The White House Office of Management and Budget (OMB) has repeatedly inserted itself in the development of a U.S. Environmental Protection Agency (EPA) program designed to study the effects of chemicals on human and animal endocrine systems.

On April 15, EPA asked OMB to approve scientific test orders it plans to send to chemical manufacturers. Under its Endocrine Disruptor Screening Program (EDSP), EPA is attempting to require manufacturers to screen certain chemicals to determine whether they are endocrine disruptors – a term used to categorize any compound capable of causing certain reproductive and developmental abnormalities. Before issuing the orders, EPA was required under the Paperwork Reduction Act to seek OMB approval. (All agencies must receive OMB clearance before collecting information from 10 or more people.)

OMB approved EPA's request Oct. 2, and EPA has said it will begin sending test orders for seven chemicals later in October. EPA will send out orders for 60 other chemicals from November through February 2010. Recipients of the test orders have the option of subjecting their chemicals to new tests or submitting existing studies.

While EPA will continue to manage the process, OMB cleared the information collection request with caveats. The primary focus of the EDSP is to require manufacturers to subject chemicals to fresh testing designed to detect endocrine effects. Manufacturers could also submit existing studies if appropriate. When OMB approved the request, it instructed the agency to consider existing studies "to the greatest extent possible."

OMB's role has caused concern among scientists and public health advocates. They say most currently available studies were not conducted with the goal of determining a chemical's effect on the endocrine system and did not study low-dose, long-term exposures.

Scientists have long suspected some chemicals, including those found in certain pesticides and plastics, of mimicking or interfering with natural hormones and disrupting development in the process. The term "endocrine disruptor" was coined in the early 1990s because these substances wreak havoc with the endocrine system – the web of glands and receptors that interact with hormones in both humans and animals. Exposure to endocrine disruptors may begin to cause adverse health effects even at very low doses.

A paucity of reliable data and rising public concern prompted Congress to pass the Food Quality Protection Act (FQPA) in 1996. The law instructed EPA to develop a screening program to determine if pesticides and other chemicals could affect endocrine systems and to pinpoint the doses at which harm occurs.

The role of OMB

At the crux of the OMB controversy is the issue of "other scientifically relevant information," a term found in the FQPA. An EPA document describing the procedures and timeline for the EDSP says manufacturers may submit other scientifically relevant information and that EPA will accept such information if it satisfies the test order. But like the information collection request approved Oct. 2, the EDSP procedures document was reviewed by OMB. Again, OMB emphasized the use of existing studies.

An EPA draft of the procedures document submitted to OMB in August 2008 includes an option whereby test order recipients could submit existing data. EPA's initial language presented the issue in stark contrast: in order for a submission of existing data to be deemed sufficient, the data would have to "satisfy the request in the test order."

OMB edited the option to add a significant amount of language about existing data and other scientifically relevant information. OMB suggested language allowing for submission of "relevant" information, regardless of whether it satisfies the order. EPA accepted OMB's edits and published the document April 15.

According to the final document, the ultimate decision rests with EPA, and EPA must provide a written determination to the recipient who submitted existing data as to whether its response is acceptable. Under the FQPA, if manufacturers do not comply with EPA test orders for a certain chemical, EPA may bar them from selling that chemical.

OMB has defended its role in the EDSP. Speaking at an American Bar Association meeting Oct. 23, Michael Fitzpatrick, associate administrator of the White House Office of Information and Regulatory Affairs (OIRA), the arm of OMB that reviews information collection requests and regulatory documents, said that OMB had not manipulated EPA's scientific work or decisions. He emphasized that EPA will maintain complete control over the EDSP and said that EPA welcomed the increased emphasis on the inclusion of other scientifically relevant information.

Still, OIRA's role raises questions. OIRA is not a scientific agency. It employs mostly economists and policy analysts and only a few scientists.

Critics have long urged OIRA to defer to agencies' scientific judgments. In November 2008, a diverse group of regulatory experts and advocates coordinated by OMB Watch recommended that agencies, including White House offices, "abstain from inappropriate interference in the work of other agencies and end secretive interagency reviews of scientific and technical information."

On Oct. 22, the Center for Progressive Reform wrote to newly confirmed OIRA administrator Cass Sunstein, criticizing OMB's role in the EDSP and saying, "As a result, there is a real danger that the EDSP's testing efforts, already behind schedule because of the Bush EPA's delays, will be postponed for many more years" because of the potential for delay from EPA's review of studies that are not ultimately relevant.

A letter from Rep. Edward Markey (D-MA), chair of the House Energy and Commerce Committee's Subcommittee on Energy and the Environment, further raised the profile of the controversy. Markey reiterated concerns voiced by the scientific community, writing, "OMB has suggested that EPA use existing data from toxicological tests, many of which have not been designed to assay whether these chemicals interfere with the endocrine system." Markey added, "These actions could put public health at risk."

Markey asked OMB Director Peter Orszag to respond to six questions, including whether OMB had assessed whether other scientifically relevant information would be legally and scientifically sufficient to fulfill the requirements of the EDSP and whether OMB had been influenced by outside parties.

The latter question alludes to the role of industry in OMB's review of the information collection request. Several industry groups filed public comments asking OMB to reject EPA's request.

Importance of reliable data

The impact, critics fear, is that EPA will not be able to receive the proper data on exposure to harmful chemicals. "Getting a clear picture of those risks requires up-to-date, evidence-based science," said Kathryn Gilje, Executive Director of Pesticide Action Network North America.

The 11 tests, or assays, EPA has developed to screen for endocrine disrupting effects would evaluate chemicals' effects on a variety of human and animal functions, including reproduction, sexual differentiation and development, and thyroid function. Under Tier 1 of the EDSP, if satisfactory existing studies do not exist, manufacturers will subject their chemicals to EPA's test battery (which has also been criticized). If a chemical is identified as an endocrine disruptor, it advances to Tier 2, where scientists will attempt to pinpoint a dose-response relationship.

An EPA scientific advisory committee formed to aid in the design of the EDSP first addressed the issue of existing studies in 1998: "There are numerous reasons for using only validated assays. These include: having confidence that the assay is detecting the effect it purports to be detecting, that the results of the assay are reproducible and comparable from laboratory to laboratory, and that the results permit a comparison of the toxicity of various chemicals."

The full impact of OMB's comments cannot be gauged until manufacturers begin responding to EPA's orders for information. If manufacturers attempt to submit other scientifically relevant information that is not sufficient to determine endocrine disrupting effects, EPA will face a choice over whether to accept it. The back and forth between EPA and industry, which could occur for multiple chemicals, will in part shape the EDSP.

EPA may also experience political consequences if it seeks to add chemicals to the EDSP beyond the 67 currently included. In addition to encouraging EPA to use other scientifically relevant information, OMB asked EPA to revise its estimates for the time the agency expects manufacturers to spend complying with EDSP test orders. EPA must present its revisions if it decides to seek approval to send test orders for additional chemicals, OMB said, at which time OMB may approve or disapprove the request.

If for any reason EPA is unable to obtain information on the endocrine disrupting properties of chemicals, public health could suffer. Endocrine disruptors have been blamed for health effects in both humans and animals, including birth defects and thyroid problems. Endocrine disruptors were also implicated after researchers discovered that 80 percent of male smallmouth bass in the Potomac River watershed are producing immature female eggs. Similar intersex fish have been discovered in other water bodies across the country.

Without reliable science on low-dose exposure to endocrine disruptors, government officials will be unable to determine the best steps to manage the risk to public health and the environment.