OAR Box 1834 

Prepped by Keeia Richards 

Document Number: 

35) IV-E-08 

Docket Number: 

A-90-07 

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

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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

3.^yt I f r 

OFFICE OF 

AIR AND RADIATION 

JAN 28 1994 

MEMORANDUM 

SUBJEICT: Meeting Between EPA, API, and CMA Regarding 

Fuels and Fuel Additives (F/FAs) Registration 

Regulations 

>M: ines del C. Figueroa, Environmental Scientis? 

Special Regulatory Projects Branch 

'Jt/f^jtf**^ 

THRU : Judith Gray, Senior Project Manager CAudw^SsX*****^ 

Special Regulatory Projects Branch [\ 

Docket No. A-90-07 

On Tuesday, January 25, 1994, EPA management and staff met 

h representatives from the American Petroleum Institute (API) 

tnd the Chemical Manufacturers Association (CMA), at their request, 

to discuss the direction of the F/FA final rule. The meeting took 

place at EPA's National Vehicle and Fuel Emissions Laboratory in 

Ann Arbor, Michigan. A list of the attendees is attached. Also 

attached is a letter from API stating their intent to meet and 

listing their main concerns. 

Topics discussed during the meeting included grouping 

provisions, compliance and timing requirements, relationships with 

other EPA rulemakings (e.g., detergents, reformulated gasoline), 

pe and testing requirements for the different tiers, adequacy 

of existing data, implementation issues, registration requirements 

new F/FAs, alternative testing in lieu of Tier 2, and emission 

generation methodology. EPA also discussed the possibility of 

1i shing a Notice of Reopening of Comment Period to clarify some 

compliance issues and to discuss some technical modifications 

developed since the proposed rule was published. 

Attachments 

JAN I {994 
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A-10-07 

EPA API/CMA MEETING ON F/FA 

25 January 1994 

NAME 

Glenn Passavant 

Judy Gray 

Chet France 

Ines Figueroa 

Kent Helmer 

Charlie Keller 

David Mongillo 

Bob Wilkenfeld 

Joe Marciner 

Anita Ducca 

Philip Bush 

ORGANIZATION 

EPA 

EPA 

EPA 

EPA 

EPA 

Exxon Chemical 

API 

Chevron 

Mobile 

API 

Amoco Oil 
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jE-e-og 

American Petroleum Institute 

1220 L Street, Northwest 

Washington, D.C. 20005 

202-682-8000 4> 

January 19, 1994 

Ms. Judith Gray 

Senior Project Manager 

Special Regulatory Projects Branch 

United States Environmental Protection Agency 

2565 Plymouth Road. 

Mail Code RDSD-12 

Ann Arbor, Ml 48105 

Dear 

API appreciates the opportunity to meet with you and the rest of the EPA staff 

preparing the final rule implementing section 211(b) Fuels and Fuel Additives (F/FA) of the 

Clean Air Act. We will be at your offices at 10:00 on Tuesday, January 25. A list of API 

member company representatives and staff who plan to attend the meeting is attached. 

API's primary concern regarding this rulemaking is its interrelationship with the recently 

promulgated rule on reformulated gasoline (RFG). Our ability to meet the energy needs of the 

nation with reformulated gasoline is dependent on providing the data that could be required 

under the F/FA rule. Thus, our primary objective in this meeting is to obtain a clear 

understanding of the direction of the Agency's plans for testing requirements in the final rule 

and how the time frames for meeting those requirements will coincide with the RFG rule's 

requirements. 

In addition, the requirements for providing test data specified in the recently proposed 

rulemaking on detergent additives will have an impact on both the F/FA rule and the RFG 

requirements. Thus, a better understanding of the interconnection between the F/FA rule's 

requirements and those of the detergent additives rule is also critical to the implementation of 

all three regulations. 

Given these objectives, we suggest that this meeting focus on the following points: 

Grouping of Fuels: How will RFG be categorized in any grouping system for testing 

purposes? If EPA decides against a single group of fuels for testing purposes, what 

will be the construct of the groups, e.g., by type of oxygenate or additive? This issue 

is of critical interest because of the language contained in the final RFG rule stating 

that "the F/FA final rule is expected to consider each gasoline/oxygenate blend as 

different formulation. Thus, fuel producers would be responsible for the testing of each 

gasoline/oxygenate blend covered by the respective fuel registration." 

An equal opportunity employer 
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January 19, 1994 

Page 2 

Timing with RFG: What are EPA's plans for ensuring that testing requirements will not 

conflict with the RFG rule's requirements to manufacture and sell reformulated gasoline 

after the three year mandated testing time period? This question relates to the final 

RFG rule which states that "Furthermore, oxygenated compounds that are listed but 

not tested within the allotted time period (i.e. three years) could not be used by the 

manufacturer." 

Scope: What is EPA's position on adopting API's recommendation to limit 

requirements for testing to the health effects of tailpipe emissions? 

Timing with Detergent Additives: How will EPA ensure that the testing requirements, 

and the timing of submitting test results required under the detergent additives 

rulemaking, will not conflict with the requirements of either the F/FA rule or the RFG 

rule? 

Fuel Designation Rule: What are EPA's plans for proposing the fuel designation rule, 

and what alternative fuels will be designated for testing? 

Speciation: What, if any, emissions speciation requirements may be included in the 

final rule? 

We have also attached a list of detailed questions which reflect some of the points that 

may need to be discussed while covering our main concerns. We hope to be able to address 

them during the meeting. 

I look forward to seeing you on the 25th. In the meantime, if there are any other 

issues you wish to discuss, please do not hesitate to call me at 202-682-8326. 

Sincerely, 

Anita T. Ducca 

Coordinator, Health and Product Stewardship 

Attachments 

cc: Chester J. France Glen Passavant 

G. William Frick Richard D. Wilson 

Charles L. Gray 
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Attachment 1 

ATTENDEES 

1. Phil Bush, AMOCO 

2. Alice Crowe, API 

3. Anita Ducca, API 

4. Charles Keller, Exxon Chemical 

5. Joe Marcinek, Mobil 

6. David Mongillo, API 

7. Robert Wilkenfeld, Chevron 
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i 

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Attachment 2 

QUESTIONS RE: PROPOSED SEC. 211(b) REGULATIONS 

Grouping Issues 

* The final RFG regulation states that: 

"In fact, the F/FA final rule is expected to consider each 

gasoline/oxygenate blend as a different formulation. Thus, 

fuel producers would be responsible for the testing of each 

gasoline/oxygenate blend covered by the respective fuel 

registration. Furthermore, oxygenated compounds that are 

listed but not tested within the allotted time period (i.e. three 

years) could not be used by the manufacturer." 

How will EPA structure the testing and data requirements of the F/FA rule to 

ensure their completion within the three years specified in the statute so that 

there are no conflicts with the requirements for manufacturing and marketing 

reformulated gasoline? 

* Will EPA allow grouping of fuels for testing purposes? Will RFG remain in a 

large baseline group with unleaded gasoline? 

If grouping is allowed, will EPA adopt API's recommended boundaries of all 

"substantially similar" and "waivered" gasoline in order to avoid the potential 

confusion that could result by establishing different regulatory definitions for 

certification and for testing? 

* Will manufacturers of "new" fuels or additives which fall within the definition of 

the baseline category be automatically included in that group and assume the 

status of "existing" fuel and additives? 

In the December 6, 1993, gasoline detergents rule, EPA proposed that all 

detergent additives be fully tested by January 1, 1996. This includes "the full 

set of requirements, including locating test fuels and conducting vehicle testing." 

Thus, this requirement will come before any required testing under section 

211(b). 

How will EPA ensure consistency of the testing requirements for these two 

rules particularly with respect to the selection of the test fuels? 

Will conventional fuel families be limited to diesel fuel and unleaded gasoline? 
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What is the status of the diesel fuel "substantially similar" rule? 

Will the definition for atypical diesel reference elements other than "carbon, 

hydrogen, oxygen, nitrogen and sulfur"? 

For grouping of similar atypical fuels, will EPA allow consortiums to present 

their rationale for claiming that selected fuels be grouped for purposes of 

registration? 

Is the presence or absence of polymers going to be used as a grouping criteria 

for atypical categories of diesel and gasoline? If so, has EPA considered 

establishing a de minimis level to allow small amounts to be included in the 

base category? 

When will the fuel designation rule be proposed? What alternative fuels will be 

designated for testing? 

Timing Issues 

Since the 18 month time frame allocated for EPA evaluation of Tier 1 

information will substantially impact the amount of testing that could be 

completed within the remainder of the three years allowed, has EPA considered 

reducing either the amount of testing required or the amount of time for its own 

evaluation? 

How will the proposed time frames for completing the test requirements in the 

detergent additives rule effect the timing of testing required in the final 211(b) 

rule? 

Given the complexity of the scientific issues that will require evaluation in 

responding to a Tier 3 testing requirement, has EPA reconsidered the 30-day 

time period in which manufacturers must respond to notification of a Tier 3 

testing requirement? 

Since many fuels could remain on the market for extensive periods of time after 

testing is completed, will EPA consider extending the reimbursement 

procedures from 5 years to 15 years as suggested by API? 
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\ 

< . J 

Health Effects Issues 

* Has EPA determined whether the lack of scientifically validated test protocols 

for vehicle emissions testing of laboratory animals will present a problem for 

meeting the statutory timing requirements? 

In light of the feasibility and laboratory capacity issues identified by API in our 

comments on the proposed rule, has EPA reconsidered the requirements for 

including reproductive, pulmonary and neurologic effects in Tier 2 of the 

proposed rule? 

What has EPA decided regarding API's suggested optimization scheme to 

require animal testing only in Tier 3, and require in vitro tests in Tier 2? 

* Does EPA still plan to mandate searches of aj[ possible toxicological effects 

associated with emissions? How will EPA define the search requirements? 

* How will EPA reconcile their proposed requirement for Good Laboratory 

Practices (GLP's) when emissions are not defined test substances and will 

likely vary during test procedures? 

* Will EPA delete from the final rule additional evaluations such as the acute 

health assessment and the inhalation reference concentration? 

* Will realistic exposure estimates and dose-response extrapolations be used 

rather than "worst case" assumptions to determine whether testing is necessary 

above and beyond what is already available? 

* Will EPA factor in the value and application of the "requisite information" using 

fixed protocols as opposed to mandating testing on a prescribed set of 

endpoints? 

Emissions Speciation Issues 

Will the extensive Auto/Oil data satisfy EPA's requirements for research and 

speciation on emissions? Or will EPA require additional emissions data? 

* Does EPA plan to limit testing to vehicle exhaust emissions? 

* Has EPA considered API's suggestion that EPA maintain a library of information 

on the effects of emissions and the constituents of emissions rather than 

require each manufacturer to conduct his own search? 
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Welfare and Environmental Effects Issues 

* Will the final rule still require a literature search for welfare effects, which API 

believes goes beyond EPA's goal of collecting only information needed for 

regulatory purposes? 

* Will modelling and evaluation of welfare effects, expected atmospheric 

transformation products and the predicted environmental partitioning of 

emissions into air, soil, water and biota be required as part of the Tier 1 

submission? If yes, will EPA offer guidance as to how this will be 

accomplished? 

Cost Issues 

* Has EPA reevaluated the estimated costs of testing? 

How has EPA decided to deal with the cost reimbursement procedures? 

Miscellaneous 

* What are the over-arching concerns and goals that the Agency intends to 

address with this rule? How does the Agency define the value added to the 

regulatory decision activities underway or planned for the near future that will 

be aided by collecting the data defined by this rule? 

* Will missing endpoint data automatically trigger Tier 2 testing even if such 

testing may not be necessary for regulatory decision making? 

* In light of the continuous advances being made in research methodologies, has 

EPA considered API's suggestion to specify Tier 3 protocols and details 

separately from this particular rule in order to allow both the Agency and the 

industry to take advantage of scientific improvements that may occur after its 

promulgation? 

Will EPA permit the use of existing data, in lieu of modelling, on ambient levels? 

* Will the final rule establish a mechanism for protocol review? 
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Given the technical difficulties with collecting emissions from cars for purposes 

of exposing animals under laboratory conditions, will the final rule require use of 

more than one car for the animal testing? 

Will the final rule include the elaborate test fuel sampling and mixing 

requirements described in the proposal? Or will there be a simplified version 

determined along with the other research decisions that need to be made at the 

time of developing the test protocols as strongly recommended in the API 

comments on the NPRM?