THE PROBLEM

A democratic, accountable, and effective government, and an engaged and participatory citizenry, rely on an open and informed exchange of ideas. Information of all types — economic, scientific, technical, and social — is critical to a well functioning democracy. Government policymakers at all levels of the U.S. federal system, and those affected by the decisions made, rely on information collected, analyzed, and disseminated by federal agencies. Whether providing information for private financial markets or determining the safety of foods at the local market, all segments of society need reliable, accurate information.

In the regulatory arena, accurate and timely information is critical to setting standards protective of health and safety. It is critical to helping the regulated community understand how to formulate voluntary standards for regulatory compliance. Equally important are the processes for determining what information should be included in regulatory decision making. The processes for determining whether a new bridge design will meet adequate weight support limits, or whether an adequate margin of safety exists to protect the public from exposure to chemical toxins in drinking water, should be sufficiently open and transparent to provide the public and those tasked with implementing government policies with confidence that the public will be protected.

Beginning 28 years ago with the advent of centralized review of agencies' proposed regulations, presidents have exerted some control over the substance of regulations. Sometimes that meant trying to control the information — usually scientific information — that went into promulgating the regulations. The current regulatory process, however, consists of unprecedented levels of restrictions, manipulation, and suppression of scientific information essential to regulatory decision making. Some major industries and their representatives have made a concentrated effort at the federal level to create a perception that there is too much scientific uncertainty, thus weakening the case for regulations.

Additionally, agency expertise is too often ignored by political appointees. While ultimately, regulatory decisions are made by political appointees, an accountable system ensures that agency decisions are formulated based on the best available information from experts within the agency, as well as others. Such a model would preclude manipulation of science, suppression of data, or silencing the voice of agency scientists. Two examples illustrate the problem:

• Former Consumer Product Safety Commission statistician Robin Ingle collected statistics on injuries and fatalities from all-terrain vehicle (ATV) accidents. The results indicated that in 2004, deaths and injuries were at a 20-year high. The general counsel at the agency tried to insert language into the executive summary of Ingle's report indicating the risk of riding these vehicles was decreasing. The general counsel at the time had been a lawyer for the ATV industry.¹


• The Department of Interior's Inspector General (IG) investigated former deputy assistant secretary for fish, wildlife and parks Julie A. MacDonald and found she had intimidated staff and changed the scientific information agency scientists developed for decisions about listing or delisting threatened or endangered species. The IG's report was released to Congress the week of March 26, 2007, and showed MacDonald's involvement in "editing, commenting on, and reshaping the Endangered Species Program's scientific reports from the field."² 

SUMMARY OF RECOMMENDATIONS

An accountable and responsive regulatory process must generate independent and credible information to be used in regulatory policy decisions. Agencies should have the most reliable scientific and technical information available from the scientific community and adhere to the highest principles of scientific integrity. Both the process and the information derived therefrom must be free from political interference. Government-sponsored research must be insulated from political interference. Agency experts, federal advisory committees, peer reviewers, and other experts involved in the design, conduct, and analysis of government research and regulations should be free from interference from political appointees within the agency and within White House offices. They should be free from political harassment and censorship and free to disclose information considered relevant to the recommendations they forward to policymakers. Agency experts must have access to and be able to generate independent scientific, technical, economic, and social information.

The recommendations below mostly address the need to restore scientific integrity to the process. They focus on: 1) ways the public can hold government officials accountable for the actions they take on behalf of the citizens that rely on them; and 2) the need to ensure that information critical to policy decisions is independently developed and constitutes the best thinking that can be brought to solving policy problems. In conjunction with transparency recommendations that stress the importance of disclosing the range of meetings and materials relevant to agencies' regulatory decisions in agency dockets, these recommendations can begin to restore integrity and accountability in the regulatory process. As with other sections in this report, the definition of "regulation" includes permitting, licensing, and other activities that provide controlling actions. 

DETAILED RECOMMENDATIONS

B.1.   The president should instruct his agency heads that scientific integrity must be a core component of regulatory actions. The president should send a clear message early in the new administration that federal agencies will adhere to the highest principles of scientific integrity and independence. Although this message can be sent in several ways, such as appointing a high-level science advisor and expanding the network of executive branch advisory panels, the message must be that the government will apply the highest standards of scientific integrity and that this is a critical aspect of an improved regulatory system. The government must be committed to having the most reliable scientific and technical information available, both from expertise within agencies and from the larger scientific community, and using that information in an objective and transparent fashion as the foundation for decisions affecting the public interest.

B.2.   Federal protections for public and private sector whistleblowers need to be strengthened to serve as a check on misconduct. Whistleblower protections are the backstop for accountability in government. Time and again, dedicated civil servants have stepped up to talk about misconduct in government science, regulation, and general decision making that can cost lives and money. Necessary improvements include:

• Strengthening the Office of Special Counsel's processes for reporting misconduct and corruption, reviewing whistleblowers' claims, and protecting from retaliation those who report abuses in good faith;
• Allowing whistleblowers to disclose to any member of Congress information regarding government misconduct or corruption;
• Strengthening the independence of agencies' inspectors general, along with creating and streamlining the mechanisms to permit agency employees to report misconduct anonymously; and
• Evaluating the effectiveness of the implementation of whistleblower reforms within agencies. 

Both houses of the 110th Congress passed legislation to address loopholes in the Whistleblower Protection Act of 1989, which has been weakened by subsequent court rulings.³ The stronger protections in the House bill include due process protections for federal whistleblowers experiencing retaliation from co-workers and employers. The president should encourage the new Congress to pass legislation quickly in each house, reconcile their differences, and send him legislation early in 2009.

On August 14, President Bush signed the Consumer Product Safety Improvement Act of 2008, which provides whistleblower protections to nearly 20 million private sector workers in the manufacturing, distribution, and sale of consumer products such as children's products and household goods. The new law provides protections, enforceable by jury trials, for workers who disclose product safety violations or refuse to engage in illegal behavior.

Congress should extend the model established under the Consumer Product Safety Improvement Act of 2008 to other industries regulated by the federal government.

The president should make clear early in the administration that he stands for strong government accountability and the independence of public information. The president should highlight the importance of whistleblower protections for federal employees.

B.3.   Strengthen the Federal Advisory Committee Act (FACA). Science advisory committees are a vital means through which agencies obtain valuable advice and information. Agencies use scientific committees and stakeholder or policy committees for different purposes. Scientific committees are used to provide agencies with expert advice and analysis of the complex scientific information critical to informing final decisions about public health or environmental quality standards, for example. Stakeholder or policy committees may be used to actively solicit the opinions of stakeholders who have expertise and are likely to be the parties impacted by regulatory actions. For example, the Department of Interior may wish to solicit the advice of western ranchers who may be affected by changes to policies about grazing practices on federal lands. Candidates for service on a federal advisory committee may be named either as "representatives," those who voice the views of specific interested parties, or "special government employees" (SGEs), those chosen to provide objective analysis and advice. It is important to note these differences when considering new ways of strengthening the use of these committees.

In some cases, agencies have stacked science advisory committees with representatives of special interests, thereby endangering the independence of the advice the FACA committees dispense.⁴ The president should emphasize to agencies the importance of implementing the intent and spirit of FACA.

Congress should consider strengthening FACA in several ways:

• Require agencies to appoint to scientific advisory committees individuals from the disciplines relevant to solving the charge of the advisory committee. Such appointments should be made without consideration of political affiliation or activity.
• End the practice of hiring private contractors to develop advisory committees to avoid FACA requirements. This practice has been used by some agencies to claim under a legal loophole that they do not have strict management over the committees. Congress should close this loophole.
• Extend FACA requirements to all subgroups of covered advisory committees.
• Make the processes by which committees operate and their members are selected fully transparent. For example:
  • Agencies should announce publicly any plans to form a new FACA committee, disclose the expected charge to the committee, and solicit nominations from the public for committee membership.
  • Agencies should disclose committee nominations and appointments on their websites so that the information is easily accessible; the names of appointees (and perhaps, the names of nominees similar, to the approaches used by the National Academy of Sciences (NAS) and the Environmental Protection Agency (EPA) for specific science advisory boards⁵) and any conflicts of interest or potential biases, as well as any waivers of conflicts should be included. Agencies should also provide a limited time for public comment on the appointments of committee members.
  • Agencies should disclose on their websites the records of all committee and subgroup meetings, the members of all committees and subgroups, and the transcripts or electronic records of any meeting. 

B.4.   Improve conflicts of interest laws. Special Government Employees (SGEs) are currently subject to the conflict of interest provisions of FACA, provisions that are enforced by the Office of Government Ethics. We believe there is a need for specific FACA conflict of interest guidelines.

As noted above in B.3, FACA committees may be used for different purposes. For scientific committees, the goal should be to establish a government-wide policy that strives for an absence of real and apparent conflicts of interest for committee membership. One model for accomplishing this policy is the approach taken by the World Health Organization's International Agency for Research on Cancer (IARC). Membership in IARC Working Groups is based on "(a) knowledge and experience and (b) absence of real or apparent conflicts of interests. Consideration is also given to demographic diversity and balance of scientific findings and views."⁶ The model recognizes that there may be instances in which special expertise is needed and may have to come from those who have real or apparent conflicts. In these instances, the "invited specialists" are limited in the ways in which they can participate in a working group.

B.5.   Disclose the scientific, technical, economic, and social analyses used in the formation and promulgation of regulatory documents. The information that forms the foundation of regulatory decisions is too often unavailable or hidden from public view. The labeling of information as classified business information (CBI) is overused, agency rulemaking dockets are not easily available, and studies are often used selectively to justify a predetermined policy outcome.

As recommended in D.1.a, all research results considered in the promulgation of regulations should be made part of the agency's rulemaking docket, which should be made available in an online searchable format. The docket should include all supporting materials — regardless of their source — unless classified or otherwise exempted by FOIA.

More specifically:

• The burden of justifying confidential business information (CBI) should be shifted to those making such claims on information critical to a substantive regulatory decision. The justification warranting the protection should be provided prior to receiving the protection and certified by a senior executive of the business requesting the protection. This approach has worked successfully in several programs, including the Toxics Release Inventory operated by the EPA. The president has substantial authority to make this shift in certain areas.


• Increasingly, information that may be important to a rulemaking is being categorized as critical infrastructure information or sensitive but unclassified. These control markings have been interpreted in an uneven manner throughout the government, oftentimes resulting in less disclosure of the information. On May 9, 2008, President George W. Bush issued a memo to agency heads that created a tiered system of designations to standardize the proliferation of these control markings under the name "Controlled Unclassified Information."⁷ The president should refine this CUI policy by reining in the use of CUI designations and making very clear that a CUI control marking has no bearing on whether the information should be disclosed under FOIA; and


• Congress should consider legislation to require the disclosure of privately sponsored research used in the regulatory process in the same way that public research should be disclosed. Agencies must often rely on private research to develop regulations. Disclosure of privately sponsored research that identifies the extent to which the sponsor controlled the research design, analysis, and reporting of the results is necessary so the public and the agencies can judge the soundness of the research. This change would bring privately funded research under similar disclosure requirements that now exist for publicly funded research under the Shelby Amendment.⁸ (See Recommendation D.1.a.)


• The president should establish a new standard of disclosure regarding non-governmental challenges to research and data used by agencies. Currently, agencies can face challenges of government-sponsored science used in rulemakings without the challenger submitting evidence of factual errors or flawed science. These challenges may call for other science to be considered instead of, or in addition to, the studies used by agencies. The president should establish a new standard that requires the challenger to submit evidence of errors in the agencies' use of science and ensure that the underlying data used for the challenge is available for public inspection for challenges to be considered valid. 

B.6.   Resurrect the Office of Technology Assessment (OTA). As previously constituted, OTA provided Congress and the scientific and technical communities with objective analyses of a wide range of scientific, technical, and comparative policy knowledge. Reconstituting OTA would provide Congress with its own scientific and technical research arm that could complement and/or check executive agencies. Congress should resurrect the OTA with sufficient funds to operate effectively and appoint a well respected scientist to head the office.

Unlike the National Academy of Sciences, which focuses on long-term analysis of scientific information, OTA was able to respond to short-term congressional needs for specialized knowledge that Congress's other two research arms, the Government Accountability Office and Congressional Research Service, cannot provide.

B.7.   For key areas of international health and safety regulation affecting Americans and U.S. businesses, Congress and the president should call for greater transparency in order to make the process more democratic. Consumers are living in a global economy, and it is vital that consumer, labor, and environmental standards be upheld as the U.S. meets its obligations under various trade agreements. Some standard-setting bodies, like the Codex Alimentarius, which establishes food standards for international trade, are operating in the absence of full transparency. Consumer organizations can only participate if they are part of an international coalition approved by the World Health Organization. All interests should have the same opportunity to influence and preview the positions taken in international fora.

The president should allow full access to documents and ensure that the rights of U.S. organizations and citizens to comment are fully preserved. The president, along with Congress, should advocate for full disclosure and open meetings for international bodies that set standards with international implications. If international standards are affecting American consumers or businesses, we believe Americans should have a place to go to find out what is required of them, and there should be an opportunity for them to make their voices heard.

B.8.   The president should encourage agency heads to adopt (or modify) guidelines to allow scientists to communicate freely. Federal scientists in some agencies are prevented from speaking with the media, the public, and even their professional colleagues. Instead, questions about the scientific studies are directed to public affairs officers, not scientists who conducted or know about the research in question. The president should encourage agencies to adopt media polices that respect two basic rights of scientific communications: 1) like any other federal employee, scientists have a right to express their personal views, with the express disclaimer that they are speaking as private citizens and not representing official agency policy; and 2) scientists have the right to review, approve, and comment publicly on publications or documents that rely significantly on their research or identify them as an author or contributor to ensure the accuracy of the information has been maintained during internal agency review processes.

B.9.   Agencies should abstain from inappropriate interference in the work of other agencies and end secretive interagency reviews of scientific and technical information. Congress delegates responsibilities to federal agencies based on its determination of which agency is most suited to fulfill certain duties. Congress may consider which agency possesses the requisite expertise to competently address a task and will consider whether that agency's mission is consistent with statutory goals.

However, agencies may also have an interest in the work of other agencies with delegated authority from Congress, and, in some cases, one agency's decision may directly impact the operation of another. For example, under the Resource Conservation and Recovery Act, EPA can order the clean up of dangerously polluted land on both private and government property. But the Department of Defense (DOD) has refused to abide by official EPA clean-up orders for three military bases. The Department of Defense has even asked the White House to intervene on its behalf.⁹

The president should ensure that when these kinds of disputes arise, agencies defer to the agency given responsibility under federal law. Agencies subject to another agency's regulations must not be allowed to delay decisions or usurp power. The primary function of regulatory agencies is to carry out federal law. Other agencies have the right to comment and make known their interest in the issues and regulations that affect them, but they should not undermine the work of the agencies given the statutory responsibility for rulemakings.

The president should also terminate inappropriate interagency review and control of scientific and technical information that serves as the basis of rulemaking. For example, the interagency review process of toxicology profiles performed under EPA's Integrated Risk Information System allows other agencies potentially impacted by the assessments to direct EPA's scientific investigations and limits the dissemination of scientific information to the public. The review affords agencies that use toxic substances, such as DOD or NASA, multiple opportunities to delay, dispute, or alter EPA's scientific research and conclusions. Such reviews can interfere with and ultimately affect the outcome of a rulemaking.

There is a clear distinction between assessing the impacts of risks to the public and the policies for managing those risks. Scientific integrity is at greatest risk in situations where considerations other than science determine the assessments. Other considerations, including political considerations, are properly included in decisions about risk management and communication. Those considerations should not be a part of the assessment process. (See Recommendation A.6.)

The president should clarify which agencies have primary authority in various areas of expertise and limit the review of scientific or technical information by other agencies to advice and comment. When review does take place, the process should be completely transparent, and the comments of other agencies should be disclosed online. 

ENDNOTES

1. Robin Ingle, "Which Toys Are Okay? Don't Ask the Safety Police," The Washington Post, December 23, 2007, available at http://www.washingtonpost.com/wp-dyn/content/article/2007/12/21/AR200712..., last accessed October 6, 2008.
2. U.S. Department of the Interior, Office of Inspector General, Investigative Report On Allegations Against Julie MacDonald, Deputy Assistant Secretary, Fish, Wildlife and Parks, available at http://www.doioig.gov/upload/Macdonald.pdf, last accessed October 6, 2008.
3. See H.R. 985, the Whistleblower Protection Enhancement Act of 2007, and S. 274, Federal Employee Protection of Disclosures Act.
4. U.S. Government Accountability Office, Federal Advisory Committees: Additional Guidance Could Help Agencies Better Ensure Independence and Balance, April 2004, available at http://www.gao.gov/new.items/d04328.pdf, last accessed September 24, 2008.
5. See, for example, EPA's Clean Air Scientific Advisory Committee (SAB) approach to forming an SAB Asbestos Panel in 2006-2007. EPA published in the Federal Register a notice request for nominations to the panel, sought comments on the short list of nominees, and then published another request for additional expertise for the panel. Documents are available at http://www.epa.gov/sab/panels/asbestos_expert_panel.htm, last accessed September 26, 2008.
6. World Health Organization, International Agency for Research on Cancer, "Preamble to the IARC Monographs, A. General Principles and Procedures," January 23, 2006, available at http://monographs.iarc.fr/ENG/Preamble/currenta5participants0706.php, last accessed September 26, 2008.
7. President George Bush, "Designation and Sharing of Controlled Unclassified Information (CUI)," Memorandum For The Heads Of Executive Departments and Agencies, May 9, 2008, available at http://www.whitehouse.gov/news/releases/2008/05/20080509-6.html, last accessed October 3, 2008.
8. The Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999. Public Law No. 105-277, also called the Data Access Act, available at http://thomas.loc.gov/cgi-bin/toGPObss/http://frwebgate.access.gpo.gov/c..., last accessed October 23, 2008.
9. Lyndsey Layton, "Pentagon Fights EPA On Pollution Cleanup," The Washington Post, June 30, 2008, available at http://www.washingtonpost.com/wp-dyn/content/article/2008/06/29/AR200806..., last accessed October 6, 2008.
10. John B. Stephenson, "Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA's Integrated Risk Information System," United States Government Accountability Office, GAO-08-440, March 2008, 35-37. Available electronically at www.gao.gov/new.items/d08440.pdf.