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INFORMATION COLLECTION REQUEST (ICR)

Part A of the Supporting Statement

 

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title: Registration of Fuels and Fuel Additives: Health-Effects

Research Requirements for Manufacturers (40 CFR part 79, subpart F)

EPA ICR Number 1696.06, OMB Control Number 2060-0297

1(b) Abstract

In accordance with the regulations at 40 CFR part 79, subparts A, B, C, D and F (there is 

no Subpart E), Registration of Fuels and Fuel Additives, manufacturers of (1) motor vehicle 

gasoline, (2) motor vehicle diesel fuel, and (3) additives for those fuels, are required to have their 

products registered by the Environmental Protection Agency (EPA) prior to their introduction 

into commerce. Registration involves providing (1) a chemical description of the fuel or 

additive, (2) certain technical and marketing information, and (3) certain health-effects 

information. Periodic reports on production and related information are required. Subpart F

requires the conduct of health-effects research. This ICR addresses the information collection 

requirements of that research. The information collection requirements of Subparts A through D, 

and the supplemental notification requirement of Subpart F (indicating how the manufacturer 

plans to satisfy the research requirements, or qualifies for an exemption) are covered by a 

separate ICR (OMB Control Number 2060-0150). 

The program is operated by the Transportation and Regional Programs Division, Office 

of Transportation and Air Quality, Office of Air and Radiation. The information developed by

the health-effects research will be used to identify products whose evaporative or exhaust 

emissions pose a particular threat to public health, thus meriting further investigation and/or 

regulation. Manufacturers of similar products are allowed to group in order to share the research 

costs. Several groups, also known as consortiums, have been formed. The largest consortium, 

organized by the American Petroleum Institute (API), represents most of the manufacturers of 

conventional gasolines, diesel fuels, and additives. The regulations define the fuel/additive 

categories for which the research is required. There are three tiers of requirements. Tier 1 

requires an emissions characterization (combustion, and in certain instances, evaporative) and a 

literature search over the past 30 years for health-effects information on those emissions. Tier 2 

(also known as standard Tier 2) requires short-term inhalation exposures of laboratory animals to 

emissions (combustion, and if required under Tier 1, evaporative) to screen for adverse health 

effects. The EPA has the authority to require “Alternative Tier 2" testing if there is a reasonable 

basis to conclude that such testing is more appropriate. The EPA reached that conclusion with 

respect to gasoline and gasoline-oxygenate blends. The API consortium was notified of the 

proposed alternative requirements in 1997. After public review and comment, and discussions 

with API, the alternative requirements were finalized and API notified in 1998. Similar 

situations existed for a manganese gasoline additive known a MMT, manufactured by the Ethyl

Corporation (now Afton Chemical Corporation), and a blend of diesel fuel and water, known as 

PuriNOx, manufactured by the Lubrizol Corporation. Tier 3 provides for follow-up research. 

Tier 3 can be required when uncertainties as to the significance of observed health effects, 
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welfare effects, and/or emissions exposures from a fuel or fuel/additive mixture interfere with 

EPA’s ability to make reasonable estimates of the potential risks posed by the emissions from 

such products. 

There are approximately 500 fuel manufacturers, 1,000 additive manufacturers, 700 

registered fuels, and 6,700 registered additives. These numbers change daily.

2. NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

Motor vehicles comprise a major source of air pollution in urban areas, and account for 

about half the toxic air emissions in the United States. Congress demonstrated its strong concern 

for the protection of public health by providing broad legislative authority to monitor and 

regulate fuels, fuel additives, and their emissions. This registration program was established by 

the Air Quality Act of 1967, carried forward into the Clean Air Act (Act) of 1970, and 

strengthened in the Act’s 1977 and 1990 reauthorizations.

Section 211(a) of the Act provides EPA with the authority to designate, by regulation, 

any mobile source fuel or additive for registration. Any fuel or additive used to such an extent 

that there is, or would be, significant public emissions exposure, is an appropriate candidate. 

Once designated, it may not be introduced into commerce until it has been registered by EPA. 

Section 211(b) requires, for the purpose of registration, that the manufacturer provide certain 

compositional and related information. It provides EPA with the authority to require healtheffects testing and the submittal of health-effects data and related data. Section 211(e), a 1977 

amendment, made the health-effects research requirements mandatory. The original regulations 

were promulgated by the Department of Health, Education, and Welfare in 1970 and transferred 

to the EPA shortly thereafter. They ultimately resided at 40 CFR 79 and were revised in 1975, 

1976, 1978, 1994, 1996, 1997 and 1998. Due to their broad public emissions exposure, motor 

vehicle gasoline and diesel fuel, and their additives, were designated.

The regulations at 40 CFR part 79, subpart F, promulgated on May 27, 1994, require 

research for each of the following fuel/additive groups whose components are derived from 

conventional petroleum, heavy oil deposits, coal, tar sands and/or oil sands:

(1) Gasoline

Baseline Group - gasoline/additive elements are limited to carbon, hydrogen, oxygen, 

nitrogen and sulfur (for convenience, hereby referred to as CHONS), gasoline oxygen 

content is less than 1.5 weight percent, and the gasoline meets the American Society for 

Testing and Materials (ASTM) specifications.

Nonbaseline Group - gasoline/additive elements are limited to CHONS, gasoline oxygen 

content is 1.5 weight percent or greater, and the gasoline meets ASTM specifications. A 

group is established for each oxygenate (e.g., ethanol).
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Atypical Group - a group is established for each non-CHONS element (e.g., manganese), 

combination of non-CHONS elements, property that does not meet ASTM specification, 

or combination of properties that do not meet ASTM specifications. 

(2) Diesel

Baseline Group - diesel/additive elements are limited to CHONS, the fuel oxygen content 

is less than 1.0 weight percent, and the fuel meets ASTM specifications. 

Nonbaseline Group - diesel/additive elements are limited to CHONS, the fuel oxygen 

content is 1.0 weight percent or greater, and the fuel meets ASTM specifications. A 

group is established for each oxygenate. An exception is biodiesel, which is one group, 

even though it consists of mixed alkyl esters of plant and/or animal origin. 

Atypical Group - a group is established for each non-CHONS element (e.g., iron), 

combination of non-CHONS elements, property that does not meet ASTM specification, 

or combination of properties that do not meet ASTM specifications.

The regulations also require research for each gasoline, diesel fuel, and additive group 

that is derived in whole or in part from sources other than those mentioned above, such as shale, 

used oil, and waste plastics. The fuel/additive group is defined by the source. Research is also 

required for fuels that do not meet ASTM specifications.

The research is structured into three tiers of requirements for each group. Tier 1 requires 

an emissions characterization and a literature search for the health effects of those emissions. 

For products registered as of May 27, 1994, the Tier 1 data were due by May 27, 1997. For 

products currently seeking registration, the Tier 1 data must be submitted before the product can 

be registered. Tier 2 requires short-term inhalation exposures of laboratory animals to emissions 

to screen for adverse health effects. For products registered as of May 27, 1994, the Tier 2 data 

were due by May 27, 1997, or evidence of a contract that would provide the Tier 2 data by May 

27, 2000. For products currently seeking registration, the Tier 2 data are due before registration 

can occur. (There are several exceptions to the above. For biodiesel products, the Tier 1 

deadline was March 17, 1998, and the Tier 2 deadline was May 27, 2000. For atypical products, 

the Tier 2 deadline for evidence of a contract was November 27, 1998, with the Tier 2 data due 

by November 27, 2001.) The regulations also allow EPA to establish Alternative Tier 2 

requirements in lieu of standard Tier 2, if warranted. Follow-up studies, if required, would occur 

under Tier 3. 

The objective of the program is to determine if there are any fuels and/or additives whose 

evaporative emissions or products of combustion pose a particular danger to public health or 

welfare. Section 211(c) of the Act provides EPA with the authority to regulate such fuels and 

additives. For example, the use of lead additives in gasoline, gasoline volatility, and the sulfur 

content of gasoline and diesel fuel, have been regulated under this section. 
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There are several exceptions to the above, in order to lessen the burden for small 

businesses. Manufacturers of baseline and/or nonbaseline products, who have an annual sales 

revenue of less than $50 million, are exempt from Tier 1 and Tier 2. Manufacturers of atypical 

products, who have an annual sales revenue of less than $10 million, are exempt from Tier 2. 

There are less burdensome provisions for the manufacturers of aerosol additives. Manufacturers 

who merely re-label a registered product are not subject to Tier 1, Tier 2 and Tier 3.

In 1994 the API formed a consortium of the major fuel and additive manufacturers. In 

1997 it submitted Tier 1 data for baseline gasoline, baseline diesel, and six nonbaseline gasoline 

groups (di-isopropyl ether (DIPE), ethanol, ethyl tertiary butyl ether (ETBE), methyl tertiary

butyl ether (MTBE), tertiary amyl methyl ether (TAME), and tertiary butyl alcohol (TBA)). Tier 

2 data were submitted for baseline diesel. In 1997 a consortium submitted information for 

aerosol additive manufacturers. In 1997 Tier 1 data were submitted for two atypical gasoline 

groups and five atypical diesel groups. In 1998 and 2000, Tier 1 and Tier 2 data were submitted 

for biodiesel, respectively. In 2000 and 2002, Tier 1 and Tier 2 data were submitted for summer 

PuriNOx, an emulsion of water and diesel. In 2003 Tier 1 data were submitted for Clean Fuels 

Technology Emulsified Diesel Fuel. In 2005 Tier 1 data were submitted for an iron-based diesel 

additive known as CleanBoost. In 2006 Tier 1 data were submitted for the cerium-based diesel 

additive Envirox, a mixture of ethanol and diesel fuel known as O2Diesel, and the diesel additive 

Green Plus 850. In 2007 Tier 1 data were submitted for Renewable Diesel Mixtures, Green Plus 

851, and a mixture of ethanol, diesel and biodiesel. In 2008 Tier 1 data were submitted for 

NExBTL Renewable Diesel and Nextfuels, Inc. biodiesel. In 2009 Tier 1 data were submitted 

for two renewable diesels.

On August 20, 1997 the API was informed of proposed Alternative Tier 2 requirements 

for baseline gasoline and the six nonbaseline gasoline groups for which Tier 1 data were 

submitted. After public notice and comment, and discussions with API, the alternative 

requirements were finalized, and API was notified on November 2, 1998. Notice was published 

in the Federal Register. The research is nearing completion. 

In 1994 the Ethyl Corporation (Ethyl) was informed that Alternative Tier 2 testing would 

be required for its manganese additive MMT and alternative requirements were proposed in a 

January 25, 1999 letter to Ethyl and announced in the Federal Register. These requirements 

were finalized in a May 11, 2000 letter to Ethyl and announced in the Federal Register. The 

research has been completed.

Alternative Tier 2 requirements were also established for winter PuriNOx. The 

procedure as described above was followed and the data were submitted in 2003.

2(b) Practical Utility/Users of the Data

These health-effects data will allow decision makers to assess the relative risks of the 

fuel/additive groups described above. Should areas of concern be identified for certain products,

further regulatory action could be taken. 
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The data may also be used by non-EPA organizations, such as fuel/additive producers 

and trade organizations, to review a product’s potential toxicity, exposure, or registration status, 

to determine whether the submittal of further information would be duplicative, or to contact 

producers to use the registration already granted and share in the cost of previous compliance. 

Public interest and environmental organizations may review the data and perform their own 

evaluations. Laboratories may review the test reports for guidance on sound laboratory practices 

and data generation. Academic and medical experts may use the information in research or to 

compare with independent findings. State and local agencies responsible for protecting the 

public health may find these data to be of interest. The California Environmental Protection 

Agency assessed the use of oxygenates in gasoline, not only from an emissions standpoint, but 

also from a groundwater contamination standpoint, due to leaking storage tanks.

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a) Non-duplication

To our knowledge, this is the only program which requires the manufacturers of motor 

vehicle fuels and fuel additives to develop emissions health-effects data. The regulations allow 

manufacturers of similar products to group and test one representative of the group, thus 

minimizing duplicative testing.

3(b) Public Notice

A Federal Register notice requesting public comment on this ICR was published on 

September 9, 2009 (74 FR 46422). No comments were received. 

3(c) Consultations

Burden estimates were discussed in general with less than 10 parties.

3(d) Effects of Less Frequent Collection

These are one-time requirements for each product.

3(e) General Guidelines

All Office of Management and Budget (OMB) guidelines are met.

3(f) Confidentiality

 Section 211(b)(2)(B) of the Act requires that the results of the Tier 2 health-effects 

testing shall not be considered confidential. Some Tier 1 data, particularly those related to 
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composition, could be claimed as confidential and would be subject to EPA’s freedom of 

information provisions at 40 CFR 2.

3(g) Sensitive Questions

There are no sensitive questions.

4. THE RESPONDENTS AND THE INFORMATION COLLECTED

4(a) Respondents/NAICS/SIC Codes

The fuel and fuel additive manufacturers are related to the following major group North 

American Industry Classification System (NAICS) six-digit codes and Standard Industrialization 

Classification (SIC) four-digit codes:

324110 - Petroleum Refineries

2911 - Diesel Fuels Manufacturing

2911 - Gasoline Made in Petroleum Refineries

324119 - All Other Petroleum and Coal Products Manufacturing

2999 - Oil-based Additives Made From Refined Petroleum

325110 - Petrochemical Manufacturing

2865 - Benzene, Olefins, Toluene, and Xylene

2869 -Butane

325193 - Ethyl Alcohol Manufacturing

2869 - Ethanol

4(b) Information Requested

(i) Data Items

The following is required to be submitted for each fuel and additive subject to the Tier 1 

requirements (40 CFR 79.52):

1. Name of the manufacturer and name of the fuel or additive;

2. Group/consortium identification;

3. Literature search over the past 30 years for existing information pertaining to health 

effects, environmental effects, and emissions of the fuel or additive; includes description 
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of data bases searched, search period, and summary of relevant information found, 

including abstracts and references;

4. Chemical characterization of combustion and evaporative emission products; report on 

emissions generation procedures, analytic methods, and results. This requirement can be 

mitigated by adequate existing information obtained during the literature search in item 3. 

The full report(s) summarized in item 3 would be required.

The following is required to be submitted for each fuel and additive subject to the Tier 2 

or Alternative Tier 2 requirements (40 CFR 79.53):

1. Name of the manufacturer and name of the fuel or additive;

2. Group/consortium identification;

3. Results of subchronic, 90-day, inhalation exposure of lab animals to combustion 

emissions, and in separate testing, if applicable, to evaporative emissions, for screening 

of general toxicity, carcinogenicity, mutagenicity, adult reproduction/teratogenicity, 

pulmonary toxicity, and neurotoxicity for Tier 2, or related negotiated testing for 

Alternative Tier 2. This requirement can be mitigated by adequate existing information 

obtained during the literature search of Tier 1. The full report(s) summarized in Tier 1 

would be required.

The following is required to be submitted for each fuel and additive subject to the Tier 3 

requirements (40 CFR 79.54):

1. Name of the manufacturer and name of the fuel or additive;

2. Group/consortium identification;

3. Results of follow-up testing to resolve uncertainties identified upon analysis of Tier 1 

and/or Tier 2/Alternative Tier 2 data. The test requirements will be established through 

notice and comment and negotiation with the manufacturer(s). The burden will likely be 

comparable to that for Tier 2 testing.

See 40 CFR 79.59(c) for the detailed documentation requirements of the Tier 1, Tier 2, 

and Alternative Tier 2 reports. See 40 CFR 79.59(d) for the detailed documentation 

requirements for a Tier 3 report. There are no recordkeeping requirements.

(ii) Respondent Activities

The following activities are required:

1. Read or hear the regulations at 40 CFR 79, Subpart F;

2. Obtain the required data;

3. Review the data;

4. Prepare the required report(s);

5. Send the report(s) to EPA.
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5. THE INFORMATION COLLECTED--AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT

5(a) Agency Activities

The following activities are required:

1. Respond to inquiries on the Tier 1, Tier 2, Alternative Tier 2, and Tier 3 requirements;

2. Provide copies of the regulations;

3. Review the Tier 1, Tier 2, Alternative Tier 2, and Tier 3 reports;

4. Upon completion of a review, notify the submitter that the report is adequate, or, if it is 

inadequate, notify the submitter of the deficiencies;

5. Establish public access to the test results, as required by the Act, while maintaining the 

confidentiality of data so entitled;

6. Store the reports.

5(b) Collection Methodology and Management

The reports will be reviewed by the Office of Transportation and Air Quality and the 

Office of Research and Development. The quality of the data will be determined by

professionals knowledgeable with emissions and health-effects testing. The review will be 

manual. The nature of the reports makes them unsuitable for automatic data processing. The 

reports will be available to the public in hard copy, and, if so submitted, electronically. They 

will be stored in the format submitted.

5(c) Small Entity Flexibility

As discussed in section 2(a), certain small businesses are exempt from some or all of 

these requirements.

5(d) Collection Schedule

There is no schedule. The requirements apply when a manufacturer applies for 

registration.

6. ESTIMATING THE BURDEN AND THE COST OF THE COLLECTION

6(a) and (b) Estimating Respondent Burden and Costs

Due to the costs, it is likely that only limited additional Tier 1 research will be done. 

Future fuels and additives subject to Tier 1 will almost exclusively be those that can group with 

existing Tier 1 data, and likely will come from manufacturers who have already paid for the Tier 

1 data. Thus, it is estimated that there will only be one Tier 1 submission per year over the next 

three years. However, manufacturers of baseline and nonbaseline products with less than $50 
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million in annual revenue are exempt from Tier 1, so there will be continuing registration activity

in that area.

In the previous ICR, it was concluded that the few new products for which a new Tier 1 

would be required are likely to be in the atypical or nonbaseline categories, with an estimated 

Tier 1 cost of about $350,000 per product, with about $100,000 for the literature search and 

about $250,000 for the emissions characterization. Estimates from three recent submitters were 

about $200,000, $775,000, and $2 million. Thus, we believe that a new estimate of about 

$437,000 is now appropriate. 

The $437,000 estimate was determined as follows:

In discussions with fewer than ten fuel and fuel additive manufacturers, four labor 

categories were identified as having involvement: managerial, legal, professional/technical 

(prof/tech), and clerical. According to the Bureau of Labor Statistics, May 2008 National 

Industry-Specific Occupational Employment and Wage Estimates, mean wages were:

Managerial $60.42 per hour

Legal $84.56 per hour

Prof/Tech $60.05 per hour

Clerical $17.34 per hour

Doubling for company overhead beyond and employing a 2% annual inflation factor to 

bring the rates to 2009, and, for convenience, rounding up to the even dollar, gives the following 

rates that will be used in this ICR:

Total Employer Cost

Managerial $124 per hour

Legal $174 per hour

Prof/Tech $124 per hour

Clerical $ 36 per hour

This is a broader cost-per-hour range that in previous estimates for this ICR. We believe 

that the previous hourly burden estimate is still representative, on average.

Worksheet 1: Tier 1 Literature Search

The estimated burden hours and costs are:

Activity mgmt legal prof/tech clerical

read regs 40/$4960 40/$6960 40/$4960 40/$1440

obtain data 40/$4960 40/$6960 200/$24,800 200/$7200
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review data 40/$4960 40/$6960 200/$24,000 200/$7200

prepare report

and send to EPA 40/$4960 40/$6960 100/$12,400 100/$3600

totals 160/$19,840 160/$27,840 540/$66,960 540/$19,440 1400/$134,080

Capital/start-up costs for the literature search are estimated at $10,000 for the purchase of 

computer hardware/software for recording the search and the purchase of filing cabinets for 

storage. Operating and maintenance costs are estimated at $2000 for computer maintenance, 

document storage, and shipping of the report and documents to EPA. This research takes less 

than a year and thus these costs are annualized costs.

Worksheet 2: Tier 1 Emissions Characterization

The estimated hours and costs are:

Activity mgmt legal prof/tech clerical

read regs 40/$4960 40/$6960 40/$4960 40/$1440

obtain data 40/$4960 40/$6960 500/$62,000 500/$18,000

review data 40/$4960 40/$6960 100/$12,400 100/$3600

prepare report

and send to EPA 40/$4960 40/$6960 100/$12,400 100/$3600

totals 160/$19,840 160/$27,8400 740/$91,760 740/$26,6400 1800/$166080

Capital/start-up costs are estimated at $25,000 for the purchase of test engines and 

computer hardware/software. Operating and maintenance costs are estimated at $100,000 for 

lease of laboratory space and test equipment. Thus, the total estimated cost for a Tier 1 

submission is $134,080 + $10,000 + $2,000 + $166,080 + $25,000 + $100,000 = $437,160. 

Standard Tier 2/Alternative Tier 2/Tier 3 activity also will be very limited. The EPA has 

concluded that existing data cover Tier 2 for baseline diesel. Alternative Tier 2 covers baseline 

gasoline, the six major nonbaseline gasoline oxygenates, and the atypical gasoline additive 

MMT. Thus, only atypical products for manufacturers with $10 million or greater in annual 

revenue, and new gasoline oxygenates for manufacturers with $50 million or greater in annual 

revenue, remain that are subject to the standard Tier 2or Alternative Tier 2 requirements. While 

EPA has yet to require a Tier 3, it is likely to have a burden similar to that for Tier 2/Alternative 

Tier 2. EPA estimates that there will be three standard Tier 2/Alternative Tier 2/Tier 3 

submittals over the next three years, at an estimated annualized cost of about $2 million each. 
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Worksheet 3: Tier 2/alternative Tier 2/Tier 3 Inhalation Research

The estimated hours and costs are:

Activity mgmt legal prof/tech clerical

read regs 160/$19840 160/$27840 160/$19840 160/$5760

obtain data 160/$19840 160/$27840 8000/$992000 4000/$144000

review data 160/$19840 160/$27840 800/$99200 800/$28800

prepare report

and send to EPA 160/$19840 160/$27840 400/$49600 400/$14400

totals 640/$79360 640/$111360 9360/1160640 5360/$192960

grand total 16000/$1,544,320

Capital/start-up costs are estimated at $150,000 for the purchase of animals, cages/related 

equipment, and computer hardware/software. Operating and maintenance costs are estimated at 

$250,000 for the lease of laboratory space and test equipment, and animal supplies. Thus, the 

total estimated cost for a Tier 2 submission is $1,544,320 + $150,000 + $250,000 = $1,944,320

It is estimated that API will spend $450,000 per year, including $20,000 per year in 

capital/start-up (C/S) costs and $30,000 per year in operating and maintenance (O&M) costs, 

over the next three years in conducting its Alternative Tier 2 animal testing. Subtracting C/S and 

O&M costs from the $450,000 leaves $400,000, and assuming an average of $200 per hour for 

labor and benefits for this specialized Alternative Tier 2 animal research, results in an annual 

burden of 2,000 hours. It is assumed that API will submit one report per year. The reasons for 

the C/S and O&M costs are the same as in the previous paragraph for Tier 2 inhalation research.

6(c) Estimating Agency Burden and Cost

It is estimated that the EPA will expend about one-half of a Full Time Equivalent (FTE) 

annually, allocated among several professionals, for the activities listed in section 5(a). 

Assuming $80 per hour, for government salary and overhead at the professional level, gives an 

annual cost of $83,200 to the EPA. Costs for storage and public availability will be nominal.

6(d) Estimating the Respondent Universe and Total Burden and Costs

As discussed, it is anticipated that Tier 1 and standard Tier 2/Alternative Tier 2/Tier 3 

activities will be very limited, with three Tier 1 submissions and three Tier 2/Alternative Tier 

2/Tier 3 submissions over the next three years, at an estimated cost of $0.44 million for each Tier 
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1 and $1.95 million for each Tier 2/Alternative Tier 2/Tier 3, for an annual burden of about $2.4

million. Adding $0.45 million per year for API gives an annual industry burden estimate of 

$2.85 million. The estimated annual EPA burden is $83,200.

6(e) Bottom Line Burden Hours and Cost Table

Worksheet 4: Annual Industry Burden

Activity Number Capital/Start-up O&M costs Total Hours Total Cost

Tier 1 1 $35,000 $102,000 3,200 $437,160

Tier 2/ 1 $150,000 $250,000 16,000 $1,944,320

Alt. 2/T3

API 1 $20,000 $30,000 2,000 $450,000

Totals 3 $205,000 $382,000 21,200 $2,831,480

6(f) Reasons for Change in Burden

The API testing program has reduced activity as it nears completion. The Afton test 

program has been completed. Other activities are estimated to be at about the same level.

Worksheet 5: Change in Burden - Annual Responses/Annual Hours

Previous Requested Change Reason

4/30,150 3/21,200 1/8,950 Adjustment (see paragraph 6(f)) 

6(g) Burden Statements

Burden Statement: The annual public reporting and recordkeeping burden for 

this collection of information is estimated to average 7,067 hours per response. Burden means 

the total time, effort, or financial resources expended by persons to generate, maintain, retain, or 

disclose or provide information to or for a Federal agency. This includes the time needed to 

review instructions; develop, acquire, install, and utilize technology and systems for the purposes 

of collecting, validating, and verifying information, processing and maintaining information, and 

disclosing and providing information; adjust the existing ways to comply with any previously

applicable instructions and requirements; train personnel to be able to respond to a collection of 

information; search data sources; complete and review the collection of information; and 

transmit or otherwise disclose the information. 

To comment on the Agency's need for this information, the accuracy of the provided 

burden estimates, and any suggested methods for minimizing respondent burden, including the 

use of automated collection techniques, EPA has established a public docket for this ICR under 

Docket ID No. EPA- HQ-OAR-2006-0525, which is available for public viewing at the Office of 
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Air and Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 

Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is 

open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 

telephone number for the Reading Room is (202) 566-1744, and the telephone number for the 

Office of Air and Radiation Docket is (202) 566-1742). An electronic version of the public 

docket is available through www.regulations.gov. Use this site to submit or view public 

comments, access the index listing of the contents of the public docket, and to access those 

documents in the public docket that are available electronically. Once in the system, select 

“search,” then key in the docket ID number identified above. Also, you can send comments to 

the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th 

Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA 

Docket ID No. (EPA-HQ-OAR-2006-0525) and OMB control number (2060-0297) in any 

correspondence. 

Part B of the Supporting Statement - Not Applicable to this ICR