Editor's Note: This morning, CPR President Rena Steinzor will testify at a House hearing regarding EPA's Integrated Risk Information System chemical database (full testimony). This post by NRDC Senior Attorney Daniel Rosenberg, cross-posted from Switchboard, explains the importance of IRIS and how the program is under attack.
Thursday morning, the House Science Committee’s Investigation and Oversight Committee will hold a hearing on EPA’s premier program for assessing the dangers of chemicals. It is called the IRIS program, (which stands for Integrated Risk Information System). The IRIS program looks at the science available on the potential dangers of a chemical and determines what hazard that chemical may pose – such as causing cancer, birth defects, diseases, etc., and what level of exposure, if any, is likely to be without an appreciable risk of harm. The IRIS program doesn’t issue regulations; it is focused on assessment of chemical hazards. But other parts of EPA, such as the air program and the water program, rely upon the IRIS assessments in setting their health standards to protect people from toxic chemicals. Other states and countries also rely upon the IRIS assessments.
Because of the importance of IRIS assessments for determining what types of harm a chemical might cause, and what levels of exposure may or may not be safe, the assessments conducted by IRIS are constantly scrutinized, challenged, and attacked by the chemical industry. New or updated assessments by the IRIS program that suggest greater harm from a chemical than was previously recognized are particularly anathema to the chemical industry, and they will do whatever it takes to prevent such determinations from being finalized. Industry’s campaign has been so successful, that in 2009 the GAO added the IRIS program to its (short) list of federal programs being at “high risk” of failure, due to its completing so few assessments that it would become irrelevant. (The GAO decision was based in part on the problems with the IRIS program, and in part with the problems with the TSCA program). The GAO will testify at Thursday’s hearing.
Full textLast month, the American Chemistry Council sent a letter to Jacob Lew, Director of the Office of Managmenet and Budget, calling on OMB to “take greater responsibility in the coordination and review of chemical safety assessments” and to “require EPA to submit all ongoing EPA IRIS assessments to the NAS for independent review.” The letter was the latest industry attack on the Integrated Risk Information System (IRIS), the EPA’s primary toxicological database. IRIS assessments of chemicals are used in regulatory decisions to protect the public, safety decisions by industry, and as evidence offered in litigation.
Today CPR President Rena Steinzor and Member Scholar Wendy Wagner wrote to Lew to rebut the ACC’s arguments, and to urge OMB not to take an inappropriate role in scientific assessments:
ACC’s request that OMB play a larger role in the scientific work of conducting IRIS assessments is a thinly veiled attempt to slow the IRIS process and thereby prevent EPA from promulgating rules that will directly benefit public health and improve the quality of life for millions of Americans. Not only will these requested delays create more work for any agency involved, including OMB, but this unnecessary review will significantly increase the costs of regulating by hundreds of thousands, if not millions, of dollars for each new IRIS assessment.
Steinzor and Wagner also argued that review of IRIS assessments by the National Academy of Sciences (NAS) would serve to delay assessments:
Contrary to ACC’s implications, perfection in an IRIS assessment will not be achieved through recurring NAS review. The science of toxicology is inherently uncertain and reasonable scientists will have different interpretations of the available data. More research will always be possible. That is why Congress empowered EPA to act with precaution to protect the public and the environment from toxic chemicals. If EPA had to obtain two rounds of NAS review for each and every IRIS assessment, as ACC requests for the next two years, the agency would fall even further behind in promulgating required rules, which would directly result in the loss of millions of dollars and human lives.
The full letter is here.
Full textWho’s the most powerful person in the Executive Branch these days, other than the President, the Vice President, their chiefs of staff, and—on any given day—the Secretaries of Defense or State? If odd Senate bedfellows Olympia Snowe (R-ME) and Tom Coburn (R-OK) have their way, the new, genuinely imperial regulatory czar will be one Dr. Winslow Sargeant, chief counsel for advocacy for the Small Business Administration (SBA). Under a plan these two have concocted (and are even trying to include as an amendment (SA211) this week in a bill (S. 493) to reauthorize two small business technology programs), Sargeant would be given the authority to render existing regulations—from Dodd-Frank financial reform to health care reform to statutorily mandated environmental protections—null and void simply because he does not like the way the sponsoring agency has handled its periodic "lookback" analysis of the impact of the rule on small business. (Under the Regulatory Flexibility Act, agencies must periodically review existing rules that have a “significant” impact on small businesses). Need to read that again? Here’s what Snowe-Coburn says:
If, after a review under paragraph (1), the Chief Counsel for Advocacy of the Small Business Administration determines that an agency has failed to complete the review required under subsection (b), each rule issued by the agency that the head of the agency determined under subsection (a) has a significant economic impact on a substantial number of small entities shall immediately cease to have effect.
Wow! If this passes, Dr. Sargeant is going to need a much bigger office as every lobbyist within a 100-mile radius of the Capitol rushes to have an audience with him.
Full textWe'll be live-tweeting today's hearing of the House Oversight and Government Reform Committee. Follow @CPRBlog.
Full textThe Obama Administration’s newly released science policy memo is an important and largely positive development in the effort to protect science and scientists from politics. In particular, the policy takes aim at many of the abuses of science and scientists that defined the Bush era. It’s particularly encouraging, for example, that the policy calls on political appointees to take a hands-off approach to science.
That said, in several areas, the policy could have, and should have, gone farther. The tension between science and politics predates the Bush Administration, and systemic reforms are long overdue. The Obama Administration science policy memo was an opportunity to address these issues, but it focused instead on fixing problems primarily from the Bush Administration.
The memo, issued by John Holdren, Director of the White House Office of Science and Technology Policy (OSTP), does not address the permissive approach many agencies have used in their reliance on privately produced science to formulate federal regulations. Private science, generally produced by regulated parties, often involves an inherent conflict of interest. Public access to underlying data and methods of privately produced science is also limited and can sometimes be completely unavailable. Yet the memo focuses on the science produced within the agencies, and not the science that agencies use more generally to develop regulations. Since private science is often the primary if not the exclusive basis for federal rulemakings in many important legislative areas, the memo avoids tackling a serious, systemic problem in the agencies’ use of science that should have at least been acknowledged, if not addressed. Ironically, in fact, the memo implies that government science lacks full credibility and adequate peer review, despite the fact that government science has strong safeguards in these areas, compared to private science.
Full textThe EPA announced this morning that it has finalized numeric nutrient criteria for Florida waters -- specific limits on the amounts of nutrient pollutants allowed in the state's water bodies. These criteria will in turn limit discharges by point and non-point sources. Currently, nutrient limits are set only by "narrative" water quality standards -- which have little teeth.
The EPA agreed last year to set the limits following a consent decree reached after a coalition of environmental groups sued the agency. Yee Huang explained in this space why the plan could be a huge step toward cleaning Florida's waters, and could help set a precedent for other states.
Affected industries and the Florida Department of Environmental Protection have lobbied hard against the EPA plan. The White House's Office of Information and Regulatory Affairs hosted a meeting on the issue back in January, and another meeting in late October (Greenwire reported a second recent meeting, with environmental groups, though it is not currently listed on the OIRA website).
The EPA went ahead with announcing the plan today. It did say that the standards won't take effect for 15 months, and it will "work closely with the state to determine the next steps to achieve the objectives of the standards." The environmental groups that have worked the issue put out a joint statement today lauding the EPA's announcement.
Full textIn Tuesday's New York Times story, “In a Feast of Data on BPA Plastic, No Final Answer,” Denise Grady characterizes the continued development of new studies about the endocrine disrupting chemical as yet another dispute between environmentalists and chemical manufacturers over a ubiquitous chemical with uncertain health effects. While her assessment of the state of the science is accurate, she expends thousands of words parsing the uncertainty and profiling the scientists who’ve made it their work to reduce the uncertainty without fully exploring the bigger picture context that would explain why this isn’t a petty dispute.
The question Grady left unanswered was, Why is there so much uncertainty about the health effects of a chemical that is produced in quantities of nearly a million tons per year? Two reasons immediately come to mind.
First, chemical manufacturers operate under a system of antiquated laws. The Toxic Substances Control Act (TSCA), allows a company to put a new chemical into commerce without having to make any explicit determination about its safety. Instead, the company simply informs EPA that it is going to manufacture the chemical, turns over whatever health and safety data it might happen to have on hand (they’re not required by law or regulation to actually do any testing), and then just waits 90 days. In the meantime, EPA may only put limits on production or use of the chemical if it is able to make a determination (in that time) that the chemical presents an unreasonable risk. Of course, without any test data that would be relevant to that determination, EPA is not likely to regulate.
Full textThe American Chemistry Council (ACC), a trade association that represents chemical industry interests and is heavily connected to the plastics industry, filed a Request for Correction Monday on the EPA's Chemical Action Plan for Bisphenol A (BPA). The request, filed under a provision of the Data Quality Act (also referred to as the Information Quality Act), is truly astonishing and bears noting. In addition to standard requests that EPA statements be toned down or removed due to conflicting studies, ACC makes several requests that EPA remove statements that are included not as “ knowledge such as facts or data,” but policy statements that reflect EPA’s intent to manage exposure to BPA.
ACC requests in several places that references to a Canadian risk assessment of BPA be deleted because the Canadian assessment was informed by the precautionary principle:
Any reliance in the Canadian assessment to support EPA’s conclusion that … action is warranted is not appropriate under the Guidelines; EPA cannot blindly rely on Canada’s screening risk assessment (particularly as Canada’s assessment incorporates the precautionary principle), but must perform its own weight-of-the-evidence assessment. (p. 9)
And ACC later objects to the use of a “conservative” model:
Full textEPA cannot rely on the highly conservative E-FAST2 modeling of BPA releases in the 2007 TRI to estimate the amount of BPA in drinking water or surface water when there exists [sic] peer-reviewed assessments of BPA in groundwater and drinking water… (p. 18, citations omitted)
Over on Slate this weekend, William Saletan posted an Elena Kagan piece in which he describes a 1996 incident in which the future presumptive Supreme Court Justice, then working at the White House, commented on a draft statement on “partial birth abortion” by the American College of Obstetricians and Gynecologists (ACOG).
Congress was then on the verge of banning certain abortion procedures lumped together under the umbrella of “partial birth,” a name made up by the right wing and not otherwise used by doctors. ACOG had drafted a statement saying that its select panel on the subject had concluded that while it could identify no circumstances under which the “intact D&X” procedure, which seemed to be the procedure the right wingers in Congress were after, “would be the only option to save the life or preserve the health of the woman…[t]he potential exists that legislation prohibiting specific medical practices, such as intact D&X, may outlaw techniques that are critical to the lives and health of women.”
ACOG submitted the draft to the White House for comment, and Kagan, in her role as associate White House counsel, proposed revisions, which ACOG subsequently incorporated, revising the relevant portion of the statement, by adding the sentence, “An intact D&X, however, may be the best or most appropriate procedure in a particular circumstance to save the life or preserve the health of a woman, and only the doctor, in consultation with the patient, based upon the woman's particular circumstances, can make this decision.”
Full textWith the strong support of their new Administrator, last year the EPA staff who administer TSCA came up with a novel idea for jump-starting a moribund regulatory program. They started publishing Chemical Action Plans (CAPs) for a selection of chemicals “that pose a concern to the public.” Having selected chemicals that are found in consumer products, produced in large volumes, have particular concerns for children’s health, or meet other criteria, EPA staff published action plans for the chemicals that provide a clear and concise profile of each chemicals’ hazards, exposures, and risks and lay out regulatory actions EPA might take in the near future. The documents are truly excellent pieces of work in that they provide a summary of complex and controversial science within the context of the agency’s duties and powers under existing law, and they do so without getting bogged down in scientific or legal minutae.
But now activists with the American Chemistry Council (ACC) have resurrected the wasteful practice of filing Requests for Correction under the Data Quality Act, this time (pdf) in response to EPA’s action plan for phthalates (pdf), proving once again that ACC will harass EPA for taking even the smallest steps.
The RfC alleges that the action plan contains “numerous factual errors” and that it therefore “fails to meet the requisite standard for objectivity.” A majority of their complaints focus on elements of EPA’s summary of potential hazards and routes of exposure, generally faulting EPA for not including references to studies that may provide evidence that would lessen the agency’s concerns. The general perspective underscores the real point of debate that ACC has manufactured with its RfC: What degree of precision is appropriate for EPA’s action plans?
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