Page 1 of 8 IUR Petition Review Report June 16, 2005 CASRN and TSCA Inventory Chemical Name: 140 88 5 2 propenoic acid, ethyl ester Alternate Chemical Name Used in Petitions: Ethyl Acrylate Petitioners and Petition Docket Numbers: The Basic Acrylic Monomer Manufacturers, Inc. ( BAMM) OPPT 2004 0008 Dow Chemical Company OPPT 2004 0016 Note: Both petitions contained additional chemicals. These additional chemicals are addressed in other petition review reports.

Summary of Decision: The petition review group recommends a denial for these petitions, as EPA has a current interest in the processing and use information collected under the Inventory Update Reporting ( IUR) rule ( see 40 CFR Part 710) for 2 propenoic acid, ethyl ester ( CASRN 140 88 5). This recommendation is based, in part, on the determination by the petition review group that there is a direct application of the IUR processing and use information to complement data collected by or identified for use under the HPV Challenge Program. See Considerations A, C, D, and E.

Background: EPA received two petitions requesting that 2 propenoic acid, ethyl ester ( CASRN 140 88 5) be added to the 40 CFR 710.46( b)( 2)( iv) list of specific chemical substances which are exempt from the reporting of industrial processing and use and commercial/ consumer use information required by 40 CFR 710.52( c)( 4). The chemical substances included on this " partial exemption" list are substances for which EPA has previously determined that there is a low current interest in the IUR processing and use information. However, as stated in the preamble to the amendment to the IUR rule promulgated on January 7, 2003 ( 68 FR 854), "... the need for processing and use information ... changes over time. The inclusion of a chemical substance under this partial exemption is not based on the potential risks of a chemical. This partial exemption is solely intended to provide a tool to assist the Agency in better managing the collection of processing and use information..." and is also " based on the Agency's current need for collecting IURA processing and use information." ( 68 FR 855) Additionally, the preamble states, " In determining whether there is low current interest in IURA processing and use information related to a specific chemical substance, EPA will look to the specific circumstances surrounding the chemical in question, and may use one or more of the considerations identified below, and/ or considerations not identified below, to make an informed decision." The considerations used by EPA in reviewing these petitions and an analysis of how those considerations relate to the chemical identified in these petitions are set forth below. 1 See the attached list of acronyms at the end of this report.

2 The petition from BAMM, which was dated December 31 2003, indicated that the OECD HPV SIDS documents for this chemical are completed and are expected to be posted on the OECD Web site in January 2004. By the time of the petition review group's review of this petition, the OECD SIDS documents had indeed become available on the OECD Web site.

Page 2 of 8 Discussion: The petition review group considered information submitted with the two petitions, as well as other information including ( but not limited to): whether the petition substance is included in TRI, IRIS, or IARC; OECD HPV SIDS program status; HPV Challenge Program status; and the petition chemical's inclusion in other regulatory programs administered by EPA. 1 The petition from BAMM ( docket number OPPT 2004 0008) referred EPA to the OECD HPV SIDS program documents for this chemical2, and stated that the information provided therein should be sufficient for EPA to make the necessary determination to include this chemical on the list of partially exempt chemicals under the IUR. Additionally, this petition stated that " There is a great deal of information on the basic acrylates use and exposure."

The petition from the Dow Chemical Company ( docket number OPPT 2004 0016) stated that 2 propenoic acid, ethyl ester ( CASRN 140 88 5) has been evaluated as part of the OECD HPV SIDS program with a conclusion of low priority for further work ( within the OECD HPV SIDS program), and therefore, processing and use data comparable to what would be collected under the IUR are currently available.

The petitions did not link information furnished in the petitions to specific considerations cited in 40 CFR 710.46( b)( 2)( ii), but provided general citations, as noted above, to an OECD HPV SIDS review. General citations alone are of limited use in establishing a rationale for adding a chemical to the IUR partial exemption list.

Consideration A: Production volume.

The petition review group found that there was at least one site reporting in 2002 with a production volume for this chemical of 300,000 pounds or greater.

Consideration B: The substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects.

The petitions did not identify specific information from the OECD HPV SIDS review that pertained to Consideration B. The OECD HPV SIDS program SIAP contained summary results of a variety of studies associated with human health and the environment and a conclusion that 2 propenoic acid, ethyl ester ( CASRN 140 88 5) " possesses properties indicating a hazard for human health and the environment" ( Ref. 1). For instance, the SIAP stated that although only slightly acutely toxic to mammals, this chemical is a strong skin and eye irritant, is likely to be a sensitizer, and is acutely toxic to aquatic organisms. The SIAP also indicated that this chemical is not considered to be carcinogenic in experimental animals; however, a 1999 IARC evaluation 3 Risk is composed of hazard and exposure. In order to screen for potential risk in the United States, both hazard data and exposure related data relative to United States situations are needed. Exposure is based upon manufacturing, processing, and use scenarios, all of which change over time as technology and other societal effects change. The changing nature of exposure scenarios means the potential risks associated with a chemical can also change, and therefore the collection of exposure related information over time is fundamental to identifying potential risks. ( See 68 FR 848, 852 for further discussion)

Page 3 of 8 classified this chemical as possibly carcinogenic to humans ( see below). The SIAP reported a conclusion that this chemical " is currently of low priority for further work" ( within the OECD HPV SIDS program).

Additionally, 2 propenoic acid, ethyl ester ( CASRN 140 88 5) has hazard and/ or potential exposure properties which have triggered inclusion in different government programs. For example, this chemical is included in the following programs:

Occupational Safety and Health Administration ( OSHA)  OSHA assigns a standard which " most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life" ( 29 U. S. C. 655( b)). This standard is otherwise known as a Permissible Exposure Limit ( PEL). 2 Propenoic acid, ethyl ester ( CASRN 140 88 5) has an OSHA PEL.

State list of chemicals of concern  2 Propenoic acid, ethyl ester ( CASRN 140 88 5) has been listed by one or more states on at least one state list of chemicals of concern.

International Agency of Research on Cancer ( IARC)  IARC has identified propenoic acid, ethyl ester ( CASRN 140 88 5) as possibly carcinogenic to humans.

Inclusion in these various programs indicates that there are hazard concerns associated with this chemical.

Consideration C: The information needs of EPA, other federal agencies, tribes, states, and local governments, as well as members of the public.

The petition review group found that 2 propenoic acid, ethyl ester ( CASRN 140 88 5) is part of EPA's HPV Challenge Program. The HPV Challenge Program seeks to collect and, where necessary, develop a screening level hazard data set for chemicals produced or imported in large quantities in the United States. EPA plans to screen and, as needed, further assess chemicals included under the HPV Challenge Program. For this purpose, the IUR processing and use information is needed by EPA to put the hazard data into context, complementing the HPV Challenge Program submission by providing EPA with exposure related information. 3 The reporting of IUR processing and use information is needed at least once and, potentially, periodically thereafter to more accurately and realistically gauge potential exposure and provide 4 For additional information on uses of IUR processing and use information, see IURA Data Use Plan, located in EPA's electronic docket OPPT 2002 0054, item number 0261.

5 See the introduction to the EPA's TRI website for further information, at http:// www. epa. gov/ tri/ whatis. htm.

6 The OECD HPV SIDS program, while it is not United States based, is a program where different countries are combining their resources to investigate at least the hazards associated with different chemicals. This allows all of the countries to benefit from this information. The United States can use information collected during and generated by the OECD HPV SIDS program to address domestic issues.

Page 4 of 8 information needed for screening, assessing, and managing exposures and risk. Other important uses of the reported information, even for low hazard chemicals, may include comparative exposure analyses, identification of safer substitutes, or pollution prevention investigations. 4 The petition review group also found that 2 propenoic acid, ethyl ester ( CASRN 140 88 5) is a TRI chemical. Chemicals listed on TRI are of proven interest, not just to EPA, but to the public. 5 Information reported under 40 CFR 710.52( c)( 4) will enhance our knowledge of the types of processes and uses that produce releases of and exposures to these toxic chemicals.

Consideration D: The availability of other complementary risk screening information.

The petitions referred EPA to the OECD HPV SIDS review of 2 propenoic acid, ethyl ester ( CASRN 140 88 5), but did not identify specific information in the OECD HPV SIDS review documents that would address Consideration D. The results of the OECD HPV SIDS review, as documented in the SIAP, indicate that this chemical is considered of low priority for further work ( within the OECD HPV SIDS program) but that this chemical possesses properties indicating a hazard for human health and the environment and that countries may wish to evaluate scenarios not covered in the OECD HPV SIDS program evaluation. 6 This chemical is also included in the HPV Challenge Program, therefore additional hazard data may become available. However, effective risk screening and risk management require both exposure information and hazard information. The availability of hazard information for this substance, coupled with the collection of IUR processing and use information as an indicator of potential exposure, will facilitate a more effective screening of this and other substances based on either exposure or risk, especially to situations within the United States. See Consideration E below for further discussion of the IUR exposure related processing and use information.

Consideration E: The availability of comparable processing and use information.

The petitions referred EPA to the OECD HPV SIDS review documents for this chemical, but did not identify specific information within those documents that addresses Consideration E. The SIAP for this chemical ( dated April 2004) included general information on production volumes for this chemical in Europe and North America, and stated that this chemical is an intermediate for the production of homopolymers and copolymers which are then used in paints, binders, polishes and adhesives. Additionally, the SIAR for 2 propenoic acid, ethyl ester ( CASRN 140 88 5), Page 5 of 8 which is not yet publically available, indicated that loading, unloading and cleaning of tank cars are potential activities that could lead to dermal and inhalation occupational exposure to 2 propenoic acid, ethyl ester ( CASRN 140 88 5), but that consumer exposure is expected to be low.

Although the United States sponsored this OECD HPV SIDS program evaluation, the petition review group recognizes that since exposure scenarios change based on uses and available technology, information quickly becomes outdated and of limited use. Because of this, the relative importance of each use may change or new uses may develop. EPA believes tracking these changes is important. The IUR provides current exposure related processing and use information in the United States every four years. This facilitates tracking changes in use patterns and the identification of new exposure scenarios, which is an important component of risk screening.

Additionally, the IUR contains some exposure related data elements not provided in the OECD HPV SIDS submission, such as data on the function of the chemical in the industrial processing and use category, the NAICS code associated with the use, and the number of potentially exposed workers and the number of sites associated with each use. For commercial and consumer uses, the IUR collects data on the amount of the chemical in various use categories, the concentration of the chemical in the use category, and the likelihood of inclusion in products intended for children. Furthermore, IUR information is updated every four years, is quantitative, and is specific to the United States.

Consideration F: Whether the potential risks for the chemical substance are adequately managed by EPA or another agency or authority.

The petitions did not identify or discuss any risk management actions taken by EPA or another agency or authority with respect to the petitioned chemical. The petitions did not explain why the downstream processing and use information should be of low current interest in light of any such risk management actions.

Other Considerations:

The SIAP noted a conclusion of " low priority for further work" under the OECD HPV SIDS program. A designation of low priority for further work within the OECD HPV SIDS program means that no further hazard testing is needed to meet the purposes of the OECD HPV SIDS program at the time the review was completed. These judgements, however, do not determine the approach that an individual OECD member country must take in considering such a chemical. Rather, the OECD HPV SIDS program assessment is seen as a starting point for assessment in countries. In the United States case, it is a starting point for a screening level risk assessment, for which IUR processing and use information provides screening level exposure information. In the past there have been a number of chemicals identified by the OECD HPV SIDS program as a " low priority for further work," but for which EPA wanted to make a confirmatory priority Page 6 of 8 judgement based on risk   i. e., screening level hazard information based on the OECD HPV SIDS program work plus screening level exposure information based on the United States situation.

Cited Reference: 1) SIAP for 2 propenoic acid, ethyl ester ( CASRN 140 88 5). Dated Jan 2004. Available on the Web at http:// cs3 hq. oecd. org/ scripts/ hpv/ NewSIDS. asp Sources Searched: ( Note: These sources are typically searched or reviewed to gather information presented in the petition review report.)

American Conference of Governmental Industrial Hygienists ( ACGIH) Threshold Limit Values ( TLV TWA). 2003. ACGIH, Cincinnati OH. pp. 12 61.

Agency for Toxic Substances and Disease Registry ( ATSDR) ToxFAQsTM ( Frequently asked questions about contaminants found at hazardous waste sites). Available at http:// www. atsdr. cdc. gov/ toxfaq. html California Air Resources Board List of Toxic Air Contaminant Fact Sheets, available at http:// arbis. arb. ca. gov/ toxics/ tac/ toctbl. htm California EPA, Safe Drinking Water and Toxic Enforcement Act of 1986: List of chemicals known to the State to cause cancer or reproductive toxicity. Listing as of Nov. 14, 2003. Available at http:// www. oehha. ca. gov/ prop65/ CRNR_ notices/ list_ changes/ 111403lsta. html International Agency of Research on Cancer ( IARC) Overall Evaluations of Carcinogenicity to Humans. Available at http:// monographs. iarc. fr/ monoeval/ crthall. html Interagency Testing Committee ( ITC) Priority Testing List. Available at http:// tsca itc. syrres. com/ Chemicals/

National Advisory Committee Acute Exposure Guideline Levels ( AEGLs). Available at http:// www. epa. gov/ oppt/ aegl/ index. htm Organisation for Economic Cooperation and Development ( OECD) Integrated HPV Database, http:// cs3 hq. oecd. org/ scripts/ hpv/ index. asp United Nations Environment Programme ( UNEP) persistent organic pollutants ( POPs), available at http:// www. chem. unep. ch/ pops/ default. html United Nations Environment Programme ( UNEP) Ozone Secretariat, Summary Control Measures, available at http:// www. unep. org/ ozone/ Treaties_ and_ Ratification/ 2B_ montreal_ protocol. asp U. S. EPA Clean Air Act ( CAA) Hazardous Air Pollutants ( HAPs). Available in the Clean Air Act, section 112( b), available at http:// www. epa. gov/ air/ caa/ caa112. txt U. S. EPA. Emergency Planning and Community Right to Know Act Section 313, List of Toxic Chemicals. 2001. Office of Environmental Information, EPA 260 B 01 001, available at http:// www. epa. gov/ tri/ chemical/ chemlist2001. pdf U. S. EPA HPV ( High Production Volume) Challenge Program and Voluntary Children's Chemical Evaluation Program ( VCCEP) Web sites under the EPA Chemical Right to Know Initiative, http:// www. epa. gov/ chemrtk U. S. EPA Integrated Risk Information System ( IRIS) Substance List. Available at http:// www. epa. gov/ iris/ subst/ index. html U. S. EPA. National Recommended Water Quality Criteria: 2002. Office of Water. EPA 822 R 02 047. Available at http:// www. epa. gov/ waterscience/ pc/ revcom. pdf U. S. EPA. 2004 Edition of the Drinking Water Standards and Health Advisories. Office of Water. EPA 822 R 04 005. Page 7 of 8 Available at http:// www. epa. gov/ waterscience/ drinking/ standards/ dwstandards. pdf U. S. EPA Substance Registry System ( SRS). Available at http:// www. epa. gov/ srs/

U. S. Occupational Safety and Health Administration ( OSHA) Permissible Exposure Limits ( PELs), available at http:// www. osha. gov/ SLTC/ pel/ index. html List of Acronyms Page 8 of 8 ACGIH American Conference of Governmental Industrial Hygienists AEGL Acute Exposure Guideline Level ARB Air Resources Board ATSDR Agency for Toxic Substances and Disease Registry CAA Clean Air Act CASRN Chemical Abstract Service Registry Number CICAD Concise International Chemical Assessment Document CPSC Consumer Product Safety Commission EHC Environmental Health Criteria EPA Environmental Protection Agency EU European Union FDA Food and Drug Administration FFDCA Federal Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act GRAS Generally Recognized as Safe HAP Hazardous Air Pollutant HPV High Production Volume HSDB Hazardous Substances Databank IARC International Agency of Research on Cancer ICCA International Council of Chemical Associations IFCS International Forum on Chemical Safety IPCS International Programme on Chemical Safety IRIS Integrated Risk Information System IRPTC International Register of Potentially Toxic Chemicals ITC Interagency Testing Committee IUCLID International Uniform Chemical Information Database IUR Inventory Update Reporting Rule IURA Inventory Update Reporting Rule Amendment NAICS North American Industry Classification System NIOSH National Institute for Occupational Safety and Health OECD Organisation for Economic Cooperation and Development OECD HPV SIDS or OECD HPV SIDS program OECD/ SIDS HPV Chemicals Programme OPP Office of Pesticide Programs OPPT Office of Pollution Prevention and Toxics OSHA Occupational Safety and Health Administration PEL Permissible Exposure Limit POP Persistent Organic Pollutant SIAM SIDS Initial Assessment Meeting SIAP SIDS Initial Assessment Profile SIAR SIDS Initial Assessment Report SIDS Screening Information Data Set SRS Substance Registry System TLV TWA Threshold Limit Value Time Weighted Average TRI Toxics Release Inventory TSCA Toxic Substances Control Act UNEP United Nations Environment Programme VCCEP Voluntary Children's Chemical Evaluation Program


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.  The federal government certainly took more then enough time to figure out what they wanted and I as the consumer should be allowed the chance to at least comment, after all your making a decision that directly effects me in a negative way that I didn't ask you to do nor do I want you to do, I can make my own!

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.  I also would very happily share my great appreciation to what you pricks do for me!

What a great f ng country, so free and yet why do I always feel I'm bent over the barrel.  It's the government who's turning this country to sh*t anyways!  If you could kindly give us six months, it's not much to ask after the Fda took their sweet time....

Sincerely, thanks!

Steve T.


[Federal Register: January 22, 2009 (Volume 74, Number 13)]
[Notices]
[Page 4063]
[DOCID:fr22ja09-82]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59097; File No. SR-FINRA-2008-057]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Update Rule Cross-References and Make Other
Various Non-Substantive Technical Changes to FINRA Rules

Correction

    In notice document E8-30319 beginning on page 78412 in the issue of
Monday, December 22, 2008, make the following correction:
    On page 78412, the subject should read as set forth above.

[FR Doc. Z8-30319 Filed 1-21-09; 8:45 am]

BILLING CODE 1505-01-D


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA, Office of Prevention, Pesticides & Toxic Substances 2. OMB control number b. G None a. 2 0 7 0  0 1 6 7 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. O Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. O Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes O No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. O Three years from approval date b. G Other Specify: / /___

7. Title: Pesticide Registration Fee Waivers 8. Agency form number( s) ( If applicable): EPA ICR # 2147.02 9. Keywords: Pesticides, information collection, pesticide registration 10. Abstract: This information collection will allow the Environmental Protection Agency ( EPA) to process requests for waivers of fees under the Pesticide Registration Improvement Act of 2003 ( PRIA). The ICR covers the collection activities associated with requesting a fee waiver and involves requesters submitting a waiver request, information to demonstrate eligibility for the waiver, and certification of eligibility. Waivers are available for small businesses, for minor uses, and for actions solely associated with the Inter Regional Research Project Number 4 ( IR 4). State and federal agencies are exempt from the payment of fees. This ICR provides burden hour and labor cost estimates for both applicants for fee waivers and EPA employees who process and approve or deny waiver requests.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. O Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1,565 b. Total annual responses 360 1. Percentage of these responses collected electronically 0% c. Total hours requested 10,670 d. Current OMB inventory 21,600 e. Difference  10,930 f. Explanation of difference 1. Program Change 2. Adjustment  10,930 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. X Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. G Recordkeeping b. G Third party disclosure c. O Reporting 1. O On occasion 2. G Weekly 3. G Monthly 4. G Quarterly 5. G Semi annually 6. G Annually 7. G Biannually 8. G Other ( describe) _____________ 17. Statistical methods Does this information collection employ statistical methods?

G Yes O No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Angela F. Hofmann, Director of Regulatory Coordination Phone: 202 564 0258 OMB 83 I 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Angela F. Hofmann, Director Regulatory Coordination Staff ( OPPTS) Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95