1 IN FORMAT ION COLLECTI ON REQUEST (ICR) Part A of the Supporting Statement 1. ID ENTIFICATION OF THE INFORMATION COLLECTION 1(a) Title: Registration of Fuels and Fuel Additives

- Health

- Effects

Research Requirements for Manufacturers (40 CFR 79

- Subpart F) EPA I CR Number 1696.0 7 , OMB Control Number 2060

- 0297 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 b y 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 o f Subpart F (indicating how the manufacturer plans to satisfy the research requirements, or qualifies for an exemption) are covered b y a separate IC R (EPA I CR Number 309.1 3 , OMB Control Number 2060

- 0150 ). The program is operated by the Compliance Divis ion, 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 w ith 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 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 con clude 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 b y the Eth yl Corporation (now Afton Chemical Corporation), and a blend of die sel 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,2

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 65 0 fuel manufacturers, 1, 3 00 additive manufacturers, 7 5 0 regist ered fuels, and 7 , 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 b y 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, b y 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 b y 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 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 b y the Department of Health, Education, and Welfare in 1970 and transferred to the EPA shortly

thereafter. They

ultimatel y 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 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, heav y oil deposits, coal, tar sands and/or oil sands: (1) Gasoline Baseline Group

- gasoline/additive elements are limited to carbon, hydrogen, ox ygen, nitrogen and sul f

ur (for convenience, hereb y 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 ox ygenate (e.g., ethanol).3

Aty pical Group

- a group is established for each non

- CH ONS 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 sp ecifications. (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 CH ONS, the fuel ox ygen content is 1.0 weight percent or greater, and the fuel meets ASTM specifications. A group is established for each ox ygenate or specified ox ygen ate combinations

. Aty pical 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 establish nonbaseline groups for each gasoline, diesel fuel, and additi ve 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. 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 registratio n, 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 dat a were due b y May 27, 1997, or evidence of a contract that would provide the Tier 2 data b y May 27, 2000. For products currentl y seeking registration, the Tier 2 data are due before registration can occur. (There are several exceptions to the above. Fo r 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 regu lations 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 additive s 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 sul f ur content of gasoline and diesel fuel, have been regulated under this section.4

There are several exceptions to the above, in order to lessen the burden for small businesses. Manufacturers of baseline and/or nonbas eline 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 merel y 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 butylether (ETBE), methyl tertiary butyl ether (MTBE), tertiary am ylmethyl 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 aty pical gasoline groups and five aty

pical diesel groups. In 19 98 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

Emu lsified 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 th e 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 NExBTLRenewable Diesel and Nextfuels, Inc. biodiesel. In 2009 Tier 1 data were submitted for two renewable diesels. In2011

- 2012 Tier 1 data were submitted for 15% ethanol in gasoline, 16% isobutanol in gasoline, four renewable diesel fuels, and three renewable gasolines. On August 20, 1997 the APIwas 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 has been completed, with the exception of some of the TBA testing, which API decided not to complet e . 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 requireme nts 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 investigation or regulatory action could be taken.5

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 d ata 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 gro undwater contamination standpoint, due to leaking storage tanks.
3. NONDUPLICATION, CONSUL TATIONS, AND OTHER COLLECTION CRI TERIA 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 I CR was published on February 20, 2013 (78 FR 11869)

. 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 te sting shall not be considered confidential. Some Tier 1 data, particularly those related to6

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 n o sensitive questions.
4. THE RESPONDENTS AND THE INFORMATION COLLECTED 4(a) Respondents/NAI CS/SI C Codes The fuel and fuel additive manufacturers are related to the following major group North American Industry

Classification Sy stem (NAICS) six

- digit codes and Standard Industrialization Classification (SI C) 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) In formation 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 pas t 30 years for existing information pertaining to health effects, environmental effects, and emissions of the fuel or additive; includes description7

of data bases searched, search period, and summary of relevant information found, including abstracts an d references; 4. Chemical characterization of combustion and evaporative emission products; report on emissions generation procedures, anal yt ic methods, and results. This requirement can be mitigated b y 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 , adul t reproduction/teratogenicity , pulmonary

toxicity , and neurotoxicity for Tier 2, or related negotiated testin g for Alternative Tier 2. This requirement can be mitigated b y 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 anal ys is of Ti er 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 requi rements 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 follow ing 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.8

5. THE INFORMATION COLLECTED

-- AGENCY ACTIVITIES, COL LECTION 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 b y 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 b y the Office of Transportation and Air Quality and the Office of Rese arch 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 rep orts will be available to the public in hard cop y, and, if so submitted, electronicall y. 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 appl y 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 onl y 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 h ave 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 ye ars. However, manufacturers of baseline and nonbaseline products with less than $509

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 category , with an est imated Tier 1 cost of about $ 437 ,000 per product, with about $1 46 ,000 for the literature search and about $2 91 ,000 for the emissions characterization. Estimates from four recent submi ssion s were about $275,000, $ 3 00,000, $ 3 75,000, and $ 475,000
. Thus, we believe that the methodology for the estimate of $437,000 is still appropriate and onl y needs adjustment due to updated labor rates

. The new estimate of $ 392,000 was determined as follows: In discussions with fewer than ten fuel and fuel additive man ufacturers, four labor categories were identified as having involvement: managerial, legal, professional/technical (prof/tech), and clerical. According to the Bureau of Labor Statistics, May 20 11 National Occupational Emplo ym ent and Wage Estimates , mean wages were: Managerial $6 2.19 per hour Legal $ 62.74 per hour Prof/Tech $ 47.81 per hour Clerical $1 5.87 per hour D oubling for company overhead and employing a 2% annual inflation factor to bring the rates to 20 13 , and, for convenience, rounding up to the even dollar, gives the following rates that will be used in this I CR: Total Employer Cost Managerial $ 1 30 per hour Legal $ 1 32 per hour Prof/Tech $ 1 00 per hour Clerical $ 3 4 per hour This is similar to the previous IC R. We believe that the previous hourl y burden estimate is still representative. Worksheet 1: Tier 1 L iterature Search The estimated burden hours and costs are: Activity mgmt legal prof/tech clerical read regs 40/$ 5200 40/$ 528 0 40/$ 4 00 0 40/$1 36 0 obtain data 40/$ 520 0 40/$ 528 0 200/$ 2 0,0 00 200/$ 68 0010

review data 40/$ 520 0 40/$ 528 0 200/$ 2 0,0 00 200/$ 68 00 prepare report and send to EPA 40/$ 520 0 40/$ 528 0 100/$ 1 0,0 00 100/$ 3 4 00 totals 160/$20,08 0 160/$ 2 1,120 540/$ 54,00 0 540/$1 8,36 0 1400/$ 1 14,2 80 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 $2000 for computer maintenance, do cument storage, and shipping of the report and documents to EPA. This research takes less than a year and thus these are annualized costs. Worksheet 2: Tier 1 Emissions Characterization The estimated hours and costs are: Activity mgmt legal prof/te ch clerical read regs 40/$ 520 0 40/$ 528 0 40/$ 4 00 0 40/$ 1 36 0 obtain data 40/$ 520 0 40/$ 528 0 500/$ 50 ,000 500/$ 1 7 ,000 review data 40/$ 520 0 40/$ 528 0 100/$ 1 0,0 0 0 100/$ 3 4 00 prepare report and send to EPA 40/$ 520 0 40/$ 528 0 100/$ 1 0,0 0 0 100/$ 3 4 00 totals 160/$ 20,80 0 160/$ 2 1,12 0 740/$ 74,00 0 740/$2 5,160 1800/$1 41080 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 $ 10 0,000 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 $ 1 1 4, 2 8 0 + $10,000 + $2,000 + $1 41 ,08 0 + $25,000 + $ 10 0,000 = $ 392 , 3 6 0. 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, six nonbaseline gasoline ox ygenates, and the atypi cal gasoline additive MMT. Thus, only atypical products for manufacturers with $10 million or greater in annual revenue, and new nonbaseline products for manufacturers with $50 million or greater in annual revenue, remain that are subject to the standard Tier 2 or Alternative Tier 2 requirements. While EPA has yet to require a Tier 3, it is like ly 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 $ 1.7 million each.11

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/$ 2 080 0 160/$ 2 112 0 160/$1 600 0 160/$ 5 44 0 obtain data 160/$ 2080 0 160/$ 2 112 0 8000/$ 800 000 4000/$1 36 000 review data 160/$ 2080 0 160/$ 2 112 0 800/$ 800 00 800/$ 2 72 00 prepare report and send to EPA 160/$ 2080 0 160/$ 2 112 0 400/$ 4 00 00 400/$1 36 00 totals 640/$ 8320 0 640/$ 8448 0 9360/ 93600 0 5360/$ 1 8224 0 grand total 16000/$1, 285,92 0 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. The research takes about a ye ar and thus these are annualized costs. Thus, the total estimated cost for a Tier 2 submission is $1, 285,92 0 + $150,000 + $250,000 = $1, 685,92 0
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 $ 83,2 00 to the EPA. Costs for storage and public availability will be nominal. 6(d) Estimating the Respondent Universe and Total Burden and Costs As disc ussed, 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. 4 million for each Tier 1 and $1. 7 million for each Tier 2/Alternative Tier 2/Tier 3, for an annual burden of about $ 2. 1 million. The estimated annual EPA burden is $ 83,2 00. 6(e) Bottom L ine Burden Hours and Cost Table Worksheet 4: Annual Industry Burde n12

Activity Number Capital/Start

- up O&M costs Total Hours Total Cost Tier 1 1 $35,000 $ 10 2,000 3,200 $ 392,3 6 0 Tier 2/ 1 $150,000 $250,000 16,000 $1, 685,9 2 0 Alt. 2/T3 Totals 2 $ 18 5,000 $3 5 2 ,00 0 19 ,20 0 $ 2,078,28 0 6(f) Reasons for Change in Burden The API testing 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 3 /21,2 0 0 2 / 19 ,20 0

- 1/

- 2,000 Adjustment (s ee 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 9,600 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 purpos es of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing way s to compl y with any previously applicable instructions and requirements; train personnel to b e 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 prov ided 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 I CR under Docket ID No. EPA

- HQ

- OAR

- 2006

- 0525, which is available for publ ic viewing at the Office of Air and Radiation Docket in the EPA Docket Cent er (EPA/DC), EPA West, Room 3334 , 1301 Constitution Ave., NW, Washington, DC. The EPA Doc ket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday , excluding legal holiday s. 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 sy stem, 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 17th13

Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Dock et ID No. ( EPA

- HQ

- OAR

- 200 6

- 0525 ) and OMB control number (2060

- 0297) in an y correspondence. Part B of the Supporting Statement

- Not Applicable to this I CR