OIRA Under Fire for Doing Its Job

Editor’s Note:  Bisphenol A has been a chemcial studied by a number of agencies.  In virtually every instance numerous questions have been raised concerning the underlying studies which question its safety.

Some five years ago, and Pump Handle, an NGO sponsored science blog, made the following statement:
On Friday, August 15, the FDA released its draft assessment of the safety of bisphenol A (BPA). To the frustration and deep consternation of many, the regulatory agency upheld the current safety standard for human exposure to BPA in food. The agency based their decision on two large multigenerational studies funded by the American Plastics Council (part of the American Chemistry Council) and the Society of the Plastics Industry. As for the large body of literature on low dose effects of BPA that originally raised concerns about the chemicals ability to disrupt reproductive, neurological and metabolic development and function at levels of exposure within the range found in humans, the FDA broadly found these studies to be inadequate or of limited utility in evaluating safety.   By relying solely on the industry-funded studies, the agency reaffirmed the trade associations ability to control what is considered to be reliable, credible science. This protracted battle over BPA safety is about more than just this one chemical. It reveals a larger struggle to define whose science gets to count, how information shapes public policy decisions and how scientific knowledge informs chemical safety.
Several observations are in order:
(1)  OMB has only around a dozen analysts, some of whom are subject to the sequestration, working these  issues; It has taken agencies decades to make a recommendation and it might well take decades for OMB to resolve the matter. In a like manner Federal agencies have citizen petitions before them for which they have not acted for a decade or more.
(2)  There is a growing bias against industry funded research in virtually all regulatory venues be it in toxic substance legislation under development or in agencies who are contemplating plans to utilize only those industry funded studies that are conducted by federally approved “independent” contractors.
The bottom line is
(1)  that once a regulation goes final it is with us for eternity, a decade of review is not out of order given that the sponsoring agencies often study, with conflciting results, an issue for decades.
(2)  the  across the board biases accorded to industry sponsorsed studies should be the subject of a Data Quality Act challenge.

 Chemicals of Concern’ list still wrapped in OMB red tape

Jim Morris Center for Public Integrity

For anyone anxious about toxic chemicals in the environment, Sunday marked a dubious milestone.

It has been three years since the “chemicals of concern” list landed at the White House Office of Management and Budget. The list, which the Environmental Protection Agency wants to put out for public comment, includes bisphenol A, a chemical used in polycarbonate plastic water bottles and other products; eight phthalates, which are used in flexible plastics; and certain flame-retardant compounds called polybrominated diphenyl ethers, or PBDEs.

The EPA wants to highlight these chemicals because “they may present an unreasonable risk to human health and/or the environment,” the agency says.

But any such listing must first be vetted by the OMB’s Office of Information and Regulatory Affairs, OIRA.

The EPA proposal arrived at OIRA on May 12, 2010. There it remains — a symbol, some say, of a broken regulatory system.

“It’s far past time for the OMB to conclude its review of the EPA’s proposal to list chemicals of concern,” Sen. Frank Lautenberg, D-N.J., said in a statement to the Center for Public Integrity. “Americans deserve access to information about the chemicals found in products throughout their homes that might pose a risk to their health.”

In a statement, OMB spokeswoman Ari Isaacman Astles wrote, “The Administration is committed to chemical safety and when it comes to complex safety rules, it is critical that we get them right.”

An EPA spokeswoman said only that the agency’s list, which has been challenged by companies such as ExxonMobil and Dow Chemical,  “remains in interagency review.”

By executive order, OIRA is supposed to review proposed rules within 90 days of receiving them, with the possibility of a single, 30-day extension. That’s four months, maximum.

Why has the chemicals of concern list been at OIRA for three years? No one is saying.

Yet in a draft of an upcoming law review article, former EPA official Lisa Heinzerling, a law professor at Georgetown University, offers some clues.

Heinzerling lays some blame on recently departed OIRA director Cass Sunstein, now teaching at Harvard Law School. In his new book, “Simpler: The Future of Government,” Sunstein makes clear “how much power he wielded” at OIRA — with the authority to make sure that some rules ” ‘never saw the light of day, ’ ” Heinzerling writes.

Sunstein did not respond to an invitation to comment. President Obama has nominated Howard Shelanski, director of the Federal Trade Commission’s Bureau of Economics and a former law clerk for U.S. Supreme Court Justice Antonin Scalia, to replace him at OIRA.

Problems at the office have become entrenched, Heinzerling argues.

“Many outside observers believe that there is in fact a deadline for OIRA review,” she writes. “Not only is there no deadline for OIRA review, but OIRA itself controls the agency’s ‘requests’ for extensions. In this way, it comes to pass that rules can remain at OIRA for years.”

EPA rules seem to draw extra scrutiny. “EPA receives more sustained attention from OIRA than any other federal agency,” Heinzerling writes. Fifteen of the 22 EPA rules under review have been at OIRA for more than a year.

What’s so threatening about the chemicals of concern list?

The American Chemistry Council, a trade group, did not respond to requests for comment.

In a statement to the Center last year, however, the group said, “We are concerned that EPA is creating a list of ‘chemicals of concern’ for potential regulatory action, without establishing consistent, transparent criteria by which these chemicals are selected. … It is OMB’s job to closely review the proposed action and consider any negative economic impact; we appreciate that officials are taking the time they need to fully study the matter.

“Failure to fully review such agency proposals undermines public and private sector confidence in the regulatory process and can seriously harm American innovation and jobs.”

Richard Denison, a senior scientist at the Environmental Defense Fund, said publication of the list would not restrict commerce and is within the EPA’s authority.

“OIRA has deprived the public of the right to even comment by refusing to allow EPA to issue the proposed rule,” Denison said. “The debate is being squelched by an office that doesn’t have any real scientific expertise and certainly shouldn’t have the ability to override the authority that Congress gave EPA.”

Leave a Reply

Please Answer: *