Author Archives: EDF Blogs

EDF Statement on House TSCA Reform Discussion Draft

In the latest indication of continued engagement toward reform of the Toxic Substances Control Act (TSCA), Rep. John Shimkus (R-IL), Chairman of the Subcommittee on Environment and the Economy of the House Energy and Commerce Committee, has publicly issued a new TSCA reform “discussion draft.”

The announcement of this proposal is a starting line in the House, not the finish.  Our preliminary review of the posted draft has identified very serious concerns that, if not addressed, would fail to fix key flaws in TSCA and would weaken current law.

The discussion draft has a very long way to go to yield a bill that ensures protection of public health.  We hope that Chairman Shimkus’ sharing of his proposed language in draft form – initially with committee Democrats and now with other stakeholders – portends a collaborative bipartisan process that leads to such a bill.

Significant progress has been made through ongoing bipartisan negotiations in the Senate to address key concerns voiced about the Chemical Safety Improvement Act (CSIA, S. 1009) since its introduction last May by the late Senator Frank Lautenberg (D-NJ) and Senator David Vitter (R-LA).

EDF looks forward to engaging with both Republican and Democratic offices and intends to offer proposals to make needed improvements in the discussion draft and move meaningful and effective TSCA reform legislation forward.

Posted in Health Policy, TSCA Reform| Tagged | Comments closed

Putting Words Into Action: Walmart releases detailed plans to implement its chemical policy

Jennifer McPartland, Ph.D., is a Health Scientist.  Boma Brown-West is a Manager for Consumer Health.

Today, Walmart unveiled its sustainable chemicals policy Implementation Guide. The Guide details how the company will work with suppliers to bring safer products to millions of American shoppers, as announced last September when the policy was introduced.

Walmart’s chemicals policy affects formulated consumable products – the non-food products that you can pour, squeeze, dab or otherwise apply to your body or use in and around your home or car, from health and beauty aids to baby products to pet supplies. There are three main components of the policy:  transparency through expanded ingredient disclosure; advancement of safer product formulation through the reduction, restriction, and elimination  of priority chemicals and use of safer substitution practices; and a plan to take Walmart private brand consumables through the U.S. EPA Design for Environment (DfE) Safer Product Labeling Program — a rigorous product certification program that reviews the safety of product ingredients. Walmart’s policy is audacious in that it attempts to evolve from the common restricted substance list (RSL) approach to one that actively promotes usage of safer chemicals.  The release of the Implementation Guide makes public how this is expected to happen.  Read More »

Posted in Health Policy, Markets and Retail| Tagged , , , | Comments closed

CDC finally describes its derivation of “safe” level in WV spill – but erroneously claims it to be “highly conservative”

Richard Denison, Ph.D., is a Senior Scientist.  Jennifer McPartland, Ph.D., is a Health Scientist.

Slowly but surely, like the movement downstream of the spill’s plume, we are learning more about how government officials derived the 1 ppm “safe” level in the drinking water for the chemical MCHM that was spilled into West Virginia’s Elk River late last week.

A few more slivers of light were cast today onto what has been a remarkably opaque procedure used by CDC and other officials to set the 1 ppm level, which got even more confused with last night’s issuance of a “Water Advisory for Pregnant Women” by the West Virginia State Department of Health. 

The slivers come from a story today in the Charleston Gazette by Ken Ward, Jr. and David Gutman reporting on their conversation with an official from the Centers for Disease Control (CDC), and a media call today with the same official. 

CDC finally gave a fuller description of their methodology, and while it appears to have more closely followed standard practice than the methodology they initially described, many questions remain about the study used as the starting point.  Release of these studies, therefore, is essential.  [UPDATE:  EVENING OF 1/16/14:  Late today, Eastman finally made its studies public:  they are available here.] 

We discuss the details further below.  But first:

CDC’s erroneous claim that its "safe" level is “highly conservative”

CDC’s claim that the 1 ppm level is “highly conservative” is not warranted on scientific grounds.  This claim is based on its use of three 10-fold adjustments, referred to by CDC as “uncertainty factors,” to extrapolate from a dose identified in an animal study to a level in drinking water consumed by people.

  1. An “interspecies extrapolation” uncertainty factor to account for the fact that humans may be much more sensitive to the effects of a chemical exposure than rats.
  2. An “intraspecies extrapolation” uncertainty factor to account for the fact that humans differ in their sensitivity to a chemical exposure (e.g., infants or the elderly vs. healthy adults).
  3. A third uncertainty factor to account for how few data are available on the chemical and hence the likelihood that its health effects that have not been identified may occur at doses much lower than the doses for the health effect that has been studied.

The CDC official referred to these adjustments as “safety factors” – implying they provide for a large margin of safety.  This is FALSE.  These are REALITY FACTORS.

Each of these accounts for known circumstances with regard to the effects of chemical exposures on people in the real world.  There are plenty of examples of chemicals where:

  1. humans are 10x (or more) more sensitive than rats to a chemical effect, and
  2. the most vulnerable/sensitive human is 10x (or more) more sensitive than the least vulnerable/sensitive, and
  3. an effect not considered in a given study occurs at a dose that is 10x (or more) lower than the effect looked at in the study.

Don’t take our word for it, but rather the National Academy of Sciences, in a seminal 2009 report titled Science and Decisions:  Advancing Risk Assessment (p. 132, emphases in original):

Another problem … is that the term uncertainty factors is applied to the adjustments made to calculate the RfD [reference dose, derived from, e.g., a no-effect level] to address species differences, human variability, data gaps, study duration, and other issues. The term engenders misunderstanding: groups unfamiliar with the underlying logic and science of RfD derivation can take it to mean that the factors are simply added on for safety or because of a lack of knowledge or confidence in the process. That may lead some to think that the true behavior of the phenomenon being described may be best reflected in the unadjusted value and that these factors create an RfD that is highly conservative. But the factors are used to adjust for differences in individual human sensitivities, for humans’ generally greater sensitivity than test animals’ on a milligrams-per-kilogram basis, for the fact that chemicals typically induce harm at lower doses with longer exposures, and so on. At times, the factors have been termed safety factors, which is especially problematic given that they cover variability and uncertainty and are not meant as a guarantee of safety.

CDC’s Methodology Revealed

Until yesterday, all indications were that the 1 ppm level was derived from a single oral lethality study in rats that is not publicly available but reported a median lethal dose value (LD50).  Yesterday, CDC referred to “additional animal studies” that were under review.  In today’s Charleston Gazette story and this afternoon’s call, the CDC official indicated for the first time that CDC used a second study – also not publicly available – as the starting point for the calculations.  This second study was stated as identifying a “No Observable Adverse Effects Level (NOAEL)” for MCHM of 100 milligrams per kilogram of body weight per day (mg/kg/day). 

[UPDATE 1/17/14:  This study, finally made available late yesterday, was performed using "pure MCHM" (97.3%) rather than the "crude MCHM" mixture that was the material actually spilled.  This adds some additional uncertainty; if other components besides MCHM present in the crude mixture are more or less toxic than MCHM, the mixture's toxicity would differ from that found for the pure material.]

Numerous questions about this study remain unanswered that bear on its relevance for the purpose to which it has been put.  Just a couple key ones:

  • What health effect(s) were looked for?  and which ones were not considered?  [UPDATE 1/17/14It appears that the study looked for changes in standard blood chemistry and biochemistry parameters, and included histopathological examination of all major organs to look for abnormalities.] 
  • How long were the animals exposed – a day? a week?  a month?  [UPDATE 1/17/14:  The study report indicates the animals were exposed for 4 weeks.] 

But at least we now know how CDC made the calculation that led to the 1 ppm level:

  1. CDC started with the reported NOAEL of 100 mg/kg/day, and divided it by the three uncertainty factors (10 x 10 x10 = 1000) to arrive at a “reference dose” of 0.1 mg/kg of body weight/day.  This is the amount of the chemical that, under the assumptions made, could be presumed “safe” to ingest.
  2. It then assumed an “average child” weighing 10 kilograms (about 22 pounds) was drinking water at an average rate of 1 liter per day (about 34 ounces).  These average values are typical assumptions for use in risk assessment.
  3. Then CDC multiplied the 0.1 mg/kg of body weight/day by the 10 kg average body weight, resulting in 1.0 mg/day for a child as the amount that could be ingested without seeing an effect, again under the assumptions used.
  4. That 1.0 mg/day was then divided by the average water consumption of 1 liter/day to yield 1.0 mg/liter as the concentration in the water consumed identified by CDC as the “safe” level.
  5. That 1.0 mg/liter is equivalent to 1 ppm.

Welcome to the wild and woolly world of risk assessment, folks.  More to come, we're sure.

Posted in Environment, Health Policy, Regulation| Tagged , | Comments closed

Making regrettable substitution a thing of the past

Michelle Harvey is a Senior Project Manager in EDF's Corporate Partnership Program.

Regrettable substitution. Informed substitution.

The first sounds like a problem – and it is. The second is the way you avoid the first.

In the world of consumer products made from mixtures of chemicals – baby lotion, shampoo, cleaners, laundry soap – chemists seek ingredients that are effective and feasible. What they too often don’t also consider are the hazardous properties of the chemical and its risk to people.  This is in part because most chemists are not trained in toxicology.  Further, many of the biological interactions between us and the ingredients in everyday products we use on our bodies and in our homes are only now being understood.  As our understanding has grown, groups such as EDF have called for the removal of some of the more concerning chemical ingredients from store shelves.

But it’s not as simple as just taking a hazardous chemical out of a product.  While in some instances a chemical of concern can be simply eliminated, in many cases these chemicals perform a key function in a product and a replacement chemical is necessary.  If the replacement isn’t carefully considered for its own potentially deleterious effects, you can end up exchanging a problem for a problem – resulting in a regrettable substitution. 

The good news is that the path forward for identifying and making informed choices about substitutes has become a lot clearer. 

Today, EDF together with BizNGO, the Toxic Use Reduction Institute and the Lowell Center for Sustainability released The Commons Principles for Alternatives Assessment with the support of over 100 representatives of business, universities and NGOs.  This broad consensus around simple, solutions-based principles, signals a growing commitment to moving hazardous chemicals out of the supply chain and driving informed, safer innovations. 

Alternatives assessment is a process for identifying, comparing, and selecting safer alternatives to chemicals of concern based on certain chemical features including hazard, performance, and economics.  The six “Common Principles” establish key elements of informed decision-making about the chemicals in a product.  Reduce hazard. Minimize exposure. Use best available information. Require disclosure and transparency. Resolve trade-offs. Take action.  They are “common principles” because they are shared by a broad, diverse group of individuals from academia, industry and the NGO community.

In September, Walmart became the first retailer to call for informed substitution as suppliers phase out of chemical ingredients of concern in products it sells. It is EDF’s hope that the Commons Principles will be used to meet this commitment, and inform the efforts of other retailers and product manufacturers.  Smart and informed decisions guided by the Commons Principles can make products safer and regrettable, hazardous substitutions a thing of the past.

 

Posted in Health Policy, Health Science, Markets and Retail| Tagged , | Comments closed

Premier medical organizations sound alarm on toxic chemicals’ harm to reproductive health

Joanna Slaney is an EDF consultant.

As a mom, I know what it’s like to worry about the health and safety of my children. You want to do everything you can to protect your kids, and help them stay healthy and strong. That’s why I think most parents will want to pay attention to the statement released today from the American College of Obstetricians and Gynecologists (ACOG) and the American Society for Reproductive Medicine (ASRM). The joint opinion from two of the country’s most prestigious medical organizations details how prenatal exposure to certain chemicals is linked to miscarriages, stillbirths, and birth defects. These groups are urging ob-gyns to advocate for government policy changes needed to ensure we identify and reduce exposure to toxic environmental agents.

EDF Health is very pleased that ACOG and ASRM are expanding awareness of the serious threats toxic chemicals can pose to our health. We urge everyone, especially parents, to take a closer look at this joint statement.

EDF Health has issued the following statement: “Today’s statement from ACOG and ASRM is the latest reminder about the devastating impact toxic chemicals can have on our health,” said Dr. Sarah Vogel, Director, EDF Environmental Health. “Even more shocking is that most everyday chemicals have never been tested for safety.  Our doctors are telling us we need to fix America’s chemical laws to protect our families’ health.”

To learn more about the health impact of toxic chemicals, please go here.

Posted in Health Policy, Health Science| Tagged , , , | Comments closed

EDF Applauds New Walmart Policy That Promises Safer Products for Consumers

Here is EDF's release on Walmart's announcement today:

FOR IMMEDIATE RELEASE

EDF Applauds New Walmart Policy That Promises Safer Products for Consumers

New chemicals policy today promises to bring safer, healthier products
to the 80 percent of Americans that shop at Walmart

September 12, 2013

CONTACT: Katie Ware, kware@edf.org, (212) 616-1283

BENTONVILLE, Ark.—Walmart announced a new chemicals policy today that promises to bring safer, healthier products to the 80 percent of Americans that shop there. The policy was unveiled during Walmart’s Global Sustainability Milestone Meeting and focuses on chemical ingredients in consumables –household cleaners, personal care products and cosmetics.

Walmart is calling for expanded ingredient disclosure, targeting about ten key chemicals of concern for substitution with better ingredients and looking to take its private brand products through a rigorous screening process.

“Today’s announcement is yet another indication that consumers, advocates and business are working together to fill the void left by Washington’s inaction on chemical safety,” said Sarah Vogel, Director of EDF’s Environmental Health program.

EDF worked closely with Walmart to prioritize the removal of toxic chemicals in household, personal care and beauty products. Walmart’s new chemicals policy targets about ten hazardous chemicals in consumer products for replacement with safer ingredients and significantly expands ingredient disclosure to the public.

“Some companies stop at issuing a restricted substances list,” said Vogel. “No other company is requiring the all-important, but often forgotten, second step to truly transformational phase-outs: putting a system in place that avoids regrettable chemical substitutions. EDF commends this aggressive new policy.”

 

# # # #

 

Environmental Defense Fund (edf.org), a leading national nonprofit organization, creates transformational solutions to the most serious environmental problems. EDF links science, economics, law and innovative private-sector partnerships. Follow us on Twitter at twitter.com/EnvDefenseFund and on Facebook at facebook.com/EnvDefenseFund.

 

Posted in Health Policy, Markets and Retail| Tagged | Comments closed
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