Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules 12165

(2) All biological products in USDAlicensed establishments, whether

licensed by USDA or by the State, shall

be prepared only in locations indicated

in legends filed in accordance with 9

CFR part 108. A description of each

State-licensed product must be filed

with the Animal and Plant Health

Inspection Service as part of the

blueprint legends and must be sufficient

for Animal and Plant Health Inspection

Service to determine any risk to the

production of other products in the

licensed establishment and to determine

that adequate procedures are followed

to prevent contamination during

production.

(3) Records in such establishments

must be maintained in accordance with

§§ 116.1 and 116.2 of this subchapter

and shall include all products licensed

by the State or USDA.

(4) Reports prescribed in § 116.5 of

this subchapter for USDA-licensed

establishments shall be submitted for all

veterinary biological products in the

establishment.

(5) Under the following conditions, an

autogenous biologic may be produced in

a USDA-licensed establishment under

either a State or U.S. Veterinary

Biological Product License:

(i) When a culture of microorganisms,

isolated from a herd in a State, is

received at a USDA-licensed

establishment that is in the same State

but that holds both a State and a U.S.

Veterinary Biological Products License

for autogenous biologics, the isolate

shall be designated by the licensee for

use in the production of an autogenous

biological product under either the State

product license, or the U.S. Veterinary

Biological Product License: Provided,

That the isolate meets the requirements

of the respective regulatory authority for

an autogenous biologic. If, after

producing the product pursuant to one

license, the licensee elects to produce

an autogenous biologic from the same

isolate under provisions of the other

license, the licensee may do so only

with the approval of the other licensing

authority.

(ii) The true name of a State-licensed

autogenous biologic shall specify the

State of licensure: e.g. ‘‘(State)

Autogenous Bacterin’’ or ‘‘(State)

Autogenous Vaccine’’.

Done in Washington, DC, this 28th day of

February 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–5407 Filed 3–3–95; 8:45 am]

BILLING CODE 3410–34–M

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1700

Requirements for the Special

Packaging of Household Substances;

Opportunity for Oral Comment

AGENCY: Consumer Product Safety

Commission.

ACTION: Opportunity for presentation of

oral public comments.

SUMMARY: The Commission announces

an opportunity for the presentation of

oral comments on two issues that were

recently raised concerning amendments

the Commission is considering to its

regulations under the Poison Prevention

Packaging Act of 1970 (PPPA) for childresistant packaging to change the child

and adult tests under which childresistant packaging is evaluated.

Immediately after issuing a rule

amending the PPPA test protocol, the

Commission was provided with

comments on the final rule that had not

previously been submitted to the agency

during the course of the rulemaking. As

a result, the Commission, on February 9,

1995, voted to withhold publication of

the final rule in order to consider these

new arguments.

The new arguments can be

summarized as follows. First, in

establishing an adult test panel

consisting of adults aged 60–75, the

Commission allegedly exceeded its

statutory authority to require that childresistant packaging not be difficult for

‘‘normal adults’’ to use properly.

Second, the rule allegedly addresses

consumer convenience, rather than

safety, which the comment claims is not

properly the subject of a Commission

regulation.

The Commission has provided that

written comments, limited to these two

issues, may be submitted until March 7,

1995. In addition, the Commission is

providing the opportunity for interested

parties to present oral comments, on

these two issues alone, limited to a

maximum of 10 minutes per

commenter.

DATES: Oral comments limited to the

new issues described below may be

presented to the Commission at a

Commission hearing beginning at 10:00

a.m., March 16, 1995. A request to

present oral comments and an outline or

text of the comments must be received

by the Commission on or before March

10, 1995.

ADDRESSES: The hearing will be held in

the Commission’s Hearing Room, 4330

East-West Highway, 4th Floor, Bethesda,

MD 20814. Requests to present

comments and outlines or text of the

comments should be mailed to the

Office of the Secretary, Consumer

Product Safety Commission,

Washington, DC 20207, or delivered to

the Office of the Secretary, Consumer

Product Safety Commission, Room 501,

4340 East-West Highway, Bethesda, MD

20814.

FOR FURTHER INFORMATION CONTACT:

Suzanne Barone, Ph.D., Project

Manager, Consumer Product Safety

Commission, Washington, DC 20207;

telephone (301) 504–0477, ext. 1196.

SUPPLEMENTARY INFORMATION: The

Poison Prevention Packaging Act of

1970 (‘‘PPPA’’), 15 U.S.C. 1471–1476,

authorizes the Consumer Product Safety

Commission to issue requirements that

certain household substances be sold in

child-resistant (‘‘CR’’) packaging. Under

the PPPA, the Commission has defined

and established standards for such

‘‘special’’ packaging. 16 CFR

1700.1(b)(4), 1700.3, 1700.15, and

1700.20. The Commission has also

determined which household

substances are required to have the

special packaging. 16 CFR 1700.14.

Congress provided that to comply

with the special packaging

requirements, a package must resist

entry by most young children and must

be ‘‘not difficult’’ for ‘‘normal adults’’ to

open and properly resecure, within

specified time periods. 15 U.S.C.

1471(4). The Commission’s existing

regulations were developed before the

widespread use of CR packaging

(‘‘CRP’’) and, therefore, without the

benefit of the actual use experience and

test data that since have become

available.

The current adult test protocol, 16

CFR 1700.20(a) (4) and (5), specifies a

test panel of 100 adults, ages 18 through

45 years. Seventy percent of the adults

must be females and 30 percent must be

males. The test period is 5 minutes. The

adults are given the test package and

asked to open and then properly close

the package. For a package to meet the

PPPA effectiveness criteria, at least 90

percent of the adults must be able to

open and, if appropriate, properly close

the package within the 5-minute test

period. 16 CFR 1700.15(b)(2).

Although the PPPA has significantly

reduced the number of poisonings of

young children, deaths and injuries

resulting from these accidental

ingestions continue to be a substantial

problem. For example, in 1993 alone,

approximately 140,000 children under 5

years old were treated in hospital

emergency rooms for suspected or

actual poisonings. Also in 1993, poison

control centers received reports of more
12166 Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules

than 6,000 poisonings of young children

with ‘‘moderate’’ or ‘‘major’’ (lifethreatening) effects. In addition, 42

children died in these accidents in

1992, the last year for which the

Commission has complete data.

During the more than 20 years since

the PPPA was adopted, the Commission

has found that, contrary to requirements

of the PPPA, ‘‘normal’’ adults of all ages

have difficulty using typical CRP.

Moreover, the Commission’s data

indicate that the difficulty in using CRP

results in a substantial number of

accidental ingestions by young children

because adults purchase hazardous

substances in non-CRP or disable CRP

by leaving the caps off or loose or

transferring the package contents to

another container.

Accordingly, the Commission sought

to address the safety hazard created by

difficult to open CRP. On January 19,

1983, the Commission published an

advance notice of proposed rulemaking

(‘‘ANPR’’) outlining its concerns in this

area and explaining and seeking

comment on possible actions to increase

the proper use of CRP, to simplify the

test procedures, and to make the test

procedures less affected by possible

variables. 48 FR 2389.

Older adults typically have the most

difficulty with CRP. Therefore, in order

to eliminate the currently-marketed CR

package designs that are most difficult

for ‘‘normal adults’’ of all ages to open,

the Commission indicated that older

adults, ages from 60–75 years, could be

substituted for the current panel of 100

18–45-year-olds.

After considering comments on the

ANPR and other available information,

the Commission proposed amendments

to the protocol to address this problem.

The proposed amendments would also

change the protocol to make the test

results more consistent and make the

child test easier to perform. The

Commission published its initial

proposal in the Federal Register of

October 5, 1990, for public comment. 55

FR 40856.

In addition to the requests for

comments in January 1983 and October

1990 noted above, the Commission

announced additional comment periods

on March 5, 1991, (56 FR 9181) and

March 21, 1994 (59 FR 13264). The

Commission’s staff evaluated the

comments received in response to each

of these requests.

On December 20, 1994, the

Commission was briefed by its staff on

the comments on the proposed rule and

the changes recommended by the staff.

On January 6, 1995, the Commission

met and decided to approve the rule

recommended by the staff, but to

exclude from the scope of the rule those

products that must be packaged in metal

cans or aerosol form. The staff made

appropriate changes to the draft Federal

Register notice that would issue the

final rule, and that notice was approved

by the Commission on February 6, 1995.

Immediately thereafter, the Coalition

for Responsible Packaging, an industry

group, raised concerns about the

Commission’s action. Most of these

concerns already had been addressed in

the rulemaking proceeding. Two

concerns, however, had not been the

subject of specific comments by

interested parties in this rulemaking.

Specifically, the new comments can

be summarized as follows. First, in

establishing an adult test panel

consisting of adults aged 60–75, the

Commission allegedly exceeded its

statutory authority to require that childresistant packaging not be difficult for

‘‘normal adults’’ to use properly.

Second, the rule allegedly addresses

consumer convenience, rather than

safety, which the comment claims is not

properly the subject of a Commission

regulation. In addition, the second

comment contends that to the extent

that child-resistant packages exist that

will pass the ‘‘senior friendly’’ test

approved by the Commission, market

forces will be an adequate and more

appropriate mechanism to ensure that

the more convenient packaging will be

adopted.

The Commission wanted to assure

that it had an opportunity to consider

these new arguments that had not

previously been raised in the

rulemaking. Accordingly, on February 8,

1995, the Commission voted

unanimously to withhold publication of

the Federal Register notice that would

have issued the final rule, to consider

the new arguments.

On February 21, 1995, the

Commission published a Federal

Register notice announcing that written

comments, limited to these two issues

only, could be submitted until March 7,

1995. 60 FR 9654. The Commission has

now decided to also receive oral

comments on these two new issues. Oral

comments on these new issues alone

may be presented to the Commission at

a Commission hearing beginning at

10:00 a.m., March 16, 1995.

A request to present oral comments

and an outline or text of the comments

must be received by the Commission on

or before March 10, 1995. The oral

comments shall be limited to 10

minutes per commenter. The

Commission reserves the right to further

limit repetitious comments. Comments

addressing other issues will not be

considered.

The hearing will be held in the

Commission’s Hearing Room, 4330 EastWest Highway, 4th Floor, Bethesda, MD

20814. Requests to present oral

comments and outlines or text of the

comments shall be mailed to the Office

of the Secretary, Consumer Product

Safety Commission, Washington, D.C.

20207, or delivered to the Office of the

Secretary, Consumer Product Safety

Commission, Room 501, 4340 East-West

Highway, Bethesda, MD 20814.

Dated: March 1, 1995.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 95–5502 Filed 3–2–95; 11:42 am]

BILLING CODE 6355–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Social Security Administration

20 CFR Parts 404 and 416

[Regs. No. 4 and 16]

RIN 0960–AB73

Determining Disability and Blindness;

Substantial Gainful Activity Guides

AGENCY: Social Security Administration,

HHS.

ACTION: Proposed rules.

SUMMARY: These proposed rules reflect

amendments to the Social Security Act

(the Act) concerning the trial work

period and the disability insurance

reentitlement period. The proposed

rules also clarify certain standards we

use to determine whether work is

substantial gainful activity and whether

an individual is entitled to a trial work

period, thereby further explaining how

we determine disability under titles II

and XVI of the Act.

DATES: To be sure that your comments

are considered, we must receive them

no later than May 5, 1995.

ADDRESSES: Comments should be

telefaxed to (410) 966–0869 or

submitted in writing to the

Commissioner of Social Security,

Department of Health and Human

Services, P.O. Box 1585, Baltimore, MD

21235, or delivered to the Office of

Regulations, Social Security

Administration, 3–B–1 Operations

Building, 6401 Security Boulevard,

Baltimore, MD 21235, between 8 a.m.

and 4:30 p.m. on regular business days.

Comments may be inspected during

these same hours by making

arrangements with the contact person

shown below.