EDF Health

Why significant but balanced changes are needed to TSCA’s new chemicals provisions

By / Published: March 17, 2016

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

A key need for reform of the Toxic Substances Control Act (TSCA) is making enhancements to the law’s provisions addressing new chemicals prior to their commercial manufacture.  The Senate bill makes moderate but critical improvements to these provisions.

These improvements arose through extended negotiations that sought to carefully balance two legitimate competing interests:  On the one hand, ensuring that the safety of new chemicals is carefully examined and a reasonable assurance of safety is provided before market entry – which the current law does not provide.  On the other hand, ensuring an efficient short process is utilized that doesn’t unduly slow or create too high a bar for market entry or have the unintended consequence of impeding innovation – which the current law does provide.

That balance was struck through a set of provisions that:

  • require for the first time that EPA make an affirmative safety finding as a condition for market entry, but using a standard – that a new chemical is likely to meet the safety standard – that is lower than that applicable to existing chemicals undergoing full reviews;
  • maintain current TSCA’s typical 90-day review period for new chemicals, even shortening that period when EPA can make a positive safety determination more quickly;
  • ensure that new chemicals can’t enter the market when information is not sufficient to make an affirmative safety finding, while retaining TSCA’s lack of a requirement for a minimum up-front data set for new chemicals; and
  • require EPA to carefully consider the need to extend to other companies any conditions or restrictions it places on a company that first brings a chemical into commerce, and either do so or explain why that is not needed.

I believe that this compromise, while unlikely to please anyone completely, represents significant improvement over the status quo, retaining its positive features while addressing its shortcomings.

There is actually considerable support that has been voiced for this balanced approach, including from industry and from the Environmental Protection Agency (EPA), as well as groups like my own.   Read More »

Posted in Health policy, TSCA reform / Tagged , , | Comments are closed

Lead service lines must be replaced as soon as possible to protect children

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 16, 2016

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

Two years ago, the Environmental Protection Agency (EPA) asked me to serve on its new multi-stakeholder workgroup to develop recommendations to improve the agency’s 1991 lead in drinking water rule. I had heard about problems with the rule but was unfamiliar with the details. My efforts to prevent lead poisoning over the past 20 years at the federal, state, and local levels focused on lead-based paint and consumer products. Lead pipes were new to me. Knowing the dangers of any lead exposure all too well, I was happy to help.

What I learned was disturbing. The rule’s shortcomings became clear when a utility representative presented a chart showing the lead levels from homeowner sampling over the years. While few in number, some lead levels in the water were literally off the scale, in the hundreds of parts per billion (ppb). And yet a utility operating a public water system would be in compliance with the rule as long as less than 90 in 100 samples were below 15 ppb. The only required action would be an alert by the utility to the homeowner. It became clear to me that lead could be found in water at extremely high levels, but these spikes—and potentially substantial public health risk—may not be investigated and corrected.

EPA’s own studies confirmed the problem. It turns out that the highest lead levels were often missed because the sampling method focused on the water in the interior plumbing and not the water sitting overnight in the lead service line – the pipe that connects the main in the street to the house. In addition, only 50 or 100 samples every three years were required; too few taken too infrequently to identify problems in a large city in a timely manner. Read More »

Posted in Drinking water, Lead / Tagged , , , | Comments are closed

EPA and business find much to like in Senate’s TSCA reform bill

By / Published: March 3, 2016

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

In the last day, two news outlets, Politico (“Administration largely sides with Senate negotiators in TSCA talks”) and CQ (“On Toxic Chemical Bills, Administration Prefers Senate’s”), published articles about two letters recently issued on pending TSCA reform bills in the Senate and House. Both articles are well worth reading but are behind a paywall, so I’m providing a brief summary and links to the letters here for those without access to these Hill publications.

One letter was signed by EPA Administrator Gina McCarthy on behalf of the Administration.  It identifies provisions in each bill that EPA prefers or has concerns about, based on the Administration’s TSCA reform principles.

The other letter was drafted by the American Alliance for Innovation (AAI), a large coalition of business interests, which provides a list of its “conference priorities.”  (While it does not directly cite either bill, it identifies provisions AAI seeks to retain in or jettison from the final bill.)

These two letters are the latest in a series of comparisons of the two measures by interested parties, issued as House and Senate negotiators look to reconcile differences between them.  We have blogged previously on the preferences and concerns expressed by two groups of state authorities (links to their assessments are provided in that post).

While the documents differ with respect to the scope of issues they address, the common characteristic of all four is that each identifies significantly more provisions they prefer in the Senate bill’s more comprehensive approach, compared to House bill.

Of course the goal is to get to the best law possible. EDF is confident that legislators on both sides of the aisle, in both chambers of Congress, are working hard to reach agreement on a strong bill to send to the president. The opportunity has never been so near at hand, if Congress can just finish the job.

Posted in Health policy, TSCA reform / Tagged , | Comments are closed

“Big data” comes to chemical testing – How to ensure more is better

By / Published: February 24, 2016

Jonathan Choi is a chemicals policy fellow.

EDF Senior Scientist Dr. Jennifer McPartland contributed to this post.

The beginning of this century will no doubt be known for a lot of things. In the biological sciences, I predict it’ll be known for big data. It’s hard to wrap your head around just how far we’ve come already. For example, the data chips that sing “happy birthday” to your loved ones in those horrendously overpriced cards have more computing power than the Allies did in 1945. When I first started using computers, the 5.4” floppy disk was being replaced by the new 256Kb 3.5” disk. Now in Korea, you can get 1 GB per second internet speeds for $20 a month. That’s around 4000 floppy disks of data per second for about as much as I spend every week at the burrito place down the street.

In the biological sciences, we’ve seen an explosion of new ways to generate, collect, analyze, and store data. We’re photographing the world’s biodiversity and sharing it with crowdsourced taxonomists. We’re creating a database of the genomes of the world’s organisms. We’re mapping chemical exposures (our exposome), inventorying the microbes that live in our guts (our microbiome), ripping apart cells and sequencing every bit of messenger RNA that floats around inside (our transcriptome), and much more.

So, it’s not too surprising that regulatory agencies like EPA are pushing their own efforts to amass large quantities of data to help meet their missions. EPA has the unenviable task of reviewing tens of thousands of chemicals currently on the market with little health and safety data, on top of hundreds of new chemicals banging at its door each year. As we have written on numerous occasions, the agency clearly needs a better law that gives it greater authority to get the data it needs to effectively evaluate and manage chemical risks. But, given the information abyss in which we operate, we could definitely stand to adopt new testing approaches that generate at least screening level data on chemicals faster.   Read More »

Posted in Emerging science, Emerging testing methods, Health science / Tagged , , | Comments are closed

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 11, 2016

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.

[pullquote]

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.

[/pullquote]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, PFAS, Regulation / Comments are closed

State authorities weigh in on Senate and House TSCA reform bills

By / Published: February 9, 2016

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 »

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