scientificbasis.pdf

Scientific Basis for Environmental Regulation Public Disclosure and Federal Rulemaking and Advisory Activities

The scientific basis o f regulation is a long-standing is­sue. In the 114th Congress, two bills have been referred for House floor consideration (H.R. 1029 and H.R. 1030) that would address the public disclosure and transparency o f scientific and technical information used as the basis for environmental regulations and other related actions o f the Environmental Protection Agency (EPA). A bill addressing similar purposes has been introduced in the Senate (S. 343).

Both H.R. 1029 and H.R. 1030 would amend the En­ vironmental Research, Development, and Dem onstration Authorization Act o f 1978 (ERDDAA), as amended, to require public disclosure o f scientific and technical infor­ mation that EPA uses as a basis for agency action. Some critics have argued that the bills may implicate confidenti­ ality and privacy of personal information if scientific and technical documents or other materials contain such infor­ mation (e.g., personal health conditions or effects and per­ sonal identifying inform ation about individuals who voluntarily participate in hum an testing). However, certain statutes, such as the Freedom o f Information Act (FOIA) and the Privacy Act, address what information the Federal Government is required or perm itted to disclose. Both bills would be implemented in the context of these statutes.

In addition to provisions that address public disclosure, H.R. 1029, the EPA Science Advisory Board Reform Act o f 2015, would revise the process for selecting members of EPA’s Science Advisory Board (SAB), address potential con­ flicts o f interest between board mem ber affiliations and matters subject to board review, and revise the board’s role in advising EPA on consideration o f scientific information in carrying out the agency’s mission.

■ EPA Science Advisory Board Reform Act

As reported by House Committee Report 114-33 on March 2, 2015, H.R. 1029 would amend Section 8 o f ERDDAA

From the Library o f Congress, Congressional Research Service CRS Insights report Scientific Basis o f Environmental Pro­ tection Agency Actions: H.R. 1029 and H.R. 1030, March 11, 2015. See http://fas.org/sgp/crs/misc/IN10244.pdf.

to “provide for Science Advisory Board member qualifica­ tions, public participation, and for other purposes.” Vari­ ous provisions o f the bill would codify in statute certain existing procedures that are similar in practical terms, whereas other provisions would establish new requirements. The bill would establish a nom ination and selection pro­ cess for members o f the SAB.

The Federal Advisory Com m ittee Act (FACA) is the general statute that governs the establishment o f the SAB and other Federal advisory committees across departments and agencies. FACA also establishes various requirements for public involvement in Federal advisory committee ac­ tivities. H .R. 1029 would expand public involvement re­ quirements for SAB only.

The nom ination and selection process for the SAB pro­ posed in H.R. 1029 would include opportunities for pub­ lic involvement and require public disclosure of qualifications and affiliations (including financial interests) o f nominees to the board. Additionally, the bill would di­ rect the composition o f SAB membership to include repre­ sentation from state, local, or tribal governments and would explicitly exclude “registered lobbyists.”

In addition to membership, H.R. 1029 would address the role o f the board in conducting scientific reviews, in­ cluding the avoidance o f potential conflicts o f interest in instances in which a member may be associated with activi­ ties subject to the board’s review. T he bill would also ex­ pand the documents subject to SAB review to include draft or proposed risk or hazard assessments, criteria documents, standards, limitations, or regulations.

T he bill would also amend Sections 8(h) and 8(i) of ERDDAA in their entirety. The new Section 8(h) would require EPA to make all reports and relevant scientific in­ formation available to the public concurrently when that information is made available to the SAB. T he bill would further require certain levels of public involvement in spe­ cific stages o f board reviews, from the development o f the scope o f a review to the performance o f the review. The bill would also require that SAB reviews be made publicly avail­ able in the Federal Register. In recent years, the board has typically released its findings on EPA’s website.

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Scientific Basis CBO Cost Analysis

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The new Section 8(i) would require the SAB to focus its reviews on rendering scientific determinations, “strive to avoid making policy determinations or recommendations,” “clearly” communicate scientific uncertainties, and disclose dissenting views among board members. The bill would also require the SAB to periodically assess whether its reviews are “addressing the most important scientific issues affecting” EPA.

Although H.R. 1029 would establish specific require­ ments for the membership and operations o f the SAB, the bill would also clarify that none o f its provisions would sup­ plant requirements o f two other laws — FACA and the Eth­ ics in Government Act of 1978. B

■ Secret Science Reform Act

As reported on March 2, 2015, H.R. 1030, the Secret Sci­ ence Reform Act o f 2015 (House Committee Report 114- 34) would broadly address the public availability of scientific and technical information used to support specific catego­ ries of EPA actions. H.R. 1029, discussed above, would ad­ dress the public availability o f EPA scientific and technical information more specifically in the context of SAB reviews.

H.R. 1030 would amend Section 6(b) of ERDDAA to authorize EPA to propose, finalize, or disseminate informa­ tion on specific types of “covered actions” only if the scien­ tific and technical information relied on to support those actions are “the best available science,” specifically identified, and made publicly available online. The bill defines these cov­ ered actions to include risk, exposure, or hazard assessments; criteria documents; standards; limitations; regulations; regu­ latory impact analyses; or guidance. Scientific and technical information is defined as materials, data, and research proto­ cols; computer codes and models; facts; and methodologies.

Although H.R. 1030 would generally require public disclosure of scientific and technical information, the bill would limit this requirement to such information only to the extent that the inform ation would be necessary “for independent analysis and substantial reproduction of re­ search results.” Information not necessary for these purposes would not require disclosure under the bill but would be subject to EPA’s discretion and other applicable statutes such as FOIA and the Privacy Act.

Whereas H.R. 1030 would establish these responsibili­ ties o f EPA, the bill would limit the agency to obligating no more than $ 1 million in annual appropriations for these specific disclosure purposes. ■

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Thus, the costs o f implementing H.R. 1030 would ul­ timately depend on how EPA adapts to the bill’s require­ ments. (It w ould also depend on the availability of appropriated funds to conduct the additional data collec­ tion and database construction activities and related coor­ dination and reporting activities under the legislation.)

CB O expects that EPA would modify its practices, at least to some extent, and would base its future work on fewer scientific studies, and especially those studies that have eas­ ily accessible or transparent data. Any such modification o f EPA practices would also have to take into consideration the concern that the quality o f the agency’s work could be compromised if that work relies on a significantly smaller collection of scientific studies; we expect that the agency would seek to reduce its reliance on numerous studies with­ out sacrificing the quality o f the agency’s covered actions related to research and development.

O n balance — recognizing the significant uncertainty regarding EPA’s potential actions under the bill — CBO ex­ pects that the agency would probably cut the num ber of studies it relies on by about one-half and that the agency would aim to limit the costs o f new activities required by the bill, such as data collection, correspondence and coor­ dination with study authors, construction o f a database to house necessary information, and public dissemination of such information.

As a result, CBO estimates the incremental costs to the agency would be around $250 million a year initially, sub­ ject to appropriation o f the necessary amounts. In our as­ sessment, that figure lies near the middle of a broad range o f possible outcomes under H.R. 1030. CBO expects that the additional costs to im plem ent the legislation would decline over time as EPA became more adept and efficient at working with authors and researchers to ensure that the data used to support studies are provided in a standardized and replicable form. ■

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