31468 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

(2) If you relinquish your insurable share

on any insurable acreage of citrus on or

before the acreage reporting date for the crop

year, insurance will not be considered to

have attached to such acreage for that crop

year unless:

(i) A transfer of coverage and right to an

indemnity, or a similar form approved by us,

is completed by all affected parties; and

(ii) We are notified by you or the transferee

in writing of such transfer on or before the

acreage reporting date.

If you relinquish your share, no premium

or indemnity will be due unless a transfer of

coverage is properly executed.

9. Causes of Loss

(a) In accordance with the provisions of

section 12 (Causes of Loss) of the Basic

Provisions (§ 457.8), insurance is provided

only against the following causes of loss that

occur during the insurance period:

(1) Adverse weather conditions;

(2) Fire, unless weeds and other forms of

undergrowth have not been controlled or

pruning debris has not been removed from

the grove;

(3) Wildlife;

(4) Earthquake;

(5) Volcanic eruption; or

(6) Failure of irrigation water supply, if

caused by an insured peril that occurs during

the insurance period.

(b) In addition to the causes of loss

excluded in section 12 (Causes of Loss) of the

Basic Provisions (§ 457.8), we will not insure

against damage or loss of production due to:

(1) Disease or insect infestation, unless

adverse weather conditions:

(i) Prevents the proper application of

control measures or causes properly applied

control measures to be ineffective; or

(ii) Causes disease or insect infestation for

which no effective control mechanism is

available;

(2) Inability to market the citrus for any

reason other than actual physical damage

from an insurable cause specified in this

section. For example, we will not pay you an

indemnity if you are unable to market due to

quarantine, boycott, or refusal of any person

to accept production.

10. Duties in the Event of Damage or Loss

In addition to the requirements of section

14 (Duties in the Event of Damage or Loss)

of the Basic Provisions (§ 457.8), the

following will apply:

(a) You must notify us within three 3 days

of the date harvest should have started if the

crop will not be harvested.

(b) You must notify us at least 15 days

before any production from any unit will be

marketed directly to consumers. We will

conduct an appraisal that will be used to

determine your production to count for direct

marketed production. If damage occurs after

this appraisal, we will conduct an additional

appraisal. These appraisals, and any

acceptable records provided by you, will be

used to determine your production to count.

Failure to give timely notice that production

will be marketed directly to consumers will

result in an appraised amount of production

to count that is not less than the production

guarantee per acre if such failure results in

our inability to make the required appraisal.

(c) If you intend to claim an indemnity on

any unit, you must notify us prior to the

beginning of harvest so that we may inspect

the damaged production. You must not sell

or dispose of the damaged crop until after we

have given you written consent to do so. If

you fail to meet the requirements of this

section, all such production will be

considered undamaged and included as

production to count.

11. Settlement Of Claim

(a) We will determine your loss on a unit

basis. In the event you are unable to provide

production records:

(1) For any optional unit, we will combine

all optional units for which acceptable

production records were not provided; or

(2) For any basic unit, we will allocate any

commingled production to such units in

proportion to our liability on the harvested

acreage for each unit.

(b) In the event of loss or damage covered

by this policy, we will settle your claim by:

(1) Multiplying the insured acreage for

each type by its respective production

guarantee;

(2) Multiplying each result in paragraph (1)

by the respective price election for each type,

or variety within a type;

(3) Totaling the results in paragraph (2);

(4) Multiplying the total production to be

counted of each type or variety, if applicable

(see section 11(c)), by the respective price

election;

(5) Totaling the results of paragraph (4);

(6) Subtracting the total of paragraph (5)

from the total in paragraph (3); and

(7) Multiplying the result of paragraph (6)

by your share;

(c) The total production to count (in

cartons) from all insurable acreage on the

unit will include:

(1) All appraised production as follows:

(i) Not less than the production guarantee

per acre for acreage:

(A) That is abandoned;

(B) Marketed directly to consumers if you

fail to meet the requirements contained in

section 10;

(C) Damaged solely by uninsured causes; or

(D) For which you fail to provide

production records that are acceptable to us;

(ii) Production lost due to uninsured

causes;

(iii) Unharvested production determined to

be marketable as fresh packed fruit; and

(iv) Potential production on insured

acreage that you intend to abandon or no

longer care for, if you and we agree on the

appraised amount of production. Upon such

agreement, the insurance period for that

acreage will end. If you do not agree with our

appraisal, we may defer the claim only if you

agree to continue to care for the crop. We will

then make another appraisal when you notify

us of further damage or that harvest is general

in the area unless you harvested the crop, in

which case we will use the harvested

production. If you do not continue to care for

the crop, our appraisal made prior to

deferring the claim will be used to determine

the production to count; and

(2) All harvested production marketed as

fresh packed fruit from the insurable acreage.

(3) All disposed or sold damaged citrus

that was disposed or sold without an

inspection or written consent.

(d) Any production will be considered

marketed or marketable as fresh packed fruit

unless, due to insurable causes, such

production was not marketed or marketable

as fresh packed fruit.

(e) Citrus that cannot be marketed due to

insurable causes will not be considered

production to count.

(f) If we determine that frost protection

equipment was not properly utilized or not

properly reported, the indemnity for the unit

will be reduced by the percentage of

premium reduction allowed for frost

protection equipment. You must, at our

request, provide us records showing the startstop times by date for each period the frost

protection equipment was used.

12. Written Agreement

Designated terms of this policy may be

altered by written agreement in accordance

with the following:

(a) You must apply in writing for each

written agreement no later than the sales

closing date, except as provided in section

12(e);

(b) The application for written agreement

must contain all terms of the contract

between you and us that will be in effect if

the written agreement is not approved;

(c) If approved, the written agreement will

include all variable terms of the contract,

including, but not limited to, crop type or

variety, the guarantee, premium rate, and

price election;

(d) Each written agreement will only be

valid for one year (If the written agreement

is not specifically renewed the following

year, insurance coverage for subsequent crop

years will be in accordance with the printed

policy); and

(e) An application for written agreement

submitted after the sales closing date may be

approved if, after a physical inspection of the

acreage, it is determined that no loss has

occurred and the crop is insurable in

accordance with the policy and written

agreement provisions.

Signed in Washington, DC., on June 13,

1996.

Kenneth D. Ackerman,

Manager, Federal Crop Insurance

Corporation.

[FR Doc. 96–15770 Filed 6–19–96; 8:45 am]

BILLING CODE 3410–FA–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 500

[Docket No. 95N–0417]

Carcinogenicity Testing of Compounds

Used in Food-Producing Animals

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31469

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

revise the regulation that sets forth the

requirements for the carcinogenicity

testing of compounds used in foodproducing animals to allow the agency

and sponsors greater flexibility when

choosing the types of studies used for

testing the carcinogenicity of

compounds used in food-producing

animals. FDA is proposing to revise the

study requirements because FDA

recognizes that advances in models used

to assess the carcinogenicity of

compounds have been made. The

specific requirement that a sponsor

must conduct oral, chronic, doseresponse studies would be deleted

under the proposed regulation.

Sponsors would have more options for

testing the carcinogenicity of

compounds used in food-producing

animals. This proposal implements the

goals stated by the National

Performance Review.

DATES: Written comments by September

3, 1996.

ADDRESSES: Written comments to the

Dockets Managements Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Comments should

be identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen at the Dockets Management Branch

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

through Friday.

FOR FURTHER INFORMATION CONTACT:

Margaret A. Miller, Center for

Veterinary Medicine (HFV–100), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0205.

SUPPLEMENTARY INFORMATION: Section

500.80(b) (21 CFR 500.80(b)) sets forth

the requirements for the carcinogenicity

testing of compounds used in foodproducing animals. Specifically, the

regulation states, ‘‘The bioassays that a

sponsor conducts must be oral, chronic,

dose-response studies and must be

designed to assess carcinogenicity and

to determine the quantitative aspects of

any carcinogenic response.’’

At the time that this regulation was

written, a chronic study was considered

to be the standard test for

carcinogenicity. However, FDA

recognizes that advances in models used

to assess carcinogenicity have been

made in recent years. For example,

scientists now agree that, depending on

the compound, a chronic study (as

required under current regulations) may

not measure the appropriate time point

necessary to assess carcinogenicity.

Study designs other than chronic may

result in a better evaluation of the

compound. Thus, FDA is proposing to

remove the requirement for oral,

chronic, dose-response studies to allow

sponsors the option of using other study

designs when assessing carcinogenicity

of compounds used for food-producing

animals.

This proposal is aligned with the

goals stated by the National

Performance Review. This proposed

rule is a result of the President’s

directive to conduct a comprehensive

review of all rules to identify those that

are obsolete and burdensome and to

delete or revise them. The agency has

determined that this rule is in need of

revision as described herein.

I. Environmental Impact

The agency has carefully considered

the potential environmental effects of

this action. FDA has determined that

this action is categorically excluded

under 21 CFR 25.24(a)(8). The

procedure for testing the carcinogenicity

of compounds used for food-producing

animals is being revised. This revision

will not cause an increase in the

existing level of use or cause a change

in the intended uses of the product or

its substitutes. Therefore, neither an

environmental assessment nor an

environmental impact statement is

required.

II. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(Pub. L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so is not subject to

review under the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because the proposed rule

would clarify FDA policy and simplify

the process for submitting certain

applications, the agency certifies that

the proposed rule will not have a

significant economic impact on a

substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

III. Paperwork Reduction Act of 1995

The agency has determined that this

proposed rule contains no collection of

information requirements under the

Paperwork Reduction Act of 1995 (44

U.S.C. chapter 35).

IV. Federalism

FDA has analyzed this proposal in

accordance with the principles and

criteria set forth in Executive Order

12612 and has determined that this

proposal does not warrant the

preparation of a Federalism Assessment.

V. Request for Comments

Interested persons may, on or before

September 3, 1996 submit to the

Dockets Management Branch (address

above) written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 500

Animal drugs, Animal feeds, Cancer,

Labeling, Polychlorinated biphenyls

(PCB’s).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 500 is

amended as follows:

Part 500—General

1. The authority citation for 21 CFR

part 500 continues to read as follows:

Authority: Secs. 201, 301, 402, 403, 409,

501, 502, 503, 512, 701 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 321, 331,

342, 343, 348, 351, 352, 353, 360b, 371).

§ 500.80 [Amended]

2. Section 500.80 Scope of this

subpart is amended in paragraph (b) by

removing the phrase ‘‘must be oral,

chronic, dose-response studies and.’’

Dated: June 13, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–15725 Filed 6–19–96; 8:45 am]

BILLING CODE 4160–01–F