Richard Denison, Ph.D., is a Senior Scientist.

[NOTE:  This post was mostly written before Monday’s sad news of the death of Senator Lautenberg.  I have decided to post it now, both out of admiration for his steadfast determination to advance meaningful reform of the Toxic Substances Control Act even in a tough political environment, and to clarify and elaborate on EDF’s position supporting the introduction of the new legislation.]

Since the May 22 introduction of the bipartisan Chemical Safety Improvement Act of 2013 (S. 1009), co-sponsored by the late Senator Lautenberg (D-NJ) and Senator Vitter (R-LA) and 19 of their Senate colleagues, stakeholders have offered various reactions, ranging from strong support to unqualified condemnation.

Among the latter are those who lament – and list – all that is “missing” or has been “lost” from Senator Lautenberg’s earlier bill, the Safe Chemicals Act.  That’s the legislation that has been introduced in various forms in each of the last five Congresses, going back all the way to 2005. EDF and I personally were intimately involved in that legislation and worked hard to pass it all along the way.

But now in 2013 we need to face some tough facts:  Despite best efforts, that legislation was unable to garner support from a single Republican member of Congress, and never got further than a Senate committee’s approval on a strictly party-line vote.  That means there is simply no basis for talking about what has been “lost” from the current bipartisan legislation – for the simple reason that you can’t lose what you never had.

In their rush to condemn the new bill (“if the chemical industry supports it, it must be bad”) and fault it for failing to channel the Safe Chemicals Act, these stakeholders also rush past what should be the real test of the legislation:  How it compares to the status quo, the Toxic Substances Control Act of 1976 (TSCA).

As an editorial that ran this past weekend in the New Jersey Star-Ledger put it [my emphasis]: 

For the first time in 17 years, Congress has a real chance to pass a major environmental law. … [T]his is a breakthrough bill that deserves our support.  Its flaws can be fixed, and it has opened up a path to reform that never existed before.  As written, this compromise would be a substantial improvement over the status quo.

Just consider the alternative: a broken law that leaves EPA with no power to do its job, and only a handful of states trying to solve a serious national problem.

The legislation is clearly a compromise, one struck in part by focusing on amending the core provisions of TSCA.  That means it does not include a number of provisions – which I have strongly supported – that would expand the scope and approach of the current law:  For example, giving EPA the authority to address “hot spots” – geographic areas where residents face disproportionately high chemical exposures; and to require immediate reductions in exposure to chemicals we already know to be dangerous, such as so-called PBTs (persistent, bioaccumulative and toxic chemicals).  If they are not included in the legislation, other ways will need to be found to advance these critical objectives.

And even within its narrower scope, the legislation has flaws that need to and can be addressed as it advances through the legislative process.  A more predictable and accountable process for reviewing and acting on chemical risks is needed, and any pre-emption of state authority should be narrowed considerably and in a manner that preserves the rights of states to act until and unless EPA takes final action on a chemical.

But what is noteworthy about the new legislation – and is ignored by its detractors – is how it directly addresses the major flaws of TSCA that have been repeatedly identified by experts.  I am attaching a more detailed side-by-side that identifies these fixes as well as some trade-offs.  Here are some highlights:

• Mandates safety reviews for all chemicals already in commerce:  When TSCA passed in 1976, it grandfathered in some 62,000 chemicals already in commerce, and gave EPA no mandate to review them for safety.  As a corollary, it falsely equated a lack of any safety data on the great majority of those chemicals with a lack of risk.

The Chemical Safety Improvement Act for the first time would require EPA to review the safety of all chemicals in active commerce.  And it makes a lack of safety data a basis for designating a chemical high-priority, which triggers EPA’s authority to require testing and a mandate to conduct a formal safety assessment and safety determination for the chemical.

• Fixes TSCA’s “unreasonable risk” standard: TSCA’s “unreasonable risk” cost-benefit standard is widely regarded to have failed for two main reasons.  First, it blurs together what should be two distinct decisions:  a science-based decision as to whether a chemical poses a significant risk; and a risk management decision as to how to address such risks where they are found.  Second, it forces EPA to engage in paralysis-by-analysis by requiring it to prove that any action it proposes to take is the “least burdensome” of all possible options.

The Chemical Safety Improvement Act would fix both problems:  It redefines the “unreasonable risk” standard as one “based solely on considerations of risk to human health and the environment;”  consideration of costs and benefits is relegated to a separate risk management stage.  And it strikes the paralyzing “least burdensome” provision.

• Requires affirmative safety decision before market entry for new chemicals:  Under TSCA, new chemicals undergo a cursory pre-manufacture review, and no affirmative safety decision is required before they can enter the market.  And in the review, the burden is on EPA to find a concern – hard to do when safety data are not required – in order to halt, slow or limit market entry.

The Chemical Safety Improvement Act for the first time would require EPA to make an affirmative finding of likely safety as a condition for the manufacture of a new chemical to commence.  And while EPA still could not directly require safety testing of new chemicals, it could suspend its review pending submission of needed data, or impose conditions needed to provide the requisite assurance of likely safety in the absence of such data.

• Allows EPA to require testing by issuing orders:  Under TSCA, EPA must promulgate a regulation in order to require a company to conduct safety testing of a chemical it makes or uses.  This process is resource-intensive and can take many years.  Moreover, to require testing, EPA has to show potential risk or high exposure – a Catch-22, given that testing would typically be the way EPA would get the data needed to make such findings!

The Chemical Safety Improvement Act authorizes EPA to issue orders to require testing.  Using orders avoids the onerous rulemaking process and subsequent court challenges.  Moreover, while EPA must justify why it is using an order rather than a rule or consent agreement, it does not need to make risk findings to order testing of a chemical.

As one would expect in a compromise bill, each of these provisions also has its drawbacks (some of these are noted in the more detailed side-by-side).  But there is no question that, in each area of EPA activity and authority under TSCA, the new bill would be significantly better than the status quo.

That’s why EDF supports the introduction of this bill and will work toward its improvement and passage.  Which brings me back to my first point:  The strong bipartisan support for this bill, in contrast to the Safe Chemicals Act, means that it could actually be enacted into law. 

That would let EPA get started on the huge task of undoing the damage that nearly four decades of inaction under TSCA have brought about.

In Memoriam: Sen. Frank Lautenberg (D-NJ)

“We at EDF join in mourning today’s death of Sen. Frank Lautenberg.

“Over his long career, Frank Lautenberg was a tireless advocate for protecting America’s health and environment. As a member of the Senate Environment and Public Works Committee, he helped pass laws that have made our air and water cleaner, promoted clean energy and made our families healthier.

“EDF had the honor of working with him many times over the years, most recently on one of his top priorities — a bipartisan effort to protect Americans from the toxic chemicals they encounter every day.

“Sen. Lautenberg will be remembered as a passionate and principled statesmen who inspired all who worked with him. We will miss him dearly.”

Fred Krupp, president of EDF

###

Rachel Shaffer is a research assistant.

Last week, Angelina Jolie announced that she recently had a double mastectomy: surgery to remove both of her breasts. She chose to undergo such a difficult procedure because she, like her mother who had breast cancer (and died of ovarian cancer), carries the BRCA1 gene, a genetic mutation that significantly raises her risk of breast and ovarian cancer. While Jolie does not have cancer, this surgery lowers her chances of developing the disease in the future.

That otherwise healthy women are choosing to take such drastic steps to reduce their risks of cancer demonstrates a willingness to make profound sacrifices for health.  But it also raises the question of what options for prevention are available to the millions of other women who develop breast cancer, even though they have no known genetic risk factor. Approximately 90-95% of breast cancer cases cannot be attributed to BRCA1 or other genetic mutations; these cases are triggered by various factors in a woman’s environment.  

My mother’s cancer, diagnosed ten years ago this month, falls into this category. So once again, I’m reminded of the obvious: the life of superstar Angelina Jolie does not reflect the life of my mother or the lives of the vast majority of women. 

For my mother, who was otherwise healthy and has no family history of the disease, the unexpected and unexplained diagnosis led only to unanswered questions and a feeling of lack of control.  And I’m left with only uncertainty about my own risks.

Given that most cancers cannot be linked to genetics, many women, like me, are searching for more reliable information about environmental factors and exposures that may contribute to the disease.

Several hundred chemicals have been identified as potential breast carcinogens, and they can be found in commonly used cosmetics, household products, plastics, and pesticides. Yet, we still do not know enough about the extent to which or how these chemicals promote disease.

In February 2013, the Interagency Breast Cancer and Environment Research Coordinating Committee (IBCERCC) published a report urging more research into the environmental contributors to breast cancer. And in a blog post response, my colleague Sarah Vogel highlighted this call for greater attention to environmental risk factors in our national cancer prevention strategy.

But undertaking this crucial research is just the first step. While Jolie was able to reduce her risk of genetically-based cancer through surgery, my mother was essentially powerless to reduce her risk of cancer from environmental exposures. That’s because suspected breast carcinogens are found in numerous everyday products, and daily exposure can occur from a variety of sources outside of an individual’s control.

A key part of a prevention strategy for breast cancer, then, must involve an overhaul of our outdated national chemical regulatory system, including increased testing of chemicals for breast carcinogenicity. Until we have strong, comprehensive policies to ensure the safety of everyday products, true prevention for the majority will remain frustratingly out of reach.   

Jolie demonstrated that women will go to great lengths to protect themselves from this devastating disease, and I have nothing but admiration for the actions that she took. But responsibility for prevention cannot fall on each individual woman alone. Jolie’s story should be a call to all of us to demand prevention-focused research and health-protective policies. Together, we can support a system that promotes the well-being of all of the women in our lives.   

Richard Denison, Ph.D., is a Senior Scientist.

It’s very disheartening to see just how far the American Chemistry Council (ACC) has moved away from anything resembling a good-faith effort to debate and advance meaningful reform of the Toxic Substances Control Act (TSCA).  There’s more than enough in TSCA reform for stakeholders to debate and disagree about without adding distortions and outright falsehoods to the mix, yet ACC seems intent on doing just that.

The latest indication?  An April 16, 2013 post to ACC’s blog titled “A new year, but the same unworkable Safe Chemicals Act.”  The post purports to identify four fatal flaws in the Safe Chemicals Act of 2013, which was introduced on April 10 and is cosponsored by 29 Senators.  The first two utterly ignore or fault the legislation for major changes made to it to address industry concerns, while the latter two once again restate outright falsehoods ACC has made about the Act – claims that ACC knows are false. 

Let’s take the latter two “flaws” first. 

ACC claim:  The Act’s safety standard is a zero-risk standard

As it has repeatedly for several years, ACC’s blog post claims the Safe Chemicals Act’s safety standard is a “zero risk” standard.  ACC knows this to be false – because its member companies that make food-use pesticides have operated under the exact same standard for nearly 20 years, since 1996.

 At issue is the section of the Act that requires that chemicals be shown to meet a standard of “reasonable certainty that no harm will result to human health or the environment.”  This language is taken directly from the Food Quality Protection Act of 1996 (FQPA).  Now here’s the irony in ACC’s claim:  The “reasonable certainty of no harm” standard was put into FQPA expressly to replace an actual zero-risk standard that applied prior to its passage – the so-called Delaney Clause.  Indeed, industry had fought hard for years against the Delaney Clause, which dated all the way back to 1958, and it hailed its replacement with the “reasonable certainty” standard in FQPA as a major victory.

The legislative history of FQPA makes clear that the “reasonable certainty” standard is not zero-risk.  Rather, it refers to EPA’s use of quantitative risk assessment to set an acceptable level of risk, taking into account exposures from all sources and the heightened vulnerability of children.  See pages 40-41 of this House Report that accompanies the final adopted version of FQPA.

Likewise, EPA’s implementation of FQPA is and always has been based on quantitative risk assessment to set an acceptable level of risk.  See, for example, EPA’s website:  “Setting Tolerances for Pesticide Residues in Foods.”

ACC claim:  “Manufacturers would be required to conduct an aggregate exposure assessment of every chemical they produce.” 

Wrong again.  EPA, not industry, assesses chemical risks under the Act.  ACC’s blog post repeats this false claim that ACC has been making since 2010.  And it knows this claim is untrue. 

Under the Act, EPA – not manufacturers – makes safety determinations, based on its assessment of the aggregate of exposure from the various uses and sources of a chemical.  The Act could not be clearer in this regard; section 6(d)(1)(B)(ii) states:

“(ii) DUTIES.—For purposes of this Act—

(I) it shall be the duty of the manufacturer or processor of a chemical substance to provide sufficient information for the Administrator to determine whether the chemical substance meets the safety standard; and

(II) it shall be the duty of the Administrator to determine whether a chemical substance meets the safety standard.”

(emphases added; see pp. 98-99 of the Act)

ACC first made this false claim at a hearing in July 2010, relating to a similar provision in TSCA reform legislation under consideration by the U.S. House of Representatives.  Cal Dooley, ACC’s President and CEO, made the following statement:

“For example, the bill requires that “aggregate exposure” to a chemical or a mixture meets the “reasonable certainty of no harm” standard.

This means that when a chemical or mixture is listed for a safety determination, the manufacturer(s) carries the burden of showing with reasonable certainty not just that the company’s use of the chemical and any resulting exposures from those uses pose no harm, but that all other aggregated exposures from all other uses of the chemical pose no harm. It is not clear to us how any company could actually do that.” (emphases in original)

At that hearing, Mr. Dooley’s statement was directly challenged and corrected, both by one of the sponsors of the bill and by me, who was also testifying at the hearing.  See pp. 95-6, lines 1815-1859 and pp. 94-5, lines 1792-1801, respectively, in this transcript of the hearing.

Since then, the language in question was even further refined to make absolutely clear that EPA, not industry, does the aggregate exposure assessments.  Yet Mr. Dooley and ACC continue unabated in repeating this false claim.

Of course, none of this addresses the substantial merits of and support for the common-sense notion that judging the safety of a chemical should take into account the fact that people are often exposed to it from more than one source.  This feature of the Safe Chemicals Act’s safety standard has been endorsed by major medical groups and is a key recommendation of the National Academy of Sciences (an august body that in other contexts ACC loves to cite as the ultimate authority).

So now let’s look at the first two “flaws” ACC claims are in the Safe Chemicals Act. 

ACC claim:  “Its proposed prioritization system is unclear and circuitous, and frankly doesn’t make much sense.” 

This claim carries two-fold irony. 

First, this section of the bill was drastically rewritten from the 2011 version, almost entirely in order to incorporate chemical industry proposals that had surfaced in various dialogues both on and off Capitol Hill. 

The batching of chemicals was introduced to “meter in” to the prioritization process the large number of chemicals on the market, so as to minimize burdens on industry as well as EPA.  Categorization of chemicals was introduced so that EPA could identify and set aside chemicals of low concern right up front.  The remaining chemicals would be prioritized:  a) based on both hazard and exposure, and b) using only existing information – both features added to respond to key industry demands.

I guess there’s just no pleasing some folks.

The second irony is that ACC has proposed a prioritization scheme of its own that is far more complex and convoluted than the one in the Safe Chemicals Act.

ACC claim:  “The SCA would … severely restrict a manufacturer’s ability to protect the identity of chemicals they have developed.”

Here again, ACC wholly ignores the major changes made to this section of the bill to address industry concerns.  Under the original 2011 bill, identities of new chemicals generally would not have been eligible for protection as confidential business information (CBI).  But under the revised 2013 bill, with the exception of chemicals of very high concern,  new chemicals can enter the market and their identity can be masked for a period of time designated by the manufacturer as necessary, as long as EPA deems the period to be reasonable.   In addition, the length of that period can itself be claimed to be CBI if it would reveal proprietary information about investment in or revenue from sales of the chemical.  Moreover, that period can be renewed for an additional five years as long as the original CBI criteria are met.  Finally, this allowance applies even to the identity of a chemical in a health and safety study – a substantial weakening of the status quo under current TSCA.

These changes amount to major concessions on the part of the bill sponsors.  Yet ACC not only fails to acknowledge them, it continues to use the same hyperbolic language to describe them that it was using to describe the original language back in 2010 and 2011.

Are TSCA chemicals really heavily regulated?

Lastly, I simply must respond to another claim ACC makes in its post, namely that EPA’s imposition of some type of condition on chemicals “more than 2600 times” constitutes extensive regulatory action.  This claim, with a bit more detail, was also made in another ACC post responding to the New York Times’ April 18, 2013 spot-on editorial, A Toothless Law on Toxic Chemicals.

What ACC fails to mention could fill a tanker truck:

• Virtually every one of those “actions” was taken on a new chemical, where TSCA gave EPA a bit more bargaining power to negotiate with companies to accept such conditions.  Only a tiny fraction represent actions taken on the 62,000 chemicals that were already on the market and were grandfathered in when TSCA passed in 1976 – chemicals that still today represent the vast majority, both by count and by production volume, of chemicals in use.
• Virtually all of the 2600 actions were applied in the context of EPA’s review of the new chemical notifications it receives.  Since TSCA was adopted, EPA has received more than 50,000 such notifications (including 37,000 premanufacture notifications (PMNs) and 14,000 exemption applications or notifications).  So the 2600 actions amount to a condition being placed on only about 5% of new chemicals – the only ones where EPA could meet its burden of finding potential risk or high exposure.
• The other 95% of new chemicals – the great majority of which are accompanied by no safety data – have literally sailed through EPA’s 90-day review period.  Moreover, once those chemicals go on the market and get added to the TSCA Inventory, anyone and everyone can make and use them for any purpose and in any amount without even notifying EPA that they are doing so.  (See this post for more detail on the limitations of EPA’s new chemicals program.)
• So, in sum, under TSCA only one in 20 new chemicals, and virtually none of the much larger number of existing chemicals, have any regulatory condition whatsoever applied.

Bottom line

All of this distortion, omission and robotic repetition of falsehoods make it hard to reach any conclusion other than that ACC has no real interest in debating or discussing meaningful TSCA reform.  Nor does it suggest much reason to hope or expect ACC will ever be willing to put in the hard work and compromise (which we in the health and environmental community and a scant few in the consumer products industry have been willing to do) that will be needed to actually reach an agreement on reform legislation. 

And that’s a shame.

Rachel Shaffer is a research assistant.

What do waterproof jackets, car wax, and non-stick pans have in common?

Aside from being great Father’s Day presents (Dad, I’m thinking ahead this year!), they also all are made with perfluorinated compounds, or PFCs. There are hundreds of different PFCs, and their oil- and water-resistant properties make them useful in a variety of products, from cookware and carpets to food-packaging and electronics.  

Unfortunately, these chemicals have less desirable properties as well. Thanks to their strong molecular bonds, PFCs do not readily break down; they persist in the environment and in our bodies. And, widespread use has led to extensive human exposure. The Centers for Disease Control’s (CDC) human biomonitoring program, the National Health and Nutrition Examination Survey (NHANES), detected four types of PFCs in over 98% of samples representative of the U.S. population collected in 2003-2004.  

Two of the compounds detected in NHANES, perfluorooctane sulfonic acid (PFOS) and perfluorootanoic acid (PFOA), are the focus of three new studies published this month in Environmental Health Perspectives. These studies, one reporting an association with osteoarthritis in women, another an association with semen quality in men, and a third an association with asthma in children, add to a growing concern about the potential adverse effects of these ubiquitous chemicals.

What follows is a brief overview of the findings of these new studies. 

PFOA and osteoarthritis in women: an inflammatory connection?

Osteoarthritis is the most common form of arthritis, affecting over 27 million people in the U.S. In this disease, cartilage breaks down, resulting in chronic pain and joint stiffness. Though not fully understood, some have hypothesized that the disease may be related to inflammation, changes in calcium levels, and oxidative stress. Because some animal studies have linked PFOA and PFOS to these same mechanisms (see here, here, and here), researchers set out to explore the associations between levels of these two compounds and the prevalence of osteoarthritis in the U.S. population.

Through an analysis of recent NHANES data, researchers found statistically significant associations between blood serum concentrations of PFOA and osteoarthritis in women, but not men. Women in the highest exposure group were almost twice as likely to have the disease as those in the lowest exposure group.  

The sex differences will need to be confirmed through further research, but these initial results indicate that males and females may exhibit differing susceptibility to these compounds. This may in part be due to variations in the ways that PFOA are processed in the male and female systems (as demonstrated in previous animal studies), and it also suggests that the compounds may interact with sex-specific hormones to promote inflammation that leads to disease.     

The authors are careful to note that because of limitations inherent in the study, they cannot make any definitive conclusions about causation (i.e., that the PFOA exposure resulted in the osteoarthritis). Nevertheless, the observed associations – seen at concentrations found in the general population – are of real concern and highlight an urgent need for future research.

Men, don’t relax yet… PFOA could affect your reproductive health

Previous animal studies have indicated that PFOA and PFOS may cause changes to the development of the male reproductive system, which could lead to reduced testosterone levels and lower sperm counts, among other effects. The authors of the second study set out to answer the question that logically follows: do these chemicals affect human males in similar ways?  

Because the developing fetus may be especially vulnerable to environmental chemicals and because PFOA and PFOS are able to cross the placental barrier, researchers investigated the connection between the level of these compounds in maternal blood during pregnancy and specific reproductive endpoints in their sons, 20 years later.  

Their findings are troubling. Higher exposure to PFOA during pregnancy was associated with lower sperm concentrations, lower total sperm counts, and higher concentrations of two reproductive hormones (LH and FSH) in the sons as adults. No association was found with PFOS.

Based on their results, the authors of this study suggest that PFOA may act as a reproductive toxicant. Once again, though, more research is needed to show causation.

One more reason it’s hard to breathe easy

PFCs have also been shown to exacerbate asthma in animal models, and this final study investigated the possible connection between levels of these contaminants and asthma in children.

Researchers looked at levels of 11 PFCs, including PFOA and PFOS, present in the blood of several hundred Taiwanese children aged 10-15 years old and then compared the incidence of asthma in the highest exposed group to the lowest exposed group. They found that children with the highest concentrations of PFOS were about twice as likely to have asthma. And those with the highest concentrations of PFOA were four times as likely to have asthma. Significant associations were also found for a variety of the other PFCs. In addition, the authors noted a relation between markers of elevated immune system sensitivity – which indicate increased likelihood of airway swelling in response to certain triggers – and concentrations of PFCs.

Numerous factors are contributing to rising asthma rates, but this study indicates that exposure to chemicals like PFCs may play a role.     

One chemical, many effects?

The studies described here examined PFCs in relation to three adverse effects, but previous studies in both animals and people have linked PFCs to a variety of others, including liver toxicity, developmental changes, immune system alterations, and cancer.

It may seem implausible that one group of chemicals could cause such diverse health problems. But the networks in our bodies are highly linked and coordinated, which, unfortunately, means that a single chemical may have the power to interfere with a range of processes. Changes to the immune system, for example, could result in increased susceptibility to inflammation or decreased ability to fight cancer-causing agents.  A disruption to normal hormonal functioning could have an impact on the development of the reproductive, immune, skeletal and nervous systems.

Governments are beginning to act – but more is needed

International and federal agencies are starting to take action, driven especially by the fact that these compounds are extremely persistent and tend to accumulate in the environment and in organisms. The Stockholm Convention recently listed PFOS as a Persistent Organic Pollutant (POP), which means that signatory countries are required to restrict its production. (Note: The U.S. has not yet ratified this international treaty).

And despite limited authority under the outdated Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) has taken a number of steps to address certain PFCs:

• In 2006, the agency initiated the 2010/2015 PFOA Stewardship Program, a commitment by major PFOA manufacturers to eliminate PFOA and related compounds in their products and manufacturing facility releases by 2015.
• In 2009, EPA issued an action plan for several of the PFCs that includes conducting further studies to investigate health effects and initiating regulations on production and use of PFCs found to pose high risks.
• In 2012, the EPA proposed a Significant New Use Rule (SNUR) and a test rule for a subset of these compounds, which, when finalized, will require companies to report to EPA before using them in new ways and to conduct testing on current uses they plan to continue.

While the steps taken by the EPA represent important progress, they are limited in scope and were initiated after widespread exposure.  The story of PFCs is another example that points to the need for the U.S. to adopt a stronger chemicals policy, which would, among other important provisions, ensure that chemicals are tested for potential health effects before being used in products. 

Meanwhile, I guess I’ll have to keep looking around for a good Father’s Day present.

Richard Denison, Ph.D., is a Senior Scientist.

It seems like only yesterday there was broad consensus on the need to strengthen the Toxic Substances Control Act (TSCA), a consensus that included the chemical industry.

But that was then.  Now there are growing indications that legislation will soon be introduced in the U.S. Senate that would not only not fix the fundamental flaws of TSCA, but would actually make the law even weaker. 

The first clue came from comments that the Republican minority filed on last year’s Safe Chemicals Act (which was just re-introduced yesterday).  Among the many objections, they argued against a standard that has been endorsed by major medical groups as necessary to protect vulnerable subpopulations, especially the developing fetus, infants and young children.  That’s a standard that also reflects the recommendations from the National Academy of Sciences to address the multiple chemical exposures that people face in the real world.

Now it appears that Senator David Vitter (LA) is close to introducing a TSCA bill of his own, written in close collaboration with the American Chemistry Council (ACC) and a scant few of its member companies.  By all reports, other chemical industry and related interests have had little opportunity for input, and other key stakeholders – the health and environmental communities, workers, consumer groups, health professionals, etc. – have been completely cut out of the process.

And while details are sketchy because few people have seen any actual text, the Minority’s comments and other sources suggest that the bill may contain provisions that would actually weaken current TSCA.  Here are just two examples:

• The bill could further limit EPA’s already highly constrained authority to ask for more information on chemicals.  It would reportedly force EPA to rely on existing data, however sparse, for key decisions.  EPA would have to document in detail why it needs more information – exacerbating the Catch-22 under current TSCA whereby EPA has to be able to show a chemical poses a potential risk in order to require testing to determine if there is a risk.  And EPA would be constrained as to when in the process it could request new information.  If true, these provisions would weaken EPA’s already inadequate information authority under current TSCA.
• The bill reportedly would wholly quash state authority to address chemical risks.  Worse, this pre-emption would start at the moment EPA initiates an assessment of a chemical – which is typically many years before any decision is made about whether to regulate that chemical.  Even putting aside the need for states to be able to address their own priorities and geographic and population factors specific to their states (e.g., native populations highly dependent on wild plants and animals for food), think of the perverse incentive this approach would create for industry to seek to delay assessments and needed regulatory actions – states would have already been pre-empted from acting to fill the void!  Again, if true, this provision would be a severe roll-back of state authority under current TSCA.

Indications are that the bill would leave unchanged the provisions under TSCA that address new chemicals.  This would perpetuate a flawed system in which EPA is compelled to review within 90 days each of more than 1,000 new chemical notifications annually, the vast majority of which include no health or environmental data whatsoever.  This lack of any upfront safety data requirement stands in contrast to the policies of virtually every other developed country in the world.  Only if EPA can meet its burden to affirmatively find that the chemical is expected to pose an unreasonable risk can it slow its review, require testing, or seek to negotiate conditions with the notifier on production or use of the chemical.  These are the kinds of problems with the TSCA new chemicals program that led EPA’s own Inspector General to reach conclusions such as this:  “EPA’s assurance that new chemicals introduced into commerce do not pose unreasonable risks to workers, consumers, or the environment is not supported by data or actual testing.”

It’s exceedingly hard to see how “reform” along these lines would do anything to restore consumer confidence in our failed system for assuring chemical safety, let alone resolve the growing debate in the market, in the scientific and medical communities and in the public square over the risks posed by the ever-expanding range of chemicals and chemical-containing products we encounter in our daily lives.

I urge any Senators thinking about signing on to this approach to reconsider whether they want to be associated with a roll-back of health protections under what is widely acknowledged to be the weakest of all of the major health and environmental laws – one that will be opposed by every environmental health organization in the country.

Richard Denison, Ph.D., is a Senior Scientist.

This morning, two major daily newspapers carried stories on initiatives to ensure the safety of products containing chemicals to which people are increasingly exposed in their daily lives.

A story in USA Today covers the launch of Mind the Store, a campaign that asks the top 10 retailers in the country to develop and make public their plans to address toxic chemicals in the consumer products they sell. 

Also today, the Philadelphia Inquirer ran a story on the introduction of the Safe Chemicals Act of 2013 in the U.S. Senate, which would amend the core provisions of the Toxic Substances Control Act (TSCA) for the first time since its passage 37 years ago. 

See more information on each of these initiatives below. 

Mind the Store

The Mind the Store campaign, managed by the Safer Chemicals Healthy Families coalition (of which EDF is a member), has provided the top 10 U.S. retailers with a list of 100 toxic chemicals and chemical groups that have been identified by authoritative bodies as posing serious hazards, as well as nearly 20 additional chemicals/groups that pose similar concerns and are in some cases being used or considered as replacements for chemicals on the first list.

In letters sent to each of the retailers, Mind the Store is asking them to work with their suppliers to identify which of the Hazardous 100+ list of chemicals are in products they sell, and to develop a public “plan to address them, including reducing, eliminating, or safely substituting the chemicals as appropriate.”  The top 10 retailers (in order of size) are:  Walmart, Kroger, Target, Walgreens, Costco, The Home Depot, CVS, Lowe’s, Best Buy, and Safeway.  The list, the letters and everything else you need to know about the campaign are all here.

Safe Chemicals Act of 2013

The Safe Chemicals Act of 2013 is sponsored by Senators Frank Lautenberg (D-NJ) and Kirsten Gillibrand (D-NY), who are joined by 27 other Senators as original co-sponsors.  It is actually a re-introduction of the same bill that was passed by the Senate Environment and Public Works Committee last July.  As you’ll recall, the bill was heavily modified relative to the original version (introduced back in 2011), specifically to address concerns raised by the chemical and consumer products industries and based on extensive input from and dialogue with those companies and trade associations that were willing to engage in improving the legislation.

Here are some additional materials describing the legislation that you may find to be of interest:

• EDF Statement on the introduction of the Safe Chemicals Act of 2013
• More detailed side-by-sides I have prepared showing:
  • How the Safe Chemicals Act of 2013 addresses the key flaws in TSCA
  • A section-by-section description of changes made to original version of the Safe Chemicals Act
• How the Safe Chemicals Act of 2013 closely aligns with the American Chemistry Council’s (ACC) 10 “Principles for Modernizing TSCA”
• Two brief summaries of the main changes made to original version of the Safe Chemicals Act:
  • The summary of the amendment prepared by the sponsors
  • A summary of the same bill prepared last year by several of us in the Safer Chemicals Healthy Families coalition

Richard Denison, Ph.D., is a Senior Scientist.

Chemical industry representatives and their consultants often argue that they should be on panels reviewing government assessments of their chemicals because “they know their chemicals best.”  Well, the mother of a young man accused of a crime may well know her son better than anyone – but that doesn’t mean we should seat mom on the jury.

I made that comment as part of my public comments delivered at this week's meeting of a new committee formed by EPA's Science Advisory Board, which has a charge of peer reviewing chemical assessments developed by EPA's Integrated Risk Information System (IRIS) program.  (If you're a regular reader of this blog and you feel like you're having a déjà vu, yes, this is yet another panel set up to oversee or assess IRIS; see this earlier post.)  I felt compelled to make that comment in part because in the preceding day and a half of the meeting, well over half of the comments offered by the 26-member committee came from just four of those members, all of them industry consultants.

It turns out that the assigned members of the committee, named the Chemical Assessment Advisory Committee, or CAAC (I recommend just saying C-A-A-C, rather than trying to pronounce the acronym), have not yet been screened for potential conflicts of interest (COI) or lack of impartiality.  This step won't happen until later, when a subset of committee members are tapped to serve on a review panel for a specific IRIS assessment.  But this process made for an awkward meeting, which was supposed to be limited to a "fact-finding" briefing by the IRIS program, but constantly veered into territory verging on providing advice to EPA (again dominated by the industry consultants).  Federal law requires that any committee offering such advice be free of conflicts of interest in all but the most exceptional of circumstances.

In my comments, I raised concerns about the high potential for conflicts of interest to arise, given the composition of the committee.  I also reiterated the points I have made to other similar panels that getting the science right in IRIS needs to be balanced with ensuring that IRIS assessments are completed in a timely manner — because there are real-world adverse public health consequences to the delays that have plagued the IRIS program.

Read on for my full comments.

Comments of the Environmental Defense Fund to
EPA’s SAB Chemical Assessment Advisory Committee (CAAC)
Briefing on the IRIS program and the Development of IRIS Toxicological Reviews
April 3, 2013

Good morning.  I am Dr. Richard Denison, senior scientist at the Environmental Defense Fund.  In my comments today, I would like to address two issues:  first, the matter of conflict of interest and bias, and second, the need to balance getting the science right with timeliness of IRIS assessments.

Conflict of interest and bias

I have noted with some concern the Science Advisory Board’s (SAB) staff’s indication that the members of the CAAC have not been screened for conflict of interest (COI) or appearance of impartiality, and instead that these screens will be done when subsets of the members are designated for specific Integrated Risk Information System (IRIS) reviews.

This has several implications.  First, this committee needs to diligently refrain from providing advice or input to EPA in the absence of a COI and impartiality screen.  While this meeting is being described as fact-finding, in my view some of the discussion has already come close to the line, with a number of members offering opinions and arguing for specific positions.  Any future meetings of this committee as a whole would likewise need to avoid providing advice or input to EPA barring a COI and impartiality screen.

Second, I believe that this committee has a high likelihood of giving rise to COI.  Let me just say at the outset that the issue of COI is difficult, and what I have to say is in no way intended to impugn anyone’s integrity or question the relevance of their expertise.  But several of this committee’s members are chemical industry consultants who are employed by – indeed, are founders or principals[1] of – firms that work mostly or exclusively for, and in some cases advocate on behalf of, companies that make or use chemicals directly relevant to IRIS, or trade associations that represent such companies.

It is often claimed that industry representatives or consultants should be included on such panels because “they know their chemicals best.”  The mother of a young man accused of a crime may well know her son best – but that doesn’t mean we seat her on the jury.

COI can rise most obviously when a committee member works or has worked on a chemical subject to an IRIS review on behalf of an industry client.  But the concern does not stop there.  As we all know, methodological and related issues affecting IRIS assessments cut across many different chemicals.  Individuals who have developed and received payment to advocate on behalf of the chemical industry for a position, say, that a mechanism of action must have been identified in order to conclude causality of a chemical and an adverse outcome, ought to be regarded as conflicted whenever that issue arises in any IRIS review.

Nor is the conflict necessarily limited to the direct activities of specific industry consultants on this committee.  If other employees of the same firm have been paid by industry to work on chemicals, or on assessment-related methodological issues, that come up for IRIS reviews, this too must be regarded as a COI for the consultant on this committee, because of the potential for financial gain by the firm – and hence the individual – depending on the outcome of an IRIS assessment or a decision about a particular methodological approach.  This concern is even more pronounced when the potential review is a founder or principal at the firm in question.

It is essential that any review of IRIS assessments or broader IRIS-related issues conducted under the auspices of this committee be, and be perceived as being, absolutely free of COI.  The IRIS program’s peer review process has already been down this road, and it was not pretty.

Even where COI is deemed not to be a concern, I am concerned at the severe lack of balance with respect to bias on this committee.  Again, several members have staked out very strong positions on specific chemicals and issues of direct relevance to IRIS – they are advocates for the industry positions on these matters.  Those strong biases are in no way sufficiently counterbalanced through other members of the committee who come from academia or state government.  Neither of these categories of experts are advocates in the same way that the industry consultants are, nor are they paid to take or develop evidence to support certain positions.

Case in point:  I have kept rough track over the last day and a half, and well over half of all comments made by committee members were made the four industry consultants.

Balancing timeliness with getting the science right – it matters to real people

We heard calls yesterday, especially from industry consultants, that the IRIS process should slow down, that we can afford to wait while more data are developed; that we should add steps to the IRIS process, e.g., stop after the hazard characterization and have the committee review that before proceeding to the dose-response assessment; that the committee should play a role at the outset of every assessment; or that we should bring revised assessments back for another round of review.  All of this before completing an IRIS review and allowing other decision-makers to act on such a review to address identified risk.

I would like to offer another perspective, as a public health and public interest scientist.  All of these calls by industry would further delay a process that is already far too slow and inefficient.  I am afraid it is a bit too easy for industry scientists to argue for such delays:  They aren’t likely to live next to hazardous waste and Superfund sites or immediately downwind of facility smokestacks; they don’t work 8 hours a day on a factory floor.  People who do are desperate for the kind of information that IRIS provides and for the actions that follow to reduce the risks they face, especially people living in heavily impacted communities in this country, or subject to compounding risk factors such as poor nutrition, or higher disease rates due to more limited access to health care. 

My point is this:  the IRIS program is not an intellectual exercise.  The chemicals in line for assessment are there for a reason:  people are being exposed to them even as we sit here and debate the finer points of IRIS assessments.  I am not suggesting these points aren’t important, but it is essential that getting the science right is balanced with the need for timely assessments and decisions.

My greatest fear about this committee’s IRIS reviews is that they become a quest for the perfect science or a call to delay action until we have near-absolute certainty about a chemical’s adverse effects.  Or that demands are placed on EPA that in an ideal world would be great, but in practice would make it harder, not easier, for EPA to do its job of protecting human health.

The chemical industry can afford to wait; indeed, under our system where a pending assessment means no action can be taken, all of the rewards of delay fall to one side – the (un)regulated industry – and all of the risks fall on the public. 

I’m not suggesting that you as scientists abandon the need to press EPA to get the science right – that’s critically important.  But I urge that you not lose sight of the equally important need not to invite or demand further delay, because that will also delay or deny protection of public health.

I also ask that you recognize that the IRIS process can and should evolve and improve over time, incorporating further enhancements at a pace commensurate with resources and without slowing down progress toward completing ongoing assessments.

By all means, make your recommendations, but provide EPA with options that recognize that the IRIS process has to work in the real world and needs to provide for timely as well as scientifically credible decisions.

Thank you.

[1] Founders and principals of a company warrant special attention because they are likely to have a financial stake in the company that goes beyond just their employment and salary.

Richard Denison, Ph.D., is a Senior Scientist.

This week I attended a workshop sponsored by the National Academy of Sciences’ Committee to Review the IRIS Process.  This committee was established in response to a rider attached to an “omnibus” spending bill passed by Congress in late 2011.  The committee’s charge is to “assess the scientific, technical, and process changes being implemented by the U.S. Environmental Protection Agency (EPA) for its Integrated Risk Information System (IRIS).”

EPA describes IRIS as "a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants."  The key outputs of IRIS assessments are one or more so-called “risk values,” quantitative measures of an “acceptable” level of exposure to the chemical for each cancer and non-cancer health effect associated with the chemical.  IRIS risk values are in turn used by regulators to set everything from cleanup standards at Superfund sites to limits in industrial facilities’ water discharge permits.

This week’s workshop – a detailed agenda is available here – was intended to provide expert input to the committee to inform its review of IRIS.  It focused on the complex and controversial issue known as “weight of evidence” (WOE) evaluation.  Here WOE refers to how EPA – in conducting an IRIS assessment of a particular chemical – selects studies, evaluates their quality, and assesses and integrates their findings, as well as how it communicates the results.  At issue in particular in a WOE evaluation is how the assessor determines the relative importance – or weight – to be given to each study.

One of the many issues that came up in the discussion of WOE is how to identify and assess the “risk of bias” in individual studies – a concept borrowed from the evaluation of the reliability of clinical trials used in drug evaluations.  (See this Powerpoint presentation by one of the committee’s members, Dr. Lisa Bero, which provides a nice overview of risk of bias in that setting).  Evaluating a study’s risk of bias is critical for assessing its quality and in turn the weight it should be given, because bias in studies can result in significant under- or overestimates of the effects being observed. 

One type of bias is so-called “funder bias.”  Dr. Bero and other researchers have documented through extensive empirical research that there is a significantly increased likelihood that a study paid for by a drug manufacturer will overstate the efficacy or understate the side effects of a drug.  As to studies of environmental chemicals, at the workshop and more generally, the chemical industry has pointed to adherence to Good Laboratory Practice (GLP) standards as a sufficient antidote to bias, including funder bias, a notion that has been heartily disputed by others.

But enough background.  My intent here is not to fully describe the workshop discussions, but rather to provide the comments I presented during the public comment period at the end of the meeting.  My comments addressed the issue of funder bias and also sought to urge the committee not to dive so deeply into the weeds in reviewing and proposing enhancements to EPA’s IRIS process that it loses sight of the need for a workable IRIS process that is able to provide in a timely manner information so critical to ensuring public health protection.

EDF comments to the National Academy of Sciences Committee to Review the IRIS Process” workshop on “weight of evidence” in chemical assessments

Good afternoon.  I am Dr. Richard Denison, Senior Scientist at the Environmental Defense Fund.

I’d like to respond to a few things I’ve heard over the past two days.

First is this issue of risk of bias, which industry representatives appear not to believe is a problem – except when it comes to EPA-funded academic scientists.  ACC has argued, including in its comments yesterday, that processes such as Good Laboratory Practice (GLP) have solved any possible problem and are sufficient to address any source of bias, including funder bias.  It’s critical to note that GLP and related developments came about in direct response to misconduct and outright, large-scale fraud on the part of the chemical, pesticide and drug industries and their contract labs.  [Wikipedia provides a good discussion of the history of GLP, the 1970s Industrial BioTest Labs scandal that led to its development, and a critique and contrast between industry-funded and academic studies.]

There is not empirical evidence to support ACC’s assertion that GLP and related measures minimize or eliminate risk of bias; contrast this with the strong empirical evidence of funder bias discussed yesterday by Drs. Robinson, MacLeod and Bero for pharmaceutical studies.

We’ve also heard calls over the last two days, especially from industry and its consultants, that we can afford to and should wait for more research, for the testing-out of all possible alternative hypotheses, for the collection of data on and a full understanding of mechanism of action, and for full consensus on how to identify, select, integrate and assess information on a chemical – all before completing an IRIS review and acting on such a review to address risk.

I would like to offer another perspective, as a public health and public interest scientist.  All of these calls by industry would further delay a process that is already far too slow and inefficient.  I am afraid it is a bit too easy for industry scientists to argue for such delays:  They don’t live next to hazardous waste and Superfund sites; they don’t typically have to rely on contaminated groundwater for drinking water or live immediately downwind of facility smokestacks; they don’t work 8 hours a day on a factory floor; they aren’t generally subject to multiple exposures from multiple pollution sources, as are many poor people living in heavily impacted communities in this country.  And they don’t typically suffer from other compounding factors such as poor nutrition, or higher disease rates due to more limited access to health care. 

I could go on.  My point is this:  the IRIS program is not an intellectual exercise.  The chemicals in line for assessment are there for a reason:  people are being exposed to them even as we sit here and debate the finer points of systematic review and weight of evidence.  I am not suggesting these points aren’t important, but it is essential that getting the science right is balanced with the need for timely assessments and decisions.

[UPDATE: I have modified this paragraph that could have been construed as discussing a confidential matter.]  A useful charge to this committee would be, not just to critique the current IRIS process or offer recommendations for its improvement, but to design a process that would actually work, within current resource constraints and data and methodological limitations, to develop and finalize X number of credible assessments each year.  This would ensure that the committee would grapple with the practicalities of effectively and efficiently carrying out an assessment process that not only is of sufficient scientific quality but also is timely and accountable to the public interest in having decisions made about the risks of chemicals to which people are actively being exposed.

My greatest fear about this committee’s IRIS review has been that it would run the risk of becoming a quest for the perfect science, yielding recommendations for enhancing IRIS’ process that in an ideal world would be great, but in practice would make it harder, not easier, for EPA to do its job of protecting human health.

The chemical industry can afford to wait; indeed, under our system where a pending assessment means no action can be taken, all of the rewards of delay fall to one side – the (un)regulated industry – and all of the risks fall on the public. 

I’m not suggesting that you as scientists abandon the need to press EPA to get the science right – that’s critically important.  But I urge that you not lose sight of the equally important need not to have the resulting process be so prescriptive and onerous that it invites delay, which will also delay or deny protection of public health.

I also ask that you recognize that the IRIS process can and should evolve and improve over time, incorporating further enhancements at a pace commensurate with resources and without slowing down progress toward completing ongoing assessments.

By all means, make your recommendations, but provide EPA with options that recognize that the IRIS process has to work in the real world and needs to provide for timely as well as scientifically credible decisions.

Thank you.

Richard Denison, Ph.D., is a Senior Scientist.

Last week, the National Academy of Sciences (NAS) held a joint meeting of its two panels that are charged with reviewing the listings of formaldehyde and styrene as carcinogens in the 12^th Report on Carcinogens, which was released in June 2011.

The 12th Report on Carcinogens (RoC) is the latest edition of a Congressionally mandated report developed by the National Toxicology Program (NTP).  It upgraded formaldehyde to the status of “known to be a human carcinogen,” and for the first time listed styrene as “reasonably anticipated to be a human carcinogen.”  That put the chemical industry into a real tizzy, what with the threat these listings pose to its profits from the huge volumes of these cash cows sold each year, not to mention the huge potential liability it faces.

Never one to go down lightly, the American Chemistry Council (ACC) has launched an all-out assault on the NTP and the RoC.  It is waging battle not only with the executive branch, but also in the courts and in Congress.  In late 2011, it managed to get its allies in Congress to slip into the Consolidated Appropriations Act of 2012, without any debate, a rider that mandated the NAS reviews of the formaldehyde and styrene listings in the 12^th RoC that are now underway.

ACC also pushed legislation in the last Congress to shut down all funding for the RoC until the reviews are completed; failing on that front, earlier this month it demanded that NTP cease all work on the next (13^th) edition of the RoC.  (For more background, see previous blog posts by EDF and NRDC.)

Lost in all this kerfluffle, however, are these salient facts:

• The formaldehyde and styrene listings are the outcome of one of the most extensive scientific assessment processes on the planet, entailing reviews by four separate groups of expert scientists for each chemical.
• ACC as well as the public had at least three separate formal opportunities for providing input to these expert bodies.
• Of a total of 52 votes cast by these scientific panels on the NTP’s recommended listings, 51 of those votes supported the recommendations and only one opposed them.

At last week’s joint panel meeting, Dr. John Bucher, head of the NTP, spent two hours laying out the process NTP uses to:  (a) determine which chemicals get selected for possible inclusion in the RoC, (b) compile and assess the evidence to reach recommendations on the potential for those chemicals to cause cancer in humans, (c) solicit and consider public comments at each stage of the process, and (d) peer review NTP’s recommendations, first, by independent scientific experts, then by scientists drawn from multiple agencies across the federal government, and finally by another group of independent experts, the NTP’s Board of Scientific Counselors.

Here’s a schematic that summarizes NTP’s process; note the multiple rounds of scientific review and solicitation of public comment:

And here are the vote tallies from the expert groups:

• Recommendation to list formaldehyde as “known to be a human carcinogen”
  • Expert panel:                                                9 yes to 0 no
  • Interagency scientific review group:        8 yes to 0 no
  • NIEHS/NTP scientific review group:         9 yes to 0 no
• Recommendation to list styrene as “reasonably anticipated to be a human carcinogen”
  • Expert panel:                                               10 yes to 0 no
  • Interagency scientific review group:        8 yes to 0 no
  • NIEHS/NTP scientific review group:         7 yes to 1 no

For those of you keeping score, that's 51 yes votes to 1 no vote.

Interestingly, two members of the interagency scientific review group for styrene actually thought that NTP’s recommendation was too weak and should be upgraded to “known to be a human carcinogen.”

None of this virtual unanimity among scientific experts has had any discernible effect on the hysterics of the chemical industry:  It dominated the NAS’s joint panel meeting, flying in its own “experts” from all over the country.  Of 11 public comments provided to the panelists, eight were from paid industry consultants or staff from ACC or its members companies.

Bracketing these loud industry voices, however, were a couple others.  The first public comment of the day came from the president and founder of a small personal care products company that is a member of the American Sustainable Business Council (ASBC).  She noted how critical it is for small businesses making consumer products to have access to timely, objective information on the hazards of chemicals, so that they can take steps to reduce or eliminate them.  She also pointed to a recent national poll of small business owners that found widespread support – regardless of party affiliation – for greater access to information about toxic chemicals and stricter regulation.

My colleague at NRDC, Dr. Jennifer Sass, and I were the last two public commenters of the day.  In her comments, Dr. Sass asked the obvious question:  “Why is the [NAS] reviewing the styrene and formaldehyde assessments, which have both already undergone years of public and scientific review?”  She also provided critical rebuttal to the industry’s claims that NTP somehow got it wrong.

I made two points in my comments:  First, delays in reaching decisions about toxic chemicals – in this case spurred by the chemical industry’s political attack on independent government science – have real-world consequences:  They mean we continue to needlessly expose millions of people to these chemicals’ harmful effects.  Industry interference has kept the federal government from completing its assessment of formaldehyde’s risks for 15 years and counting.  Had those delays not occurred, we might well have avoided the national scandal that arose when victims of Hurricane Katrina were poisoned after being housed in those infamous FEMA trailers that were laced with formaldehyde-emitting plywood.

Second, I urged the members of the NAS panels, when carrying out their charge to ensure the science behind NTP’s listings is sound, to avoid demanding “perfect” science and raising the bar so high before government can act that they inadvertently contribute to even more delay in securing critical health protections for workers, people of color and lower socioeconomic status and others who disproportionately bear the impact of toxic chemical exposures.