Regulatory Developments

EPA Issues ICR Concerning Health Effects Research Requirements for Manufacturers of Fuels and Fuel Additives

February 21, 2013 PRINT

The U.S. Environmental Protection Agency (EPA) published in the February 20, 2013, Federal Register a notice announcing its intent to extend an Information Collection Request (ICR) concerning "Registration of Fuels and Fuel Additives -- Health-Effects Research Requirements for Manufacturers." Manufacturers (including importers) of fuels and additives designated by EPA, including motor-vehicle gasoline, motor-vehicle diesel fuel, and additives for those fuels, are required to register their products with EPA before introducing them into commerce. Registrants must submit certain health effects information, and the development of this data is the subject of the ICR. The ICR is currently approved through August 31, 2013. Comments are due April 22, 2013.

According to the notice, EPA will use the health effects data to determine if there are any products that have evaporative or combustion emissions that may pose an unreasonable risk to public health, thus warranting further investigation and potential regulation. EPA has required submission of health effects data for groups of fuels and additives that share certain specified characteristics. For example, the notice states, gasoline and gasoline additives that consist of only carbon, hydrogen, oxygen, nitrogen, and/or sulfur, and that involve a gasoline oxygen content of less than 1.5 weight percent, fall into a "baseline" group. Oxygenated additives, such as ethanol, when used in gasoline at an oxygen level of at least 1.5 weight percent, define separate "nonbaseline" groups for each oxygenate. Fuels and additives that contain elements other than carbon, hydrogen, oxygen, nitrogen, and sulfur fall into separate "atypical" groups. There are similar grouping requirements for diesel fuel and diesel fuel additives.

EPA notes that manufacturers may perform the research independently or may join with other manufacturers to share in the costs for each applicable group, and that several research consortiums have been formed. According to the notice, the largest consortium, organized by the American Petroleum Institute (API), represents most of the manufacturers of baseline gasoline, baseline diesel fuel, baseline fuel additives, and the prominent nonbaseline oxygenated additives for gasoline. Research is structured into three tiers of requirements for each group:

  • Tier 1 requires an emissions characterization and a literature search for information on the health effects of those emissions. API and others submitted "voluminous" Tier 1 data for gasoline and diesel fuel in 1997. Tier 1 data have been submitted for biodiesel, water/diesel emulsions, several atypical additives, and renewable gasoline and diesel fuels.
  • Tier 2 requires short-term inhalation exposures of laboratory animals to emissions to screen for adverse health effects. Tier 2 data have been submitted for baseline diesel, biodiesel, and water/diesel emulsions. Alternative Tier 2 testing can be required in lieu of standard Tier 2 testing if EPA concludes that such testing would be more appropriate. EPA states that it reached that conclusion with respect to gasoline and gasoline-oxygenate blends, and it established alternative requirements for the API consortium for baseline gasoline and six gasoline-oxygenate blends. EPA also has established alternative Tier 2 requirements for the manganese additive MMT manufactured by the Afton Chemical Corporation (formerly the Ethyl Corporation).
  • Tier 3 provides for follow-up research, at EPA's discretion, when remaining uncertainties as to the significance of observed health effects, welfare effects, and/or emissions exposures from a fuel or fuel/additive mixture interfere with EPA's ability to make reasonable estimates of the potential risks posed by emissions from a fuel or additive. To date, EPA has not imposed any Tier 3 requirements.

In general, the applicable testing requirements for existing fuel/fuel additive groups have already been satisfied by the affected registrants. New testing requirements may be imposed if EPA determines that a new fuel/fuel additive group must be created, or if EPA determines that new data are needed for an existing fuel/fuel additive group.

The notice includes the following information regarding the ICR:

Form Numbers: None.
Respondents/affected entities: Manufacturers of motor-vehicle gasoline, motor-vehicle diesel fuel, and additives for those fuels.
Respondent's obligation to respond: Mandatory per 40 CFR 79.
Estimated number of respondents: 2.
Frequency of response: On occasion.
Total estimated burden: 19,200 hours per year. Burden is defined at 5 CFR 1320.03(b).
Total estimated cost: $2 million per year, includes $0.5 million annualized capital or operation and maintenance costs.
Changes in Estimates: There is a decrease of 2,000 hours in the total estimated respondent burden compared with the ICR currently approved by the Office of Management and Budget (OMB). This decrease is due to the conclusion of a testing program included in the previous ICR.

In the notice, EPA states that it is soliciting comments and information to enable it to: (i) evaluate whether the proposed collection of information is necessary for the proper performance of its functions; (ii) evaluate the accuracy of EPA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond. EPA will consider the comments received and amend the ICR as appropriate. EPA will then submit the final ICR package to OMB for review and approval.

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