Data Quality act: response from the center for regulatory effectiveness.

Sass and Devine assert that the CRE has taken a position with regard to the U.S. EPA's review of the pesticide atrazine that

   [under the new federal Data Quality standards] a
   federal agency may not base any regulatory action
   on scientific research unless it has been performed
   in accordance with a preexisting, government-approved
   test protocol

and that if accepted, this CRE position "could jeopardize the government's ability to consider most published scientific research." Sass and Devine do not fully characterize the CRE's position and the atrazine research issues, nor the U.S. EPA response.

The scientific issue raised by the CRE was the reliability of certain research suggesting that atrazine disrupts endocrine function in frogs. This research was, as Sass and Devine point out, published in peer-reviewed scientific journals. However, the research methods were novel, and attempts to reproduce the experiments in other laboratories failed to produce similar results (Carr et al. 2003). This raised a clear issue of "reliability" under the new federal data quality guidelines [Office of Management and Budget (OMB) 2001, 2002; U.S. EPA 2002]. The CRE took the position that, given this issue, the U.S. EPA could not disseminate information which concluded that atrazine had been found to cause certain endocrine effects in frogs.

The U.S. EPA (2003) agreed with the CRE position and made editorial changes to its atrazine review document to clarify that

   The revised assessment does not suggest that
   endocrine disruption, or potential effects on
   endocrine-mediated pathways, be regarded as a
   legitimate regulatory endpoint at this time.

The U.S. EPA (2003) went on to affirm that it was justified in considering unvalidated research published in the peer-reviewed scientific literature as a means "to identify uncertainties and additional research that may need to be conducted...."

The CRE agrees with this U.S. EPA response (U.S. EPA 2003) and has consistently taken the position that the agency must consider all peer-reviewed scientific studies when it conducts a risk assessment. However, the CRE has also taken the position that after such studies are considered, they cannot be endorsed or used in setting regulatory standards unless they meet the reproducibility and reliability standards of the data quality legislation and guidelines (OMB 2002). Publication of a research article in a peer-reviewed scientific journal does not mean that the research has been accepted as valid by the scientific community and that it should be considered reliable for regulatory purposes. Research is often published because it is believed to contain significant observations, suggest a new hypothesis, or describe potentially useful new test methods or materials. This published research then becomes subject to "postpublication peer review," in which the broader scientific community scrutinizes the methods, materials, and results and attempts to replicate or reproduce the research. Under the data quality guidelines, prepublication peer review raises only a rebuttable presumption of objectivity (which encompasses accuracy and reliability), and postpublication peer review may reveal that the published data is not of sufficient quality to be used or endorsed by a federal agency.

When novel research such as that involved here has not been validated, the CRE believes that the data quality standards of "reproducibility" and "reliability" have not been met; thus, the research results cannot be relied on or endorsed by a federal agency. An agency's assessment of such situations will necessarily involve careful review of the published peer-reviewed research, which the CRE supports.

The authors are employed by the Center for Regulatory Effectiveness, which accepts contributions from companies and wade associations but acts independently and does not represent supporters.

REFERENCES

Carr JA, Gentles A, Smith EE, Goleman WL, Urquidi LJ, Thuett K, et al. 2003. Response of larval Xenopus laevis to atrazine: assessment of growth, metamorphosis, and gonadal and laryngeal morphology. Environ Toxicol Chem 22:396-405.

OMB. 2001 Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies. Final guidelines. Fed Reg 66:49718-49725.

OMB 2002. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies; Republication. Final guidelines. Fed Reg 67:8452-8460.

U.S. EPA. 2002. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and integrity of Information Disseminated by the Environmental Protection Agency, EPA/260R-02-008. Washington, DC:U.S. Environmental Protection Agency. Available: http://www.epa.gov/oei/qualityguidelines/EPA_OEI_IQG_FINAL_10-2002.pdf [accessed 5 September 2003].

U.S. EPA. 2003. EPA Response to Comments from Syngenta and Its Contractors, the Triazine Network, the Center for Regulatory Effectiveness, the American Water Works Association, the State of New York Office of Attorney General, the US Department of Interior Fish and Wildlife Service, The California Regional Water Control Board, the American Farm Bureau Federation, and the Louisiana Farm Bureau Federation, about the EPA Reregistration Eligibility Science Chapter for Atrazine, Environmental Fate and Effects Chapter, dated April 22, 2002. Washington, DC:U.S. Environmental Protection Agency. Available: http://www.epa.gov/oei/qualityguidelines /afreqcorrectionsub/2807Response_03_27_03.pdf [accessed 5 September 2003].

Jim J. Tozzi

William G. Kelly, Jr.

Scott Slaughter

Center for Regulatory Effectiveness

Washington, DC

E-mail: [e-mail].