EDF Health

Perchlorate regulation: Critical opportunities for EPA and FDA to protect children’s brains

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 15, 2016

Tom Neltner, J.D., is Chemicals Policy Director

All Americans who have been tested have perchlorate in their bodies. Perchlorate threatens fetal and child brain development by impairing the thyroid’s ability to transport iodine in the diet into the gland to make a thyroid hormone, known as T4, that is essential to brain development. Both the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) are scheduled to make decisions in 2017 that could significantly reduce exposure to this hazardous chemical.

Based on statements in a new report by EPA, we estimate that at least 20% of pregnant women are already iodine deficient, resulting in T4 levels that put the fetuses’ developing brains at risk. For this population of pregnant women, any perchlorate exposure results in an even greater risk of impaired brain development in their children and potentially a lifetime of behavioral and learning difficulties.

This is why it is critical that our public health agencies take actions to reduce exposure to perchlorate with a focus on this vulnerable population. There are three key decisions to be made in the coming year:

  1. EPA will decide in January 2017 whether hypochlorite bleach, an antimicrobial pesticide, degrades to perchlorate in significant amounts. If EPA agrees it does, the agency must set standards to limit that degradation as part of its 15-year update to the pesticide’s registration. Bleach is a widely-used disinfectant in food manufacturing facilities and likely a significant source of perchlorate in contaminated foods. Research shows that reducing hypochlorite concentration limits degradation and this, coupled with expiration dates on the product would significantly reduce exposure to perchlorate.
  2. FDA will decide whether perchlorate should continue allowing perchlorate to be added to plastic packaging for dry food at levels up to 12,000 ppm to reduce buildup of static charges. The agency has evidence that the perchlorate migrates from the packaging into food, especially when it flows in and out of the container. In response to a lawsuit filed by public interest organizations, FDA told a court that it aims to make a final decision by the end of March 2017. A 2008 report by FDA indicated that almost 75% of all food types are contaminated with perchlorate.
  3. EPA told a court that it will complete external peer review of a dose-response model in October 2017 and sign a proposed rule to regulate perchlorate in drinking water a year later. This model is a critical step in establishing a drinking water standard for perchlorate pursuant to its 2011 determination that an enforceable standard was necessary under the Safe Drinking Water Act. The perchlorate is most likely from contaminated source waters (e.g. from military and defense industry activities and some fertilizer use in agricultural regions) or from degradation of hypochlorite bleach used to disinfect water. EPA acted in response to a lawsuit by the Natural Resources Defense Council.

To guide their decision-making, FDA and EPA collaborated to develop a biologically-based dose-response model to predict T4 levels in pregnant women, fetuses, and infants exposed to perchlorate. EDF and NRDC submitted joint comments on the model and the summary report requesting that EPA ensure protection of fetuses during the first two trimesters for pregnant women with serious iodine deficiencies.  These fetuses are particularly vulnerable because their thyroids is not yet functioning. The current fetal model only considers the third trimester when the fetus has a functioning thyroid. The current model fails to adequately protect their vulnerable subpopulations, falling shot of both the EPA’s Science Advisory Board recommendation and the Safe Drinking Water Act requirements.

For decades, federal agencies have been charged with protecting children from environmental health risks with the recognition that they are uniquely vulnerable to chemical exposures. The upcoming decisions on perchlorate present critical opportunities to protect what many of us value the most—our children’s health and their ability to learn and thrive to their fullest potential.

Also posted in Drinking water, Emerging science, FDA, Food, General interest, Health policy, Perchlorate / Tagged , , , , , , , , | Comments are closed

Remarks at EPA stakeholder meeting on New Chemicals Review Program

By Joanna Slaney / Published: December 14, 2016

Joanna Slaney is the Legislative Director for EDF Health.

Today the EPA held a public meeting on the new requirements for the New Chemicals Review Program under the reformed Toxic Substances Control Act. EDF oral comments, as prepared for delivery, follow below.

Strong implementation restores public and market confidence.

EDF believes that the reforms to the New Chemicals program in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and the robust implementation of these reforms by the EPA, are absolutely essential to the task of restoring public and market confidence in our national chemical safety system. It is this shared objective, restoring public and market confidence, that allowed disparate stakeholders and lawmakers to come together to support the Lautenberg Act in the first place. And without a strong New Chemicals program, there is no restored public confidence.[pullquote]Without a strong New Chemicals program, there is no restored public confidence.[/pullquote]

It’s a public health issue.

With between 500 and 1,000 new chemicals entering the market every year, ensuring the safety of these chemicals is clearly a public health priority. It is critical that new chemicals clear a safety bar before they are allowed in products and in our homes. For decades, chemicals have been allowed on the market simply because there wasn’t enough information to make a safety decision one way or another. In 2007 EPA reported that 85% of pre-manufacture notices contained no health data. That’s not right, and it puts the public’s health at risk, most especially the health of vulnerable populations like children, pregnant women, and workers. Any chemical entering the market should be reviewed and managed to provide a reasonable assurance of its safety. In fact, I expect that most Americans believe that their government already does so in order to protect their health and the health of their families.

It’s congressional intent.

Many in Congress worked hard to drive significant improvements to the new chemicals provisions in the new law; indeed, for some it was a central reason for their involvement in reforming TSCA. And the record is clear that even where certain Members were less inclined to see the need for change, they acknowledged that significant changes were made to the New Chemicals program as part of the compromise legislation. The changes that were made were a compromise on both sides but they were not insignificant, and the new requirements are clearly laid out in the language of the Lautenberg Act.

It’s a primary purpose of TSCA.

It has been argued that EPA’s implementation of the new chemicals program under the Lautenberg Act risks impeding innovation and is at odds with the intent of the law. In fact, the intent of the law is quite clear:

It is the policy of the United States that— authority over chemical substances and mixtures should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the primary purpose of this Act to assure that such innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment.

While innovation is central, it cannot come at the expense of protection for public health and the environment. Innovation without safety is not true innovation.

The changes made to the New Chemicals program are fundamental to the reform of TSCA and the promise of the new system. Given that the development and application of new chemicals are a clear source of innovation, how else is that primary purpose of TSCA – providing an assurance that innovation and commerce in chemicals do not present unreasonable risk – to be realized other than through robust scrutiny of new chemicals prior to their commercialization.

The public has a right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety.  The lack of that basic assurance has undermined consumer confidence in our chemical safety system.  The most efficient and effective stage at which to provide assurance of safety is before commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.

Environmental Defense Fund supports the actions taken by EPA to date in implementing the New Chemicals Program and believes they are clearly required under the new law.  We look forward to EPA continuing to implement a robust New Chemicals program that can restore public and market confidence in our national chemical safety system, while both protecting human health and the environment and fostering safe innovation.

Also posted in Health policy, Industry influence, TSCA reform / Tagged , , , , , | Comments are closed

Making federally-assisted housing lead-safe for children

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 30, 2016

Tom Neltner, J.D., is Chemicals Policy Director

Housing supported by the Federal Government should not be poisoning children.

That was the simple message Congress delivered to the Department of Housing and Urban Development (HUD) in the Residential Lead-Based Paint Hazard Reduction Act of 1992. Despite some real progress since then, recent cases of lead poisoning in federally-assisted housing in Chicago and Indiana suggest there is still much work to be done.

Thanks to a strong public push to highlight these failings, HUD recently proposed changes to its “Lead Safe Housing Rule.” At the heart of these changes is lowering the level of lead in children’s blood considered “elevated,” the trigger for local housing authorities to conduct detailed inspections of a child’s home for lead. HUD has continued to use a level of 20 µg/dL set in 1999, despite a consensus that lead is harmful to children at much lower levels. HUD is on track to finalize the rule in January 2017 after sending it to the Office of Management and Budget on November 21 for final review.  Jan. 13, 2017 update: HUD issued a final rule that was similar to what was proposed.

Read More »

Also posted in Health policy, Lead / Tagged , , , , , , | Comments are closed

Crucial – but unfulfilled – role local code officials have in protecting children from lead

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 21, 2016

Tom Neltner, J.D., is Chemicals Policy Director

The tragedy in Flint, Michigan has reminded us once again how dependent we are on state and local officials to protect us from hidden threats like lead. In hindsight, anyone with a basic understanding of the role of corrosion control in keeping lead out of the water we drink knows that changing the source of that water, especially to one as corrosive as the Flint River, must be done with extreme care. Based on criminal indictments that have been handed down, the officials ignored the federal regulations designed to prevent such a tragedy.

State and local building code officials will have a chance this October to show whether they have learned from Flint. As voting members of the International Code Council (ICC), code officials will cast their ballot on a simple proposal that can significantly improve the protections for children from lead hazards. The proposal by the National Center for Healthy Housing (NCHH) would require that any contractor seeking a building permit to conduct renovations in homes built before 1978 be properly certified to ensure that their work leaves behind no dangerous levels of lead contaminated dust. Read More »

Also posted in General interest, Health policy, Lead / Tagged , , , , , , , | Read 1 Response

People deserve to know if lead pipes and paint are present where they live and work

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 20, 2016

Tom Neltner, J.D., is the Chemicals Policy Director

We live in an increasingly transparent world. When it comes to the real estate market, companies are mining local government databases to let us know the size of a home, how much it’s worth, and even when the roof was last replaced.

Yet, you can’t find out if the house you might buy could poison your children with toxic lead. Federal law only requires that the seller or landlord reveal the presence of lead paint when you sign a contract to buy or rent a home.

We think that has to change.

People should be able to readily know if lead is present in the paint and water pipes where they live and work when they begin making important decisions, not when they are finalizing the deal. When shopping for a place to live, the best time to learn if there is lead at a property is when it is listed for sale or rent. Some opponents claim that revealing this information invades the resident’s privacy, but the presence of lead is not about anyone’s behavior. Rather, it’s a fact about the house, a legacy of the construction of the building. It is no different from the type of furnace or number of bedrooms.

There are signs of progress. In Washington, DC, the water utility has launched an online map that reveals information that can help improve transparency on lead pipes. Anyone can check online and see what’s known (and not known) about the presence of lead service lines that connect the drinking water main under the street to their home or business.

It’s a model other communities should follow. The U.S. Environmental Protection Agency has made this type of transparency a priority for states and utilities. And the private sector needs to play a role, too — real estate innovators like Zillow and Redfin, who have transformed how we find homes, should include this information in their online listings.

It’s time that people begin to know the possible health impacts of their housing options when evaluating homes to buy or rent.

Also posted in Drinking water, General interest, Lead, Markets and Retail / Tagged , , , , , , , , , | Comments are closed

Lost opportunity for safer food additives

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 12, 2016

[pullquote]In DC, “Take Out the Trash Day” refers to federal agencies releasing unpopular decisions on Friday when the media and public are not watching.  It is especially common around the holidays or in August when many people, especially those in Congress are on vacation.  On Friday, August 12, FDA took out the trash by issuing a final rule regarding chemicals added to food more than two weeks before a court ordered deadline[/pullquote]

Tom Neltner, J.D., is Chemicals Policy Director

On August 12, the Food and Drug Administration (FDA) issued a final rule defining how companies should voluntarily notify the agency when they conclude that a chemical added to or used to make food is “Generally Recognized as Safe” (GRAS).

The decision is a lost opportunity to close a widely-abused loophole that allows chemicals to be approved for use in food with no notification to or review by FDA. The rule allows the industry to continue making secret decisions about what we eat without the agency’s – or the public’s – knowledge.  The agency has the legal authority to significantly narrow the GRAS loophole to prevent companies from deliberately avoiding FDA’s safety review process.

Just two years ago, the senior FDA official overseeing food safety acknowledged that the agency “cannot vouch for the safety of many of these chemicals” as a result of the GRAS loophole. Read More »

Also posted in FDA, Food, Health policy / Tagged , , , | Authors: / Comments are closed