Revocation of Certain Animal Food and Drug Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

21 CFR Parts 500, 505, 507, 508, 510, and 570

[Docket No. 95N-310V]

Revocation of Certain Animal Food and Drug Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revoking certain

regulations regarding animal food and animal drugs that are obsolete or

no longer necessary to achieve public health goals. These regulations

have been identified for revocation as the result of a page-by-page

review of the agency's regulations. This regulatory review is in

response to the administration's ``Reinventing Government'' initiative

which seeks to streamline Government to ease the burden on regulated

industry and consumers. These regulations are being consolidated in

order to respond to ``Reinventing Government.''

EFFECTIVE DATE: August 19, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Kristi O. Smedley, Center for

Veterinary Medicine (HFV-238), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301-594-1737.

SUPPLEMENTARY INFORMATION:

I. Background

On March 4, 1995, President Clinton announced plans for the reform

of the Federal regulatory system as part of the administration's

``Reinventing Government'' initiative. In his March 4 directive, the

President ordered all Federal agencies to conduct a page-by-page review

of all of their regulations and to ``eliminate or revise those that are

outdated or otherwise in need of reform.'' In the Federal Register of

October 13, 1995 (60 FR 53480), FDA provided its initial efforts in

implementing the President's plan. The proposed rule announced

regulations that FDA intended to eliminate based on the page-by-page

review.

The agency received no comments regarding their intention to

eliminate any of the regulations that cover animal food or animal drug

regulations. Therefore the agency is removing the following

regulations:

1. Section 500.49 Chlorofluorocarbon propellants (21 CFR 500.49).

This section prohibits the use of chlorofluorocarbons as propellants in

self-pressurized containers in animal drugs. Chlorofluorocarbons are

prohibited by the Clean Air Act Amendments of 1990 (42 U.S.C. 7671) and

can no longer be marketed for this use. This section is unnecessary

because coverage in Sec. 2.125 (21 CFR 2.125) of this prohibition is

sufficient.

2. Section 505.3 Warnings on animal drugs intended for

administration to diseased animals (21 CFR 505.3). This section states

that no warning or caution statements recommended for use in the

labeling of animal drugs intended for administration to diseased

animals shall be construed to suggest or imply that a product of

diseased animals is suitable for food use. This provision cautions

against misuse of language in Sec. 505.20 (21 CFR 505.20) which is now

being withdrawn and is, therefore, unnecessary.

3. Section 505.20 Recommended animal drug warning and caution

statements. This section provides recommended animal drug warning and

caution statements for specific drugs. The statements provided are

voluntary label statements that do not contain requirements and need

not appear in the CFR.

4. Part 507--Thermally Processed Low-Acid Foods Packaged in

Hermetically Sealed Containers (21 CFR part 507). This part contains

the criteria that apply in determining whether the facilities, methods,

practices, and

[[Page 37681]]

controls used by the commercial processor in the manufacture,

processing, and packing of low-acid foods for animals in hermetically

sealed containers are operated or administered in a manner adequate to

protect the public health. Part 507 is identical to part 113 (21 CFR

part 113), which applies to human foods. Therefore, the agency is

removing part 507, and adding a new Sec. 500.23 to state that the

provisions in part 113 apply to animal foods.

5. Part 508--Emergency Permit Control (21 CFR part 508) covers the

requirements and issuance of emergency control permits for the

manufacturer or packer of thermally processed low-acid foods packaged

in hermetically sealed containers. Part 508 is identical to part 108

(21 CFR part 108), which applies to human foods. Therefore, the agency

is removing part 508, and adding a new Sec. 500.24 to state that the

provisions in part 108 apply to food intended for animals.

6. Section 510.120 Suspension of approval of new-drug applications

for certain diethylstilbestrol and diethylstilbestrol-containing drugs

(21 CFR 510.120). This section provides the suspension of approval of

the seven listed diethylstilbestrol (DES)-containing animal drug

products. There are no approved new animal drug applications for DES-

containing products. This regulation is obsolete and should be deleted.

7. Section 510.200 Export of new animal drug (21 CFR 510.200). This

section states that to export a new animal drug the product must comply

with regulations issued under section 512 of the act (21 U.S.C. 360b).

This provision has been superseded by changes in the act (see 21 U.S.C.

381).

8. Section 510.310 Records and reports for new animal drugs

approved before June 20, 1963 (21 CFR 510.310). This section sets out

separate requirements for recordkeeping and reporting to the agency for

drugs approved prior to June 20, 1963. These requirements are outdated

and inaccurate. The agency believes it is appropriate to apply the

current recordkeeping and reporting requirements to drugs that were

approved before 1963.

9. Section 510.413 Chloroform used as an ingredient (active or

inactive) in animal drug products (21 CFR 510.413). This section

prohibits the use of chloroform as an ingredient in animal drugs and

provides certain requirements for products that contain chloroform that

must be met by October 3, 1977. Chloroform is no longer used as an

ingredient in any animal drug formulations. Drug formulation is

reviewed by the manufacturing chemists in FDA's Center for Veterinary

Medicine (CVM), and this regulation is no longer necessary.

10. Section 570.22 Safety factors to be considered (21 CFR 570.22).

This section sets out a proposed safety factor to be used by CVM

scientists when there is not justification of a different safety

factor. The safety factors provided in the regulations are

scientifically obsolete for food additives intended for animals and are

best handled within the review process.

II. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 12866, the Regulatory Flexibility Act (Pub. L. 96-354), and Pub.

L. 104-121. 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 final rule is consistent with the

regulatory philosophy and principles identified in the Executive Order.

In addition, the final 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 deletions have no compliance costs and

do not result in any new requirements, the agency certifies that the

final 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.

Pub. L. 104-121 provides for a major rule is to be effective 60

days after date of publication in the Federal Register or 60 days after

submission of the rule to Congress for review, whichever is later. This

rule is not a major rule for purposes of Pub. L. 104-121. Therefore,

this rule is effective 30 days after date of publication.

III. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(9) 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.

List of Subjects

21 CFR Part 500

Animal drugs, Animal feeds, Cancer, Labeling, Polychlorinated

biphenyls (PCB's).

21 CFR Part 505

Animal drugs, Labeling, Over-the-counter drugs.

21 CFR Part 507

Animal foods, Packaging and containers, Reporting and recordkeeping

requirements.

21 CFR Part 508

Animal foods.

21 CFR Part 510

Administrative practice and procedure, Animal drugs, Labeling,

Reporting and recordkeeping requirements.

21 CFR Part 570

Animal feeds, Animal foods, Food additives.

Therefore, under the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 301 et seq.) and under authority delegated to the Commissioner

of Food and Drugs, 21 CFR parts 500, 505, 507, 508, 510, and 570 are

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).

2. Section 500.23 is added to subpart B to read as follows:

Sec. 500.23 Thermally processed low-acid foods packaged in

hermetically sealed containers.

The provisions of part 113 of this chapter shall apply to the

manufacture, processing or packing of low-acid foods in hermetically

sealed containers, and intended for use as food for animals.

3. Section 500.24 is added to subpart B to read as follows:

Sec. 500.24 Emergency permit control.

The provisions of part 108 of this chapter shall apply to the

issuance of emergency control permits for the manufacturer or packer of

thermally processed low-acid foods packaged in hermetically sealed

containers, and intended for use as food for animals.

[[Page 37682]]

Sec. 500.49 [Removed]

4. Section 500.49 Chlorofluorocarbon propellants is removed.

PART 505--[REMOVED]

5. Part 505 is removed.

PART 507--[REMOVED]

6. Part 507 is removed.

PART 508--[REMOVED]

7. Part 508 is removed.

PART 510--NEW ANIMAL DRUGS

8. The authority citation for 21 CFR part 510 continues to read as

follows:

Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e).

Sec. 510.120 [Removed]

9. Section 510.120 Suspension of approval of new-drug applications

for certain diethylstilbestrol and diethylstilbestrol-containing drugs

is removed.

Sec. 510.200 [Removed]

10. Subpart C, consisting of Sec. 510.200, is removed and reserved.

Sec. 510.310 [Removed]

11. Section 510.310 Records and reports for new animal drugs

approved before June 20, 1963 is removed.

Sec. 510.413 [Removed]

12. Section 510.413 Chloroform used as an ingredient (active or

inactive) in animal drug products is removed.

PART 570--FOOD ADDITIVES

13. The authority citation for 21 CFR part 570 continues to read as

follows:

Authority: Secs. 201, 401, 402, 408, 409, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 346a, 348,

371).

Sec. 570.22 [Removed]

14. Section 570.22 Safety factors to be considered is removed.

Dated: July 3, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96-18234 Filed 7-18-96; 8:45 am]

BILLING CODE 4160-01-F