OAR Box 1834 

Prepped by Keeia Richards 

Document Number: 

45) IV-F-03 

Docket Number: 

A-90-07 

Printed 11/10/2008 2:14:35 PM Sheet 45 of 61 

P.1 
P.2 

4-^0-07 

iv-f-03 

ENVIRONMENTAL PROTECTION AGENCY 

DOCKET NO. A-90-07 

TESTIMONY 

FUELS AND FUEL ADDITIVES REGISTRATION PROGRAM 

NOTICE OF PROPOSED RULEMAKING 

(56 FED.REG. 13168, APRIL 15, 1992) 

Presented by Dr. John Sepesi 

on behalf of 

The American Petroleum Institute 

May 28,1992 

Ann Arbor, MI 
P.3 

TESTIMONY 

AMERICAN PETROLEUM INSTITUTE 

before 

THE ENVIRONMENTAL PROTECTION AGENCY 

Proposed Fuels and Fuel Additives Regulations (40 CFR Part 79) 

May 28,1992 

Ann Arbor, MI 

I. INTRODUCTION 

My name is John Sepesi. I am here today on behalf of the American Petroleum Institute 

to respond to the proposed regulation for Fuels and Fuel Additives under Section 211 of 

the Clean Air Act. API is a national trade association with over 250 member companies 

that represent all aspects of the petroleum industry. API members account for the vast 

bulk of fuels manufactured and marketed in this country. 

II. OVERVIEW 

There are three major principles that should be applied in the fuels and fuel additives 

rulemaking: 

(1) Because the proposed reeulation goes to the heart of the petroleum industry's business 

- making fuels for automotive vehicles - we believe that it should encourage, not interfere 

with, the manufacturing of reformulated gasoline mandated under the Clean Air Act 

Amendments of 1990. An all out effort should be made to avoid timing conflicts with the 

recently proposed reformulated gasoline rule, as well as other key regulations that will 
P.4 

follow. To avoid duplication of effort and assure consistency of definitions and 

requirements, the Fuels and Fuel Additives Regulation should build on existing regulatory 

programs, such as EPA's "substantially similar" regulations. 

(2) The rule must be crafted to allow manufacturers to take full advantage of the use of 

existing information on emissions speciation and potential public health impacts. We feel 

strongly that the rule should recognize the substantial emissions speciation data developed 

under the multi-million dollar Auto/Oil Air Quality Improvement Research Program. That 

program has developed state-of-the-art capability in emissions speciation, and should not 

be exceeded by the requirements of this rule. Likewise, scientifically valid and relevant 

toxicological and exposure studies done in the past must be able to be used to fulfill Tiers 

I and II requirements, and not be limited by what we believe is an unnecessarily restrictive 

definition of what constitutes "adequate" data in the proposed rule. 

(3) Reasonable requirements must be set so that manufacturers can comply within the 

three-year timeframe without sacrificing scientific integrity. I cannot convey too 

emphatically the reservations that API has on this point because of the lack of current 

facilities, and even more significant, the lack of accepted scientific methods to perform 

some of the studies proposed. 

API feels strongly that any testing that is required under this rule must conform to 
P.5 

accepted scientific methods and protocols, so that resulting data will stand up to scientific 

peer-review and be capable of integration into the existing testing information. It should 

also be research that, on its face, adds value to the body of knowledge on the subject, will 

assist EPA in evaluating potential adverse effects, and is specifically directed to the 

determination of whether further risk assessment or regulatory action is needed under 

Section 211 (c). Adding data requirements for purposes that are inconsistent with this 

statutory goal is, at best, inappropriate, and at worst, an unacceptable waste of the nation's 

environmental research capability. 

API endorses many of the concepts in the proposed rule such as the tiered testing 

approach, and the fuels grouping option ( Option B ) which places all "sub. sim." and 

waivered fuels and additives, including reformulated gasoline (RFG), in the baseline 

group. We believe that the correct focus of the rule is on tailpipe exhaust rather than raw 

fuels. Our comments will contain suggestions for some revisions to the proposal that we 

believe will improve implementation of the rule. API will file extensive written 

comments in June. 

III. NEED TO NOT INTERFERE WITH CAA AMENDMENTS 

Concurrent with this rulemaking, EPA is also developing regulations for Reformulated 

Gasoline Certification Requirements under the Clean Air Act Amendments of 1990. It 

is a complicated matter based on principles agreed upon in the lengthy regulatory 
P.6 

negotiation. It established procedures for certifying reformulated gasoline by vehicle 

testing or use of a predictive model. Either the simple or complex model can be used for 

certification of RFG from 1995-1997. The complex model is the only allowable model 

from 1997 onward. The use of the complex model is a particularly important part of that 

rulemaking because it will provide the flexibility necessary for refiners to produce RFG 

in a cost-effective manner. Because of the timetable for the regulations on the complex 

model, API is concerned that this registration rule might limit the ability of fuel and 

additive manufacturers to move forward speedily with the entrance of RFG into the 

market. Of particular concern is that health effects data for Tiers I and II must be 

presented to EPA before registration will be granted to any fuel that is not registered by 

June 1,1993. Because the complex model for new RFG will not be available until March 

1993, at the earliest, it would be most difficult to register an RFG under the complex 

model before the June 1 deadline. 

IV. FUEL AND ADDITIVES GROUPING 

The proposed rule presents two major options for grouping of fuels. API strongly 

supports Option B. This would allow the "substantially similar" regulations for fuels, a 

regulatory program which is in place and working, to be the basis for Baseline grouping. 

Based on the experience that EPA has with that program, as well as the research findings 

to date from the Auto/Oil Air Quality Improvement Research Program, there is no 

technical or scientific need for reformulated gasolines to be included in a Non-Baseline 
P.7 

I.. 

category -- especially since RFG will, by definition, have lower toxic emissions. Inclusion 

of RFG in the Baseline category will avoid unnecessary duplication of testing of 

essentially similar materials. Furthermore, such grouping would avoid potential timing 

conflicts for reformulated fuels and additives that will be "sub. sim." or "waivered", but 

may not be registered by the time this regulation becomes final. 

We believe that any gasoline or diesel fuel or additive - whether it is currently marketed, 

whether it is reformulated, or whether it is registered before or after this regulation 

becomes effective - should be included in the Baseline category based solely on its 

conformance with the definition of "sub. sim." or "waivered". Any test substance should 

represent both the fuels and the additive package that is within the Baseline definition. 

There is no appreciable difference in the emissions among this broad grouping that would 

warrant a more complex grouping system. 

The Non-Baseline category is properly held for products containing only baseline 

elements, but in concentration limits that exceed substantially similar or waivered criteria. 

We concur with EPA that the atypical category should be for fuels and additives that 

contain unique chemical elements beyond those recognized by the "sub. sim." rule, and 

that have been intentionally added. 
P.8 

V. THE DEFINITION OF WHAT DATA CAN BE USED TO SHOW 

"ADEQUACY OF EXISTING DATA" IS TOO NARROW 

A. HEALTH EFFECTS INFORMATION / TOXICOLOGY DATA 

In Section 211(e)(3), Congress authorizes EPA to take existing information into account 

to avoid duplicative testing requirements. API believes that the proposed rule contains 

such a narrow definition of what constitutes "adequate existing testing" that the purpose 

of the regulation becomes one of required testing, not of determining potential adverse 

public health risk. EPA is proposing that existing studies can only be relied upon in lieu 

of Tier II tests if they conform to (or are "reasonably comparable to") the guidelines for 

Tier II tests, as outlined in the proposal. We believe this is an unnecessarily rigid 

approach, particularly because most of the proposed testing methodology breaks new 

scientific ground, and therefore, from that perspective, prior studies could well be judged 

not to conform. 

This limitation in use of existing data is in direct contrast to EPA's proposed literature 

search strategy, which is quite broad and inclusive. It includes historical review, and 

study of individual emission products as well as whole exhaust. As proposed, it requires 

analysis of all relevant scientific information, including emissions speciation, that may 

shed light on the potential health and welfare effects of the fuel/additive in question. In 

establishing the adequacy of existing data, registrants must be able to use this same 

approach. All valid and relevant scientific information that, taken together, allows an 
P.9 

I.. 

informed assessment of the potential health risk of exposure to vehicle emissions must be 

considered. 

The definition of what constitutes adequacy would also preclude all but studies of whole 

emissions. But, it should be noted that there are substantial amounts of data on the major 

constituents of motor gasoline and diesel fuel vehicle emissions. This information is 

sufficient to make reasoned scientific judgments as to the potential for toxicity of the 

defined endpoints. It is especially relevant when one considers that the ambient urban 

concentrations for these constituent hydrocarbons are in the parts-per-billion range. Even 

in the exhaust, they are a small fraction of the total. Such existing information is most 

certainly relevant to the issues at hand, even though conducted on the constituents, 

because in reviewing ambient air monitoring data one can only consider constituents. 

Most studies conducted by EPA and others to assess ambient environments are based on 

concentrations of specific constituents. 

B. EMISSIONS SPECIATION DATA 

The proposed rule contains detailed and complex requirements for the speciation of 

emissions, in both the fuel groupings and the emissions generation sections. There is a 

significant research program underway in this country that addresses these speciation 

questions in great detail, and that research represents the state-of-the-art in emissions 

speciation. It is the Auto/Oil Air Quality Improvement Research Program, jointly funded 

8 
P.10 

by the petroleum and automotive industries. This research should provide the gasoline 

emissions speciation information required under this program. Further speciation as 

prescribed in the proposal is beyond the capability of current technology. 

VI. PROPOSED TESTING GOES BEYOND THE STATE-OF-THE-ART IN 

METHODS AND QUALIFIED TESTING FACILITIES 

API is greatly concerned that much of the toxicology testing being proposed involves 

untried scientific methods and unverified protocols. Even in cases where there are 

established protocols, the generation of emissions and delivery of controlled doses to 

animals pose significant difficulties. Examples of major technical problems are: 

The dilution factor necessary to deliver the test substance to the animals is not 

known, and trials will have to be conducted to determine what is appropriate. The 

standard eight-fold dilution factor suggested in the proposal may no longer be 

appropriate because of changes in emissions control systems. 

A method of cooling the exhaust and controlling the oxygen supply will need to 

be developed and trial tested so that the appropriate environmental conditions can 

be maintained to support the test animals. 
L. 

P.11 

The delivery of the test substance to the animals must be accomplished directly -

that is from running vehicle to the animal. This means the facilities must be in 

proximity, and that confounding variables of noise and vibration must be 

engineered out before a valid study could be run. 

The availability of testing facilities will be a major problem. To the best of our 

knowledge, testing facilities will have to be constructed. There are existing laboratories 

that generate emissions, and there are existing laboratories that perform toxicology 

research, but we know of no testing facility that is prepared now to conduct these studies 

as proposed. Testing under this proposed rule would require those two capabilities to be 

integrated, and that means appropriate test facilities will need to be constructed. 

There are companies that we believe can develop the capability of conducting these tests, 

once methods are developed, but they do not currently have the facilities necessary to 

perform the studies as proposed. The design and construction of laboratory facilities is 

costly and seems not to have been considered in EPA's cost estimates for this regulation. 

We do not believe that it was Congressional intent for registrants to build new laboratory 

facilities and develop new methods in order to fulfill registration requirements that must 

be completed within three years. 

10 
P.12 

VII. SCIENTIFIC METHODS AND PROTOCOLS MUST BE TESTED, 

VERIFIED, AND ACCEPTED WITHIN THE FRAMEWORK OF GOOD 

SCIENTIFIC PRACTICES 

Any testing that is conducted under this regulatory program must stand up to scientific 

scrutiny. Testing results of our products are of critical importance to the industry, and we 

are concerned that using untried scientific methods and abbreviated test protocols will 

render study results meaningless. While we appreciate the Agency's openness to 

innovative test protocols, the time and money saved by such changes will be minimal, and 

far outweighed by the cost of developing methods and building facilities. API does not 

believe that Congress intended to compromise scientific methods in order to meet the 

three-year timeframe. We do not wish to see a final rule that would develop test 

guidelines outside the accepted practices of the scientific community. 

VIII. TIMING FOR SUBMISSION OF TIER I AND II DATA FOR ALREADY 

REGISTERED FUELS/ADDITIVES 

There are several timing issues of concern in the proposed rule. In addition to the 

potential conflicts for RFG, the other timing issues are related to the timing of Tiers I and 

II review for those fuels and additives that are registered when the rule becomes effective. 

Congress allowed three years for submission of data. When Congress included the threeyear timeframe for submission of initial information, we believe that they envisioned 

requirements that could be completed within that period. Indeed, with commodities such 

11 
P.13 

as fuels and additives that seems the only economically wise interpretation. 

EPA has discretion to determine what "requisite information" should be submitted to the 

Agency within the three-year timeframe. We believe that what is proposed goes well 

beyond the capability of what can be accomplished in three years. 

We have addressed the absence of facilities and the need to develop and test new 

inhalation toxicology methods to perform some of these studies. The cost to do this is not 

accounted for in the rule, nor is the time. Development, construction and testing cannot 

occur in three years. 

Furthermore, if registrants want to rely on existing data which we believe to be 

"adequate", the timeframe is so short that we could not gamble on EPA's approval without 

conducting some back-up testing in order to ensure that registration will not be withdrawn 

at the end of the three-year period. 

Finally, the initial requirements will apply to all fuels/additives registered in the same 

timeframe, making the availability of test facilities even less likely. If testing on more 

than one endpoint for more than one fuel or additive had to be done concurrently, it is 

even more unlikely that the three-year deadline can be met. 

12 
P.14 

Clearly, the proposed requirements for the initial three-year period surpass: (1) the 

capability of current scientific methods, (2) the availability of facilities, (3) the ability for 

EPA to analyze Tier I submissions, while still allowing time for subsequent testing. These 

are critical matters within the rule, because the penalty outlined - principally the 

withdrawal of the right to market - is substantial. 

IX. CONCLUSION 

There are a number of important issues we have not addressed in this hearing. For 

example, diesel fuel registration is quite important to the petroleum industry, but we have 

focused primarily on gasoline because of the Clean Air Act Amendments of 1990 which 

will affect formulation and marketing of gasoline in the near future. We have not 

addressed evaporative emissions, and do not believe there is any need for further 

evaluation on evaporative emissions because of the existence of other legislative/regulatory 

requirements to reduce and control such emissions. We agree with EPA that evaporative 

emissions from diesel fuel are not significant due to the low volatility of this material. 

API's written submission in June will provide detailed comments on the full range of 

topics outlined in the preamble. It is our intent to work with EPA to make this a 

reasonable regulatory program. We will strongly resist efforts to make it a testing 

program for which the results do not add value to our ability to assess potential public 

health or welfare risk. 

13 
We will strongly encourage the Agency to make full use of the ongoing Auto/Oil research 

and of existing regulatory programs such as "sub. sim." and the waiver program, so that 

the fuels registration process does not provide a barrier to the development of new and 

cleaner fuels. 

14