Detailed Information on the
EPA Chemical Risk Review and Reduction Assessment

Program will develop a biomonitoring performance measure with NHANES data from the Center for Disease Control or other biomonitoring data (NATA) for chemicals of concern.

Risk Screening Environmental Model will be updated annually to reflect updated TRI data to ensure performance measures are updated within 2 years that rely on TRI data.

Complete design of ChAMP document management system and successfully track and maintain records through second quarter FY 2009

Develop long-term and annual performance measures to reflect risk-based recommendations for HPV Chemicals

Measure: Cumulative Reduction in the production adjusted risk based score of releases and transfers of toxic chemicals from manufacturing facilities.

Explanation:This measure tracks EPA's cumulative progress in reducing existing and new chemical risks. The measure is based on the Risk Screening Environmental Indicator (RSEI) model, which calculates a risk index based on releases of the Toxic Release Inventory (TRI) chemicals. The measure is normalized to account for changes in production in the manufacturing sector. Baseline: TRI Results through 2003 show there has been a 6.8% reduction in the RSEI index from 2001-2003. The 2001 baseline was selected because of changing TRI reporting thresholds for persistent, bioaccumulative, toxic chemicals that took effect in 2001. These changes significantly affect the RSEI model, making comparisons with prior years inappropriate. A consistent set of chemicals can be used from 2001 forward. Updates to the RSEI model in 2008 include changes in air dispersion assumptions and methodology. These updates impact the calculation of actual results. The actual figure for 2006 (as calculated in 2008 based upon the two year data lag from industry) takes into account this new methodology which is under consideration for approval by OMB.

Measure: Reduction in the current year production-adjusted risk-based score of releases and transfers of toxic chemicals from manufacturing facilities.

Explanation:This measure tracks EPA's annual progress in reducing existing and new chemical risks. The measure is based on the Risk Screening Environmental Indicator (RSEI) model, which calculates risk index based on releases of Toxic Release Inventory (TRI) chemicals. The measure is normalized for changes in production. Baseline: Utilizing revised TRI data, there has been a 6.8% reduction in the RSEI index from 2001-2003. The 2001 baseline was selected because of changing TRI reporting thresholds for persistent, bioaccumulative and toxic chemicals that took effect in 2001. These changes significantly affect the RSEI model, making comparisons with prior years inappropriate. A consistent set of chemicals can be used from 2001 forward. Updates to the RSEI model in 2008 include changes in air dispersion assumptions and methodology. These updates impact the calculation of actual results. The actual figure for 2006 (as calculated in 2008 based upon the two year data lag from industry) takes into account this new methodology which is under consideration for approval by OMB.

Measure: Percent of new chemicals or organisms introduced into commerce that do not pose unreasonable risks to workers, consumers, or the environment.

Explanation:This measure analyzes previously reviewed Premanufacturing Notice (PMN) chemical reviews with incoming Toxic Substances Control Act (TSCA) 8(e) notices of substantial risk. TSCA requires that chemical manufacturers, importers, processors and distributors notify EPA within 30 days of new information on chemicals that may lead to a conclusion of unreasonable risk to human health or the environment. Information from approximately 30 8(e) notices each year is used to check accuracy of New Chemicals analytical tools and to make process improvements for future review of new chemicals. The baseline was developed from a 2 year analysis from 2004-2005 comparing 8(e) reports to PMN submissions. This analysis is conducted on an annual basis.

Measure: Reduction in cost of managing Premanufacture Notice (PMN) submissions through the Focus Meeting as a percentage of baseline year cost.

Explanation:This measure tracks the annual percentage reduction in cost of managing PMN submissions through the stage called the Focus Meeting from the baseline year cost. The program expects substantial cost savings as a result of automation of the PMN submission and review process. The savings is from the reduction of the need to sort and process paper-based PMN submissions and the ability to search and retrieve new submissions electronically. This is a new measure generated in 2007 which will first be reported on in 2010. The baseline was developed from the total annual cost of $459,800 to process and search New Chemical PMN submissions. EPA contractors account for 1/3 of the baseline cost, and EPA employees are 2/3 of the baseline cost.

Measure: Annual number of chemicals with final values for Acute Exposure Guideline Levels (AEGL).

Explanation:This measure tracks the annual number of chemicals for which final AEGL values have been developed. AEGL values are short-term exposure limits for a wide range of extremely hazardous substances and are used by first responders in chemical emergencies. AEGLs help to deal with threats of chemical terrorism and assists with homeland security. Baseline from program initiation in 1996 through 2008 is 37 chemicals. The baseline was developed through 2008 because 2008 was the first year that a targeted effort to complete final AEGL values as opposed to proposed AEGL values was initiated. The Universe of chemicals is the same as for the proposed AEGLs, 287 chemicals.

Measure: Cumulative number of chemicals for which proposed values for Acute Exposure Guideline Levels (AEGL) have been developed.

Explanation:This measure tracks the number of chemicals for which AEGL values have been proposed. AEGLs are short term exposure limits applicable for a wide range of extremely hazardous substances and are used by first responders in a chemical emergency. These values also assist with the ability to deal with threats of chemical terrorism and assists with Homeland Security. AEGLs can be used by first responders after being proposed. Proposed chemicals go on to interim and final status. Beginning in FY 2009, the program will focus more on developing final AEGLs as the development of proposed AEGLs nears completion. The baseline from 1996, the first year of the program, through 2002 is 78 chemicals with proposed AEGL values. After September 11, 2001, EPA received a substantial increase in funding for this activity which has remained consistent since this time.

Measure: Annual number of chemicals with proposed values for Acute Exposure Guideline Levels (AEGL).

Explanation:This measure tracks the number of chemicals for which AEGL values have been proposed. AEGLs are short term exposure limits applicable for a wide range of extremely hazardous substances and are used by first responders in a chemical emergency. These values also assist with the ability to deal with threats of chemical terrorism and assists with Homeland Security. AEGLs can be used by first responders after being proposed. Proposed chemicals go on to interim and final status. Beginning in FY 2009, the program will focus more on developing final AEGLs as the development of proposed AEGLs nears completion. The baseline from 1996, the first year of the program, through 2002 is 78 chemicals with proposed AEGL values. After September 11, 2001, EPA received a substantial increase in funding for this activity which has remained consistent since this time.

Measure: Percent reduction from baseline year in total EPA cost per chemical for which proposed Acute Exposure Guideline Levels (AEGL) value sets are developed.

Explanation:This measure tracks the annual percent reduction from the baseline year in total EPA cost per chemical for each AEGL value set. The costs include both EPA employee and contract costs and is adjusted for inflation with 2006 as the base year. Reductions in cost per AEGL value are expected to result from improvements and efficiencies in the program. While our 2007 result is substantially higher due to increasing number of AEGLs produced as a result of backlog of chemicals which were not completed in 2006, we anticipate that results for 2008-2011 should be more in line with projected targets. The baseline of $38,178 is the cost to develop one AEGL, averaged over two years from 2005-2006. This cost is for both EPA employees and contractors who contribute to developing the AEGL values.

Measure: Reduction in PFOA, PFOA precursors, and related higher homologue chemicals in facility emissions by PFOA Stewardship program participants.

Explanation:Perfluorooctanoic Acid (PFOA) is a chemical that is extremely persistent in the environment and low levels of PFOA have been found in the blood of the general population. The long term goal of the PFOA stewardship initiative is to reduce PFOA emissions by 95% by 2010 and work towards eliminating PFOA from product content and facility emissions by 2015. Each of the eight companies who are participating will be held to this standard for both their domestic and global operations. Baseline: Zero percent reduced as of 2004. In the baseline report, companies picked year closest to 2000 for which they have available data. Data is compiled and analyzed on a two year data lag.

Measure: Cumulative reduction in the production-adjusted risk-based score of releases and transfers of High Production Volume (HPV) chemicals from manufacturing facilities.

Explanation:This measure shows the percent reduction of chronic human health risk from environmental releases of HPV chemicals in commerce since 1998. This measure compares the trends in the Risk Screening Indicator Model (RSEI) -- which calculates a risk index based on releases of the Toxic Release Inventory chemicals -- and chemicals produced in excess of 1 million pounds a year. The baseline is 1998 because this was the first year for the HPV program and the start of data collection. Targets were not established for this measure until 2004, however, a 13% reduction has been observed from 1998-2003. Updates to the RSEI model in 2008 include changes in air dispersion assumptions and methodology. These updates impact the calculation of actual results. The actual figure for 2006 (as calculated in 2008 based upon the two year data lag from industry) takes into account this new methodology which is under consideration for approval by OMB.

Measure: Annual reduction in the production-adjusted risk based score of releases and transfers of High Production Volume (HPV) chemicals from manufacturing facilities.

Explanation:This measure shows the annual percent reduction of chronic human health risk from environmental releases of HPV chemicals in commerce since 1998 to support the same long term measure. Because this measure is new, the program did not set targets for the years 1999-2003. Based on preliminary data, targets can be set for 2004 and 2005, with actual data available in July 2007. The baseline is 1998 because this was the first year for the HPV program and the start of data collection. Targets for this measure were established in 2004, however, a 13% reduction has been observed from 1998-2003. Updates to the RSEI model in 2008 include changes in air dispersion assumptions and methodology. These updates impact the calculation of actual results. The actual figure for 2006 (as calculated in 2008 based upon the two year data lag from industry) takes into account this new methodology which is under consideration for approval by OMB.

Measure: Annual number of High Production Volume (HPV) chemicals with Risk Based Prioritizations (RBPs) completed through the Chemical Assessment and Management Program (ChAMP).

Explanation:The Office of Pollution Prevention and Toxics (OPPT) is moving forward in implementing its Security Prosperity Partnership (SPP) commitments and is utilizing data from Hazard Characterization Reports to complete RBPs under the Chemical Assessment and Management Program (ChAMP). These RBPs are the end product for HPV chemicals through the SPP initiative. With no additional resources devoted to the SPP initiative in FY 2008 and FY 2009, the program is striving to continue to move forward while recognizing the inherent trade offs that limited resources present. Most importantly, this measure captures the ultimate product which the public sees for the ChAMP program and the Security Prosperity Partnership Initiative outlined by President Bush in August 2007. Baseline is zero as of 2007 because the ChAMP program was formalized following up on SPP commitments in 2008. The universe of chemicals receiving risk based prioritizations is approximately 2,750 chemicals.

Measure: Annual number of Moderate Production Volume (MPV) chemicals with Hazard Based Prioritizations completed through the Chemical Assessment and Management Program (ChAMP).

Explanation:This measure tracks Hazard Prioritization Reports completed for MPV chemicals assessed under the Chemical Assessment and Management Program (ChAMP). MPV chemicals are produced above 25,000 pounds per year but less than 1,000,000 pounds per year. Prioritizations assess hazard and fate information from MPV and supporting analogue chemicals to prioritize future chemical management actions. Baseline is zero as of 2007 because the Chemical Assessment and Management Program (ChAMP) program was formalized following up on Security and Prosperity Partnership (SPP) commitments in 2008. The universe of MPV chemicals through the ChAMP program is approximately 4,000 chemicals.

Is the program purpose clear?

Explanation: Element 1 EPA's Chemical Risk Review and Reduction (CRRR) program is authorized under the Toxic Substances Control Act (TSCA) and is charged with identifying and managing "unreasonable risks" to human health and the environment associated with the production, importation, processing, distribution, use and disposal of chemicals in U.S. commerce. There are two major components to this effort. The New Chemicals Program (NCP) reviews and manages the potential risks of chemicals before they enter commerce. The Existing Chemicals Program (ECP) reviews and manages the risks of chemicals already in commerce -- chemicals that are already on the TSCA Inventory. The NCP requires anyone who plans to manufacture or import a new chemical substance to provide EPA with a notice before initiating the activity. Notices may take the form of a premanufacture notice (PMN) or an exemption request. PMNs must include known information on the chemical's physical/chemical properties, uses, hazards and exposures and have a 90-day review period. Exemption requests have similar reporting requirements and have a 30- or 45-day review period. During the PMN or exemption request review period, EPA assesses a chemical's prospective risks and if necessary imposes conditions, including health or environmental testing, protective equipment, use restrictions, release restrictions, etc., on the manufacture, processing, and use of a new chemical before it enters into commerce. The ECP takes a variety of steps to assess and mange the risks of chemicals already in commerce. These steps are similar to those taken in the NCP but given its prospective nature and the time constraints its review process, the NCP operates in a more truncated fashion. Key steps in ECP's risk review and reduction process include: ?? Problem identification ?? Information collection, development and dissemination ?? Hazard, exposure and risk assessment ?? Risk management through regulatory or voluntary action It should be noted that NCP risk review and reduction activities are initiated by the submission of a new chemicals notice while similar ECP activities are initiated at EPA's discretion as specific concerns are identified through the receipt of new information or some other mechanism. The CRRR program's purpose is clear and unambiguously understood as evidenced by the following: ?? Toxic Substances Control Act [A]; ?? Large numbers of submissions in response to program requirements (e.g., the submission of more than 44,000new chemicals notices [B] as well as 16,000 self-initiated TSCA §8(e) substantial risk notices [C] submitted since 1977); ?? High demand for chemical hazard [D], exposure [E] and risk information [F] developed by the program; ?? Requests for program actions by entities other than the Office of Pollution Prevention and Toxics (OPPT) [G]; ?? Exceedingly high participation rates by the chemical industry, and others, in voluntary programs [D] [F]; ?? The chemical industry's compliance with a variety of types of TSCA-based regulatory actions including new chemical consent agreements, information collection regulations, test rules and Enforceable Consent Agreements; and ?? Congressional testimony [H].

Evidence: A. TSCA Section 1 - 15 U.S.C. 2601 (intent of TSCA) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite:+15USC2601 B. New Chemicals website, www.epa.gov/oppt/newchems/. C. TSCA 8e Notices of Substantial Risk website; http://www.epa.gov/opptintr/tsca8e/ D. High Production Volume Challenge Program website http://www.epa.gov/chemrtk/index.htm E. Inventory Update Rule website http://www.epa.gov/oppt/iur/ F. Voluntary Children's Chemical Evaluation Program website http://www.epa.gov/chemrtk/vccep/index.htm G. Interagency Testing Committee website http://www.epa.gov/oppt/itc/ H. Testimony Before the Senate environments and Public Works Committee: http://epw.senate.gov/hearing_statements.cfm?id=260423

Does the program address a specific and existing problem, interest, or need?

Explanation: Element 1 The NCP is intentionally designed to ensure that chemical substances introduced into U.S. commerce do not pose an unreasonable risk to human health or the environment [A]. Since the enactment of TSCA in 1976, NCP has reviewed more than 33,000 PMNs. Nearly 1,800 of these chemicals were regulated, and an additional 1,700 were withdrawn by industry, usually in the face of regulation. Approximately 21,000 of the reviewed chemicals have entered into commerce, and have been added to the TSCA Inventory. Additionally, the Agency has received about 11,200 exemption requests under TSCA section 5(h)(4) that have been approved for entry into commerce subject to the provisions of the exemption. The ECP also addresses both a specific problem and need. In 1976, there were 62,000 chemicals on the TSCA Inventory (i.e., already in commerce). Since then, chemicals that have entered the market after NCP review have been added and the TSCA Inventory now includes over 83,000 chemicals [B]. Existing chemicals pose a specific problem if their production, importation, processing, distribution, use or disposal generates an 'unreasonable risk' to human or environmental health. ECP uses a variety of tools (see Question 1.5) to assist in identifying and preventing unreasonable risks to human health and the environment. Risks range from acute risks (rendering them amenable for use in acts of terror or other threats to Homeland Security) to longer-term chronic risks (contributing to increased rates of diseases such as cancer, birth defects, childhood learning disorders, endocrine disruption, etc.). Working together to achieve reliable CRRR, NCP and ECP concentrate their efforts on ensuring a sustainable and prosperous future by protecting human health and the environment. Element 2 EPA continues to receive and review approximately 1,300 new chemical submissions (PMNs and exemption requests) each year. NCP also continues to encourage development of safer chemical substances by minimizing regulatory burdens on new chemicals that can replace riskier substances already in the marketplace and publicly honoring producers of innovative substances through the Pollution Prevention (P2) Recognition Project [C, D, E]. The Sustainable Futures Project [F] provides a mechanism for companies to conduct pre-screening on chemicals using EPA's models, resulting in expedited NCP reviews. New information about existing chemicals continually emerges. The need for information on the risks of these industrial chemicals, and the strategies and actions needed to manage them has increased over the last two to three years as chemicals such as polybrominated diphenylethers (PBDEs) [G], PFOA, perfluorooctanesulfonic acid (PFOS)[H], and nanotechnology have received national and international attention. CRRR activities include the following: ?? An average of 300 TSCA 8(e) self-initiated substantial risk notices continue to be received by OPPT each year since 1996 [I]. ?? The HPV Challenge Program has resulted in information on thousands of chemicals, now being made public and used by the ECP to prioritize its work. The ECP is using data collected under the HPV Challenge Program to develop Hazard Assessments on HPV chemicals. [Ex. December 2004 status report on HPV] [J] ?? External (non-OPPT) entities continue to request that the program develop chemical testing data (e.g., TSCA Section 4 chemical test rules on numerous chemicals of interest). [K] ?? There are new assessment and management challenges presented by the emerging issue of nanotechnology. EPA is working collaboratively with stakeholders both domestically and internationally to address industrial chemical nanoscale materials.[L] [M] CRRR program involvement in the Stockholm Convention, Rotterdam Convention, and other international fora ensures that US data and expertise are available to support international risk-based decisions on chemicals.[N]

Evidence: A: TSCA, Section 2 (Findings, Policy and Intent) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite:+15USC2601 B: TSCA Inventory http://www.epa.gov/opptintr/newchems/pubs/invntory.htm C: Chemicals P2 Recognition Project www.epa.gov/oppt/newchems/pubs/p2.htm D: NPPTAC Recommendation to EPA to Integrate Pollution Prevention Across EPA and Within OPPT http://www.epa.gov/oppt/npptac/pubs/recommendationp220050713.pdf E: Page 11 of the PMN Form http://www.epa.gov/oppt/newchems/pubs/pmnpart2.pdf F: Sustainable Futures Website http://www.epa.gov/oppt/newchems/pubs/sustainablefutures.htm G: PBDEs Website http://www.epa.gov/oppt/pbde/ H: PFOA Website http://www.epa.gov/oppt/pfoa/ I: 8(e) Website www.epa.gov/oppt/tsca8e/index.htm J: HPV Website www.epa.gov/hpv K: Chemical Testing Website www.epa.gov/oppt/chemtest/pubs/vision.htm L: Nanotechnology Website www.epa.gov/oppt/nano/nano-facts.htm M: OECD Website www.oecd.org/home/0,2987,en_2649_201185_1_1_1_1_1,00.html N: Stockholm Convention Website http://www.pops.int/

Is the program designed so that it is not redundant or duplicative of any other Federal, state, local or private effort?

Explanation: TSCA provides EPA with comprehensive authority to regulate the production, importation, processing, distribution, use and disposal of chemical substances (i.e., authority to control the entire life cycle of a chemical). Certain chemicals are not covered under TSCA, including: pesticides; tobacco/tobacco products; firearms and ammunition; food, food additives, drugs, or cosmetics, etc. TSCA provides EPA with the statutory authority to collect information, require the development of needed data, and the ability to ban or limit production or impose other requirements [A]. No other Federal or non-Federal program has a purpose similar to that of the TSCA ECP and NCP. Programs established by other government agencies to implement various environmental and public health laws concerning chemicals generally address a specific scope (e.g., exposures in the workplace or through use of consumer products). Although there is apparent overlap between the ECP/NCP and some of these programs, TSCA §9 includes procedures under which EPA can refer the regulation of chemicals to other agencies and requires that EPA coordinate actions taken under TSCA with those taken by other Federal agencies "for the purpose of achieving the maximum enforcement of this act [TSCA] while imposing the least burdens of duplicative requirements on those subject to the Act" [B]. In addition, TSCA §26 authorizes EPA to request other Federal departments and agencies assist EPA in the administration of TSCA [C]. Thus, the CRRR program fills recognizable gaps in the regulatory authorities of other Federal statutes and government entities, facilitating but not duplicating chemical risk identification and management. To ensure that the ECP and NCP are not redundant or duplicative of other Federal efforts, OPPT collaborates on a regular basis with other Federal agencies, including CPSC through the Toxic Action Committee (TAC) and with OSHA, MSHA, and NIOSH through the OMNE Committee to ensure that duplication of efforts is minimized, resources are leveraged efficiently, and opportunities for collaboration are identified. EPA is also a member of the TSCA Interagency Testing Committee (ITC), an independent advisory committee (includes 16 U.S. Government member organizations) established to identify chemicals for which member organizations have data needs. As mandated by TSCA §4(e), the ITC adds these chemicals to the Priority Testing List and recommends them for testing or information reporting in reports to EPA. [D] OPPT also coordinates and consults with other Federal agencies on an as-needed basis, for example, as an EPA representative in the National Nanotechnology Initiative (NNI), a U.S. government initiative to coordinate nanotechnology research and development across the federal government. [E, F] OPPT's partnerships with State and Tribal leaders increase mutual understanding and improve collaboration on toxics issues. A prime example is the Forum on State and Tribal Toxic Action (FOSTTA), which serves as a forum to help identify, discuss and address the needs of States and Tribes in their efforts to manage toxics-related and pollution prevention issues. FOSTTA provided input for developing national initiatives such as the Agency Action Plan on PBDE's and PFOA. [G] OPPT also coordinates its activities with other countries and international organizations to ensure that its efforts are not redundant or duplicative. For example, OPPT participates actively in the OECD's Chemicals Program, a comprehensive program of expert working groups and projects that includes activities to facilitate the coordinated investigation of HPV Chemicals, promote better exchange of information on the hazards of chemicals and mixtures, and develop protocols for studies to assess physicochemical properties, fate, ecotoxicity, and health toxicity endpoints. [H-K]

Evidence: A. TSCA, Subchapter I (Control of Toxic Substances) (15 USC) http://www.access.gpo.gov/uscode/title15/chapter53_subchapteri_.html B. TSCA, Section 9 (Relationship to other Federal laws 15 USC 2608) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite:+15USC2608 C. TSCA, Section 9 (Administration) (15 USC 2625) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite:+15USC2625 D. TSCA Interagency Testing Committee (ITC) website http://www.epa.gov/opptintr/itc/ E. National Nanotechnology Initiative (NNI) website http://www.nano.gov/html/gov/home_gov.html F. Nanotechnology under the Toxic Substances Control Act website http://www.epa.gov/opptintr/nano/index.htm G. Forum on State and Tribal Toxic Action (FOSTTA) website http://www.epa.gov/oppt/tribal/pubs/fostta.htm H. OPPT International Activities - Harmonization and Regulatory Coordination website http://www.epa.gov/oppt/international/pubs/harmony.htm I. OECD Cooperation on the Investigation of Existing Chemicals website http://www.oecd.org/department/0,2688,en_2649_34379_1_1_1_1_1,00.html J. U.S. High Production Volume (HPV) Challenge Program website http://www.epa.gov/chemrtk/ K. Globally Harmonized System (GHS) for Classification and Labelling of Chemicals website http://www.epa.gov/oppfead1/international/globalharmon.htm

Is the program design free of major flaws that would limit the program's effectiveness or efficiency?

Explanation: Element 1 TSCA is a powerful yet flexible statute. The regulatory authorities provided by TSCA work together effectively to provide a comprehensive oversight capability for dealing with new and existing chemicals in commerce. This is evidenced by the combination of regulatory and voluntary actions taken to identify, assess, and manage unreasonable risks. The provisions of TSCA §5 enable EPA to design an efficient and effective new chemical review process that includes continuous improvements. NCP is intentionally designed to manage potential unreasonable risks from new chemicals in a timely way that supports economic growth (e.g., chemical industry innovation and fast entry to market) and minimizes unnecessary burdens on manufacturers. No other approach has been shown to be more effective or efficient. Both NCP and ECP use the strengths of regulatory and voluntary tools to protect human health and the environment. Thus, EPA has credibly ensured effective, timely chemical management decisions. While some TSCA authorities are viewed as cumbersome, the Program has successfully surmounted a number of challenges to accomplish its goals and objectives. The most significant difficulties are associated with high statutory hurdles for action imposed by some of the statute's authorities that, at times, can limit EPA's ability to promulgate "command and control" regulations for existing chemicals under TSCA section 6[A, B]. In order to justify an action under section 6, EPA must find, inter alia, that there is a reasonable basis to conclude that a chemical substance "presents or will present" an unreasonable risk of injury. Despite these limitations, EPA has developed a wide array of regulatory and voluntary approaches and tools to effectively protect human health and the environment. Element 2 There is no evidence that any alternative program could comprehensively manage chemical risk in the US. TSCA is a unique authority and has served as a model for foreign governments' [K] approaches to chemical risk management. See Question 1.3 for examples of other US programs focused on particular elements of chemical safety, which do not duplicate, but rather support and complement TSCA programs. The NCP review process minimizes the chances of not identifying a substance that poses unreasonable environmental or human health risks. The fact that EPA has not received any TSCA 8(e) [C] notices on PMN-reviewed substances that are not regulated demonstrates that EPA's new chemicals decisionmaking has been effective. EPA created Sustainable Futures to assist industry in evaluating risks prior to PMN application in order to expedite and strengthen PMN processes. As evidence of its success, Sustainable Futures has been recently privatized; EPA now provides only training. Over the past ten years, ECP has striven for better ways to accomplish its mission, using a mix of regulatory and innovative voluntary efforts. These efforts are proving effective mechanisms for data collection and assessment of chemicals. An example of this is the development of the HPV Challenge program, [as evidenced in the Status and Future Directions of the HPV Challenge Program report], the Voluntary Children's Chemical Evaluation Program (VCCEP) [E], and the recent implementation of the PFOA Stewardship Program [I, J]. The HPV and PFOA efforts aim at assessing and reducing risk with data gathering activities initiated through voluntary means and supported by regulatory activities. This includes the use of test rules, significant new use rules (SNURs [D]), MOU-based testing efforts [H], and Enforceable Consent Agreements [F, G] to back up voluntary programs. These initatives address challenges efficiently and with greater flexibility than regulatory approaches alone may achieve.

Evidence: A. Court decision striking asbestos ban, which provides insight into how the promulgation of the Section 6 rules is resource intensive. B. General Accounting Office, Toxic Substances Control Act: Legislative Changes Could Make the Act More Effective (September, 1994) For discussion on difficulties of managing risk of chemicals in commerce see Chapter 2, pages 15-31 C. TSCA Section 8(e) Policy Statement and Guidance Promulgations and Proposals D. TSCA Section 5 SNURs for benzidine dyes, Perfluoroalkyl Sulfonates (PFAS), and Perfluorooctyl Sulfonates (PFOS) chemicals. E. "VCCEP;" notice (65 FR 81700 at 81705 and 81712, December 26, 2000). F. FR for initiation of TSCA §4 ECA development: 68 FR 18626, April 16, 2003 G. ECAs: 70 FR 39630, July 8, 2005, and 70 FR 39624, July 8, 2005 H. Monitoring MOUs: EPA-HQ-OPPT-2004-0112 and EPA-HQ-OPPT-2004-0113 I. http://www.epa.gov/opptintr/pfoa/pubs/pfoastewardship.htm J. http://www.epa.gov/opptintr/pfoa/pubs/commitments.htm K. http://www.europarl.europa.eu/oeil/file.jsp?id=5295432

Is the program design effectively targeted so that resources will address the program's purpose directly and will reach intended beneficiaries?

Explanation: Although the program does target resources to intended beneficiaries, the New Chemicals program incurs costs in excess of fees received to process Pre-Manufacturing Notices (PMNs) for chemicals before they are introduced in commerce for manufacturers and importers. This cost is a subsidy. The current fees collected (approximately 10-20% of total cost) are for prenotice consultations, review of new submissions, and maintenance of the infrastructure necessary to conduct risk reviews and are in support of developing new chemicals for commerce. The program proposes legislation to remove the cap and collect additional PMN fees to cover the full cost and eliminate the subsidy. Another subsidy the program identified was in the New Chemicals Program. This program transferred its costs in 2007, and future costs, to the private sector for training and guidance and othe assistance for manufacturers and importers (intended beneficiaries). These activities are more appropriate to be completed by the private sector and do not require a subsidy for the program.

Evidence: A. New Chemicals Program Guidance Materials (http://www.epa.gov/oppt/newchems/pubs/guideman.htm) B. TSCA 8(e) website C. TRI Website D. IURA Amendments www.epa.gov/EPA-TOX/2003/January/Day-07/t32909.htm E. FR for initiation of TSCA §4 ECA development: 68 FR 18626, April 16, 2003, F. ECAs: 70 FR 39630, July 8, 2005, and 70 FR 39624, July 8, 2005 G. 71 FR 47130, August 16, 2006. Health and Safety Data Reporting; Addition of Certain Chemicals, 71 FR 47122, August 16, 2006. H. Preliminary Assessment Information Reporting; Addition of Certain Chemicals. "VCCEP;" notice (65 FR 81700 at 81713, December 26, 2000). I. Implementation of the Pilot Voluntary Children's Chemical Evaluation Program; request for Comment (71 FR 67122 at 67123 - 67124, November 20, 2006). http://www.epa.gov/fedrgstr/EPA-TOX/2006/November/Day-20/t19574.htm VCCP Agreement No. X-830419-01-0. J. PFOA Stewardship website - http://www.epa.gov/opptintr/pfoa/pubs/pfoastewardship.htm K. HPVIS website - www.epa.gov/hpvis L. HPV Challenge website - www.epa.gov/hpv

Does the program have a limited number of specific long-term performance measures that focus on outcomes and meaningfully reflect the purpose of the program?

Explanation: The program has four long-term outcome measures and one long-term key output measures that cover the breadth of both the New and Existing Chemicals Programs. These measures meaningfully reflect the purpose of the program - to screen, assess and manage unreasonable risks to human health and the environment associated with new and existing chemicals. All of the long-term measures provide information to inform budget and management decisions. However, this program must develop additional long term measures that focus on the the analysis of National Health and Elimination Survey Data, and any other available monitoring data, to ensure that chemicals of concern do not cause unreasonable risks to human health. Following are existing long term measures: EPA's Risk Screening Environmental Indicator (RSEI) PART measure applies to both the Existing and New Chemicals programs and tracks the percent cumulative reduction of chronic human health risk from environmental releases and transfers of toxic chemicals in commerce since 2001. This EPA 2011 Strategic Target [A] is based on the RSEI model, which calculates a risk index based on releases of Toxic Release Inventory (TRI) chemicals, health effects data sets, fate and transport models, and census information. The measure reflects reductions in chronic human health risks from all TRI releases and is normalized to account for changes in production. [B] EPA's current New Chemicals Program measure tracks the percent of new chemicals or organisms introduced into commerce that do not pose unreasonable risks to workers, consumers, or the environment. The long-term target reflects EPA' mission to ensure that 100% of new chemicals entering commerce will not pose unreasonable risks to workers, consumers, or the environment [A]. TSCA §8(e) Substantial Risk Notices are checked against previously reviewed Pre-Manufacture Notices (PMNs) to determine whether the report identifies a previously reviewed chemical as posing an unreasonable risk. [C] If this is the case, EPA will fall below the 100% target. Even where unreasonable risks are not presented, the measure helps the program refine its chemical assessment tools in response to new information about chemicals. One additional long-term measures track the goals and progress of the PFOA Stewardship Initiative, one focusing on reducing by 95% facility releases of PFOA and related chemicals and the other on reducing by 95% these chemicals in product content - both targeting 2010 for their achievement and both encompassing participant's global operations. The eight companies in the U.S. that produce the vast majority of PFOA, PFOA precursors, and/or higher homologue chemicals voluntarily committed to reducing PFOA from emissions and product content by 95 percent by 2010 and to work toward eliminating PFOA from emissions and product content no later than 2015. [E]

Evidence: A: EPA's FY 2006-2011 Strategic Plan: Strategic Targets in Goal 4 http://www.epa.gov/cfo/plan/2006/goal_4.pdf B: EPA RSEI Website http://www.epa.gov/oppt/rsei/ C: Study Comparing PMNs/LVEs to Related 8(e) chemicals FY 2005 D: RSEI/HPV Trend Analyses: FY 1995-2003 E: PFOA Stewardship Initiative Website http://www.epa.gov/opptintr/pfoa/pubs/pfoastewardship.htm

Does the program have ambitious targets and timeframes for its long-term measures?

Explanation: Program has five long term measures that have ambitious targets and timeframes. Improvements are needed for: Long Term Measure: Through the PFOA Stewardship Program, achieve 95% reduction of PFOA, PFOA precursors, and related higher homologue chemicals in facility emissions by 2010. There are no targets for this long term measure to demonstrate how 95% will be reached within the timeframe. Data will be available in October 2007 to develop targets for this measure. This is not a key measure. Program has provided a baseline for all long term outcome measures.

Evidence: A: EPA's FY 2006-2011 Strategic Plan: Strategic targets in Goal 4 Page 83 PDF page 6 http://www.epa.gov/cfo/plan/2006/goal_4.pdf B: EPA's Congressional Justification FY 2008: Chemical Risk Review and Reduction Fact Sheet Page 241 PDF page 245 http://www.epa.gov/ocfo/budget/2008/epm.pdf C: EPA's Congressional Justification FY 2008: Verification and Validation Page 237 to 241 http://www.epa.gov/ocfo/budget/2008/verify_validation.pdf D: PFOA Stewardship Initiative Website http://www.epa.gov/opptintr/pfoa/pubs/pfoastewardship.htm E: Study Comparing PMNs/LVEs to Related 8(e) chemicals FY 2005 F: HPV Quarterly Management Report Graphic G: AEGL Website http://www.epa.gov/oppt/aegl/

Does the program have a limited number of specific annual performance measures that can demonstrate progress toward achieving the program's long-term goals?

Explanation: The program has four annual performance measures - one of which is outcome-oriented. These annual measures focus on achieving the programs long-term goals. The annual reduction in the current year production adjusted risk based score of releases and transfers of toxic chemicals demonstrates a reduction in existing and new chemical risks. This measure is based on the Risk Screening Environmental Indicator Model (RSEI), which calculates a risk index based on releases of the Toxic Release Inventory chemicals. A supplemental measure for the High Production Volume (HPV) program highlights the annual number of HPV chemicals with Screening Data Assessment Reports completed. This is currently an EPA Quarterly Management Report measure. Through tracking the number of screened chemicals, EPA can prioritize risk reduction efforts on those HPV chemicals that are reported to be the most hazardous. Work under the AEGL program supports the Homeland Security program area. AEGL values are short-term exposure limits for extremely hazardous chemicals and are used by first responders. This measure ensures the program evaluates these chemicals in a timely manner.

Evidence: A: EPA's Congressional Justification FY 2008: Verification and Validation Page 134-136 http://www.epa.gov/ocfo/budget/2008/verify_validation.pdf B: EPA's Congressional Justification FY 2008: Chemical Risk Review and Reduction Fact Sheet Page 241 PDF page 245 http://www.epa.gov/ocfo/budget/2008/epm.pdf C: HPV/RSEI Analysis: FY 1995-2003 D: HPV Quarterly Management Report Graphic E: FY 2006 Performance and Accountability Report Page 168 PDF page 178 http://www.epa.gov/ocfopage/finstatement/2006par/par06report.pdf

Does the program have baselines and ambitious targets for its annual measures?

Explanation: All annual measures for the program have ambitious targets that are evaluated twice a year for performance to ensure ambitiousness. All annual measures have baselines that are developed from credible data sources and are appropriate for the measure. For the annual measure "Reduction in the current year production-adjusted risk based score of releases and transfers of toxic chemicals from manufacturing facilities". Targets are currently ambitious, however additional data will be collected and analyzed in the future from the National Health and Examination Survey (NHANES) as well as from EPA's Office of Air and Radiation to confirm that future targets are appropriate for performance.

Evidence: 1)Science Advisory Board Report (1998) 2)NHANES/RSEI analysis/memo 3)NATA/RSEI analysis/memo

Do all partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) commit to and work toward the annual and/or long-term goals of the program?

Explanation: Element 1 All partners of the CRRR program work in support of the Program's goals. The CRRR program is administered entirely by OPPT and has not been delegated to the States through grants or other mechanisms. It collaborates with state partners to address information and risk management needs associated with specific chemicals of interest to both EPA and the States. All partners (e.g. sponsoring companies, trade associations, Toxicology Excellence for Risk Assessment (TERA) organization, CEHN, and EPA) continue to be committed to the CRRR's goals of identifying, and making publicly available, information on chemical hazards and exposures. Since the development of the HPV Challenge Program, industry has become a substantial EPA partner in ensuring that the highest quality HPV chemical data is made available to the public. As evidence of industry's strong performance in support of this program, we cite commitments from 373 companies and 104 consortia to sponsor approximately 1400 chemicals. In addition, the International Council of Chemical Associations (ICCA) HPV Initiative includes approximately 800 chemicals, giving a total exceeding 2200 HPV commitments [A, B, C]. PMN reviews are conducted by the NCP, however certain elements of tool development and training (i.e., P2 Framework, PBT Profiler, and Sustainable Futures) are conducted under contracts and grants. Considerable technical support of the CRRR program is completed with contractor assistance. In order to ensure that the work done by these partners is in support of CRRR's annual and long-term goals, EPA defines the scope of work of these extramural activities and holds contractors accountable to deliverables and time schedules. Element 2 NCP partners measure and report how their progress meets the Program's goals. Contractors and grantees document risk reduction and pollution prevention benefits derived from P2 Framework and PBT Profiler by chemical producers. This process allows these partners to provide insight into how to improve the program's screening methodologies and how to apply technology transfer to Agency risk reduction efforts. ECP partners measure and report their progress in relation to overarching goals. At the state-wide level for example, the EPA and states establish and strengthen state chemical risk management infrastructures through the Forum on State and Toxic Tribal Actions (FOSTTA) and other forums. HPV Program commitments entail providing existing chemical data in the form of robust summaries and a test plans identifying gaps where new test data will be developed and submitted to the Agency. Each company sponsoring a chemical in the VCCEP pilot has made a written commitment to provide health effects, exposure, risk, and data needs information for its chemical and to present that information at a Peer Consultation. [G]. As a mechanism to promote the fulfillment of commitments, unsponsored chemicals or unmet commitments may become candidates for TSCA §4 or §8 rulemaking action. ECP's non-governmental partners have participated actively in providing comments to the Agency and the public on test plans and robust summaries submitted by HPV Challenge Program sponsors. For example, the Environmental Defense (ED) has submitted comments on 89% of all chemical submissions posted to the website. ED has also published their HPV Chemical Tracker as a way to share the HPV Challenge Program data in addition to the Agency's website. The PFOA industry partners who publicly committed [D, E] to the global goals of the PFOA Stewardship Program are committed to providing baseline data in 2006. They are also tracking their progress in meeting Program goals in annual reports each successive October, beginning in 2007 [F].

Evidence: A. http://www.epa.gov/hpv/pubs/update/spncomp.htm B. http://www.epa.gov/hpv/pubs/update/smrestbl.htm C. http://www.environmentaldefense.org/go/hpvtracker D. http://www.epa.gov/opptintr/pfoa/pubs/pfoastewardship.htm E. http://www.epa.gov/opptintr/pfoa/pubs/commitments.htm F. http://www.regulations.gov G. www.epa.gov/chemrtk/vccep

Are independent evaluations of sufficient scope and quality conducted on a regular basis or as needed to support program improvements and evaluate effectiveness and relevance to the problem, interest, or need?

Explanation: In June 2005, the U.S. Government Accountability Office (GAO) published a major program assessment study that included a comprehensive review of EPA's ability to assess health risks under its new and existing chemical review programs [A]. The report considered the role of EPA's voluntary High Production Volume (HPV) Challenge Program in meeting chemical testing and analysis needs. The breadth of the report, covering both NCP and ECP, meets the PART guidance criterion for scope. GAO performed the study, so it can be considered independent in character. Several additional studies GAO conducted in the 1990's address topics relevant to the administration of the Existing Chemicals Program (ECP). For example, a 1994 study recommended legislative changes to make TSCA more effective [B]. Two other reviews addressed exposure assessment and chemical regulation [C, D]. In 1995, the program was reviewed by the Office of Technology Assessment [E]. In 2003, Environmental Defense (ED) issued a well-regarded evaluation of EPA's HPV Challenge Program [F]. ED's June 2004 follow-up report [G] recommended encouraging corporate sponsorship of the small but significant remaining number of "orphaned" chemicals. Collectively, these studies meet the PART standards for frequency of evaluations. The studies exhibit independence of authorship and, in the case of GAO the studies, were conducted by an agency with a demonstrated reputation for careful document review, literature review, and interviewing. Although the ED reports do not discuss methodologies in detail, the reports appear carefully researched and well documented. The second ED report describes a methodology that includes letter contacts made to CEOs of 202 companies and subsequent evaluation of 110 responses. This suggests careful research and follow-up. In aggregate- and individually in the case of the 2005 GAO report- the studies cover the entire scope of the ECP. A number of independent evaluations of the New Chemicals Program (NCP) have been performed over its 26-year existence. Together, these studies meet the PART criteria for quality, scope and independence, as they generally exhibit a reasonable degree of rigor, breadth, and independence of authorship.

Evidence: A. GAO. Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage its Chemical Review Program, GAO-05-458, June 2005. Link: www.gao.gov/cgi-bin/getrpt?GAO-05-458 -- See especially pp. 18-29 on Existing Chemicals Program and pp. 16-17 on New Chemicals Program. B. GAO. TSCA: Legislative Changes Could Make the Act More Effective, RCED-94-103, September 1994. http://archive.gao.gov/t2pbat2/152799.pdf C. File name: GAO. RCED.00.80. May 2000. Toxic Chemicals: Long Term Coordinated Strategy Needed to Measure Exposures in Humans.pdf. Link: http://www.gao.gov/archive/2000/he00080.pdf D. File name: GAO RCED.94.212. 1994 EPA's Limited Progress in Regulating Toxic Chemicals.pdf Link: http://archive.gao.gov/t2pbat3/151661.pdf E. File name: OTA. 1995. Screening and Testing Chemicals in Commerce.pdf F. File name: Environmental Defense_2684_Facing the ChallengeExec.pdf G. File name: Env. Defense Status Report Orphan Chemicals.pdf H. Executive Summary from October, 2000, EC Joint Research Centre report on "Regulation and Innovation in the Chemical Industry". ftp://ftp.jrc.es/pub/EURdoc/eur19735en.pdf or http://scholar.google.com/scholar?hl=en&lr=&q=cache:7ZhLd1CAkFsJ:www.teesvalley-jsu.gov.uk/dicidauk/keyissues/chemstrat/eur19735en.pdf+EC+Joint+Research+Centre++%E2%80%9CRegulation+and+Innovation+in+the+Chemical+Industry%E2%80%9D+October+2000

Are Budget requests explicitly tied to accomplishment of the annual and long-term performance goals, and are the resource needs presented in a complete and transparent manner in the program's budget?

Explanation: Element 1 The Chemical Risk Review and Reduction Program's activities include screening, assessing and reducing risks of new and existing chemicals. The new and existing chemicals program's resources are aligned with the program's annual and long-term outcome performance measures. [B] Budget requests affect performance towards those goals, as evidenced in EPA's internal Budget Analysis System (BAS) and in the FY 2008 Annual Performance Plan and Congressional Justification. [B, C, F] The program's resource information is derived directly from an internal EPA budget database that links resources directly to strategic objectives in the agency's strategic plan. Element 2 The program has an integrated budget presentation that makes clear the impact of funding, policy, or legislative decisions and provides evidence that the requested performance/resource mix will enable the program to achieve its performance goals. [B] An integrated presentation is provided for each Program articulating the activities to be supported by the requested resources and the associated external annual performance measures and targets. [B, C] Key elements of this presentation (resources and performance measures/targets) are continued in BAS through the development of the Agency Operating Plan. All spending categories and the resource levels and activities associated with the program included in the annual Congressional Justification. In establishing the FY 2007 Operating Plan and in formulating the FY 2008 President's budget, the program conveyed the impact of significant budget reductions by making clearly communicated adjustments to its annual performance measure targets. This provided a performance/resources mix that is still considered ambitious but also achievable. Element 3 The program reports all direct and indirect costs needed to attain the performance results, including applicable Agency overhead, retirement, and other costs that might be budgeted elsewhere. In addition to Agency-level procedures that account for fully loaded personnel, enabling support and infrastructure (e.g., Working Capital Fund) costs, OPPT conducts a rigorous annual program planning process, requiring all of its programs to justify funding requests on the basis of expected performance. Program Plan Project Forms identify performance to be provided at requested funding levels and clearly indicate how performance levels change with changes in allocated resources. The entire program plan process is captured in OPPT's Program Plan Database that links funding decisions with program performance. [E]

Evidence: A: 2006-2011 EPA Strategic Plan: Goal 4 Excerpts Pages 83-86 PDF Pages 6-9 http://www.epa.gov/ocfo/plan/2006/goal_4.pdf B: 2008 Annual Performance Plan and Congressional Justification Excerpts Pages 237-241 http://www.epa.gov/ocfo/budget/2008/epm.pdf C: Budget Automation System Powerpoint D: OPPT Finance Center Program DCN Log print screens E: OPPT Finance Central Program Plan print screens F: FY EPA 2006 Annual Plan www.epa.gov/ocfo/budget/2006/final_for_printing.pdf

Has the program taken meaningful steps to correct its strategic planning deficiencies?

Explanation: The program has taken meaningful steps to address strategic planning deficiencies. In the Agency's Strategic Plan revision efforts during FY 2003, the program worked to establish better long-term and annual performance measures. The success of these preliminary efforts in setting ambitious targets and demonstrating results has been illustrated in the improved PART score for FY 2005. Most notable was the creation of a long-term outcome-focused measure examining the percent reduction of chronic human health risk from environmental releases of industrial chemicals in commerce. The Existing Chemicals program is continuing its efforts to improve performance measurement in response to FY 2005 PART findings by developing long-term and associated annual efficiency measures. [A, B] In 2007, the program added a group of outcome-and output-focused measures to address deficiencies. Some measures under development to gauge performance of the existing chemicals program take the form of a long-term outcome measure to eliminate or effectively manage risks associated with HPV chemicals for which unreasonable risks have been identified through EPA risk assessments. The programs participates fully in the Agency strategic planning process; and has also created its own cohesive, systematic process for review of program focal areas, goals, and priorities to strengthen strategic planning. Priorities are evaluated, among other things, for their potential and actual outcome results in preventing risks posed by new and existing chemicals. [B, C]

Evidence: A: 2008 Annual Performance Plan and Congressional Justification Excerpts Pages 237-241 http://www.epa.gov/ocfo/budget/2008/epm.pdf B: 2006-2011 EPA Strategic Plan Goal 4: Excerpts Pages 83-86 PDF Pages 6-9 http://www.epa.gov/ocfo/plan/2006/goal_4.pdf C: OPPT Finance Central Program Plan print screens

Does the agency regularly collect timely and credible performance information, including information from key program partners, and use it to manage the program and improve performance?

Explanation: Element 1 The Chemical Risk Review and Reduction program is responsible for identifying and managing potential risks to the environment and public health associated with the introduction of chemicals into commerce. This program has 3 outcome performance measures that are directly related to this key program goal. Performance information should be collected regularly for these measures which are related to the reduction of human health risk from environmental releases of chemicals. Performance data is not available for these outcome measures for 2004-2006, although the program does utilize a Risk Screening Environmental Indicator Model which provides annual release and screening-level risk information. In addition, a National Health and Nutrition Examination Survey is completed every 2 years (possibly every year in the future) by the Center for Disease Control which takes direct measurements of some of the chemicals that are managed by this program however this data is not utilized to determine performance. The program has identified this as an area to strengthen in the Improvement Plan. For output performance measures, this program collects a large amount of test data for new and existing chemicals which has lead to the development of the High Production Volume and Voluntary Children's Chemical Evaluation Program in order to develop better risk assessments to protect public health and the environment.

Evidence: A: Environmental Defense, HPV Chemical Tracker, 2006. http://www.environmentaldefense.org/go/hpvtracker B: FacingtheChallengefinal.pdf, Environmental Defense, Facing the Challenge, 2003. http://www.environmentaldefense.org/documents/2682 C: Environmental Defense, Orphan Chemicals in the HPV Challenge: A Status Report, 2004. http://www.environmentaldefense.org/documents/3810 D: EPA Website for the Voluntary Children's Chemical Evaluation Program (VCCEP) http://www.epa.gov/chemrtk/vccep/index.htm E: Implementation of the Pilot Voluntary Children's Chemical Evaluation Program; request for Comment (71 FR 67122 at 67123 - 67124, November 20, 2006). http://www.epa.gov/fedrgstr/EPA-TOX/2006/November/Day-20/t19574.htm -

Are Federal managers and program partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) held accountable for cost, schedule and performance results?

Explanation: The CRRR Program evaluates performance of contractors and grantees at periodic intervals for quality, timeliness, and cost. Contract awards and renewals consider past performance. These contracts include all program mission contracts. EOY1: The CRRR program identifies managers responsible for achieving key program results and applies performance standards to them.[E, F] The ECP monitors managerial performance against GPRA targets at mid-year, including a program review with the Deputy Administrator, and again at year end to prepare the Annual Report. At each level of the Agency, explanations are required for targets that are not met. EOY2: Regulatory actions have their own tracking system, with monitoring of schedule and completeness beginning at the program level and leading to a regular meeting and discussion with the Deputy Administrator. A list of documents, deadlines and significant milestones is compiled each month and shared with managers to ensure they understand the Agency's monthly performance goals. These performance objectives are then discussed at weekly meetings to monitor managers' progress against them and make adjustments. Cost issues are addressed at a macro level through budget expenditure monitoring meetings held two to three times annually. Where corrective action or adjustments cannot prevent difficulties with cost/performance/schedule, a 'lessons learned' approach may be used if the issue seems systemic rather than isolated. Regular senior- and middle-management meetings address systemic issues as they are identified. EOY3: Program partners are also held accountable against performance standards. Program partners associated with the HPV Challenge Program, the VCCEP, and the PFOA Stewardship Program provide letters to the Agency that reflect their commitment to the goals and objectives of the respective Program. [A, B, C] At the Agency level, there are both contract and grant standards for the program to apply in managing their procurements, and training is required. To better manage contracts, recent tools have been incorporated by the ECP, including more site visits; program reviews; teleconferences; and audits. The Agency requires program offices to provide long-term and 2-year acquisition plans for planning purposes. In order to properly prepare these, managers have to know where they envision their procurement needs. All contractor statements of work contain clear performance targets, time frames, deliverables, costs and schedules. Project Officers (POs) and other Contracting Officer Representatives must be trained and certified in contracts management on both pre- and post-award activities. [G, H, I] OPPT has in large part centralized and standardized its financial tracking and management. Program reviews are also conducted. OPPT's Quality Management Plan captures SOPs for contracting/grant functions. This includes procedures designed to facilitate early management notice of problems with contracts and grants so that corrective actions can be undertaken. Following these procedures, as an example EPA POs have regularly monitored the performance of CEHN (the grantee that provides support to NGO participation in VCCEP) and TERA (coordinator of Peer Consultations under a cooperative agreement with EPA) and where deficiencies were found, if any, they were brought to the attention of the funding recipients and improved performance has followed. [D]

Evidence: A: PFOA website http://www.epa.gov/opptintr/pfoa/pubs/commitments.htm B: VCCEP website http://www.epa.gov/HPV/vccep/pubs/partmain.htm C: HPV Challenge Program website http://www.epa.gov/hpv/pubs/general/makecom.htm D: "Off-Site Evaluative Review of Cooperative Agreement with CEHN." (June 22, 2005) E: Typical Performance Agreement for an OPPT Manager under the EPA Performance Appraisal and Recognition System (PARS) F: EPA Office of Grants and Disbarment Policy Memorandum - Assessing Grants Management Performance under the Performance Appraisal and Recognition System (PARS). GPI 06-02. G: OMB/OFFP Policy Letter 05-01 - Developing and Managing the Acquisition Workforce http://www.whitehouse.gov/omb/procurement/policy_letters/05-01_041505.html H: EPA Office of Acquisition Management Policy - Implementation of the Continuous Learning Policy for the USEPA Acquisition Workforce Members. I: EPA Mandatory Grants Management Training for Managers and Supervisors. Memorandum from Marylouise M. Uhlig (OPPTS Senior Resource Official) to OPPTS Office Directors and Deputy Office Directors. March 14, 2007.

Are funds (Federal and partners') obligated in a timely manner, spent for the intended purpose and accurately reported?

Explanation: Element 1 Program funds are obligated consistently with the program plan and only a limited amount of program funds remain unobligated prior to lapsing. OPPT builds upon Agency-level processes and systems with additional office- and program-level planning, and financial and performance management processes and systems. The keystone to OPPT's performance-based management processes is OPPT Finance Central, an internally designed system, implemented to support key aspects of program planning, financial management and performance accountability. [A, B, C, D, E] Four key points of Finance Central: ?? Prior to Congressional enactment, Project Forms detailing funding requests and associated performance commitments are entered into Finance Central. ?? Upon establishment of the Final Operating Plan, program resource targets are adjusted to reflect Agency-level decisions, with corresponding adjustments at the Project level negotiated by managers. ?? Final project-level allocations are established in Finance Central and spending against those allocations is tracked using unique project codes attached to IFMS commitments and obligations. ?? Finance Central has supported OPPT in achieving record-setting obligation rates for allocated funds, approaching the 100% level in each of the past four fiscal years. OPPT's use of Finance Central played a key role in EPA's successful efforts to secure a Green rating on the President's Management Agenda for Financial Management. [F] Element 2 The program and its partners establish schedules for obligations that properly correspond with the needs of the program. Headquarters funds allocated through the OPPT Program Plan process are associated with specific milestones and schedules for use of funds and completion of key activities. [A] Element 3 Adequate procedures exist for reporting actual expenses, comparing them against intended use, and taking timely action to correct problems. As Finance Central is refreshed daily, reports at the project and organizational levels inform management on exceptions from established financial management requirements, including spending beyond allocated resource levels, significant delays between commitment vs. obligation, incomplete obligations of committed funds and use of funds for unintended purposes. [B, C, D] Element 4 Monthly reports addressing HQ funds are provided to the Office Director for identification of potential spending deficits. [C] Quarterly meetings are also held between the OPPT central financial management staff and individual program managers to assess financial management performance at a detailed project level. [D]

Evidence: A: OPPT Finance Central Program Plan print screens B: OPPT Finance Center Program DCN Log print screens C: OPPT Monthly Resource Overview Report D: OPPT Quarterly Resource Overview Report E: 2005 President's Management Agenda Results Report Excerpt Page 21 http://www.epa.gov/pmaresults/pdfs/2005report.pdf F: Finance Central DCN Log FOC Guide

Does the program have procedures (e.g. competitive sourcing/cost comparisons, IT improvements, appropriate incentives) to measure and achieve efficiencies and cost effectiveness in program execution?

Explanation: Element 1: A number of built-in program policies exist in the CRRR program to ensure efficiency and cost effectiveness, including: ?? Investment in improved IT systems; ?? Competitive sourcing of program support activities; ?? Use of incentives to encourage efficient stakeholder participation; and ?? Cross-program and inter-agency coordination to avoid duplicative efforts. The Capital Planning and Investment Control (CPIC) process ensures efficient development of IT projects within the Agency. Related ECP initiatives include: ?? Re-haul of the Confidential Business Information Tracking System (CBITS) to expand its capability and integrate tracking and search functions; and create a sister system for Non-Confidential information. ?? Streamlined (electronic) TSCA §8 data submissions through the OEI Central Data Exchange reducing the need for document handling; ?? Support for the Agency's re-engineered electronic docket system; ?? Launch of a data-searchable Web application called the HPV Information System (HPVIS) [A] that allows users quick and comprehensive chemical data search for HPV chemicals; and ?? Reliance on the VCCEP Web site to communicate results at minimal cost to the Agency or its partners. OPPT has been successful in a competitive A-76 review of selected functions, including aspects of the NCP. Specifically, after two streamlined cost comparison competitions were performed for Risk Assessment/Information Management and Risk Assessment/Risk Management in 2003, the government decided that EPA should continue to the perform the associated services in-house through the in-house organization that was evaluated. OPPT tracks staffing and workload levels, as well as performance associated with these functions and provides a quarterly update to EPA's Office of Competitive Sourcing. Procedures to achieve efficiencies and cost effectiveness include the launch of MTS (Manage Toxic Substances) that will allow electronic submission of PMNs, reduce Agency costs of managing CBI, and enable automated workflow management for the processing and review of PMNs Element 2: The program has developed two efficiency measures for the ECP: 1) "Percent change in total EPA cost per chemical for which proposed AEGL value sets are developed," which targets improvements in AEGL Program's expertise in assembling and reviewing data. [B] 2) "Percent change in average cost of TSCA 8(e) processing and searches, " which targets efficiencies achieved through automation of the TSCA 8(e) notification process using the MTS system described above. [C], [D] The program has two efficiency measures for the NCP: 1) "Percent change from the prior year in cost savings achieved through new chemical prescreening" . Prescreening models, available through the Sustainable Futures Program, enable companies to incorporate pollution prevention approaches into new chemical design and help the Agency achieve cost savings in the later stages of PMN review by reducing the need for time-consuming process steps (i.e., consent decree negotiation) that are seen more often with chemicals that have had less advance scrutiny [E], [F] 2) "Percent change from the prior year in the average cost of pre-Focus PMN handling, processing and searches," which focuses on efficiencies achieved in the earlier stages of PMN review, including implementation of a new target architecture for the program's information technologies that reduce manual processing of new chemical submissions and provide data to reviewers electronically. [G]

Evidence: A: Environmental Protection Agency, High Production Volume Information System (HPVIS). http://www.epa.gov/hpvis/index.html(B) File name: Efficiency measures - AEGLs - V&V - Final to OMB.doc (C) File name: Efficiency measures 8(e) V&V.doc (D) File name: Efficiency measures 8(e) HG baseline - targets - table.doc (E) File name: Efficiency measures - Post-Focus - V&V - Final to OMB.doc (F) File name: 2003-PE-PMI-Effcy-measrues-tables-FINAL.xls (G) File name: Efficiency measures - Pre-Focus - IMD cost matrix - 3-28-07.xls

Does the program collaborate and coordinate effectively with related programs?

Explanation: Element 1: The CRRR program's collaborative work leads to greater efficiency in meeting Program goals and objectives. Agency-wide: ?? CRRR facilitated an industry phase out of production of certain PBDEs (flame retardants) and is a key participant in an Agency Workgroup that developed a PBDE Project Plan [A]. ?? CRRR supports the goal of reducing toxic chemicals in products and waste through the Agency's Resource Conservation Challenge. [B] ?? CRRR coordinates Agency science and policy for assessment and potential regulation of nanotechnology through the EPA Science Policy Council (SPC). Federal Agency collaboration: ?? TSCA section 9 includes procedures under which EPA can refer chemicals to other Agencies and requires that EPA coordinate actions taken under TSCA with regulatory actions taken by other Federal agencies "for the purpose of achieving the maximum enforcement of this act [TSCA] while imposing the least burdens". ?? EPA meets regularly with CPSC, OSHA, MSHA, and NIOSH to minimize duplication of effort, efficiently leverage resources, and identify opportunities for collaboration [C]. ?? EPA develops test rules and enforceable consent agreements (ECAs) at the request of other federal agencies and EPA offices to help them meet their chemical data needs. Examples include test rules and ECAs listed under "Evidence" [C - K], developed for ATSDR (in coordination with EPA's ORD and OAR), OSHA, and CPSC. ?? The Interagency Testing Committee (ITC) adds chemicals to a Priority Testing List and recommends them for testing or information reporting to EPA. In response, EPA promulgates TSCA section 4 test rules, 8(a) PAIR rules and 8(d) rules [L]. ?? The CDC, at EPA's request, included PFOA and related chemicals in human biomonitoring to establish an exposure baseline with the aim of evaluating the effectiveness of programs focused on reducing exposures.[M, N] ?? The National Toxicology Program, at EPA's request, implemented a chemical class study to develop an understanding of the hazards posed by PFOA and PFOS-related chemicals. International collaboration: ?? CRRR participates in relevant policy and technical discussions with inter-governmental organizations and regulatory partners to promote consistent, effective approaches to risk reduction and worksharing. Examples of OECD cooperation include: ?? New Chemicals Task Force (NCTF) - The NCTF, under CRRR program leadership, is working cooperatively to develop multilateral arrangements among countries; a standardized OECD Notification Form; and standardized hazard/risk assessment procedures; and to enhance exchange of assessments between governments. ?? HPV Chemicals Screening Information Data Sets (SIDS) program - The CRRR collaborates with the OECD on generating and sharing screening information data sets on high production chemicals globally, including in development of an eChemPortal to more broadly share information on chemical substances, scheduled for public release in April 2007. ?? OECD Test Guidelines program - The CRRR works jointly with OECD members to develop test guidelines for hazard, chemical property and environmental fate endpoints, and set forth the conditions that need to be met to ensure that test data developed for chemical substances are reliable. Mutual Acceptance of Data aspects of this work saves upwards of $ 11 million annually. ?? OECD Working Party on Manufactured Nanomaterials (WPMN) - The WPMN, under CRRR program leadership, is working cooperatively to coordinate research on nanomaterials, develop appropriate test guidelines and to ensure that certain manufactured nanomaterials are tested for health and environmental safety. ?? CRRR has coordinated US involvement in the North American Commission for Environmental Cooperation's (NACEC's) Sound Management of Chemicals program (SMOC) to develop and implement North American Regional Action Plans (NARAPs) to reduce risks for toxic chemicals and pesticides.

Evidence: A: Agency PBDE website, with link to Project Plan. http://www.epa.gov/opptintr/pbde/ B. Resource Conservation Challenge website -- http://www.epa.gov/rcc/ C: Final TSCA Section 4 Test Rule: In Vitro Dermal Absorption Rate Testing of Certain Chemicals of Interest to the Occupational Safety and Health Administration (69 FR 22402; April 26, 2004) http://www.epa.gov/fedrgstr/EPA-TOX/2004/April/Day-26/t9409.htm D: Proposed TSCA Section 4 Test Rule for Certain Chemicals on the ATSDR/EPA CERCLA Priority List of Hazardous Substances (71 FR 61926; October 20, 2006) http://www.epa.gov/fedrgstr/EPA-AIR/2006/October/Day-20/a17569.htm E: Dibasic Esters; Final Enforceable Consent Agreement and Testing Consent Order (64 FR 42692; August 5, 1999) http://www.epa.gov/fedrgstr/EPA-TOX/1999/August/Day-05/t20205.htm F: Dibasic Esters (DBEs) EPA Program Review; Notice of Availability and Solicitation of Comments (70 FR 48418; August 17, 2005 http://www.epa.gov/fedrgstr/EPA-TOX/2005/August/Day-17/t16297.htm G: 1,2-Ethylene Dichloride; Final Enforceable Consent Agreement and Testing Consent Order (68 FR 33125; June 3, 2003) http://www.epa.gov/fedrgstr/EPA-TOX/2003/June/Day-03/t13721.htm H: Proposed Test Rule for Hazardous Air Pollutants. http://www.epa.gov/fedrgstr/EPA-TOX/1996/June/Day-26/pr-24153DIR/pr-24153.txt.html I: TSCA Section 4 ECA on Phenol issued (62 FR 2607; January 17, 1997) and all testing completed. http://www.epa.gov/fedrgstr/EPA-TOX/1997/January/Day-17/t1263.htm J: TSCA Section 4 ECA on Methyl Isobutyl Ketone issued (64 FR 20298; April 26, 1999) and testing is completed. http://www.epa.gov/fedrgstr/EPA-TOX/1999/April/Day-26/t10390.htm K: TSCA Section 4 ECA on 1,1,2-Trichloroethane issued (65 FR 37550; June 15, 2000) and testing is underway. http://www.epa.gov/fedrgstr/EPA-TOX/2000/June/Day-15/t15162.htm L. List of TSCA Section 8d Health and Safety Data Reporting Rules Promulgated from July 1995 - Present. http://www.epa.gov/opptintr/chemtest/pubs/8d716.htm M: National Report on Human Exposure http://www.cdc.gov/exposurereport/pdf/fr_093003.pdf . N: National Report on Human Exposure to Environmental Chemicals http://www.cdc.gov/exposurereport/default.htm

Does the program use strong financial management practices?

Explanation: Element 1 The program is not the subject of any material internal control weaknesses reported in the FY 2005 EPA Inspector General's annual FMFIA report. [A] Element 2 The program meets all of the additional criteria for this question. ?? The program follows EPA financial management guidelines for committing, obligating, reprogramming and reconciling appropriated funds. OPPT process and systems described in the 3.3 response ensure that payments of program funds are made properly for the intended purposes. [B] ?? EPA's financial management systems meet statutory requirements and agency officials have a system of controls and accountability, based on GAO, Treasury and OMB guidance as well as generally accepted accounting principles Generally Accepted Accounting Principles (GAAP), to ensure that improper payments are not made. At each step in the process, the propriety of the payment is reviewed. EPA trains individuals to ensure that they understand their roles and responsibilities for invoice review and for carrying out the financial aspects of program objectives. ?? EPA received "green" progress scores for all four quarters in FY 2006. [C] ?? OPPT developed and uses Finance Central to provide even greater financial management oversight, providing state-of-of-the-art project- and program-level financial reports, issue identification and resolution, and program/project planning capabilities. [B, D, E, F] ?? EPA received an unqualified audit opinion on its FY 2006 financial statements. [G] The audit found no Agency-level material weaknesses and no substantial noncompliance.

Evidence: A: OPPT FMFIA Assurance Letter B: OPPT Finance Center Program DCN Log print screens C: FY 2006 Performance and Accountability Report Section 1 pg. 27 PDF Page 37 http://www.epa.gov/ocfo/finstatement/2006par/par06report.pdf D: OPPT Finance Central Program Plan print screens E: OPPT Monthly Resource Overview Report F: OPPT Quarterly Resource Overview Report G: Audit of EPA's FY 2006 and 2005 Consolidated Financial Statements Excerpt Page 3 PDF Page 9 http://www.epa.gov/oig/reports/2007/20061115-2007-1-00019.pdf

Has the program taken meaningful steps to address its management deficiencies?

Explanation: No material weaknesses were identified in the agency-level and program-level review process. The program has a system for identifying and correcting program management deficiencies and uses it to make corrections within agreed time frames. For the existing chemicals program, the ability of EPA to make HPV data publicly available was substantially enhanced in FY 2006 through the release of the HPV Information System (HPVIS), a searchable on-line database. As of August 2006 this powerful new tool contained 300 submissions, representing 863 chemical substances, either as single chemical submissions or as members of chemical categories. For the new chemicals program, an efficiency measure will be introduced in Spring of 2007 that is targeted to improve the early stages of the PMN Review Program by increasing the use of information technology for receiving and processing submissions. The program's systematic approach for identifying and correcting program management deficiencies includes the following elements. ?? Annual review to address FMFIA material weaknesses. [A] ?? Annual program plan reviews. [B] ?? Semi-annual, office-level planning sessions. [B] ?? Annual program-wide priority-setting (at macro level every third year in tandem with the Agency strategic planning process, and at micro level during years in between). [C] ?? A Human Capital Strategy and Action Plan. The plan has goals, strategies, and actions supported by measures and time frames for (a) retaining and attracting a diverse and skilled workforce to meet critical needs and ensuring growth, (b) developing the vitality of the workforce; and, (c) promoting effective management approaches. ?? Review of IT for continual improvement. [D] ?? A Performance Appraisal Management System (PARS) for all managers and employees that link job performance standards to Agency strategic goals and objectives. ?? Enterprise-wide assessments of OPPT's information management architecture and structured implementation of the target architecture, leading to quantifiable increases in efficiency of key business processes including IUR, PMN, and TSCA 8(e) data submission and management. [E]

Evidence: A: OPPT FMFIA Assurance Letter B: OPPT Finance Central Program Plan print screens C: 2006-2011 EPA Strategic Plan http://www.epa.gov/ocfo/plan/2006/goal_4.pdf D: FY 2006 Performance and Accountability Report Section 1 pg 36 PDF Page 46 http://www.epa.gov/ocfo/finstatement/2006par/par06report.pdf E: Implementation Plans Office of Pollution Prevention and Toxics Applications Integration Strategy - Draft

Has the program demonstrated adequate progress in achieving its long-term performance goals?

Explanation: The program has five long term performance measures. Three out of five long term performance measures are not able to demonstrate adequate progress. The Chemical Risk Review and Reduction program has made some progress to meet its 2011 goal of a 26% cumulative reduction of chronic human health risk from environmental releases of industrial chemicals in commerce. Progress through 2003 demonstrates a 5.8% reduction. [A] However, performance data for FY 2004 and FY 2005 are not available as expected based on targets developed by management. Data is expected to be available in July 2007 for the Fall Update, therefore it is not possible to demonstrate adequate progress on this measure at this time. The Existing Chemicals Program has continually exceeded its projected pace for developing Proposed AEGL values for priority chemicals. Progress through 2006 demonstrates a total of 185 chemicals with proposed AEGL values, 65% progress toward its long-term goal that expects to achieve by 2011. [A] However the long term goal for reduction in PFOA does not have targets currently available. Assessment of whether the long term goals are being met is not possible at this time. The additional long term measure in the Existing Program regarding a reduction in production-adjusted risk-based score of releases and transfers of HPV chemicals does not currently have available data for targets in 2004 and 2005 as scheduled by management. This data should be available in July 2007 for the fall update. Therefore, it is not possible to demonstrate adequate progress at this time. The New Chemicals Program achieved its desired success in meeting its long-term target to prevent new unreasonable risks in 2005 and 2006. No chemicals were introduced in either of those two years and the program achieved their target of zero chemicals. [B] The PFOA measure is a new measure with a goal of 95% reduction by 2010. The first year that actual data will be available is 2007. Therefore, it is not possible to demonstrate adequate progress on this measure at this time. Program partners contributed significantly to the program's ability to achieve its long-term performance measure results. For instance, the 400+ sponsors of HPV chemicals identify and assess the adequacy of existing screening data, conduct new testing (if adequate data do not exist), and make the new and existing tests results available to EPA and the public. In the case of the Voluntary Children's Chemical Evaluation Program (VCCEP), industry voluntarily agrees to submit exposure and toxicity data on chemicals identified by the EPA as priority concerns to children. VCCEP represents an important partnership between EPA and industry, with industry committed to providing information on a total of 20 chemicals. Industry shares the goal of EPA and other stakeholder of protecting children's health and without their commitment and resources vital hazard and exposure information would not be available to evaluate and characterize potential chemicals risks to children. [D] The PFOA Stewardship Initiative relies on voluntary commitment from the eight major companies in the U.S. committing to voluntarily reduce their facility emissions and product content of PFOA by 2010. All eight participants met the program's requirement to provide baseline and initial progress data in the fall of 2006. However, targets are still being developed for this new measure.[E] Element 3: The PFOA Stewardship Program is working towards eliminating emissions and product content levels of PFOA, PFOA precursors, and related higher homologue chemicals by 2015 with the most substantial reductions of 95% expected by 2010. [G]

Evidence: A: FY 2006 Performance and Accountability Report Page 168 PDF page 178 http://www.epa.gov/ocfopage/finstatement/2006par/par06report.pdf B: Study Comparing PMNs/LVEs to Related 8(e) chemicals FY 2005 C: HPV Website www.epa.gov/hpv D: EPA Website for the Voluntary Children's Chemical Evaluation Program (VCCEP) http://www.epa.gov/chemrtk/vccep/index.htm E: PFOA Commitment Letters http://www.epa.gov/opptintr/pfoa/pubs/commitments.htm F: Geologics New Chemicals Environmental Indicators: Worker Safety Graphs G: 2010/15 PFOA Stewardship Program __http://www.epa.gov/opptintr/pfoa/pubs/pfoastewardship.htm

Does the program (including program partners) achieve its annual performance goals?

Explanation: This program has four annual measures. Two of the annual measures collect data to determine a production adjusted risk based score of releases and transfers of high production volume and toxic chemicals from manufacturing facilities. However, data is not available for 2004 and 2005 for these annual measures to determine if they are meeting their annual performance goals. For annual measure "Cumulative number of High Production Volume (HPV) chemicasl with screening level hazard characterization reports completed" is new and targets are starting in 2007. The program achieved its FY 2007 first quarter target for its HPV Hazard Characterization measure, as documented in EPA's Quarterly Management Report to the Deputy Administrator. Through 2006, 630 chemicals with Tier II Equivalent Screening Data Assessment Reports were made publicly available; 1st quarter results increased that total to 662 chemicals, [A] The remaining measure on the AEGL program has consistently exceeded its annual performance targets. In FY 2003, the AEGL program exceeded its annual performance target of 15 chemicals by completing 26 chemicals with proposed AEGL values. In FY 2004, the program exceeded its annual performance target of 15 chemicals by completing 29 chemicals with Proposed AEGL values. In FY 2005, the program exceeded its annual performance target of 20 chemicals by completing 29 chemicals with proposed AEGL values. In FY 2006, the program completed 23 chemicals, one below the annual performance target of 24, resulting from cancellation of a key meeting for reasons beyond the program's control at which the Program's additional AEGL submissions were scheduled to be approved. The New Chemicals program has also achieved its zero-tolerance target since the baseline study was completed in 2004 and 2005. [B]. Program partners contributed significantly to the program's ability to achieve its annual performance measure results, as detailed in Question 4.1 above. The Sustainable Futures program is a voluntary program that has proved to be successful with seven companies having met the qualifications to graduate. These companies are committed to producing safer chemicals with risk reduction and pollution prevention benefits. These activities directly relate to achievement of the program's performance and efficiency measures. [C] In addition to the companies that qualify for graduation, one of the major chemical trade associations, The Synthetic Organic Chemical Manufacturers Association (SOCMA), has agreed to help implement Sustainable Futures. In particular, OPPT and SOCMA signed a MOU under which SOCMA has agreed to assist the Agency in training stakeholders in the appropriate use of OPPT's Sustainable Futures tools. SOCMA has agreed to sponsor two Sustainable Futures Training Workshops in FY 07' and three to four workshops in FY 08', with the possibility of offering additional, specialized training. SOCMA has also established their training center as described in Section 1 of the MOU [D].

Evidence: A: HPV Quarterly Management Report Graphic and Data B: Study Comparing PMNs/LVEs to Related 8(e) chemicals FY 2005 C: Sustainable Futures Website http://www.epa.gov/oppt/newchems/pubs/sustainablefutures.htm D: MOU between SOCMA and EPA for Sustainable Futures Program

Does the program demonstrate improved efficiencies or cost effectiveness in achieving program goals each year?

Explanation: Element 1: The program exceeded its sole efficiency measure target in place for FY 2006, doubling the savings expected as a result of pre-screening of chemicals by PMN submitters using EPA's risk screening tool (in response to training and encouragement provided through the Sustainable Futures program). In 2005, the program saved $51,000 from prescreening. In 2006, the program saved $58,700, an increase of 15.1%. [A, B, C] This exceeded the target increase of 6.67%, Other improved efficiencies in identifying and managing chemical risks have been achieved by the program each year. 1) The program continues to increase efficiency through improved expertise and coordination with other agencies and governments. These efficiencies are particularly notable in our efforts on HPV, VCCEP, and AEGL [D, E, F]. For example, the HPV Challenge Program uses the Screening Information Data Sets (SIDS), an international agreed upon set of guidelines for screening data developed by the OECD. Using the prescribed SIDS approach provides greater familiarity with testing guidelines and limits duplicative testing. [G] 2) The program is making substantial IT improvements which will enable EPA to reduce processing and review time for many activities as well as reduce industry reporting/submission costs. Electronic reporting for IUR was just launched in 2006. [H] Data collected under the HPV Challenge Program and the SIDS Programs managed by the OECD are housed in the new E-Portal Database which results in efficient use of data already developed and enables sharing worldwide. 3) To expeditiously address environmental and health risks associated with PFOS/PFOA, the program used ECAs and MOUs instead of pursuing traditional regulatory solutions. [I, J, K, L] On 1/25/06, U.S. EPA invited 8 companies to voluntarily join in a global program to commit to 1) achieving, no later than 2010, a 95% reduction in both facility emissions to all media and product content of PFOA, PFOA precursor chemicals, and related higher homologue chemicals, measured from a year 2000 baseline; and 2) working toward elimination of PFOA, PFOA precursors, and related higher homologue chemicals from emissions and products by 2015. The 8 companies submitted baseline data on emissions and product content in November 2006, additionally companies will submit annual progress reports toward goals each year beginning October 31, 2007; report progress in terms of both US and global operations. 4) LVEs were created in 1985, partially because they are a very efficient management and regulatory mechanism. LVE submissions as a percent of total submissions increased almost every year from 1985 - 2001 and now appear to be leveling off at around 35%. [M] 5) NCP staffing levels decreased 73% from 1990 to 2006. As a result, the number of submissions received per NCP staff has risen from 12 to 19. The fact that the program continues to meet its statutory deadlines and make high-quality decisions provides direct evidence that significant efficiencies have been achieved. [N] 6) The program successfully underwent an A-76 competition. [O]

Evidence: A: File name: 2003-PE-PMI-Effcy-measure-tables-FINAL.xls B: File name: PART Post-Focus FY06 actual value calculation.doc C: File name: PART Prescreening rate.doc D: EPA website for the HPV Challenge Program, http://www.epa.gov/chemrtk/ E: EPA website for the VCCEP Program, http://www.epa.gov/chemrtk/vccep/index.htm F: EPA website for the AEGL Program, http://www.epa.gov/opptintr/aegl/ G: SIDS website, http://www.epa.gov/hpv/pubs/general/sidsappb.htm H: EPA website for the TSCA Inventory Update Reporting, http://www.epa.gov/oppt/iur/index.htm I: http://www.epa.gov/fedrgstr/EPA-TOX/2003/April/Day-16/t9418.htm J: 2 3M/Dyneon (EPA-HQ-OPPT-2004-0112): http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-HQ-OPPT-2004-0112 K: DuPont MOU (EPA-HQ-OPPT-2004-0113): http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-HQ-OPPT-2004-0113 L: EPA website on PFOA, http://www.epa.gov/opptintr/pfoa/pubs/pfoastewardship.htm M: Exemptions Analysis: LVE File N: Draft 25 Anniversary Report for the New Chemicals Program O: A-76 Competition-New Chemicals

Does the performance of this program compare favorably to other programs, including government, private, etc., with similar purpose and goals?

Explanation: Chemical substances not covered under TSCA include pesticides, tobacco, ammunition, special nuclear material, food, food additives, drugs, and cosmetics.[A] No other U.S. government program has a purpose or goals similar to that of the CRRR for the chemical substances covered by TSCA. The programs established by other government agencies to implement laws concerning such chemicals address a limited scope (e.g., exposures in the workplace). TSCA provides EPA with comprehensive authority to regulate the entire life cycle of a chemical. Aspects of the CRRR have served as a model for other government programs. For example, NCP is a model and template for the FDA's Food Contact Substance pre-market notification program. FDA's program, established in 1999, has similar purpose and goals as EPA's NCP: both programs act as gatekeepers to protect public health by reviewing chemicals to be introduced into commerce. In 2005, GAO compared chemical review/control under TSCA with the Canadian Environmental Protection Act (CEPA), the current European Union (EU) legislation, and the proposed EU legislation known as REACH.[G] GAO noted that TSCA requires chemical companies to submit data in their possession on chemicals' effects, potential exposures and physicochemical properties for EPA's review. EPA relies instead on SAR models to predict a new chemical's properties and toxicity, as needed. Under REACH, chemical companies would be required to develop and submit such data with the initial notification and before the chemicals reach certain levels of production.[G] Published international reviews have found that the NCP SAR process is comparable to the EU approach, while supportive of innovation in the chemical industry.[H, I] The study conducted by the European Commission [I] recognized the NCP's relative advantages for fostering innovation in the commercialization of new chemicals when compared to EU and Japanese new chemicals systems. The number of new chemical patents and the lower financial barriers to market entry were evidence of NCP's competitiveness advantage. The HPV Challenge Program compares favorably with similar programs initiated by the private sector and foreign governments. The HPV Challenge is based on the OECD SIDS Program, which established a set of endpoints for screening HPV chemicals for human and environmental hazards.[B, C] Following the announcement of the HPV Challenge Program, the International Council of Chemical Associations (ICCA) established a complementary program, the HPV Chemicals Initiative, to generate screening level hazard data for the OECD SIDS Program.[D] EPA designed its HPV program to ensure no duplication of effort under the three programs. While no formal analyses comparing the HPV Challenge Program to these other programs have been conducted, the HPV Challenge Program has received direct commitments for 1,385 chemicals compared to commitments of 300 chemicals in the OECD Program and commitments of 865 chemicals in the ICCA Initiative. A unique aspect of the HPV Challenge Program is that data are quickly and efficiently made publicly available on EPA's website and HPVIS. EPA has received and made publicly available screening level data on 1,354 HPV chemicals as of March 2007. Accessibility to data received under the OECD SIDS and ICCA programs is much slower. The HPV Challenge Program has also served as a model for similar initiatives. The Japan HPV Challenge Program is modeled after the U.S. HPV Challenge and focuses on HPV chemicals not already covered in the U.S. or OECD programs. [E] Also, the American Chemistry Council, among others, recently initiated the Extended High Production Volume Program, a voluntary, industry-led initiative under which industry sponsors collect and make available screening data for "new" HPV chemicals, i.e., those not included in the U.S. HPV Challenge.[F]

Evidence: A: TSCA, Subchapter I (Control of Toxic Substances) (15 USC) http://www.access.gpo.gov/uscode/title15/chapter53_subchapteri_.html B: U.S. High Production Volume (HPV) Challenge Program website http://www.epa.gov/chemrtk/ C: OECD Cooperation on the Investigation of Existing Chemicals website http://www.oecd.org/department/0,2688,en_2649_34379_1_1_1_1_1,00.html D: International Council of Chemical Associations, ICCA High Production Volume (HPV) Chemicals Initiative. http://www.icca-chem.org/section02b.html E. Tanaka, Hideaki. 2006. Outline of the Japan HPV Challenge Program. Austin, TX: First U.S. Conference on Characterizing Chemicals in Commerce: Using Data on High Production Volume (HPV) Chemicals. December 12-14, 2006. http://www.newmoa.org/prevention/chemicalspolicy/hpv/presentations/JPHPV%20(Tanaka).ppt F: American Chemistry Council, Extended HPV Program Announcement. http://www.americanchemistry.com/s_acc/sec_acc_rcol.asp?SID=1&VID=120&CID=199&DID=530&RTID=0&CIDQS=&Taxonomy=&specialSearch= G: GAO. 2005. Chemical Regulation: Approaches in the United States, Canada, and the Eurpoean Union. http://www.gao.gov/new.items/d06217r.pdf H: USEPA/EC Joint Project on the Evaluation of the (Quantitative) Structure Activity Relationships, EPA 743-R-94-01/, March 1994 (Environment Monograph No. 88, OCDE/GD(94)28, Paris, 1994). This report provides the results of a study conducted on the predictive power of (Q)SAR analysis. It was concluded that "The MPD/SAR exercise served to confirm that the SAR approach to screening new chemicals is useful and effective in identifying chemicals that may be toxic and in need of further scrutiny....." The study identified several areas in which SAR predicts less well under the conditions of the study, and in response the NCP modified its regulatory approach so that when a specific test might significantly improve the NCP's ability to assess a new chemical's hazard or risk, these tests are considered for inclusion within the Program's normal regulatory approach. http://www.epa.gov/opptintr/newchems/pubs/ene4147.pdf I: The European Commission JRC-IPTS and the Enterprise DG: Regulation and Innovation in the Chemical Industry, October, 2000 (EUR 19735EN). This was a comparative study analyzing the impact of the notification systems for new substances on innovation in the chemicals sector in the EU, Japan and the U.S.A. The study concluded that "The companies in the U.S.A. are confronted with the most efficient risk-oriented chemicals control system. That system provides exemptions that promote innovation." http://www.jrc.es/home/pages/detail.cfm?prs=467

Do independent evaluations of sufficient scope and quality indicate that the program is effective and achieving results?

Explanation: The program has been evaluated several times in the last 7 years. The most recent a General Accountability Office 2005 Report titled "Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program" (GAO-05-458). This report addresses effectiveness by focusing on EPA's efforts with this program "to control risks of new chemicals not yet in commerce and assess the risks of existing chemcials used in commerce." This is the main purpose of the program which is identifying and managing "unreasonable risk" to human health and the environment associated with production and disposal of chemicals in US commerce. The following is a brief explanation of the evaluations. The GAO assessment of EPA chemical regulations [C] presented findings specific to the review and assessment of new chemicals, documenting that despite limitations in the information available on new chemicals, EPA's reviews of new chemicals have resulted in numerous control actions. EPA's reviews have resulted in some form of action being taken to reduce the risks associated with over 3,500 new chemicals. "These actions ranged from chemical companies voluntarily withdrawing their notices of intent to manufacture new chemicals, chemical companies entering into consent orders with EPA to produce a chemical under specified conditions, and EPA promulgating significant new use rules requiring chemical companies to notify EPA of their intent to manufacture or process certain chemicals for new uses prior to manufacturing or processing the chemicals for such uses." [D] However, for the Existing Chemicals program this GAO report identifies that EPA has limited information on health and environmental risks. The report does acknowledge that the High Production Volume program will provide basic data on the characteristics of about 2,800 existing chemicals produced in excess of 1 million pounds a year. In addition, the two studies by the European Commission (EC) further demonstrate the success of NCP results. The first study, "Regulation and Innovation in the Chemical Industry," [ E] demonstrates that the U.S. NCP is better designed to minimize government constraints on private sector innovation when compared to the parallel E.U. program. The second study, "U.S. EPA/EC Joint Project on the Evaluation of (Quantitative) Structure Activity Relationships," [ F] found that EPA's cost effective SAR method for hazard assessment of new chemicals resulted in similar hazard judgments when compared to results obtained with the E.U.'s "base set testing". As stated in the report: "...the SAR approach ...is useful and effective in identifying..." hazards of new chemicals. The study recognized that the U.S. methods for assessing health and environmental effects were effective (with accuracy for various endpoints ranging from 82-94%) but, like any tool, could be improved [ F]. Based on these reports, EPA took actions to improve its assessment methods and modify its regulatory and testing policies The Environmental Defense (ED) study referenced in 2.6 concluded that the HPV program, by far the largest component of the Existing Chemicals Program "is poised to dramatically increase public access to basic hazard data on the chemicals used in the largest amounts in U.S. commerce." [A] ED found that the program has greatly accelerated the rate of screening-level testing beyond what has been observed in the past, demonstrating the program's impact and effectiveness in achieving its aims only a few years after being initiated.In a June 2004 follow-up to this initial report, ED gave recommendations encouraging corporate sponsorship of the relatively small (but significant) number of chemicals that remained "orphans." [B]

Evidence: A. Environmental Defense, "Facing the Challenge: A Status Report on the U.S. HPV Challenge Program," 2003. File name: Environmental Defense_2684_Facing the ChallengeExec.pdf Page 7 B. Environmental Defense, "Orphan Chemicals in the HPV Challenge: A Status Report," June 2004. File name: Env. Defense Status Report Orphan Chemicals.pdf C. File name: GAO.05.458. June 2005.Chemical Regulation Options Exist to Improve EPA's Ability to Assess Health Risks and Manage its Chemical Review Program.pdf Link: www.gao.gov/cgi-bin/getrpt?GAO-05-458 D. File name: GAO.05.458. June 2005.Chemical Regulation Options Exist to Improve EPA's Ability to Assess Health Risks and Manage its Chemical Review Program.pdf page 16 Link: www.gao.gov/cgi-bin/getrpt?GAO-05-458 E. Executive Summary from October, 2000, EC Joint Research Centre report on "Regulation and Innovation in the Chemical Industry". ftp://ftp.jrc.es/pub/EURdoc/eur19735en.pdf or http://scholar.google.com/scholar?hl=en&lr=&q=cache:7ZhLd1CAkFsJ:www.teesvalley-jsu.gov.uk/dicidauk/keyissues/chemstrat/eur19735en.pdf+EC+Joint+Research+Centre++%E2%80%9CRegulation+and+Innovation+in+the+Chemical+Industry%E2%80%9D+October+2000 F. OECD Environment Monographs, No. 88 and EPA 743-R-94-001, see http://www.epa.gov/opptintr/newchems/pubs/ene4147.pdf; United States-Canada-European Union Staff Exchange documents .