Aimee Simpson on CPRBlog {Bio}

EPA on the Right Track for Addressing Endocrine-Disrupting Chemicals, but Should be Wary of Potential Detours

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:

  • Do NMDRCs capture adverse effects that are not captured using our current chemical testing strategies (i.e. false negatives), and are there adverse effects that we are missing?
  • Do NMDRCs exist for chemicals, and if so under what conditions do they occur?
  • Do NMDRCs provide key information that would alter EPA’s current weight of evidence conclusions and risk assessment determinations, either qualitatively or quantitatively?
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On the Farm and Looking to the Future of the CWA

Last week I visited a dairy farm with my two year-old son.  Complete with hayrides, homemade ice cream, cows mooing, and a bluegrass band, the fall festival provided us with some good, wholesome entertainment.  My son giggled as the baby cows licked his hand, oohed and awed at the fluffy baby chicks, and, of course, consumed the decadent ice cream as if I had not fed him in weeks. 

It was a memorable scene for us city-dwellers, but as my son climbed over hay bails and pretended to drive a tractor, I found myself longing for the ignorance of childhood.  Because as he moved from one gleeful experience to the other, questions filled my mind as I took in each detail of the land and farming process.  As I listened to the tour leader describe the careful separation of sick and antibiotic-treated cows during the milking process, I was unsatisfied with the mere assurances of this milk being separated from the milk bound for the grocers’ shelves or front doorsteps.  I wanted to know, where did the “bad” milk go—down the drain?  Driving past the chicken barn and cow fields and breathing in the air, pungent with what can only be described as “that farm smell,” made me wonder if they were taking appropriate measures to prevent contamination of surrounding streams, rivers, and even groundwater. 

As I voiced some of these questions to my spouse and friends whose children also romped through the pastoral scene, most of them looked at me as if I was crazy and incapable of enjoying myself.  “I’m sure a farm like this follows the rules.  You worry too much,” my friend said.  Again, a part of me wished for ignorance—in this case, my friend’s.  In this farm’s defense, they at least appeared to be taking the initiative on many sustainable energy and soil conservation practices, but this was most likely not because of the rules or laws, especially when it came to water pollution.

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New CPR Report: Maryland and Federal Authorities Should Prosecute Water Polluters More Frequently

Today, CPR releases a new white paper examining criminal enforcement of water pollution laws in Maryland.  In Going Too Easy? Maryland’s Criminal Enforcement of Water Pollution Laws Protecting the Chesapeake Bay, CPR President Rena Steinzor and I analyze a number of key questions concerning the critical, deterrence-based enforcement mechanism of criminal prosecution and its role in the Chesapeake Bay restoration efforts:

  • What have water pollution criminal enforcement efforts in Maryland looked like for the past 10 to 20 years?
  • What institutional challenges did criminal enforcement of water pollution laws in Maryland face?
  • What improvements could regulators, legislators, and practitioners make to better utilize this critical accountability tool?

In answering these questions, we reviewed publicly available data on criminal enforcement cases at both the state and federal level involving water pollution in Maryland, interviewed a number of past and present environmental prosecutors, and reviewed the existing policies and laws that enable criminal enforcement for certain kinds water pollution violations.

Our overall finding was that criminal enforcement was underutilized in Bay restoration efforts, by both federal and Maryland authorities. A few of the specifics:

  • During the past five years, federal water pollution concluded cases in Maryland shifted away from Clean Water Act-based charges to those involving violations of maritime laws, focusing on a narrow subset of pollution in the Bay;
  • At the federal and state levels, courts rarely impose incarceration for water pollution-based convictions, thus significantly reducing the deterrence value of criminal enforcement;
  • One of the greatest hindrances to environmental criminal enforcement is the lack of resources, particularly investigative resources; and
  • State and federal environmental criminal authorities collaborate too infrequently, reducing the effectiveness of the criminal enforcement mechanism.

Based on these and a number of other findings, we make several recommendations to encourage a stronger, more deterrence-based criminal enforcement program for water pollution violations in Maryland.  From restoring emphasis on environmental criminal enforcement to developing and participating in a Chesapeake Bay criminal task force, the recommended actions and policy improvements will allow a critical enforcement tool to help in achieving a cleaner Chesapeake Bay.

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FDA Takes Baby Step Toward Protecting the Public from BPA

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.

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To Protect the Public, FDA Should Go Beyond Industry's Petition on BPA

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:

  • Issuing new regulations encompassing the ACC’s Petition and Rep. Edward Markey’s March 16, 2012 Petitions concerning abandoned uses;
  • Banning a much broader range of BPA uses without reference to age limits or target consumers; and
  • Mandating labeling of BPA in all food contact materials.

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.

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FDA's "Wait and See" Approach to BPA Not Acceptable -- and Not the Only Option

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.

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New CPR White Paper: What FDA, EPA, and OSHA Should do about BPA

Today CPR releases Protecting the Public from BPA: An Action Plan for Federal Agencies (press release), outlining steps the FDA, EPA, and OSHA can take to use existing authorities to warn the public about the dangers of the chemical, and prepare longer-term regulatory controls. The paper was written by CPR Member Scholars Tom McGarity, Noah Sachs, and Rena Steinzor, and Senior Policy Analyst Matthew Shudtz and myself.

Bisphenol A (BPA) makes me want to cry.  Not in the sad or mournful way, but in the “I want to kick and scream on the floor and throw a tantrum like my toddler” kind of way.   I didn’t always feel this way.  These feelings concerning BPA (an endocrine-disrupting chemical added to plastics to increase clarity and durability, and used in myriad other sources such as can linings, kitchen appliances, and water bottles) began to arise when I started working with CPR Member Scholars and fellow staff on BPA policy. The more I learned about BPA, the more I felt like its presence in my life was like mosquitoes in D.C.—a summer BBQ killjoy.

Then I became a parent, and the frustration and concern escalated, because the more I found out about BPA, the more I recognized that the industries using it did not truly understand how it affected my health, but more importantly, the health of my child.  Even worse, the new approaches to testing its “safety” and potential adverse health effects were churning out new evidence of its dangers.  Evidence that did not fit the traditional “risk assessment” model used by health and safety regulators and thus spurred no change in protective standards.

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EPA Moves Forward Toward Test Rule for BPA; Effects on Humans Still Primarily Outside Scope of Process

EPA made further progress this week in its efforts to move forward with a potential Bisphenol-A (BPA) Test Rule, publishing an Advance Notice of Proposed Rulemaking (ANPRM) in the Federal Register. Overall this progress is good news, though it’s not without its flaws.

EPA completed a draft of the ANPRM in December and sent it over to the Office of Information and Regulatory Affairs (OIRA) for review, pursuant to Executive Order 12866. Despite a 10-working-day deadline for review of ANPRMs, OIRA spent more than seven months on its review. OIRA’s edits were also released this week and placed in EPA’s docket.

Mind you, this ANPRM is not a notice for the actual BPA Test Rule, but rather a solicitation for comments and input on whether such a rule is necessary, and, if so, what procedures, target test sites, testing standards, and protocols would best serve the intended purpose of such a rule. The actual chemical test rule, authorized by section 4 of the Toxic Substances Control Act (TSCA), would impose specific exposure monitoring and toxicity effects testing requirements on the processors, manufacturers, and importers of the subject chemical. For example, a sewage treatment plant might have to monitor how much BPA remains in the post-treatment sewage sludge that it distributes to farms, incinerators, and landfills, or a plastics manufacturer may have to conduct testing (most likely through a third party) on BPA’s low-dose toxicity effects on certain aquatic populations.

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Holding its Legal (and Parental) Ground: EPA Responds to the American Chemistry Council's Request for Correction of the BPA Action Plan

Being a parent is not easy, but some of the most difficult moments arise when you know what needs to be done to protect your child and your child has other sentiments. Call it a temper tantrum, a battle of wills, or disobedience, it all evokes a sense of frustration, exhaustion, and, let’s face it, self-doubt. There is that brief moment when you think to yourself, “Wouldn’t it just be easier to let them have their way? Maybe I am being too harsh or paranoid? Is it really going to hurt them?” Unfortunately, for the EPA, these questions and many more weave their way into the complex and detailed decisions that the agency must make on a daily basis in its quasi-parental role. At its core, EPA exists to protect us from dangerous toxins, pollution, and multitudes of health hazards that plague our environment. The “children” with whom EPA deals on a daily basis range in form from individuals to corporations depending on the issue; however, recent events concerning Bisphenol A (BPA), a high production volume chemical used in manufacturing polycarbonate plastics and epoxy resins, starred the American Chemistry Council (ACC) in the role of the strong-willed child.

In March 2010, EPA released its BPA Action Plan, summarizing a variety of scientific findings concerning BPA’s risks and presence in our environment, while also outlining the agency’s intended next steps based on the science. Most of these next steps involved coordinated risk assessment efforts with other government research divisions, such as the National Institute of Environmental Health Sciences, and agencies, like the Food and Drug Administration and the Centers for Disease Control. Additionally, EPA stated that it would “consider” taking steps to place BPA on a Chemicals of Concern List, authorized under section 5(b)(4) of the Toxic Substances Control Act (TSCA) and “consider” initiating an environmental effects test rule under section 4(a) of TSCA. In the grand scheme of EPA’s “parental” authority, the BPA Action Plan was a concerned look and word of caution.

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