EDF Health

FDA sued for delay in deciding perchlorate food additive petition

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 31, 2016

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

[pullquote]At the end of 2014, FDA agreed to consider a food additive petition from NGOs to ban perchlorate – a chemical that can impair a child’s brain development – as an additive to food packaging. The agency had 180 days to act, but fifteen months later, the petitioners are still waiting for a response. Today, they sued.[/pullquote]

It’s been 15 months since a group of environmental, consumer, and public health advocates petitioned the Food and Drug Administration (FDA) to remove the agency’s approval of perchlorate uses in packaging.

Traditionally, FDA’s food additive petition process has been the exclusive purview of food manufacturers seeking approval to use new chemicals or expand uses of already approved chemicals in food production. However, nothing in the law prohibits the public from using the process to ban or restrict the use of certain chemicals. Read More »

Also posted in Drinking water, FDA, Food, General interest, Perchlorate, Regulation / Comments are closed

Will private interests trump public ones when it comes to our right to know under TSCA?

By / Published: March 29, 2016

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

Why this matters …

… to an exposed worker

Today: You are a worker handling a new product. You look at the label, which lists it as containing the chemical dimethyl doorknob. You want to know what health information is available on the chemical, so you go to EPA’s TSCA chemical information databases and search for dimethyl doorknob. You find several studies EPA has received from a company indicating it found dimethyl doorknob to be a potent carcinogen in animal studies it conducted. This is because, under EPA’s TSCA CBI policy, EPA has declassified those studies, making them public and linking them to dimethyl doorknob. You are now able to alert your coworkers and management, and press for actions to reduce or eliminate your exposure to dimethyl doorknob.
If SOCMA gets its way: You are a worker handling a product containing the same chemical. You do your search and find none of the studies EPA has received. This is because under SOCMA’s TSCA, the company was able to claim the identity of dimethyl doorknob to be CBI when it submitted the studies, and EPA could not challenge the claim; it made the studies public – but did not link them to dimethyl doorknob.

… to an environmental health researcher

Today: You are a university-based researcher studying the water quality in a local town. You identify a chemical – unobtanium trichloride – in water samples you’ve collected that has quadrupled in concentration since a local business significantly expanded its production. You want to know what health information is available on unobtanium trichloride, so you go to EPA’s TSCA chemical information databases and search for unobtanium trichloride. You find several studies EPA has received from a company indicating it found unobtanium trichloride to cause birth defects in animal studies it conducted at levels at or below those you’re seeing in the water the submitted studies. This is because, under EPA’s TSCA CBI policy, EPA has declassified those studies, making them public and linking them to unobtanium trichloride. You are now able to alert state authorities of your findings, which leads it to tighten restrictions on discharges of wastewater from the company’s production site containing unobtanium trichloride. The cost of these additional regulations leads the company to reformulate its product, eliminating altogether the use of unobtanium trichloride.
If SOCMA gets its way: You are the same university-based researcher. You do your search and find nothing. This is because under SOCMA’s TSCA, the company was able to claim the identity of unobtanium trichloride to be CBI when it submitted the studies, and EPA could not challenge the claim; it made the studies public – but did not link them to unobtanium trichloride.

One of the few bright spots of the original Toxic Substances Control Act (TSCA) was Congress’ clear intention that the public have access to health and safety information on chemicals and mixtures.

The very first section of the 1976 law expressly states:  “It is the policy of the United States that adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment.”  The law goes on to expressly exclude “data from health and safety studies” submitted to the Environmental Protection Agency (EPA) from the reach of TSCA’s confidential business information (CBI) provisions, by stating that those provisions do not prohibit disclosure of health and safety information.  Congress provided only two narrow exceptions:  where disclosure of such information would disclose the process by which a chemical is made or processed, or the portion of a mixture that a particular chemical comprises.

Now some in the chemical industry are brazenly pressing to thwart that original intent, by codifying into the law the ability of companies to black out the names of chemicals when health and safety studies they submit on a chemical are released to the public.

The Society of Chemical Manufacturers and Affiliates (SOCMA), a trade association of specialty chemical manufacturers, is publicly taking credit for adding a provision to the House’s TSCA reform legislation that would do just that.  In its annual report, SOCMA touted “successfully inserting provisions strengthening Confidential Business Information protections.”  (SOCMA also took credit for the fact that the House bill maintains TSCA’s current New Chemicals provisions, another of its severe weakness about which I blogged last week.)

Should SOCMA get its way and its pet provision ends up in the final TSCA legislation, then you – whether you are a worker, consumer, business, researcher, or concerned member of the public – would get to learn that a new study shows a chemical in a product you may make, use, study or are otherwise exposed to is, say, a potent human carcinogen.  What you would not be allowed to know, however, is what chemical it is!  How useless is that?

See the sidebar for why this matters.

More background for TSCA geeks

I’ll spend the remainder of this post diving a little deeper into the law and history on this issue that SOCMA seeks to wipe out with just a few words inserted into a bill.   Read More »

Also posted in TSCA reform / Tagged , | Comments are closed

Household Action Level for Lead in Water: EPA Needs to Release Health-based Estimate

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 25, 2016

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

A new article in USA Today’s series on lead in drinking water shines a light on the Environmental Protection Agency’s (EPA) delays in releasing a health-based “household action level” for lead. EPA’s National Drinking Water Advisory Council (NDWAC) recommended that the agency develop this number to help parents, in consultation with their pediatrician and public health agency, decide whether to invest in a filter for the water they use to make up their child’s infant formula.

Without a health-based number, people are mistakenly using EPA’s current “lead action level” of 15 parts per billion (ppb) as the level below which no action is needed. The problem is that this level has no relation to the health risk. It is based on a provision in the drinking water rule that requires utilities to undertake corrosion control and, potentially, lead service line replacement when at least 10% of worst-case sample results exceed that level.

A year after committing to develop a household action level, it appears tied up in the agency’s long overdue overhaul of its broken 1991 regulation designed to protect people from lead in drinking water. Communities all across the country are raising legitimate concerns about the safety of their water and need proper public health guidance. They should not have to wait on rulemaking for this important information. I know EPA is a regulatory agency that thinks in terms of rulemaking. But first and foremost EPA is a public health agency with responsibility to consumers for the safety of drinking water. Read More »

Also posted in Drinking water, Health science, Lead / Tagged , , , , , , , | Authors: / Read 1 Response

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 »

Also posted in TSCA reform / 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.

Also posted in TSCA reform / 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 »

Also posted in Emerging science, Emerging testing methods, FDA, Food, Health science, Regulation / Tagged | Comments are closed