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OAR Box 1846 

Prepped by Ollie Stewart 

Document Number: 

57) ll-H-5 

Docket Number: 

A-90-07 

Printed 11/18/2008 7:30:16 AM Sheet 57 of 93 
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UNITED STATES OF AMERICA 

ENVIRONMENTAL PROTECTION AGENCY 

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A-90-O-7 

IN THE MATTER OF: 

Fuels and Fuel Additives Registration 

Advance Notice of Proposed Rulemaking 

) EPA Air Docket 

) Docket #A-90-07 

.) 

Public Hearing of the Environmental Protection Agency in 

the above-entitled matter, held at Domino's Farms, Ann Arbor, 

Michigan, on Wednesday, September 26, 1990. 

APPEARANCES: 

otf* 0' .<*$ 

CHARLES GRAY 

Director, Emission Control Technology Division 

GLEN PASSAVANT 

Senior Project Manager, Standards Development and 

Support Branch 

CAROLYN KRUEGER 

Standards Development and Support Branch 

MARGARET GILHOOLEY 

Office of General Counsel 

HEIDI SIEGELBAUM 

Office of Toxic Substances 

JUDY GRAHAM 

Office of Research and Development 

Western Wayne Court Reporting Service 

Plymouth, Michigan 

Susan Beale, Reporter 
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INDE X 

Introduction: 

CHARLES GRAY 

Du Pont Company: 

DAVID ZIMMERMAN 

Discussion 

American Petroleum Institute: 

RICHARD CAVALLI 

Discussion 

Motor Vehicles Manufacturers Association: 

MARCEL HALBERSTADT 

Discussion 

Chemical Manufacturers Association: 

CHARLES KELLER 

Discussion 

Page: 

3 

12 

18 

39 

49 

69 

73 

79 

93 

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Ann Arbor, Michigan 

Wednesday, September 26, 1990 

MR. GRAY: First, I want to welcome you 

to this Public Hearing on fuels and fuel additives 

registration regulations that we proposed in the Advance 

Notice of Public Rulemaking. Dick Wilson, who was 

scheduled to be the presiding officer this morning, 

could not make it. My name is Charles Gray, and I will 

serve as the presiding office for today's hearing. 

Also, on the panel with me today are Glen Passavant, at 

the far end; Carolyn Krueger of the Emission Control 

Technology Division of EPA's Mobile Source Program; 

Margaret Gilhooley from our Office of General Counsel; 

to Carolyn's right, three down from me, Heidi Siegelbaum 

from our Office of Toxic Substances, next to the last on 

the end; and Judy Graham from our Office of Research and 

Development. 

Because of the nature of this 

regulation, it cross-cuts a lot of different program 

activities within the Agency, we feel real fortunate to 

have a very good representation of different offices 

today on our program. Usually our rulemakings are 

fairly specific, and generally the Office of Mobile 

Sources and usually the Office of General Counsel serve 

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on the panel. So, this rulemaking is a very complex 

rulemaking, and we're fortunate to have such a good 

representation. Also, Karl Mazza from our Assistant 

Administrators Office was scheduled to be here, but also 

couldn't make it. 

The purpose of today's hearing is to 

accept public testimony and/or comment on the August 7 

Federal Register Advance Notice concerning registration 

regulations for fuels and fuel additives under Clean Air 

Act Section 211(b)(2). 

The statutory authority for such 

regulations is contained in Clean Air Act Sections 

211(a), 211(b), and 211(e). As you may know, Section 

211 (b)(2) has never been implemented in spite of the 

requirement stating the regulations implementing the 

Section were to be in place within one year of enactment 

of the 1977 Clean Air Act Amendments. Although an 

Advance Notice of Proposed Rulemaking was published in 

1978, the rule was not completed. As a result of a 

lawsuit in late summer of 1989, we are now working under 

a court-ordered schedule by which the rulemaking is to 

be implemented. It calls for a Notice of Proposed 

Rulemaking to be signed no later than January 1, 1992 

and a Final Rule signed no later than June 1, 1993. 

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Currently, fuels and additives are 

required to be registered, and producers must conform to 

certain requirements in order to do so. These requirements are found in 40 CFR Part 7 and consist of 

providing certain information on the fuel or additive 

such as chemical composition, percent used in the fuel, 

and purpose-in-use. These requirements are the result 

of implementation of Section 211(a) and 211(b)(1) of the 

Clean Air Act. Implementing the 211(b)(2) testing 

program will add health, welfare, and emission control 

system effects information to the registration process. 

There are three main areas these 

regulations must address: health effects, emission 

control system effects, and welfare impacts. For each 

of these areas, fuels and additives will have to be 

evaluated for their effects. For those fuels and 

additives registered at the time the regulations are 

promulgated, that have already been registered, this 

evaluation period can cover up to three years. For 

those fuels and additives not registered at the time of 

the promulgation of the final rules, these effects must 

be determined prior to registration. 

In determining the effects of fuels and 

additives on health, emission control systems, and 
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welfare, we have suggested a tiered approach in the 

Advanced Notice whereby increasing levels of requirements would be organized into four tiers. The first 

tier would involve a comparison to those, if any, fuels 

or additives for which it had been determined that 

sufficient information is already available. Such fuels 

or additives would be labeled "base" fuels/additives. 

Tier 2 then would require a literature search and 

submittal of available information on the various 

effects of concern. Tiers 3 and 4 would involve 

increasingly sophisticated testing requirements if 

adequate information was not submitted or if the 

submitted information indicated a possible unreasonable 

risk. After each tier, once adequate data were 

collected and it was determined that the fuel or 

additive in question did not pose an unacceptable 

hazard, then the fuel or additive in question would 

represent a "base" fuel or additive, and registration 

would be granted. 

Again, a similar tiered approach is also 

being considered for assessing emission control system 

and welfare effects. 

There are many difficult issues involved 

with developing a program which implements the Clean Air 
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Act requirement, yet does not represent an unnecessary 

burden upon producers or EPA to carry it out. We have 

identified and discussed many of these issues in the 

Advance Notice of Proposed Rulemaking and ask for your 

detailed input in these areas. In addition, we have 

laid out a number of technical questions in the Advanced 

Notice which we hope you will take time to address in 

your written comments. With the rulemaking being 

conducted under a restricted schedule, your comments and 

suggestions will receive the greatest consideration if 

received early in the process. We consider your inputs 

and viewpoints extremely important as we enter into the 

development of this proposal. This is a very complex 

rulemaking, but our restricted schedule does not allow 

for a great deal of time for follow-on discussions and 

meetings, 

There is a sign-in sheet for attendance 

in the lobby where you came in. Hopefully all of you 

have signed in. If you have not done so, we would 

request that you do that at your convenience. 

A separate sheet for presenting 

testimony was also available at the table in the lobby, 

and those of you testifying hopefully have already 

contacted Carolyn and are signed in at the lobby. We 
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actually have, I think, four different organizations 

that are signed up to testify, if you're not on the 

list and wish to testify, we would appreciate it if you 

would let us know as soon as possible so that we can 

anticipate our schedule and work you in. 

Our plan is to receive testimony in the 

order of the sign-up sheet. If the audience has any 

questions, we request that you write the questions down 

on a piece of paper and then pass it along to one of the 

members on the panel. 

The hearing will continue throughout the 

day or at least until all the comments have been made. 

If necessary, we will break for lunch at a convenient 

time and, if necessary, finish the hearing this afternoon. As you may have noticed on your way into the 

conference room, there is a small snack bar just outside 

the entrance, and you can purchase snacks or beverages. 

It's probably pretty obvious, but I guess other options 

involve the Domino's Pizza Store located nearby. 

There's a full-size cafeteria, petting farm and some 

other things around here. If we break early, some of 

you may want to take a look around. It's an interesting 

place actually. I've not had a chance to see it myself, 

but it is an interesting complex, just to find your way 

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here. I guess maps are available in the information 

lobby, if any of you really are interested in that. 

The written comment period ends 30 days 

from this hearing, or October 26. Written comments 

should be addressed to the Public Docket Number A-90-07 

at EPA's Air Program Docket. It would also be helpful 

if a copy could be forwarded to Ann Arbor, to the 

attention of Carolyn Krueger. 

Before we begin today, let me ask if 

there are any questions from the audience regarding our 

plans for today's events? If not, let me go over the 

list of organizations that have indicated interest in 

presenting a statement to us. The first is Du Pont; the 

second would be the American Petroleum Institute; third 

would be the Motor Vehicle Manufacturers Association; 

and the fourth would be CMA/Exxon Chemical. So, if your 

name is not on this list and you would like to make a 

statement, let us know as quickly as possible. 

As was stated in the opening statement, 

we do acknowledge that this is a complex rulemaking. 

It's close to 13 years after the requirement was 

instituted as part of the Clean Air Act Amendments of 

1977. We have had activity earlier through the issuance 

of the Advance Notice sometime back. We received a 
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great amount of comment on the way we should proceed 

with the process of implementing these regulations. 

The potential for economic burden is 

very large here, but the subject matter is very crucial 

as well. With the advance in the energy sector, motor 

fuel sector, as unsettled as they are at this point in 

time, I think it's likely to see renewed interest in 

setting in place a framework for evaluating future new 

fuels or fuel modifications or additives. 

So, we do sincerely hope that you will 

participate with us in putting together the best 

possible, in terms of effective, and yet a proposal that 

would minimize the burden of implementing it on both the 

Agency and the affected parties. This is the stage 

where your input can be most useful to us. We would 

even be interested in ideas about how we should continue 

the process of receiving input. We do have a quarterly 

schedule, and we will need to be issuing our Notice of 

Proposed Rulemaking on schedule. For those of you 

familiar with our process, that means that we will 

really have to be drafting our Notice probably even 

within this upcoming year to be able to coordinate such 

a complicated proposal through the Agency and other 

agencies that will be interested. 

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So, even though it seems like a little 

longer schedule than oftentimes our regulations 

represent, because of its nature we hope that you will 

be able to give providing input at this stage a very 

high priority because we are looking for constructive 

input. We hope that you will work with us during this 

phase so that the Notice of Proposed Rulemaking can be 

as close to the character of the final rulemaking as we 

can make it. 

Again, those of you that have 

participated in EPA rulemakings know that it becomes 

somewhat more complicated to interject major changes 

after a formal proposal because other parties need to 

have an opportunity to react to major changes after the 

proposal. So, again, I just want to stress the 

importance of beginning to work with us at this time. 

We'd hoped for a lot more people participating in this 

hearing. I'm somewhat disappointed, maybe because again 

the schedule, that more people have not shown up, but 

now is the best time to be working with us, and we are 

quite receptive. We do appreciate those of you that are 

presenting testimony, and look forward to a constructive 

hearing. 

If there's nothing else from the 

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audience, no questions of any type, I think we can ask 

Du Pont to come forward and begin. There is someone 

here from Du Pont, David Zimmerman. 

MR. ZIMMERMAN: Good morning, my name is 

David Zimmerman. I'm Product Manager for Petroleum 

Additives with the Du Pont Company, Wilmington, 

Delaware. 

We welcome this opportunity to comment 

on the ANPR regarding Fuels and Fuel Additives 

Registration. We realize that the EPA has a mammoth 

undertaking ahead of it in dealing with this issue. As 

stated in the Notice for this meeting, there are many 

complex issues, many fuels and a multitude of additives 

involved. Obviously, the EPA needs as much well thought 

but, sound input as possible from industry, technical 

groups, and other interested parties in order to 

conclude this matter to the mutual satisfaction of all 

involved, hopefully, as you state, without causing the 

results to be unduly burdensome and still resulting in a 

program that is reasonable and necessary. 

Just as the EPA has a major undertaking 

before it, we, who would like to provide input in the 

form of written comments, also face a monumental task in 

attempting to respond to the many questions and issues 

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raised in the Advance Notice. It's realized that these 

comments, to be significant, must be comprehensive and 

with as much documentation as we can possibly give you. 

For this reason we would first off respectfully request 

that, if possible, within your time constraints, that 

the deadline for written comments be extended by another 

60 days to December 24. 

Although we can provide much more input 

if the period for written comments is expanded, there 

are two issues we would like to discuss at this time. 

The first is the issue of Small Business Provisions. 

We do not feel, for fuel additives at 

least, that a case can properly be made for the 

exclusion from the program of any company or its 

products based upon revenues. Instead, we feel that any 

program of this type should be based solely upon the use 

volume and/or potential risk of the product involved. 

While we think, and we believe the 

industry thinks that the Du Pont Petroleum Additives 

business is a substantial factor in the marketplace, it 

is conceivable that our total annual sales of those 

products specifically falling under the proposed 

requirements are less than the EPA suggested small 

volume trigger of 40 million. This is an extremely 

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fragmented industry, made up of many small components, 

some.independent, and others owned by large corporations. To exclude from any proposed requirements those 

companies whose sales are below a certain figure would 

penalize those businesses owned by a larger corporation. 

Any argument that the larger corporations can afford the proposed burdens better than the 

smaller companies is false. The businesses within a 

larger corporation must go to their management, just as 

the smaller companies must go to their bankers, for the 

capital necessary to keep the business healthy and to 

expand upon it. Unfortunately, this is an industry with 

very small profit margins. If costs are not borne 

equally by all participants, managements of the larger 

corporations will be hesitant to continue to invest 

needed capital in businesses in which they have a noncompetitive position. This, in time, could reduce 

competitive activity by causing the companies burdened 

by testing to leave the business to the smaller firms, 

who would then be exempted from the program, thus 

defeating its purpose. 

Also, larger corporate businesses tend 

to have a larger product line. The number of currently 

active Du Pont Petroleum Additives potentially falling 

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under the proposed regulations is approximately 125. 

While many of these products' annual volumes are 

insignificant, they could be included in the program 

because of the manufacturer's total revenues from all 

businesses. At the same time, a smaller, private 

corporation with only a few products in the line could 

have individual product volumes manyfold greater, yet be 

excluded from the program. This, again, seems contrary 

to the intent of the program, both in the assessment of 

the risk and the desire to avoid unnecessary testing and 

registration evaluation burden. 

Therefore, should it become necessary to 

propose regulations for the testing of fuel additives, 

we would propose that such rules apply to all 

manufacturers equally. 

You will note that I just said, "should 

it become necessary to propose regulations for the 

testing of fuel additives." This leads me into the 

second area we would like to discuss today, that of 

which fuel additives, if any, need to be tested for 

human health and environmental effects. 

Most fuel additives are sold via drum or 

tank truck for use in refineries or, in some cases, oil 

company product terminals. The addition process is 

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conducted by well-trained, industrial personnel, and the 

additives are already well diluted to levels of two to 

650 parts per million before they reach the consumer. 

Thus, exposure potential is minimal. Additionally, in 

most cases the significant hazards presented by the 

additives are those which can be attributed to the 

solvents used as carriers or diluents. These solvents, 

since they are all common petroleum-based materials, are 

already well-known to the petroleum industry personnel 

handling them, and well documented as to health hazards 

and are generally no more hazardous than the fuels into 

which they are being introduced. We feel that the low 

exposure potential of these products as they are 

normally handled, coupled with their relatively low 

health hazards, presents a risk to human health and 

environment below that which would justify additional 

testing and evaluation under a reasonable and necessary 

program. Further quantification of the exposure 

potential can be provided through written comments. 

As for the emission effects of petroleum 

additives, we can come up with an argument which at 

first glance seems contradictory, that most additives 

used in small concentrations have a positive effect on 

the effort to improve our air quality, yet are of no 

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impact by and of themselves on that air quality. To 

explain further, additives are used to improve the 

quality of the fuels or the performance of the engines 

in which they are consumed. By the prevention of 

deterioration of fuel quality and the process of keeping 

the components of the engine clean and performing as 

designed, these additives are beneficial to the effort 

to improve the air quality around us. At the same time, 

the combustion products of these additives are 

negligible, being for the most part water vapor and 

carbon dioxide. This argument is not contradictory when 

one realizes that the case for beneficial effects upon 

the environment is due to the action of the additive in 

question upon the fuel in which it is used, while by 

themselves, the combustion products of an additive are 

minimal when compared to that of the fuel. 

As an example of this latter point, I 

have one chart. What we're showing here is from typical 

additives used in gasoline, motor fuels, and in diesel 

fuels, at their treat levels, their contribution to 

exhaust. As you can see, the product currently used in 

the highest dosage, the intake valve detergent additive, 

still has a several-fold factor difference between its 

contribution to the ultimate emissions and that of the 

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fuel. 

Given the statements already made, we 

would, therefore, propose that, as a first screen, 

additives comprised of only carbon, hydrogen, nitrogen, 

and oxygen, and used in concentrations less than onetenth percent weight/volume in fuels be exempted from 

further evaluation under this proposed rulemaking. 

We are grateful for the opportunity to 

present our input to this massive undertaking by the 

EPA. We plan to expand upon the comments already 

presented, as well as discuss additional areas of 

concern for which you've requested comments in a written 

submission. Again, in order to address these issues as 

well as possible, we reiterate our request that the EPA 

extend the comment period to December 24, 1990; thank 

you. 

MR. GRAY: You seem to generally be 

suggesting a concept where, either because of very low 

volumes or because of the chemical composition being 

similar to, perhaps other organics, organic-derived 

compounds being marketed, that that should be sort of a 

framework for which to at least exclude a large number 

of materials, and then concentrate on the remaining ones 

with respect to testing programs. You didn't really 

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elaborate on what the procedure might be, beyond your 

recommendation to screen compounds that have only 

hydrogen, oxygen, carbon, and hydrogen, I think. 

MR. ZIMMERMAN: Yes, I think we can 

reduce the burden on all of us by having a first cut 

that reduces or eliminates from the program those that 

are essentially basic, organic materials, again, very 

similar to the fuels in which they're already being put, 

at low treat levels under closely controlled addition 

conditions, and then apply the bulk of the effort on 

other products which are potentially dangerous to the 

catalytic converter or which we know or suspect have 

serious health or environmental consequences. 

MR. GRAY: Do you see this idea as being 

similar to what we suggested in the ANPRM? 

MR. ZIMMERMAN: Similar, but not quite 

the same, I don't think. 

MR. GRAY: How do you see it differing? 

It seems so similar, I'm having a hard time. 

MR. ZIMMERMAN: Well, as I read the 

ANPRM, you're proposing, as your first tier, data from 

like chemistry. I guess maybe this is the same, but it 

is a difference in what you propose as like chemistry. 

I was thinking of like chemistry as a chemical class of 

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compounds. What I'm proposing is at least as an initial 

cut, like chemistry be closer to that which was 

originally considered, what was that term — substantially similar, rather than chemical classes 

themselves, but an overall grouping. 

MR. GRAY: Well, I think we used the 

phrase, base fuel or base fuel additive, and then even 

for those, say, more common materials, we still read the 

statute as requiring us to have an obligation to insure 

that there's sufficient public health information 

available on even those materials. At some point we 

probably need to be involved in discussing whether we 

have enough information, even the most basic, with fuels 

and fuel additives, to find out, for example, if there's 

any possibility of establishing under this statute any 

materials as base materials early in the process, which 

is in effect what you're suggesting, I think, probably 

the broadest definition of the most common makeup of 

fuels and fuel additives and suggesting or seeing that 

we have enough information available on that broad class 

of compounds. There are around four elements involved, 

but there can be a large number of compounds, and so we 

think probably we need to have some more discussion 

about whether or not that's too broad of a grouping, you 

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know, for us to be able to satisfy our responsibilities. 

But, follow up in that regard to help us 

better understand how maybe we can work the process of 

having a broad category, but having confidence that all 

the possible compounds under that categorization, we can 

have reasonable confidence we have all the information 

we need. That's where we're seeing the real difficulty 

in trying to even put together the concept of the 

Advance Notice, because we still have to feel that this 

base fuel or base fuel additive, that we have sufficient 

information to whatever its definition could encompass 

in terms of compounds. 

Again, that's the real technical, first 

difficult step of sorting this all out, but at least it 

strikes me that your statement is suggestive of an 

approach like that. Certainly as we get into the process more, we need to come to some, hopefully, agreement 

that there is a framework for a process that makes sense 

broadly, and then get into the next most difficult step, 

which is to sort that out in terms of the technical 

details of how to frame it. So I think we look forward 

to the next level of detail from you in that regard. 

Let me ask if there are any other 

questions from anybody on the panel? 

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MS. SIEGELBAUM: I was curious, on page 

three of your testimony, you have a statement regarding 

the exposure potential for fuel additives as being 

minimal. At this time has Du Pont conducted any stats 

on the long-term, chronic effects of that exposure? 

MR. ZIMMERMAN: Of the chemicals 

themselves? 

yes? 

MS. SIEGELBAUM: Or the fuel additives, 

MR. ZIMMERMAN: I would then have to 

turn to my assistant in the audience here. 

MR. DASTUR: The key issue here is one 

of risk assessment. In risk assessment you have — I 

think what Dave is reiterating here is that from an 

exposure based standpoint there is hardly any exposure 

potential. That is what we are saying — (inaudible). 

MS. SIEGELBAUM: Are you saying that 

there's no exposure? 

MR. DASTUR: Yes, we're saying exposure 

is essentially minimal and that at the levels that we're 

describing over here, they are of much less magnitude 

than the fuels themselves. 

MR. PASSAVANT: I might add that you 

made the presumption that we have already assumed that 

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the fuel risks are acceptable, and if you make that 

assumption, then your argument follows logically. You 

make the assumption in your statement that we accept the 

fuel risks, that we've already made that finding, and 

then, therefore, you can make this finding. That's part 

of what this rulemaking is about, is to make that 

finding. 

t he table, 

MR. GRAY: Please use the microphone at 

MR. DASTUR: My name is Kavsy Dastur. 

I'm with the Du Pont Company. The essential point that 

we're making here is one where what you're trying to — 

or what we think needs to be done is that a risk 

assessment finding needs to be made. There are two 

components to that. There's exposure based assessment 

and a risk based assessment. 

Dave's comments essentially have been, 

o ur comments have essentially been addressed towards the 

fuel additive issue because we're really not in the 

fuels business, but we accept the point of course that 

from an overall standpoint, yes, you have to look at 

both the fuel as well as the additive. 

MR. ZIMMERMAN: I might add, if I may, 

my thoughts in putting this together was not that we 

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have accepted the risk of the fuels. My feeling on this 

is, for instance, a corrosion inhibitor present in the 

fuel of three parts per million, and when tested in the 

fuel, its presence is so minimal, any effect due to that 

corrosion inhibitor, for instance, would be masked by 

the many effects of the fuel. I'm not saying you've 

accepted the fuel; I'm just saying you couldn't find the 

difference within that fuel. 

MR. PASSAVANT: I recognize that even 

making that assessment on a combustion basis would be 

quite difficult because of the fact that the fuels 

themselves could mask the results of the small ppm 

additives. I just want to say, I think that is part of 

what the decisions are that need to be made by EPA over 

the course of this ruling. 

I wanted to follow up with another 

question related to your concerns about small business 

impacts. This is one of the areas that the Act speaks 

to, is that EPA should consider it, but provides us 

almost no guidance beyond that in terms of saying what 

our cut-point should be or anything more than just 

saying, consider it. What we tried to do in our ANPRM 

was to lay out some ideas, as she suggested, the $40 

million, but I think we also cut to this point fairly 

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well when we began talking about the concept of 

groupings, in the sense of saying that if you find three 

or four different companies, maybe some small, maybe 

some large, that make the same basic additive or a 

highly similar additive, you would be putting them in a 

position to make the decision to act as a group in 

meeting these requirements or to act separately in 

meeting these requirements. 

So, I want to make my point here, is 

that we don't necessarily want to be in a position that 

we exclude any one given manufacturer or small producer 

from requirements, but at the same time we're hoping to 

see it being more of a combined effort, that the 

industry pull together on their own to do this. I don't 

think you're going to find EPA ultimately specifying 

that you three or four companies will be grouped 

together to do this testing. That will have to be an 

industry decision. But we really think that our concept 

of groupings, as we talked about in the Advance Notice, 

might get at this more than just flat out exemptions or 

exclusions. 

All I'm going to say just in closing, I 

hope that anyone here will address this point because it 

is a very difficult one, without any basis in the Act, 

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to call us onto specific requirements. Our options are 

many, and they do have effects, as you're pointing out, 

in terms of differential effects across businesses and 

such, and so we'd really like to hear what you think 

about that, and specifically on the point of how the 

groupings might be used to meet that need. 

MR. DASTUR: I'd like to address that 

issue for a moment, please. The key point that we want 

to make here is that if EPA concludes that there is a 

Section 4 finding that — 

MR. PASSAVANT: Well, there's a Section 

211 finding. 

MR. DASTUR: Okay, but I'm saying that 

if there's a Section 4 finding under TSCA that you're 

required to do testing, and that if this testing program 

goes beyond the acute testing phase into chronic 

testing, and chronic testing, you know, you're talking 

about six and seven figure tests in terms of dollar 

value, per compound, per test, and that's going to be 

several tests on each compound, what we don't want to 

have to happen is for a small segment of the industry to 

have to bear that burden, and essentially by exclusion 

we don't want to, for example, in any way jeopardize the 

reimbursement provisions under Section 4 of TSCA. That 

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would prevent us from having a more equitable sharing of 

this burden by the industry itself. 

So, that's really the issue that we 

tried to make, is that if EPA makes a judgment here that 

any company that has sales volumes of less than $40 

million is exempted, we might have a tough time going 

after them under Section 4 for reimbursement, if EPA's 

conclusion eventually plays out that large scale tests 

are required on these chemicals. 

MR. PASSAVANT: Well, you understand 

that you're referring to TSCA, and we're referring to 

the Clean Air Act, and under the Clean Air Act we have 

no such exclusions. We have very great latitude in what 

provisions we ultimately put forth. The reason we put 

forth the $40 million was that that was, you know, one 

stick in the mud that we could look at and say, well, 

here's what one other program has done, and we want to 

get your response to that, and I can see we got it. 

MR. DASTUR: My concern is that if 

testing is required under Section 4, if EPA finds that 

the authority under Section 4 of TSCA provides it with 

more latitude, let's say, than under Section 211 of the 

Clean Air Act, then we don't want some position taken 

under the Clean Air Act to have legal impact on Section 

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4. 

MS. GRAHAM: I have a question about 

your statements here on the combustion of those 

additives that consist only of carbon, hydrogen, 

nitrogen, and oxygen. I'm not a chemist, so I'm 

curious. You say here that the combustion products are 

negligible, being for the most part water vapor and 

carbon dioxide. These products, how well have they been 

studied? Is there complete combustion? Is there 90 

percent combustion? What are the details there? 

MR. ZIMMERMAN: That's something we're 

working on right now in our laboratories when we came up 

with trying to put this program together and one of the 

reasons we asked for an extension on the deadline for 

written comments, so we can get all this data. Running 

thermographic analyses, I can say the initial work I 

have seen, most recently just yesterday before I left, 

shows that most of these additives are totally broken 

apart by 500 C, and the temperatures inside the 

combustion engines are considerably greater than 500 C. 

So, again, we want to develop more information on that, 

provide more documentation, but it appears that these 

will be completely combusted with the fuel. 

MS. GRAHAM: Thank you. 

28 
P.30 

"~l 

MS. GILHOOLEY: Have there ever been any 

studies that ever showed that some compounds made of 

these four elements posed health hazards? 

MR. ZIMMERMAN: Oh, yes, certainly. 

MS. GILHOOLEY: Well, could you give any 

examples? 

MR. PASSAVANT: Hydrogen cyanide. 

MS. GILHOOLEY: Hydrogen cyanide, 

certainly; so is benzene, I guess that's a carcinogen. 

So, there's some. This would exempt some substances 

which are, I take it, known carcinogens? 

MR. ZIMMERMAN: I'm talking about 

exemption from emissions testing, combustion of these. 

Also, we know these, and we go into these under TSCA 4 

and everything else. I'm saying, the risk on these at 

the treat level to the consumer, when he sees something 

that is added back at the beginning of the pipeline as a 

pipeline corrosion inhibitor that finally gets in the 

fuel at the end at a couple parts per million, we need 

to consider and weigh this risk and the exposure level 

at that point. 

MR. PASSAVANT: Mr. Zimmerman, are you 

saying exemption from the emission control system 

impacts a portion of this rule, or all, because of the 

29 
P.31 

exposure basis? 

MR. ZIMMERMAN: I think total exemption, 

carbon, hydrogen, nitrogen, and oxygen, from the 

emissions cycle. 

MR. PASSAVANT: I mean, specifically the 

emission control system impacts the issues? 

MR. ZIMMERMAN: Right, and I think a 

more considered approach may be a first tier cut from 

the other issues. 

MS. GILHOOLEY: Would there be any way 

that you would know that the risk would be below a 

certain level, you know, below one in a million, or 

below some possibly acceptable risk level if you 

exempted testing based on their concentrations? 

MR. DASTUR: Yes, I think if the EPA 

were to use this information in their risk assessment 

models, and I don't know what the triggers are that you 

would use in this case, were it to be one in ten million 

or one in a million or whatever it is, but you could, on 

the basis of exposure, exempt these from the base, from 

the standpoint of saying that there would be little or 

no risk of cancer, for example, because people who would 

be handling the chemical in the industrial atmosphere, 

basically they wear protective clothing, masks and so 

30 
P.32 

l 1 

L. J 

forth. By the time the ultimate consumer is exposed to 

the chemical, he's really not exposed to it because the 

molecule unzips in the automobile engine, and you're not 

exposed to these very complex organic compounds, but 

just to their component elements, like carbon, hydrogen, 

oxygen, and so on, carbon dioxide and water vapor. 

MS. GRAHAM: You've mentioned that 

several times, and I just feel obligated to comment that 

everything you say can be true, but as you say, you 

haven't studied it, so you don't know that it's true. 

There's still the matter of the potency of the compound, 

that none of us would want to be exposed to even a grain 

of plutonium. The exposure would be really, really 

small, but if it's plutonium, God forbid. 

Likewise, it's okay to get exposed to a 

very high level of an innocuous compound. So, when we 

think about risk, as you said, there is the exposure, 

there is the health, but we can't focus exclusively on 

one or the other. They get tied together. So, your 

point is well taken, but I feel that the health side is 

being underemphasized in your statements. 

MR. DASTUR: Well, I guess you could say 

that, except that I think you have to take into account 

the cost of developing. For example, if you were to run 

31 
P.33 

a cost — the only way to definitively answer the 

question as to whether the chemical has carcinogenic 

potential is to run a carcinogen bioassay. You would 

have to run, for these chemicals, probably by the dermal 

route or the inhalation route. By the inhalation route, 

if you were to run a two year bioassay on rats, you're 

talking about testing costs of about a million and a 

half per chemical for the large number of compounds that 

are available. Are we really saying that it's really 

justified from a resource standpoint to put those kind 

of resources into answering these questions? I think 

that's basically one of the questions that we're asking. 

One way to approach it would be to look 

at it from the exposure standpoint. Now, I agree that 

you have to look both at exposure and at health hazard, 

but I think you can weight it. I think you can say that 

if the exposure is so minimal, is it really necessary to 

spend $2 million to test the carcinogenicity? 

MS. GILHOOLEY: Is there anything to 

give you any handle on whether it could be extremely 

potent, besides running a bioassay? 

MR. DASTUR: Well, it all depends on the 

endpoint that you're trying to answer. You can get a 

very good assessment of general compound toxicity from a 

32 
P.34 

"~l 

J 

chronic standpoint running a 90 day sub-chronic study, 

let's say. That would give you an indication for almost 

all endpoints except cancer, unless you have something 

in the protocol for developmental or reproductive 

effects or teratogenicity, which are separate endpoints. 

But you could get some kind of an 

indication if you were to run, let's say, an acute test 

battery. From an acute hazard standpoint, if you were 

to run something up to, let's say, a 14 day study, you 

would have some indications as to whether the compound 

has some measure of toxicity. For example, someone 

mentioned hydrogen cyanide. There is not much 

information on the chronic toxicity of hydrogen cyanide. 

The reason is very simple, because it's such a strong 

acute poison that, you know, the animal is going to keel 

over long before you've tested for chronic effects. 

So, those are some of the things we can 

do, but we need time. We need time to assess all of 

that; we need time to put this all together, and that's 

really what we aim for. 

MS. GILHOOLEY: I had one other area of 

questions about your request about the small business 

exemption, which, I take it, is that everybody should be 

treated alike and that if there is one, all companies 

33 
P.35 

1—1 

L J 

should be eligible for it if they make a small volume, 

irrespective of the size of their revenues, or 

conversely, it shouldn't be available to anybody. 

On allowing the large company to be 

eligible if their volume is small in a certain category, 

do you know if there's any precedence, if any statute 

has ever been interpreted that way, because there have 

been small business exemptions in other statutes, I'm 

sure, but it would be interesting to know if any of them 

have been interpreted that way or if any of these small 

business provisions, SBA, the Small Business 

Administration has ever done that? 

MR. ZIMMERMAN: That is not what I was 

trying to imply in what I was writing. I was just 

trying to bring out the point that we're thought of as 

Du Pont, a very large company. My business, the 

petroleum additives business, were it not within Du 

Pont, and we're only dealing with fuel additives, the 

big Du Pont Company would be a small business, is all I 

was trying to say. 

I was not saying that you should 

interpret it that way and just look at that segment and 

fit it in. I think if you did that, you'd find almost 

everybody here is small business. I think that's really 

34 
P.36 

"~l 

J 

the point I'm trying to make, is this industry does not 

have giants in fuels additives. It's mostly an industry 

of a large number of small businesses. So, to penalize 

those who happen to be associated with a larger company, 

I think, is unfair. 

MS. GILHOOLEY: So, would you think that 

your unit should be eligible for the small business? 

I'm saying. 

MR. ZIMMERMAN: No, no, that's not what 

MR. DASTUR: That's one way to look at 

it, except that there's nothing in the statutes that 

would allow us to use that because the way the statute 

is defined, it's the parent company's assets and sales 

volume that applies. It's not the business unit itself. 

But even if this testing had to be done, 

the point we're making is, let's say if you had compound 

X, and there were 20 companies involved in it, and even 

if Du Pont was not the largest manufacturer, let's say 

that it was decided to run the cancer bioassay which 

costs a million and a half, then we say that that money, 

that that cost should be shared, on a volume basis, for 

example, and there is precedent for that under Section 4 

of TSCA. You know, if companies come together, they 

share costs, and they share costs primarily on the basis 

35 
P.37 

of their production volumes. So, we're saying that that 

should be the way that this testing is also handled, if 

it comes to that. 

MR. GRAY: How do you handle a new 

organization that starts manufacturing that material 

after the basic testing has been conducted? Is there 

some means of then, if the testing's been paid for by 

the existing marketers, does the new entry company just 

basically have a free ride in terms of that cost of 

doing business? 

MR. DASTUR: Well, I believe under 

Section 4 of TSCA there is a requirement that allows the 

reinvestment clause to apply for a period of five years 

from the time that the last test result is submitted to 

EPA. I'm not sure of the exact timing, but I think 

that's right, which means that someone would have to 

wait for that period of time. If he decides to come in 

after that period, yes, I guess he would get a free 

ride, unless there's some way to get him in. 

MR. GRAY: Any more questions? 

MS. SIEGELBAUM: Yes, in connection with 

your proposed exclusion for the additives comprised of 

the carbon, hydrogen, nitrogen, and oxygen, you 

mentioned that the workers who were putting the fuel 

36 
P.38 

J 

additives into the fuel are wearing certain protective 

equipment that would mitigate risk. I'm curious as to 

your views on including certain basic criteria for the 

mandatory use of protective equipment as necessary, as 

part of the exclusion, because if we were to develop an 

exclusion for baseline additives like this in small 

quantities, we would probably want to create some 

reasonable criteria that could be used across the board 

without having to go through establishing permissible 

exposure limits. 

MR. ZIMMERMAN: I'm not quite sure I 

heard the question. I'm having a great deal of 

difficulty hearing you. 

MS. SIEGELBAUM: I'm sorry; essentially 

the question was, I was seeking your views on the use of 

worker protection for the proposed exclusion for the 

fuel additives found on page four of your presentation. 

You mentioned before that these workers are generally at 

low risk of exposure because of their use of certain, 

whether it, be gloves or face masks, and I was curious as 

to what assurances the Agency would have that these 

types of measures would be taken on a consistent basis? 

I mean, are we supposed to assume that they are used? 

MR. ZIMMERMAN: I think that already 

37 
P.39 

l_ J 

falls under other guidelines as in OSHA and so on, our 

safety data material sheets. Our customers are all 

reminded of these, worked with these, and our customers, 

being large oil companies, are not going to take a 

chance and not work safely. 

MR. PASSAVANT: I was just involved with 

that, although I don't know that that's particularly 

relevant to this rule. I think that the point is that 

there is not a permissible exposure for every chemical. 

So, I think Heidi's question is more along the lines of, 

if we were to take that, take your premise that this is 

acceptable, then what enforcement provisions are there 

for us along those lines? 

I'm not sure that's directly relevant to 

what we're trying to do here, but it is an important 

point. I think you are making the statement that 

there's not a risk in the refinery area of the plants 

because these people take on the added personal 

protective equipment or ventilation systems or whatever 

now, and you may not be necessarily able to count on 

that. 

MR. DASTUR: Well, one approach that the 

EPA could take is, I believe under Section 9 of TSCA, 

for example, you could go to OSHA, and OSHA could 

38 
P.40 

1 1 

v. J 

establish permissible exposure limits based on a certain 

criteria, and say that once you have an OSHA PEL, then 

there's an incumbent (inaudible) that's mandated on the 

industry to be able to meet that requirement and leave 

it up to the industry to decide how best they want to 

meet it, whether they want to meet it through 

engineering controls, such that they operate below the 

PEL, or in cases where they cannot operate under those 

limits, that they put people in masks and things of that 

nature, 

MR. GRAY: Thank you very much; we're 

looking forward to your continued assistance in 

developing the proposal. 

MR. ZIMMERMAN: Thank you. 

MR. DASTUR: Thank you. 

MR. GRAY: Next we have the American 

Petroleum Institute, if you'll come forward, please. 

MR. CAVALLI: Good morning; my name is 

Richard Cavalli. I'm a toxicologist by training and 

manager of product safety and health risk assessments 

for Chevron Corporation. I also serve as the chairman 

of the American Petroleum Institute's Health Strategy 

and Response Task Force. With me today are Jerry Levine 

of Amoco Oil Company, David Deal of the API staff, and 

39 
P.41 

L J 

Gerry Raabe of Mobile, who will help with the questions 

and answers, or the answers to the questions. Today, on 

behalf of API, I'd like to share with you our 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. 

The American Petroleum Institute is a 

national trade association with over 200 member companies which 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 fuel 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. 

We will be submitting extensive written 

comments in the course of this important rulemaking, but 

today, at what we feel is an early formative stage, we 

will address three basic issue areas, namely, the need 

to focus the testing rule, the need to adopt appropriate 

testing methodology, and the need to address certain 

critical, practical considerations. 

With regard to focusing the test rule, 

40 
P.42 

~1 

J 

in the ANPR, EPA recognized that the sheer number of 

candidate substances for testing under a 211 rule is 

staggering. Over 6,000 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, the 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 the 

scientific uncertainty, while recognizing the practical 

limits of our resources, but without compromising the 

statutory purpose of 211(b). 

Firstly, 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 gasoline but, as 

the ANPR suggests, fuels such as methanol, ethanol, 

liquefied petroleum gas, and compressed natural gas, as 

41 
P.43 

well as any other motor fuel. The terms of the Clean 

Air Act and its statutory history make it clear that 

Section 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, such as eye, skin, or oral 

exposure. However, any testing to discern these effects 

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

These other kinds of exposures are already addressed by 

other statutes. To the extent that 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. 

Parenthetically, I would like to note 

42 
P.44 

"~1 

J 

that at this time there is a meeting being held in 

Sweden to address the question of what data are 

available on petroleum products and what data may be 

needed. I believe that EPA, as well as API, and 

representatives from many other governments are in 

attendance at that meeting. 

Our second point is that EPA should take 

full advantage of the relevant information already 

developed or being developed outside any 211(b) testing 

process. For example, there already exists a database 

on the health effects of fuel and fuel additive 

emissions. This database includes animal studies, human 

exposure studies and epidemiological studies involving 

fuels and exhaust. 

More specifically, over the past 13 

years, the TSCA program has been evaluating data needs, 

including health and environmental effects testing for 

liquid fuels and fuel additives. During the early 

1980's, the Interagency Testing Committee 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 

43 
P.45 

industry provided EPA with data on 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 examine the health effects 

from exposure to MTBE. 

Thirdly, whatever the universe of fuels 

and fuel additives is, those deemed essentially the same 

should be grouped to avoid duplicative testing. In the 

ANPR, EPA recognizes this common sense principle, 

observing further that the experience already collected 

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 the 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 

44 
P.46 

•"1 

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 to very low levels. This program 

will evaluate the evaporative and exhaust emissions of 

17 different gasoline formulations, as well as methanol, 

ethanol, MTBE and ETBE blends, in both new vehicles and 

a 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 

45 
P.47 

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 exposure can be assessed, groupings 

determined, and testing priority decisions made. 

With regard to adopting appropriate test 

methodology, at this early stage in the rulemaking, with 

so many threshold questions unresolved, it is not 

possible for us to offer the agency a prescription for 

the selection of testing protocols. The shaping 

considerations API has already suggested, focusing on 

emissions, using groupings, and taking full advantage of 

data now existing or being developed outside the 

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, 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 the 211(b) testing program. 

Moreover, we believe, as the ANPR 

46 
P.48 

suggests, that a tiered approach, properly constructed, 

could identify those substances that need further 

evaluation. This would eliminate unnecessary testing 

and focus limited resources, such as our limited testing 

facility capabilities, 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 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. 

With regard to addressing certain 

critical, practical considerations, in the ANPR, EPA 

recognized that the shaping of an appropriate 211(b) 

testing program not only involves a selection of which 

47 
P.49 

fuels and fuel additives to test and how to test them, 

but also involves a constellation of practical considerations: cost, 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 we will 

submit later in the rulemaking, we will address these 

concerns, but for the purpose of today's hearing, we 

will limit our 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 that EPA can issue a temporary 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 

48 
P.50 

"~l 

J 

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 this relationship between 

the emerging 211(b) program and the existing 211(f), 

substantially similar, program, each of which may 

involved 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. 

The 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. We welcome the opportunity to participate 

in this process and hope that EPA will take full 

advantage of the expertise we have to offer in what 

promises to be an extensive and challenging rulemaking; 

thank you. 

MR. GRAY: Thank you; it sounds like if 

the ANPR was the essence of our job, we've done a pretty 

good job, but the next step of moving this concept into 

49 
P.51 

l_ J 

some more specific requirements is going to be the 

crucial phase. I'm not detecting any basic disagreement 

though in terms of the framework of what was laid out in 

the ANPRM, of the tiered approach, of the definition of 

certain base materials, fuels or fuel additives, 

comparing others, or new fuel or fuel additives to those 

base, in terms of the determination of whether more 

testing should be required, et cetera. Those basic 

principles seem consistent with your suggestion. Am I 

missing something there, first of all? 

MR. CAVALLI: The one factor that you 

didn't mention is that in the ANPR it is not clear that 

all of those principles would be applied with the 

emission spectrum of a fuel or fuel additive in mind. 

We are not encouraging you to adopt a broad-based 

testing system for raw fuels and raw additives, but 

rather to concentrate on the emissions as driving the 

need for any testing and to focus any testing on new and 

different or on unstudied or uncharacterizable 

emissions. 

MR. GRAY: Well, as you can recognize, 

we are trying to coordinate well within the Agency to 

address other possible environmental effects of fuel or 

fuel additives, whether it be in ground water, or as you 

50 
P.52 

1 1 

u J 

said, direct exposure of the material, and definitely 

we'll be working with your comment in mind. 

But focusing then, for example, on the 

exhaust and evaporative emissions side, as you talked 

about, you still qualified it, the tiered approach, like 

in the ANPRM, if properly constructed, what other 

features, fundamental features should we be considering? 

What we hope to do is frame an overall 

approach through this process pretty quickly, so that we 

can then get into the business of defining, are there 

base fuels, being fuels where there is sufficient 

information available to be classified as base? If not, 

what additional information would be appropriate to have 

collected for the various fuels that we might be 

considering? Those are the stages where we need to be 

moving to, but first we would like to hear if there are 

other components of the process that should be added or 

components of what we suggested in the Advance Notice 

that aren't appropriate. Any other specifics there that 

you can give us? 

MR. CAVALLI: I can only give you a 

piece of general guidance there. The most critical 

step, to me, in your tier is step one, and possibly step 

two, where you collect the information that is known 

51 
P.53 

L J 

about a fuel or additive in this case and its emissions 

spectrum and look at the information known on the 

potential health effects, environmental effects, and 

effects on emission control systems. There is a vast 

array of information available on those subjects for 

fuels that have been manufactured and distributed over 

the past 30 to 50 years, and I would urge the Agency 

personally, as a scientist, to pay a great deal of 

attention to that body of information and what it says 

about the emissions of those kinds of fuels. 

That will be a much more difficult 

exercise than making a list of toxicology studies, as 

one finds under Section 4 of TSCA, and putting little 

checks after it. A lot of that information is not in 

that form, but that information is very valuable. The 

vast bulk of it is scientifically valid, even though it 

doesn't conform to specific, current TSCA testing 

protocol 

MR. PASSAVANT: Mr. Cavalli, one of the 

things, as I hear you say, is that we're dealing, as you 

recognize, with potentially 6,000 products. While some 

are similar, many are dissimilar, and it puts us in a 

position for me to ask you this question. While it is 

certainly our intent to take a look at everything that's 

52 
P.54 

" I 

J 

been done over the last 20 or 30 years in this area, 

where would you suggest we go for those situations where 

nothing has been done? That is what brought us to the 

idea of looking at structural activity relationships and 

things such as that, as opposed to just assuming that we 

would walk into it with the assumption that we're going 

to have to do a full-blown program? 

MR. CAVALLI: I think the simplifying 

procedure that we've laid before you is, under the Clean 

Air Act, if you narrow your concern to emissions and 

differences in emissions that different kinds of fuels 

or fuel additives produce, you can greatly simplify, I 

believe, your problem, since emissions, at least as I 

understand them, do appear to be far more similar for 

different kinds of fuels than they are different for 

different kinds of fuels. 

If you are concerned under this Act with 

emissions, evaporative and tailpipe, you do not have to 

concern yourself with the acute, oral toxicity of a fuel 

or an additive, because that is not part of the 

emissions equation. What you do have to be concerned 

about is what evaporates. I think that's what the 

gentlemen from Du Pont were trying to get across. If 

you have a non-volatile additive in a volatile fuel, 

53 
P.55 

L J 

that which is going to evaporate from the automobile is 

going to be the volatile part, not the non-volatile 

part. So, by focusing on that kind of thing, you do 

begin to eliminate blocks of material from that which 

you have to consider under the Clean Air Act. 

MS. KRUEGER: On page four of your 

testimony you mention an existing health effects data 

base. Which one are you referring to? 

MR. RAABE: There's probably more 

published literature on fuels and fuel health effects 

than any other class of compounds in the world. IR 

devoted an entire monograph to fuels, IR Monograph 45, 

that was completed and published in 1989. There's also 

IR Monograph 46, which was devoted exclusively to 

automotive emissions. There is an enormous database 

being developed, as was alluded to, as auto program that 

will speciate a vast number of emissions under different 

fuels. So, taken together, there is an enormous database already in existence. 

Further, API has a large epidemiology 

program ongoing, looking at the distribution health 

effects associated with gasoline distribution. So, 

collectively there's an enormous set of data out there 

to build on, and it should be looked at first, including 

54 
P.56 

product testing of motor fuels, 

MS. GILHOOLEY: Would you submit that 

for the record, or cites to it? 

MR. RAABE: Excuse me? 

MS. GILHOOLEY: With respect to that 

testing that's out there, will you be submitting cites 

to it, to the record? 

MR. RAABE: I would think IR Monograph 

45 and 46 is readily available to the Agency. All that 

has been published and is already in the record. All of 

it has been submitted to EPA, numerous times probably. 

MR. PASSAVANT: One of things I'd like 

to follow up on is the concept that seems to be put 

forth by both Du Pont and you folks, that the Agency, at 

this point, is going to be in a position to make 

judgments or rule in the near term, by the time this 

rulemaking is done, be in a position to make judgments 

about certain things, and it seems to me to be somewhat 

inconsistent with the basic requirement that we're 

looking at in the Clean Air Act which says that there 

has to be testing done. 

What I hear you saying on the one hand 

is, there has been testing done, but on the other hand, 

I hear you saying, Agency, you go ahead and make that 

55 
P.57 

judgment for us; you go through the registration wheels 

for us, and excuse us from those requirements. 

Is that what I'm hearing you say? 

MR. CAVALLI: Well, I can't testify as 

to what you heard, but I can testify that I don't think 

I said that. 

MR. PASSAVANT: Okay. 

MR. CAVALLI: With regard to that point, 

I think that we would like to see you do what I do when 

I'm faced with a question like that, that comes to me on 

a daily basis within my company, and that is to set up a 

rule which essentially says that we will focus for our 

testing on the kinds of exposure that results from the 

use of the fuel in a motor vehicle and the emissions 

that come out into the air from that process. And we 

will use, you use, or we use, the database that exists 

to make a finding that the fuel has been well-studied 

and well-characterized, a sort of TSCA type of finding 

where we have a sufficient amount of information to make 

a regulatory decision. Where there's a gap in that 

database, and where there is testing that would be 

useful to fill that data base, then that would be a 

testing recommendation in my case, requirement, perhaps 

in yours. 

56 
P.58 

1 1 

i 

L-.J 

MR. PASSAVANT: In our ANPR we suggested 

that-the Tier 1 processing would involve the different 

companies seeking registration to bring that data before 

the Agency. I hear you suggesting that the opposite 

should be done. Is that true or not, is that what 

you're saying? 

MR. RAABE: I think what Dick and I are 

trying to say is probably that if, you go through the 

process, which is court mandated in your circumstance 

now, you will conclude that there is probably very 

little need for additional testing. That would be an 

expectation. We're not saying that is 100 percent, but 

we're saying that there is a vast body of data out 

there, and it's probably not necessary for EPA to 

apologize for not having used that test rule provision 

availability, because they knew there was a lot of 

material out there and have been working with it for 

years in other parts of the program. 

So, the fact that you're now under a 

court ordered mandate to go through the process 

essentially, we're saying that there's a large database 

available for the process, and as you work through that 

process, you will probably conclude that there are base 

fuels that have essentially adequate data out there. 

57 
P.59 

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Whether the Clean Air Act Amendments 

would necessitate a modification of what base fuels are 

is a different issue, and there's certainly new fuels 

and alternative fuels on the horizon, for which there 

are not extensive testing programs in place or already 

completed. So, it depends on which phase of the scheme 

that we're talking about, to what extent there will be 

additional testing required. 

MR. CAVALLI: Let me try and get back to 

the question that you asked. Our comments were not 

intended to reflect on whom the proper party to gather 

information, review it, analyze it, and present it is, 

and I was making no attempt to say that that was the 

business of the Agency, as opposed to the business of 

the regulated industry. Further down the line we may 

reach some conclusions on that, but we did not intend to 

make that proposal. 

MR. PASSAVANT: I guess you could see 

that our ANPR did make that. We took a stab at saying 

that we felt that was the responsibility of the parties 

that were seeking registration. 

MR. CAVALLI: Again, I can only comment 

that that's not inconsistent with most of the other 

activities of this sort that take place, but that's not 

58 
P.60 

an official position, 

J 

MS. GILHOOLEY: I guess you kept 

emphasizing that you shouldn't test the raw fuel, you 

should test the emissions product. I was trying to make 

sure I understood your point. Do you mean it should be 

inhalation testing, or you should test the fuel after 

it's been all mixed together and not test separate 

components? I wasn't fully following what the point was 

that you were trying to focus on. 

MR. CAVALLI: I think there is a 

difference between the need to test, period, and the 

need to test under the Clean Air Act. The Clean Air 

Act, we believe, focuses on air that people breath, and 

further, we're talking about ambient air, as opposed to 

air in the workplace. With that construct, we would 

urge that any testing required of fuels and additives 

bear a relationship to that particular situation. 

TSCA examines and has examined actually 

the general hazards from fuels as items of commerce. 

The OSHA deals with the hazards of fuels in the workplace. The Consumer Products Safety Commission deals 

with the hazards of fuels as consumer products. Rather 

than trying to take the whole constellation of health 

effects of fuels and pull it into the Clean Air Act, we 

59 
P.61 

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would suggest that you concentrate your efforts in this 

rulemaking on that to which the Act is responsive, 

namely air emissions. It doesn't have anything to do 

with whether you test raw fuel or not somewhere. It has 

to do with whether you spend an awful lot of time and 

energy looking at testing of fuels under the Clean Air 

Act. 

MS. GILHOOLEY: Well, I guess part of it 

is the jurisdictional point, and I do want to pursue 

that. Your other point there is that you should be 

focusing on emissions. Does that also relate to how you 

do the test? You're saying that EPA should focus on the 

emissions from fuels, and that sounds like, therefore, 

we should be focusing on inhalation tests, you know, how 

it comes out of the tailpipe, to judge whether the 

existing testing is adequate? 

MR. CAVALLI: If a data gap existed and 

an inhalation test was the best means of addressing it, 

then that would be very appropriate. If an inhalation 

test was not the best means of approaching it, then we 

would want you to test the best way. There will be 

occasions when an inhalation test will probably not 

answer the question that we both have. 

MS. GILHOOLEY: The other point that you 

60 
P.62 

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were raising, I guess, is this jurisdictional one that 

w as in your testimony too. I guess you were saying that 

EPA should focus on the hazards, the effect on the Clean 

Air, and not the other potential toxicity concerns that 

may exist with fuels, and there have been concerns 

raised with some fuels about poisoning and the like. I 

take it your position is that that would not be covered 

by this program? 

I mean, we're going to have to look at 

this further, and I guess 211(b) is written very 

broadly. Is it, nonetheless, your position that we 

would not, under this testing program, look at any kind 

of poisoning effects that people may get from fuels when 

they syphon it from the gas tank or some of these other 

concerns that were raised about possible risks from 

fuels? 

MR. DEAL: I'd like to address that 

question. That is our position. We're very much aware 

of the jurisdictional issue here, and we've touched on 

it in our testimony. We'll be addressing it in a more 

fine grained way. I believe what it boils down to, and 

let the record be clear on this, we're not suggesting 

that you should be, and we certainly are not, 

insensitive to other health effects that might be 

61 
P.63 

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associated with fuels. All we're saying here is, 

recognizing the context here, this particular rulemaking, the context is the Clean Air Act, the context is 

fuels. We think it would be a mistake as a public 

policy matter and also really beyond the EPA's 

jurisdiction, to turn 211(b) into an omnibus, for-allpurposes testing provision. 

We think there are other statutes and 

other processes in place which can round out the 

universe of testing that might be necessary. We look at 

the Clean Air Act and Section 211 as being related to, 

as being focused on air quality, not only human health 

effects, but welfare effects, and in an indirect way, 

looking at the effects on emission control technology. 

It seems to us that if you look at the 

totality of Section 211, it's clear EPA has broad 

authority under 211, but it seems also clear to us that 

that authority has some sideboards on it. It is focused 

on emissions, whether they be evaporative or whether 

they be tailpipe emissions, and we think that theme is 

pretty strong in Section 211. We'll be addressing this 

in a lot of detai1. 

I guess the other side of the coin, 

apart from the legal jurisdictional part, we think it 

62 
P.64 

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makes good sense to look at it that way because we're 

not talking about a situation where if EPA doesn't look 

at the whole universe of testing under 211, none of that 

testing can be done or will be done. We think that's 

just not true. TSCA already exists and complements 

Section 211(b) very nicely. That's really our 

proposition. 

MR. CAVALLI: I think a quick look at a 

typical unleaded gasoline material safety data sheet 

will show you that a good deal of the kinds of things 

you've expressed concern about have been done and are 

being done. 

MS. GILHOOLEY: Well, we'll look at this 

further, because 211(b) by itself is written broadly, so 

we'll have to look at that. 

I guess you also talked about how it's 

important that if fuels are essentially the same, they 

should be grouped, and we shouldn't have duplicative 

testing. It's one of the factors in the ANPR that EPA 

raises and asks about criteria for judging that. One 

possibility is to look at the substantially similar 

criteria. But I think one of the things that would be 

useful to have is any information that would toxicological! y give us information on how you make these 

63 
P.65 

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comparisons. 

Does API have any additional information 

to supply on that, if they could give it today or supply 

it in the comments? 

MR. CAVALLI: I think what we've said, 

you must realize that, I know while you were working 

under some time constraints, we were working under an 

even greater time constraint than you were. There is a 

great deal of analytical information available and a 

great deal more forthcoming on the subject of emissions, 

both evaporative and tailpipe. Where we are at the 

moment is that we would certainly start, I think, in 

looking at a fuel under the Clean Air Act, let's make an 

assumption that we can establish that we do know something about the health effects of the current kinds of 

emissions that we get from the current kinds of fuels 

that are in use in this country, the biggies, gasoline 

and diesel. 

We have, you know, a fairly good idea of 

what their emissions spectrum looks like, and we know it 

contains benzene, and we know it contains polynucleararomatic hydrocarbons, and we know something about how 

much, and what the range from each automobile is. We 

know an enormous amount about how much of that ends up 

64 
P.66 

~l 

j 

in the ambient air a few feet away from an automobile or 

truck, but we have a new fuel, or a different fuel, a 

reformulated gasoline, for example. We would look at 

the emissions spectrum we expected from that fuel, 

evaporative as well as tailpipe, and if there are no big 

differences in those, and I realize, big differences, 

has to be defined, and I can't define that for you 

today, but then I think one would be in a position to 

argue that from a Clean Air Act perspective these two 

fuels were the same, regardless of the composition of 

the original fuel. 

That might not be the case under TSCA. 

You wouldn't write an unleaded gasoline MSDS for that 

substance, but from the point of view of the Clean Air 

Act, you would have a similar substance. Does that 

help? 

MS. GILHOOLEY: Well, I take it what 

you're saying is, look at the emissions to come out and 

see how similar they are? 

MR. CAVALLI: Yes, because the 

emissions, which is our concern under the Clean Air Act, 

is a product of fuel evaporative emissions control, 

combustion process, and exhaust treatment, and those are 

all controllable variables. Fuel is only one component 

65 
P.67 

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of the emissions, and as we get more sophisticated, it 

may even become a minor one. 

MR. GRAY: I hope that as you prepare 

your detailed comments, you will look at the scope of 

the specifications, if you will, for perhaps base fuels 

and fuel additives that you think might be close to 

qualifying, or that you think might qualify under a 

program like this even right off the starting line. 

Certainly, the range of specifications, the broader the 

range, the more that would of course be of concern, and 

the greater the burden for providing confidence that 

broadening those ranges won't introduce components that 

might pose information gaps that you otherwise would be 

arguing aren't there. 

So, if you could help us in terms of the 

process by maybe addressing what fuels and fuel 

additives you think might already, as I think some of 

your comments have suggested, be so-called base fuels or 

fuel additives. The comments, specifically from Du 

Pont, for example, that the fuel additives have a tenth 

of a weight of volume percent of any compound, you know, 

only composed of the four elements mentioned, could be a 

pretty broad range of compounds. Maybe in your detailed 

comments you could address how broad the range of 

66 
P.68 

'—1 

L. J 

specification should be to really have high confidence 

that-a new material made that meets the same 

specifications won't pose any new environmental risk. 

MR. LEVINE: Let me say something on 

that, Charles. With the oil auto test program we are 

looking at a broad range of fuel compositions, for 

example, looking at aromatic solubles, 45 percent and 20 

percent, and we have, or we will have, speciated exhaust 

from those two types of fuels, and we can see then 

whether the exhaust components look like relative to 

what is a very, very broad range of aromatics, or 90 

percent point or whatever, all the main compositional 

factors of fuel. So, I think we'll be able to narrow 

that down, and we'll provide that, obviously. In fact, 

while EPA participates in the oil auto scene, you will 

have that. 

Additionally, maybe to answer one other 

question earlier, volunteer work for the API staff will 

obviously provide you with the cites of all the existing 

data that we know of, and a lot of it you already have 

because we share that with you or others share it with 

you. I mean, the vast body of data that's there, I 

think both of us know most all of it. API plans to 

write extensive comments and will provide that. 

67 
P.69 

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J 

MR. GRAY: I think the request was just 

to be sure that appropriate cites were given in your 

statement for the record of these proceedings, to be 

sure that the record of these proceedings reflected this 

large body of information. I think it would be part of 

any suggestion that you would have that, for example, 

gasoline might be a base fuel, because of all this 

information. If the API or EPA could identify another 

really important test, we'd probably be, one or the 

other, working on it now. 

So, we recognize, I think, some common 

sense kind of parameters but nonetheless have to have a 

thorough process here to both, you know, define whether 

it's sufficient and what sufficient information is in 

the context of this requirement, and then, how broadly 

the specification for that fuel or fuel additive should 

be, such that we can have reasonable confidence that 

your database that you're comfortable with covers any 

new development within that specification. 

In the context of when these provisions 

were being drafted, there was much discussion about 

synthetic fuels from shale and coal and quite a bit of 

concern about potentially new environmental risk from 

fuels, and yet, I would imagine a distillate from shale 

68 
P.70 

might have some of the same properties, but might cause 

new concerns environmentally as well. So, it's 

important that we set up a good framework here that's 

both reasonable but yet satisfies the obligation of 

insuring that there aren't, especially new, problems 

introduced, and to do that we have to establish this 

base concept, we think. 

Again, to the extent that your comments 

can give us specific ideas on these topics, I think the 

better we'll be able to find a proposal and go ahead, 

and I look forward to that. 

Any more questions? 

Thank you very much. 

I think the Motor Vehicle Manufacturers 

Association is next. 

We have a request for a five minute 

break. If there's no objection, we'll do that. 

(Proceedings recessed.) 

Mr. GRAY: Mr. Halberstadt, if you're 

ready, I think we can begin. 

MR. HALBERSTADT: Thank you, Mr. 

Chairman; my name is Marcel Halberstadt. I'm Director 

of the Environmental Department on MVMA staff. The 

members of the Motor Vehicle Manufacturers Association 

69 
P.71 

manufacture 94 percent of the cars, trucks and buses 

built in the United States, and those members are listed 

in the statement which I've made available for the 

record. 

MVMA appreciates the opportunity to 

comment on the Agency's ANPRM on fuels and fuel additive 

registration, as published in the August 7 Federal 

Register. In that notice EPA announced its intent to 

develop regulations and establish program protocols and 

test procedures related to the testing of motor vehicle 

fuels and fuel additives for purposes of registration as 

prescribed in Sections 211(b) and (e) of the Clean Air 

Act. The regulations are to provide for tests to 

determine potential public health effects and such other 

information as is reasonable and necessary to determine 

emissions control system effects and welfare impacts. 

My brief remarks will be confined to emission control 

system effects. 

It's clear from the reading of the 

Advance Notice of Proposed Rulemaking and Section 211 of 

the Clean Air Act that the requirement for determining 

the public health, welfare, and emission control system 

effects of fuels and fuel additives must be fulfilled by 

the fuel and fuel additive manufacturers. MVMA believes 

70 
P.72 

this responsibility should remain with the fuel and fuel 

additive makers under the new protocols and procedures 

established by EPA. 

Requirements for testing of effects of 

fuels and fuel additives on emission control systems 

should be as rigorous as those presently required for 

vehicle certification. This is especially critical 

because, under the proposed new Clean Air Act 

Amendments, vehicle manufacturers will be required to 

build vehicles that meet very stringent emissions 

standards. Vehicle manufacturers must be assured that 

any fuel or fuel additive will not compromise the 

manufacturer's ability to meet those standards. 

Testing requirements must also assess 

the impact of fuels and fuel additives on long-term 

durability of emission control systems. Vehicle 

manufacturers currently are responsible for the in-use 

durability of emission control systems for 50,000 miles 

for passenger cars and 120,000 miles for light-duty 

trucks. For cars, this is likely to be increased to 

100,000 miles with the Clean Air Act amendments. Fuels 

or fuel additives which undermine the integrity of 

emission control systems designed to perform for the 

required in-use period must not be approved. In 

71 
P.73 

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addition, testing of control system effects must include 

a statistically significant sample of vehicle systems 

and be conducted under appropriate driving conditions to 

be considered valid. 

It's also important that the data and 

information generated from testing fuel and fuel 

additive effects on emission control systems be 

available for public review, as is presently done for 

fuel additive waiver applications. I might mention 

here, in total concurrence with the API testimony, that 

the Motor Vehicle Manufacturers are just as optimistic 

that the auto oil research program will provide information to the Agency which is going to be absolutely 

invaluable and crucial to some of these determinations. 

The public review of this information is important 

because, as the designers and producers of the systems, 

vehicle manufacturers are in a unique position to 

understand best the implications and results of the 

testing protocols and the results. 

I would also like to mention that we are 

concerned about application of the, substantially 

similar, clause and urge that it not be interpreted too 

broadly because of the potential effects on emission 

control systems. 

72 
P.74 

J 

In summary, MVMA supports the need for 

regulations to establish fuel and fuel additive effects 

on emission control systems. Testing must be conducted 

in a statistically valid and appropriate protocol, with 

opportunity for public review, evaluation and assessment 

of test results. MVMA favors the use of fuel additives 

that can provide consumer benefits such as improved fuel 

quality, improved engine performance and durability, 

reduced deterioration of emission control systems and 

increased fuel supplies. However, fuel additives must 

not adversely affect the emission control performance 

and must not unreasonably increase the public's exposure 

to potentially harmful emissions. 

That concludes my statement, Mr. 

Chairman, and I will try to answer your questions. 

MR. GRAY: Your comments seem to focus 

exclusively, except for the last sentence, on 

manufacturer's liability for the regulated emissions and 

probably in particular concern about recall implications 

of different fuels and fuel additives, is that correct? 

MR. HALBERSTADT: It is the 

manufacturers' position that any new fuels or fuel 

additives must not adversely affect the emission control 

systems in use. So, certainly recall is one of the 

73 
P.75 

potential considerations, but in general as vehicles are 

built and certified, the manufacturers must be able to 

anticipate that the emission control systems will not be 

adversely affected by the fuels and the additives. 

MR. GRAY: How do you see the waiver 

provisions that you mentioned in your comments interacting with regulations that might be adopted here, 

since the large focus is often on the effect on the 

regulated emissions under the waiver process? Is that 

not sufficient for the type of concerns that you 

expressed in your statement? 

MR. HALBERSTADT: It may be. We're not 

absolutely certain. For example, the very important 

question is raised in the ANPRM about what might 

constitute a base fuel or base fuel additive combination, and while we've had extensive discussions on the 

subject, we're not absolutely sure what might constitute 

such a base line system. So, I'm not really prepared to 

answer your specific question right now, even though we 

share your concern. 

MR. GRAY: Is the concern that, for 

example, on the fuel side, the base fuel might be 

defined to have a broader range of specifications than 

the, substantially similar, gasoline type rule that's 

74 
P.76 

"1 

used in the waiver process? 

MR. HALBERSTADT: That would appear to 

be a possibility. We feel that any fuel that's adopted 

and interpreted to be a base line fuel, or it will more 

likely be a fuel and fuel additives package, must not 

have adverse affects on the emission control system. 

Beyond that, the requirements, well, let me just stop at 

this point. I'm not certain I grasp the essence of what 

you're trying to ask. 

MR. GRAY: The question is, relative to 

the concerns you expressed in your statement, why isn't 

the waiver process sufficient to guard against these 

concerns? 

MR. HALBERSTADT: The waiver process, as 

I understand it, applies to new additives or to fuels 

which may not be substantially similar to what's already 

available. If indeed the implementation of this rule 

were to concentrate on those particular chemical 

systems, then I don't believe we would have any concerns. That is, the present system in place is working 

quite adequately. 

Our concern is whether the Agency, 

through this process, might identify fuel and fuel 

additive systems that are not covered under the 211(f) 

75 
P.77 

Section, which then would cause us concern. That is, if 

for some reason fuels that are presently adequate in 

ewery way were to be identified as potentially causing 

problems, then we would revert to the concerns expressed 

in my statement about, at least as far as the effects on 

the emission control systems are concerned. 

MR. GRAY: Are you concerned that there 

could be unleaded gasoline specifications that could 

exist under the, substantially similar, ruling that 

might have significant adverse effects on the in-use 

performance of your vehicles, is that it? 

MR. HALBERSTADT: We believe that under 

a very broad, possibly a very broad interpretation of 

the term, substantially similar, that sufficient changes 

might creep into the fuel that have adverse effects on 

the exhaust control, emission control systems, would 

become evident, 

MR. GRAY: So, your concern is that the 

waiver process, because of the flexibility under, 

substantially similar, as it's now defined, may be too 

broad and that this rulemaking perhaps should in-depth 

establish more stringent or restrictive restrictions on 

the definition of, substantially similar, gasolines? 

I'm trying to better understand how we 

76 
P.78 

"~l 

.J 

can use this concern in developing the proposal by 

trying to understand what we need to be fixing that 

might not be working well with the current process, 

because the main focus of your comments deals with, it 

appears, regulated emissions and manufacturer's 

liability, not the toxic, unregulated type emissions 

that is the other part of the issue that we're focusing 

on. 

MR. HALBERSTADT: Well, as I mentioned 

at the outset, it was not my intent to talk about the 

health effects portion of the ANPRM, and perhaps the way 

I stated my concern about the interpretation of the, 

substantially similar, clause was misleading. I had no 

intention of raising a point about a portion of the 

system which is working very well right now. I did want 

to mention the concern in connection with the recommendation in the ANPRM concerning the grouping of 

chemicals of substances and the interpretation of what 

might constitute similar fuels as they presently exist 

and as they might be developed in the future. 

For this reason I really raised this 

caution flag, in the sense that if the substantially 

similar clause were interpreted too broadly in terms of 

grouping fuels or fuel additive combinations, we might 

77 
P.79 

leave the realm of something which is acceptable, that 

is, something which causes no adverse affects on the 

emission control systems, into a combination which, even 

though chemically appears very similar to the original, 

might cause some deterioration of the emission control 

systems. 

MR. GRAY: So, in essence your 

suggestion is that to keep our eyes open. The process 

should have sufficient safeguards to assure that some 

new fuel or fuel additive, even though it might qualify, 

for example, under, substantially similar, under the 

waiver process, that it still might have an adverse 

affect on the in-use performance of the emission control 

systems as they relate to the regulated emissions and 

manufacturer's responsibilities. In essence that's the 

thing you're asking us to do? 

MR. HALBERSTADT: Yes. 

MR. GRAY: Any questions? 

MS. KRUEGER: Do you have any proposed 

ideas for the tiered approach for assessing emission 

control effects, and if so, I would encourage you to 

submit those in writing. 

MR. HALBERSTADT: Okay, once again, 

we're considering the submission of comments on some 

78 
P.80 

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other portions of the ANPRM in writing for the record, 

and we will include your suggestion. 

MR. GRAY: Thank you very much. 

MR. HALBERSTADT: Thank you. 

MR. GRAY: The last scheduled testimony 

will come from CMA/Exxon Chemical; Mr. Keller. 

MR. KELLER: Thank you; in the interest 

of saving time, I will not be reading the full statement 

as you have printed in front of you. I'll be skipping 

through some sections and skipping some paragraphs 

entirely. I'll try to keep this possibly to a 12 

o'clock conclusion. 

My name is Dr. Charlie Keller, and I'm 

here today representing the Chemical Manufacturers 

Association, Petroleum Additives Panel. This panel 

represents a group of major manufacturers of fuel and 

lubricant additive components, and the companies 

represented on this panel are Amoco Petroleum Additives 

Company, Lubrizol Petroleum Chemical Company, the Ethyl 

Corporation, the Oronite Division of Chevron Chemical 

Company, the Paramins Division of Exxon Chemical 

Company, Texaco Chemical Company, and Mobil Chemical 

Company, 

As a parenthetical note, my comments 

79 
P.81 

today are going to focus almost entirely on the impact 

of this rule on fuel additives as fuel additives, as 

opposed to fuel additives in combination with hydrocarbon fuels. So, our perspective may be a little bit 

different than, for instance, that of the American 

Petroleum Institute, but the perspective is different 

only because we're focusing on one part of the issue, 

rather than much broader issues, I think, which are 

raised in the ANPRM. 

Fuel additives are specialty chemicals 

which are generally sold as proprietary mixtures to 

refiners and marketers of gasoline and distillate or 

diesel fuels. They're critical to the operation of 

modern emission-controlled engines. They act as 

antioxidants. Very importantly, they prevent fuel 

injector fouling; they reduce or prevent valve deposits 

and provide a host of other performance features. These 

functions of fuel additives have become increasingly 

critical to maintaining engine emission control in 

recent years, and I think we see that in advertising 

campaigns even and concerns raised by motor vehicle 

manufacturers. 

Now, while there's a general tendency 

among the general public to view chemicals as 

80 
P.82 

environmentally harmful, our industry, and in particular 

this CMA group, feels that we produce fuel additive 

chemicals which have made substantial contributions to 

maintaining low emissions in modern engines. In the 

ANPRM, EPA stated that there are currently 3,790 active 

registrations for fuel additives. Now, not all these 

are distinctly different products, as I'm sure EPA 

recognizes, but we believe that this very large number 

reflects the dynamic and innovative nature of fuel 

additives. We feel the industry has worked very hard in 

recent years and spent considerable research and 

development money to meet the challenges of fuel systems 

and engines which are now much more sensitive to deposit 

formation. I guess what we're trying to say is that we 

think we're part of the solution, not part of the 

problem. 

Now, the ANPRM raises a very large 

number of questions and unresolved issues, many of which 

affect fuel additives. The issues and questions raised 

include complex technical issues on emissions and 

toxicology testing, as well as some issues of public 

policy, risk assessment and the relationship of these 

proposed regulations to existing EPA regulations and 

ultimately to amendments to the Clean Air Act, which we 

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expect in this term of Congress. 

For example, just to focus on one thing, 

we believe that the ANPRM suggests toxicity testing 

which would probably go beyond the limits of established 

methodology and technology. While there has been 

toxicity testing of combustion emissions, and I think 

API has noted that quite well, this testing has not 

encompassed the full and broad spectrum of endpoints the 

ANPRM identified. Furthermore, in our opinion this 

testing has been directed at answering what would appear 

to be very narrow research questions. 

An important technical aspect of this 

problem is the selection of an appropriate baseline to 

compare and assess the toxicity of emissions from new 

fuel and additive combinations. Now, in just a casual 

view of this, and we haven't done any in-detail 

analysis, we think it could probably take years and 

millions of dollars just to develop and validate a 

baseline procedure and sets of protocols for testing 

combustion emissions in an inhalation toxicity test, for 

example. 

Now, in addition to variability issues, 

statistical variability in emissions, another technical 

problem is definition and control of variability in 

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animal response. That has been a problem in other 

tests, as I'm sure EPA recognizes, and this would be 

really a new area of comparative testing. We believe 

that developing and validating such test standards for 

emissions toxicity testing would require a massive 

effort on EPA's part and consequently, I think, on the 

part of the regulated industry. 

Beyond the examples I've just cited, we 

believe there are probably a lot of other examples of 

technical or practical concerns which could present 

obstacles to the testing program envisioned in the 

ANPRM. We recognize that EPA faces a real challenge in 

sorting through these issues to develop a focus for your 

rulemaking, 

To help focus on a direction for 

rulemaking, we believe it's helpful to examine the 

legislative debate in the 1970 and 1977 Clean Air Act 

Amendment process. In this regard we examined some of 

the documents that you have in your public docket for 

the rulemaking. As you know, the original 1970 Clean 

Air Act was in fact an amendment of predecessor 

provisions which were contained in the '67 Act. In 1970 

the legislative debate on fuels and fuel additives 

focused almost exclusively on the use of lead compounds 

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as anti-knock additives. However, in our review of the 

docket we did not find a single reference to 

congressional concerns for any specific fuel additive, 

other than lead anti-knock compounds. 

In the '77 Amendment process, 

congressional debate was also very narrowly focused. In 

1977, the fuel additive concerns of Congress focused on 

the use of the single additive chemical, and there was 

very limited mention of concern over general use of fuel 

additives. In addition, it appears from some 

congressional summaries of the time as though Congress 

was primarily interested in the issue of fuel additive 

effects on vehicle emission systems. As you know, 

that's included in Section 211(b)(2)(B). There didn't 

seem, as a comment or an opinion, there didn't seem to 

be a lot of congressional concern in the written record 

on health effects of emissions. Despite these apparent 

narrow concerns, Congress added, as you know, Section 

211(e) to the Act, which is your mandate to promulgate 

regulations under 211(b). The 211(e) mandate and the 

211(b) testing requirements are quite broad in potential 

scope, 

We believe that EPA should consider this 

information in the docket which is relevant to the 1970 

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and 1977 Amendments of Section 211. If EPA agrees that 

Congress focused only on a couple of specific additive 

chemicals of high concern to them and also on combustion 

emissions, then this could serve to help you focus your 

efforts in this rulemaking activity. 

Turning now to the statutory requirements in the Clean Air Act, the 1970 Act and its 

Amendments did not provide EPA with clear directions for 

rulemaking. Instead, EPA is given great latitude and 

discretion in regulating testing of fuels and additives. 

I have here the relevant section, on the slide, from 

211(b). 

The important thing here is, I think, 

the conditional phrase, may also require, and we believe 

this is critical to the ANPRM and the rulemaking because 

it allows, and for that matter even arguably mandates, 

that EPA utilize its judgment in preparing the 

regulations required under Section 211(e). As noted in 

the ANPRM, the legislative history of the '77 Amendments 

indicates Congress' intent that testing regulations not 

be unduly burdensome, and that costs should also be 

considered, 

To us, the ANPRM suggests that EPA may 

be interpreting the, may also require, statutory 

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language to mean, shall require. At this stage of 

rulemaking, we believe this emphasis on broad-based 

testing is somewhat premature. We feel that effective, 

more focused options for health and environmental 

protection, which would of course include testing, may 

not have been given sufficient consideration as yet. 

We believe EPA must focus their 

rulemaking to meet both the legislative intent and the 

statutory language which mandates some reasonable 

judgment. 

The current ANPRM addresses a very large 

number of very broad issues, but does not identify 

specific environmental, health, or public welfare 

concerns, or problems. This may sound like a cynical 

comment, but in some ways the ANPRM appears to be a 

solution in search of a problem. The possibility of a 

vast scope of testing, on possibly hundreds or thousands 

of products, raises the danger that these regulations 

could needlessly disrupt the use and innovation of 

additives with proven value in the reduction of 

emissions. The potential costs of testing could easily 

lead to reduced research and innovation and product 

withdrawals from the market, without any identified 

environmental benefit. We think that in this case, that 

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there's a case to be made, though not explicit in the 

statute, for some balancing of costs and benefits, 

particularly when the costs, in terms of environmental 

harm, haven't really been identified yet. 

EPA must assess their objectives in this 

rulemaking. In contrast to most EPA regulations with 

high potential impact, EPA has not included a regulatory 

analysis of their concerns and possible options. I 

think we're sympathetic to EPA's plight and your very 

tight timetable, since we've also been faced with a 

tight timetable and understand how difficult this issue 

is on this timetable. To focus rulemaking on issues of 

real concern, EPA should conduct a thorough regulatory 

analysis. This analysis should evaluate whether 

combinations with a fuel cause adverse environmental or 

health effects. It should address whether exposure to 

liquid fuels or evaporative emissions are a concern 

which is not being addressed by current EPA or perhaps 

OSHA regulations. The regulatory analysis should assess 

existing information on fuel additives to determine if 

there is sufficient reason to believe that registered 

additives adversely affect combustion emissions. The 

analysis should also determine how testing data would be 

used in Section 211(c) regulatory actions. 

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Finally, we feel it's very important 

that the analysis examine how the proposed regulations 

relate to the 1990 Clean Air Act Amendments which will 

potentially result in fundamental changes in vehicle 

fuels. In the 1990 Amendments, as currently being 

discussed in conference committee, neither Section 

211(b) nor (e) provisions are changed. There are 

proposed amendments which are relevant to this ANPRM, 

however. In particular, both bills, the Senate and the 

House version, actually require the use of fuel 

additives to prevent the formation of deposits in fuels 

systems. So, there's been some recognition on Congress' 

part of what I have said earlier in my presentation. In 

addition, CMA believes that fuel additives will be a 

crucial part of the clean fuels approach to reducing 

combustion emissions. Finally, the 1990 proposed 

Amendments would further limit evaporative emissions 

during refueling and from vehicles. Because this will 

further reduce human and environmental exposure, we 

believe this should be considered by EPA in the 

rulemaking in assessing whether there is a need for 

testing of liquid fuels and fuel additives. 

This leads us to another issue which we 

think is very important, which should be addressed, 

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P.90 

regarding the use of toxicity testing data which would 

be generated as a result of the rule developed from this 

ANPRM. EPA should carefully consider how toxicity 

generated by fuel and fuel additive manufacturers would 

be useful to EPA in carrying out their responsibilities 

under the Clean Air Act. The ANPRM proposes broad 

testing of fuel and fuel additive products, yet Section 

211(c) of the Act explicitly authorizes EPA to regulate 

fuel additives only on the basis of adverse effects of 

emissions. This is supported by the legislative history 

contained in the EPA docket which summarizes what had 

become the 211(e) provision. 

Since EPA lacks regulatory authority to 

regulate on the basis of non-emissions based effects, it 

would make little sense to us to require testing to 

evaluate these potential effects. 

Recognizing that these potential effects 

are still a concern, we believe that the toxicity of 

chemical components contained in fuels and fuel 

additives are already adequately addressed by the Toxic 

Substances Control Act, or TSCA. New fuel additive 

chemicals introduced since 1978 have been subject to EPA 

review and hazard assessment as part of the Premanufacturing Notification process. Existing fuel 

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additive chemicals are, of course, subject to potential 

regulation and testing under Section 4 of TSCA. In 

fact, EPA has already exercised this authority in at 

least one case, in fact more than one case, regarding 

MTBE, where there's a very large scale testing program 

for MTBE, whose primary use is in fuels. 

To change gears a little bit, talk about 

the matrix approach, while we would urge EPA to reevaluate their objectives and to focus on what may be 

the key environmental issues, we also believe that some 

of the concepts identified in the ANPRM merit further 

consideration. We believe that the tiered matrix 

approach is one of these, and it may offer a potentially 

flexible, focused process to identify fuel and fuel 

additive combinations for which further emissions 

toxicity testing may be needed. However, we feel that 

the matrices identified in the ANPRM are not optimally 

structured for decision-making, because toxicity testing 

could be required before there has been sufficient 

analysis and judgment exercised to determine whether 

this testing is really necessary or would even be useful 

to achieving regulatory objectives under Section 211(c). 

In this regard, the ANPRM notes that 

Congress' approach was to mandate a risk assessment for 

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potential adverse effects on health, welfare, and 

emission control systems. 

We strongly support this approach. 

However, we question whether the proposal to use 

production volume as a factor in the risk assessment is 

really all that valid. However, most importantly, we 

feel that the ANPRM does not sufficiently consider 

potential exposure as a major factor in this risk 

equation. As with many chemicals, very low exposure 

potential may negate the need for toxicity testing if 

there is sufficient information, including, for example, 

structure activity or SAR data, to assess a combustion 

emissions's approximate toxicity. 

Turning now to current regulations, we 

think this is another area where some links need to be 

made. We would support linking these proposed regulations to existing fuel additive registration procedures 

based upon the, substantially similar, definition for 

fuel additives. We believe the, substantially similar, 

provisions of the current registration process provides 

a workable mechanism for reviewing and registering 

additives. We think that these provisions are 

sufficient for considering combustion emissions, which 

we feel is the most important health and environmental 

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concern which was raised in the ANPRM. 

J 

Finally, to draw some conclusions from 

all of this, we believe EPA can succeed in this complex 

rulemaking if it follows the statutory mandate which 

requires judgment, discretion, and a focused approach on 

potential health and environmental concerns. The ANPRM 

identified a wide spectrum of issues. In fact, I think 

you probably covered the vast majority of potential 

issues and did a good job of pulling that together in 

the time that you had, but at this point we would hope 

that EPA could now begin to focus its effort to develop 

testing regulations from the proposed regulations, which 

would address real concerns, consistent with EPA's 

regulatory powers under Section 211(c). Any regulation 

which indiscriminately requires broad testing without 

regard to these issues or concerns runs the danger of 

causing needless disruption and economic hardship on 

producers and consumers. As I pointed out earlier, we 

believe, and Congress apparently concurs, that fuel 

additives are part of the solution, not the problem. We 

feel the regulations should reflect this, and EPA should 

not jeopardize future additive innovations which will 

benefit the environment and which will be necessary for 

the success of clean fuels requirements in the upcoming 

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P.94 

'90 Amendments, 

CMA would like to offer EPA our 

assistance in providing additional technical information 

in discussing what regulatory options you may have, what 

specific regulatory options you may have. However, we 

believe we could provide much more useful information if 

the comment period were extended another 30 or 60 days, 

to provide us with more time. We'd like to make the 

formal request that EPA consider extending the docket 

for written comments. 

Thank you for this opportunity to 

present our views, and we're very hopeful that we can 

work together to achieve a productive outcome on this 

rulemaking. 

MR. GRAY: Thank you for your statement, 

and we also look forward to continuing to work together. 

Although much of your statement focused on what at first 

you seemed to be characterizing as an EPA intent to 

seize all the opportunity for the broad authority, 

shaping of rulemaking, which is an apparent concern of 

yours, but then you did acknowledge that the more 

specific concept that was proposed was the tiered 

concept which was an attempt to, I think, respond to the 

kind of concerns that you raised, that the statute 

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could give a very broad impact maybe, and to some, 

suggest a very broad set of testing requirements, but it 

was an attempt to propose something that could build 

upon existing information of course. 

Also, I think, and that part you 

recognized, a key to that is the definition of the 

groupings, and you mentioned the, substantially similar, 

requirements for gasoline under the waiver process, but 

in your introductory kind of description of your 

association, it seemed to be principally fuel additive, 

maybe exclusively fuel additive companies, and I'm 

wondering how you view fuel additives under the, 

substantially similar, definition? What kind of 

flexibilities does that give you now? 

MR. KELLER: Because I'm representing a 

trade association, I guess I can't speak for each of the 

member companies. So, I'll speak in generalities, from 

my perspective in Exxon Chemical. I think the current, 

substantially similar, provisions under the current 

registration procedures offer sufficient flexibility and 

are realistic in terms of their operation. From our 

perspective in Exxon Chemical, I think we find them 

quite satisfactory. 

MR. GRAY: Because most fuel additives 

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were either already included or they're expected to be 

basic, organic-type materials that would be included? 

MR. KELLER: Yes; of course, as you 

know, there are exceptions which then would subject them 

to the waiver process. 

MR. GRAY: Right. 

MR. KELLER: But with discussions that 

we have had within the CMA group, would not indicate 

that there is any general dissatisfaction with the way 

the current registration procedures are operating and in 

particular with the definition which you've provided 

for, substantially similar. 

MR. GRAY: I think the concern that we 

probably would have to explore is whether or not though 

there's too much flexibility with regard to how we would 

be charged to implement this Section of course, and the 

examples of fuel or fuel additives that have been 

required to go through waiver processes of either 

inorganic materials in gasoline before or the addition 

of substantial amounts of a new organic material, and it 

allows considerable flexibility in other organic 

materials in low concentrations, like many of the fuel 

additives are, of course. 

So, I guess to the extent that we can 

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categorize, perhaps more finely, organic-based fuel 

additives to provide maybe more assurances that our 

obligations are being met under this rulemaking, if you 

could, in your follow-up comments, give us more specific 

help on how we can do that, I think that would be very 

helpful to us. 

MR. KELLER: I think we can probably do 

that in subsequent written comments. What we've 

suggested is that the, substantially similar, provisions 

are currently working, and working, in our view, quite 

well, and that we believe that they're protective of 

environmental and health issues. They're at least a 

good starting point for continuing the assessment, and I 

think you recognize that this is a different rule, this 

is a different rulemaking. The definition from 1981 may 

need to be re-looked at in terms of the objectives EPA 

has in this rulemaking and the mandate under 211(b). 

So, I think what we would suggest is, 

take a hard look at, substantially similar, and maybe we 

can provide some additional information, and some finetuning of the definition may or may not be appropriate. 

But I think that gets back to the general thrust of our 

presentation which is, the important thing here is to 

focus really on what the environmental health objectives 

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P.98 

are, and where the big concerns are. 

I think we've pointed out that we would 

feel that the concerns are in the combustion/emissions 

area, and as API has pointed out, there's a tremendous 

amount of information and work that have been done on 

combustion emissions, though that work was not 

specifically focused, as you know, on issues raised in 

this rulemaking. You can read that mass of information 

and learn a lot about combustion emissions and what 

concerns there might be for fuels or fuel additives. I 

think that information really needs to be strongly 

considered and assessed before you go too much further 

in the rulemaking process. 

MS. GILHOOLEY: I had a question about 

the exposure level from the fuel additives. There's one 

place in here that you say that all the new fuel 

additives would meet the TSCA criteria for high exposure 

chemicals. The early discussion suggested that a lot of 

fuel additives, the testimony from Du Pont, were low 

exposure. Could you explain that? 

MR. KELLER: Yes, I skipped through that 

in the presentation. It gets to be pretty technical. 

You have, on your group, an expert on this, I know, so 

I'll have to state, I guess, EPA's high volume, high 

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P.99 

exposure policy. We think exposure is low. However, in 

the PMN process high volume products are products which 

would be manufactured in quantities of greater than 

100,000 kilograms a year, or for which there would be 

exposure to greater than a thousand consumers, I 

believe, or 250 workers chronically. The numbers are 

something like that; Heidi may have them. 

In any case, those are thresholds in the 

PMN review process which trigger a more detailed evaluation of the PMN submission. They don't necessarily 

trigger testing under a consent order or under a 

voluntary suspension of the PMN period, but they do 

trigger a closer EPA look at the chemical and its uses. 

We feel that, given the way fuel 

additives are used, in low concentration, in products 

that are going to consumers, in generally enclosed uses 

to control for exposure to the hydrocarbon solvents 

which are used, or benzene containing gasoline, and 

because of the low vapor pressure of these fuel 

additives in general, at least of the specialty components, that all these things tend to suggest that 

human exposure to the additives through manufacturing, 

blending, distribution and consumer use in gasolines is 

probably very, very low. I can't cite specific studies, 

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but we think on just sort of a common sense, quick pass, 

surface view of this, it would appear that, in a risk 

assessment context, the exposure is going to be pretty 

low. 

MS. GILHOOLEY: Including in the 

emissions from the car? 

MR. KELLER: Well, I think that's an 

issue we're going to have to take a look at in a lot 

more detail, and that's why our comments suggested that 

that's where EPA ought to be looking as well, at 

emissions effects. However, as API has noted, there's 

already a lot out there that needs to be looked at. 

I guess my comments on TSCA and high 

volume chemicals had to do only with the way these 

chemicals are being reviewed within EPA already, not to 

suggest that EPA would agree or disagree with our 

assessment of exposure. I'm sure Heidi is going to want 

to say something now. 

MS. SIEGELBAUM: Well, just to clarify 

one point, the triggers that Dr. Keller is referring to 

deal primarily with widespread, although probably very 

small, exposures, and the way the statute is written has 

an eye towards looking at chronic effects over a long 

period of time, but what's happening now in the PMN 

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program at least, for the many chemicals that meet this 

exposure-based criteria, after receiving the base set, 

either both health and eco-toxicity data are dropping 

out of further review, you'll be happy to note. 

MR. KELLER: Good. 

MS. SIEGELBAUM: So, we're finding that 

the acutes are coming up negative, therefore, not 

necessitating any further chronic testing, or subchronic testing. 

MR. KELLER: I think it's also important 

to remember that the statutory powers under TSCA are 

quite broad and quite powerful, much more powerful and 

much broader than those in 211(b), and so under the PMN 

process, EPA has great powers to regulate and restrict. 

MS. SIEGELBAUM: I think your previous 

points are very well taken about circumscribing these 

regulations to take into account the other regulatory 

initiatives that are being taken, primarily under TSCA, 

in both the new chemicals program to a lesser extent, 

and perhaps more significantly under the existing 

chemicals program in regards to test rules. I think 

that one of the big challenges for the Agency will be 

coordinating those efforts, which is sometimes fairly 

difficult, to take into consideration the results from 

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NTP and other studies that are being conducted on the 

TSCA- side and using those up front to help more finely 

tailor these regulations so they're not overbroad and 

out of the scope of 211(b). So, you can help us work on 

that. 

MS. GILHOOLEY: I guess you also 

mentioned something about using the structure activity 

relationship as a way to get a combustion emissions 

approximate toxicity, as a way to assess it. You did 

that in the context of talking about low exposure 

levels. Is that something that could also be used in 

determining whether something is substantially similar, 

or whether you should group something? 

MR. KELLER: Yes, I think you can. I 

think that's really the basis of EPA's 1981 interpretive 

guideline on, substantially similar. Without going into 

a lot of detail in the statement, I wanted to raise 

structure activity relationships as a valid way to 

assess not only animal toxicity or human health 

concerns, but also concerns over emission or combustion 

products. I think it's kind of a useful concept to 

build into your tiered matrix approach. I think it 

needs some more thought and some polishing up and some 

specific details added to it, but I think it's a concept 

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that ought to be there. 

MS. GILHOOLEY: I guess just one last 

one. I guess you talked a lot about the legislative 

history, which I'm sure will be very useful. In your 

comments I guess you'll talk about the legislative 

history of the 1977 addition of 211(e) and its concerns 

about making sure that there is enough testing? 

MR. KELLER: Yes, again, that debate in 

'77 was pretty narrowly focused on one additive in 

particular. I think, without criticizing Congress too 

much, it's not clear that in 1970 or 1977 they really 

understood fuel additives. Having dealt with them in 

1987 in subcommittee, I know that in 1987, that the 

members of that subcommittee certainly didn't understand 

fuel additives. It took us a little while to educate 

them, but I think they finally understood that there 

were a lot of fuel additives out there, it wasn't just 

methanol and ethanol. 

So, I'm not sure how EPA can use that 

information in this rulemaking, but I think you ought to 

be looking at the legislative history to see what 

Congress had in mind when they wrote these provisions. 

I think it can be useful support for focusing your 

efforts. 

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MS. GILHOOLEY: I guess part of it is 

that they also have this concern that there be enough 

testing before you make decisions, so that's part of it 

we have to look at too. 

MR. KELLER: That's right, but, well, 

remember the statutory language in 211 (c) is, may also 

require, and so I think what's important for EPA to do 

is to justify any decision that they do make regarding 

either testing or non-testing in any particular 

registration. So if the regulations are written so as 

to provide you enough decision-making process based on a 

risk assessment, based on this Tier 1 or Tier 2 matrix 

information that's submitted by the registrant, I think 

that can be used to support a non-testing decision. 

Again, you do have other options too with TSCA powers, 

so I think there's a way to structure this around what 

you've already described, if you can begin to focus this 

thing a little bit more. 

MS. GRAHAM: I have a question about the 

toxicity testing. It goes to the points you're raising 

on the bottom of page two and some points you raised 

verbally, and I guess I'd like to ask you to expand a 

little bit upon them. 

Basically you suggested or you said that 

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the toxicity testing which would probably go beyond the 

limits of established methodology and technology, and if 

I try and subset that into, one can discuss the 

availability of methods, one can also say for whatever 

methods are available how difficult they are and another 

category would be how costly they are, but at least in 

my reading of this paragraph, I sense a lot of it is the 

method itself, as opposed to difficulty or cost. Would 

you like to expand a little bit more on your points? 

MR. KELLER: I'm not sure that cost is 

going to be big issue for the businesses involved. I'm 

not sure how big an issue it is in EPA's mind in this 

rulemaking, so I didn't focus on the cost issue at all. 

What I think we do need to be very concerned about is a 

point, I think, that was raised in the Du Pont presentation, where if you were looking at combustion emissions 

and looking for the effect of a particular fuel 

additive, which may be there at very low concentrations, 

for instance, 50 parts per million in the liquid fuel, 

you are going to need a test which is very, very 

sensitive to detect any differences whatsoever. 

In our view of current testing 

methodologies, a lot of this is based upon the lubricant 

additives experience we've had in testing lubricants, 

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for instance, in engine test stands. There's a lot of 

variability in the way the engines operate, from stand 

to stand, in the same engine from week to week. There's 

all kinds of effects that happen as the engine breaks 

in, as the engine starts to wear. A chronic toxicity 

test would probably go beyond the useful life of an 

engine on a stand, so you'd have to switch out engines 

during the test, and you would see spikes in your 

emissions because of that. 

So, I think because we would expect that 

you're looking for very, very fine differences, perhaps 

no difference at all, and because these tests have not 

been developed to look for these differences and that we 

know there's a lot of variability in stand testing of 

engines and of lubricants in these engines, we're not 

confident that these methods are very close to being 

applicable for biological testing. Beyond the problem 

of just running an engine consistently within very, very 

close specifications with as little variability as 

possible, you're now adding on the variability that you 

see in all toxicology experiments, and that compounds 

the overall variability of the entire study. 

So, I think what you're left with is a 

situation where you could very easily predict that 

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you're not going to see differences between a base line 

fuel and additive combination versus your tested 

mixtures, and it would then be pointless to do that kind 

of testing. So, I think we really are running into a 

technological wall here, and I think EPA needs to 

consider that and look at that issue pretty hard because 

it's going to drive where these regulations can 

effectively be. 

The other point that I made is that we 

don't think that anybody could agree today on what the 

proper base line combination would be in terms of whose 

fuel it's going to be, whose additive it's going to be, 

whose engine it's going to be, you know, what kind of 

test stand, operating under what load conditions for the 

engine. There's so many issues that would come up, this 

could be a five day symposium, and I don't think we 

would reach a resolution at the end for the operating 

conditions for those tests. 

MS. GRAHAM: I sense in you answer 

there, which is very useful and very informative, I 

sense another comment that might be directly pertinent 

to the protocols, and let me just ask if I interpreted 

properly. Essentially you're envisioning any possible 

testing guidelines as not being on the individual 

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chemical as it is combusted out, as it is an emission 

product. So, for example, if an additive is used, you 

would envision the testing being the additive present in 

the gasoline is combusted, as opposed to the admitted 

fraction combusted as a pure chemical. So you're 

envisioning this all as a complex mixture program? 

MR. KELLER: It would have to be, even 

in the base line engine that you'd run for comparison 

purposes as a control group. You could not run it 

without additives, unless you were going to run an 

engine that was specifically constructed with a fuel 

system to prevent deposit formation, and then you'd 

still be running a risk on deposits during the test. 

So, I would anticipate that even in the base line 

control group you would have to have some combination of 

additives and some accepted fuel. 

I think that, yes, it would be almost 

pointless to test individual additive components in a 

fuel. You would want to test the additives as they're 

registered in a fuel, in combination. As I stated 

before, gasoline needs more than just deposit control 

additives. There's other things that are added as well, 

including dyes. 

MS. GRAHAM: Right, but that takes in a 

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complex mixture because like if we used the example of 

lead as being an additive, one can measure lead coming 

out of a tailpipe, would know what its species is and do 

studies on lead and then make some extrapolations about 

what leaded gasoline might do. Of course lead is a 

nice, easy example here. The real world is quite more 

complex, so you wouldn't propose testing any emitted 

product as an individual chemical, would that be 

correct? 

MR. KELLER: I'm not sure what we would 

propose at this point. This is so far beyond where we 

think we can go with the technology right now that I'm 

not sure I can answer. That might not be right or it 

might not be wrong at this point. What I could comment 

is I think we need to put lead behind us and not let 

lead become the model of fuel additives because I, and I 

think the rest of the industry, I don't want to speak 

for everyone else, this is more of a personal opinion, 

but I think we've allowed lead to become the model for 

fuel additives, and it's really not an appropriate 

comparison for the vast majority of additives, including 

those which are currently covered by the, substantially 

similar, provisions. 

MS. GRAHAM: Thank you. 

108 
P.11 

MR. PASSAVANT: I'd like to ask two 

questions, if I could, please. Number one, I'd like to 

ask you, if you can't respond now, respond for the 

record to the comments that were made by Du Pont 

regarding the Small Business provisions, CMA representing a number of companies, I'm sure, of various sizes 

and various interests. We would really appreciate your 

input as to how your different member companies or your 

association might view those provisions and how they can 

best be implemented. 

My second question is really generic in 

nature. I'd really like to ask you, what in the ANPRM, 

the contents put out in the ANPRM, you would specifically take issue with, if any? We really want to get an 

idea if we're going in the right direction in your point 

of view or if there's some changing course you might 

suggest we make? 

MR. KELLER: To comment on the first 

question of small business, we will comment in the 

written provisions. We didn't see it as being a threshold issue at this point, though it is an important 

issue, and I also recognize that to some extent your 

hands are tied by statute on this one. You have to 

write provisions on it, on small businesses. 

109 
P.12 

' 1 

i. J 

MR. PASSAVANT: Actually it says, may; 

it doesn't say, must. 

MR. KELLER: Well, you may also require 

testing, and you seem to have gone down that road pretty 

far too. 

In terms of your overall direction and 

how the CMA Petroleum Additives Panel feels about that 

direction, I think at this point our concern is that 

because you haven't had any time, because of the strict 

timetable that's been sent in the consent order which 

you signed, that there hasn't been enough time to 

evaluate the information that's out there, the 

regulatory backdrop, the interaction of this potential 

regulation with existing regulations and statutes, and 

hence, at this point you're rather unfocused. I think 

that's our biggest concern, that there needs to be more 

focus in this rulemaking. 

MR. PASSAVANT: You're saying, focus, or 

are you saying preliminary decision making? 

MR. KELLER: Well, it may be in fact, in 

the way you write rules, preliminary decision making, 

based on the data that's out there. 

MR. PASSAVANT: Well, you can understand 

that in an ANPRM we specifically try to avoid that. We 

110 
P.13 

don't want to make decisions in havoc. 

MR. KELLER: Yes, I think you've got the 

issues on the table. There may be some more that get 

raised in written comments, but I think most of the 

issues are now on the table. I think it's now time to 

start putting some of those to bed and to get to the 

important issues which we think are setting up a matrix 

which fits into what the real environmental and health 

concerns are. 

MR. PASSAVANT: Do you support the 

concepts, such as groupings that we've talked about? 

MR. KELLER: Yes, with substantially 

similar provisions being at least a starting point for 

those groupings. 

MR. PASSAVANT: And your statement 

generally supported the tiered approach as well in terms 

of approach, in your written comments, if you have any 

thoughts on how those tiers might be optimized, as it 

seemed to us? 

MR. KELLER: Yes, I think in fact that's 

something we had intended to do, is to provide comments 

on those and maybe a suggestion on how they might be 

modified, 

MR. PASSAVANT: Thank you. 

111 
P.14 

MR. GRAY: Thank you very much. 

A last chance, if anyone in the audience 

would like to make a statement of any type, almost any 

type, now is your last chance. 

We thank you all for coming and we do 

look forward to follow-up participation, and as we said 

at the beginning, we really want to sincerely solicit 

some help in putting these together so that they are 

effective, but realistic as well. Thank you again for 

coming. 

(Proceedings concluded at 12:15 p.m.) 

112 
P.15 

STATE OF MICHIGAN ) 

COUNTY OF WASHTENAW) 

I, Susan Beale, Court Reporter, hereby do certify that 

this transcript, consisting of 112 pages, is a complete, true 

and correct record of the Public Hearing of the Environmental 

Protection Agency, in the matter of Fuels and Fuel Additives 

Registration, Advance Notice of Proposed Rulemaking, EPA Air 

Docket [LE-131], Docket #A-90-07, held at Domino's Farms, 

Ann Arbor, Michigan, on Wednesday, September 26, 1990. 

<^^^r^ /CisieA 

<7 

Susan Beale, CSMR 2741 

Western Wayne Court Reporting 

Plymouth, Michigan 

(313) 453-7232 

October 10, 1990 112a