Proposed Alternative Tier 2 Requirements for Methylcyclopentadienyl Manganese Tricarbonyl (MMT)

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 79

[FRL-6231-9]

Proposed Alternative Tier 2 Requirements for

Methylcyclopentadienyl Manganese Tricarbonyl (MMT)

AGENCY: Environmental Protection Agency.

ACTION: Notice of proposed requirements.

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SUMMARY: The purpose of this document is to announce that the

Environmental Protection Agency (EPA) has notified the Ethyl

Corporation (Ethyl), manufacturer of the fuel additive

methylcyclopentadienyl manganese tricarbonyl (MMT), and other affected

registrants of fuels and additives containing MMT, of proposed

Alternative Tier 2 health and exposure testing requirements. The

purpose of the proposed testing requirements is to assist in

characterizing potential health risks associated with use of the

additive in unleaded gasoline. By this document, EPA is affording an

opportunity for members of the public to comment on these proposed

requirements.

DATES: EPA will review and consider all comments on the proposed

Alternative Tier 2 testing requirements for MMT which are received by

EPA no later than March 30, 1999.

ADDRESSES: Written comments on this proposed action should be addressed

to Public Docket Number A-98-35, Waterside Mall (Room M-1500),

Environmental Protection Agency, Air Docket Section, 401 M Street,

S.W., Washington, D.C. 20460. A copy of the notification transmitted to

Ethyl and the notification transmitted to other affected registrants

have been placed in Docket A-98-35. Documents may be inspected between

the hours of 8:00 a.m. to 5:30 p.m., Monday through Friday. A

reasonable fee may be charged for copying docket material.

FOR FURTHER INFORMATION CONTACT: Joseph R. Sopata, Chemist, U.S.

Environmental Protection Agency, Office of Air and Radiation, (202)

564-9034.

SUPPLEMENTARY INFORMATION:

Regulated Entities

Entities who may be regulated pursuant to the notifications

referenced in this document are those that manufacture or use the fuel

additive MMT. Regulated categories and entities include:

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Category Examples of regulated entities SIC codes

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Industry............................ The Ethyl Corporation, petroleum 2911, 5172, 2899.

refining, gasoline importers, fuel

additive manufacturers.

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This table is not intended to be exhaustive, but rather provides a

guide for readers regarding entities likely to be regulated by this

action. This table lists the types of entities that EPA is now aware

that could potentially be regulated pursuant to the notifications.

Other types of entities not listed in this table could also be

regulated. If you have any questions regarding the applicability of the

notifications to a particular entity, consult the person listed in the

preceding section dealing with EPA contacts.

I. Introduction

The Clean Air Act (CAA), as amended, required the Administrator of

EPA to promulgate regulations requiring manufacturers of fuels and fuel

additives to conduct tests to determine potential health effects of

such products. The final rule, promulgated on May 27, 1994, established

new health effects testing requirements for the registration of

designated F/FAs as authorized by CAA sections 211(b)(2) and 211(e) of

the CAA.

The registration requirements are organized within a three-tier

structure. Tier 1 requires F/FA manufacturers to supply to EPA (1) the

identity and concentration of certain emission products of designated

F/FAs and an analysis of potential emission exposures, and (2) any

available information regarding the health and welfare effects of the

whole and speciated emissions. 40 CFR 79.52. Tier 2 requires that

combustion emissions of each F/FA subject to the testing requirements

be tested for subchronic systemic and organic toxicity, as well as the

assessment of specific health effect endpoints. 40 CFR 79.53. Tier 3

testing may be required, at EPA's discretion, when remaining

uncertainties as to the significance of observed health or welfare

effects, or emissions exposures interfere with EPA's ability to

reasonably assess the potential risks posed by emissions from a F/FA.

40 CFR 79.54. EPA's regulations permit submission of adequate existing

test data in lieu of conducting new duplicative tests. 40 CFR 79.53(b).

At its discretion, EPA may modify the standard Tier 2 health

effects testing requirements for a F/FA (or group thereof) by

substituting, adding, or deleting testing requirements, or changing the

underlying vehicle/engine specifications. 40 CFR 79.58(c). EPA will

not, however, delete a testing requirement for a specific endpoint in

the absence of existing adequate information, or an alternative testing

requirement for that endpoint. 40 CFR 79.58(c). When EPA exercises its

authority under this special provision, it will allow an appropriate

time for completion of the prescribed alternative tests.

II. Proposed Alternative Tier 2 Requirements for MMT

The purpose of this document is to announce that the Environmental

Protection Agency (EPA) has notified the Ethyl Corporation (Ethyl), the

manufacturer of MMT, and other affected registrants of fuels and

additives containing MMT, of proposed Alternative Tier 2 testing

requirements under 40 CFR 79.58(c) for fuels containing up to 1/32 gram

per gallon (gpg) manganese in the form of MMT. This document also is

intended to afford an opportunity for public comment on the proposed

requirements.

The purpose of the proposed Alternative Tier 2 test requirements is

to address specific research needs related to assessment of the

potential risks associated with use of fuels containing MMT. The

proposed Alternative Tier 2 test requirements are within two general

categories, pharmacokinetic testing of manganese compounds and

characterization of manganese emissions from vehicles utilizing fuels

containing MMT. These Alternative Tier 2 testing requirements are

intended to be the first stage in a two-stage Alternative Tier 2 test

program. EPA intends to evaluate the results produced in the first

stage of testing, as well as any other information which may be

submitted to or obtained by EPA in the meantime, in determining the

specific nature and scope of the second stage of Alternative Tier 2

testing. Any additional Alternative Tier 2 tests proposed for fuels and

additives containing MMT in the future will be announced in a separate

Federal Register document.

On January 29, 1999, Ethyl was notified by certified letter of the

specific tests which the Agency is proposing to require under the

Alternative Tier 2 provisions for MMT, and the proposed schedule for

completion and submission of such tests. Other affected registrants of

fuels and additives containing MMT were also notified by certified

letter. A copy of the notification to Ethyl and the notification to

other registrants, including a description of the proposed Alternative

Tier 2 tests and the proposed schedule for such tests, has been placed

in the Public Docket Number A-98-35, Waterside Mall (Room M-1500),

Environmental Protection Agency, Air Docket Section, 401 M Street,

S.W., Washington, D.C. 20460. The notifications are also available on

the internet via EPA's Mobile Source home page at http://www.epa.gov/

OMSWWW/. The Agency is affording an opportunity for public comment on

these proposed requirements.

III. Environmental Impact

EPA's health effects testing notifications for MMT will result in

no immediate environmental impact. Section 211(c) of the CAA, however,

authorizes EPA to take regulatory action to control or prohibit

manufacture or sale of fuels and fuel additives if testing information

submitted by registrants or other information available to EPA

indicates that use of such products may be reasonably anticipated to

endanger public health or welfare. Thus, information obtained from

health effects testing conducted by manufacturers of F/FAs may provide

a basis for subsequent regulatory action.

IV. Economic Impact

The proposed testing requirements which are the subject of this

document will have a potential economic impact on the affected

registrants, who are obligated to make expenditures to conduct any

required testing. EPA does not anticipate that there will be any direct

economic impact on registrants of fuels and additives containing MMT

other than Ethyl, because Ethyl has stated that it will be responsible

for satisfying any test requirements imposed by EPA for the group of

fuels and additives containing MMT.

The regulations at 40 CFR 79.58(d) also contain special provisions

limiting testing obligations for those fuel or fuel additive

manufacturers whose total annual sales are less than $10 million. EPA

does not believe that the testing requirements which are the subject of

these notifications will have any economic impact on small entities.

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List of Subjects in 40 CFR Part 79

Environmental protection, Air pollution control, Gasoline,

Conventional gasoline, Methylcyclopentadienyl manganese tricarbonyl,

and Motor vehicle pollution.

Dated: February 2, 1999.

Robert A. Perciasepe,

Assistant Administrator, Office of Air and Radiation.

[FR Doc. 99-3141 Filed 2-8-99; 8:45 am]

BILLING CODE 6560-50-P