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OAR Box 1165 

Prepped by Ollie Stewart 

Document Number: 

256) F. R. November 18, 1996 

Docket Number: 

A-90-07 

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Protection Agency 

40 CFR Parts 79 and 80 

Regulation of Fuels and Fuel Additives: 

Minor Revisions; Final Rule 
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5874 4 Federa l Register / Vol. 61 , No. 223 / Monday, November 18, 1996 /Rule s and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 79 and 80 

[FRI.-565I-3] 

Regulation of Fuels and Fuel 

Additives: Minor Revisions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

located at die U.S. Environmental 

N . Protection Agency, Air Docket Section 

£ (LE-131), 401 M Street, S.W., 

Washington, DC 20460 in Room M-1500 

of Waterside Mall. Documents may be 

inspected between the hours of 8:00 

a.m. and 5:30 p.m., Monday dirough 

Friday. A reasonable fee may be charged 

for copying. Those wishing to notify 

, EPA of their intent to submit an adverse 

^fs^ comment or request a public hearing 

' should contact Jeff Herzog (313) 668-

„,,.....„„ _., ,".". * ?. . • 4227, U.S. EPA, Office of Mobile SUMMARY: The purpose of this action is r»»~ j , , . - „ . ... 

, .

 v r . , ' :. V^Sources, Fuels and Energy Division, to make minor revisions and corrections^ ____ „. ' ., _ , .

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. , .. . . 

affectine recentlv-nromulgated rules ^ 256 5 ply

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 m attecting recently promulgated rules. . .. ( ^ l d JJ (2fJ2 ) 2 33-9303, 

First, a regulatory prov1Sion included ihf - ^ ^ o f Mob . , e ^^ . ^ ^ 

[ part 79) 

sufficient scheduling flexibility when \ FOR FURTHER INFORMATION CONTACT: For 

test laboratories encounter technical -^ L information related to the registration of 

problems. Second, a provision ^-V,fuels and fuel additives under 40 CFR 

inadvertently omitted from both the par t 79, contact: Joseph Femandes (202) 

Interim Detergent Program and the 233-9756 or James W. Caldwell (202) 

Detergent Certification Program is added 233-9303, U.S. EPA, Office of Mobile 

to the regulations (at 40 CFR part 80). 

The new provision will allow a 

detergent additive manufacturer to 

apply one set of performance 

demonstration tests to multiple 

detergent additive products containing 

the same active ingredients. Finally, aregulatory numbering error and a 

syntactical error affecting the Detergent 

Certification rule are corrected. 

These changes are being implemented 

without prior notice because EPA 

believes that they are not controversial. 

Both of the affected programs serve die 

public health and environmental 

protection goals of the Clean Air Act 

(CAA). The detergent certification 

program is intended to ensure.the 

emission reduction and fuel efficiency 

benefits of gasoline detergent additives. 

The fuel and fuel additive (F/FA) health 

effects testing program is designed to 

determine if die emissions of certain 

gasoline or diesel F/FAs present an 

unacceptable risk to die public health. 

The corrections implemented by today's 

action will facilitate attainment of these 

program objectives by simplifying'the 

regulatory requirements which might 

otherwise pertain to some regulated 

parties. 

DATES: This action will be effective on 

January 17,1997 unless EPA receives an 

adverse comment or a request for a 

pnhlir hparinrj hv ner;emher 18f 1996. If 

EPA receives an adverse comment or 

hearing request by that date, EPA will 

publish timely notice in die Federal 

Register withdrawing this rule. 

ADDRESSES: Materials relevant to this 

rulemaking have been placed in Dockets 

A-90-07 and A-91-77. The dockets are 

Sources, Fuels and Energy Division, 

Mail Code 6406J, 401 M Street, SW., 

Washington, DC 20460. For information 

related to detergent additive 

certification under 40 CFR part 80, 

contact: Jeffrey A. Herzog, U.S. EPA. 

(FED), Office of Mobile Sources, Fuels 

and Energy Division, 2565 Plymouth 

Road,-Ann Arbor, MI 48105. 

SUPPLEMENTARY INFORMATION: 

I. Regulated Entities 

Regulated categories and entities 

potentially affected by this action 

include: 

Category 

Industry 

Examples of regulated entities 

Manufacturers of gasoline and 

diesel fuel. 

Manufacturers of additives for 

gasoline and diesel fuel.' 

This table is not intended to be 

. exhaustive, but rather provides"a guide 

for readers regarding entities likely to be 

regulated by this action. This table lists 

the types of entities diat EPA is now. 

aware could potentially be regulated by 

this action. Other types of entities not 

listed in the table could also be 

regulated. To determine whether your 

entity would be affected by diis actibn, ' 

you should carefully examine this 

preamble and the proposed changes to. ; 

the regulatory text. You should also 

carefully examine the existing 

provisions of die Fuels and Fuel 

Additives Registration Program at 40 

CFR part 79 and the Detergent 

Certification Program at 40 CFR part 80. 

II. F/FA Health Effects Testing Program 

Correction 

A. Background 

In accordance with CAA sections 211 

(a) and (b)(1), EPA issued, in 1975, basic 

registration requirements applicable to 

gasoline and diesel fuels and their 

additives. These regulations require 

manufacturers to submit information oh 

their F/FA products (e.g., commercial 

identity, chemical composition, 

purpose-in-use, and recommended 

range of concentration) in order to have 

such products registered by EPA and to 

be permitted to market them in the U.S. 

Additional registration requirements, 

implementing sections 211 (b)(2) and 

(e), were finalized on May 27,1994 (59 

FR 33042, June 27,1994). These 

regulations require manufacturers, as 

part of tiieir F/FA registration 

responsibilities, to conduct tests and 

submit information on the health effects 

of their F/FA products. Organized 

within a three-tier structure, the 

requirements include detailed emissions 

analysis, literature search, and 

toxicologic studies involving die 

exposure of laboratory animals to F/FA. 

emissions. 

On July 11,1996, EPA published two 

additional Federal Register notices 

concerning the F/FA registration and 

health effects testing requirements. One 

was a Notice of Proposed Rulemaking 

(61 FR 36535) requesting public 

comment on proposed changes designed 

to clarify and streamline a variety of 

organizational, technical, and record 

keeping provisions of the program. The 

second notice (61 FR 36506) was a -

direct final rule which, in die absence 

of adverse public comment prior to 

August 12,1996, implemented several 

other, relatively minor technical 

changes. 

One of the regulatory sections affected 

by the direct final rule was.§ 79.61(d)(5), 

which contains general rules governing 

exposure interruptions during 

toxicologic studies. In changing diis 

section, the intent was to clarify the 

rule's language and to make the 

exposure interruption rules more 

consistent with customary laboratory 

practices. EPA wished to allow 

reasonable flexibility in die scheduling . 

and conduct of these complex studies. 

On the otiier hand, EPA's interest in die 

relative toxicity of different F/FAs 

dictated that controllable sources of. 

variability between tests and test labs 

should be minimized. Thus, as 

discussed in the preamble to the rule, 

EPA expressly intended not to include 

allowances for Federal holidays in the 

exposure rules. It was for this reason 

that the revised language included the 
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FeieirklilRegister /* Vol;61,iNo . 223 7 Monday, November 18, 1996 /Rule s and^.Regulatiohs-: 587-11^* 

constraint that "No more than two nonexposure days may occur consecutively 

during the exposure period, including 

days on which die minimum exposure 

time has not been met." Toxicologic 

studies which did not comply with this 

rule would be considered void. 

B. Today's Action 

EPA now realizes that, as revised, die 

exposure rules are considerably more 

stringent than intended. While the 

prohibition against three consecutive 

non-exposure days does effectively 

disallow holiday.downtime, it may also' 

unreasonably penalize testers who 

unintentionally miss a tiiird consecutive 

exposure day due to technical - - •-

difficulties. This might occur, for 

example, if unexpected equipment 

problems are encountered on a Monday 

after an ordinary two-day weekend off. 

As currently written, the rule does not 

provide a way to remedy such 

occurrences. Thus, studies which are 

otherwise acceptable could become void 

unnecessarily, and large, financial 

expenditures for repeat testing might be 

incurred. 

The revisions finalized today will 

prevent these unintended results. The 

new version still specifies that three 

consecutive non-exposure days are 

normally not permitted. However, if a 

tiiird consecutive day is missed due to 

circumstances beyond the tester's 

control, die rule provides that it may be 

cured by adding a supplementary 

exposure day at the next available 

opportunity or, if necessary, at the end 

of the standard test period. These 

mechanisms should furnish the 

scheduling flexibility needed to address 

equipment and other technical problems 

which arise during die conduct of 

laboratory studies. Nevertheless, 

sufficient regulatory controls are . 

retained to encourage good-faith efforts 

to adhere to regular, test schedules, 

technical procedures, and effective 

preventive maintenance practices. 

It should be noted diat, in instances 

where the exposure requirements of a 

specific test protocol differ from the 

general exposure guidelines finalized 

today, tiien the requirements of the 

specific test protocol take precedence. 

For example, the general exposure 

guidelines do not affect the exposure. 

timing requirement specified in . 

-§ 79.63(e)(4)(iii) of die fertility 

assessment-teratology guideline, which, 

states that pregnant animal subjects 

. "shall be exposed to the test atmosphere 

on each-and every day between (and 

. including) the first and fifteendi day of 

gestation." 

HI. Detergent Additive Program 

Correction 

A. Background 

The final rule establishing the 

Detergent Certification Program was 

published July 5,1996 (61 FR 35309). 

The certification rule modified, and will 

later supersede,1 the existing Interim 

Detergent Program, which was 

published October.14,1994 (59 FR 

54678) and became effective January 1, 

1995. These rules were promulgated in 

compliance with CAA section 211(1), 

which requires all gasoline sold or 

transferred to the consumer beginning 

January 1,1995 to contain additives 

preventing the accumulation of deposits 

in engines or fuel supply systems. The 

.CAA charged EPA with die task of 

establishing specifications for such -

detergent additives. 

The interim detergent program 

requires virtually all gasoline used by 

die consumer to contain effective 

detergent additives for the control of 

port fuel injector deposits (PFED) and 

intake valve deposits (IVD). However, 

the interim program does not include 

specific performance tests and standards 

for the additives. In contrast, the 

detergent certification program requires 

manufacturers to conduct specific 

vehicle-based performance tests, using 

industry-standard test procedures and 

specified test fuels, to demonstrate the 

effective control of IVD and PFID. These 

certification tests are the basis for 

determining the minimum . 

concentration at which a detergent 

additive can be used in gasoline (i.e., 

the lowest additive concentration or 

LAC). 

B. Today's Actions 

1. Multiple Versions of Detergent 

Packages .' 

Detergent additive manufacturers 

commonly produce and market (and 

thus must register under 40 CFR part 79) 

a number of commercial additive 

products containing the same detergentactive ingredient(s) at different 

concentrations. EPA understands diat 

this is a normal business practice, and 

does not believe it is necessary or 

desirable to require the effectiveness of 

each such product variant to be 

demonstrated in separate certification 

tests. As EPA stated in ti e preamble to 

the interim detergent rule: 

. EPA agrees that separate performance tests 

should not be needed for multiple detergent 

additive packages which contain the same 

1

 In general, the requirements of the certification 

program become mandatory for detergentjidditive 

manufacturers and blenders on July 1,1997 and for 

gasoline retailers on August 1,1997. 

active detergent ingredients in different •-

concentrations, provided that the minimum 

recommended treat rate specified in the 

registration information for each additive 

package properly accounts for the variations 

in concentration. Specifically, for each 

registered detergent package which the 

manufacturer intends to support with a 

single set of test data, the final concentration 

of active detergent ingredients (resulting 

when the detergent package is added to 

gasoline at its respective minimum 

recommended treat rate) must be no less than 

the minimum concentrations shown to hie 

effective by'the testing • * .• [SJeparate 

supporting data are needed only .if the actual 

chemical identity of an active detergent 

ingredient is changed. (59 FR 54688-89) 

Thus, it has not been EPA's intent to 

require duplicative certification testing 

for different versions of a particular 

detergent additive package. Through an 

oversight, however, a regulatory 

provision to codify this principle'was 

not included in the interim detergent 

program regulations, nor did such a 

provision appear in die final 

certification program regulations. 

Today's action corrects diese 

unintentional oversights by adding new 

regulatory text at § 80.141(c)(3)(v) and 

§ 80.161(b)(l)(ii)(D). The new regulatory 

provisions permit a detergent additive 

manufacturer to apply one set of 

performance data to multiple detergent 

additive products containing die same 

active ingredients, provided that the 

minimum recommended concentration 

or LAC recorded for each product is 

adjusted accordingly. 

2. Typographical Corrections 

The Federal Register document 

which published the detergent 

certification final rule (61 FR 35309) 

contained a numbering error affecting a 

regulatory provision. Specifically, die 

provision on "Procedures for curing use 

restrictions," which should have been 

labeled as paragraph (9) (nine) in 

§ 80.169(c), was mistakenly labeled as. . 

paragraph (g) in §80.169. In the same 

paragraph, a reference to "this , 

paragraph (g)" should have referred to 

"this paragraph (c)(9)". In addition, the 

title of die paragraph-should have 

appeared in italic ratiier than regular 

type font. These errors are corrected in 

this direct final rule. 

Finally, a syntactical error was made 

in § 80.172(e), which concerns penalties 

related to non-conformity widi the •; 

product transfer document requirements 

of die detergent certification program. In 

paragraph (2) of this section, there is an 

erroneous reference to "gasoline not . -

additized in conformity widi interim 

detergent program requirements," rather 

than a proper reference to "gasoline not 

additized in conformity with detergent 
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' 158746 •^•F^errfi'Sa^i^^fVol.--61,-Na 223 / Monday, November 18, 1996 / Rules and Regulations 

certification prograrh requirefnehts." 

This error is corrected iii this direct 

final rule. 

IV. Administrative Requirements 

A. Administrative Designation and 

Regulatory Analysis 

Under Executive Order 12866 (58 FR 

51735, Oct. 4,1993), the Agency must 

determine whether diis regulatory 

action is "significant" and therefore 

subjectto OMB reyiewand the 

requirements of the Executive Order. 

The order defines "significant . . 

regulatory action'- as any regulatory 

action that is likely to result in a rule 

that may: -•- ••. ^S^-^ksx it* ; 

(1) Have an annual effect on the . 

economy of $100 million.or more or 

adversely affect in a material way the 

economy, a sector of die economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal governments or 

communities; 

(2) Create a serious inconsistency or 

otherwise interfere widi an action taken 

or planned by another ajgency; 

(3) Materially alter the budgetary 

impact of entitlements, grants, user fees, 

or loan programs or the rights and 

' obligations of recipients thereof; or, 

(4) Raise novel legal or policy issues 

arising out of legal mandates, the 

President's priorities, Or the principles 

set forth in the Executive Order. 

Pursuant to the terms of Executive 

Order 12866, EPA has determined that 

this direct final rule is not a "significant 

regulatory action". The regulatory 

corrections included in this notice will 

result in reduction of potential testing 

costs and related compliance burdens. 

B. Regulatory Flexibility Analysis 

EPA has determined that it is not 

necessary to prepare a regulatory 

flexibility analysis iii connection with 

this direct final rule. EPA has 

determined that this rule Will riot have 

a significant adverse economic impact 

on a substantial number of small 

businesses. On the cohtraiy, the 

corrections implemented by tins rule 

will simplify compliance and reduce 

potential testing requirements for all 

affected parties.' .' . . 

C. Paperwork Reduction Act 

The PaperworkReduction Act of 

1980, 44 U.S.C. 3501 et seq/and 

implementing regulations, 5 CFRPart1320, do not apply fothis action as it 

does not involve die collection' of 

information as defined dierein.-. 

D. Unfunded Mandates Reform Act 

Under section 202 of the Unfunded 

Mandates Reform Act of 1995 

("Unfunded Mandates Act"), signed 

into law on March 22,1995, EPA must 

prepare a budgetary impact statement to 

accompany any proposed or final rule 

diat includes a Federal mandate that 

may result in expenditure by State, 

local, and tribal governments, in die 

aggregate; or by the private sector, of 

$100 million or more. Under Section 

205, EPA must select the most cost-

' effective and least burdensome

 v 

alternative that achieves the objectives 

of ti e rule and is consistent widi' 

statutory requirements. Section 203 ".-

requires EPA to establish a plan for .. 

informing and advising any small ''••"''•; 

governments that may be signjficintly 

or uniquely impacted by iienile : Th e 

Agency has determined that the. direct';. 

final rule promulgated today does hot 

include a federal mandate that may 

result in estimated costs of $100 million 

or more to eitiier State, local, or tribal 

] governments in the aggregate, or to the 

private sector. This action does not 

establish regulatory requirements diat -

may significantly or uniquely affect ' \ 

small governments. In fact, tins action 

has the effect of reducing potential 

regulatory burdens. Therefore, the. 

requirements of the Unfunded Mandates 

Reform Act do not apply. 

E. Submission to Congress and the 

General Accounting Office •' 

Under 5 U.S.C, 801(a)(1)(A) as added 

t

 by the Small Business Regulatory 

Enforcement Fairness Act of 1996, EPA 

submitted a report containing this rule 

and otiier required information tp the 

U.S. Senate, the U.S. House of 

Representatives and die Comptroller 

General of the General Accounting 

Office prior to publication of die rule in 

today's Federal Register. This rule is 

not a "major rule" as defined by 5 

U.S.C. 804(2). • . . ;' 

V. Electronic Copies of Rulemaking 

Documents 

Electronic copies of this rule, and 

earlier rulemaking documents related to 

the F/FA Registration Program, the 

Interim Detergent Program, and the 

Detergent Certification Program, are . 

available free of charge on EPA's 

Technology Transfer Network Bulletin 

Board System (TTNBBS) and on the •''• 

Internet. For specific instructions;: •'•-

contact Joseph Femandes at die phone 

. number or address above.'These ' 

documents are also available in the ,. 

public dockets referenced above.-

List of Subjects 

40 CFR Part 79 \ -

Environmental protection, Fuels, Fuel 

additives, Gasoline, Motor vehicle 

pollution, Penalties, Reporting and 

recordkeeping requirements. 

40 CFR Part 80 

Environmental protection, Fuel 

additives, Gasoline detergent additives, 

Gasoline, Motor vehicle pollution, 

Penalties, Reporting and recordkeeping 

requirements. 

Dated: November 7,1996. 

Carol M. Browner, 

Administrator. " '•' 

Eor the reasons set forth in the . 

preamble, parts 79 and 80 of title 40 of 

die Code of Federal Regulations are 

amended as follows: 

PART 79—[AMENDED] 

1. The authority citation for part 79 

continues to read as follows: 

Authority: 42 U.S.C. 7414, 7524, 7545 and 

7601. 

2. Section 79.61 is amended by 

revising paragraph (d)(5) to read as 

follows: 

§79.61 Vehicle emissions inhalation 

exposure guideline. 

* * * * * 

(d)* * * 

(5) Exposure conditions. Unless 

precluded by die requirements of a -

particular test protocol, animal subjects 

shall be exposed to the test atmosphere 

based on a nominal 5-day-per-week 

regimen,.subject to the following rules:. • 

. (i) Each daily exposure must be at 

least 6 hours plus the time necessary to 

build the chamber atmosphere to 90 

percent of the target exposure 

atmosphere. Interruptions of daily 

exposures caused by technical 

difficulties, if infrequent in occurrence 

and limited in duration, may be made 

up die same day by adding equivalent. 

exposure time after the .technical 

problem has been corrected and the . 

exposure atmosphere restored to the . 

required level. 

(ii) Normally, no more tiian two nonexposure days may occur consecutively 

during the test period. However, if a 

third consecutive non-exposure day 

should occur due to circurnstances 

beyond die tester's control, it may be • 

remedied by adding a supplementary 

exposure day. Federal and other' 

holidays do not constitute such •'•••". 

circumstances. Whenever possible, a 

make-up day should be taken at the first • 

qpportunity-.i.e., on die next day which 

would otherwise have been an " 

intentional non-exposure day. If a 

compensatory day must be scheduled at 

the end of the standard test period;then 

it mav occur either: 

II .•-.-"• - ' - - AMm.U^.1 
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Federal Register / Vol. 61, No. 223 / Monday, November 18, 1996 / Rules and Regulations 58747 

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(A) Immediately following die last 

standard exposure day, ividi h o 

intervening non-exposure days; or 

(B) With up to two intervening nonexposure days, provided that no fewer 

than two consecutive compensatory 

exposure days are completed before the 

test is terminated and the animals 

sacrificed.. 

(iii) Except as allowed in paragraph 

(d)(5)(ii)(B) of this section, in no case 

shall there be fewer than four exposure 

days per week at any time during die 

test period. * 

<iv) A nominal 90 day (13-week) 

subchronic test period shall include no 

fewer than 63 total exposure days. '• 

PART 80—{AMENDED] 

1. The authority citation for part 80 

continues to read as follows: 

Authority: 42 U.S.C. 7414. 7545 and 

7601(a). 

2. § 80.141 is amended by adding 

paragraph (c)(3)(v) to read as follows: 

§80.141 Interim detergent gasoline 

program. 

**** * 

(c) * * * 

(3) * * * 

(v) A manufacturer may use a single 

set of test data to demonstrate die 

deposit control effectiveness of more 

than one registered detergent additive 

product, provided that: 

(A) the additive products contain all 

of die same detergent-active ' " •. \. ~~ / 

components and no detergent-active 

components other than tiiose contained 

in common; and . . 

(B) the minimum concentration 

recommended for the use of each such 

additive product is specified such that, 

when each additive product is mixed in 

gasoline at the recommended 

concentration, each of its detergentactive components wiii be present at a 

final concentration no less than the 

lowest concentration for diat cornponent 

shown to be effective by die data 

available for the tested additive product. 

* * * * *•.';.-.• • 

3. § 80.161 is amended by adding 

paragraph (b)(l)(ii)(D) to read.as follows: 

§ 80.161 Detergent additive certification 

program. 

**** * 

(b)* * * 

(D*-* * 

(ii) * * * 

(D) A manufacturer may use a single 

set of certification test data to 

demonstrate the deposit control 

effectiveness of more than one 

registered detergent additive product, 

provided that: 

(1) the additive products contain all of 

the same detergent-active components 

and no detergent-active components 

otiier than those contained in common; 

and 

(2) the minimum concentration 

recommended for die use of each such 

• additive product is specified such that, 

when each additive product is mixed in 

gasoline at die recommended 

concentration, each of its detergentactive components will be present at a 

final concentration no less than the 

lowest concentration of diat component 

which was present when the tested 

additive product met die PFID and IVD 

performance standards specified in 

§80.165. 

§80.169 [Amended] 

4. § 80.169 is amended by 

redesignating paragraph (g) as paragraph 

(c)(9); in newly designated paragraph ' 

(c)(9) introductory text, by revising the . 

reference "diis paragraph (g)" to read 

"this paragraph (c)(9)"; and by 

italicizing die heading of paragraph 

(c)(9). 

5. § 80.172 is amended by revising 

paragraph (e)(2) to read as follows: 

§80.172 Penalties. 

*

 : ' * * * * 

(e) . * * 

(2) The day that gasoline not 

additized in conformity widi detergent 

certification program requirements, as a 

result of the PTD non-conformity, is 

offered for sale or is dispensed to die 

ultimate consumer. 

. * • *• * * * 

[FR Doc. 96-29180 Filed 11-15-96; 8:45 ami 

BILLING CODE 6560-60-P