FDA decides 3 PFCs are unsafe: Detailed look at the decision

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

FDA’s decision to remove its approval of three long-chain perfluorinated compounds sets important precedents on the assessment of food ingredients, food contact substances, and chemicals used to make food.

FDA concluded:

  • Class: All long-chain chemicals with at least one linear, perfluorinated chain of eight or more carbon atoms should be considered a class.
  • Data gaps: Where reproductive and developmental toxicity data are lacking for any chemical in this class, the data available for perfluorinated octanoic acid (PFOA) should be used to fill the gaps.
  • Study methods: If a chemical is biopersistent in the body, standard toxicology methods used to evaluate food additives need to be upgraded.

On Jan. 4, 2016, the Food and Drug Administration (FDA) announced that it changed its regulations to remove the agency's approval of three specific long-chain perfluorinated compounds (PFCs) as food additives. The agency approved use of these chemicals between 1967 and 1997, allowing them to be added to paper and paperboard that comes in contact with aqueous and fatty foods. Until the late 2000s, they were commonly used in pizza boxes, sandwich wrappers, and paper in frozen food packaging – virtually anywhere a food manufacturer wanted to use paper packaging that would repel oil and water.

Domestic PFC manufacturers report that these food contact substance (FCS) uses have been abandoned, although others report trace levels still appearing in paper products used for food, most likely as a result of contamination. There are reports, however, that foreign companies have begun producing PFCs. As long as these additives are officially allowed by FDA, there is a possibility that food manufacturers who are not diligent could resume their use without knowing it. The agency’s decision makes it less likely that will happen.

FDA’s decision marks the first time it has used a food additive petition to remove an approval based on safety concerns; a few years ago, it removed approvals for use of bisphenol A in infant formula packaging and baby bottles and sippy cups – but those removals were based on market abandonment, not safety. This safety-driven decision sets a precedent and serves as a roadmap for how safety decisions should be made for all additives including those considered by industry to be ‘generally recognized as safe’ (GRAS).

No longer safe – unpacking the agency’s reasoning for a class of chemicals and safety concerns Read More »

Posted in Emerging Science, Emerging Testing Methods, FDA, Food, Health Policy, Health Science, Regulation| Leave a comment

State authorities weigh in on Senate and House TSCA reform bills

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

In recent weeks, two documents have been released by state government officials and organizations that take a deep dive into those aspects of the Senate and House bills to reform the Toxic Substances Control Act (TSCA) most relevant to them.  The documents explicitly point to specific provisions in one or both bills that are preferred or opposed.

The bills the documents compare are the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697), passed by the full Senate on December 17, 2015; and the TSCA Modernization Act of 2015 (H.R. 2576), passed by the House of Representatives on June 23, 2015.

Here are the documents:

  • Environmental Council of the States (ECOS): An 11-page table dated January 7, 2016 posted in the “Featured” section of ECOS’ home page provides a side-by-side comparison of the two bills, focused mainly but not exclusively on state-federal relationship issues.  (Note that the preamble to the table indicates it does not represent a formal consensus, and many of the indications of preferences begin with a qualifier such as “Many states believe … .”)
  • 12 State AGs letter: A 7-page letter dated January 19, 2016 signed by the Attorneys General of 12 states (MA, CA, HI, IA, ME, MD, NH, NY, OR, RI, VT and WA) to the relevant Senate and House committee Chairmen and Ranking Members sets forth principles for state-federal relationships under TSCA reform and provides recommendations for reconciling those provisions of the Senate and House bills.

Both documents are well worth reading in their entireties.  To help me understand them, I have developed the table below that lists each specific provision identified in these documents for which a preference or opposition has been expressed or is readily discernible with respect to the Senate or House bill.   Read More »

Posted in Health Policy, TSCA Reform| Tagged , , | Leave a comment

EPA simply must do better on transparency and chemical data access

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Research Analyst.

[This is Part Two of a two-part series.  Here is a link to Part One.]

Under this Administration, EPA has taken some significant steps toward reversing decades of passivity and secretive practices that evolved under the Toxic Substances Control Act (TSCA) when it came to transparency in decision-making and providing access to chemical information it obtains or develops.

Several initiatives undertaken through what EPA originally termed its enhanced chemicals management program have developed and laid out clearer policies and procedures in areas such as:  chemical prioritization (leading to its Work Plan Chemicals Program); enforcing limits on and reviewing confidential business information (CBI) claims asserted by industry (leading to its declassification of hundreds of previously hidden chemical identities and health and safety studies that companies had illegitimately claimed confidential or no longer merited protection from disclosure, but that EPA had not bothered to review or challenge before now); and EPA’s regulatory efforts to reduce risks from exposures to toxic chemicals (leading to its Action Plans on high-concern chemicals and proposed follow-up activities for work plan chemicals where assessments – the first completed in decades – have identified significant risks).

EPA has also developed new databases and tools to provide greater access to chemical information in its possession and regulatory decisions and supporting documents it develops; these include the Chemical Data Access Tool and ChemView.

All of these efforts are still very much works in progress but hold significant potential to improve transparency, information access and risk reduction.

But sometimes the Agency does something that makes clear just how far it still has to go in these respects.  Unfortunately, a case in point is its recent effort toward assessing risks of a cluster of flame retardant chemicals, the brominated phthalates, some of which are in wide use and are showing up in everything from house dust to dolphins.   Read More »

Posted in EPA, Health Policy| Tagged , , , , | Leave a comment

Very little, very late: EPA still lacks data on safety of widely used flame retardant chemicals

Lindsay McCormick is a Research Analyst.  Richard Denison, Ph.D., is a Lead Senior Scientist.

[This is Part One of a two-part series.  Here is a link to Part Two.]

Last summer, EPA released a Problem Formulation and Data Needs Assessment describing the inadequacy of data available to conduct risk assessments on a group of brominated phthalate flame retardants – two of which are major components in widely used Firemaster products. 

This is the first of two blog posts on the comments EDF recently submitted to EPA on this document.  In this post, we discuss the growing public health and environmental concerns over use of Firemaster products and the recommendations we made to EPA on steps it needs to promptly take to address these concerns.  In our second post, we’ll lay out our serious concerns about the lack of transparency, limited data access, and allowance of unwarranted confidentiality claims that our review of EPA’s document brought to light.

 

First, a brief history

In the mid-2000s, Great Lakes Chemicals Corporation (now Chemtura) agreed to phase out production of polybrominated diphenyl ether (PBDE) flame retardants due to mounting evidence of their health effects and their persistence and accumulation in people and the environment.  Soon after, the use of the company’s replacement Firemaster products skyrocketed.

The two main components of Firemaster products, 2-Ethylhexyl 2,3,4,5- tetrabromobenzoate (TBB) and bis(2-Ethylhexyl) -3,4,5,6- tetrabromophthalate (TBPH), are  high production volume (“HPV”) chemicals – each produced at more than one million pounds annually.

Unfortunately, use of these chemicals rose to such levels – replacing PBDEs in consumer products like polyurethane foam-based furniture and electronics – without sufficient data and review to establish their safety.   Read More »

Posted in Emerging Science, EPA, Health Policy, Health Science| Tagged , , , | Leave a comment

Seeing Red on Food Dyes

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

The Center for Science in the Public Interest’s (CSPI) “Seeing Red: Time for Action on Food Dyes” report, released yesterday, makes clear that certified colors added in food are not safe at the current levels that children consume them. The Food and Drug Administration (FDA), the food industry, and consumers should take action to protect children from the behavior problems associated with these chemicals.

What are color additives?

  • The FD&C number on a color means it is a “certified” color pursuant to 21 CFR Part 74. These colors are synthetically made from oil or coal. Decades ago, FDA determined they were safe and only certifies that each batch meets quality standards and does do not contain particularly dangerous contaminants.
  • A color additive is not safe unless there is “convincing evidence that establishes with reasonable certainty that no harm will result from the intended use.”
  • FDA labeling rules maintain that all added colors to food are artificial. Technically, there are no natural colors – not even beet juice – since they mask the natural color of the food.
  • FDA does not limit the amount of a certified color that can be added to food except in one case. The food manufacturer decides how much is needed.

Last Friday, FDA released a stream of five consecutive tweets telling people why certified artificial color additives, commonly known by their FD&C number, are used and how to avoid them if people are sensitive to them. The tweets, while true, said nothing about who may be sensitive to the chemicals. They should have said that any child may be sensitive and that the 6.4 million children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) appear to be particularly sensitive.

So what prompted FDA’s tweets? Most likely the agency anticipated CSPI’s report “Seeing Red: Time for Action on Food Dyes” issued January 19. It follows on the organization’s 2010 “Food Dyes: Rainbow of Risks” report and its 2008 citizens petition calling on the agency to: 1) revoke its approvals of eight synthetic food dyes; 2) require warning labels on the package in the interim; and 3) correct statements about the dyes on its website and other materials.

While FDA has yet to take action on the citizens petition, the marketplace has already passed judgment. In 2015, leading food manufacturer and restaurants committed to reformulating their iconic brands to remove certified artificial colors. They follow the lead of major retailers who reformulated their private brands to remove the chemicals.

Read More »

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Will we take this best chance ever to fix the law that helped bring about DuPont's PFOA debacle?

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

A remarkable exposé in yesterday’s New York Times Magazine documents the “brazen, decades-long” withholding by DuPont of mounting evidence of widespread exposure to and health effects from one of its signature chemicals (nicknamed PFOA) used in manufacture of its line of Teflon brand products.

The article is compelling in many respects, not the least of which is its scathing indictment of the federal laws that are supposed to protect Americans from toxic chemical exposures.  In particular, the article highlights the deep failures of the Toxic Substances Control Act (TSCA) – now limping into its 40th year of existence without ever having been substantially amended.  TSCA is the law that – in principle – regulates most uses of PFOA and other so-called “industrial chemicals,” thousands of which are widely used in everyday consumer products and materials ranging from household cleaners to furniture to paint to electronics.

The article’s focus on TSCA is more than justified:  PFOA is one of 62,000 chemicals that were already on the market when TSCA passed in 1976.  All of these chemicals were “grandfathered” under the law, effectively presumed safe without any requirement that they be tested or reviewed for safety.  And while, as evidence of harm and widespread exposure mounted, the Environmental Protection Agency (EPA) did conduct a review of PFOA (which more than a decade later is still only in draft form), its authority under TSCA is so weak that it has not even attempted to use that authority to restrict any uses of the chemical, instead having to negotiate a gradual voluntary phase-out.  Indeed, EPA hasn’t tried to regulate any existing chemical under TSCA since 1991, when a court threw out its regulation of the known killer asbestos, on the grounds that EPA had not met its burden of proof of harm under TSCA.

Not mentioned in the article, however, is that for the first time ever Congress is on the verge of finally reforming TSCA.  Reform bills have passed both the Senate and the House, and negotiations toward a final reconciled bill are expected to get underway any day now.

While no single law could by itself have prevented the tragic story of PFOA from unfolding, provisions of one or both bills would go a long way to help prevent such events from happening again.  Let me mention some of the most important:   Read More »

Posted in Health Policy, TSCA Reform| Tagged , , | Read 3 Responses
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