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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-6418-5]

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 part 79--subpart F) (OMB Control Number 2060-0297, expiration

date: October 31, 1999). 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 September 13, 1999.

FOR FURTHER INFORMATION CONTACT: Sandy Farmer at EPA by phone at (202)

260-2740, by E-Mail at Farmer.S[email protected] or download a copy

of the ICR off the Internet at http://www.epa.gov/icr and refer to EPA

ICR No. 1696.03.

SUPPLEMENTARY INFORMATION:

[[Page 44007]]

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

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

(OMB Control Number 2060-0297, EPA ICR Number 1696.03) expiring October

31, 1999. This is a request for an extension of a currently approved

collection.

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

CFR part 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 part 79 are

covered by a separate ICR (EPA ICR Number 309.09, OMB Control Number

2060-1050). The health-effects research is divided into three tiers of

requirements for specific categories of fuels and additives. Tier 1

requires an emissions characterization and a health-effects literature

search for those emissions. Tier 1 data were submitted in 1997 and 1998

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. EPA reached that conclusion with respect to baseline

gasoline, oxygenated gasoline additives, and Ethyl Corporation's

manganese gasoline additive MMT. 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 document. 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 April 7, 1999 (64 FR 16960); one

comment was received. It was a brief statement from the Ethyl

Corporation referencing the continuing dialogue over the appropriate

testing for MMT.

Burden Statement: It is likely that only limited additional Tier 1

research will be done. New fuels and additives subject to Tier 1 will

almost exclusively be those that can group with existing Tier 1 data,

and come from manufacturers that have already paid for the Tier 1 data.

Thus, over the next three years only one Tier 1 submission is

anticipated. Standard Tier 2 activity will also be very limited. The

EPA has concluded that existing data cover Tier 2 for baseline diesel.

Alternative Tier 2 testing will be conducted over the next five years

and covers baseline gasoline, the six major nonbaseline gasoline

oxygenates, and the atypical gasoline additive MMT. Thus, only up to

four standard Tier 2 submissions are anticipated over the next three

years. The annual public reporting and recordkeeping burden for this

collection is estimated to average 20,695 hours per response. 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: 6.

Frequency of Response: On occasion.

Estimated Total Annual Hour Burden: 67,467 hours.

Estimated Total Annualized Capital, O & M Cost Burden: $6.5

million.

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 1696.03 and OMB Control Number 2060-0297 in any

correspondence.

Ms. Sandy Farmer, U.S. Environmental Protection Agency, Office of

Policy, 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: August 6, 1999.

Richard T. Westlund,

Acting Director, Regulatory Information Division.

[FR Doc. 99-20864 Filed 8-11-99; 8:45 am]

BILLING CODE 6560-50-P