7684 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. In §180.284, paragraph (c) is

amended by revising the introductory

text and adding in alphabetical order

new entries to the table to read as

follows:

§ 180.284 Zinc phosphide, tolerances for

residues.

* * * * *

(c) Time-limited tolerances are

established for residues of phosphine

resulting from the use of the rodenticide

zinc phosphide in connection with use

of the pesticide under FIFRA section 18

emergency exemptions granted by EPA.

The tolerances are specified in the

following table. The tolerances expire

on the date specified in the table.

Commodity

Parts

per million

Expiration/

Revocation

Date

Alfalfa (forage) .... 0.1 April 15, 1998

Alfalfa (hay) ......... 0.1 April 15, 1998

Clover (forage) .... 0.1 April 15, 1998

Clover (hay) ........ 0.1 April 15, 1998

* * * * *

Timothy (forage) 0.1 April 15, 1998

Timothy (hay) ...... 0.1 April 15, 1998

Timothy (seed) .... 0.1 April 15, 1998

[FR Doc. 97–3931 Filed 2–19–97; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 261

[SW–FRL–5690–6]

Hazardous Waste Management

System; Identification and Listing of

Hazardous Waste; Amendment

AGENCY: Environmental Protection

Agency.

ACTION: Final rule; amendment.

SUMMARY: The Environmental Protection

Agency (EPA or the Agency) is

amending 40 CFR part 261, appendix IX

to reflect changes in ownership and

name for United Technologies

Automotive, Inc., Jeffersonville, Indiana.

Today’s amendment documents these

changes.

EFFECTIVE DATE: February 20, 1997.

FOR FURTHER INFORMATION CONTACT:

RCRA Hotline, toll free at (800) 424–

9346 or at (703) 412–9810. For technical

information contact Ms. Judy Kleiman,

Waste Management Branch (DRP–8J),

Waste, Pesticides and Toxics Division,

U.S. Environmental Protection Agency,

77 W. Jackson Blvd, Chicago, IL 60604,

(312) 886–1482.

SUPPLEMENTARY INFORMATION: In this

document EPA is amending appendix

IX to part 261 to reflect changes in the

ownership and name for United

Technologies Automotive. The petition

process under §§ 260.20 and 260.22

allows facilities to demonstrate that a

specific waste from a particular

generating facility should not be

regulated as a hazardous waste. Based

on waste specific information provided

by the petitioner, EPA granted an

exclusion to United Technologies

Automotive on April 29, 1986, for F019

wastes at its Jeffersonville, Indiana,

facility (51 FR 15888). On November 20,

1995, Region 5 received notice that

ownership of the United Technologies

Automotive facility in Jeffersonville,

Indiana, was transferred to Profile

Extrusion Company. On November 14,

1996, Region 5 received notice that

ownership of Profile Extrusion

Company was transferred to Alumnitec,

Inc.

In this notification Alumnitec noted

that no changes had been made in the

management of the F019 waste excluded

by the Agency, and that all conditions

of the exclusion will continue to be met.

Today’s notice documents this change

by updating Appendix IX to incorporate

this change in name.

This change to 40 CFR Part 261,

Appendix IX will be effective February

20, 1997. The Hazardous and Solid

Waste Amendments of 1984 amended

section 3010 of RCRA to allow rules to

become effective in less than six months

when the regulated community does not

need the six-month period to come into

compliance. As described above,

Alumnitec will continue to meet all

conditions of United Technologies

Automotive’s exclusion. Therefore, a

six-month delay in the effective date is

not necessary in this case. This provides

a basis for making this amendment

effective immediately upon publication

under the Administrative Procedures

Act, pursuant to 5 U.S.C. 5531(d).

List of Subjects in 40 CFR Part 261

Environmental protection, Hazardous

waste, Recycling, Reporting and

recordkeeping requirements.

Dated: January 21, 1997.

Jo Lynn Traub,

Acting Regional Administrator, Region 5.

For the reasons set out in the

preamble, 40 CFR part 261 is to be

amended as follows:

PART 261—IDENTIFICATION AND

LISTING OF HAZARDOUS WASTE

1. The authority citation for part 261

continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6921,

6922, 6924(y) and 6938.

2. 40 CFR Part 261, Appendix IX,

Table 1, is amended by removing the

entry for ‘‘United Technologies

Automotive, Inc.’’ and by adding in

alphabetical order the entry for

‘‘Alumnitec, Inc.’’ to read as follows:

Appendix IX to Part 261—Wastes

Excluded Under §§ 260.20 and 260.22

TABLE 1.—WASTES EXCLUDED FROM NON-SPECIFIC SOURCES

Facility Address Waste description

* * * * * * *

Alumnitec, Inc. (formerly Profile Extrusion Co., formerly

United Technologies Automotive, Inc.).

Jeffersonville, IN ................. Dewatered wastewater treatment sludge (EPA Hazardous Waste No. F019) generated from the chemical

conversion of aluminum after April 29, 1986.

* * * * * * *
Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations 7685

[FR Doc. 97–4121 Filed 2–19–97; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

42 CFR Part 100

RIN 0906–AA36

National Vaccine Injury Compensation

Program: Revisions and Additions to

the Vaccine Injury Table—II

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Final rule.

SUMMARY: The Secretary has made

findings as to certain illnesses and

conditions that can reasonably be

determined in some circumstances to be

caused or significantly aggravated by

certain vaccines. Based on these

findings, the Secretary is amending, by

final rule, the existing regulations

governing the National Vaccine Injury

Compensation Program (VICP) by

revising the Vaccine Injury Table

(Table) as authorized under section 313

of the National Childhood Vaccine

Injury Act of 1986 and section 2114 (c)

and (e) of the Public Health Service Act

(the Act).

The VICP provides a system of nofault compensation for certain

individuals who have been injured by

specific childhood vaccines. The

Vaccine Injury Table included in the

Act establishes presumptions about

causation of certain illnesses and

conditions, which are used by the Court

to adjudicate petitions.

EFFECTIVE DATE: This regulation is

effective March 24, 1997.

FOR FURTHER INFORMATION CONTACT:

Geoffrey Evans, M.D., Chief Medical

Officer, Division of Vaccine Injury

Compensation, Bureau of Health

Professions, (301) 443–4198, or David

Benor, Senior Attorney, Office of the

General Counsel (301) 443–2006.

SUPPLEMENTARY INFORMATION:

Introduction and Procedural History

On November 8, 1995, the Assistant

Secretary for Health, with the approval

of the Secretary of Health and Human

Services (the Secretary), published in

the Federal Register (60 FR 56289) A

Notice of Proposed Rulemaking (NPRM)

to amend the Vaccine Injury Table (the

Table) and to revise the Qualifications

and Aids to Interpretation of the Table

(Qualifications and Aids). The NPRM

was issued pursuant to section 2114(c)

of the Act, which authorizes the

Secretary to promulgate regulations to

modify the Table, and section 2114(e),

which directed the Secretary to add to

the Table, by rulemaking, coverage of

additional vaccines which are

recommended by the Centers for Disease

Control and Prevention for routine

administration to children.

As stated in the preamble to the

NPRM, under section 313 of the Act,

Congress mandated that the Secretary

review the scientific literature and other

relevant information to determine

whether, based upon the available

evidence, a causal relationship exists

between certain adverse events

examined and exposure to vaccines

against diphtheria, measles, mumps,

poliomyelitis, and tetanus. The review

was broadened to include the vaccines

against hepatitis B, and Hemophilus

influenzae type b (Hib). The Secretary

entered into a contract with the Institute

of Medicine (IOM), as recommended by

Congress, to perform this review. The

IOM issued its findings in a report

entitled Adverse Events Associated with

Childhood Vaccines; Evidence Bearing

on Causality. (Institute of Medicine,

K.R. Stratton, C.J. Howe, R.B. Johnson,

Eds., 1994.) Upon consideration of the

IOM report, consultations with the

Advisory Committee on Childhood

Vaccines (ACCV), and the National

Vaccine Advisory Committee (NVAC),

and review of other relevant scientific

information, the Secretary published the

proposed changes to the Table and the

Qualifications and Aids.

There was a 6-month comment period

after publication. The Secretary received

three written comments in response to

the NPRM. A public hearing was

scheduled for February 29, 1996, as

announced in the Federal Register on

February 5, 1996 (61 FR 4249), but no

individual or organization appeared to

testify.

One of the commenters, an

association representing pediatricians,

extended its full support for the

proposed additions and revisions to the

Table.

A second comment was submitted by

a manufacturer of several childhood

vaccines. The manufacturer’s comment

was that the proposed revisions to the

Table did not definitively state how the

proposed revisions would affect persons

who have pending civil actions against

vaccine manufacturers or administrators

when the revisions to the Table become

effective. The manufacturer suggested

that language should be added to the

rule which affirmatively gives plaintiffs

in the tort system the ability to file a

claim, within 2 years after the effective

date of the revision or before judgment,

if the injury or death allegedly

attributable to the vaccine occurred no

more than 8 years before the effective

date of the revision. Section 2116(b) of

the Act provides a 2-year period after

the effective date of a revision to the

Table for a petition to be filed based on

the revision. The injury or death alleged

to be related to the vaccine must have

occurred no more than 8 years before

the date of the revision. However,

section 2111(a)(5)(B) of the Act states

that ‘‘[i]f a plaintiff has pending a civil

action for damages for a vaccine-related

injury or death, such person may not

file a petition under the subsection (b)

(of the Act) for such injury or death.’’

reading these provisions together, it

appears that if a plaintiff in such a case

dismisses the civil action and files a

Program petition within the applicable

time limit, the petition may proceed. (If

the civil action led to an award of

damages or a settlement, section

2111(a)(7) of the Act would prohibit the

filing of the petition.) In the light of

these statutory provisions, we believe

that the issue raised by the commenter

is adequately addressed.

The final comment was from a group

representing vaccine-injured persons

and their families. The group had

comments in several areas. The

Secretary has carefully considered these

comments and responds to them below.

The first assertion of the group was that

two independent IOM committees

concluded that the scientific evidence

favors a causal relationship between

oral polio vaccine and tetanus vaccine

and Guillain-Barre Syndrome (GBS).

The commenter questions why, given

this information, the Secretary is

proposing to remove GBS from the

Table. First, it is worth noting that this

condition has never been included in

the Table. Moreover, the preamble to the

NPRM explained in detail the

Department’s reasons for proposing not

to extend the Table’s coverage to this

condition. (60 FR 56292–3 and 56296–

7.) The commenter’s reference to the

IOM committee’s report does not

provide a sufficient basis to reverse the

Department’s analysis, given that this

analysis fully considered the IOM

committee’s report, as well as other

relevant data.

The commenter’s second concern

asked for an explanation of why

anaphylaxis is the only Table injury for

hepatitis B vaccine when the IOM

review stated that no scientific studies

have been conducted to determine if

there is a causal relationship between

hepatitis B and arthritis, Sudden Infant

Death Syndrome (SIDS), GBS, myoptic

(sic: optic) neuritis, multiple sclerosis,

transverse myelitis or other central