24584 Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Proposed Rules

(11) The name, mailing address, and

telephone number of the person to

whom the hedgehog or tenrec will be

delivered in the United States.

(12) The location of the place where

delivery will be made in the United

States.

(13) Any remarks regarding the

shipment.

(d) What will happen to the

application for an import permit. Upon

receipt of the application, APHIS will

review the application. If the hedgehog

or tenrec appears to be eligible to be

imported into the United States, APHIS

will issue an import permit indicating

the applicable requirements under this

subpart for the importation of the

hedgehog or tenrec. Even though an

import permit has been issued for the

importation of a hedgehog or tenrec, the

animal may enter the United States only

if all applicable requirements of this

subpart have been met.

§ 92.705 Health certificate.

A hedgehog or tenrec may not be

imported into the United States unless

accompanied by a health certificate

either issued by a full-time salaried

veterinary officer of the national

government of the exporting country, or

issued by a veterinarian authorized or

accredited by the national government

of the exporting country and endorsed

by a full-time salaried veterinary officer

of the national government of that

country. The health certificate must

contain the names and street addresses

of the consignor and consignee and

must state:

(a) That the hedgehog or tenrec

originated in a country that has been

recognized as free of foot-and-mouth

disease by the USDA;

(b) That the hedgehog or tenrec has

never been in a country where foot-andmouth disease exists;

(c) That the hedgehog or tenrec has

not been commingled with any other

hedgehog or tenrec that originated in or

has ever been in a country where footand-mouth disease exists;

(d) That the hedgehog or tenrec was

inspected by the individual issuing the

health certificate and was found free of

any ectoparasites not more than 72

hours before being loaded on the means

of conveyance which transported the

animal to the United States;

(e) That all body surfaces of the

hedgehog or tenrec were treated for

ectoparasites under the supervision of

the veterinarian issuing the health

certificate at least 3 days but not more

than 14 days before being loaded on the

means of conveyance that transported

the animal to the United States;

(f) That the pesticide and the

concentration used was adequate to kill

the types of ectoparasites likely to infest

the animal to be imported;

(g) That the hedgehog or tenrec, after

being treated for ectoparasites in

accordance with paragraphs (e) and (f)

of this section, had physical contact

only with, or shared a pen or bedding

materials only with, treated hedgehogs

or tenrecs in the same shipment to the

United States; and

(h) The name and concentration of the

pesticide used to treat the hedgehog or

tenrec.

§ 92.706 Notification of arrival.

Upon the arrival of a hedgehog or

tenrec at the port of first arrival in the

United States, the importer or his or her

agent must present the import permits

and health certificates required by this

subpart to the collector of customs for

the use of the inspector at that port.

§ 92.707 Inspection at the port of first

arrival.

(a) A hedgehog or tenrec from any

part of the world must be inspected by

an APHIS inspector at the port of first

arrival. Subject to the other provisions

in this subpart, a shipment of hedgehogs

or tenrecs may enter into the United

States only if each hedgehog or tenrec

in the shipment is found free of

ectoparasites and any clinical signs of

communicable diseases.

(b) If any hedgehog or tenrec in a

shipment is found to be infested with

ectoparasites or demonstrates any

clinical signs of communicable diseases,

then the entire shipment will be refused

entry. The importer will be given the

following options:

(1) Remove the shipment from the

United States; or

(2) Release the shipment to the U.S.

Department of Agriculture. The

Administrator will destroy or otherwise

dispose of the shipment as necessary to

prevent the possible introduction into

the United States of communicable

animal diseases.

Done in Washington, DC, this 27th day of

April 1995.

Lonnie J. King,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–11374 Filed 5–8–95; 8:45 am]

BILLING CODE 3410–34–P

9 CFR Parts 112 and 113

[Docket No. 94–046–1]

Viruses, Serums, Toxins, and

Analogous Products; Marek’s Disease

Vaccines

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: This proposed rule would

amend the standard requirements for

Marek’s disease vaccines by including

vaccines prepared from any of the three

Marek’s disease virus serotypes, and by

defining the identity, safety, and

efficacy requirements for vaccines

prepared from each serotype or

combinations of serotypes. The

proposed rule would also amend the

requirements for labeling Marek’s

disease vaccines. These proposed

amendments are necessary based on the

evolution of the disease in the field,

advances in the types of vaccines

currently prepared to prevent the

disease, and advances in the methods of

evaluating such vaccines. The effect of

the proposed rule would be to save

licensees time during the application

process by clarifying and codifying the

guidelines developed for licensing these

products over the past several years.

DATES: Consideration will be given only

to comments received on or before July

10, 1995.

ADDRESSES: Please send an original and

three copies of your comments to

Docket 94–046–1, Regulatory Analysis

and Development, PPD, APHIS, Suite

3C03, 4700 River Road Unit 118,

Riverdale, MD 20737–1238. Please state

that your comments refer to Docket No.

94–046–1. Comments received may be

inspected at USDA, room 1141, South

Building, 14th Street and Independence

Avenue SW., Washington, DC, between

8 a.m. and 4:30 p.m., Monday through

Friday, except holidays. Persons

wishing to inspect comments are

requested to call ahead on (202) 690–

2817 to facilitate entry into the

comment reading room.

FOR FURTHER INFORMATION CONTACT:

Dr. David Espeseth, Deputy Director,

Veterinary Biologics, BBEP, APHIS,

4700 River Road Unit 148, Riverdale,

MD, 20737–1237, (301) 734–8245.

SUPPLEMENTARY INFORMATION:

Background

Veterinary biologics are regulated

under the Virus-Serum-Toxin Act of

1913, as amended by the Food Security

Act of 1985 (21 U.S.C. 151–159,

hereinafter referred to as the Act). In

accordance with this Act, the Animal
Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Proposed Rules 24585

and Plant Health Inspection Service

(APHIS) promulgates standard

requirements that establish the purity,

safety, potency, and efficacy

requirements for these products.

The current standard requirements in

§ 113.330 (hereinafter referred to as the

regulations) for licensing Marek’s

disease vaccines were promulgated at a

time when only Serotype 3 Marek’s

disease vaccines were prepared. Also,

the standard requirements did not

include a standard for evaluating

vaccine efficacy. Since that time,

vaccines for Serotypes 1 and 2 have

been developed, very virulent forms of

the field virus have emerged, and other

advances in our understanding of this

virus have occurred. In response to

these changes, APHIS has developed

guidelines over the past several years for

licensing these products. APHIS now

proposes to amend the standard

requirement for Marek’s disease

vaccines to include Serotypes 1 and 2,

and to codify appropriate efficacy

standards and guidelines which license

applicants currently utilize.

Although all three Marek’s disease

virus serotypes have been used to

prepare licensed vaccines, the current

true names found on the labels of

Marke’s disease vaccines do not contain

this information. Therefore, we propose

to add new § 112.7(m) which would

require that the true names of all

Marke’s disease vaccines specify the

virus serotypes contained in the product

(e.g., ‘‘Serotype(s) 1, 2, and/or 3, Live

Virus’’). Also, the true names currently

found on labels of many of these

products include the final form in

which the product is prepared (e.g.,

‘‘Cell Associated’’ or ‘‘Cell Free’’). The

reference to final form in the current

true name is not consistent with the

labeling of other live virus vaccines.

Therefore, APHIS would no longer

include references to ‘‘Cell Associated’’

or ‘‘Cell Free’’ when assigning true

names for Marek’s disease vaccines.

The current standard requirements

limit the preparation of Marek’s disease

vaccines to five passages from the

master seed virus (see § 113.330,

introductory paragraph). A number of

exemptions from this requirement,

however, have been granted to

accommodate production problems,

particularly in the propagation of

Serotype 2 viruses. Therefore, we

propose to remove the five-passage

restriction from the introductory

paragraph of § 113.330. Licensees,

however, would still be required to

specify the highest passage, established

by efficacy data, that may be contained

in the final product for each master seed

virus pursuant to § 113.330(c) of the

regulations.

Due to the lack of an acceptable

identity test at the time the current

standard requirements were published,

the current regulations provide in

paragraph (a) and introductory

paragraph (d) of § 113.330 an exemption

from identity testing for Marek’s disease

master seed viruses and final products

that is no longer appropriate. Current

vaccines contain any of the three

Marek’s disease virus serotypes, and the

reagents and techniques to identify the

different serotypes are available.

Therefore, the proposed rule would

remove the identity test exemption in

paragraph (a) and the introductory

paragraph (d) of § 113.330 and would

require a serotype-specific identity test

in proposed paragraph (a) and

introductory paragraph (d) of § 113.330.

Sections 113.330 (a) and (d)(1) of the

current standard requirements permit

applicants to disregard lesions typical of

turkey herpes virus when evaluating

master seed viruses and final products

for extraneous agents in the chicken

embryo inoculation test prescribed in

§ 113.37. Such lesions may arise when

a vaccine virus override occurs during

the performance of this test. This

exemption for herpes virus lesions is

inconsistent with the evaluation of other

master seed viruses and products,

which are typically evaluated in the

chicken inoculation test prescribed in

§ 113.36 when a vaccine virus override

occurs. Therefore, APHIS would require

in proposed paragraphs (a) and (d)(1) of

§ 113.330 that the chicken inoculation

test be conducted if a vaccine virus

override occurs during the chicken

embryo inoculation test for a Marek’s

disease virus master seed or vaccine

serial.

The current regulations do not

contain an efficacy standard for Marek’s

disease vaccines. APHIS addressed the

need for such standard by issuing

Veterinary Biologics Memorandum No.

800.82 on January 19, 1993. This

memorandum prescribed efficacy

criteria on the basis that Serotype 1 and

2 vaccines typically provide protection

against a more (‘‘very’’) virulent

challenge, while the Serotype 3 vaccines

typically provide protection against a

less (‘‘standard’’) virulent challenge.

The proposed rule would codify the

efficacy guidelines found in that

memorandum in proposed

§ 113.330(c)—Immunogenicity.

Furthermore, because licensees have

obtained approval for label claims for

both subcutaneous and in ovo routes of

administration for these products, the

proposed efficacy standard has been

written to include the requirements for

either route.

The master seed virus safety test

found in § 113.330(b) of the current

standard requirements requires

modification in order to adequately

evaluate all three Marek’s disease virus

serotypes. As with the efficacy standard,

the safety test is addressed in the

Veterinary Biologics Memorandum No.

800.82. The memorandum describes the

appropriate challenge virus for the

positive control group and adds a

contact control group for the evaluation

of Serotype 1 viruses, which have an

increased potential for horizontal

spread. This proposed rule would

codify these guidelines with some

modifications. Also, this proposed rule

would expand the safety test to cover

the use of embryos as well as chickens

as test subjects (See proposed

§ 113.330(b).

Because Marek’s disease vaccines may

include more than one serotype in each

final container, the proposed rule would

require that the potency test for the final

product be serotype-specific for all

products containing more than one

serotype. Also, the acceptable virus

titers for product release and expiration

would be based on the titers used in the

efficacy study for each serotype, with

specified minimum titers (See proposed

§ 113.330(d)(3)).

Executive Order 12866 and Regulatory

Flexibility Act

This proposed rule has been reviewed

under Executive Order 12866. The rule

has been determined to be not

significant for purposes of Executive

Order 12866, and, therefore, has not

been reviewed by the Office of

Management and Budget.

The proposed amendments to the

standard requirements for Marek’s

disease vaccines would codify

guidelines developed for licensing these

products over the past several years.

These amendments would affect all

(currently a total of eight) manufacturers

of Marek’s disease vaccines, some of

which may be small businesses. By

clarifying licensing requirements for

Marek’s disease vaccines, the proposed

rule would save time during the

application process and would cause no

adverse economic impact on the

regulated industry.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action would not

have a significant economic impact on

a substantial number of small entities.
24586 Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Proposed Rules

Executive Order 12372

This program/activity is listed in the

Catalog of Federal Domestic Assistance

under No. 10.025 and is subject to

Executive Order 12372, which requires

intergovernmental consultation with

State and local officials. (See 7 CFR part

3015, subpart V.)

Executive Order 12778

This proposed rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. If this proposed rule is

adopted: (1) All State and local laws and

regulations that are inconsistent with

this rule will be preempted; (2) no

retroactive effect will be given to this

rule; and (3) administrative proceedings

will not be required before parties may

file suit in court challenging this rule.

Paperwork Reduction Act

This proposed rule contains no new

information collection or recordkeeping

requirements under the Paperwork

Reduction Act of 1980 (44 U.S.C. 3501

et seq.).

List of Subjects

9 CFR part 112

Animal biologics, Exports, Imports,

Labeling, Packaging and containers,

Reporting and recordkeeping

requirements.

9 CFR part 113

Animal biologics, Exports, Imports,

Reporting and recordkeeping

requirements.

Accordingly, 9 CFR parts 112 and 113

would be amended as follows:

PART 112—PACKAGING AND

LABELING

1. The authority citation for part 112

would continue to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

2. Section 112.7 would be amended

by adding paragraph (m) to read as

follows:

§ 112.7 Special additional requirements.

* * * * *

(m) In the case of biological products

containing Marek’s disease virus, all

labels shall specify the Marek’s disease

virus serotype(s) used in the product.

PART 113—STANDARD

REQUIREMENTS

3. The authority citation for part 113

would continue to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

4. Section 113.330 would be revised

to read as follows:

§ 113.330 Marek’s Disease Vaccines.

Marek’s disease vaccine shall be

prepared from virus-bearing tissue

culture cells. Only Master Seed Virus

which has been established as pure,

safe, and immunogenic shall be used for

preparing the production seed virus for

vaccine production.

(a) The Master Seed Virus shall meet

the applicable requirements prescribed

in § 113.300, and the requirements

prescribed in this section. The identity

test required in § 113.300(c) shall be

conducted in a serotype-specific manner

by a method acceptable to APHIS. Each

lot of Master Seed Virus shall also be

tested for pathogens by the chicken

embryo inoculation test prescribed in

§ 113.37, except that, if the test is

inconclusive because of a vaccine virus

override, the chicken inoculation test

prescribed in § 113.36 may be

conducted and the virus judged

accordingly.

(b) Safety test. The Master Seed Virus

shall be nonpathogenic for chickens as

determined by the following procedure:

(1) Specific pathogen free chickens or

embryos, negative for Marek’s disease

virus antibodies, and from the same

source, shall be isolated into the

following groups:

(i) Group 1. At least 50 test subjects

shall be inoculated with 10 times as

much viable virus as will be contained

in one dose of vaccine, by the route

recommended for vaccination.

(ii) Group 2. At least 50 test subjects

shall be injected with a very virulent

Marek’s disease virus provided or

approved by APHIS, at a dosage level

that will cause gross lesions of Marek’s

disease in at least 80 percent of the

chickens within 50 days.

(iii) Group 3. Fifth uninoculated

controls. For in ovo studies, this group

should receive a sham inoculation of

diluent.

(iv) Group 4. For studies evaluating

Serotype 1 Master Seed Viruses a group

of 50 uninoculated control chickens

shall be housed in contact with the

group 1 vaccinated chickens.

(2) At least 40 chickens in each group

shall survive to 5 days of age. All

chickens that die shall be necropsied an

examined for lesions of Marek’s disease

and cause of death. The test shall be

judged according to the following

criteria:

(i) At 50 days of age, the remaining

chickens in group 2 shall be killed and

examined for gross lesions of Marek’s

disease. If at least 80 percent of this

group do not develop Marek’s disease,

the test is inconclusive and may be

repeated.

(ii) At 120 days of age, the remaining

chickens in groups 1, 3, and 4 shall be

weighed, killed, and necropsied. If less

than 30 of the chickens in group 3

survive the 120 day period, or if any of

the chickens in group 3 have gross

lesions of Marek’s disease at necropsy,

the test is declared inconclusive. If less

than 30 chickens in groups 1 and 4

survive the 120 day period; or if any of

the chickens in groups 1 and 4 have

gross lesions of Marek’s disease at

necropsy; of if the average body weight

of the chickens in groups 1 or 4 is

significantly (statistically) different from

the average in group 3 at the end of the

120 days, the lot of Master Seed Virus

is unsatisfactory.

(3) For tests involving in ovo

innoculation, hatchability results shall

also be reported for each group.

(c) Immunogenicity. Each lot of

Master Seed Virus used for vaccine

production shall be tested for

immunogenicity at the highest passage

level allowed for the product, and the

virus dose to be used shall be

established as follows:

(1) Specific pathogen free chickens or

embryos, negative for Marek’s disease

antibodies, and from the same source,

shall be isolated into the following

groups:

(i) Group 1. A minimum of 35 test

subjects shall be inoculated with the

vaccine, using the recommended route,

at 1 day of age for chicks or 18 days of

embryonation for embryos. The dose

used shall be established by 5 replicate

virus titrations conducted by a cell

culture system or other titration method

acceptable to APHIS.

(ii) Group 2. A minimum of 35

nonvaccinated test subjects shall be

held as challenge controls.

(iii) Group 3. A minimum of 25

nonvaccinated test subjects shall be

held as nonchallenge controls.

(iv) Group 4. Except for studies

evaluating vaccines which contain only

a Serotype 3 virus as the Marek’s

disease fraction, a minimum of 35

chicks shall be vaccinated at 1 day of

age with a licensed Serotype 3 vaccine,

in order to document the severity of the

very virulent challenge.

(2) At least 30 chickens in groups 1,

2, and 4, and at least 20 chickens in

group 3, shall survive to 5 days of age.

All chickens in groups 1, 2, and 4 shall

be challenged at 5 days of age in the

following manner:

(i) For studies evaluating vaccines

which contain only a Serotype 3 virus

as the Marek’s disease fraction, groups

1 and 2 shall be inoculated with a

standard virulent challenge virus

provided or approved by APHIS.

(ii) For all other Marek’s disease

vaccines, groups 1, 2, and 4 shall be

inoculated with a very virulent
Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Proposed Rules 24587

challenge virus provided or approved by

APHIS.

(3) All chickens shall be observed

until 7 weeks of age, necropsied, and

examined for grossly observable lesions

consistent with Marek’s disease. All

chickens dying before the end of the 7

week observation period shall be

necropsied and evaluated for gross

lesions of Marek’s disease. Any

chickens not so examined shall be

scored as positive for Marek’s disease.

(4) For a valid test, at least 80% of the

chickens in group 2 must develop

grossly observable lesions, none of the

chickens in group 3 shall develop

grossly observable lesions, and (when

included) at least 20% of the chickens

in group 4 must develop grossly

observable lesions.

(5) For a valid test to be considered

satisfactory, at least 80% of the chickens

in group 1 must remain free of grossly

observable lesions. the appropriate

product claim resulting from a

satisfactory test would be to aid in the

prevention of Marek’s disease, for

vaccines containing only a Serotype 3

virus as the Marek’s disease fraction, or

to aid in the prevention of very virulent

Marek’s disease, for all other vaccines.

(d) Test requirements for release. Each

serial and subserial shall meet the

applicable requirements prescribed in

§ 113.300. The identity test required in

§ 113.300(c) shall be conducted in a

serotype-specific manner by a method

acceptable to APHIS. Final container

samples of completed product shall also

meet the requirements in paragraphs

(d)(1), (2), and (3) of this section. Any

serial or subserial found unsatisfactory

by a prescribed test shall not be

released.

(1) Purity test. The chicken embryo

inoculation test prescribed in § 113.37

shall be conducted, except that, if the

test is inconclusive because of a vaccine

virus override, the chicken inoculation

test prescribed in § 113.36 may be

conducted and the virus judged

accordingly.

(2) Safety test. At least 25 one-dayold, specific pathogen free chickens

shall be injected, by the subcutaneous

route, with the equivalent of 10 chicken

doses of virus (vaccine concentrated

10X). The chickens shall be observed

each day for 21 days. Chickens dying

during the period shall be examined,

cause of death determined, and the

results recorded.

(i) If at least 20 chickens do not

survive the observation period, the test

is inconclusive.

(ii) If lesions of any disease or cause

of death are directly attributable to the

vaccine, the serial is unsatisfactory.

(iii) If less than 20 chicks survive the

observation period and there are no

deaths or lesions attributable to the

vaccine, the test may be repeated one

time, Provided, that if the test is not

repeated, the serial shall be declared

unsatisfactory.

(3) Potency test. The samples shall be

titrated using a cell culture system or

other titration method acceptable to

APHIS. For vaccines composed of more

than one Marek’s disease virus serotype,

each fraction shall be titrated in a

serotype-specific manner.

(i) Samples of desiccated vaccine

shall be incubated at 37°C for 3 days

before preparation for use in the

potency test. Samples of desiccated or

frozen vaccine shall be reconstituted in

diluent according to the label

recommendations, and held in an ice

bath at 0°C to 4°C for 2 hours prior to

use in the potency test.

(ii) For a serial or subserial to be

eligible for release, each serotype

contained in the vaccine shall have a

virus titer per dose which is at least 3

times greater than the number of plaque

forming units (pfu) used in the

immunogenicity test prescribed in

paragraph (c) of this section, but not less

than 1000 pfu per dose.

(iii) When tested (without the pretest

incubation of desiccated products) at

any time within the expiration period,

each serotype contained in the vaccine

shall have a virus titer per dose which

is at least 2 times the number of pfu

used in the immunogenicity test, but not

less than 750 pfu per dose.

Done in Washington, DC, this 28th day of

April 1995.

Lonnie J. King,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–11375 Filed 5–8–95; 8:45 am]

BILLING CODE 3410–34–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 94–NM–135–AD]

Airworthiness Directives; British

Aerospace Model Viscount 744, 745D,

and 810 Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes the

supersedure of an existing airworthiness

directive (AD), applicable to certain

British Aerospace Model Viscount 744,

745D, and 810 airplanes, that currently

establishes time-in-service limits for

components of the fuselage pressure

vessel, and requires modifications and

inspections of various fuselage

components to assure the continued

structural integrity of these airplanes

through the manufacturer’s design life

goal. This action would require

additional modifications and

inspections of the fuselage pressure

vessel to extend the fuselage pressure

vessel life from 30 to 45 years since

new. This proposal is prompted by

results of a review of fatigue test

findings, stress analysis, and in-service

history associated with pressure vessel

components. The actions specified by

the proposed AD are intended to

prevent reduced structural capability of

the fuselage pressure vessel.

DATES: Comments must be received by

June 20, 1995.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–103,

Attention: Rules Docket No. 94–NM–

135–AD, 1601 Lind Avenue, SW.,

Renton, Washington 98055–4056.

Comments may be inspected at this

location between 9:00 a.m. and 3:00

p.m., Monday through Friday, except

Federal holidays.

The service information referenced in

the proposed rule may be obtained from

British Aerospace Regional Aircraft Ltd.,

Engineering Support Manager, Military

Business Unit, Chadderton Works,

Greengate, Middleton, Manchester M24

1SA, England. This information may be

examined at the FAA, Transport

Airplane Directorate, 1601 Lind

Avenue, SW., Renton, Washington.

FOR FURTHER INFORMATION CONTACT:

William Schroeder, Aerospace Engineer,

Standardization Branch, ANM–113,

FAA, Transport Airplane Directorate,

1601 Lind Avenue, SW., Renton,

Washington 98055–4056; telephone

(206) 227–2148; fax (206) 227–1320.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested persons are invited to

participate in the making of the

proposed rule by submitting such

written data, views, or arguments as

they may desire. Communications shall

identify the Rules Docket number and

be submitted in triplicate to the address

specified above. All communications

received on or before the closing date

for comments, specified above, will be

considered before taking action on the

proposed rule. The proposals contained