A year ago this month, CPR published a white paper that laid out a two-phased action plan for federal agencies to take some critical steps toward protecting the public from Bisphenol-A (BPA). The report provided both short-term and long-term action items for the EPA, FDA, and OSHA that could establish stronger safeguards, risk assessment practices, and warning mechanisms for families and consumers concerning BPA and other endocrine-disrupting chemicals. We said an underlying requirement for both short-term and long-term action items is for federal agencies to acknowledge the unique low-dose effects and non-monotonic dose response curves (NMDRC) of endocrine-disrupting chemicals and adapt existing scientific protocols to reflect these unique risks.
Shortly before the conclusion of 2012, EPA announced a promising new effort in turning these action items into a reality. The agency is forming a working group dedicated to investigating and analyzing low-dose effects and NMDRCs for endocrine disrupting chemicals, and intends to release a “state of the science” paper, which will undergo peer review and “help inform how the safety of chemicals are assessed.” The working group will focus on three critical questions in conducting its work:
When Barack Obama took office, reform of U.S. chemical regulation appeared to be an area of some bipartisan agreement, especially when compared to climate change, where it was clear a contentious fight would loom on Capitol Hill. Prominent Members of Congress had called for reform of the outdated Toxic Substances Control Act (TSCA) of 1976, EPA Administrator Lisa Jackson soon laid out the Administration’s key principles for TSCA reform, and the largest chemical industry trade association acknowledged that TSCA needed to be “modernized” and “updated.”
Four years later, though, progress on TSCA reform has been frustratingly slow. The 2010 Republican victory in the House dashed hopes for quick action on the Hill, and the chemical industry is once again defending the status quo.
The stakes are enormous. Under TSCA, more than 90% of all chemicals in use have never been tested for their health and environmental effects. TSCA requires the EPA to demonstrate that chemicals pose “unreasonable risk” prior to restricting their manufacture or use, and it erects elaborate procedural hurdles before EPA can make that finding. Since TSCA was enacted, EPA has attempted to restrict only six chemicals under those provisions of the Act, and the last attempt was in 1989.
We are “flying blind” by allowing massive public exposure to untested chemicals. As a result of flaws in TSCA, we also lack solid comparative information about the toxicity of chemicals. For example, while many companies have stopped using Bisphenol-A (BPA) in baby products and food containers, we have little information about substitutes for BPA, and companies are not required to disclose what substitutes they are using. From hydraulic fracturing fluids to flame retardants in furniture to construction materials in our homes, we simply do not know the health and environmental effects of tens of thousands of chemicals to which we are exposed.Full text
The White House’s message on its program for retrospectively reviewing existing regulations just shifted a little further away from recognizing the need for protective regulations for health, safety, and the environment. First the White House said it was interested in "expanding" certain existing regulations, if appropriate. Then it said it was interested in hearing ideas from the public on expanding regulations, but officially considers those ideas to be a lower priority than ideas that would weaken regulations. Now today, a new website launched by the White House pushes the notion of any balance in regulatory review further off the table.
Let me step back. Executive Order 13,563, issued by President Obama in January of 2011, announced the regulatory look-back program we’ve discussed a lot here:
To facilitate the periodic review of existing significant regulations, agencies shall consider how best to promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.
A key word there was expand. If agencies were to divert some of their current staff from working on needed new public protections to re-evaluate existing ones (the White House has never sought, let alone received, any new funding for the look-back programs at the agencies), at least it might, in theory, be a somewhat balanced exercise that could identify needed expansions to existing rules. Cass Sunstein, the Administrator of OIRA, has himself publicly noted the importance of the word “expand.” The process, we hoped, might not be simply weakening existing rules.Full text
Yesterday, the U.S. Food and Drug Administration (FDA) announced that it would amend an existing food additive regulation to prohibit the use of Bisphenol A (BPA) in “infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups).” BPA, a chemical commonly added to polycarbonate resins (a fancy word for plastics), continues to raise concerns over its low-dose, endocrine-disrupting health effects. Despite these health and safety concerns, the FDA’s decision to ban BPA in these limited items responds to a petition from the American Chemistry Council (ACC), which cites abandonment as the reason for the regulation amendment—not safety.
The good news about FDA’s BPA ban: FDA finally took an affirmative step toward protecting some of the public from BPA. The bad news: the step is a meager one that establishes little more protection than state legislatures and grass-roots campaigns have already achieved through state bans and market pressures. FDA, in other words, permanently banned BPA from products that already have removed it.
As I explained in a previous blog posting concerning CPR Member Scholar Noah Sach’s and my comments on the ACC’s petition and in CPR’s previous white paper on BPA regulatory options, FDA can take much larger and more meaningful steps to protect the public. These steps begin with recognizing the safety and health risks associated with BPA and include implementing broader bans without regard to age and use limitations and mandating BPA labeling requirements.Full text
Member Scholar Noah Sachs and Policy Analyst Aimee Simpson have sent a letter to the EPA nominating the chemical Bisphenol A (BPA) to be included on the “Fourth Contaminant Candidate List” for possible regulation. They write:
Pursuant to the Safe Drinking Water Act Amendments of 1996 (SDWA), the U.S. Environmental Protection Agency (EPA) must compile a list of unregulated contaminants that are known or anticipated to occur in public water systems and may require regulation under the SDWA. EPA then must make a decision about whether or not to regulate a least five of the contaminants on the list. EPA recently issued a notice and request for nomination of chemical and microbial contaminants for possible inclusion in the fourth drinking water Contaminant Candidate List (CCL 4). Under existing guidelines, EPA selects contaminants for a CCL based on a scoring system that addresses two primary factors: health effects and occurrence in water supplies. BPA received a low score on this scale during deliberations on the CCL3 and was not included on that list. We believe that new information published since the CCL3 deliberations will change BPA’s score. It deserves your close attention, and BPA should be added to the CCL 4.
Sachs and Simpson explain that the scientific research on BPA has advanced significantly, particularly with regard to low-dose impacts. They write: “these low-dose health effects are not properly accounted for in current risk assessments of BPA and CCL evaluations.” The full letter is here.Full text
The end of the school year always leaves me wishing that I could have lectured more clearly or somehow covered more in my classes on environmental law and policy. There was really just too much to discuss. How does one do justice to all those doubtful arguments in support of the Keystone XL pipeline? It’s a job creator! A gasoline price cap! A floor wax! Or the continuing saga of how the Obama administration should reorganize the offshore drilling responsibilities assigned to the MMS, I mean BOEMRE, I mean BOEM/BSEE. And there is never enough time to test it all.
This year I’ve assembled a few questions that have been on my mind this semester but that didn’t make it onto the exam. (Answers are posted at the bottom of this page). By the way, if you’re a regular reader of CPRBlog, this should be a snap: All of the answers can be found in CPRBlog entries from the last five months.
So find a quiet spot, sharpen that No. 2 pencil, and test your knowledge.
1. Last year, when the EPA began limiting emissions of CO2 from coal-burning power plants and other sources, the energy industry blew a fuse. Affected companies publicly argued that greenhouse gas regulation had gone too far. But last February during oral argument before the U.S. Court of Appeals, lawyers for some of those same companies argued that the agency’s rule was invalid because it did not go far enough. According to them, what was wrong with the rule?Full text
Two years ago tomorrow, Saturday, EPA sent a seemingly modest idea over to the White House for a quick review. The agency wanted to establish a simple list of “chemicals of concern.” These weren’t chemicals that were necessarily going to be subject to bans or other restrictions, but they present significant enough hazards and are distributed widely enough in the environment to raise some eyebrows among EPA’s toxics staff. Among the chemicals that were being proposed for inclusion on the list: phthalates, PBDEs, and BPA. The rule wasn’t expected to cost much, but EPA sent it to the White House anyway, probably because this was the first time the agency would use a particular statutory authority Congress first granted in 1972. But two years after EPA sent the proposal to the White House, it is still sitting on a desk somewhere at OIRA, and I think it’s time to say it: OIRA has killed this rule.
It’s troubling that such a small thing as a list of dangerous chemicals could be dashed by the White House. In 2009, GAO added EPA’s toxics program to its list of “high-risk programs warranting attention from Congress and the executive branch.” Surely, this is not the kind of attention GAO had in mind. GAO’s auditors have noted that
EPA has a limited ability to provide the public with information on chemical production and risk because of TSCA's prohibitions on the disclosure of confidential business information. About 95 percent of the notices companies have provided to EPA on new chemicals contain some information claimed as confidential.
CPR Member Scholar Noah Sachs and I submitted comments yesterday to FDA regarding the American Chemistry Council’s (ACC) petition to the agency on BPA. In September, the ACC petitioned FDA to remove approval for the use of BPA in “infant feeding bottles and certain spill-proof cups” (Rena Steinzor and I explained at the time the story behind the seemingly counter-intuitive move).
In our comments this week, we advocate for FDA to utilize its full rulemaking authority and take broader regulatory action to protect the public against BPA. Specifically, we propose:
As we explain in the comments, convincing scientific evidence supports these broader measures because of the demonstrated low-dose effects of BPA and other endocrine disrupting chemicals. These low-dose effects are not properly accounted for in current risk assessments of BPA and it is the role of FDA to act on behalf of all consumers' safety.Full text
Last Friday, the FDA denied the Natural Resources Defense Council’s (NRDC) citizen petition requesting that the agency ban Bisphenol A (BPA) as an approved food additive and food contact substance. The agency took nearly three years to issue this decision, and did so only under a court’s order. The FDA’s denial of the petition was disappointing, because the existing science on BPA is strong enough to warrant restrictions on its use. The announcement was an unsurprising continuation of the federal government’s “wait and see” approach to BPA regulation.
FDA spokesman Douglas Karas said that “this announcement is not a final safety determination and the FDA continues to support research examining the safety of BPA.” There is no question that continued risk assessment and scientific study of BPA should be part of the FDA’s action plan for addressing the health and safety concerns that recent scientific studies on BPA have raised. Earlier this year, CPR released a white paper, Protecting the Public from BPA: An Action Plan for Federal Agencies, providing a list of short-term and long-term actions that federal agencies could take to address some of these mounting concerns about BPA. At the top of our list for FDA was a continued and aggressive pursuit of the Agency’s collaborative research projects with the National Center for Toxicological Research and the National Toxicology Program.
In the meantime, however, I would remind FDA that a large body of scientific evidence already exists (and continues to collect) that supports increased restrictions on BPA’s use in food contact materials. FDA itself has taken note of these concerns in its previous statements on BPA. While FDA may see an all-out ban of this endocrine-disrupting chemical as too extreme or time-consuming, and continued scientific study is indeed imperative, there are a number of safeguards that would provide the public with some protections in the interim – much better than simply a “wait and see” approach.Full text
The Economist’s February 18 edition offers a cover package of five articles on “Over-regulated America” (1, 2, 3, 4, 5). Our British friends want you to know there’s a problem here in the States that needs fixing:
A study for the Small Business Administration, a government body, found that regulations in general add $10,585 in costs per employee. It’s a wonder the jobless rate isn’t even higher than it is.
You can almost feel The Economist’s pain: the jobless rate should be a lot higher than it is, if the premise about the costs of regulations is correct. Surely if the regulatory burden were actually 12 percent of GDP – that’s what the SBA numbers say, if you draw them out – things would be far worse than they are. Ideologically unable to consider the obvious alternative – that regulations don’t add $10,585 in costs per employee, The Economist, just, well, “wonders” aloud.
Here’s what The Economist would have found if they’d dug just a little bit: Fully 70 percent of the SBA estimate was actually based on a regression analysis using opinion polling data on perceived regulatory climate across countries (in a strange twist, a separate article in the same issue actually questions the study, briefly). Whole reports have been written on why that number is bogus.
Our economy is still recovering from a tremendous collapse largely caused by under-regulation of financial institutions. But in its group of articles, The Economist wants us to think the opposite: “The home of laissez-faire is being suffocated by excessive and badly written regulation.” That premise, in turn, leads the magazine to – you guessed it – a series of warmed-over right-wing policy ideas aimed at gutting regulations. Let’s take a closer look.Full text