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OAR Box 1846 

Prepped by Ollie Stewart 

Document Number: 

56) ll-H-4 

Docket Number: 

A-90-07 

Printed 11/18/2008 7:30:16 AM Sheet 56 of 93 
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Environmental Protection Agency 

Docket No. A-90-07 

TESTIMONY ON 

THE FUELS AND FUEL ADDITIVES REGISTRATION PROGRAM 

ADVANCE NOTICE OF PROPOSED RULEMAKING 

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Presented by: 

Charles Keller 

on Behalf of the 

Chemical Manufacturers Association 

Petroleum Additives Panel 

September 26, 1990 

Ann Arbor, Michigan 
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I. Introduction and Background: 

My name is Dr. Charlie Keller and I am here today representing the 

Chemical Manufacturers Association (CMA) Petroleum Additives Panel. 

The CMA Petroleum Additives Panel represents a group of major 

manufacturers of fuel and lubricant additive components. The following 

companies are represented on the Panel: Amoco Petroleum Additives 

Company; Lubrizol Petroleum Chemical Company; Ethyl Corporation; 

Oronite-Chevron Chemical Company; Paramins-Exxon Chemical Company; 

Texaco Chemical Company; and Mobil Chemical Company. 

Fuel additives are specialty chemicals which are generally sold as 

proprietary mixtures to refiners and marketers of gasoline and 

distillate fuels. Fuel additives are critical to the operation of 

modern emission-controlled engines. They act as antioxidants, prevent 

fuel injector fouling, reduce or prevent valve deposits and provide a 

host of other performance features. These functions of fuel additives 

have become increasingly critical to maintaining engine emission 

control in recent years. 

While there is a tendency among the general public to view 

chemicals as environmentally harmful, our industry produces fuel 

additive chemicals that have made a substantial contribution to 

maintaining low emissions in modern engines. In the ANPRM, EPA states 

that there are currently 3790 active registrations for fuel additives. 

While these are not all distinctively different products, we believe 

this reflects the dynamic, innovative nature of fuel additives. The 
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fuel additive industry has worked hard in recent years, and spent 

considerable research and development money, to meet the challenge of 

fuel systems and engines that are more sensitive to deposit formation. 

II. We urge EPA to clearly focus their efforts to develop testing 

regulations which address "real" concerns, consistent with EPA's 

authority under the Clean Air Act. 

The ANPRM raises a very large number of questions and unresolved 

issues, many of which affect fuel additives. We believe this broad 

uncertainty is an inevitable consequence of the wide scope of the 

testing envisioned in the ANPRM. The issues and questions raised in 

the ANPRM include complex technical issues on emission and toxicology 

testing, as well as issues of public policy, risk assessment and the 

relationship of these proposed regulations to existing EPA regulations. 

For example, we believe that the ANPRM suggests toxicity testing 

which would probably go beyond the limits of established methodology 

and technology. While there has been some toxicity testing of 

combustion emissions, this testing has not encompassed the broad 

spectnia of toxicity endpoints the ANPRM identifies. Furthermore, this 

testing has been directed at answering very narrow research questions. 

We are not confident that methods/and protocols have been developed to 

the point where they could be justifiably used for the wide-scale 

screening of fuels and additive/ emissions suggested by the ANPRM. 
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•An important technical aspect of this problem is the selection of 

an appropriate baseline in order to compare and asses the toxicity of 

emissions from new fuel and additive combinations. We believe it could 

take years, and millions of dollars, just to develop and validate a 

"baseline" and protocols for testing combustion emissions in an 

inhalation toxicity test. This effort would require basic, fundamental 

research to select the most appropriate fuel, fuel additives, engine 

type, engine operating conditions and animal exposure procedures. In 

addition, the "baseline" procedures would have to be run over time in 

several laboratories to validate the method, and to establish 

statistical control limits. 

In addition to statistical variability in the emissions, another 

technical problem is definition and control of the variability in 

animal response. As an example, the EPA should review their history in 

developing testing guidelines under the Toxic Substances Control Act. 

Even though these were originally "off-the-shelf" testing 

methodologies, EPA expended substantial effort defining and codifying 

these guidelines. We believe that developing and validating test 

standards for emissions toxicity testing would require a massive effort 

on EPA's part. 

Our review of the Public Docket for the rulemaking suggests that 

EPA recognizes the absence of validated toxicity testing protocols and 

methods to assess exhaust and evaporative emissions. To quote from an 

October 5, 1989 internal memorandum (Docket //A-90-07, II-B-3) which 

summarized literature references on fuel toxicity: 
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"While these references appear to be numerous, they do not really 

address the key issues that will face us in the rulemaking. 

Specifically, none of the studies are devoted to a principle topic 

of the rulemaking: what testing procedures and protocols are best 

suited to determining the health and welfare effects of fuels and 

fuel additives." 

Beyond the examples I've cited today, we believe there are other 

examples of technical or practical concerns which would present 

obstacles to the testing program envisioned in the ANPRM. We recognize 

the challenge which EPA faces in sorting through these issues to 

develop a focus for rulemaking. 

III. Our position is strengthened by the legislative history of this 

issue. 

To help focus on a direction for rulemaking, we believe that it is 

helpful to examine the legislative debate in 1970 and 1977. In this 

regard, we examined the documents contained in the public docket for 

this rulemaking. The original 1970 Clean Air Act was, in fact, an 

amendment of predecessor provisions in the 1967 Act, now included in 

Sec. 211(a), 211(b)(1) and 211(b)(3). In 1970, the legislative debate 

on fuels and fuel additives focused almost exclusively on the use of 

lead compounds as anti-knock additives. While the EPA's predecessor 

had some powers, it was clear that Congress believed that they lacked 

the statutory basis to regulate or ban lead in gasoline. It was this 

Congressional objective which led to the incorporation of the "may also 
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require" testing provision now granted in Sec. 211(b)(2). However, in 

our review of the docket, we did not find a single reference to ' 

Congressional concern for any specific fuel additive other than lead 

anti-knock compounds. 

In the 1977 Amendment process, Congressional debate also was very 

narrowly focused. In 1977, the fuel additive concerns of Congress 

focused on the use of a single additive chemical, and there was very 

limited mention of concern over the general use of fuel additives. In 

addition, it appears from Committee summaries as though Congress was 

primarily addressing the issue of fuel additive effects on vehicle 

emission control systems as regulated under Sec. 211(b)(2)(B) when they 

drafted the Sec. 211(e)(1) mandate. Despite these apparently narrow 

concerns, Congress added Sec. 211(e) to the Act, which required EPA to 

promulgate regulations under Sec. 211(b)(2). 

CMA believes that the EPA should consider information in the 

docket relevant to the 1970 and 1977 Clean Air Amendments of Sec. 211. 

If EPA agrees that Congress focused only on a couple specific additive 

chemicals of high concern to them, and on combustion emissions, then 

this would serve to focus this rulemaking. 
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IV. Clean Air Act considerations provide further guidance for this 

rulemaking. 

Turning now to the statutory requirements, the 1970 Clean Air Act 

Amendments did not provide EPA with clear directions for rulemaking. 

Instead, EPA is given great latitude and discretion in regulating 

testing of fuels and additives. The Clean Air Act states in Sec. 

211(b)(2)(A) that: 

"the Administrator may also require the manufacturer of any fuel 

or fuel additive to conduct tests to determine potential public 

health effects of such fuel or additive..." 

The conditional phrase "may also require" is critical to the ANPRM 

and rulemaking as it allows, and for that matter even mandates, that 

EPA utilize its judgment in preparing the regulations required by Sec. 

211(e). As noted in the ANPRM, the legislative history of the 1977 

amendments to the Clean Air Act indicates Congress' intent that testing 

regulations not be unduly burdensome, and that costs should also be 

considered. Yet, the ANPRM recognizes that the Section 211 program is 

potentially "vast in scope" with potential serious adverse economic 

impacts as a result of undue testing burdens. To quote from the ANPRM: 

"In exercising its regulatory judgment, it is EPA's intent to 

develop a workable, useful prograa which satisfies the goals of 

the Act, allows for the adequate assessment of potential health, 
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welfare, and emission control system performance impacts as 

required, but does not introduce an infeasible or needless 

testing burden on the producers of the fuels and additives." 

To us, the ANPRM suggests that EPA may be interpreting the "may 

also require" language to mean "shall require". At this stage of 

rulemaking, we believe this emphasis on broad-based testing is 

premature. Effective, more focused options for health and 

environmental protection, which include testing, may not have been 

given sufficient consideration. 

We believe the EPA must focus their rulemaking to meet both the 

legislative intent and the statutory language which mandates reasonable 

discretion. Again, to quote the ANPRM: 

"The program design needs to focus on the potential effectiveness 

of a given regulatory requirement in meeting the goals of the Act 

and whether the results of such requirements will provide useful 

information for decision making." 

The key to meaningful decision making is to identify the 

objectives and intended outcomes up-front. The decision making process 

should lead to a decision with relevance to environmental or health 

concerns. 

The current ANPRM addresses a very large number of broad issues 

but does not identify specific environmental, health or public welfare 
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issues, concerns or problems. In some ways the ANPRM appears to be a 

solution in search of a problem. The possibility of a "vast scope" of 

testing, on possibly hundreds or thousands or products, raises the 

danger that these regulations could needlessly disrupt the use and 

innovation of additives with proven value in the reduction of 

emissions. The potential costs of testing could easily lead to reduced 

research and innovation, and product withdrawals from the market, 

without any identified environmental benefit. 

We believe EPA must assess the objectives in this rulemaking. In 

contrast to most EPA regulations with high potential impact, EPA has 

not included a complete regulatory analysis of their concerns and 

possible options. To focus rulemaking on issues of real concern, EPA 

should conduct a thorough regulatory analysis. This regulatory 

analysis should evaluate whether combinations with a fuel causes 

adverse environmental or health effects. It should address whether 

exposure to liquid fuels or evaporative emissions are a concern which 

is not being addressed by current EPA or OSHA regulations. The 

regulatory analysis should assess existing information on fuel 

additives to determine if there is sufficient reason to believe that 

registered additives adversely affect combustion emissions. The 

analysis should determine how testing data would be used in Sec. 211(c) 

regulatory actions. 

V. The Clean Air Act Amendments should also be considered in 

relationship to this issue. 
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Finally, the analysis should examine how the proposed regulations 

relate to the 1990 Clean Air Act Amendments which potentially will 

result in fundamental changes in vehicle fuels. Although Sec. 211(b) 

and (e) provisions are not changed in either the Senate or House bills, 

there are other proposed amendments which are relevant to the ANPRM. 

In particular, both bills actually require the use of fuel additives 

to prevent the formation of deposits in fuel systems. In addition, CMA 

believes that fuel additives will be a crucial part of the "clean 

fuels" approach to reducing combustion emissions. Finally, the 1990 

proposed Amendments would further limit evaporative emissions during 

refueling and from vehicles. Because this will reduce human and 

environmental exposure, we believe this should be considered by EPA in 

the rulemaking in assessing whether there is a need for testing 

of liquid fuels and fuel additives. 

VI. EPA should consider how toxicity data would be useful to the 

Agency in carrying out its responsibilities under the Clean Air 

Act. 

This leads to another important issue which needs to be addressed 

regarding the use of toxicity testing data which would be generated as 

a result of the rule developed from the ANPRM. EPA should carefully 

consider how toxicity data generated by fuel and additive manufacturers 

would be useful to the EPA in carrying out their responsibilities under 

the Clean Air Act. The ANPRM proposes broad testing of fuel and fuel 

additive products, yet Sec. 211(c) of the Clean Air Act explicitly 
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authorizes EPA to regulate fuel additives only on the basis of the 

adverse effects of emissions. This is supported by legislative history 

contained in the EPA docket which summarizes what became the 1977 Sec. 

211(e) provision: 

"First, testing could be required to determine the health 

effects of emission products of fuels or fuel additives." 

Since EPA lacks regulatory authority to regulate on the basis of 

non-emissions based effects, it would make little sense to require 

testing to evaluate these potential effects. We believe EPA should 

avoid testing for the sake of testing. 

In this regard, we believe that the toxicity of chemical 

components contained in fuels and fuel additives are already adequately 

addressed by the Toxic Substances Control Act (TSCA). "New" fuel 

additive chemicals introduced since 1978 have all be subject to EPA 

review and hazard assessment as part of the Premanufacturing 

Notification (PMN) process. In 1988, the EPA Office of Toxic 

Substances instituted new internal guidelines for the review of 

chemicals with high production volumes, and potentially large worker 

and consumer exposures. We believe virtually all new fuels additives 

(except polymers) would meet these new TSCA criteria for "high 

exposure" chemicals. As such, they are subject to intense EPA TSCA 

Sec. 5(e) Consent Orders. 
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"Existing" fuel additive chemicals are, of course, subject to 

potential regulation and testing under Section 4 of TSCA. In fact, EPA 

has already exercised this authority. There is currently a very large 

scale testing program for methyl tertiary butyl ether (MTBE), which is 

used primarily in fuels. 

VII. A tiered matrix approach may offer a focused process to 

identify emissions toxicity testing needs. 

While we urge EPA to re-evaluate their objectives and focus on the 

key environmental issues, we also believe that some of the concepts 

identified in the ANPRM merit further consideration. We believe that 

the tiered matrix approach may offer a potentially flexible, focused 

process to identify fuel and fuel additive combinations for which 

further emissions toxicity testing may be needed. However, we feel 

that the matrices identified in the ANPRM are not optimally structured 

for decision-making, because toxicity testing is required before there 

has been sufficient analysis and judgment exercised to determine 

whether this testing is really necessary, or would even be useful in 

achieving regulatory objectives. 

VIII. Potential exposure needs to be a major factor in the risk 

equation. 

The ANPRM notes that Congress' approach was to mandate a risk 

assessment for potential adverse effects health, welfare, and emission 

control systems. It states (to quote): 
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"Since risk is a function of exposure and toxicity, one key tenet 

of the program will be to assess potential risk using these 

factors." 

We strongly support this approach. However, we question whether 

the proposal to use "production volume" as a factor is valid. Most 

importantly, we feel that the ANPRM does not sufficiently consider 

potential exposure as a major factor in this risk equation. As with 

many chemicals, very low exposure potential may negate the need for 

toxicity testing if there is sufficient information, including for 

example "structure-activity relationship" (SAR) data, to assess a 

combustion emission's approximate toxicity. However, we do believe 

that a matrixed tiered approach is probably the best mechanism for 

identifying testing needs. 

IX. The "generally similar" definition should be carried forward into 

this proposed rule. 

The additives manufacturers support linking these proposed 

regulations to existing fuel additive registration procedures based 

upon the "generally similar" definition for fuel additives. We believe 

that the "generally similar" provisions of the current registration 

provide a workable mechanism for reviewing and registering fuel 

additives. We think that the "generally similar" provision is 

sufficient in considering combustion emissions which is the most 

important health and environmental concern. 
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X. Conclusions 

We believe EPA can succeed in this complex rulemaking if it 

follows the statutory mandate which requires judgment, discretion and a 

focused approach on potential health and environmental concerns. The 

ANPRM identified a wide spectrum of issues, but we would hope that EPA 

now intends to focus its efforts to develop testing regulations which 

address real concerns, and which are consistent with EPA's regulatory 

powers under Sec. 211(c). Any regulation which indiscriminately 

requires broad testing without regard to actual environmental issues or 

concerns runs the danger of causing needless disruption and economic 

hardship on producers and consumers of fuels and fuel additives. As I 

pointed out at the beginning of this presentation, we believe, and 

Congress apparently concurs, that fuel additives are part of the 

solution, not the problem. We feel the regulations should reflect this 

fact and EPA should not jeopardize future fuel additive innovations 

which will benefit the environment, and which will be necessary for the 

success of the "clean fuels" requirements. 

The CMA Petroleum Additives Panel would like to offer EPA our 

assistance in providing technical information in discussing regulatory 

options. We believe we could provide more useful information if we 

were given 60 days in which to comment. We would like to request that 

EPA extend the period for submission of written comments to this docket. 

Thank you for this opportunity to present our views, and we hope 

that we can continue to work with EPA to achieve a productive outcome.