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OAR Box 1846 

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Document Number: 

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Docket Number: 

A-90-07 

Printed 11/18/2008 7:30:16 AM Sheet 54 of 93 
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i^r 

Testimony 

of 

Richard Cavalli 

on behalf of the 

American Petroleum Institute 

on the 

U.S. Environmental Protection Agency's 

Advance Notice of Proposed Rulemaking 

on 

Testing of Fuels and Fuels Additives 

under 

Section 211 of the Clean Air Act 

55 Federal Register 32218 (Aug. 7, 1990) 

Ann Arbor, Michigan 

September 26, 1990 
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Testimony of American Petroleum Institute 

on EPA ANPR for Testing of Fuels and Fuel 

Additives under §211 of the Clean Air Act 

55 FR 32718 (Aug. 7. 1990) 

INTRODUCTION 

Good morning. My name is Richard Cavalli. I am a 

toxicologist by training and manager of product safety and health 

risk assessment for Chevron. I also serve as the Chairman of the 

American Petroleum Institute's Health Strategy and Response Task 

Force. Today, on behalf of API I'd like to share with you API's 

preliminary thinking on the emerging Clean Air Act §211(b) testing 

rule described in the agency's August 7, 1990 advance notice of 

proposed rulemaking. 

API is a national trade association whose over 2 00 member 

companies represent all sectors of the petroleum industry: 

exploration, production, transportation, refining and marketing. 

Given the focus of this rulemaking, it is significant that API 

members account for the vast bulk of fuels and a substantial amount 

of the fuel additives manufactured and marketed in the nation. API 

members are, therefore, directly and significantly affected by the 

outcome of this rulemaking. 

API will submit extensive written comments in the course of 

this important rulemaking. But today, at this early formative 

stage, we will address three basic issue areas: 
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the need to focus the testing rule; 

the need to adopt appropriate testing methodology; and 

the need to address certain critical practical 

considerations. 

I. FOCUSING THE TESTING RULE 

In its ANPR EPA recognizes that the sheer number of candidate 

substances for testing under a §211(b) rule is staggering. Over 

6000 fuels and fuel additives are already registered. Moreover, 

when the pending Clean Air Act Amendments are passed, the 

requirements for alternative fuels and reformulated gasolines could 

increase that number significantly. Furthermore, if a §211(b) 

testing rule were to address not only registered fuels and fuel 

additives but the many possible combinations thereof, the number of 

testing possibilities would expand further. 

Accordingly, API proposes that EPA employ a few interlinked, 

simplifying principles to reduce the scale of the undertaking to a 

manageable size. If employed, these principles could reduce 

scientific uncertainty, while recognizing the practical limits of 

resources, but without compromising the statutory purpose of 

§211(b). 

First, the §211(b) testing program should be limited to air 

emissions attributable to evaporation and combustion of motor 

vehicle fuels. This would include not only diesel fuel and 
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gasoline but, as the ANPR suggests, fuels such as methanol, 

ethanol, liquefied petroleum gas, and compressed natural gas or any 

other motor vehicle alcohol fuel. The terms of the Clean Air Act 

and its statutory history make it clear that §211(b) testing was 

added to the statute to provide a factual base for the 

Administrator's exercise of regulatory authority under §211(c). 

While §211(c) is broad in some respects, giving the 

Administrator authority to "control or prohibit" the use of fuels 

or fuel additives, that authority, by the express terms of the 

statute, is limited to fuels or fuel additives whose "emission 

products" endanger the public health or welfare directly or impair 

to a significant degree the performance of any emissions control 

system in general use. 

To be sure, raw liquid fuels and fuel additives have exposure 

properties not linked to evaporation or combustion (e.g., eye, skin 

or oral exposure). However, any testing to discern those effects 

is, we believe, outside the scope of the Clean Air Act. These 

other kinds of exposure are already addressed by other statutes. 

To the extent these other kinds of exposure raise concerns within 

the responsibility of EPA, any testing deemed necessary should be 

undertaken under the Toxic Substances Control Act (TSCA). 
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Second, EPA should take full advantage of relevant information 

already developed or being developed outside the §211(b) testing 

process. For example, there already exists an database on the 

health effects of fuel and fuel additive emissions. This database 

includes animal studies, human exposure studies and epidemiological 

studies on fuels and exhaust. 

More specifically, over the past thirteen years, the TSCA 

program has been evaluating data needs, including health and 

environmental effects testing, for liquid fuels and fuel additives. 

For example, during the early 1980's the Interagency Testing 

Committee (ITC) prepared and reviewed several Toxicological 

Profiles on key petroleum substances, including unleaded gasoline. 

Specifically, the ITC looked at the health and environmental 

effects information available on unleaded gasoline. As part of 

that study, API and other members of the petroleum industry 

provided EPA with data on unleaded gasoline and assisted the ITC in 

characterizing exposures. In addition, the ITC has also evaluated 

various fuel additives. For example, one of these investigations 

led to the decision to conduct a test program to evaluate the 

health effects from exposure to MTBE. 

Third, whatever the universe of fuels and fuel additives is, 

those deemed "essentially the same" should be grouped to avoid 

duplicative testing. In its ANPR EPA recognizes this commonsense 

principle, observing further that the experience already collected 
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in connection with the "substantially similar" provisions of 

§211(f) may assist in grouping for §211(b) purposes. API strongly 

concurs. 

What we urge EPA not to do, however, is to formulate grouping 

criteria on the basis of the chemical composition and/or structural 

activity properties of raw fuels and fuel additives alone. 

Consistent with the emission focus of the Clean Air Act, grouping 

for testing purposes should take into account a substance's 

evaporative properties, as well as those features of the combustion 

process and exhaust treatment process that affect the type and 

amount of emission. With respect to exhaust emissions 

specifically, the fact is that combustion and exhaust treatment 

processes are designed to operate on a wide range of fuels and fuel 

additives but form a much narrower range of emission products. Any 

§211(b) testing program should take advantage of this simplifying 

aspect of the process. 

Perhaps even more relevant, the Air Quality Improvement 

Research Program, being carried out by the oil and auto industries 

on an expedited basis, should provide within the next two years 

both a detailed emission component analysis and the analytical 

ability to extend measurement capabilities to extremely low levels. 

This program will evaluate the evaporative and exhaust emissions of 

seventeen different gasoline formulations, as well as methanol 

ethanol, MTBE and ETBE blends, in both new vehicles and a 
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representative fleet of older vehicles. These tests are being 

overseen by a panel of independent experts from academia and these 

data will be given in their entirety to EPA and other regulatory 

agencies. Data from the first phase could be available by the end 

of this year or early next year. 

The point here is that these types of data are critical for 

characterizing the nature and exposure potential of motor fuel 

emissions. These data, when viewed in combination with the 

emissions reducing potential of applicable regulations and existing 

emission reduction technology, are critical for shaping and 

implementing the emerging §211(b) program. With these data EPA 

should establish a baseline against which the significance of 

exposures can be assessed, groupings determined, and testing 

priority decisions made. 

II. ADOPTING APPROPRIATE TEST METHODOLOGY 

At this early stage in the rulemaking, with so many threshold 

questions unresolved, it is not possible to offer the agency a 

prescription for the selection of testing protocols. The "shaping" 

considerations API has already suggested — focusing on emissions, 

using grouping, and taking full advantage of data now existing or 
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being developed outside the §211 (b) program — all have major 

implications for the selection of testing protocols. 

Consistent with the suggestions already made, however, API 

urges EPA to take full advantage of the standardized guidelines for 

health effects, environmental effects and chemical fate tests that 

have already been developed, recognizing, of course, that some of 

these guidelines may need to be modified to suit the purposes of a 

§211(b) testing program. 

Moreover, we believe, as the ANPR suggests, that a tiered 

approach, properly constructed, could identify those substances 

that need further evaluation. This would eliminate unnecessary 

testing and focus limited resources (e.g., limited testing 

facilities) on the in-depth testing needed in critical areas. 

One fundamental underlying question is the technical and 

scientific difficulty of carrying out these evaluations at the low 

levels of exposure actually encountered. Great scientific 

uncertainty exists for the easier but far more questionable 

practice of extrapolating exposure effects from higher test levels 

to the very low levels of actual exposure. 

However the agency resolves this dilemma, and whatever 

screening procedures it employs, we urge the agency to focus 
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testing on risk evaluation rather than simple hazard 

identification. To the fullest extent possible, the §211(b) 

testing program should enhance the agency's ability to assess and 

compare risks as the antecedent for sound regulatory action. 

III. ADDRESSING CRITICAL PRACTICAL CONSIDERATIONS 

In its ANPR, EPA recognizes that the shaping of an appropriate 

§211(b) testing program not only involves the selection of which 

fuels and fuel additives to test and how to test them but also 

involves a constellation of practical considerations: cost and 

cost sharing, handling of proprietary data, avoidance of undue 

disruption of the motor fuel market, and the need to harmonize the 

various §211 programs. In the detailed written comments API will 

submit later in the rulemaking, we will address these concerns. 

But for purposes of today's hearing, we will limit its remarks to 

the latter two. 

First, API believes that EPA has the authority to implement a 

§211(b) testing program in a manner which avoids inordinate 

disruption of the motor fuel market. Specifically, for those fuels 

registered by the §211(b) testing rule's promulgation date, we 

believe that the three year period for marketing prescribed by 

§211(e) can be extended while testing is being completed. 

Likewise, for those fuels not registered by the §211(b) testing 

rule's promulgation date, we believe EPA can issue a temporary 
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registration, at least for those fuels deemed "substantially 

similar" to fuels already registered and being marketed. In 

reviewing the ANPR, it is clear that EPA recognizes these 

possibilities; API encourages EPA to adopt them. 

Second, EPA needs to harmonize its different §211 programs, 

paying special attention to any new fuel certification program 

established by the Clean Air Act Amendments now pending before 

Congress. To some extent, the ANPR does address the relationship 

between the emerging §211(b) program and the existing §211(f) 

"substantially similar" program, each of which may involve testing. 

When Clean Air Act Amendments are enacted, it will become clearer 

to EPA and industry just what needs to be done to harmonize these 

two programs with any new fuel certification program. But here 

again, we believe EPA has ample authority under the existing Clean 

Air Act to harmonize all three programs. 

# 

API recognizes that the formulation of a §211(b) testing 

program poses many issues involving high levels of scientific 

uncertainty and whose resolution involves major resource 

implications for EPA and industry. API welcomes the opportunity to 

participate in this process and hopes EPA will take full advantage 

of the expertise we have to offer in what promises to be an 

extensive and challenging rulemaking.