDA therefore concludes, based on all

the evidence before it, that irradiation of

seeds for sprouting under the conditions

set forth in the regulation below will not

have an adverse impact on the

nutritional adequacy of a person’s diet.

III. Labeling

FDA has also considered whether

irradiated seeds for sprouting and

sprouts grown from such seeds must

bear special labeling. In particular, FDA

evaluated the application of § 179.26(c)

(21 CFR 179.26(c)) to these products.

A. Seeds for Sprouting

Since any permissible use of ionizing

radiation on seeds for sprouting must be

in conformance with § 179.26(b), the

label and labeling of such seeds for

sprouting must comply with the

requirements in § 179.26(c).

B. Sprouts Grown From Irradiated Seeds

for Sprouting

It is important to recognize that in the

use of radiation that is the subject of this

rule, the irradiated article is not what is

generally eaten because the unsprouted

seeds are not normally consumed.

While irradiation of the seeds for

sprouting may cause some changes in

the seed (for example, reduced viability

of sprouting), the nutritional and flavor

characteristics of the sprouts will derive

from the fact that they were grown and

not from the fact that the seeds were

processed by irradiation. Moreover, the

agency has no reason to believe that

sprouts grown from irradiated seeds will

differ in their sensory characteristics

from sprouts grown from seeds that

have not been irradiated. Therefore, the

agency concludes that sprouts grown

Federal Register / Vol. 65, No. 210 / Monday, October 30, 2000 / Rules and Regulations 64607

from seeds that have been irradiated

need not be labeled as treated by

irradiation where the sprouts

themselves have not been irradiated.

Based on the data and studies

submitted in the petition and other

information in the agency’s files, FDA

concludes that: (1) The proposed use of

irradiation on seeds for sprouting at

levels not to exceed 8 kGy is safe, (2) the

irradiation will achieve its intended

technical effect, and therefore, (3) the

regulations in § 179.26 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.

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

IV. Environmental Impact

The agency has determined under 21

CFR 25.32(j) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

V. Objections

Any person who will be adversely

affected by this regulation may at any

time file with the Dockets Management

Branch (address above) written

objections by November 29, 2000. 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 at 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. FDA Memorandum, K. Morehouse to J.

Ziyad, February 23, 2000.

2. FDA Memorandum, I. Chen to J. Ziyad,

February 28, 2000.

3. FDA Memorandum, M. Walderhaug to J.

Ziyad, December 15, 1999.

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: 21 U.S.C. 321, 342, 343, 348,

373, 374.

2. Section 179.26 is amended in the

table in paragraph (b) by adding entry

‘‘10.’’ under the headings ‘‘Use’’ and

‘‘Limitations’’ to read as follows:

§ 179.26 Ionizing radiation for the

treatment of food.

* * * * *

(b) * * *

Use Limitations

*******

10. For control of microbial pathogens on seeds for sprouting. Not to exceed 8.0 kGy.

* * * * *

Dated: October 20, 2000.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 00–27735 Filed 10–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314 and 601

[Docket No. 99N–1852]

Postmarketing Studies for Approved

Human Drug and Licensed Biological

Products; Status Reports

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revising the

requirements for annual postmarketing

status reports for approved human drug

and biological products, and is requiring

applicants to submit annual status

reports for certain postmarketing studies

of licensed biological products. This

rule describes the types of

postmarketing studies covered by these

status reports, the information to be

included in the reports, and the type of

information that FDA would consider

appropriate for public disclosure. This

action will implement the Food and

Drug Administration Modernization Act

of 1997 (FDAMA).

DATES: This rule is effective February

27, 2001.