[Federal Register Volume 61, Number 223 (Monday, November 18, 1996)]
[Rules and Regulations]
[Pages 58744-58747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29180]



[[Page 58743]]

_______________________________________________________________________

Part II





Environmental Protection Agency





_______________________________________________________________________



40 CFR Parts 79 and 80



Regulation of Fuels and Fuel Additives: Minor Revisions; Final Rule

  Federal Register / Vol. 61, No. 223 / Monday, November 18, 1996 / 
Rules and Regulations  

[[Page 58744]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 79 and 80

[FRL-5651-3]


Regulation of Fuels and Fuel Additives: Minor Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: The purpose of this action is to make minor revisions and 
corrections affecting recently-promulgated rules. First, a regulatory 
provision included in the health effects testing requirements for fuel 
and fuel additive registration (at 40 CFR part 79) is revised to ensure 
sufficient scheduling flexibility when test laboratories encounter 
technical problems. Second, a provision inadvertently omitted from both 
the Interim Detergent Program and the Detergent Certification Program 
is added 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, a regulatory 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 the 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 the 
emissions of certain gasoline or diesel F/FAs present an unacceptable 
risk to the 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 public hearing by 
December 18, 1996. If EPA receives an adverse comment or hearing 
request by that date, EPA will publish timely notice in the 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 located at the U.S. 
Environmental 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 through Friday. A reasonable fee may be charged for 
copying. Those wishing to notify EPA of their intent to submit an 
adverse comment or request a public hearing should contact Jeff Herzog 
(313) 668-4227, U.S. EPA, Office of Mobile Sources, Fuels and Energy 
Division, 2565 Plymouth Rd., Ann Arbor, MI 48105 or Jim Caldwell (202) 
233-9303, EPA, Office of Mobile Sources, Fuels and Energy Division, 
Mail Code 6401J, 401 M St. SW., Washington DC 20460.

FOR FURTHER INFORMATION CONTACT: For information related to the 
registration of fuels and fuel additives under 40 CFR part 79, contact: 
Joseph Fernandes (202) 233-9756 or James W. Caldwell (202) 233-9303, 
U.S. EPA, Office of Mobile 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                  Examples of regulated entities   
------------------------------------------------------------------------
Industry..........................  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 that 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 this action, you should carefully 
examine this preamble and the proposed changes to the regulatory text. 
You should also carefully examine the existing provisions of the 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 on 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 their 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 the 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 the 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 Sec. 79.61(d)(5), which contains general rules governing exposure 
interruptions during toxicologic studies. In changing this 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 the scheduling and 
conduct of these complex studies. On the other hand, EPA's interest in 
the 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

[[Page 58745]]

constraint that ``No more than two non-exposure days may occur 
consecutively during the exposure period, including days on which the 
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, the 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 third 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 third 
consecutive day is missed due to circumstances beyond the tester's 
control, the 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 the 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 that, in instances where the exposure 
requirements of a specific test protocol differ from the general 
exposure guidelines finalized today, then the requirements of the 
specific test protocol take precedence. For example, the general 
exposure guidelines do not affect the exposure timing requirement 
specified in Sec. 79.63(e)(4)(iii) of the 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 fifteenth day of gestation.''

III. 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(l), 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 the task of establishing specifications for such 
detergent additives.
---------------------------------------------------------------------------

    \1\ In general, the requirements of the certification program 
become mandatory for detergent additive manufacturers and blenders 
on July 1, 1997 and for gasoline retailers on August 1, 1997.
---------------------------------------------------------------------------

    The interim detergent program requires virtually all gasoline used 
by the consumer to contain effective detergent additives for the 
control of port fuel injector deposits (PFID) 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 detergent-active ingredient(s) at 
different concentrations. EPA understands that 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 the 
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 
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 be 
effective by the testing * * * [S]eparate 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 the final 
certification program regulations. Today's action corrects these 
unintentional oversights by adding new regulatory text at 
Sec. 80.141(c)(3)(v) and Sec. 80.161(b)(1)(ii)(D). The new regulatory 
provisions permit a detergent additive manufacturer to apply one set of 
performance data to multiple detergent additive products containing the 
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, the provision on 
``Procedures for curing use restrictions,'' which should have been 
labeled as paragraph (9) (nine) in Sec. 80.169(c), was mistakenly 
labeled as paragraph (g) in Sec. 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 the paragraph should have 
appeared in italic rather than regular type font. These errors are 
corrected in this direct final rule.
    Finally, a syntactical error was made in Sec. 80.172(e), which 
concerns penalties related to non-conformity with the product transfer 
document requirements of the detergent certification program. In 
paragraph (2) of this section, there is an erroneous reference to 
``gasoline not additized in conformity with interim detergent program 
requirements,'' rather than a proper reference to ``gasoline not 
additized in conformity with detergent

[[Page 58746]]

certification program requirements.'' This error is corrected in 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 this regulatory action is ``significant'' and 
therefore subject to OMB review and 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:
    (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 the 
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 with an 
action taken or planned by another agency;
    (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 in connection with this direct final rule. EPA has 
determined that this rule will not have a significant adverse economic 
impact on a substantial number of small businesses. On the contrary, 
the corrections implemented by this rule will simplify compliance and 
reduce potential testing requirements for all affected parties.

C. Paperwork Reduction Act

    The Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq., and 
implementing regulations, 5 CFR Part 1320, do not apply to this action 
as it does not involve the collection of information as defined 
therein.

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 that includes a Federal mandate that may result in 
expenditure by State, local, and tribal governments, in the aggregate; 
or by the private sector, of $100 million or more. Under Section 205, 
EPA must select the most cost-effective and least burdensome 
alternative that achieves the objectives of the rule and is consistent 
with statutory requirements. Section 203 requires EPA to establish a 
plan for informing and advising any small governments that may be 
significantly or uniquely impacted by the rule. The Agency has 
determined that the direct final rule promulgated today does not 
include a federal mandate that may result in estimated costs of $100 
million or more to either State, local, or tribal governments in the 
aggregate, or to the private sector. This action does not establish 
regulatory requirements that may significantly or uniquely affect small 
governments. In fact, this 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 by the Small Business 
Regulatory Enforcement Fairness Act of 1996, EPA submitted a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives and the Comptroller General of the 
General Accounting Office prior to publication of the 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 
Fernandes at the 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.

    For the reasons set forth in the preamble, parts 79 and 80 of title 
40 of the 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:


Sec. 79.61  Vehicle emissions inhalation exposure guideline.

* * * * *
    (d) * * *
    (5) Exposure conditions. Unless precluded by the 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 the 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 than two non-exposure days may occur 
consecutively during the test period. However, if a third consecutive 
non-exposure day should occur due to circumstances beyond the 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 
opportunity, i.e., on the 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 may occur either:

[[Page 58747]]

    (A) Immediately following the last standard exposure day, with no 
intervening non-exposure days; or
    (B) With up to two intervening non-exposure 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 the 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. Sec. 80.141 is amended by adding paragraph (c)(3)(v) to read as 
follows:


Sec. 80.141  Interim detergent gasoline program.

* * * * *
    (c) * * *
    (3) * * *
    (v) A manufacturer may use a single set of test data to demonstrate 
the deposit control effectiveness of more than one registered detergent 
additive product, provided that:
    (A) the additive products contain all of the same detergent-active 
components and no detergent-active components other than those 
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 
detergent-active components will be present at a final concentration no 
less than the lowest concentration for that component shown to be 
effective by the data available for the tested additive product.
* * * * *
    3. Sec. 80.161 is amended by adding paragraph (b)(1)(ii)(D) to read 
as follows:


Sec. 80.161  Detergent additive certification program.

* * * * *
    (b) * * *
    (1) * * *
    (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 other than those 
contained in common; and
    (2) 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 
detergent-active components will be present at a final concentration no 
less than the lowest concentration of that component which was present 
when the tested additive product met the PFID and IVD performance 
standards specified in Sec. 80.165.
* * * * *


Sec. 80.169  [Amended]

    4. Sec. 80.169 is amended by redesignating paragraph (g) as 
paragraph (c)(9); in newly designated paragraph (c)(9) introductory 
text, by revising the reference ``this paragraph (g)'' to read ``this 
paragraph (c)(9)''; and by italicizing the heading of paragraph (c)(9).
    5. Sec. 80.172 is amended by revising paragraph (e)(2) to read as 
follows:


Sec. 80.172  Penalties.

* * * * *
    (e) * * *
    (2) The day that gasoline not additized in conformity with 
detergent certification program requirements, as a result of the PTD 
non-conformity, is offered for sale or is dispensed to the ultimate 
consumer.
* * * * *
[FR Doc. 96-29180 Filed 11-15-96; 8:45 am]
BILLING CODE 6560-50-P