                     INFORMATION COLLECTION REQUEST (ICR)
           Part A of the Supporting Statement (Draft  -  April 2023)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title:	Registration of Fuels and Fuel Additives: Health-Effects
                  Research Requirements for Manufacturers (40 CFR 79 - Subpart F) (Renewal)
			EPA ICR Number 1696.11, OMB Control Number 2060-0297
			Docket ID Number EPA-HQ-OAR-2006-0525

	1(b)	Abstract

	In accordance with the regulations at 40 CFR 79, Subparts A, B, C, D and F (there is no Subpart E), Registration of Fuels and Fuel Additives, manufacturers (includes importers) 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 (EPA ICR Number 309.15, OMB Control Number 2060-0150, expiration date: 3-31-2024).

	The program is operated by the Compliance 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 with evaporative or exhaust emissions that may 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 (1) operation of an engine on the candidate fuel, (2) identification of the emissions  (emissions characterization), and (3) 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 candidate-fuel 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 as 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, 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. Tier 3 requirements are established via a public process comparable to that for Alternative Tier 2. No Tier 3 requirements have been established.

	There are approximately 625 fuel manufacturers, 1,350 additive manufacturers, 1,000 registered fuels, and 9,000 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 that the manufacturer provide certain compositional and related information. It provides EPA with the authority to require health-effects 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, 1998, 2014 and 2020. Due to their broad public emissions exposure, motor vehicle gasoline and diesel fuel, and their additives, were designated.

	The regulations at 40 CFR 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 ASTM International specifications.

      Non-baseline Group - gasoline/additive elements are limited to CHONS, gasoline oxygen content is 1.5 weight percent or greater, and the gasoline meets ASTM International specifications. A group is established for each oxygenate (e.g., ethanol).

      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 International specification, or combination of properties that do not meet ASTM International 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 International specifications.

      Non-baseline Group - diesel/additive elements are limited to CHONS, the fuel oxygen content is 1.0 weight percent or greater, and the fuel meets ASTM International specifications. A group is established for each oxygenate or specified oxygenate combinations.

      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 International specification, or combination of properties that do not meet ASTM International specifications.

	The regulations also establish non-baseline groups 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 animal fats and plant oils. The fuel/additive group is defined by the source.

	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 (exhaust/evaporative for gasoline, exhaust only for diesel) 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.

	There are several exceptions to the above, to lessen the burden for small businesses. Manufacturers of baseline and/or non-baseline products, who have an total annual sales of less than $50 million, are exempt from Tier 1 and Tier 2. Manufacturers of atypical products, who have an total annual sales 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 non-baseline 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. In 2011-2015 Tier 1 data were submitted for 15% ethanol in gasoline, 16% isobutanol in gasoline, seven diesel fuels with renewable content, and eight gasolines with renewable content. In 2016 Alternative Tier 2 data were submitted for16% isobutanol in gasoline. For 2019-2023 four Tier 1s were submitted for renewable gasolines and one Tier 1 for a renewable diesel.

	On August 20, 1997, the API was informed of proposed Alternative Tier 2 requirements for baseline gasoline and the six non-baseline 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 has been completed, except for some of the TBA testing, which API decided not to complete.

	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.

      Per 40 CFR 79.53(d)(1), existing data may be submitted in lieu of Tier 2 or Alternative Tier 2 if it can be demonstrated that such data are "reasonably comparable" to the data that would be obtained from the Tier 2 or Alternative Tier 2 testing.

	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 investigation or regulatory action could be taken.

	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 July 5, 2023.

	3(c)	Consultations

	Information was requested from the following three fuel industry companies:
 A fuel manufacturer
 An industry consultant
 A consulting company to the fuel/additive industry

Discussion of responses:   AAAAA

	3(d)	Effects of Less Frequent Collection

	These are one-time requirements for each fuel or additive unless follow-up research is warranted.

	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 health-effects research shall not be considered confidential. Some Tier 1 data, particularly those related to 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 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 (if Tier 2), 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 "reasonably comparable" 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. No Tier 3 requirements have been established.

      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.

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 links to, or 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 on occasion by 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 of a fuel or fuel additive under 40 CFR 79.

6.	ESTIMATING THE BURDEN AND THE COST OF THE COLLECTION

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

	The pace of Tier 1 submissions has been about one per year for the past four years. 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 non-baseline products with less than $50 million in annual sales are exempt from Tier 1, so there may be continuing registration activity in that area.

      In the previous ICR, with capital/start-up costs included, the estimated Tier 1literature search cost was $136,980, the estimated Tier 1emissions characterization cost was $339,380, and the estimated Tier 2/Alternative Tier 2/Tier 3 cost was $3,220,640.

	The new estimates were 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 2021 National Occupational Employment and Wage Estimates, mean wages were:

Managerial      $59.31 per hour
Legal		$54.38 per hour
Prof/Tech	$44.10 per hour
Clerical	$20.88 per hour

	Doubling for company overhead and employing a 5% annual inflation factor to bring the rates to 2023, and, for convenience, rounding up, gives the following rates that will be used in this ICR:

Total Employer Cost

Managerial 	$135 per hour
Legal		$120 per hour
Prof/Tech	$100 per hour
Clerical 	$  50 per hour

	Our estimates are:

Worksheet 1: Tier 1 Literature Search

	The estimated burden hours and costs are:

Activity		mgmt		legal		prof/tech	clerical

read regs		40/$5400	40/$4800	40/$4000	40/$2000

obtain data		40/$5400	40/$4800 	200/$20000	200/$10000

review data		40/$5400	40/$4800	200/$20000	200/$10000

prepare report
and send to EPA	40/$5400	40/$4800	100/$10000	100/$5000

totals			160/21,600	160/$19,200	540/$54,000	540/$27,000
grand total	1400/$121,800

	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 to EPA. This research takes less than a year and thus these are annualized costs.

Worksheet 2: Tier 1 Emissions Characterization

	The estimated hours and costs are:

Activity		mgmt		legal		prof/tech	clerical

read regs		40/$5400	40/$4800	40/$4000	40/$2000

obtain data		40/$5400	40/$4800	500/$50000	500/$20000

review data		40/$5400	40/$4800	100/$10000	100/$5000

prepare report
and send to EPA	40/$5400	40/$4800	100/$10000	100/$5000

totals			160/$21,600	160/$19,200	740/$74,000	740/$32,000

grand total	1800/$146,800

	Capital/start-up costs are estimated at $150,000 for the purchase of a test engine and computer hardware/software. Operating and maintenance costs are estimated at $150,000 for lease of laboratory space and test equipment. This research takes less than a year and thus these are annualized costs. Thus, the total estimated cost for a Tier 1 submission is $121,800 + $10,000 + $2,000 + $146,800+ $150,000 + $150,000 = $580,600.

	Tier 2/Alternative Tier 2/Tier 3 activity is projected to be very limited. The EPA has concluded that existing data cover Tier 2 for baseline diesel. Alternative Tier 2 covers baseline gasoline, five non-baseline gasoline oxygenates, and the atypical gasoline additive MMT. Thus, only atypical products for manufacturers with $10 million or greater in annual revenue and new non-baseline products, such as gasoline and diesel from renewable sources that haven't already been tested, would be subject to the Tier 2 or 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. The most recent Tier 2 report was submitted 20 years ago. The most recent Alternative Tier 2 report was submitted six years ago. Since, manufacturers have been able to rely on existing Tier 2 and Alternative Tier 2 reports. We believe that it is very unlikely that additional Tier 2/Alternative 2 testing, which involves animal exposure to vehicle emissions, will be necessary. However, as a placeholder, below is our estimate for one Tier 2/Alternative Tier 2/Tier 3 report over the next three years, at an estimated annualized cost of about $3.3 million.

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		320/$43200	  320/$38400	   320/$32000		320/$16000

obtain data		320/$43200	  320/$38400	   16000/$1600000 	8000/$400000

review data		320/$43200	  320/$38400	   1600/$160000	1600/$80000

prepare report
and send to EPA	320/$43200	  320/$38400	    800/$80000		800/$40000

totals			1280/$172,800  1280/$153,600  18720/$1,872,000 	10720/$536,000

grand total	32000/$2,734,400

	Capital/start-up costs are estimated at $300,000 for the purchase of a test engine, animals, cages/related equipment, and computer hardware/software. Operating and maintenance costs are estimated at $300,000 for the lease of laboratory space and test equipment, and animal supplies. The research takes about a year and thus these are annualized costs. The total estimated cost for a Tier 2/Alternative Tier 2/Tier 3 report is $2,734,400 + $300,000 + $300,000 = $3,334,400. Since we estimate one report for the next three years, a third of the above will be used in the annual burden discussed below.

	6(c)	Estimating Agency Burden and Cost

	It is estimated that the EPA will expend about one-quarter of a Full Time Equivalent (FTE) annually, allocated among several professionals, for the activities listed in section 5(a). Assuming $100 per hour, for government salary and overhead at the professional level, gives an annual cost of $52,000 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. There may be three Tier 1 submissions and one Tier 2/Alternative Tier 2/Tier 3 submissions over the next three years, at an estimated cost of $0.6 million for each Tier 1 and $3.3 million for each Tier 2/Alternative Tier 2/Tier 3, for an annual burden of about $2 million. The estimated annual EPA burden is $93,600.

	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		$160,000		$152,000	3,200		   $580,600

Tier 2/		0.33		$100,000		$100,000	10,667		$1,111,467
Alt. 2/T3

Totals		1.33		$260,000		$252,000	13,867		$1,692,067

	6(f) 	Reasons for Change in Burden

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

Previous	Requested	Change	Reason

2/35,200	1.33/13,867	-.67/-21,333	Significantly reduced need for animal testing.

	6(g)	Burden Statements

	Burden Statement:  The annual public reporting and recordkeeping burden for this collection of information is estimated to average 10,426 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 Air and Radiation Docket in the EPA Docket Center (EPA/DC), WJC 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<PHONE_NUMBER>, and the telephone number for the Office of Air and Radiation Docket is<PHONE_NUMBER>). 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