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Sunstein Watch: OMB Meddling on Endocrine Disruptor Screening Program Means Shifting a Key Burden From Industry to EPA

Responsive Government

Greenwire and the Los Angeles Times ran pieces last week shining a light into a dark corner where staff at the Office of Information and Regulatory Affairs once again meddled in scientific regulatory programs where they do not belong, second-guessing EPA’s administration of the Endocrine Disruptor Screening Program (EDSP). The program, mandated by Congress under the Food Quality Protection Act, is designed to identify pesticides like DDT that cause profound changes in wildlife and, potentially, people, through the ubiquitous application of pesticides. Both articles highlighted the key problem, which is that the OMB-promoted changes to the EDSP would undercut EPA’s attempt to get a full suite of new test data on 67 chemicals’ potential endocrine-disrupting effects. But there's an additional important issue: OMB’s meddling, under the auspices of its power to enforce the Paperwork Reduction Act, shifted a heavy burden from industry’s shoulders to EPA’s.

Put another way, Obama’s OIRA snuck through the back door changes that industry had failed to get through the front door of the normal administrative process during the Bush Administration, ultimately forcing changes that threaten to completely undermine the EDSP, which has been moving at a snail’s pace in the face of ferocious industry opposition for well over a decade. Once again, like the episode we reported yesterday ("Don't OMB Economists Have Better Things to Do Than Channel Industry Opposition to EPA Science?"), this particular bit of mischief was a fait accompli before Cass Sunstein was confirmed as OIRA Administrator. And, once again, the episode shows how much work Sunstein will have to do to transform and redirect an institution that in far too many ways continues to behave as if George W. Bush and his anti-regulatory appointees were still running the government.

Aware that chemicals used as active and “inert” ingredients in pesticides have the potential to disrupt the delicate balance of estrogen, androgen, and thyroid hormones, Congress mandated that EPA develop a research program that would help government regulators better understand the effect of pesticides on such systems. After years of advisory committee meetings, stakeholder input, and internal study, EPA in late 2007 proposed a two-tiered strategy for implementing the EDSP. First, EPA would issue test orders to pesticide registrants requiring them to put certain chemicals through a series of assays, screening to see which chemicals have the potential to interact with estrogen, androgen, and thyroid hormones (“Tier 1 Screening”). EPA would then require that the chemicals that exhibited a potential to interact with the hormones be run through a series of more demanding tests to determine how they actually interact (“Tier 2 Testing”).

The companies that register pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) have done a significant amount of testing on their chemicals, and to be perfectly frank, much of it is designed to show that the chemicals do not have unreasonable effects on endocrine systems. When EPA proposed in its draft of the regulation that the companies conduct a new round of very specific, high-tech, low-dose assays under the Tier 1 Screening program, the companies recognized that the more sensitive testing might identify some chemicals that cause problems that have so far gone undetected. So they argued against the new testing, on grounds that the burden of conducting the new tests was too heavy. Their counterproposal was that EPA should just use all of their old test data for screening the chemicals.

EPA took a reasonable approach to the problem in its original proposal, essentially saying: If you receive a test order and think that your existing test data fulfills the requirements of the test order, feel free to send it in, along with a scientific justification as to why your old data should be substituted for data that would be derived from our new screening assays. By the way, the test orders call for new assays and we doubt any old studies will reach the same endpoints.

Industry found this approach completely unappealing, and orchestrated a multidimensional campaign to force EPA to change its proposal. The public dimension of the campaign involved formal administrative petitions asking EPA to change the EDSP filed by CropLife America, a pesticide industry trade group, and the Center for Regulatory Effectiveness. CRE is an industry-sponsored advocacy organization that specializes in appealing to OIRA for assistance with regulatory problems. It is led by Jim Tozzi, an OMB veteran of the Reagan White House, and chief architect of the Data Quality Protection Act. (Tozzi is most vividly profiled in Chris Mooney’s book The Republican War on Science.) The behind-the-scenes dimension of the campaign involved meetings, lengthy electronic mail exchanges, and telephone conversations between the industry advocates and their OIRA allies. Notably, none of these meetings were noted on the OMB website in time for any interested observer to register a contrary view.

After Obama was elected, OIRA denied the CropLife petition. Blocked at the front door, CropLife and Tozzi went around the back, knowing that EPA still had one more hurdle to clear: OMB approval of its testing requests under the Paperwork Reduction Act. And it was here, in an obscure cul de sac of the bureaucracy, that the final mischief got done.

EPA rejected the CropLife petition and passed the buck on the CRE petition. But there’s a paper trail that shows a rather strong concordance between industry’s arguments and OIRA’s proposed changes to EPA’s draft EDSP documentation.

The most obvious place where we can see the industry-OIRA link is in the background documentation that EPA sent to OMB for approval under the Paperwork Reduction Act. In its draft form, EPA had one paragraph explaining that test order recipients could:

“indicate that they intend to submit or cite existing data (including other relevant scientific information) that satisfies the request in the test order. … If the study is not exactly as specified in the protocols attached to the test order, recipients should provide an explanation as to why the data should be accepted as satisfaction of the test order. The Agency would expect that any such data would be scientifically comparable to data that would be generated by the order. EPA recognizes that for the initial screening, opportunities for order recipients to respond in this manner will be limited.” (emphasis added)

But the OMB-approved version of the same passage, which contains five times as much text, states: “Other scientifically relevant information can include data from studies other than the EDSP Tier 1 assays, e.g., studies conducted to satisfy a 40 CFR part 158 or part 161 data requirement, data from other studies conducted to address an identified issue, or data from studies found in the scientific literature.” (40 CFR parts 158 and 161 describe old tests required under FIFRA.) While the OMB-approved version of the document still asks for some justification as to why old data would satisfy the EDSP test orders, it states explicitly that “EPA will review any existing study submitted or cited in response to the Order to determine whether the study is of sufficient quality and can be used to satisfy the Order.” The critical difference in the two formulations is that the OMB-imposed version shifts the burden of explanation. Industry is no longer called on to demonstrate why old, lower tech tests are sufficient. Instead, EPA has taken the responsibility of demonstrating why they are not and why new tests are needed. The practical impact of that is that it virtually ensures that EPA will be mired for many years in a pile of paperwork, never getting to the Tier 2 Testing stage. And ironically enough, that comes in the name of Paperwork Reduction.

The before-and-after documents are noteworthy for their stark contrast, but to get a more detailed picture of the debate between EPA and OIRA (carrying water for the pesticide industry), take a look at EPA’s response to OMB’s initial comments on the draft of the Federal Register notice describing the final EDSP policies and procedures. Then, examine the red-lined draft. Or, look at the initial proposal, the August 2008 draft that went to OMB for approval, and the final, OMB-approved version. The clear trend has two problematic features. First, EPA abandoned its strong preference for data derived from the Tier 1 Screening assays that were carefully chosen to fulfill the needs of the EDSP, opting instead to take any old data industry wanted to dump on the agency. Second, EPA must now shoulder the burden of considering all of industry’s old data in conjunction with whatever new data it can muster, using a weight-of-the-evidence approach that will demand significantly more resources of the already stretched-thin agency.

As we explained yesterday, we had a good initial meeting with Cass Sunstein and gave him a series of recommendations for changing the fundamentally destructive culture at OMB, producing a situation where OIRA staff serve a the direct conduit for industry capture of the regulators. Each revelation like this one shows the need for a dramatic intervention—an office retreat—that convinces OIRA staff to stop thinking of industry as their clients, and start focusing on how to help regulatory agencies like EPA do the jobs that Congress has required of them – in this case, protecting Americans from endocrine disruptors, instead of protecting industry from badly needed regulations.

Responsive Government

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