Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Proposed Rules 24253

dated November 30, 1995] is considered

acceptable for compliance with AD 95–19–

10, amendment 39–9372; and AD 95–20–51,

amendment 39–9398.

(h)(1) An alternative method of compliance

or adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Seattle

ACO. Operators shall submit their requests

through an appropriate FAA Principal

Maintenance Inspector, who may add

comments and then send it to the Manager,

Seattle ACO.

Note 5: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

(2) Alternative methods of compliance,

approved in accordance with AD 96–03–02,

amendment 39–9497; or AD 93–03–02 R1,

amendment 39–9526; are approved as

alternative methods of compliance with this

AD.

(i) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

Issued in Renton, Washington, on May 8,

1996.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 96–12021 Filed 5–13–96; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 96N–0135]

RIN 0910–AA91

Substances Prohibited From Use in

Animal Food or Feed; Protein Derived

From Ruminants Prohibited in

Ruminant Feed

AGENCY: Food and Drug Administration,

HHS.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is soliciting

comments on the issue of using protein

derived from ruminants (e.g., cattle,

sheep, goats, mule deer, and elk) in

ruminant feed. Animal feed containing

protein derived from ruminants may

contain the disease agent that causes

transmissible spongiform

encephalopathy (TSE) in animals.

Epidemiological evidence gathered in

the United Kingdom (U.K.) suggests a

link between an outbreak of ruminant

TSE, specifically bovine spongiform

encephalopathy (BSE) and feeding

animals protein derived from

ruminants. In addition information from

the U.K. also suggests that exposure to

BSE may explain some of the recent

cases of variant Creutzfeldt-Jakob

disease (v-CJD) in the U.K. This action

is being taken to protect the health of

animals and to reduce any risk which

might be faced by humans. FDA is

requesting scientific and economic

information and other comments

relating to the prohibition of ruminant

protein in ruminant feed.

DATES: Written comments by June 13,

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:

George Graber, Center For Veterinary

Medicine (HFV–220), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1724.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of August 29,

1994 (59 FR 44584) FDA issued a

proposed rule declaring that specified

offal from adult (more than 12 months

of age) sheep and goats is not generally

recognized as safe for use in ruminant

feed and is an unapproved food additive

when added to ruminant feed. The

proposed rule defined ‘‘specified offal’’

as any tissue from the brain, spinal cord,

spleen, thymus, tonsil, lymph nodes, or

intestines of sheep or goats, or any

processed product that is reasonably

expected to contain specified offal.

Processed products that may contain

specified offal include, but are not

limited to, meat meal, meat and bone

meal, animal byproduct meal, meat

byproducts, glandular meal, and cooked

bone meal. Accordingly, in the absence

of an approved food additive regulation

or investigational exemption, the use in

ruminant feed of ingredients containing

specified offal from adult sheep or goats

would cause the feeds to be considered

adulterated within the meaning of the

Federal Food, Drug, and Cosmetic Act

(the act). FDA proposed the action

because the specified offal may contain

the agent that causes scrapie, a TSE of

sheep and goats. Since the proposal was

issued, the agency has been evaluating

the comments submitted on the

proposal, monitoring the scientific

advances made in understanding the

interrelationships among the animal

TSE’s, and participating in a number of

national and international task force/

symposia to better understand the BSE

epidemic. The actions that would have

been prohibited in the proposed rule are

considered in this advance notice of

proposed rulemaking. If it is determined

that some action is necessary, the

agency believes issuing an advance

notice of proposed rulemaking

(ANPRM) will hasten that process.

In the U. K., scrapie has been

epidemiologically associated with the

occurrence of BSE, another form of TSE.

The initial cases of BSE may have been

the result of feeding supplements to

cattle that were contaminated with

prions from scrapie-infected sheep offal.

Prions are highly resistant to procedures

that modify or destroy nucleic acids.

(Refs. 1 and 2). Prions are believed by

many scientists to be the agents

responsible for TSE’s, and they appear

to be modified forms of normal proteins.

BSE has been diagnosed in over

155,600 head of cattle from almost

33,000 herds in the U.K. No cases of

BSE have been diagnosed in the United

States. BSE is postulated to have been

spread in the U.K. among cattle by the

feeding of processed ruminant protein

to cattle. A July 1988 U.K. ban on this

feeding practice has resulted in a steady

reduction in the number of cases of BSE

detected in cattle, with the new cases

occurring mainly in animals born before

the ban was fully implemented.

Ten cases of CJD have been identified

in the U.K. in recent months with a new

neuropathological profile. Other

consistent features that are unusual

include the young age of the cases (16

to 39 years old at onset of clinical signs),

clinical findings, and the absence of the

electroencephalogram features typical

for CJD. Similar cases have not been

identified in other countries in the

European surveillance system. These 10

cases appear to represent a new variant

of CJD (v-CJD), which may be unique to

the U.K. The appearance of these 10

cases of v-CJD raises the possibility that

they are causally linked to BSE.

Although this may be the most plausible

explanation for these cases, a link with

BSE cannot be confirmed on the basis of

this evidence alone. (Ref. 3). Sporadic

occurrences of spongiform

encephalopathy in humans are known

to occur at a rate of 1 to 2 per million

population worldwide. A group of

international experts convened in April

1996 by the World Health Organization

concluded that there is no definite link

between BSE and v-CJD, but that

circumstantial evidence suggests

exposure to BSE may be the most likely

explanation. Among other

recommendations, the group

recommended that all countries should
24254 Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Proposed Rules

ban the use of ruminant tissues in

ruminant feed (Ref. 4).

II. Issues for Comment

No cases of BSE have been diagnosed

in the United States. Despite the fact

that there is no problem with BSE in the

United States, the agency believes it

would be prudent to solicit information

and receive comments on this issue.

Therefore, the agency is assessing

whether to provide that protein derived

from ruminants is not generally

recognized as safe for use as a ruminant

feed or prior sanctioned for such and is

a food additive subject to section 409 of

the act (21 U.S.C. 348). Absent a

determination that it is safe for use as

a food additive under section 409 of the

act, the use in ruminant feed of

ingredients containing protein derived

from ruminants would cause the feed to

be adulterated. Ruminant-derived

protein could be defined as any feed

ingredient that is reasonably expected to

contain proteinaceous material that

derives from ruminant species.

Processed feed ingredients that may

contain ruminant-derived protein

include, but are not limited to, products

meeting the following animal feed

definitions: animal byproduct meal,

blood meal, cooked bone meal,

glandular meal, meat and bone meal,

meat byproducts, and meat meal. The

agency is prepared to consider the

exclusion of specific ruminant products

from the prohibition, such as milk

products, blood products, fetal bovine

serum, and gelatin based on appropriate

and adequate scientific information

which demonstrates no infectivity.

In addition, the agency is considering

labeling requirements for ruminantderived proteins for enforcement

purposes.

III. Agency Request for Information

FDA is soliciting comments on all

aspects of this ANPRM, and specifically

requests comments on the following

issues:

1. The occurrence in the United States

of TSE’s in animals.

2. Scientific information on how

TSE’s occur and are spread among

animals and among humans and what

vectors might be involved.

3. Scientific information on the

ecology of TSE agents, and the

epidemiology, etiology, and

pathogenesis of TSE diseases.

4. Scientific information supporting

the exclusion of any ruminant-derived

proteins from the proposed prohibition.

5. Establishment of Hazard Analysis

and Critical Control Points (HACCP) for

the rearing of ruminants, and rendering

or other processing of ruminant derived

feed ingredients, that may reduce the

need to prohibit the feeding of ruminant

protein to ruminants.

6. Details of rendering or processing

practices that may inactivate the TSE

agents and information and evidence

which shows that these practices are

effective.

7. Data on the amount of material

affected by this ruminant protein to

ruminant feed prohibition, specifically:

(a) The total volume of the processed

feed ingredients that may contain

ruminant-derived protein which were

produced in the United States in recent

years, (b) details of the total volume

used for each of these ingredients in the

rations of the various animals in the

United States, (c) information on the

percentage of the diet each ingredient
Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Proposed Rules 24255

typically comprises for each species and

what percentage of the total volume is

fed to each species, and (d) other

information.

8. Economic and environmental

adverse consequences or benefits

resulting from a ruminant protein to

ruminant feed prohibition on: (a) The

farmer/producer, (b) the slaughter

operation, (c) the rendering industry, (d)

the public, (e) the feed manufacturer, (f)

other parties that may be affected.

9. Potential mitigating factors that

would lessen the economic and

environmental impact of the

prohibition, specifically: (a)

Identification of nonfeed uses of

products containing ruminant-derived

protein, (b) development of rendering or

processing processes that would allow

the safe feed use of a portion of the

prohibited feed ingredient, (c) alternate

disposal methods, and (d) other

mitigating factors.

10. Descriptive and incremental cost

data for incremental tasks required by

the proposed change with respect to

person-hours, type of labor

(professional, technical, and clerical),

type of equipment to be purchased,

disposal costs, capital expenditures, loss

of current markets, expansion of

alternative markets, etc.

11. Estimates of the average total cost

of compliance (including any expected

reporting and recordkeeping costs) for

both large and small businesses in each

affected industry segment. Descriptions

and numbers of small businesses

affected in each sector.

12. Information which identifies and

explains effective alternative policy

actions which would minimize any

negative economic effects on small

businesses and the affected industry as

a whole.

13. Estimates of the level of

compliance with the voluntary ban on

feeding ruminant protein to ruminants

announced by the livestock industry on

March 29, 1996.

14. Information on restrictions placed

upon beef or sheep imports by foreign

countries that would directly affect U.S.

beef or sheep producers.

15. Identification of potential

analytical methods that may be used in

detecting ruminant proteins in feed.

16. Labeling requirements (i.e.,

declaring the source of the animal

protein; a prohibition of use statement).

17. Development of antemortem tests

to accurately determine if an animal has

a TSE.

18. Alternate actions the agency could

take to prevent the spread of TSE’s

among ruminants.

IV. Comments

Interested persons may, on or before

June 13, 1996, submit to the Dockets

Management Branch (address above),

written comments regarding this

ANPRM. 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 may be seen in the office

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

Monday through Friday.

This ANPRM is issued under sections

201, 402, 409, and 701 of the Federal

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

321, 342, 348, and 371) and under the

authority of the Commissioner of Food

and Drugs.
24256 Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Proposed Rules

1Liebman, D.A., and Schwartz, J.A., Police

Programs in Crisis Intervention: A Review, (J.R.

Snibbe and H.M. Snibbe eds. 1973). See also

Charles C. Thomas, The Urban Policeman in

Transition: A Psychological and Sociological

Review (1973).

2 Garner, J., Fagan, J., and Maxwell, C., Published

Findings from the Spouse Assault Replication

Program: A Critical Review, Journal of Quantitative

Criminology, 11[1], 3–28, 1995.

Fagan, J., The Criminalization of Domestic

Violence: Promises and Limits, Presentation at the

1995 National Institute of Justice Conference on

Criminal Justice Research and Evaluation, January,

1996, available through the National Criminal

Justice Reference Service, 1–800–851–3420.

3Hart, B.J., Coordinated Community Approaches

to Domestic Violence, presented at the Strategic

Planning Workshop on Violence Against Women

sponsored by the National Institute of Justice in

Washington, D.C., March 31, 1995, available

through the National Criminal Justice Reference

Service, 1–800–851–3420.

4Layden, J., Domestic Violence, Headliners, 1994.

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. Prusiner, S. B. , ‘‘Novel Proteinaceous

Infectious Particles Cause Scrapie,’’ Science,

216:136–144, 1982.

2. Stahl, N. and S. B. Prusiner, ‘‘Prions and

Prion Proteins,’’ FASEB Journal, 5:2799–

2807, 1991.

3. Will, R. G. et al., ‘‘A New Variant of

Creutzfeldt-Jakob Disease in the UK,’’ Lancet,

347, 921–925, 1996.

4. WHO press release, April 3, 1996,

‘‘International Experts Propose Measures to

Limit Spread of BSE and Reduce Possible

Human Risk from Disease.’’

Dated: May 8, 1996.

David A. Kessler,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 96–12081 Filed 5–9–96; 2:16 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Office of Justice Programs

28 CFR Part 90

[OJP No. 1019]

RIN 1121–AA35

Grants To Encourage Arrest Policies

AGENCY: U.S. Department of Justice,

Office of Justice Programs.

ACTION: Proposed rule.

SUMMARY: This notice announces a

proposed rule for the Grants to

Encourage Arrest Policies authorized by

the Violence Against Women Act, Title

IV of the Violent Crime Control and Law

Enforcement Act of 1994. For Fiscal

Year 1996, Congress has appropriated

$28 million to the United States

Department of Justice, Office of Justice

Programs, for Grants to Encourage

Arrest Policies. This regulation is being

published under the general statutory

grant of authority to issue rules and

regulations pursuant to the Omnibus

Crime Control and Safe Streets Act of

1968. The purpose of this regulation is

to provide a general outline of the

program and its purposes as set forth in

the statute.

DATES: All comments must be received

by June 13, 1996. The length of the

comment period has been limited to

thirty days in order to provide States

timely access to the available program

funds. It would be contrary to the public

interest to delay implementation of the

program.

ADDRESSES: All comments should be

addressed to Kathy Schwartz, Violence

Against Women Grants Office, Office of

Justice Programs, Room 446, 633

Indiana Avenue, N.W., Washington,

D.C. 20531.

FOR FURTHER INFORMATION CONTACT: The

Department of Justice Response Center

at 1–800–421–6770 or (202) 307–1480,

or Catherine Pierce, Violence Against

Women Grants Office, Office of Justice

Programs at (202) 307–6026.

SUPPLEMENTARY INFORMATION:

Title IV Grants To Encourage Arrest

Policies

For Fiscal Year (FY) 1996, Congress

authorized a federal discretionary grant

program under Title IV of the Violent

Crime Control and Law Enforcement

Act of 1994, Pub. L. No. 103–22, 108

Stat. 1796, 1902–55, codified as

amended at 42 U.S.C. § 3796hh et seq

(1994) [hereinafter the ‘‘Act’’], for States,

units of local government, and Indian

tribal governments to encourage the

treatment of domestic violence as a

serious violation of criminal law. The

Act gives the Attorney General and an

authorized designee, in this case the

Assistant Attorney General for the

Office of Justice Programs, the authority

to make grants to the above mentioned

entities. Omnibus Crime Control and

Safe Streets Act of 1968 § 805, codified

as amended at 42 U.S.C. § 3768 (1994)

[hereinafter the ‘‘Omnibus Act’’].

Section 2104 of Title IV of the Act,

codified as amended at 42 U.S.C.

§ 3796hh-3, requires that regulations be

issued specifically to implement these

policies and programs.

Statement of the Problem

In the past, police departments, and

the criminal justice system as a whole,

generally treated domestic violence as a

private, family matter unlike any other

violent crime. Many police departments

maintained informal non-arrest policies

for domestic violence, focusing instead

on alternative responses such as family

crisis intervention and counseling for

domestic abusers.1 In recent years, many

departments have implemented new

policies and practices that encourage or

mandate arrest of a perpetrator of

domestic violence for probable cause or

for violating a protection order.2 To

ensure the effectiveness of these new

policies, some departments have created

special domestic violence units that

train personnel; develop guidelines and

protocols for enforcing laws related to

domestic violence; create sophisticated

tracking and communication systems;

investigate both misdemeanor and

felony domestic assaults; develop

accountability measures which ensure

enforcement of the law by all officers in

the department; and coordinate with

other criminal justice agencies and

victim service providers. Despite these

very significant accomplishments, many

more police departments require the

tools and resources necessary to

implement similar innovations in their

own communities.

For arrest to be an effective domestic

violence intervention, it must be part of

a coordinated and integrated response to

the problem on the part of the entire

criminal justice system.3 That is,

mandatory or proarrest policies will be

effective only if police departments

implement clear guidelines and

protocols for the arrest of domestic

violence perpetrators; if police and

prosecutors alike conduct thorough and

careful investigations of domestic

violence cases; if judges impose

appropriate sentences; if batterers

remain in custody after they are

arrested; if probation and parole

departments devise ways to effectively

supervise batterers; and if victims feel

confident that all professionals in the

system are committed to their safety and

the safety of their children.

Policies that Mandate or Encourage

Arrest

Laws and policies that encourage or

mandate the arrest of a domestic

violence perpetrator based on probable

cause are not new. Currently, at least 27

States and the District of Columbia have

adopted laws that mandate or encourage

arrest of a person who assaults a family

member, or of a person who violates a

domestic violence protection order.4

Federal law also requires all states

honor certain protection orders issued

by other jurisdictions. Act § 4022(a), 18