Final Notification of Alternative Tier 2 Requirements for Methylcyclopentadienyl Manganese Tricarbonyl (MMT)

AGENCY:

Environmental Protection Agency.

ACTION:

Notice.

SUMMARY:

The purpose of this notice is to announce that the Environmental Protection Agency (EPA) has notified the Ethyl Corporation (Ethyl), manufacturer of the motor fuel additive methylcyclopentadienyl manganese tricarbonyl (MMT), and other affected registrants of motor fuels and additives containing MMT, of Alternative Tier 2 health and exposure testing requirements.

DATES:

The Alternative Tier 2 testing requirements for MMT are effective upon receipt by Ethyl of the notification letter discussed in this notice.

ADDRESSES:

Written requests for information regarding this notification should be addressed to Public Docket Number A-98-35, Waterside Mall (Room M-1500), Environmental Protection Agency, Air Docket Section, 401 M Street, SW, Washington, DC 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 notice are those that manufacture or use the fuel additive MMT. Regulated categories and entities include:

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 has concluded 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 (“F/FAs”) 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

On January 29, 1999, Ethyl was notified by certified letter of certain tests which the Agency proposed 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 fuel additives containing MMT were also notified by certified letter. An associated Federal Register notice (64 FR 6294) initiated a 60-day public comment period. Copies of the documents associated with the proposed tests and schedule under the Alternative Tier 2 provisions have been placed in the docket.

The purpose of this notice is to announce that the Environmental Protection Agency (EPA) has notified Ethyl, the manufacturer of MMT, and other affected registrants of fuels and additives containing MMT, of the adoption of 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.

The purpose of the 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 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 notice.

On May 19, 2000, Ethyl was notified by a certified letter of the specific tests which the Agency is requiring under the Alternative Tier 2 provisions for MMT, and the 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 Alternative Tier 2 tests and the 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, SW, Washington, DC 20460. The notifications are also available on the internet via EPA's Mobile Source home page at http://www.epa.gov/OMSWWW/.

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 testing requirements which are the subject of this notice 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.

List of Subjects in 40 CFR Part 79

• Environmental protection
• Air pollution control
• Gasoline
• Conventional gasoline
• Methylcyclopentadienyl manganese tricarbonyl, and Motor vehicle pollution