[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.
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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:
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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.
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\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.
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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]
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