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OAR Box 1834 

Prepped by Keeia Richards 

Document Number: 

43) IV-F-01 

Docket Number: 

A-90-07 

Printed 11/10/2008 2:14:35 PM Sheet 43 of 61 
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)V-f- ol 

UNITED STATES OF AMERICA 

ENVIRONMENTAL PROTECTION AGENCY 

IN THE MATTER OF: [*' 

Fuels and Fuel Additives Registration ) EPA Air Docket 

Regulations: Proposed Rule _ T _) Docket #A-90-07 

Public Hearing of the Environmental Protection Agency 

in the above-entitled matter, held at Best Western Domino's 

Farms Hotel and Conference Center, Ann Arbor, Michigan, on 

Thursday, May 28, 1992. 

APPEARANCES: 

RICHARD WILSON 

Director, Office of Mobile Sources 

Charles Gray 

Director, Regulatory Programs and Technology Division 

GLENN PASSAVANT 

Chief, Special Regulatory Projects Branch 

JUDY GRAY 

Project Manager, Special Regulatory Projects Branch 

JUDY GRAHAM 

Office of Research and Development 

MARY ELLEN LEVINE 

Office of General Counsel 

Western Wayne Court Reporting Service 

Plymouth, Michigan 
I N D E X 

INTRODUCTION 

Richard WiIson 

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Page 

CHEMICAL MANUFACTURERS ASSOCIATION 

Charles Keller 

Discussion 

6 

23 

AMERICAN PETROLEUM INSTITUTE 

John Sepesi 

Discussion 

44 

57 

SOLVALL CORPORATION 

Ken Whittet 

Discussion 

64 

65 

ALKEN-MURRAY CORPORATION 

John Turkal 

Discussion 

72 

86 

AMOCO OIL COMPANY 

Philip Bush 92 
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Ann Arbor, Michigan 

Thursday, May 28, 1992 - 9:00 a. m. 

MR. WILSON: Good morning; my name is 

Dick Wilson, and I'd like to welcome you to this public 

hearing on EPA's proposed regulations for the registration of 

fuels and fuel additives. As Director of the Office of Mobile 

Sources, I will be serving as the presiding officer for 

today's hearing. On the panel with me today are: Charles 

Gray, to my right, Director for Regulatory Programs and 

Technology; Glenn Passavant, down the table and Judy Gray of 

the Regulation Development and Support Division; Judy Graham 

from the Office of Research and Development; and Mary Ellen 

Levine from EPA's Office of General Counsel. 

The purpose of this hearing is to accept 

public testimony and comment concerning the Notice of Proposed 

Rulemaking on Fuels and Fuel Additives Registration, which 

appeared in the Federal Register on April 15th. For those who 

need them, copies of the Federal Register notice and the proposed regulatory text are available at the back of the room. 

EPA's authority to require the 

registration of motor vehicle fuels and fuel additives is 

contained in Section 211 of the 1970 Clean Air Act, and 

producers have been required to register their fuels and f .-' 

additives with the EPA since 1975. The existing registra-
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regulations require producers to submit some basic information 

on the identification, composition and purpose-in-use of their 

fuels and additives. These regulations implement Sections 

211(a) and 211(b)(1) of the Act. The proposed rule we are 

here to discuss today would implement the additional 

registration provisions contained in Sections 211(b)(2) and 

211(e), which require health, welfare and emission control 

system test results and other information to be submitted to 

EPA as part of the registration process. 

In developing the proposed rule, we have 

had to resolve many complex and sometimes controversial issues 

and have tried to find the most appropriate balance between 

the demands of science, public policy and practical economics. 

We believe the proposed requirements can furnish the 

information EPA needs to evaluate the possible adverse effects 

associated with fuel and additive use in motor vehicles, while 

offering a number of provisions designed to circumscribe the 

potentially vast scope of the program and to keep the related 

costs and burdens at reasonable levels. 

While we believe the proposal provides a 

useful, balanced and feasible approach to a complex regulatory 

area, many issues remain to be resolved before the rule can be 

finalized. The proposal discusses a number of alternative 

provisions for consideration and asks for public comment on 
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numerous subjects. Please note that we are preparing this 

rule under a consent decree, which calls for the Final Rule to 

be completed about one year from now. During the next few 

months, we will be making a number of difficult technical and 

policy decisions. We sincerely welcome your suggestions, 

whether at today's hearing or in the subsequent written 

comment period. 

Attendance sheets were available in the 

lobby as you arrived this morning, and if you have not signed 

in, please do so at your convenience. 

A separate sign-in sheet for presenting 

testimony was also available in the lobby. If you are planning 

to testify and have not yet signed up, please do so as quickl 

as possible so that we can anticipate your statement and make 

sure you are given a time slot. 

Our plan is to receive the testimony in 

order of sign-up. The hearing will continue throughout the 

day until everyone who wishes to give testimony has been 

heard. If necessary, we will break for lunch at a convenient 

time and reconvene afterward. A court reporter is here today 

to record the proceedings, and anyone wishing to receive a 

copy may make individual arrangements with her. A copy will 

also be placed in the public docket. 

If there are any questions from the 

v 
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audience regarding the testimony presented today, please write 

them on a sheet of paper and pass them forward to the EPA 

panel for consideration. 

The written comment period for this 

proposed rule ends on June 30th. Written comments should be 

addressed to Public Docket Number A-90-07 at the EPA's Air 

Docket. It would also be helpful if a copy could be forwarded 

to us in Ann Arbor, to the attention of Carolyn Krueger. 

Before we begin, are there any questions 

from the audience regarding today's hearing? 

I would mention that one of the 

participants asked to videotape the hearing, so unless 

somebody objects, we'll do that. 

Any other questions or comments before 

we begin? 

If not, the first witness in order of 

people signing up today is John Turkal. 

MR. TURKAL: I had originally requested 

that I would be the last to testify after the various 

associations, APT and the Chemical Manufacturers. I 

telephoned in that last week. 

MR. WILSON: Fine; next then is Charles 

Keller. 

MR. KELLER: I'm Charlie Keller and I 
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work for Exxon Chemical Company, but today I'll be 

representing the Chemical Manufacturers Association and 

presenting comments on behalf of the CMA's Petroleum Additives 

Panel. The Panel represents major manufacturers of performance additives for gasoline and diesel fuel. Our members 

include many companies that you'll recognize including Amoco, 

BASF, Chevron, DuPont, Ethyl, Exxon, Lubrizol, Nalco, Mobile, 

Texaco, Shell, Shell International, Rohm GmbH, Rohm and Hass 

and Witco Corporation. 

The manufacturers represented on the CMA 

Panel produce virtually all of the non-oxygenate fuel 

additives used in U.S. gasoline and diesel fuel. We've been 

actively participating in this rulemaking, and of course we 

remain vitally interested in its outcome. 

Fuel additives are critical to the 

operation of modern emission-controlled vehicles, and we 

believe that additives will gain in importance as the 1990 

Clean Air Act is implemented. Therefore, we believe that any 

fuel additive regulations under Section 211(b) should 

encourage, and certainly not interfere with, the use and 

development of fuel additives which are essential to achieving 

these critical objectives under the 1990 Clean Air Act. 

In our review of the April 15 NPRM, we 

noted a broad spectrum of technical and procedural issues that 
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we will address later in our detailed written comments. Today 

I'd like to focus my presentation on just a few of what we 

consider to be the really few key points that are raised in 

the proposed rule. 

First, while we would like to really 

compliment EPA on its efforts thus far, and I think there's 

been a lot of progress made from the ANPRM in terms of getting 

the issues on the table and focusing on what we think are the 

key issues, we do believe that the proposal leaves a number of 

critical issues unresolved, and certainly I think the NPRM 

recognizes that as well in terms of raising options and 

questions about what the best approach may be. I think I can 

characterize our comments into two major areas which I'll be 

working today. 

First, and most importantly, any rulemaking under Section 211(b) should not be an impediment to 

achieving critical objectives of the 1990 Clean Air Act. The 

additives industry is concerned, and in fact I would say very 

concerned, that regulatory options identified in the proposal 

could stifle product innovation and registration of new 

additives that can advance clean air objectives. In particular, we fear that some aspects of this proposed rulemaking 

could adversely affect implementation of regulations under 

Section 211(1), the Detergent Additive Specification 
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requirements, and Section 211(k), Reformulated Gasoline or 

RFG. The additive industry believes that the Section 211(b) 

registration requirement must be consistent with these two new 

developing regulations, but at this juncture we think that EPA 

is considering options that are really incompatible with the 

goals of the two regulations I've noted. 

Secondly, the Panel supports EPA's 

general approach of grouping fuels based upon characteristics 

of the raw product and on the use of a tiered approach for 

submitting emissions and biological data. 

In addition, we think the Agency has 

appropriately focused the rulemaking on the collection of 

emissions information rather than on the raw fuels and fuel 

additives. Although we support these two general concepts of 

what I'll call grouping and tiering, the Panel does have a 

number of concerns regarding the specific proposals in the 

proposed rule, and we will be suggesting some modifications to 

the grouping and tiering procedures. I'd like to emphasize 

that we think that both of those concepts are good ideas, and 

it's now really an issue of how those will be implemented and 

actually how the procedures will work under the regulations. 

As I go through this, you'll see that there are some areas 

where we've taken agreement with the proposed rules and some 

areas where, I think, we could characterize it as a 
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disagreement with the tack taken in the rule. I hope that our 

comments are constructive. I don't mean any of them to be 

taken negatively or personally. 

One of the Panel's principal concerns is 

that regulation under Section 211(b) must be consistent with 

other current rulemaking under the Clean Air Act. While we 

have not participated in the Section 211(k) RFG Regulatory 

Negotiation, we have observed that the current RFG proposal 

takes an entirely different regulatory tack to qualifying 

fuels. The RFG rulemaking relies upon what EPA concedes is a 

massive body of data on automotive emissions to create 

mathematical models for predicting combustion emissions from 

gasolines of varying composition. From the existing data, EPA 

has already derived what's now called a "Simple Model" for RFG 

emission and will be issuing a Final Rule for a "Complex 

Model" within nine months. 

Now, similar models have not yet been 

developed for diesel fuels, but we believe there is probably 

also sufficient data on diesel fuel emissions relative to fuel 

composition. The database may not be as extensive as it is 

for gasoline, but we feel there's a lot of data out there on 

diesel fuel and diesel fuel emissions. 

In the RFG rulemaking, EPA has expressed 

a strong regulatory preference for using mathematical models 

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P.12 

•*1 

rather than actual vehicle emissions testing. In fact, the 

proposed RFG rule allows for testing only under very limited 

and circumscribed conditions and for a limited time period, at 

which point the mathematical model must be used. In the case 

of the RFG rule, EPA has clearly indicated that the massive 

quantity of existing data linking fuel composition and 

emissions is a more reliable predictor than an emissions 

testing program on any single fuel and a single emissions 

test. 

Now in contrast, and recognizing there 

are slightly different regulatory objectives, the current 

proposal for Section 211(b) regulation focuses upon fuels and 

fuel additives testing in preference to use of existing data. 

While the proposed rule indicated that existing data can be 

submitted in lieu of Tier II test data, we believe that EPA 

has structured the Proposed Rule and its timetable so that no 

manufacturer would take the risk of having their fuel or fuel 

additive registrations voided if EPA were to decide that the 

existing data submitted in Tier I did not meet the regulatory 

requi rements. 

The Panel strongly urges EPA to consider 

focusing the 211(b) regulations more precisely or strongly on 

existing emissions data, rather than creating a regulatory 

scenario that essentially forces, and I think inadvertently 

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forces, manufacturers to conduct testing, even if equivalent 

and sufficient information already exists. This is a 

situation of risk-taking. I don't think any manufacturer is 

going to be willing to take a risk without knowing that you'll 

accept Tier I existing data and potentially void a fuel or 

fuel additive registration that could essentially wipe him out 

of the market. So it essentially forces, even though the rule 

allows for the submission of Tier I data, we don't think that 

that allowance creates a level playing field. 

Now a critical timing issue for our 

Panel is the effect of Section 211(b) rulemaking on 

implementation of the Detergent Additive Specifications and 

RFG. EPA is currently developing regulations, and the statute 

requires that all gasolines contain additives to meet these 

specifications by January 1, 1995. Since it is anticipated 

that the Final Rule for 211(b) will not be issued until May of 

1993, this would give additive manufacturers a maximum of 18 

months to develop data for registration of a new additive. We 

believe this is impossible. We don't think it can be done for 

a number of reasons, which we'll get into more detail in our 

technical written comments. Hence, additives manufacturers 

will be unable to register new additives which will be needed 

to meet the requirements of the 211(1) Detergent Additive 

regulations which will be taking effect in '95. 

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While it is a little premature to make 

any absolute statements, we also believe that new additives, 

and hence new additive registrations, will be required for 

RFG, which is mandated also for January of 1995. RFG will 

result in additional product performance challenges for the 

additives industry, since reformulated gasoline is different 

from current conventional gasoline, and as with the 211(1) 

requirements I noted before, Section 211(b) could impede or 

even prevent us from responding with the best additive 

products for RFG. 

We believe this timing effect of the 

Section 211(b) regulations on fuels and fuel additives 

compliance with 211(1) and (k) is a very, very serious issue 

with potentially disastrous consequences for our industry. 

The 211(b) regulations could result in what would amount to an 

unintended moratorium on the registration of new products, 

just at a time when these new products are needed to meet 

Clean Air Act initiatives. 

The additives industry strongly belie.e 

that the highly positive environmental benefits of the RFG and 

the Gasoline Detergent Additive regulations should not be 

compromised by regulations under 211(b). Clearly, we thirt 

EPA must carefully consider these broader consequences in :• s 

211(b) rulemaki ng. 
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I'd like to shift gears just a little 

bit and talk about the availability of facilities for doing 

the Tier II biological testing. Now this also constitutes 

another critical timing issue in the availability of testing 

facilities for Section 211(b) testing. While we believe that 

there are contractors, contract labs, capable of conducting 

emission speciation testing, we believe there are no 

contractors who currently are capable of both generating 

combustion emissions and conducting biological testing on 

those emissions. There are labs that do engine testing that 

can generate combustion emissions, and there are other labs 

that can do a great job with toxicology testing. 

Unfortunately, none of these labs are connected together and 

in fact in our review of the available facilities, there area 

no labs currently that do both. We think the EPA comes to the 

same conclusion in the proposed rule, that these facilities 

currently just don't exist, and these tests have not been run 

as specified in the NPRM. 

Now given the lack of facilities, we are 

very concerned with the proposed timetable for Tier II data 

submission. While we recognize your statutory constraints 

under 211(e), we're afraid that no independent laboratory will 

be able to construct facilities, develop protocols and, most 

importantly, validate the testing within a time frame which 

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would allow us, the industry, to submit data within the three 

year statutory 211(e) window. We believe EPA must more 

thoroughly evaluate laboratory availability and gain an 

understanding of the effort required to develop the working 

protocols and especially to validate these protocols in actual 

engine toxicology testing. You really need to become more 

familiar, I think, with the challenges that are going to be 

faced in terms of doing these kinds of studies, and we think 

they're substantial. 

I'd now like to comment on EPA's 

proposed approach to testing and data submission, and this is 

our general support of the grouping and tiering concepts. As 

I indicated earlier, the Panel supports EPA's proposal to 

group fuels and to utilize a tiered approach to testing and 

data submission. We believe the grouping and tiering 

proposals, in combination with the focus upon evaporative 

combustion emissions, are a sensible solution to collecting 

information for thousands of registered fuels and fuel 

additives. We agree with EPA that fuel grouping, according to 

the composition of the raw uncombusted fuel, is an appropriate 

basis for testing and registration. We also agree that the 

tiered approach to data submission allows for the most 

effective use of resources, yet allows for a professional, 

scientific review of the data and for an assessment of further 

j 

1 5 I 
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testing and data needs. 

Even though we strongly support these 

two general concepts of grouping and tiering, the additives 

industry has several specific concerns which I would like to 

briefly discuss, and we'll be submitting more detailed 

comments for the Docket on each of these issues. 

The first issue is that baseline fuels 

should include typical additives. First, we believe that 

gasoline and diesel fuel additives that meet 211 sub-sim 

criteria should be explicitly included in the baseline fuel 

formulation for each fuel family. For gasoline additives we 

believe that the additive or additives in the baseline fuel 

should meet the upcoming requirements of 211(1), the Detergent 

Fuel Additive regulations, since all gasoline will be required 

to meet this performance standard in 1995 and beyond. This 

becomes essentially baseline fuel in '95. 

In addition, we believe that baseline 

gasoline should also contain additives necessary for rust 

protection and other essential functions. The 211(1) 

detergent regulations really address only one specific aspect 

of gasoline and gasoline additive performance. There are many 

other essential functions in gasoline which are necessary. 

Similarly, baseline diesel fuels should contain additives 

typically used in commercial fuels, such as low temperature 

i 

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flow improvers, cetane improvers and corrosion inhibitors. 

CMA opposes a specific requirement that the test fuels contain 

either the minimal required additive or the maximum 

concentration recommended by the manufacturer, since we 

believe both of these cases may not be representative of 

commercial fuels. We believe really that the additive treat 

for a particular baseline fuel should be set taking that fuel 

into consideration as well as what's being commercially used 

in the marketplace. We're not sure that concepts as simple as 

maximum recommended concentration or minimal required additive 

really have much meaning in terms of the real world. 

A second point, CMA believes that the 

current proposal on tiered submission of data needs to be 

modified in light of the unavailability of Tier II biological 

testing facilities and the timing problem with registration of 

new additives needed for compliance with 211(k) and (1). It 

is not possible to conduct and submit Tier II testing in time 

for either the 1995 implementation of (k) and (1), or before 

the three year statutory 211(b) deadline, what we're terming 

the timing effects. 

CMA believes that EPA must reconsider 

the scheme for Tier II testing and the timetable for 

submission of this data. We suggest, and this is a step-out, 

but we're going to suggest it anyway, that rather than require 

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submission of both Tier I and Tier II data, that only the Tier 

I information be required within the three year time frame. 

EPA could then evaluate existing or new emission speciation 

test data for each fuel grouping, comparing it to baseline 

fuels and to existing data such as the extensive testing being 

conducted under the Auto/Oil Program, which is being used for 

development of the complex model under the RFG rule. Based 

upon this assessment, EPA could then require Tier II testing 

if emissions characterization indicated that a particular fuel 

had an emissions profile which raised potential health 

concerns. Recognize also that Tier I data submissions will 

include a very comprehensive search of the existing health 

effects and toxicological information that's been published 

and unpublished so that Tier I will be a pretty comprehensive 

view of what is out there now. However, we believe a review 

of Tier I information will indicate that there is no need for 

additional testing of sub-sim gasoline and diesel fuels. 

That's our own expectation based upon what we think is out 

there. It may not be EPA's conclusion after reviewing the 

data, but we thought we'd tell you what we expect. 

CMA believes this alternative approach 

would be more consistent with other Clean Air Act regulations, 

with existing data and with the status of currently available 

facilities and testing protocols, and we also think it 
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satisfies your statutory requirements. 

The third point we'd like to make, CMA 

believes that EPA should take a broader view of existing data 

submitted in Tier I as alternatives to specific Tier II tests. 

I guess we're a little bit concerned about some of the wording 

in the preamble and some of the discussion in the preamble 

discussing the sufficiency of Tier I data in lieu of Tier II 

data, and we think EPA should accept existing Tier I data 

which may be equivalent, but not necessarily identical to Tier 

II protocols which are specified in the proposed rule. Now 

this is a common procedure under TSCA, where TSCA for 

submission of premanfacturing notices will accept what I call 

read-across data on similar material or will accept non-GOP 

protocols where there was evidence of adequate scientific 

conduct of the studies, just non-compliance with specific GOP 

requirements on record-keeping, but where the validity of the 

study wasn't questioned, for example. In addition, what we're 

talking about is the use of epidemiological studies or human 

exposure studies, the kind of things that you'd use in a risk 

assessment type of situation. Now EPA recognized that there's 

a lot of existing data in the RFG rulemaking. The current 

Section 211(b) rulemaking also recognizes this existing 

information by requiring submission of existing data in the 

Tier I literature search and submission. However, the 
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proposed rule would seem to require Tier II tests, unless 

these precise tests were submitted in Tier I. We think the 

Agency should take a little bit broader view of this. 

In addition, we believe there are 

substantial data available on emission speciation of sub-sim 

fuels and that additional Tier I emission testing may not be 

needed. Again, this is our expectation of what's out there, 

and you may or may not agree when it finally comes down to it. 

We believe the current approach is too narrow an approach and 

that EPA needs to consider all the available data using a 

weight of the evidence approach in assessing Tier I data and 

what's needed under Tier II or even potentially Tier III. 

The fourth point, CMA strongly supports 

EPA's suggestion that testing could be conducted by 

manufacturer consortia. We believe that data submissions will 

in fact be handled by consortia and request that EPA include 

in the regulations provisions which support this approach. 

However, we would like the industry to be allowed to form 

testing consortia without direct Agency involvement. So what 

we're asking for, I think, is encouragement and not regulatory 

barriers to the formation of these consortia. 

A key to success of the consortia 

approach will be a workable mechanism for data compensation. 

While the NPRM notes the TSCA Section 4, that's the existing 

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chemicals testing procedures for cost-sharing, we do not 

believe that TSCA provides the best model for obtaining 

funding from non-participating companies. In fact, the NPRM 

notes that this mechanism exists, and I think it also notes 

that it's actually never been implemented, and one of the 

reasons for that is because the approach really is so 

burdensome on those paying for the studies that it's not worth 

the effort to try to get non-participants to chip in what may 

be a relatively small amount of money on the order of tens of 

thousands of dollars. So I guess within the industry we're 

not quite so sure that the Section 4 data compensation 

mechanisms really work very well. We'd like to propose an 

alternate approach in our written comments, but quite frankly, 

we haven't come up with one yet, so we'll work on that. 

Beyond the need for a data compensation 

mechanism, we believe EPA should allow industry to form 

consortia without Agency involvement. We think that the free 

market really works pretty well in this regard, and that's 

been true under TSCA. I think most companies are pretty 

satisfied with TSCA Section 4 group data submissions and the 

way that's being handled within trade associations. 

Next point, we strongly support 

inclusion Option B for oxygenated fuels. Now the EPA 

requested comments on the inclusion of oxygenated fuels and 

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the baseline formulation class for gasoline. Additive 

manufacturers strongly support the inclusion of what EPA has 

identified as "Option B." We believe emission testing data 

generally support inclusion of all oxygenated fuels into a 

single group, with the caveat that we have noted that this 

issue is now being addressed in the Supplemental NPRM for RFG, 

and that there may be some oxygenated fuels which are 

exceptions to the statement which I just made. I think the 

Auto/Oil program and some additional testing under the RFG 

will probably flesh out exceptions to the oxygenate rule. 

For the non-oxygenate sub-sim 

performance additives that we actually manufacture, we do not 

believe there is any point to conducting separate testing of 

these additives with each type of oxygenated fuel. We believe 

a single test of these additives in a baseline formulation is 

sufficient, as it is expected that sub-sim additives will not 

adversely affect emissions at the concentrations that they're 

being used, the types of additives that are being used, et 

cetera, et cetera, all that's included in the sub-sim 

definition. 

I'm at the point of summarizing now; 

while the additives industry generally supports the overall 

approach to fuels and fuel additives testing proposed in the 

April 15 proposed rule, we are concerned about some of the 

22 
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specific procedures and requirements. Our greatest concern is 

that the proposed regulation would have the effect of 

inadvertently stifling the innovation required to meet other 

Clean Air Act fuel requirements. We do not believe that the 

very, very important objectives of the 211(k) RFG rule and the 

211(1) Detergent Additive rule should be compromised or even 

put at risk for what we think are the much more modest 

objectives of this Section 211(b) rulemaking. We, therefore, 

urge EPA to reconsider some of the issues raised in this 

proposal in light of the RFG Reg-Neg outcome and the principal 

goal of improving fuel and fuel additive performance. 

We believe that Section 211(b) 

rulemaking can be consistent with these other, more critical 

Clean Air Act objectives, and that the general approach 

outlined in the proposed rule is still applicable, as long as 

key modifications are made in the grouping and tiering 

procedures. Most importantly, we believe this can be 

accomplished without compromising any significant environmental or health objectives; thank you. 

MR. WILSON: Thank you very much for 

coming and for your testimony. 

MR. GRAY: Could you explain a litt'e 

more specifically the sense of the conflict that you see «-*.n 

the other Clear Air Act fuel requirements, take, for exa^c'-. 
P.25 

the reformulated gasoline requirement? I understand the 

concepts that you put across, but I don't quite get your point 

of it in a specific case how it would really be inconsistent? 

MR. KELLER: Is this the timing effect, 

you mean? 

to time, 

MR. GRAY: I assumed you were relating 

MR. KELLER: Yes. 

MR. GRAY: You were talking about the 

timing of the program, but still if you could give us an 

example maybe to be sure it's clearly understood? 

assumption 

gasoline, 

new fuels 

assumption 

MR. KELLER: Okay, let's work on the 

that RFG or 211(1) detergent additive fuel, 

will require new registrations of new additives or 

in order to meet the RFG and 211(1) requirements. 

MR. GRAY: Is that a critical 

? 

MR. KELLER: Yes, it's a critical but a 

very reasonable assumption. For at least some of our member 

companies, 

certainty. 

going to h 

that's an absolute certainty, and I mean absolute 

RFG gasolines are not now registered. They're 

ave to be registered. They're going to have to 

contain fuel additives which in all probability will be 

di fferent. Now the Detergent Additive Performance rule has 

24 
P.26 

1 

not yet even reached the proposed rule stage, so we're not 

sure where the performance specifications are going to be set. 

MR. GRAY: I think that's a key point. 

You're not saying that it has to be an entirely new fuel, but 

that since it's a new requirement, there may be certain 

companies that will feel in the marketplace to be competitive 

or what have you, that they will need to offer a new product 

in order to be able to really participate in the market for 

those new requirements. 

MR. KELLER: That's a certainty for some 

gasoline marketers who are not selling, for instance, gasoline 

which now meets, say, the 211(1) detergent additives 

standards. I think you know in other rulemaking discussions 

we've stated that where we think that standard is going to end 

up is probably met by the majority of gasolines currently 

being sold in 1992, but there's a minority of fuels which do 

not meet the expected 211(1) standards as of today and 

probably won't meet them until the requirements take effect in 

'95. So for those fuels, they will require new registrations 

with new additives. Now those may be already existing, registered additives, but at least the fuel may need registration. 

In addition, on the additives side we're 

pretty sure that we're going to have to register new additives 

for 211(1) and for 211(k). They may be reformulations of 

25 
P.27 

existing components, but under current rules they're going to 

require new registration. So I think it's a virtual certainty 

that both 211(1) and 211(k) are going to require new additive 

and new fuel registration for virtually every company 

participating. It may be different for each company. I can't 

state with any certainty, but it's a certainty that new 

registrations will be required. 

So taking that as a baseline assumption, 

let me move into the timing effect. The problem becomes that 

effective with this rule we will not be able to register any 

new additives, and with the expected effective date of, say, 

June 1, 1993, for example, we would not be able to register 

any new additives after that date unless we submitted, as 

proposed here, Tier I and Tier II data. What we're saying is, 

we cannot generate Tier II data because existing facilities do 

not exist. We don't even think we can generate it within the 

three year window that's allowed under 211(e), never mind the 

18 month window that we're going to have for commercialization 

of those products for 211(1) and (k). So we're saying, it's a 

virtual impossibility for us to be able to register new 

additives to meet RFG and detergent additive requirements 

under (1) and (k) by January 1, '95, and we don't even th ••-,;< 

we can meet the three year window for what amounts to reregistration of existing additives which are in the mari-e-
P.28 

place prior to next June. 

That's the timing effect, and it's a 

very, very serious effect because if this falls out, as I've 

just described, it could cause some severe dislocations within 

the industry for what we see as very, very modest environmental, health and environmental safety objectives. We really 

think you need to take a hard look at that timing effect and 

what happens in the real world. 

MR. GRAY: So in essence it's really an 

argument that any company that needs to be able to respond to 

one of the other regulations with a new product really be, 

fairness suggests, should be given an opportunity to be able 

to register it under these provisions in order to not be 

precluded from the initial market that's created by the other 

regulations. That's in essence what it is because from a 

technical standpoint there may be some companies that could 

comply with already registered compounds, but since it's a new 

requirement, other companies may not have been participating 

that may now want to and may be precluded, you think, from a 

timing standpoint? 

MR. KELLER: Yes, that's the critical 

issue. The secondary issue is that if the testing under Tier 

II can't be completed within the three year window, we could 

be at a situation where there would be no one in compliance 

____ 
P.29 

three years after the implementation of 211(b) simply because 

we couldn't get the testing facilities constructed, validated 

and the testing done in time. 

MR. GRAY: But that's a broader issue. 

MR. KELLER: Right, I think I've noted 

before, that means that service stations will be selling bread 

and milk instead of gasoline. So I think that's a serious 

concern that we have, and obviously EPA isn't going to void 

the registration of every gasoline in the country because it 

was impossible to get the testing done because no facility 

existed. So in reality, the more severe situation we see is 

the marketplace impact that this could cause in uneven playing 

field. 

A secondary economic consideration is 

that we're always changing additives and additive 

formulations, and I think you only need to ask Jim Caldwell 

about how many registrations are filed to know that. That's 

not done because we like to file paperwork with the EPA. It's 

because we're in a very competitive market situation where 

both cost and performance are critical. So we have to keep 

filing new registrations to get better performance for our oil 

company customers and lower costs for them. 

If this blocks all registrations 

effective June 1, 1993, for example, we're not going to be 

28 
P.30 

able to make those cost benefit improvements in our additives 

for some period of time. That's the moratorium I referred to. 

Now that has economic impact on the sale of fuel and fuel 

additives and on the general economy. It ma not be a multibillion dollar impact like RFG, but there is a measurable 

impact there. So I think that's a secondary concern. 

MR. GRAY: I'm sure some of the other 

people on the panel will get into it in more detail, but just 

from a broader perspective, what is your estimate of a 

reasonably aggressive time frame that would be still feasible? 

MR. KELLER: I'll tell you, I can't 

honestly say. We've talked to one potential contract lab who 

we feel is probably the most capable of conducting this type 

of testing under Tier II and really don't have a good feel in 

having had one day's worth of meetings with them as to what we 

could actually do in reality. 

The problem that we face is that nobody 

has really done this testing before with a chassis dynamometer 

and a heavy-duty stand engine, and you end up with a lot of 

issues that got raised as to how we would do this. For 

example, I don't know if any of you have been in the same room 

with a heavy-duty Cummins diesel running full tilt or even 

three-quarters tilt on a dyno or on a stand. That engine 

throws off a lot of heat and a lot of vibration, and the 
P.31 

feeling is, if we're going to have to do any kind of neuro-tox 

testing or neuro-tox assessment, that that engine test stand 

is going to have to be in a separate building on a separate 

foundation or the animals are going to be vibrating for eight 

hours a day, seven days a week and that the neuro-tox testing, 

the functional observational battery, will be meaningless 

given the fact that we've been shaking these animals from the 

effect of this ten liter diesel engine going up and down for 

eight hours. So I think that's a total unknown for us at this 

point, and we don't know how much of a problem that's going to 

be, 

MR. GRAY: Are you suggesting that 

vibration emissions may be a critical — 

MR. KELLER: Yes, I think we are. I 

think any neuro-toxicologist could say if you put somebody on 

a vibrating platform eight hours a day, he's probably not 

going to respond too normally to any stimulus after that. 

It's going to take at least a few strong belts of bourbon to 

get him back to any semblance of normal. 

MR. GRAY: It probably is surprising 

that the vibration loads are sometimes ten to a hundred Gs at 

the engines, 

MR. KELLER: Yes, and there's heat 

effects. You know, a heavy-duty diesel is throwing off a 
P.32 

tremendous amount of BTUs. How much cooling are we going to 

have to do? Are we going to have to put in, for instance, a 

cooling system on the exhaust just to get the exhaust 

temperatures in the chamber to something that the animals can 

survive? I mean, we were joking about cooking the mice and 

rats just from the heat of the diesel exhaust. These engines 

throw off tremendous amounts of heat. 

MR. GRAY: Well, certainly you'd have to 

isolate the generation of the emission, which would be an 

engine dynamometer, from any testing environment, and that 

gets back into a question of how long that would take. 

MR. KELLER: Right. 

MR. GRAY: And people have done that, so 

you have a base of knowledge about what would be involved, and 

so it's really bringing together the two types of testing 

expertise, you might say, is really what you're getting at. 

MR. KELLER: That's right, that's what 

we're getting at, that what we think is lots of testing 

expertise for running heavy-duty stands and running chassis 

dynamometers for light-duty vehicles, and we think there's 

technology available to do that and to speciate the exhaust 

right now, that that's not a problem. That's being done in 

Auto/Oil, and it wouldn't be a problem to extend that to 

diesel. It would take a little bit of technology on the 
P.33 

sampling, et cetera, et cetera, but it's not a problem, it 

can be done 

The problem is hooking that into animal 

exposures and into the chambers where there's a lot of 

engineering and other concerns that would have to be worked. 

People know how to do inhalation toxicology experiments. 

They've just never done it with this kind of configuration in 

this scope. So it's an engineering problem for the most part, 

and there's going to be the issue of just validating the 

testing, and that's not something that can be done in a month 

or two. It's going to take time to design, engineer, 

construct and then validate the testing, including emissions 

generation, emissions sampling in the chamber, a lot of things 

like that. That can't be done in 18 months. I mean, it can't 

be done in 18 months, and we don't think it can be done in 

three years, 

MR. GRAY: Of course there are some 

experiments in inhalation testing with, in fact, diesel 

exhaust and a certain amount of data that's been collected 

over the last few years in that area. 

MR. KELLER: Right, but I think from 

what we've seen, that's all been with light-duty diesel. The 

work that I've seen has been with a 1.6 liter Volkswagen, it's 

a Golf diesel engine, and that's a different situation than a 
P.34 

ten or a 13 liter Cummins or take your pick. 

MR. GRAY: I understand your position. 

I think certainly in those areas we have experience too that 

can address the length of time it takes to put the facilities 

together. I just wanted to give you an opportunity to address 

what you saw as the critical, sort of lead time perspectives. 

It sounds like you're suggesting that front end lead time to 

get capacity in place is one component of it, and then there's 

a separate component of turn-around time of information from 

such a facility. What about the latter? Once facilities are 

in place, what's your sense of how long it would take to 

reasonably get this Tier II information? 

MR. KELLER: I've been managing or 

supervising the management of toxicology testing for 12 years, 

and to do a Tier II program from contract negotiation to 

contract signing in a consortia type situation where you've 

got a lot of companies involved, where you're dealing with a 

contract lab, assuming what we're doing in 90 days, subchronic study with a neuro-tox added on at the end, plus the 

reproductive studies, that's not something that can be done in 

12 months, and I think what you need to do is you need to look 

at how long it's taken to do similar kinds of programs under 

TSCA Section 4. The allowance for time there is a lot more 

than 12 months on an inhalation study of 90 days plus reprc 
P.35 

tests, you know. It's not even clear that you can do the 

repro testing simultaneously. 

The other issue is, because of what we 

think are going to be substantial capital investment costs 

just to put the facility in, there may be no more than one 

facility capable of running one test at a time. So with 

multiple fuels, multiple engines, I don't know that we'll be 

looking at a situation where these things would be testing 

simultaneously. It may be that they're going to have to be 

tested sequentially because of the capital investment and 

engineering 

that throws 

this is pure 

who we could 

answered the 

would be you 

to say that 

211(e)? 

investment up front. 

all kinds of problems 

ly speculation at this 

go to right 

MS. 

If that'. 

into the 

> point, ; 

now who can 

GRAHAM: 

questions that I had. 

MS. LEVINE: 

r legal rationale for 

Tier I would 

MR. 

I 

I 

do th 

think 

3 the case, 

timetables. 

since there' 

is test. 

I mean, 

Again, 

s nobody 

you've already 

wanted to ask you 

interpreting Section 

be sufficient for 

KELLER: I 

the whole debate or discussion that's 

really mandates and what 

require. Th is is obvious 

211(b) sa ys 

ly your call 

think 

been 

satisfying 

that brings 

had on what 

in terms of the, 

, what 

211(e) 

Section 

us into 

211(e) 

may also 

in OGC as to what the 

34 
P.36 

statutory requirement is on EPA. I don't want to presume to 

interpret the Clean Air Act for EPA, but I'll just read the 

211(b) section which is relevant. It says: for the purpose of 

registration of fuels and fuel additives, the Administrator 

may also require the manufacturer of any fuel or fuel additive 

to conduct tests to determine the potential public health 

effects of such fuel or additive, including but not limited 

to, carcinogenic, teratogenic or mutagenic effects. That part 

of 211(b) doesn't specify what kinds of tests. It says, may 

also require tests, and emissions speciation tests to determine the type of emissions in combination with a literature 

search and available literature data on the toxicity or hazard 

of those speciated emissions could constitute, at least in my 

own personal view, the test that the EPA could also, may also 

require, under 211(b). I don't think that's a stretch of the 

statutory language at al1. I think that's consistent with the 

statutory language and with the requirement for the three year 

implementation under 211(e). I guess what I'm suggesting is 

that EPA needs to take a look at what really does need to be 

required within the three year window and whether the Tier II 

testing has to fall under the statute within the three year 

window. 

MS. LEVINE: How could you reconcile 

that language with a literature search that gives no 
P.37 

information on the three endpoints specified in Section 

211(b)? 

MR. KELLER: No information? 

MS. LEVINE: Right. 

MR. KELLER: Well, no information would 

be tough to reconcile it, but there is not going to be no 

information. I mean, if you look at the available data and 

the sense that we recommend it, in a little bit broader sense 

than what's addressed in the current NPRM, and consider 

structure activity relationships and read-across and 

everything else that's out there, I don't think the Agency's 

going to reach the conclusion that no information exists. 

Again, the position that we've taken in 

our comments is not that Tier II testing won't be needed. 

It's that we don't think it's going to be needed in the case 

of sub-sim fuels and fuel additives, but that if the Agency 

does think it's needed, that it could follow in the tiered 

approach as Tier III currently does. So what we're saying is 

that it just doesn't fit within the three year window in terms 

of feasibility and because of the impact that this has on 

211(1) and (k) compliance. 

MS. LEVINE: I would encourage you to 

consider that in your written comments, particularly in light 

of the three year explicit statutory mandate in Section 
P.38 

211 (e 

those 

). We'd be interested in loo 

MS . GRAY: I 

comments should also address 

and additives which have 

elements since there may 

MR 

king at that. 

'd just like to add that 

the non-sub-sim additives 

things that we have termed atypical 

very wel1 

KELLER: 

not be applicable testing. 

I'm not sure that the CMA 

comments will address the atypicals. The manufacturers on our 

panel 

under 

make < 

them. 

manuf< 

| indiv 

group 

are almost exclusively concerned with what now falls 

sub-sim. 

MS GRAY: I 

that clear because we have to 

MR. KELLER: 

acturers on our group who may 

hope your comments will 

be concerned about all of 

Right, there are some 

choose to respond 

idually on the atypical classes, but I think thus far the 

has focused on sub-•sim additives, the non-oxygenated 

sub-sim additives specifically. 

point 

MR. 

that I wanted to as 

PASSAVANT: You began to touch on a 

>k you to expand upon when you respond 

back to us and that is exactly who 

total 

that. 

would 

broad 

additive market, ar 

You probably have 

id I think 

does CMA represent in this 

you started to touch on 

some literature or something that 

give us a rough idea on that. 

idea of who we're r 

We're trying to get a 

tearing from, and based upon how many 

3 7 
P.39 

companies are registered in the database, there seems to be a 

lot of companies out there that you don't represent. So it 

would help us out to know that. 

MR. KELLER: My comment that we 

manufacture the vast majority, we don't have a good figure on 

that, but it certainly is in the nineties, in terms of 90 

percentage range up. It may be much higher than that, of the 

non-oxygenated fuel additives sold in the U.S. Some of our 

companies also manufacture oxygenates as well. I think you've 

recognized some of the big chemical company names in our 

petroleum affiliates as being major manufactures of oxygenates 

as well, but this group is focusing primarily on those nonoxygenated sub-sims. 

Now there's many companies that are 

essentially re-labelers or re-registrants of products that we 

make. They'll combine our additive products bought from 

several of us into one product and sell that in the retail 

market, and there's some re-labelers out there. So the actual 

product that's being manufactured, almost all of it in the 

market in the U.S. is coming from one of the CMA panel 

companies. 

MR. PASSAVANT: On page five of your 

comments, you encourage the Agency to make maximum use of 

existing information and that if we don't come forward with 

^__ _ 33 
P.40 

something that allows you to do that, that you're going to 

feel forced to do testing. In your comments would you please 

give us some feed-back on what criteria you think we should 

consider as part of that process? That was one of the things 

that we wrestled with, was an adequate level of specificity in 

the NPRM versus what we think, what you think, what others 

think, might really be required. So if you could help us with 

that, it would help us better to perhaps allow you to make 

those kinds of decisions. 

MR. KELLER: We'll try, but we recognize 

that this is a problem. How do you specify what amounts to a 

scientific process and use of professional judgment, and it's 

something that the Agency always struggles with, and it's 

something that we always struggle with. There's many, many 

conferences and symposiums being held on risk assessment, and 

it's very difficult to get people to agree what the steps are 

in a generic sense. 

It's a lot easier to do it in the case 

of specifics where you have a pile of data in front of you and 

a specific situation. It's much easier to get agreement on 

how to do that when you've got an actual case, but in terms of 

a generic approach, without a specific case in front of you, 

it's really difficult to put the scientific process down on 

paper. 
P.41 

MR. PASSAVANT: We agree with that, and 

that's why we were unable to really just be real specific 

right now. 

MR. KELLER: Right. 

MS. LEVINE: Another alternative 

approach is to come up with some kind of performance standards 

in place of the guidelines, and we would be interested in 

looking at general performance standards as an alternative way 

of providing certain data. 

MR. KELLER: Right. 

MR. PASSAVANT: On page nine in your 

comments, this is in the area where you're talking about 

basically making Tier I that requires submission within three 

years, are you ultimately suggesting something that the Agency 

considered that we would have to have two rulemakings, one 

rulemaking that would just require the submission of the Tier 

I data and then another which would regroup and then go 

forward with the Tier II requirements based upon what we 

learned from the Tier I submissions? 

MR. KELLER: I guess we haven't thought 

it through that far. I don't know Whether we're suggesting 

that you'd need to do that. You may be able to do it in one 

rulemaking. Maybe it would make more sense to do it in two. 

I guess we haven't really thought about how you would do it. 

• » : i 
P.42 

We just thought we'd propose this as a possible alternative to 

what you've got right now that seems to address the timing 

issue and the facilities issue. 

MR. PASSAVANT: It does. One final 

point that gives me a little bit of concern is early in your 

testimony you give a pretty good emphasis on the use of 

mathematical modeling with no emission results, and I expect 

you're focusing that more on the sub-sim problem? 

MR. KELLER: Yes. 

MR. PASSAVANT: Obviously the data 

doesn't exist for the non-sub-sims, and also I have a broad 

concern as a matter of toxicology, not being one, but understanding some of your game, that one of the reasons we felt it 

was important to require the emission speciation to be done is 

that you're going to use that same vehicle to actually expose 

the animals. If I were the toxicologist doing this testing, I 

wouldn't want to know what I was putting in those cages before 

I did it and during when I did it and when I was done doing 

it, just sort of some kind of a history of what that exposure 

looks like, and to rely upon mathematical model for that would 

probably not give me the adequate information to be able to 

really have that cause and effect link that I would be looking 

at. 

MR. KELLER: Yes, I don't want to get 
P.43 

into writing a protocol up here right now, but I think if we 

were moving into Tier II testing, we wouldn't use a 

mathematical model to predict animal exposures. I mean, we 

wouldn't have any confidence in that either. We'd want to 

know what those animals would be exposed to. Who knows what 

could go wrong with the car and you wouldn't pick it up with 

normal operating parameters. You'd want to follow at least 

some of the emission components' constituents in the exposure 

chamber. I mean, you might not want to try to follow on a 

daily basis the entire Auto/Oil characterization of whatever 

it is, 140, 150 constituents, but you'd probably want to 

follow the critical ones, certainly carbon monoxide and carbon 

dioxide. It would be critical to follow those two. 

MR. PASSAVANT: And I guess the Auto/Oil 

studies of the models that are coming out are not looking at a 

real broad spectrum of toxic pollutants, it's half a dozen or 

so, and we're talking about a lot of others that are of 

potential concern here that are of much, much smaller 

concentrations than that half dozen or so quoted there. 

MR. KELLER: Well, the Auto/Oil is 

looking at a long list. 

MR. PASSAVANT: But they're not modeling 

after those, is what I'm saying. 

MR. KELLER: Right, the RFG is looking 

42 
P.44 

at currently regulated plus the toxics. That's in the model, 

not the entire scope of Auto/Oil, so it is a narrower list. 

But I think what we were suggesting was is that the RFG rule 

is taking a different approach, and we think that at least 

some of that is applicable here. Given those different 

regulatory objectives, or slightly different objectives, we 

think you need to think about that a little bit more because 

we think there was a lot of validity in that RFG approach and 

maybe some of that can rub off here as well. 

MR. PASSAVANT: Well, I'm just saying, 

I'm not so sure that the data there is adequate to make the 

kind of determinations that we would need to make because here 

we're talking about a half a dozen pollutants, the data being 

adequate for half a dozen pollutants versus perhaps many, many 

others that would be of concern if we were getting into this 

level of testing, that's all. 

MS. GRAHAM: I have a question that was 

raised in one of your answers. You spoke earlier about an 

expectation that in many cases, if not most cases, that the 

Tier I literature searches were going to reveal much of the 

information needed in Tier II, and indeed if that's the case, 

that's good for everybody concerned. But you mentioned that 

in some cases there will not have been testing of the whole 

emissions as required. I'm not familiar with any pub!icat• . -s 
P.45 

yet, particularly on some of the alternative for reforms and 

even in terms of some of the more conventional. You mentioned 

structure activity testing, maybe information in individual 

compounds. I don't know if you'd want to comment here or 

perhaps in your written comments, your views on how 

representative the information on structural activity or 

individual chemical is of that whole combustion mixture. 

MR. KELLER: I think we can comment on 

that. Just let me make sure you understand, the comment that 

I made or the observation that I made that I thought there was 

existing data in Tier I already, really applies to sub-sim 

fuels. I don't mean that to apply to alternative fuels. I 

don't mean that to apply to atypical fuels. I'm saying, for 

sub-sim fuels, conventional or baseline, however you want to 

say it, that there's a lot of data out there. So our comments 

are focused on those sub-sim fuels, not on everything else. 

MR. WILSON: I think that's all the 

questions. Thank you very much. 

MR. KELLER: Thank you. 

Sepesi 

MR. WILSON: The next witness is John 

MR. SEPESI: My name is John Sepesi, and 

I work for Shell Oil, but today I'll be representing API in 

discussions on the fuel and fuel additive rule. Joining me at 

44 
P.46 

the table is Phil Bush who works for Amoco and is also 

representing API in this discussion. 

We're here today on behalf of API to 

respond to the proposed regulations for Fuels and Fuel 

Additives under Section 211 of the Clean Air Act. API, as 

most of you may know, is a national trade association with 

over 250 member companies that represent all aspects of the 

petroleum industry. API members account for the vast bulk of 

fuels manufactured and marketed in this county. 

I'd like to divide my presentation, 

which most of you have, into several sections, and the first 

section we'd like to talk about is the overview. In the 

overview, there are three major principles that we believe 

should be applied in the fuels and fuel additives rulemaking. 

Number one, because the proposed regulation goes to the heart 

of the petroleum industry's business — making fuels for 

automotive vehicles — we believe that it should encourage, 

and not interfere with, the manufacturing of reformulated 

gasoline mandated under the Clean Air Act Amendments of 1990. 

An all out effort should be made to avoid timing conflicts 

with the recently proposed reformulated gasoline rule, as well 

as other key regulations that will follow. To avoid 

duplication of effort and assure consistency of definitions 

and requirements, the Fuels and Fuel Additives Regulation 

45 
P.47 

should build on existing regulatory programs, such as EPA's 

"substantially similar" regulations. 

Number two, the rule must be crafted to 

allow manufacturers to take full advantage of the use of 

existing information on emissions speciation and potential 

public health impacts. We feel strongly that the rule should 

recognize the substantial emissions speciation data developed 

under the multi-million dollar Auto/Oil Air Quality 

Improvement Research Program. That program has developed 

state-of-the-art capability in emissions speciation and should 

not be exceeded by the requirements of this rule. Likewise, 

scientifically valid and relevant tox and exposure studies 

done in the past must be able to be used to fulfill Tiers I 

and II requirements, and not be limited by what we believe is 

an unnecessarily restrictive definition of what constitutes 

adequate data that's in the proposed rule. 

Number three, reasonable requirements 

must be set so that manufacturers can comply within the three 

year time frame without sacrificing scientific integrity. I 

cannot convey too emphatically the reservations that API has 

on this point because of the lack of current facilities, and 

what may be even more significant, the lack of accepted 

scientific methods to perform some of the studies proposed. 

API feels strongly that any testing fat 
P.48 

is required under this rule must conform to accepted 

scientific methods and protocols, so that resulting data will 

stand up to scientific peer-review and be capable of 

integration into the existing testing information. It should 

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

knowledge on the subject, will assist EPA in evaluating 

potential adverse effects, and is specifically directed to the 

determination of whether further risk assessment or regulatory 

action is needed under Section 211. Adding data requirements 

for purposes that are inconsistent with this statutory goal 

is, at best, inappropriate, and at worst, an unacceptable 

waste of the nation's environmental research capability. 

API endorses many of the concepts in the 

proposed rule such as the tiered testing approach and the 

fuels grouping option, Option B, which places sub-sim and 

waivered fuels and additives, including reformulated gasoline, 

RFG, in the baseline group. We believe that the correct focus 

of the rule is on tailpipe exhaust rather than raw fuels. Our 

comments will contain suggestions for some revisions to the 

proposal that we believe will improve implementation of the 

rule. API will file extensive written comments in June. 

* 

The fuel and additives grouping is the 

section I'd like to comment on next. The proposed rule 

presents two major options for grouping of fuels. API 

vrHr. Stpesi. t'n«-_Wti4tAf l y Li^4 a_> a, _._&-»-A. 4 h * prcs*n.-fu,_io>t 

fcM. of |W5t frojrlsoripts. rv\r. Stftsi toisfc-d. bt- -h u <*u4 til -tU 

*IX.'ir% I _,. . i_ I •- .» _ _ _._! * ( 

otftaaj public ntordi. 
P.49 

strongly supports Option B. This would allow the 

"substantially similar" regulations for fuels, a regulatory 

program which is in place and working, to be the basis for 

Baseline grouping. Based on the experience that EPA has with 

that program, as well as the research findings to date from 

the Auto/Oil Air Quality Improvement Research Program, there 

is no technical or scientific need for reformulated gasolines 

to be included in a Non-Baseline category, especially since 

RFG will, by definition, have lower toxic emissions. 

Inclusion of RFG in the Baseline category will avoid 

unnecessary duplication of testing essentially similar 

materials. Furthermore, such grouping would avoid potential 

timing conflicts for reformulated fuels and additives that 

will be "sub-sim" or "waivered," but may not be registered by 

the time this regulation becomes final. 

We believe that any gasoline or diesel 

fuel or additive, whether it is currently marketed, whether it 

is reformulated, or whether it is registered before or after 

this regulation becomes effective, should be included in the 

Baseline category based solely on its conformance with the 

definition of "sub-sim" or "waivered." Any test substance 

should represent both the fuels and the additive package that 

is within the Baseline definition. There is no appreciable 

difference in the emissions among this broad grouping that 

48 
P.50 

would warrant a more complex grouping system. 

The Non-Baseline category is properly 

held for products containing only baseline elements, but in 

concentration limits that exceed substantially similar or 

waivered criteria. We concur with EPA that the atypical 

category should be for fuels and additives that contain unique 

chemical elements beyond those recognized by the "sub-sim" 

rule and that have been intentionally added. 

The next section deals with the 

definition of data can be used to show "adequacy of existing 

data." The health effects information and toxicology data is 

what we'll concentrate on. In Section 211(e)(3), Congress 

authorizes EPA to take existing information into account to 

avoid duplicative testing requirements. API believes that the 

proposed rule contains such a narrow definition of what 

constitutes "adequate existing testing" that the purpose of 

the regulation becomes one of required testing, and not of 

determining potential adverse public health effects. EPA is 

proposing that existing studies can only be relied upon in 

lieu of Tier II tests if they conform to or are "reasonably 

comparable to" the guidelines for Tier II tests, as outlined 

in the proposal. We believe this is an unnecessarily rigid 

approach, particularly because most of the proposed testing 

methodology breaks new scientific ground, and therefore, from 
P.51 

that perspective, prior studies could well be judged not to 

conform. 

This limitation in use of existing data 

is in direct contrast to EPA's proposed literature search 

strategy, which is quite broad and inclusive. It includes 

historical review and study of individual emission products as 

well as whole exhaust. As proposed, it requires analysis of 

all relevant scientific information, including emissions 

speciation, that may shed light on the potential health and 

welfare effects of the fuel/additive in question. In 

establishing the adequacy of existing data, registrants must 

be able to use this same approach. All valid and relevant 

scientific information that, taken together as a body, allows 

an informed assessment of the potential health risk of 

exposure to vehicle emissions must be considered. 

The definition of what constitutes 

adequacy would also preclude all but studies of whole 

emissions. But, it should be noted that there are substantial 

amounts of data on the major constituents of motor gasoline 

and diesel fuel emissions. This information is sufficient to 

make reasoned scientific judgments as to the potential for 

toxicity of the defined endpoints. It is especially relevant 

when one considers that the ambient urban concentrations for 

these constituent hydrocarbons are in the parts-per-bi11 ion 
P.52 

range. Even in the exhaust, they are a small fraction of the 

total. Such existing information is most certainly relevant 

to the issues at hand, even though it's conducted on the 

constituents, because in reviewing ambient air monitoring data 

one can only consider constituents. Most studies conducted by 

EPA and others to assess ambient environments are based on 

concentrations of specific constituents. 

Going to the emissions speciation data, 

the proposed rule contains detailed and complex requirements 

for the speciation of emissions, in both the fuel groupings 

and the emissions generation section of the proposal. There 

is a significant research program underway in this country 

that addresses these speciation questions in great detail, and 

that research represents the state-of-the-art in emissions 

speciation. It is the Auto/Oil Air Quality Improvement 

Research Program, jointly funded by the petroleum and 

automotive industries. This research should provide the 

gasoline emissions speciation information required under this 

program. Further speciation as prescribed in the proposal, we 

believe, is beyond current technology. 

We believe also that the proposed 

testing goes beyond the state-of-the-art in methods and 

qualified testing facilities, and this point was certainly 

mentioned by Mr. Keller in his earlier testimony. API is 
P.53 

greatly concerned that much of the toxicology testing being 

proposed involves untried scientific methods and unverified 

protocols. Even in cases where there are established 

protocols, the generation of emissions and delivery of 

controlled doses to animals pose significant difficulties. 

Examples of some of the major technical problems are: 

The dilution factor necessary to deliver 

the test substance to the animal is not known, and trials will 

have to be conducted to determine what is appropriate. The 

standard eight-fold dilution factor suggested in the proposal 

may no longer be appropriate because of changes in emissions 

control systems. 

A method of cooling the exhaust and 

controlling the oxygen supply will need to be developed and 

trial tested so that the appropriate environmental conditions 

can be maintained to support the test animals. 

In addition, the delivery of the test 

substance to the animals must be accomplished directly, that 

is from the running vehicle to the animal. This means the 

facilities must be in proximity and that confounding variables 

of noise and vibration must be engineered out before a valid 

study could be run. 

The availability of testing facilities 

will be a major problem. To the best of our knowledge, 

5 2 
P.54 

testing facilities will have to be constructed. There are 

existing laboratories that generate emissions, and there are 

existing laboratories that perform tox research, but we know 

of no testing facility that is prepared now to conduct these 

studies as proposed. Testing under this proposed rule would 

require those two capabilities to be integrated, and that 

means appropriate test facilities will need to be constructed. 

There are companies that we believe can 

develop the capability of conducting these tests, once the 

methods are developed, but they do not currently have the 

facilities necessary to perform the studies as proposed. The 

design and construction of laboratory facilities is costly and 

seems not to have been considered in EPA's cost estimates for 

this regulation. We do not believe.that it was Congressional 

intent for registrants to build new laboratory facilities and 

develop new methods in order to fulfill registration requirements that must be completed in the three year time frame. 

The next section deals with the 

scientific methods and protocols, the need for verification 

and being accepted within the framework of good scientific 

practices. Any testing that is conducted under this 

regulatory program must stand up to scientific scrutiny. 

Testing results of our products are of critical importance to 

the industry, and we are concerned that using untried 
P.55 

scientific methods and abbreviated test protocols will render 

study results meaningless. While we appreciate the Agency's 

openness to innovative test protocols, we believe the time and 

money saved by such changes will be minimal and be far outweighed by the cost of developing methods and building 

facilities. API does not believe that Congress intended to 

compromise scientific methods in order to meet the three year 

time frame. We do not wish to see a final rule that would 

develop test guidelines outside the accepted practices of the 

scientific community. 

I'd also like to address the timing 

issue, as Mr. Keller did in the testimony before. There are 

several timing issues of concern in the proposed rule. In 

addition to the potential conflicts for RFG, the other timing 

issues are related to the timing of Tiers I and II review, 

especially for those fuels and additives that are registered 

when the rule becomes effective. Congress allowed three years 

for submission of data. When Congress included the three year 

time frame for submission of initial information, we believe 

that they envisioned requirements that could be completed 

within that period. Indeed, with commodities such as fuels 

and additives, that seems the only economically wise 

interpretation. 

EPA has discretion to determine what 

54 
P.56 

"requisite information" should be submitted to the Agency 

within the three year time frame. We believe that what is now 

proposed goes well beyond the capability of what can be 

accomplished in three years. 

We have addressed the absence of 

facilities and the need to develop and to test new inhalation 

tox methods to perform some of these studies. The cost to do 

this is not accounted for in the rule, nor is the time. 

Development, construction and testing cannot occur in three 

years. 

Furthermore, if registrants want to rely 

on existing data which we do believe is "adequate," the three 

year time frame is so short that we could not gamble on EPA's 

approval without conducting some back-up testing in order to 

ensure that registration will not be withdrawn at the end of 

the three year period. 

Finally, the initial requirements apply 

to all fuels/additives registered in the same time frame, 

making the availability of test facilities even less likely. 

If testing on more than one endpoint for more than one fuel or 

additive had to be done concurrently, it is even more unlikely 

that the three year deadline can be met. 

Clearly, the proposed requirements for 

the initial three year period surpass: one, the capability of 
P.57 

current scientific methods; two, the availability of 

facilities; and three, the ability for EPA to analyze Tier I 

submissions, while still allowing time for subsequent testing. 

These are critical matters within the rule, because the 

penalty outlined — principally the withdrawal of the right to 

market — is substantial. 

In conclusion, there are a number of 

important issues we have not address in this hearing. For 

example, diesel fuel registration is quite important to the 

petroleum industry, but we have focused primarily on gasoline 

because of the Clean Air Act Amendments of 1990 which will 

affect formulation and marketing of gasoline in the near 

future. We have not addressed evaporative emissions and do 

not believe there is any need for further evaluation on 

evaporative emissions because of the existence of other 

legislative/regulatory requirements to reduce and control such 

emissions. We agree with EPA that evaporative emissions from 

diesel fuel are not significant due to the low volatility of 

this material. 

Our written submission in June will 

provide detailed comments on the full range of topics outlined 

in the preamble. It is our intent to work with EPA to make 

this a reasonable regulatory program. We will strongly resist 

efforts to make it a testing program for which the results do 

56 
P.58 

not add value to our ability to assess potential public health 

or welfare risk. 

We strongly encourage the Agency to make 

full use of the ongoing Auto/Oil research and of existing 

regulatory programs such as "sub-sim" and the wavier program, 

so that the fuels registration process does not provide a 

barrier to the development of new and cleaner fuels. 

MR. WILSON: Thanks very much for that 

testimony. 

MS. GRAY: I have a few questions 

concerning some of the comments here on the adequacy of 

existing data, the bottom of page four and the top of page 

five. We do want to be able to make free use of the available 

information, and that's why I wondered if you'd care to expand 

on some of the points that you made here? On page five at the 

top, you express concern that we have an unnecessarily rigid 

approach because most of the proposed testing methodology 

breaks new scientific ground. In terms of breaking new 

scientific ground, are you referring to the inhalation 

exposure technology or the health protocols themselves? 

DR. SEPESI: Mostly to the technology of 

delivering the substance to the animals; if you hold to the 

guidelines that would have to be developed in order to 

accomplish that, much of the existing information, because 

57 
P.59 

it's never been done before, would address that guideline. 

MS. GRAHAM: I think that picks up on a 

point you make a couple paragraphs down. Are you trying to 

make a case here that if we have knowledge about a couple of 

the constituents of the mixture that we, therefore, understand 

the mixture in terms of its health effects, is that your 

point? 

DR. SEPESI: What I'm trying to say is 

that the constituents of the mixture are certainly relevant in 

considering the toxicity of the mixture itself, and the guidelines for adequacy or the proposal for adequacy, as it is 

written, seem to preclude one from using that constituent 

information, and that's what we disagree with. 

MS. GRAHAM: I have a question on page 

six, and this is where you go into some questions about the 

inhalation exposure aspects. As you know, in the body of the 

proposed rule we share your concern about the- availabi1ity of 

testing facilities, but in the very beginning here of the 

testimony: API is greatly concerned that much of the tox 

testing being proposed involves untried scientific methods and 

unverified protocols. I guess I don't quite understand what 

you mean. When I think of the work that Lovelace has done, 

that EPA did many years ago, that the Japanese have done, that 

the Fraunhofer-Institut has done, I guess I don't understand 

_____ 
P.60 

the words, untried and unverified. 

DR. SEPESI: That mainly concerns with 

the possibility of using some of the 42 day mouse reproductive 

studies that have not been tried, and we appreciate your 

willingness to be innovative with those protocols and save 42 

days, but that's not very important when you have to build a 

facility and develop the whole method. That's the point we 

were trying to make there. 

MS. GRAHAM: Okay, that clarifies a lot. 

That's a good point. 

I think that same point is raise on page 

seven, so I think that answers my questions; thank you. 

MR. PASSAVANT: John, thank you for your 

comments this morning. I hope there were some things in here 

you liked. I do have a couple of things I'd like to ask you 

to respond to. One is, given the three year time frame that 

we're constrained to here and given there is flexibility we 

can work with, what would be your expert opinion or API's 

expert opinion on how long this would actually take to do this 

program? 

DR. SEPESI: Glenn, as I'm sure you 

realize, there were many people that contributed to writing 

these comments, all of which cannot attend, but what I can do 

is take that specific question which you also asked Charlie 
P.61 

and make sure that we address that in our written comments. 

MR. PASSAVANT: Okay, that would be 

useful because I think you realize, as we said in the 

proposal, that we are working with a statute that was 

something on the order of 13 years old, and had things been 

written in 1990 instead of 1977, it might have been done 

differently. 

DR. SEPESI: That's exactly right. 

MR. PASSAVANT: So we're constrained by 

that to some degree. One of the flexibilities we do have is 

in the area of adequate existing information, and in your 

write-up you mentioned that and talked about the constituents 

as a possible surrogate for some of these things, and in our 

conversations with Charlie we talked about sort of the 

difficulty of trying to prescribe up front what we would 

consider to be adequate. 

I too would like to ask you and your 

folks to give some thought to what we might be able to do to 

draw a box around that for you so that we could feel like 

we're giving you criteria that you can understand, you'll feel 

comfortable with, and you won't feel like EPA is going to hold 

the proverbial sword of Damocles over your heads regarding our 

review of your products. There would be much better certainty 

on both ends if we could have that. Those are really my only 

— — 
P.62 

two points; thank you. 

MS. GRAY: I have one question about 

your comments about the grouping system on page four. You say 

there is no appreciable difference in emissions among the 

broad grouping which would include reformulated gasolines in 

the baseline unleaded gasoline category. I know there's lots 

and lots of data from the Auto/Oil studies. Are there data 

available that compare the emission products of different reformulated gasolines that 

DR. 

about this during Charlie 

use different oxygenate compounds? 

SEPESI: I am certainly — we talked 

s testimony. You referred to a half 

a dozen or so compounds in the Auto/Oil that have been 

speciated in the emissions section. There are 150. 

MS. 

species, for example. 

DR. 

MS. 

GRAY: There are a 150 hydrocarbon 

SEPESI: Right. 

GRAY: I mean, comparing one 

reformulated gasoline to another reformulated gasoline, 

regardless of raw constituents, the oxygenate, for example, 

that is involved in that reformulation process, I'm wondering 

about your statement that 

DR. 

gasoline that uses MTBE as 

they are all alike? 

SEPESI: Certainly a reformulated 

> the oxygenate versus one that might 

use ETBE as an oxygenate would have MTBE in one and ETBE in 

6 4 — 
P.63 

the other, but that, I think, can be handled with the 

constituent data. 

Phil, do you have any thought on what 

exactly was in the Auto/Oil speciation emissions? 

MR. BUSH: I don't know categorically 

that each of the oxygenates that Auto/Oil has looked at have 

all been speciated. I'm just not that knowledgeable about 

that program, but certainly most of them have. There's data 

available both there and other places in the literature on 

speciated emissions certainly from ethanol, MTBE, methanol 

products. 

MR. PASSAVANT: In other words, I think 

the point here is that you were making the supposition that 

these are similar, and we're trying to say, is the data there 

to prove that supposition? That's really what it comes down 

to. 

MR. BUSH: Well, the one significant 

difference is that you may have this new compound which is the 

oxygenate itself present in the evaporative emissions or in 

the exhaust, and that incremental effect can be judged from 

knowledge about that constituent. 

MS. GRAY: Do we know that the 

combustion emissions would be the same? 

MR. BUSH: Pardon? 

____ 
P.64 

MS. GRAY: Do we know that they would 

not differ in terms of the combustion emissions? 

MR. BUSH: It is a critical factor. 

They will differ in mass emission rates of some of the 

constituents, but that's not particularly important to this 

rulemaking. What should trigger or bring up a significant 

concern in EPA's mind is the appearance of new compounds, and 

one good case in point is the aldehyde emissions. 

Formaldehyde is present in gasoline that has no oxygenate. 

It's there in a different level with ethanol present, 

different level with MTBE, but all of that falls well within 

the range of different concentrations of emission rates you 

get just with plain gasoline. You haven't significantly 

changed any of the facts you're going to use for your risk 

assessment process just because the emission rates have 

changed a little bit, 

DR. SEPESI: In addition, if you look at 

the ultimate purpose of the rule, which is public health 

effects, those differences on parts-per-bi11 ion in the 

atmosphere, parts-per-mi11 ion in the exhaust, and those 

differences would certainly be encompassed by any high, medium 

or low dose that would be in a tox study. 

MR. WILSON: Thank you very much. 

The next witness is Ken Whittet. 

& • * 
P.65 

MR. WHITTET: Good morning, my name is 

Ken Whittet, and I'm the president of Solvall Engineering, a 

small business that manufacturers fuel additives. My sales 

average about half a million dollars a year. I have concerns 

on this regulation, proposed regulation, that quite frankly 

can force closure of my business, that the cost of doing this 

will be so high that they'd be way out of the capability, the 

economic capability of my company to pay for. 

I read in the Federal Register that the 

cost of testing an additive would be on the order of, for Tier 

I and Tier II, of $800,000 per additive if I went it alone, 

and it would be on the order, if I was in a pool, of something 

like $25,000 per additive. I may be reading this wrong, but I 

was thinking there could be -- I've talked to other small 

additive companies that are my competitors in the Northeast, 

and they all expressed concern. I don't know if any of them 

are here today, but they all expressed some concern over this 

too. There were some companies that had additives as a 

division, and they said, well, we won't sell them any more, 

and so what are they going to do for the people that were 

working in that division? Do they put them in other parts of 

the company, do they lay them off? 

So I think the impact in terms of joos 

on small business may be more severe than is described in t---. s 

. *± 
P.66 

Federal Req 

the people 

suggestions 

possi bi1ity 

maybe subsi 

that comes 

provision f 

ister published on April 

that I made contact with 

MR. WILSON: 

? 

MR. WHITTET: 

is the SBA come up with 

dize some of this stuff. 

to mind. 

MR. WILSON: 

15, based on talking to 

. 

Do you have specific 

I think what could be a 

some grants for a group, 

That's one possibility 

Have you looked at the 

or companies to get together who are making similar 

additives and jointly fund --

in my mind 

exact same 

would be th 

MR. WHITTET: 

on that is on the formul 

formulas or substantial! 

Yes, but another question 

as, do all have to have the 

y similar formulas? What 

e criteria for a substantially similar formula in 

here that would apply with the EPA? 

and concern 

would be if 

reasonable 

for cost sh 

we have as wel1. 

MR. GRAY: I 

that grouping was such 

That was another question 

think the question still 

that it was including a 

range of additives, is the process or the concept 

aring a good approach fo 

that you raise? 

that? 

MR. WHITTET: 

r dealing with this problem 

Would you please repeat 

& £ — 
P.67 

MR. GRAY: You raised a question that 

said that there's some uncertainty in your mind as to how 

broad the parameters would be on grouping similar additives. 

MR. WHITTET: Exactly. 

MR. GRAY: If that grouping was 

sufficient to include several different similar compounds, is 

the concept though for sharing costs a reasonable concept? 

MR. WHITTET: I think it would be, yes, 

but also the thing is, I've got about 900 diesel additives, 

and a lot of them are similar. A lot of them have fuel 

colorants in them, and I guess there's another reg that's 

coming up next year on the coloring of fuels, so that will 

make the green diesel additive and the blue diesel pretty much 

obsolete to begin with. So I still have the red diesel 

additive, which as I can see in the regulations, it looks like 

it's a pretty sure bet that red diesel fuel will still be 

allowed, but not any more green diesel or blue diesel fuel, 

now that heating oil is supposed to be dyed green or blue, but 

I do have blends. 

Another question I had was about blends. 

A lot of my blends have additives that are made by the major 

manufacturers. They're just blended into a broad spectrum 

additive, let's say, it'll add detergency characteristics, 

flow improvement or cetane improvement, and I was also 
P.68 

wondering if, say, you have three approved additives and 

tested additives, you blend them together, does that make a 

new additive? 

Also, the treatment levels in my 

additives are all above this, I think they call it the 

de minimus level, which means that the treatment levels are 

usually like a thousand parts per million or less, like a 

thousand parts per million or four thousand parts per million, 

and going on, there's a thing in here that talks about you can 

get some kind of exemption if there's 25 hundred parts per 

million or less concentration of the additive in the fuel, but 

I'm not sure exactly how that's going to happen. So I have 

questions here. 

MR. PASSAVANT: Mr. Whittet, since 

you're talking diesel, that whole area is an area that's under 

development right now. We are working on a separate program 

and a substantially similar rule for diesel which will, I 

think, help to resolve a lot of these kinds of questions that 

you have. 

Given that ou are a small company, 

probably one of the most useful things that you could do, for 

you and for us, would be for you to tell us what it is about 

your company and companies like yours that would help us to 

better define what is a small fuel additive manufacturer. If 

67 
P.69 

you look near the end of the proposal you have there, we did a 

study trying to sort of do like an industry characterization, 

and we got to the point of finishing the characterization, and 

the one thing we couldn't find was a common element among your 

companies, other than their bottom lines, and it was really 

hard to write a set of rules for small manufacturers that said 

if you have less than this much revenue. That kind of stuff 

would be the most useful thing, I think, in terms of allowing 

us a tool by which to identify who a small company is and, 

therefore, to write a special rule for you. The law allows us 

to do that, but we just need to be able to help to better 

identify it. 

MR. WHITTET: What would be the amount 

of sales in a year or — 

MR. PASSAVANT: Any type of information, 

sales, almost anything; you can talk to your other folks and 

see what it is about your companies that makes you small. Be 

it sales or that you're offering your products cheaper, things 

that we often see that help out volumetric sales, how many 

gallons or how many pints of given product that you sell, and 

you could submit it to us confidentially, if that would be 

useful for you. 

MR. WHITTET: Okay. 

MR. PASSAVANT: That kind of stuff is 

fiA 
P.70 

probably the key missing ingredient, if you will, in our 

analysis for small businesses, that we couldn't figure out 

what it was that made you small, other than the fact that you 

didn't get a lot of dollars. 

Also, if you have a lot of specific 

questions, we are more than willing to sit down with you 

either on the phone 

any of these things 

or in person and talk to you, 

with you. It is really compl 

there's no doubt about that. 

and Mr. Gray picked 

I think another thing that 

up on it, is the fact that we 

you to understand better where perhaps you'd fit 

grouping scheme and 

and will be sub-sim 

much less. 

additives — 

fuel. 

elements other than 

sulfur? 

whether or not your additives 

in which case the effects wi 

MR. WHITTET: Okay, sub-sim 

MR. PASSAVANT: Look just 1 

talk through 

icated, 

would help, 

need to help 

in the 

are sub-sim 

11 be much, 

means 

ike diesel 

MR. WHITTET: That don't have any 

carbon, hydrogen, nitrogen, oxygen and 

MR. PASSAVANT: But that's 

definition. We're working on a diesel definition 

the gasoline 

right now 

* a -
P.71 

which may or may not have the same elements to it. 

MR. WHITTET: Okay, in diesel fuels, 

number two oil, there's all kinds. I think there would 

probably be a lot more trace elements in diesel fuel than 

there is in gasoline. 

MR. PASSAVANT: Yes, there would. 

MR. WHITTET: I know in heating oil, 

often people have trouble with venadium. It occurs in some 

heating oils and number fours and number six oils. 

MR. PASSAVANT: So I think that as we 

work our way through this process, that kind of information 

will be useful to us, and we stand ready to work with you on 

it. 

MR. WHITTET: Okay, that's great. 

MS. GRAY: I'd like to ask also, the 

Chemical Manufacturers Association that Charlie Keller 

represented earlier, and he mentioned some of the companies 

that belong to that trade organization and many of the ones he 

mentions at least are quite large companies, we don't have a 

good idea to what extent smaller companies like yours and the 

other people you've talked to are represented by trade organizations that could maybe assist in your groupings practices to 

lower the price to each company very considerably. 

MR. WHITTET: I think that's the way it 
P.72 

would have to be done, is there has to be more involvement 

with a lot of these. Most of these additive companies that 

I've talked to apparently didn't belong to any organizations, 

and they're sitting out there, and I don't know, they think, 

well, it's not going to happen to me, or they're just swamped 

with all kinds of other stuff, or they're sticking their heads 

in the sand. But I've been trying to say, hey, this affects 

all of us; we've got to get together and form or we should 

form an association and have the testing done or join an 

association like what I belong to. I belong to CSMA, Chemical 

Specialties Manufacturers Association. We all ought to join 

up with CSMA and get some kind of a testing program done if 

it's required. 

MS. GRAY: Yes, in effect our proposed 

grouping system would allow additive manufacturers to group 

with fuel manufacturers if they fall into the same grouping 

definition, and all total the grouping system is one of our 

major provisions to lower the cost. So I think it would 

behoove smaller companies to form associations or join in with 

existing ones to work together on it. It's pretty complex to 

go it alone. 

MR. WHITTET: Or just get one huge one 

going; probably the more people get into a group, the lower 

the cost will go. 

£ 4 — 
P.73 

know. 

right now, 

MS. GRAY: Absolutely. 

MR. WHITTET: The more the merrier, you 

MR. WILSON: Any other comments? 

MR. WHITTET: None that I can think of 

MR. WILSON: We appreciate your coming 

We'll follow up with you to make sure that we understand your 

business and make sure you can help us be sure we're 

communicating wi 

trying 

either 

to get th 

get into 

into or form our 

what's the best, 

same time be the 

work wi 

Turkal. 

th you. 

I'm here at the 

represent and al 

a f i rm that has 

th others 

MR. 

em organiz 

a group or 

own group 

see what 

most cost 

MR. 

in similar situations. 

WHITTET: I started doing that, 

ed so we can get into a group, 

look for the best group to join 

, check out all the options and see 

will fly with the EPA and at the 

effective. 

WILSON: Well, we'll be happy to 

Thanks very much for coming. 

The 

MR. 

request of 

so work as 

last witness we have listed is John 

TURKAL: My name is John Turkal. 

Alken-Murray Corporation who I 

a consultant for. Aiken-Murray 

over 60 years experience in the fuel additi 

is 

ve 

7? 
P.74 

business. They're a small firm, have been known to 

manufacture for others through re-blending, and unfortunately, 

the documentation did not specify the diesel folks didn't have 

to show up or I wouldn't be here, but maybe it's just as well. 

The firm, for the audience, is a woman-owned firm, and sometimes the perception of the CEO, who is a woman who runs 

another aspect of the company called Fenton Farms, her 

intuition sometimes amazes me, why I get picked for these 

assignments, 

I have here a letter that I would like 

to read because I think it conveys a small/medium firm's 

attitude towards some of the testing that's to be conducted, 

and especially from that of the newly emerging management 

that's coming out there in small business. It was written by 

Ms. Valerie Anne Edwards, who is the president of the 

corporation, 

"As the President of a New York harborbased firm with nearly sixty years experience manufacturing 

fuel additives, I would like to contribute our observations 

and opinions of your proposed new testing protocols for motor 

fuels and fuel additives. 

First, our experienced personnel have 

observed that the finished petroleum products brought into the 

harbors from Boston to Baltimore, through the spot market 
P.75 

alone, would involve testing hundreds of shiploads of oil. 

The Eastern seaboard uses the largest percentage of finished 

petroleum products refined throughout the world. 

Second, as a small, woman-owned firm, we 

would like to express that the costs you have estimated for 

the proposed testing would enforce a financial hardship on us. 

We do, however, agree that emissions testing should be 

requi red. 

Third, our board of directors is 

expressly opposed to animal testing unless there is no viable 

alternative from which to gather required data. We believe 

that you will find data on the fuels and additive components 

from previous studies made by automobile manufacturers and 

others. To endlessly repeat studies that require the 

suffering and death of animals is morally reprehensible." 

The last paragraph identifies me as her 

representative, and she has signed it. 

Now our comments are broken down into 24 

sections. As previously indicated, Aiken-Murray is a firm 

that has over 60 years experience, specifically in the areas 

of additives, and D-1 and D-2 additives. I do have personal 

experience with gasoline. 

We wish to point as a small firm that 

the "Toxline" database lists over 30 studies on the effects or 
P.76 

organometal1ic toxicity in diesel exhaust. These studies 

include use of rats/mouse mammals in the tests for reaction to 

diesel exhaust in their atmosphere. These studies were funded 

by agencies of the U.S. government. They are the Department 

of the Interior, U.S. Air Force and NIOSHA. Other studies 

were conducted for the Society of Automotive Engineers, also 

by the Volkswagenwerks of Germany and also by the National 

Health Institutes of France and the Soviet Union. 

Third; we are concerned that the EPA 

staff is not considering this data relevant due to the fact 

the Agency itself has not conducted the testing. We feel that 

this could be prompted by a fear that acceptance of the data 

would downgrade the proposed testing program by the Agency. 

Fourth; we have no doubt that products 

of combustion can have some potential harmful effects on the 

environment. Our point is that data exists. Diesels have 

difficulty obtaining 100 percent combustion. Additives used 

for improving combustion reduce total emissions. As it's 

number one priority, we believe that the EPA should be 

focusing on exhaust emissions and not the redundant testing. 

Five; testing categories for D-1 and 

D-2, which is baseline, do not reflect the marketplace. 

Actual diesel fuels marketed in the U.S. vary due to crude 

source, refining process and blending procedures of the 

— . ^5__ 
P.77 

wholesaler/pipeliner. To categorize a D-2 as a base fuel is 

unrealistic. The New York Spot Market has historically 

provided #2 fuel oils for the diesel/home fuel oil market that 

range from heavy kerosene to light gas oil. By light gas oil, 

I can refer you to Algerian manufactured products. 

In our opinion, API criteria for fuels 

should be used for baseline testing of fuels. Fuels should be 

tested at all API gravities. The testing criteria should 

include various fuel and combustion air temperatures, 

humidity, various engine designs and fuel blends marketed 

throughout the two major weather seasons. Fuels should come 

from all major markets of the North American continent. A 

registered fuel does not retain the same chemical composition 

throughout the year. 

Seventh; we believe the EPA should 

develop this data for baseline on stationary engine 

dynamometers without animals to establish its baseline. 

Combustion data should confirm the information from "Toxline." 

Eighth; all fuels at some point are 

exposed to additives used by pipelines, tank farms and 

refiners to protect their employees and facilities from 

corrosion, hydrogen embriddlement and bacteria among others. 

These products are generally amines, biocides and emulsion 

breakers. These would be present in baseline fuels, and I'm 

7fi 
P.78 

of course referring to at the retail or wholesale market. 

We feel, number nine, additives for 

diesel fuels should have specific categories. We have broken 

them down by application: Pour Point/Cold Flow Improvers; 

Cetane Improvers; Combustion Improvers; Anti-Stats; and our 

fifth category is Multiple combinations. 

It is our opinion that previous 

testimony given by engine suppliers is generally oriented 

toward Cetane Improvers and Combustion Improvers. The mature 

suppliers of diesel additives recognize that over-dosage of 

nitrogen-based additives will adversely affect the metallurgy 

of engine components. 

Pour Point or Cold Flow Improvers would 

by their nature be used both in home fuel oils and D-2 fuels. 

This is determined by the fuel distributor and location. 

These products themselves would be virtually indistinguishable 

from the fuels even if gas chromagraphy was used and the fuel 

was heavily dosed at 1:250 gallons, or 4000 parts-per-mi11 ion. 

Combustion Improvers are the class of 

additives which we feel will respond to the testing procedures 

advocated by the Agency. In the case of one material, 

Manganese, we already know from previous work performed by 

other agencies and the SAE that particulate filters will 

remove this and other organometal1ics from the exhaust of 
P.79 

diesel. We do not see any logic in testing all additives and 

fuels to see which is more likely to be potentially harmful, 

rather we advocate work in the area of filtration and improved 

engine design. 

Anti-Stats are additives used in lighter 

fuels which are used for blending D-1 and D-2 fuels. These 

additives are proven to prevent explosions due to static 

electricity in pumping, tanker trailer loading and switch 

loading. When used, these products would not normally be 

distinguished from the fuel. We added a highlight that in one 

case a nylon jacket created enough static electricity to blow 

up an Air Force storage tank. 

We do not believe the focal point of 

this regulation is to test all additives in all types of fuel 

used. A small manufacturer like Aiken-Murray Corporation 

cannot afford this type of expense. We rely on government 

agencies to set acceptable standards based upon the needs of 

industry and the country. The FDA standards for boiler water 

treatment is an example. 

Generally, small and large firms in the 

additive industry have proprietary formulations. Any 

procedure which may give a competitor an edge is closely 

guarded against. To patent a product in many cases is to give 

it away. 

_____ 
P.80 

The next comment is based from a small 

corporation, not someone who has a partner in Japan, like a 

Monsano or Petrolite. We recently were requested to supply a 

specific additive to Japanese industries. Prior to our 

product being accepted in Japan, our formulas had to be given 

to the Japanese EPA, and they would determine if any Japanese 

firms manufactured a "similar product" using the same 

components. Experience has shown that when an American firm 

falls for this explanation that a Japanese firm always shows 

up with the product. 

We feel that even an innocuous 

discussion between a member of the EPA staff and another 

company's technical staff with a statement phrased in the 

manner of, "Have you ever heard of anyone using components X, 

J and A," could cause us irreputable harm economically. 

Technology is already over-taking the 

fuel industry. Due in part to the efforts of the U.S. and 

European scientists, vegetable oil-based gasolines and diesel 

fuels have passed their commercial trials in both areas. Two 

refining plants are now being constructed in Europe to 

manufacture this product. We already know that used cooking 

oils from restaurant fryers can be successfully used in 

Volkswagen diesels when the combustion of air is enriched with 

methanol vapor. This is being done, by the way, in Albany. 
P.81 

New York. The U.S. military has historically purchased 

vehicles which can run on various fuels. The available of 

this new fuel would have kept its multi-fuel trucks in 

production, and our current database for commercial fleet 

would have been already available. 

Some additives will and should be grandfathered in. Pour Point or CFI and Anti-Stats should receive 

this protection. Precedent was set by the FDA which permitted 

the continued use of phenolic-based demulsifiers in a froth of 

the extraction process for penicillin manufacturing. This was 

done simply because production would be reduced 80 percent, 

and no other product was ever developed that could replace it. 

No traces of this product was ever developed that could 

replace it. No traces of this product were found — excuse 

me, I lost my place; none of this product was found to have 

caused symptoms in patients who had to use penicillin. The 

manufacturer has a representative here; that's the Petrolite 

Corporation. 

Twenty; even though Alken-Murray 

Corporation recognizes that the use of small animals is 

periodically needed in testing potentially toxic materials to 

protect the human race and to acquire knowledge, it is the 

opinion of the Board of Directors that in this case more than 

sufficient data exists to make the exposure of small mammals 

80 
P.82 

totally unnecessary. Alken-Murray Corporation does not relish 

the prospect of its name being associated with these types of 

test procedures. This is due to the fact that our corporation 

is also associated with the pet, animal husbandry and aquaculture industries through our Clear-Flo products. Our 

company does have a reputation among breeders of small mammals 

and horse breeders which is impeccable. 

Technically speaking, we find that the 

exclusion of off-the-road and marine applications to make the 

underlying reason for testing these additives suspect. In our 

experience through the actual application of the technologies 

under question, the similarity of engines, combustion 

efficiencies and use of additives will apply to all areas of 

diesel and gasoline technologies. 

I'd like to make a comment specifically 

to the marine, pleasure craft, diesel or gasoline additives, 

that we are also a water treatment firm. Before we put a 

biocide on the market for a cooling tower or air conditioning 

system, we have to run fish kills, and as I tell the kids at 

home, 50 percent of the guppies better die. We feel that 

whether it's gasoline or diesel, that unless you are going to 

consider the marine applications and consider the effect of 

exhaust of additives in fuels on a marine environment, that 

the whole purpose of this really is not relevant because we 

& 4 — 
P.83 

now know since the time this was passed that the Great Lakes 

in particular, especially here in Michigan where it is a 

tremendous economic resource, is adversely affected by 

discharges of industry, and in this case also would be any 

type of marine vessel or emissions which have come down with 

any time of mineralogical discharge, whether it be snow or 

rain, 

To continue, in our opinion, the 

project's relevance can only be evaluated when all 

applications of the fuels and additives are addressed. The 

EPA should consider aquatic tests for pleasure craft and offthe-road equipment used in forested or natural areas in 

conjunction with other tests. These are only some of the 

reasons we consider filtration of exhaust a priority, not 

testing of compounds. The saying, "A rose is a rose is a 

rose," can be applied to the application of fuels and fuel 

additives in many cases. 

The acquiring of vehicles and using a 

baseline of miles before testing appears unnecessary. Engine 

manufacturers are capable of providing engines with the 

required amount of hours on them. Dynamometer tests should 

provide the data required to fill in gaps left from previous 

testing. 

Aiken-Murray Corporation would be 

_____ 
P.84 

willing to discuss funding for tests oriented toward 

combustion efficiencies and particulate removal, as long as 

the tests did not include small mammals, as proposed in the 

document. 

The Agency offered the opinion that 

dosages under 1:250 gallons, or 2000 parts-per-mi11 ion, may be 

excluded from this testing program if the product is only used 

in these amounts. This policy would, except in one case, 

remove our products from the testing procedure. The maximum 

dosage recommended for the singular product is 1:250 gallons, 

which is 4000 parts-per-mi11 ion. Generally speaking, the 

dosage rates apply to the entire product and not the active 

ingredients. If this rule applies to active organometal1ic 

ingredients, in our case our entire line would probably be 

removed from the testing procedure along many competitors. 

We've also include for you just copies 

of our MSDA sheets, I believe, one test that we did with D-1 

in Boston. 

I was originally not going to come up 

here, that's why I requested last, until the other gentleman 

who is a small business firm came up here and you asked him 

some of the questions. We would, under another name, on 

occasion, if he knew who we were, provide the product for him. 

We have been known under different names because we are a 

93_ 
P.85 

re-blender besides doing our own. 

Some of the things that have been 

brought up today that I'll address for you, number one, there 

probably, you will find, is not a good way of getting to the 

small manufacturer or re-blender of these products. You will 

have to go through a variety of organizations. Ironically, 

the American Water Treatment Association is going to be the 

best source because, generally speaking, most small firms that 

are involved in this also at some point or another are 

involved in water treatment. So they have a different focus 

than would be an Amoco, Exxon or even Nalco, who also retails 

but at a larger level than what they do. 

The document did not really infer that 

this was for a gasoline type package. It was interpreted to 

mean gasoline and diesel, and the reason I was asked to this 

is that at one time I worked for a firm called Petrolite and 

treated boatloads of fuel oil that came in from overseas. 

When I saw the term, baseline, I thought that that was a very 

nice joke because what comes into the harbors from Bangor, 

Maine down to North Carolina has no similarity to the products 

that will be refined in a refinery like where I work, Sun Oil, 

Toledo. The quality isn't there. The cost and technology for 

many years wasn't there, which the API advocated here in the 

states. There's real garbage that shows up. The firm I'm 

34 
P.86 

with and many of the small firms are basically East Coast 

fi rms. 

When you start really getting into this, 

whoever is doing the test is going to have an inquiring mind, 

and the inquiring mind is going to go out and begin to grab 

samples. For a firm like Aiken-Murray, you could potentially, 

if you find out your baseline data is wrong, which it will be 

the way you propose it, find that someone like Aiken-Murray, 

let alone Nalco, is going to get out of business because an 

additive or a combination of additives into 300 potential different types of fuel oil coming into the harbors of the East 

Coast is something that even your Agency can't afford to do. 

From the technical things of designing 

these things, I'm a pipe designer, there's nothing 

mechanically that can't be designed if you're patient. We 

feel though that the work that's been done is more than 

adequate and that all we're doing here, and now I'm talking 

1ike a politician because I do sit on a governmental board on 

occasion, is that it's not your fault, okay, but someone 

dragged their heels for ten years and now we're in crisis 

management. Private industry, other governments, other 

agencies of the government did not go with crisis management. 

They assumed that within three to four years of the original 

passage of the law that you folks would be having this 

85 
P.87 

meeting, so they've done a lot of your homework. 

We feel that the emphasis should be to 

fill in the small gaps and go with the work that was done by 

the Bureau of Mines for diesel exhaust in mines and get on 

with filtration and also with the development of better 

processes. There are people here who aren't going to testify 

who can tell you that it isn't a matter of worrying about the 

additives, it's a matter of making sure that a lot of the raw 

material is available in the world around to make these 

products in the future. 

MR. WILSON: Thank you for coming and 

for that information. I guess I had one question on your 

filtration point. Are you suggesting that rather than 

reviewing additives, we should require technology on the 

engines to capture whatever was coming out of them? 

MR. TURKAL: And that work has already 

begun. We're a very small firm. Unlike some of these firms 

who have more PhDs than offices, we have more offices than 

PhDs, so we have to rely on that little miracle called a 

computer, and we plug into things like "Toxline." In this 

case the Bureau of Mines, along with the Canadian government 

and SAE, has already done testing on ceramic filters for 

diesel emissions. Even with the work done by Volkswagen for 

the German labs, they were anticipating this. The German 

86 
P.88 

studies were done for the American market. They weren't done 

for Germany. 

MR. WILSON: We have separately a fairly 

aggressive program in terms of reducing particulate emissions 

from diesel engines. 

MR. TURKAL: When a small firm punches 

into "Toxline" to get a database, your name doesn't show up, 

and that's the aspect that you have to remember with small 

business, is that we're actually used to friendly government 

agencies. Now that may sound crazy to some people, but let me 

get to the fact that the water treatment industry is on very 

good, amicable terms with the FDA and the USDA. They give us 

standards. They don't come and say, we want you to fund 

tests. They have developed the standards. They realize, as 

you should, that although every one of these men and women in 

this room represents a retail name of an additive, that 

basically instead of having a hundred, we still are back to 

five or ten or maybe 20 basic additive ingredients. The one 

that scares the small additive manufacturer really is 

manganese, which comes out with particulate filters. 

Our focus is, and you're not going to 

get another letter on this unless Valerie wants one, is very 

simply that you should be testing, not products A, B, C and 0, 

because it looks like empire building to the small additive 

87 
P.89 

manufacturer, and it is empire building. You should be going 

after the base compounds which the manufacturing association 

can provide you, make a generic solution because that's all we 

do. When we need a new formula, who do we call? We call 

these guys up; hey, I want to do this, what do I do — well, 

why don't you use X, Y and Z. In our case, one of our own 

people found out that if you add A and B to it, it works even 

better, but we didn't tell them. 

You can do what you want to do without 

putting a financial hardship on these people, whether they're 

very large or only selling a half a million dollars a year, by 

sitting down and looking at the actual applications and understanding what the additives are used for because I perceive 

from the cover letter of the Federal Register and from your 

questions that there is no real understanding of the 

applications of additives, in what we consider in the industry 

to be additives. I doubt if I will find anyone in your 

organization who has gone down to a real expert on what 

happens with additives in engines and talked to one yet. Any 

good diesel mechanic with 15 years experience can tell you 

what's going to happen from additives and even tell you what 

brand it is almost. And you will invariably find that a lot 

of the problems are going to be with cetane improvers and also 

with combustion improvers, ovei—use. 

88 
P.90 

Your regulation is wonderful for these 

people here, but in the real world that's not how additives 

are added. In America we have a philosophy when it comes to 

using chemicals. If a little bit is great, a lot must be a 

heck of a lot better, and this is very prevalent in every bus 

garage in a school system, any truck department that you want 

to go to. Whether it be Yellow Transit or Roadway, you are 

going to find that's where you're having your particulate 

problems. 

Also, we have the philosophy, and the 

government is responsible for this, is you actually want the 

cheapest fuel. You write a spec. I don't know if you've ever 

been on a government contract, but I think you should take the 

time to do it, and you would come back to your own Agency and 

say, we have to start with procurement first, because it's not 

these folks' fault. To get gasoline on the market, you're 

going to take a retailer, and he's going to buy a good 87 

octane gasoline from Amoco or Sun Oil. He's going to call up 

another firm who sells him rapenate (phonetic), and then he's 

going to blend off his good octane, and then he's going to 

throw some ethanol in it, and you are not going to have a fuel 

that you think you think you've regulated because he could 

care less. Once he gets that number, he's got a license to 

sell what he wants. 

- _ 
P.91 

That's what our whole approach on the 

diesel additive is, is that in the New York market, the New 

York Spot Market, all you have to do is sit down with any 

buyer of fuel oils in the New York Spot Market, whether it be 

Serill (phonetic) Brothers, or Axle Johnson from Sweden, or 

any of the larger firms. You have no consistency in fuels as 

used in the automotive, home fuel oil or marine, light marine 

industry. It's not there. Truthfully, if you want to 

establish a baseline just for the East Coast, you can't do it 

in five years without the animal testing. You cannot do it. 

You will have to test the products of every refinery in the 

world because it goes through that harbor. 

That's what this gentleman from New 

England is talking about. If he is from New England, he sees 

things come on the market that the API wishes never showed up 

because they don't know. He's liable to get something and 

find minnows flowing out of it. I've treated oil that came up 

from South America, where we had to put demulsifiers in it at 

a one to a hundred just so that we could get rid of the 20 

percent water that had been picked up by the tanker. Who 

knows what trace elements, what complexities happen when you 

get into situations like this? This happens all the time. 

I'll relate one incident to you because 

I did do a lot of additive treatment on the East Coast for 

90 
P.92 

Axle Johnson Corporation of Sweden at their New England 

refinery. I got a call on Monday that I was to treat a 

tanker load, which is a ship, of oil refined in the Crimea 

from the Soviet Union. When it was close enough for them to 

fly a helicopter out to get a sample, they got a better buy on 

a shipload of oil coming out of Texas. That boatload went 

back somewhere in Europe. The boat from Texas had a leak in 

its hold, and that stopped off in South Carolina for his other 

refinery, and what I ended up with was two boatloads later. 

They didn't know until the ship showed 

up where it came from, what composition it was, what grade of 

diesel it was or home fuel it was, and it was a 29 gravity 

diesel, which everyone here will tell you was closer to a 

number four oil, or at least the old grade of number three. I 

had exactly two hours to run all the CFIs on that or pour 

point tests, and then I treated that entire ship, 250,000 

gallons of diesel fuel, as it was pumped off the ship. So I 

varied the amount of additive I had to use with that one load, 

depending on what was coming out of each of the different 

sections of that ship. That is the world of additives at the 

retail end, and that's what confronts people who work with 

imported oi1. 

What you're doing is very nice for the 

American manufacturers, but I think that you have to sit down 

91 
P.93 

in New York harbor and get some real data on what is coming 

into this country and what you think is a registered fuel and 

what it really is, because just the difference in fuels will 

throw that entire testing program you have right down the 

sinkhole because it doesn't exist. I think you're better off 

taking a range of fuels, taking the data, making, based on the 

base manufacturer's recommendation, maximum concentrations for 

that additive and running your tests. Ten years from now 

you'll have some data that these gentlemen can work with. I 

think you're far better off going after filtration, removing 

the particulates and work on alternate fuel technology. 

MR. WILSON: Thank you very much for 

coming today; we appreciate it. 

We do have one other witness, I guess. 

Phil Bush would like to make some comments specifically for 

Amoco. 

Is there anybody else that we don't have 

who wanted to testify today? 

MR. BUSH: Good morning, my name is 

Philip Bush and I work in the Planning Department of Amoco Oil 

Company. Certainly this regulatory program affects us and our 

products, and I am not a toxicologist, so today I want to 

address my comments more towards those aspects of the proposal 

having to do with the data that's currently available in .-.. 
P.94 

literature, adequacy of Tier I, relative to vehicle emissions 

and speciation suggestions. 

Now we appreciate the progress that's 

been made since the prior proposal in moving this towards what 

we think is a more manageable program by the concepts of 

tiering and baseline category which is fairly broad. We think 

there's some very good technical reasons for that. We are 

very concerned that, as proposed, this program has the 

potential to seriously disrupt some other programs we think 

are more important and should have higher priority for both 

protecting health and the environment. I want to deal with 

these with some fairly broad concepts which we think answer a 

lot of the questions raised in the preamble and in the 

regulations and just use very specific examples to illustrate 

the points 

We think the Agency has a very difficult 

time in making the judgmental decisions that they have to make 

as the focus of this rulemaking. We certainly sympathize with 

that. We think this public forum regulatory process goes a 

long way towards bringing all the issues out in the open where 

everybody can discuss them, and I want to put forth some 

concepts today primarily because I want people to address them 

in their written comments, as to whether they're appropriate 

or not. So the public phase is very important in helping the 

93 
P.95 

Agency to identify the issues, focus the program where it 

needs to go and elicit proper responses. 

I want to disagree with one remark made 

earlier by Mr. Keller in that he said we know how to do 

speciation. In most of our judgments, yes, we do, but 

certainly to no where near the extent that's being proposed in 

this rule. There are significant technical proposals in here 

which are just straight infeasible. Let me illustrate with 

one example. 

The proposal is that we be required to 

identify in speciation and quantify all hydrocarbon compounds 

of C-12 and less. Now when you go to the literature and look 

at a study of engine combustion where they took a single 

chemical compound as the fuel and they pass it through the 

combustion process, that molecule gets broken up into all the 

possible sub-fractions that you can conceive of, and some of 

those re-combine to create new and even larger molecules than 

were there to start with. 

I remember one study where they took a 

single liquid fuel, passed it through the combustion and 

identified 40 different species in the exhaust. Now if that's 

a good rule of thumb, you get 40 for each of the compounds in 

the original liquid fuel, then gasoline, for example, where 

there may be 100, 200 or more compounds in the liquid fuel 

94 
P.96 

itself, we're talking about there being species in the exhaust 

of four to 10,000 or more. We cannot feasibly identify and 

quantify all those species, and we need not in this rule. The 

reason that those are not high priority concerns, or should 

not be, is they're extremely small. Hydrocarbons in total as 

a fraction of exhaust is very small, and the big constituents 

are methane, which we know is pretty benign, and on down the 

1 ine. 

Technical feasibility so far has been 

demonstrated by Auto/Oil, where they've managed to identify 

something in the neighborhood of 150 of these potentially 

thousands of compounds. If the Agency really thinks there's a 

strong need for all of this detail, then we're not going to 

get it done in three years. Nobody in the world knows how to 

measure all those things. It's just impossible. So we need 

to focus back on something we think is more practical for 

routine registration. 

We propose that for the Tier I criteria, 

the Agency already has in its possession sufficient speciation 

data for sub-sim fuels and additives. It's come primarily 

from the Auto/Oil program, but in addition to that, there's a 

lot of older studies that have been done by the Agency itself, 

by other category. As long as the definition of adequacy 

allows us to bring that prior knowledge and use it in this 

95 
P.97 

rulemaking, and let me point to one other specific proposal 

that eliminates that, again in the speciation requirements the 

Agency is suggesting that each speciation measurement be made 

in triplicate. That wasn't necessary for Auto/Oil. The data 

that's going to be used for developing the whole reformulated 

gasoline program was not measured in triplicate and almost 

never was. So that requirement by itself eliminates the 

possible use of almost all of the prior knowledge that's in 

the library. Those types of things need to be reassessed, 

reevaluated as to what the criteria should be used in terms of 

adequacy, so I think this is a large problem. 

Again, I suggested that the speciation 

data that we already had, if we're allowed to use it and if 

it's adequate for the Agency's needs, is already there in the 

literature. So there shouldn't be a major focus within the 

proposed rules requiring a lot of people to go out and do a 

lot of speciation measurement which isn't going to add to our 

current knowledge in a useful way. 

I want to turn and look at mass emission 

rates because this question came up earlier even here, and 

talk just a little bit about why we, in our minds, have 

determined that that type of information has very little use 

to the Agency within what should be the focus of this 

rulemaking. 

96 
P.98 

When you do toxicology tests, you always 

overdose the animals, and you do it by many, many, many orders 

of magnitude. Again, the results of this rulemaking are going 

to be used to determine human risk assessment of the compounds 

in ambient air at sub part-per-mi11 ion type level, and yet 

we're going to dose the animals with something like raw 

exhaust, probably dilluted so that there's some oxygen in 

there, we'd like to keep the animals alive for a while, while 

we do the test, and cool it, but you typically dose the 

animals with a thousand times, 10,000, 100,000 times the level 

you're really trying to get at, and you do it at three levels 

so you get a dose response curve. You then take that curve 

and you extrapolate it backwards down towards reality, and if 

that's what you're doing in the risk assessment toxicology 

part of this program, it doesn't make any difference whether 

the emission rate of that species out of the actual tailpipe 

was two milligrams, five milligrams, ten or a.hundred, because 

you tested it many times that level. 

When you look at the risk assessment 

part, again what people are exposed to is the ambient level 

concentration of the species, and that's the basis and the 

controlling factor on where you end up as an estimate for your 

overall risk assessment. So ambient air concentrations are 

quite valuable to that process, but what emission came o_* 
P.99 

a specific car on an artificial test is not very useful. If 

y©u get that number, you then try to extrapolate it to what it 

means to the real urban area ambient concentration. You start 

factoring in factors like some cars out there are missing 

catalysts, and this multiplies those emission rates by large 

factors, and that multiplicative interpretation is less wellknown than the emission rates. 

And in other parts of the risk 

assessment process there are areas that are less well defined, 

and we already know about the emissions of those species out 

of the cars, so we shouldn't be focusing a whole lot of 

manpower and effort trying to define very precisely what an 

emission test was on a specific car running on that fuel one 

time, which is not very useful for the overall purpose. So 

the requirement for triplicate speciation for mass emission 

measurements at all within this rulemaking, we think, can be 

eliminated. It doesn't need to be there at all. 

The next point I want to make is coming 

back to the description that I gave earlier that you can take 

a single liquid fuel and pass it through the combustion, and 

you get a whole range of compounds there. Once you have a 

fairly wide range of compounds in the liquid fuel, more than 

just one, you get essentially the same speciation list of 

compounds in the exhaust, pretty much regardless of what the 

98 
P.100 

specifics of the fuel were within the categories of sub-s im. 

And I think if you look at the Auto/Oil 

data and the speciated data where you've taken a look at a 

very wide range of fuel parameters for 18 fuels, that 

certainly covers most of the available commercial gasoline, 

you find that new compounds are not appearing and disappearing 

in that speciation list. The concentration, the emission rate 

may change. Again, the emission rate is not particularly 

relevant to what's really trying to be accomplished here. I 

think what should raise the concern of potential health issues 

and be focused on is the appearance of new compounds. 

Certainly when you go into an atypical category where you've 

brought in a new heavy element to an additive or the fuel, I 

mean, that deserves much more scrutiny, partly because we know 

that a lot of elements have toxic consequences. 

So in that part of the rule you need 

more prescription as to what you will do to evaluate those new 

compounds than you do for sub-sim. We think there's a very 

extensive database that should be allowed to be used to judge 

current fuels, and I think a lot of that data can be 

extrapolated to a lot of the alternative fuels coming down the 

line. Certainly some of the studies done on gasoline would 

adequately cover compressed natural gas. We expect compressed 

natural gas as a vehicle fuel to be cleaner and, if anything, 

99 
p.1 

have a lot less potential problems and concerns than gasoline. 

So I don't think it's desirable here up front in the 

rulemaking to require an awful lot of manpower, facilities 

expense, going out and trying to nail down those specifics, 

unless there's a useful need to it for the Agency. We'd like 

to focus back on the data that we already have. 

I think I want to bring up a point for 

Tier I, if we are allowed to use all the extensive data that 

we've already developed. Just the one small category of 

diesel particulate, health effects and regulation is a huge 

volume of material. It certainly should be applicable to the 

diesel fuel judgment by the Agency of whether anything further 

is needed. How, in a practical sense, do we and the Agency 

handle that mass of studies and available literature and get 

it organized into a fashion that could be used in a practical 

sense and that people could refer to and understand what 

you're referring to? In my mind, what that drives you to is 

the conclusion that the Agency needs to build a library and 

organize the available data so that it can be used by everybody and used in even the other categories. 

We think Tier I information in the 

public literature and what the Agency already has is 

sufficient for sub-sim fuels. What we would suggest is that 

EPA take their current registration form, and it's included in 

100 
P.2 

the packet and there were some handouts in the back, and this 

registration form asks for quite a bit of information about 

aeromatics levels, olefins, saturates, trace elements that 

might be in gasoline in even the highest, lowest and average 

type concentration, and also we identify the methods of 

analysis for these various things that we use to generate 

those numbers, Reid vapor pressure, distillation, octane 

number, et cetera. This information is sufficient to decide 

whether this new fuel that we're coming in to register fits 

within the definition and category of baseline and 

substantially similar, and we think this is all that's needed 

to make that initial assessment, certainly for the baseline, 

baseline fuels. 

The next step seems to be that we need 

to tie the available health literature of Tier I to the 

specific registration process that Amoco is coming in to do, 

and Amoco has about 25 different fuels registered with the 

Agency. I think what accomplishes that is to simply add a 

section to this form which asks if the available data, number 

one, whether this fuel fits, in our opinion, the definition of 

substantially similar, and most everything will, except for 

our alternative fuels, for both the definitions of gasoline 

and diesel, and then ask the registrant whether the data that 

the Agency already has, and my concept again is that the 

101 
P.3 

studies are sitting here in a library, and EPA has made a 

determination that they apply and satisfy the Tier I requirements, does this apply to this particular product of gasoline. 

That seems sufficient for the routine, day-to-day registration 

process. It avoids the possibilities of having to bring in 

duplicative reports, to apply them to different categories. 

We could have a health study which is applicable to both 

diesel and gasoline and methanol or an M-85 type category. We 

should do that by reference to this baseline set of data. 

We will be addressing these same issues 

in our written comments in more detail, and we'll try to point 

out each and every place in the proposed regulations where we 

think they've gone beyond what's technically feasible 

certainly and beyond what is needed for purposes of this 

particular program. But we want to get the concepts out of 

what drives you to certain conclusions in answering the 

questions that have been raised. I thank you. 

MR. WILSON: Thank you. 

That concludes the people who wanted to 

testify this morning, so with that, I'll thank all of you for 

coming and for the time and effort put into the comments we 

got today. We look forward to hearing from all of you during 

the comment period, and with that we'll close this hearing; 

thank you again. 
P.4 

(Proceedings concluded at 11:55 a.m.) 

STATE OF MICHIGAN ) 

COUNTY OF WASHTENAW) 

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

this transcript, consisting of 103 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 Regulations; Proposed Rule, EPA Air Docket 

#A-90-07, held at the Ann Arbor Regent - Best Western Domino's 

Farms Hotel and Conference Center, Ann Arbor, Michigan, on 

Thursday, May 28, 1992. 

sA 

/ 

y-Cttf ^ 

Susan Beale, CSMR 2741 

Western Wayne Court Reporting Service 

Plymouth, Michigan 

(313) 453-7232 

103 
P.5 

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

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

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

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

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

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

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

environmental research capability. 

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

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

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

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

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

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

comments in June. 

h.'s priu.rba.hM-fbr Aft. ft i'i t*.kfiA {UrUXJUf fnDirvv o. WW-<f *»* 6*Wr 

III. NEED TO NOT INTERFERE WITH CAA AMENDMENTS 

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

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

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

4 
P.6 

negotiation. It established procedures for certifying reformulated gasoline by vehicle 

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

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

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

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

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

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

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

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

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

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

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

model before the June 1 deadline. 

IV. FUEL AND ADDITIVES GROUPING 

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

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

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

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

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

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