OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION (OCSPP)

OCSPP primarily oversees the regulation of new and existing chemicals under the Toxic Substances Control Act (TSCA)38 and the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)39 and Federal Food, Drug, and Cosmetic Act (FFDCA).40 These activities are managed in two separate offices within OCSPP: the Office of Pollution Prevention and Toxics (OPPT, chemicals) and Office of Pesticide Programs (OPP, pesticides). OCSPP is constantly pressured to ban the use of certain chemicals, typically based on fear as a result of mischaracterized or incomplete science.

Needed Reforms and New Policy in OPPT (Chemicals)

Ensure that decision-making is risk-based rather than defaulting to precautionary, hazard-based approaches like the Integrated Risk Information System (IRIS). Focus the scope of chemical evaluations on pathways of exposure that are not covered by other program offices and other environmental statutes, and eliminate scope creep to ensure that evaluations can be completed in a timely manner consistent with the statutory requirements.

For new chemicals, reset the program to ensure that reviews are completed on a timeline that is consistent with the statute. This includes revising the regulations governing the reviews of new chemicals. Ensure that risk evaluations and risk management rules presume that workplaces are following all OSHA requirements, including requirements for personal protective equipment (PPE).

Apply real-world use of chemicals when assessing conditions of use for risk evaluations.

Transition the Safer Choice program to the private sector. Right-size the TSCA fee’s rule so that it is consistent with the tasks that the agency is actually completing within the timelines of the statute and is not covering the costs of EPA inefficiency or overreach.

Ensure that new chemical evaluations are conducted in a timely manner, consistent with statutory requirements, to ensure the competitiveness of U.S. manufacturers.

Revise existing policies to address the requirements of the 2016 Lautenberg amendments to the TSCA.41 Develop a framework rule for risk management approaches that will be used under TSCA for existing chemicals.

Needed Reforms and New Policy in OPP (Pesticides) l OPP should rely on Department of Agriculture and state usage data that reflect actual pesticide use in registration reviews and Endangered Species Act (ESA)42 analyses. The U.S. Fish and Wildlife Service and National Marine Fisheries Service should rely on similar data in their ESA analyses. OPP has rigorous testing requirements that registrants must meet before pesticides are allowed on the market. However, when pesticides undergo registration review every 15 years, EPA relies on publicly available data with differing levels of quality and transparency. Data standards are needed to ensure that information relied on by EPA is made available to the agency at a similar level as the original testing data conducted by registrants to ensure that EPA can conduct a robust review and analysis of the data.

ESA reform for pesticides is necessary. When approving pesticides, FIFRA allows for cost-benefit balancing, recognizing that pesticides are effective precisely because they harm pests. However, the ESA does not allow for any consideration of the beneficial effects of pesticides. In order to meet ESA obligations, pesticide uses are severely restricted, leaving growers with limited tools for crop protection.

New policies are needed to ensure that other program offices (such as ORD, OW, and OLEM) will defer to OPP on toxicity issues. OPP has rigorous testing requirements for pesticide ingredients and products to ensure before they go to market that their use will not harm human health and the environment. Assessments by other offices are redundant. While individual pesticide registrations are considered adjudications and not reviewed by the Office of Management and Budget (OMB), consistent with a 1993 OMB guidance, when pesticide tolerances and registrations are withdrawn by the agency (as opposed to being withdrawn voluntarily by registrants), these actions should undergo coordinated interagency review managed by OMB. Budget

OFFICE OF RESEARCH AND DEVELOPMENT (ORD) AND RELATED SCIENCE ACTIVITIES

While much of this work has not been authorized by law, EPA conducts a wide variety of intramural and extramural research, development, regulatory science,

The Biden Administration has expanded the scope and breadth of regulatory actions with respect to OPPT and OPP, but both programs continue to maintain that resources are insufficient. OPPT (chemicals) suffers from a lack of leadership and an inability to complete the most basic requirements efficiently and in a timely fashion. While EPA has asked for more resources, including higher industry fees, it is not clear that it has the capacity to use additional dollars efficiently.

With regard to OPP (pesticides), pesticide manufacturers feel that the program is underfunded and would like its budget to be increased so that pesticide actions can be reviewed more quickly. Manufacturers are also willing to pay higher fees to the fee-based portion of the program. However, grower groups have been dis- appointed by EPA’s actions and have significant concerns about EPA’s ability to conduct science-based risk assessments and take risk management actions that appropriately balance benefits and risks as required by FIFRA. Guardrails and third-party audits should be part of any funding increases through the Pesticide Registration Improvement Act (PRIA)43 or other mechanisms.

science advisory, peer review, risk assessment, and risk management activities. This enterprise includes the Office of Research and Development (ORD), the agency’s largest employer, as well as science activities across other key programs, regions, and cross-cutting parts of the Administrator’s office. EPA’s scientific enterprise, including ORD, has rightly been criticized for decades as precautionary, bloated, unaccountable, closed, outcome-driven, hostile to public and legislative input, and inclined to pursue political rather than purely scientific goals.

Needed Reforms: Day One Priorities

Notify Congress that EPA will not conduct any ongoing or planned science activity for which there is not clear and current congressional authorization. This priority should be underscored in the President’s first budget request. The new President’s Inauguration Day regulatory review/freeze directives should avoid exceptions for EPA actions. This freeze should explicitly include quasi-regulatory actions, including assessments, determinations, standards, and guidance, that have failed to go through the notice-and- comment process and may date back years. Pause for review all contracts above $100,000 with a heavy focus on major external peer reviews and regulatory models.

Call for the public to identify areas where EPA has inconsistently assessed risk, failed to use the best science, or participated in research misconduct. Eliminate the use of unauthorized regulatory inputs like the social cost of carbon, black box and proprietary models, and unrealistic climate scenarios, including those based on Representative Concentration Pathway (RCP) 8.5.

Personnel

Quickly nominate a reform-minded Assistant Administrator for Research and Development. Appoint and empower a Science Adviser reporting directly to the Administrator in addition to a substantial investment (no fewer than six senior political appointees) charged with overseeing and reforming EPA research and science activities. Qualifications for these positions should emphasize management, oversight, and execution skills (including in leading state environmental agencies) as opposed to personal scientific output.

Suspend and review the activities of EPA advisory bodies, many of which have not been authorized by Congress or lack independence, balance, and geographic and viewpoint diversity. Retract delegations for key science and risk-assessment decisions from Assistant Administrators, regional offices, and career officials. Eliminate the use of Title 42 hiring authority that allows ORD to spend millions in taxpayer dollars for salaries of certain employees above the civil service scale.

Announce plans to streamline and reform EPA’s poorly coordinated and managed laboratory structure. Budget: Back-to-Basics Rejection of Unauthorized or Expired Science Activities Needed EPA Advisory Body Reforms EPA currently operates 21 federal advisory committees.45 These committees often play an outsized role in determining agency scientific and regulatory policy,

A top priority should be the immediate and consistent rejection of all EPA ORD and science activities that have not been authorized by Congress. In FY 2022, according to EPA’s opaque budgeting efforts, science and technology activ- ities totaled nearly $730 million. EPA’s FY 2023 budget request for the Office of Research and Development seeks funds for more than 1,850 employees—a dramatic increase for what is already the largest EPA office with well above 10 percent of the agency’s workforce.44 ORD conducts a wide-ranging series of science and peer review activities, some in support of regulatory programs established by our envi- ronmental laws, but often lacks authority for these specific endeavors.

Several ORD offices and programs, many of which constitute unaccountable efforts to use scientific determinations to drive regulatory, enforcement, and legal decisions, should be eliminated. The Integrated Risk Information System, for example, was ostensibly designed by EPA to evaluate hazard and dose-response for certain chemicals. Despite operating since the 1980s, the program has never been authorized by Congress and often sets “safe levels” based on questionable science and below background levels, resulting in billions in economic costs.

The program has been criticized by a wide variety of stakeholders: states; Congress; the National Academies of Science, Engineering, and Medicine (NASEM); and the U.S. Government Accountability Office (GAO), among others. EPA has failed to implement meaningful reforms, and this unaccountable program threatens key regulatory processes as well as the integrity of Clean Air Act and TSCA implementation. and their membership has too often been handpicked to achieve certain politi- cal positions. In the Biden Administration, key EPA advisory committees were purged of balanced perspectives, geographic diversity, important regulatory and private-sector experience, and state, local, and tribal expertise. Contrary to con- gressional directives and recommendations from the GAO and intergovernmental associations, these moves eviscerated historic levels of participation on key com- mittees by state, local, and tribal members from 2017 to 2020. As a result, a variety of EPA regulations lack relevant scientific perspectives, increasing the risks of economic fallout and a failure of cooperative federalism. EPA also has repeatedly disregarded legal requirements regarding the role of these advisory committees and the scope of scientific advice on key regulations.46

Needed Science Policy Reforms

Instead of allowing these efforts to be misused for scaremongering risk com- munications and enforcement activities, EPA should embrace so-called citizen science and deputize the public to subject the agency’s science to greater scrutiny, especially in areas of data analysis, identification of scientific flaws, and research misconduct. In addition, EPA should:

Shift responsibility for evaluating misconduct away from its Office of Scientific Integrity, which has been overseen by environmental activists, and toward an independent body.

Work (including with Congress) to provide incentives similar to those under the False Claims Act47 for the public to identify scientific flaws and research misconduct, thereby saving taxpayers from having to bear the costs involved in expending unnecessary resources.

Avoid proprietary, black box models for key regulations. Nearly all major EPA regulations are based on nontransparent models for which the public lacks access or for which significant costs prevent the public from understanding agency analysis.

Reject precautionary default models and uncertainty factors. In the face of uncertainty around associations between certain pollutants and health or welfare endpoints, EPA’s heavy reliance on default assumptions like its low-dose, linear non-threshold model bake orders of magnitude of risk into key regulatory inputs and drive flawed and opaque decisions. Given the disproportionate economic impacts of top-down solutions, EPA should implement an approach that defaults to less restrictive regulatory outcomes.

Refocus its research activities on accountable real-world examinations of the efficacy of its regulations with a heavy emphasis on characterizing and better understanding natural, background, international, and anthropogenic contributions for key pollutants. It should embrace concepts laid out in the 2018 “Back-to-Basics Process for Reviewing National Ambient Air Quality Standards” memo48 to ensure that any science and risk assessment for the NAAQS matches congressional direction.

Legislative Reforms

While some reforms can be achieved administratively (especially in areas where EPA clearly lacks congressional authorization for its activities), Congress should prioritize several EPA science activity reforms:

Reform EPA’s Science Advisory Board and other advisory bodies to ensure independence, balance, transparency, and geographic diversity. Build on recent bipartisan proposals to increase transparency for advisory bodies, subject to the Federal Advisory Committee Act49 as well as recommendations from the Administrative Conference of the U.S., to strengthen provisions for independence, accountability, geographic diversity, turnover, and public participation. This should include a prohibition on peer review activities for unaccountable third parties that lack independence or application of these same principles to non- governmental peer review bodies (including NASEM).

Add teeth to long-standing executive orders, memoranda, recommendations, and other policies to require that EPA regulations are based on transparent, reproducible science as well as that the data and publications resulting from taxpayer-funded activities are made immediately available to the public. Reject funds for programs that have not been authorized by Congress (like IRIS) as well as peer review activities that have not been authorized by Congress.

Revisit and repeal or reform outdated environmental statutes. A high priority should be the repeal or reform of the Global Change Research Act of 1990,50 which has been misused for political purposes.

Use of the Congressional Review Act for Congress to disapprove of EPA regulations and other quasi-regulatory actions and prohibit “substantially similar” actions in the future.

Repeal Inflation Reduction Act programs providing grants for environmental science activities.