Agency Information Collection Activities: Submission for OMB Review; Comment Request; Registration of Fuels and Fuel Additives Health-effects Research Requirements

ENVIRONMENTAL PROTECTION AGENCY

[FRL-5970-1]

Agency Information Collection Activities: Submission for OMB

Review; Comment Request; Registration of Fuels and Fuel Additives--

Health-effects Research Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501

et seq.), this document announces that the following Information

Collection Request (ICR) has been forwarded to the Office of Management

and Budget (OMB) for review and approval: Registration of Fuels and

Fuel Additives: Health-effects Research Requirements for Manufacturers

(40 CFR 79--subpart F) (OMB Control Number 2060-0297, expiration date:

4-30-98). The ICR describes the nature of the information collection

and its expected burden and cost; where appropriate, it includes the

actual data collection instrument.

DATES: Comments must be submitted on or before March 25, 1998.

FOR FURTHER INFORMATION CONTACT:

For a copy of the ICR, call Sandy Farmer at EPA, by phone at (202) 260-

2740, by E-Mail at Farmer.S[email protected] or download off the

Internet at http://www.epa.gov/icr/icr.htm, and refer to EPA ICR No.

1696.02.

SUPPLEMENTARY INFORMATION

Title: Registration of Fuels and Fuel Additives: Health-effects

Research Requirements for Manufacturers (40 CFR 79--subpart F), (OMB

Control Number 2060-0297, EPA ICR Number 1696.02) expiring 4-30-98.

This is a request for an extension of a currently approved collection.

Abstract: In accordance with the Clean Air Act regulations at 40

CFR 79, manufacturers (including importers) of gasoline, diesel fuel,

and additives for gasoline or diesel fuel, are required to have their

products registered by the EPA prior to their introduction into

commerce. Registration involves providing a chemical description of the

fuel or additive, and certain technical, marketing, and health-effects

information. The health-effects research is the subject of this ICR.

The other information collection requirements at 40 CFR 79 are covered

by a separate ICR (EPA ICR Number 309.09, OMB Control Number 2060-

0150). The health-effects research is divided into three tiers of

requirements for specific categories of fuels and additives. Tier 1

requires a health-effects literature search and emissions

characterization. Tier 1 data were submitted in 1997 and will be

applicable for most new products seeking registration. Tier 2 requires

short-term inhalation exposures of laboratory animals to emissions to

screen for adverse health effects, unless comparable data are already

available. Alternative Tier 2 testing can be required in lieu of the

standard Tier 2 if EPA concludes that such testing would be more

appropriate. Certain small businesses are exempt from some or all of

the Tier 1 and Tier 2 requirements. Tier 3 provides for follow-up

research, if necessary. (However, no Tier 3 requirements have been

established. Thus, it is not covered in this notice.) This information

will be used to determine if there are any products whose evaporative

or combustion emissions may pose an unreasonable risk to public health,

thus meriting further investigation and potential regulation. In

accordance with the Clean Air Act, the results of this research shall

not be considered confidential. An agency may not conduct or sponsor,

and a person is not required to respond to, a collection of information

unless it displays a valid OMB control number. The OMB control numbers

for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter

15. The Federal Register document required under 5 CFR 1320.8(d),

soliciting comments on this collection of information, was published on

December 1, 1997 (62 FR 63544); no comments were received.

[[Page 8980]]

Burden Statement: The burden covered by this document is limited

because little additional Tier 1 activity is anticipated and the EPA is

in negotiation with the regulated parties on Alternative Tier 2

requirements for most of the registered products for which standard

Tier 2 testing would otherwise be required. This ICR will be amended

once the Alternative Tier 2 requirements are established. Thus, over

the next three years only one Tier 1 submission and one standard Tier 2

submission are anticipated, with a total burden of 10,400 hours and

cost of $1 million. The annual public reporting and recordkeeping

burden for this collection is estimated to average 3,467 hours. Burden

means the total time, effort, or financial resources expended by

persons to generate, maintain, retain, or disclose or provide

information to or for a Federal agency. This includes the time needed

to review instructions; develop, acquire, install, and utilize

technology and systems for the purposes of collecting, validating, and

verifying information, processing and maintaining information, and

disclosing and providing information; adjust the existing ways to

comply with any previously applicable instructions and requirements;

train personnel to be able to respond to a collection of information;

search data sources; complete and review the collection of information;

and transmit or otherwise disclose the information.

Respondents/Affected Entities: Manufacturers of gasoline, diesel

fuel, and fuel additives.

Estimated Number of Respondents: 2.

Frequency of Response: On occasion.

Estimated Total Annual Hour Burden: 3,467 hours.

Estimated Total Annualized Cost Burden: $154,000.

Send comments on the Agency's need for this information, the

accuracy of the provided burden estimates, and any suggested methods

for minimizing respondent burden, including the use of automated

collection techniques, to the following addresses. Please refer to EPA

ICR Number 1696.02 and OMB Control Number 2060-0297 in any

correspondence.

Ms. Sandy Farmer, U.S. Environmental Protection Agency, OPPE Regulatory

Information Division (2137), 401 M Street, SW, Washington DC 20460;

and

Office of Information and Regulatory Affairs, Office of Management and

Budget, Attention: Desk Officer for EPA, 725 17th Street, NW,

Washington, DC 20503.

Dated February 19, 1998.

Joseph Retzer,

Director, Regulatory Information Division.

[FR Doc. 98-4519 Filed 2-20-98; 8:45 am]

BILLING CODE 6560-50-M