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OAR Box 1868 

Prepped by Ollie Stewart 

Document Number: 

15) VII-A-3 

Docket Number: 

A-90-07 

Printed 11/26/2008 8:35:12 AM Sheet 15 of 258 
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ENVIRONMENTAL PROTECTION AGENCY 

Notice of Proposed Rulemaking 

FUELS AND FUEL ADDITIVES 

REGISTRATION REGULATIONSTECHNICAL REVISIONS 

Proposed Changes to Regulatory Text 

(40 CFR Part 79) 
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For the reasons described in the preamble, part 79 of Title 40 of 

the Code of Federal Regulations is proposed to be amended as 

follows: 

1. The authority citation for part 79 is proposed to remain as 

follows: 

Authority: 42 U.S.C. 7414, 7524, 7545 and 7601. 

2. Section 79.2 is proposed to be amended by revising paragraphs 

(d) and (e), and by adding paragraph (k), to read as follows: 

S 79.2 Definitions. 

(d) Fuel manufacturer means any person who, for sale or 

introduction into commerce, produces, manufactures, or imports a 

fuel or causes or directs the alteration of the chemical 

composition of a bulk fuel, or the mixture of chemical compounds in 

a bulk fuel, by adding to it an additive, except that (1) a party 

who adds a quantity of additive(s) amounting to less than 1.0 

percent by volume of the resultant additive(s)/fuel mixture is not 

thereby considered a fuel manufacturer, and (2) a party who 

qualifies as a small business under the criteria in § 79.58(d)(2) 

of this subpart, and who adds an oxygenate compound(s) to fuel is 

not thereby considered a fuel manufacturer. 

(e) Additive means any substance, other than one composed 

solely of carbon and/or hydrogen, that is intentionally added to a 

fuel named in the designation (including any added to a motor 

vehicle's fuel system) and that is not intentionally removed prior 

to sale or use. 

(k) Oxygenate compound means an oxygen-containing, ashless 

organic compound, such as an alcohol or ether, which may be used as 

a fuel or fuel additive. 
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3. Section 79.51 is proposed to be amended by revising paragraphs 

(c) (1) (ii) (A) and (B) to read as follows: 

§ 79.51 General requirements and provisions. 

**** * 

(c) .* * * 

(l)(i) * * * 

(ii) For these, products, the manufacturer must also satisfy 

the requirements and time schedules in either of the following 

paragraphs (c)(1)(ii)(A) or (B) of this section: 

(A) No later than May 27, 1997, all applicable Tier 1 and 

Tier 2 requirements must be submitted to EPA, pursuant to §§ 79.52, 

79.53, and 79.59; or 

(B) No later than May 27, 1997, all applicable Tier 1 

requirements (pursuant to §§ 79.52 and 79.59), plus evidence of a 

contract with a qualified laboratory (or other suitable 

arrangement) for completion of all applicable Tier 2 requirements, 

must be submitted to EPA. For this purpose, a qualified laboratory 

is one which can demonstrate the capabilities and credentials 

specified in § 79.53(c)(1). In addition, by May 26, 2000, all 

applicable Tier 2 requirements (pursuant to §§ 79.53 and 79.59) 

must be submitted to EPA. 

4. Section 79.51 is also proposed to be amended by revising the 

first sentence of paragraph (e) (1) to read as follows: 

S 79.51 General requirements and provisions. 

(e) Inspection of a testing facilitv. (1) A testing 

facility, whether engaged in emissions analysis or health and/or 

welfare effects testing under thes- regulations, s'\a31 permit an 

authorized employee or duly designe • \Jd representat; i of i A at 

reasonable times and in a reasonable manner, to inspect the 

facility and to inspect (and in the case of records also to copy) 

all records and specimens required to be maintained regarding 

studies to which this rule applies. 
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5. Section 79.51 is also proposed to be amended by revising the 

introductory text to paragraph (h) as well as paragraph (h)(1)(ii) 

to read as follows: 

S 79.51 General requirements and provisions. 

(h) Special Requirements for Additives. When an additive is 

the test subject, the following rules apply: 

(1)(ii) Additives belonging to more than one fuel family. 

(A) If an additive product is registered in two or more fuel 

families as of May 27, 1994, then the manufacturer of that additive 

is responsible for testing (or participating in group testing of) 

the respective additive/base fuel mixtures in compliance with the 

requirements of this subpart for each fuel family in which the 

manufacturer wishes to maintain a registration for its additive. 

(B) If a manufacturer is seeking to register such additive in 

two or more fuel families then, for testing and registration 

purposes, the additive shall be considered to be a member of each 

fuel family in which the manufacturer is seeking registration. The 

manufacturer is responsible for testing (or participating in group 

testing of) the respective additive/base fuel mixture in compliance 

with the requirements of this subpart for each fuel family in which 

the manufacturer wishes to obtain a product registration for its 

additive. 
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6. Section 79.51 is also proposed to be amended by adding a new 

paragraph (i)(4), to read as follows: 

S 79.51 General requirements and provisions. 

(i) * * * 

**** * 

(4) The presence in a particular oxygenating additive of small 

amounts of other unintended oxygenate compounds as byproducts of 

the manufacturing process of the given oxygenating additive does 

not affect the grouping of that additive and does not create 

multiple testing responsibilities for manufacturers who blend that 

additive into fuel. 

7. Section 79.52 is proposed to be amended by revising paragraph 

(a) and removing and reserving paragraph (c), to read as follows: 

§ 79.52 Tier 1 

(a) General Specifications. Tier 1 requires manufacturers of 

designated fuels or fuel additives (or groups of manufacturers 

pursuant to § 79.56) to supply to the Administrator: the identify 

and concentration of certain emission products of such fuels or 

additives; and any available information regarding the health and 

welfare effects of the whole and speciated emissions. In addition 

to any information required under § 79.59 and in conformance with 

the reporting requirements thereof, manufacturers shall provide, 

pursuant to the timing provisions of § 79.51(c), the following 

information. 

(b) * * * 

(c) Reserved 

**** * 
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8. Section 79.52 is also proposed to be amended by revising 

paragraphs (b)(1)(iii) and (b)(1)(iv), as well as the introductory 

text to paragraphs (b)(2)(iii)(D) and (b)(2)(iii)(E), to read as 

follows: 

§ 79.52 Tier 1. 

* * * * 

(b) Emissions Characterization. 

**** * 

(1)(iii) Measurement of background emissions: It is required 

that ambient/dilution air be analyzed for levels of background 

chemical species present at the time of emissions sampling (for 

both combustion and evaporative emissions) and that sample values 

be corrected by substracting the concentrations contributed by the 

ambient/dilution air. Background chemical species 

measurement/analysis during the FTP is specified in §§ 86.109-

94(c)(5) and 86.135-94 of this chapter. 

(1)(iv) Concentrations of emission products shall be reported 

either in units of grams per mile (g/mi) or grams per brakehorsepower/hour (g/bhp-hr) (for chassis dynamometer and engine 

dynamometer test configurations, respectively), as well as in units 

of weight percent of measured total hydrocarbons. 

(2)(iii)(D) The analytical method used to measure species of 

PAHs and NPAHs should be capable of detecting at least 1 ppm 

(equivalent to 0.001 microgram (/xg) of compound per milligram of 

organic extract) of these compounds in the extractable organic 

matter. The concentration of each individual PAH or NPAH compound 

identified shall be reported in units of microgram per mile or 

nanograms per brake-horsepower/hour (for chassis dynamometer and 

engine dynamometer test configurations, respectively). Each 

compound which is present at 0.001 /xg per mile (0.5 nanograms per 

brake-horsepower/hour) or jre must be identified, measured, and 

reported. The following individual species shall be measured: 

(2) (iii) (E) The analytical method used to measure specie -- and 

classes of PCDD/PCDFs should be capable of detecting at leas- 1 

part per trillion (ppt) (equivalent to 0.001 picogram (pg) of 

compound per milligram of organic extract) of these compounds in 

the extractable organic matter. The concentration of each 

individual PCDD/PCDF compound identified shall be reported in units 

of picograms (pg) per mile or picograms per brake-horsepower/hour 

(for chassis dynamometer and engine dynamometer test 

configurations, respectively). Each compound which is present at 
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0.5 pg/mile (0.3 pg/bhp-hr) or more must be identified, measured, 

and reported. 

9. Section 79.56 is proposed to be amended by deleting the phrase, 

"heavy oil deposits," from paragraphs (e)(3)(i)(B) and (ii)(B), to 

read as follows: 

S 79.56 Fuel and fuel additive grouping system. 

**** * 

(e) * * ' * 

**** * 

(3)(i)(B) The Non-Baseline Gasoline category is comprised of 

gasoline fuels and associated additives which -w^nform to the 

specifications in paragraph (e)(3)(i)(A) of this section for the 

Baseline Gasoline category except that they contain 1.5 percent or 

more oxygen by weight and/or may be derived from synthetic crudes, 

such as those prepared from coal, shale and tar sands, and other 

non-conventional petroleum sources. 

(3)(ii)(B) The Non-Baseline Diesel category is comprised of 

diesel fuels and associated additives which conform to the 

specifications in paragraph (e)(3)(ii)(A) of this section for the 

Baseline Diesel category except that they contain 1.0 percent or 

more oxygen by weight and/or may be derived from synthetic crudes, 

such as those prepared from coal, shale and tar sands, and other 

non-conventional petroleum sources. 

10. Section 79.56 is also proposed to be amended by deleting the 

phrase "or process" from the introductory text to paragraphs 

(e) (4) (ii) (A. (3) and (B) .3) . and by revising paragraph 

(e)(4)(ii)(A.(3)(ii.. the introductory text to paragraph 

(e)(4)(ii)(B)I21, paragraphs (e)(4)(ii)(B)(2)(i) and (ii), and 

paragraph (e)(4)(ii)(B. (3) (ii) . to read as follows: 

S 79.56 Fuel and iuel additive grouping system. 

(e) * * * 

* * * * * 

(4) * * * 
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****, * 

(ii) * * * 

**** * 

(3.) Separate non-baseline gasoline groups shall also be 

defined for gasoline formulations derived from each particular nonconventional petroleum source. 

(ii) The representative for any such group shall be a fuel 

refined entirely from the applicable synthetic source or, if a 100 

percent synthetic fuel is unfit for engine operation, then the 

representative shall be a fuel refined from the highest percentage 

of synthetic feedstock suitable for operating the relevant engine 

type. The representative fuel may contain a limited complement of 

additives which are essential for the fuel's production and/or for 

the successful operation of the test vehicle/engine throughout the 

mileage accumulation and emission generation periods. Such 

additives shall conform to the additive guidelines prescribed in § 

79.55(b)(2) for gasoline base fuel. 

(B) * * * 

**** * 

(2.) A separate non-baseline diesel group is also defined for 

each of the following classes of oxygenating compounds: mixed 

nitroso- compounds; mixed nitro-.compounds; mixed alkyl nitrates; 

mixed alkyl nitrites; peroxides; furans; mixed alkyl esters of 

plant and/or animal origin ("biodiesel"). In the case of any 

biodiesel fuel group, the representative to be used in testing 

shall be formulated as specified for synthetic diesel fuels in 

paragraph (e)(4)(ii)(B)(3)(ii> of this section. For any other 

diesel groups defined by the listed classes of oxygenating 

compounds, the representative to be used in testing shall be 

formulated as follows: 

(i.) From the class of compounds which defines the group, a 

particular oxygenate compound (or mixture of compounds) shall be 

chosen from among all such compounds recorded for any fuel or 

additive in the group. 

(ii) The selected compound (or mixture) shall be the one 

recorded with the highest actual or recommended maximum 

concentration-in-use for any member product. This compound or 

mixture, when mixed into the diesel base fuel at the indicated 

maximum concentration, shall serve as the group representative. 
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(3_) A separate non-baseline diesel group shall also be 

defined for each diesel fuel derived from a particular synthetic 

petroleum source. 

(ii) The representative for any such group shall be a fuel 

refined entirely from the applicable synthetic source or, if a 100 

percent synthetic fuel is unfit for engine operation, then the 

representative shall be a fuel refined from the highest percentage 

of synthetic feedstock suitable for operating the relevant engine 

type. The representative fuel may contain a limited complement of 

additives which are essential for the fuel's production and/or for 

the successful operation of the test vehicle/engine throughout the 

mileage accumulation and emission generation periods. Such 

additives shall conform to the additive guidelines prescribed in § 

79.55(c)(2) for diesel base fuel. ' 
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11. Section 79.57 is proposed to be amended by revising paragraphs 

(b)(2), and adding new paragraphs (e)(1)(i)(c) and (e)(1)(iii)(A), 

to read as follows: 

S 79.57 Emission generation. 

**** * 

(b)(2)(i) A vehicle or engine may be used to generate 

emissions for the testing of more than one fuel or additive, 

provided that all such fuels and. additives belong to the same fuel 

family pursuant to § 79.56(e)(i), and that, once a vehicle or 

engine has been used to generate emissions for an atypical fuel or 

additive (pursuant to § 79.56(e)(2)(iii)), it shall _ot be used in 

the testing of any other fuel or additive. Sections 79.57(a)(2) 

and (3) shall apply only to the first fuel or additive tested. 

(ii) Prior to being used to generate emissions fcr testing an 

additional fuel or additive, a vehicle or engine which has 

previously been used for testing a different fuel or additive shall 

undergo an effective intermediate preconditioning cycle to remove 

the previously used fuel and its emissions from the vehicle's fuel 

and exhaust systems and from the combustion emission and 

evaporative emission control systems, if any. 

(iii) Such preconditioning shall,include, at a minimum, the 

following steps: 

(A) The canister (if any) shall be removed from the vehicle 

and purged with 300° F nitrogen at 20 liters per minute until the 

incremental weight loss of the canister is less than 1 gram in 30 

minutes. This typically takes 3-4 hours and removes 100 to 120 

grams of adsorbed gasoline vapors. 

(B) The fuel tank shall be drained and filled to capacity 

with the, new test fuel or additive/fuel mixture. 

(C) The vehicle or engine shall be operated until at least 

95% of the fuel tank capacity is consumed. 

(D) The purged canister shall be returned to the vehicle. 

(E) The fuel tank shall be drained and filled to 40% capacity 

with test fuel. 

(F) Two-hour fuel tank heat builds from 72°-120° F shall be 

performed repeatedly as necessary to achieve canister breakthrough. 

The fuel tank must be drained and filled prior to each heat build. 
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(e) * * * 

**** * 

(1)(i)(C) For Tier 2 testing, the engines shall operate on 

repeated bags 2 and 3 of the UDDS or back to back repeats of the 

heavy-duty transient cycle of the EDS. 

l(iii)(A) In the case of combustion emissions generated from 

light-duty vehicles/engines, the samples consist of three bags of 

vapor emissions (one from each segment of the light-duty exhaust 

emission cycle) plus one sample of particulate-phase emissions and 

one sample of semi-volatile-phase emissions (collected over all 

segments of the exhaust emission cycle). If the mass of 

particulate emissions or semi-volatile emissions obtained during 

one driving cycle is not sufficient for characterization, up to 

three driving cycles may be performed and the extracted fractions 

combined prior to chemical analysis. Particulate-phase emissions 

shall not be combined with semi-volatile-phase emissions. The test 

laboratory should focus on the characterization of the limit of 

detection for particulates and semi-volatile emissions. 

12. Section 79.57 is also proposed to be amended by revising 

paragraphs (e)(2)(i), (e)(2)(ii), (e)(2)(ii)(B), (e)(2)(iii), 

(e)(2)(iii)(C), (e) (2) (vi) (B), (e)(2) (vii), (e) (3) (i) , 

(e)(3)(i)(A), and (f)(3), to read as follows: 

(2) Generating whole combustion emissions for biological 

testing, (i) Biological tests requiring whole combustion 

emissions shall be conducted using emissions generated 

from the test vehicle or engine operated in accordance 

with general FTP requirements. 

(ii),Light-duty test vehicles/engines shall be repeatedly 

operated over the Urban Dynamometer Driving Schedule (UDDS) (or 

equivalent engine dynamometer trace, per paragraph (e) (1) (i)'(A) of 

this section) and heavy-duty test engines shall be repeatedly 

operated over the Engine Dynamometer Schedule (EDS) (see 40 CFR 

part 86, appendix I). 

(ii)(B) The UDDS or EDS shall be repeated as many ti. _s as 

required for the biological test session. 

(iii) An apparatus to integrate the large concentration 

swings typical of transient-cycle exhaust is to be used between the 

source of emissions and the exposure chamber containing the animal 

test cages(s). The purpose of such apparatus is to decrease the 

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variability of the biological exposure atmosphere and achieve the 

necessary concentration of CO or N0X, whichever is limiting. 

(iii)(C) The mixing chamber (or any alternative emission 

moderation apparatus) must function such that the average 

concentration of total hydrocarbons leaving the apparatus shall be 

within 10 percent of the average concentration of hydrocarbons 

entering the chamber, taking into account any further intentional 

dilution occurring in the apparatus pursuant to paragraph 

(e)(2)(iv)(C) of this section. 

**** * 

(vi)(B) These procedures include requirements that the mean 

exposure concentration in the inhalation test chamber shall be 

within 10 percent of the target concentration for the single 

species being controlled (established in the development phase of 

testing) on 90 percent or more of exposure days and that daily 

monitoring of CO, C02, N0X, S0X, and total hydrocarbons in the 

exposure chamber shall be required. Analysis of the particle size 

distribution shall also be performed to established the stability 

and consistency of particle size distribution in the test exposure. 

(vii) To allow for customary laboratory scheduling and 

unforeseen problems affecting the combustion emission generation or 

dilution equipment, biological exposures may be interrupted on 

limited occasions, as specified in § 79.61(d)(5). Interruptions 

exceeding these limitations shall cause the affected test(s) to be 

void. Testers shall be aware of concerns for backup 

vehicles/engines cited in paragraph (a)(7)(ii) of this section. 

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(3) * * * 

(i) Salmonella mutagenicity testing, pursuant to § 79.68, 

shall be conducted on extracts of the particulate and semi-volatile 

emission phases separately. These emissions shall be generated by 

operating the test vehicle/engine over the appropriate FTP driving 

schedule .. . 

(A) Particulate emissions shall be collected on particulate 

filters and extracted from the collection equipment for use in 

biological tests. The number of repetitions of the applicable 

driving schedule required to collect sufficient quantities of the 

particulate emissions will vary, depending on the characteristics 

of the engine, the test fuel, and the requirements of the 

biological test protocol. The particulate sample may be collected 

on one or more filters, as necessary. 

(f) * * * 

**** * 

(3) For biological testing, vapor shall be withdrawn from the 

EEG at a constant rate, diluted with air as required for the 

particular study, and conducted immediately to the biological 

testing chamber(s) in a manner similar to the method used in § 

79.57(e), excluding the mixing chamber therein. The rate ofemission generation shall be high enough to supply the biological 

exposure chamber with sufficient emissions to allow for a minimum 

of fifteen air changes per exposure chamber per hour. To allow for 

customary laboratory scheduling and for unforeseen problems with 

the evaporative emission generation or dilution equipment, 

biological exposures may be interrupted on limited occasions, as 

specified in § 79.61(d)(5). Interruptions exceeding these 

limitations shall cause the affected test(s) to be void. 

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13. Section 79.58 is proposed to be amended by revising the last 

sentence of paragraph (d)(1), adding a sentence at the end of 

paragraph (d)(3), and by adding a new paragraph (f) , to read as 

follows: 

§79.58 Special provisions. 

(d) Small Business Provisions. (1) For purposes of these 

provisions, 

Total annual sales means the average of the manufacturer's total 

sales revenue, excluding any revenue which represents the 

collection of federal, state, and/or local excise taxes and/or 

sales taxes, in each of the three years prior to such 

manufacturer's submittal to EPA of the basic registration 

information pursuant to § 79.59(b)(2)-(5) . 

(3) Any fuel manufacturer using an additive which is not 

required to meet the requirements of Tier 2 pursuant to this 

paragraph, shall also not be required to meet the requirements of 

Tier 2 with respect to that additive. 

(f) De minimis Provisions. (1) The manufacturer of an 

atypical additive (pursuant to § 79.56) which meets the criteria in 

paragraph (f) (2) of this section, or the manufacturer of a fuel 

containing such an atypical additive, is not required to meet the 

requirements of Tier 2 (specified in § 79.53) in regard to such 

atypical additive or fuel product. Upon such manufacturer's 

satisfactory completion and submittal to EPA of the basic 

registration data specified in § 79.59(b) and the Tier 1 

information specified in § 79.52 for an atypical fuel or additive, 

the manufacturer may request and EPA shall issue a registration for 

such product, subject to £ 79.51(c) and paragraph (f) (3) of this 

section. Compliance with Tier 1 requirements under this paragraph 

may be accomplished by the individual manufacturer or as a part of 

a group pursuant to § 79.56. 

(2) The special prc/ision described in paragraph (f)(. > of 

this section applies in regard to an atypical additive (or a i-el 

containing such additive) which (i) contains no atypical element(s) 

other than aluminum, boron, calcium, iron, magnesium, phosphorus, 

potassium, sodium, and/or zinc, and (ii) contains these elements in 

an amount such that, when the additive is mixed into the applicable 

base fuel at the highest treatment rate recommended by the additive 

manufacturer, the total of these elements added to the base fuel 

does not exceed 25 ppm (0.0025 percent) by weight. 

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(3) Any registration granted by EPA under the provisions of 

this section are conditional upon satisfactory completion of any 

Tier 3 requirements which EPA may subsequently impose pursuant to 

§ 79.54. In such circumstances, the Tier 3 requirements might 

include (but would not necessarily be limited to) information which 

would otherwise have been required under the provisions of Tier 2. 

14. Section 79.59 is proposed to be amended by adding a new 

sentence to paragraph (b)((5)(ii) to read as follows: 

§ 79.59 Reporting Requirements 

**** * . 

(b)(5)(ii) If the manufacturer claims applicability of any 

small.business provisions pursuant to § 79.58(d), the average of 

the manufacturers total annual sales revenue for the previous three 

years shall be given. Upon written EPA request, the manufacturer 

shall supply supporting documentation. 

15. Section 79.61 is proposed to be amended by revising paragraph 

(d)(5) to read as follows: 

§ 79.61 Vehicle emissions inhalation exposure guideline. 

**** * 

(d) * * * 

**** * 

. (5) Exposure Conditions. The preferred exposure regimen 

consists of exposing the study animals to the test atmosphere on a 

repeated basis for at least 6 hours per day on a 7-day per week 

basis for the exposure period. However, unless precluded by the 

requirements of a particular test protocol, exposures based on a 

nominal 5-day-per-week regimen will, be considered acceptable, 

subject to the following rules: 

(i) Each daily exposure during the exposure period must be at 

least 6 hours plus the time necessary to build the chamber 

atmosphere to 90 percent of the target exposure atmosphere. A day 

in which this minimum exposure time has not been achieved does not 

count as an exposure iey. 

(ii) Nominally, animal exposures should be conducted for six 

hours per day for five days per week. In no case should the 

exposures occur less than four days per week for a total of 65 + 2 

exposure days. 

(iii) 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. 

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16. Section 79.63 is proposed to be amended by inserting a new 

paragraph (e)(4)(iii) to read as follows: 

§ 79.63 Fertility assessment/teratology. 

* * * * * 

(e) * * * 

**** * 

(4) * * * 

(iii) Pregnant females • shall be exposed to the test 

atmosphere on each and every day between (and including) the first 

and fifteenth day of gestation. 

17. Section 79.68 is proposed to be amended by revising paragraphs 

(f)(1) and (f)(5)(vi) to read as follows: 

S 79.68 Salmonella typhimurium reverse mutation assay. 

**** * 

(f) Data and report (1) Treatment of results. Data 

shall be presented as number of revertant colonies per plate, 

revertants per kilogram (or liter) of fuel, and as revertants per 

kilometer (or mile, or brake-horsepower/hour, as appropriate) for 

each replicate and dose. These same measures shall be recorded on 

both the negative and positive control plates. The mean number of 

revertant colonies per plate, revertants per kilogram (or liter) of 

fuel, and revertants per kilometer (or mile, or brakehorsepower /hour) , as well as individual plate counts and standard 

deviations shall be presented for the test substance, positive 

control, and negative control p'.ates. 

(5) * * * 

**** * 

(vi) Individual plate counts, mean number of revertant 

colonies per plate, number of revertants per kilometer (or mile, or 

brake-horsepower/hour), and standard deviation; and 

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