So tell me about TSCA reform

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Perhaps you have heard: over the past couple of weeks, the Senate Committee on the Environment and Public Works has begun to consider a pair of dueling bills to overhaul the regulation of chemicals in America. Perhaps you have seen this debate described under the heading of "TSCA reform." Perhaps you have wondered what TSCA is, why everybody seems to want to reform it, and what substantive differences lie behind the competing proposals for doing so.

Perhaps you haven't.  But you should! The bills under consideration have significant stakes for human health, the environment, and businesses that produce, processe, trade in, or use any of the tens of thousands of chemicals in American commerce. And - not to be glib about such weighty matters - chemical regulation is also pretty fun grist for nerding out.

http://www.asbestos.com/blog/2013/08/19/asbestos-victim-advocates-against-proposed-changes-toxic-substances-law/
In this post, I'll take you on a quick tour through the history of chemical regulation in America, the concerns that motivated the current legislative efforts, and how the two bills under consideration propose to address these concerns. In a separate post, I'll delve in a little more detail into the particular issues at play.

In my discussions of the particulars of the two bills, I'm drawing on the analyses of each published by Bergeson & Campbell,a law firm that assists chemical firms with TSCA compliance.* In case you're interested, you can find links to full text of the two bills here.

What is TSCA, anyway?

The Toxic Substances Control Act is the legal framework for the regulation of chemical substance in commercial use in the US. It is administered by the US Environmental Protection Agency.

A little background: in the US, chemicals are regulated under a patchwork of laws and agencies that has developed over the course of the 20th century. Food and drugs came first, with the passage of the 1906 Pure Food and Drug Act, administered (eventually) by the Food and Drugs Administration. Then came pesticide legislation, administered by the US Department of Agriculture until the EPA was created in 1970.  The EPA also took charge of the Clean Air Act and the Clean Water Act. The Occupational Safety and Health Administration (OSHA), formed around the same time as the EPA, handles the regulation of chemicals in the workplace.

TSCA was intended to serve as an umbrella statute, regulating the production and use of chemicals in America outside of the particular contexts addressed by this patchwork of laws and agencies. After years of negotiations, the act made it through Congress in 1976 and was signed into law by Gerald Ford in the waning days of his presidency.

Okay, so what are the problems with TSCA?

There's a long list. The most frequently-cited:


  • Testing. TSCA mandates that firms seeking to bring a new chemical to market must apply to the EPA for permission to do so and submit any relevant information. However, the manufacturer is not required to carry out any particular tests on the substance. As a result, the EPA has often had to make judgments about the safety of a new substance without the benefit of any experimental data on the substance in question.
  • Existing substances. Alongside the mandatory evaluations of new chemicals, TSCA charged the EPA with evaluating  chemical substances that were already in commerce as of the late 1970s (so-called "existing" chemicals). They were to be subject to a less stringent safety standard than that applied to new substances, but they were nevertheless to be assessed. However, just keeping up with the new substances was about all that the EPA could manage with the resources available to it, and there has continued to be an enormous backlog of chemicals whose safety has never been evaluated.
  • Confidential business information. Information regarding most chemicals regulated under TSCA is available in a publically-accessible database. However, firms can claim a particular compound or mixture as a trade secret. Under TSCA, the EPA is required to keep "confidential business information" (CBI) regarding the structure and properties of such chemicals out of public view.

Stories about the "failure" of TSCA most often focus on asbestos. As is well-documented, these mineral fibers, long used as fire-resistant insulation in clothing and buildings, have been found to caused lung cancer and other particularly terrible forms of lung disease. The EPA banned the substance in 1989. However, as a chemical substance whose use predated TSCA, the law's language required the EPA to demonstrate that asbestos “will present an unreasonable risk” and that the agency's regulatory action imposed the “least burdensome requirements” necessary to alleviate the risk. In 1991, a federal judge ruled that the EPA had not met these high thresholds, and overturned the ban.

Absestos under the microscope. Scary, right? http://en.wikipedia.org/wiki/Asbestos
What's the background to the current reform bills?

The asbestos episode confirmed to many within and outside the EPA that TSCA offered a very limited basis for adversarial regulation. The EPA turned to voluntary testing agreements with chemical firms to generate data; legislators and environmenal groups turned their attention elsewhere, including to state-level regulation.

In the late 2000s, both the chemical industry and environmental groups began calling for reform of the law. Concern over the health dangers of substances in consumer products, such as the plastic bisphenol A (BPA), brought increased public attention to the question of chemical safety. Meanwhile, chemical firms were concerned with the accumulation of various state-level chemical regulations passed in the absence of a more robust federal statute. Environmentalists and public health advocates looked to a new EU framework for chemical regulation, REACH, as a model for legislation in the US (for more on all of this, see Vogel and Roberts, 2011).

Two reform bills were introduced in late 2010, but failed to gain traction. In 2013, the late Senator Frank Lautenberg (D-NJ) and Senator David Vitter (R-LA) introduced the Chemical Safety Improvement Act. The current proposal sponsored by Vitter and Senator Tom Udall (D-NM) is based on the 2013 bill, revised to take into consideration some of the critiques of that bill by environmental and public health groups.

Ok, so talk to me about the Udall-Vitter bill.

You mean the "Frank R. Lautenberg Chemical Safety for the 21st Century Act"? Yeah, let's call it the Udall-Vitter bill.

As I mentioned, I'll cover its ins and outs in a little more detail in a separate post, but here are the main points:


  • There's a plan to clear the backlog of existing substances. Chemicals currently in commerce but whose safety has not yet been evaluated would be assigned either high-priority or low-priority status. High-priority compounds would have to be evaluated according to a series of deadlines that would assure a final decision within seven years.
  • For chemicals designated high-priority, state law would be superseded by the EPA's ruling.
  • There's still no mandatory testing for new substances. However, when the agency determines that testing is necesssary, the EPA gets to charge approximately 25% of the cost of testing to the chemical firm that submitted the new substance (up to an annual maximum of $18 million).
  • Firms would need to reapply for their existing claims of confidential business information. All CBI evaluations would be subject to slightly more stringent requirements. CBI approvals would be limited to ten years, though they would be renewable.
  • The determination of a chemical's safety would take into account not just the general population but also any populations particularly at risk in a given case.


What's the deal with that other bill?

Senator Barbara Boxer (D-CA), the ranking Democrat on the Environment and Public Works Committee, has argued that the Udall-Vitter bill provides insufficient protection to public health and the environment. She and Senator Ed Markey (D-MA) have introduced the "Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act."

Their bill has the same basic structure as the Udall-Vitter bill, but it differs on numerous important particulars, from funding (the EPA could get more money from firms to support testing) to the definition of what makes a chemical "safe"  to cost-benefit analysis in rule-making (under Boxer-Markey it could only be applied above a threshold of $100 million). It also specifically mandates the fast-track consideration of asbestos for additional regulatory action.

What's really at issue here?

There are two big disputes at the root of the dueling bills.

The first is the pre-emption of state law. Boxer's home state of California has passed some of the nation's toughest chemical laws. The Vitter-Udall bill would invalidate state regulations for chemicals with "high-priority" status - precisely the cases in which the evaluation of a chemical's safety is determined to be most important. Furthermore, economic significance and, under certain conditions, a chemical firm's petition could earn a chemical high-priority status, further empowering firms to circumvent state regulatory authority by encouraging regulation at the federal level.

Boxer isn't the only one concerned about pre-emption. Attorneys General from ten states - some predictable (California, New Jersey, New York), some less so (Maine, Iowa) - have weighed in against the pre-emption provisions of the Udall-Vitter bill.

The second is the definition of the standard of safety for a chemical substance. The debate over the safety standard is not nearly as heated as the pre-emption fight. However, as the asbestos case demonstrates, the precise threshold that EPA determinations must satisfy can have enormous consequences for the agency's ability to regulate.

The Udall-Vitter bill's safety standard is "no unreasonable risk of harm." In order to make a rule, therefore, the agency would have to demonstrate risk in order to regulate a substance. The standard of the Boxer-Markey bill is "reasonable certainty" that a chemical causes "no harm"; thus, the EPA would be required to demonstrate safety in order not to either continue the evaluation (subjec t to deadlines) or make a rule.

Would you care to comment on the politics of this dispute?

Not really, but plenty of others would.

Okay, let's try again. Are there any interesting STS-type angles here?

Glad you asked!

The European regulatory framework, REACH, specifies a "base set" of tests to be applied in the evaluation of all chemicals produced in large quantities. The 2013 version of the TSCA reform bill had similarly proposed defining particular testing methods to be used. However, neither the Udall-Vitter nor (to my knowledge) the Boxer-Markey bill includes any such list. Instead, the bills specify that the "best available science" be used in evaluating the safety of chemicals.

The Society of Toxicology, a professional association for toxicologists, was a vocal proponent of the "best available science" standard over the specification of particular tests. Its president wrote, in an op-ed:
“Best available science” means that experiments and their findings are transparent and reproducible and the methods used are underpinned by our current understanding of the underlying biology. This understanding is not static but is constantly evolving. Congress should resist the temptation to try to spell out specific scientific methods in law and allow scientific evolutionary progress to continue.
This seems to me to illustrate an interesting catch-22 of regulatory science.  If you specify particular tests to be done, you run the risk of writing legislation that will quickly become outmoded, mandating reliance on evidence that may turn out to be substandard, expensive, or even inaccurate according to future scientific standards.

On the other hand, the standard of "best available science" seems to open the door to legal contestation of decisions, regulatory capture, and the like.  As we all know, in many cases dealing with systems as complex as the environment and human health, what exactly constitutes the "best available science" can be defined convincingly (convincingly enough for legal purposes, at least) in different ways.

What are the prospects that these bills are going to make it through Congress?

For what it's worth, the legislation-prediction website govtrack.us forecasts a 35% chance of Udall-Vitter making it out of committee and a 5% chance of the bill getting passed.  From what I've read, and from the relative breadth of support for the bill, this seems a bit low. But I am no expert on the mechanications of Congress.

As things stand, Boxer's bill seems to stand little to no chance. Its central distinction from Udall-Vitter - no preemption of state regulations - removes the bargaining chip that has brought the chemical industry to the table. In the current legislative climate, it's difficult to imagine a bill getting passed without some degree of industry support. It may be, however, that there is middle ground to be found on this issue. (See my next post for more on this.)

What happens if neither bill passes?

The EPA, which has taken care not to take a position on either bill, will go on regulating under the framework of TSCA. Over the past couple of years, the agency has focused on developing its framework for evaluating existing chemicals. The current "TSCA workplan" for assessing such substances is generally similar to the high-priority list that the two bills propose, though less ambitious in scope (especially in comparison to Boxer-Markey). In a statement of the agency's plans for 2015, the Assistant Administrator for Chemical Safety discussed how these efforts would continue, without mentioning the ongoing efforts to overhaul the laws governing his work. This was surely a politic omission; if the current conventional wisdom about Congress is to be believed, it was a realistic one as well.

Stay tuned for a more detailed breakdown of the reform bills soon.

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* Of course, the lawyers for chemical firms are not a disinterested party when it comes to chemical regulation, to put it mildly. Still, they presumably have an incentive to analyze the proposed legislation accurately.

2 comments

Hello,

I work in the regulatory affairs department of a French company which makes business in the US and, therefore, I am interested to know more about the TSCA reform so the company will be able to anticipate the TSCA changes in order to continue to have its products in compliance with the American chemical legislation and,therefore, I would like to know if you could answer me this questions:

1- I would like to know how the EPA would, precisely, determine if a chemical meets the 'safety standard' ? There would be tests to determine whether the definition of 'safety standard' is met?
2- Among the products that the companies have sold more than 10 years ago, which ones of them will be on the list of active chemicals?
3- Cost-benefit factors may be considered for the chemicals assessment procedure? And for eventual control or regulatory measures?
4- The exemption categories of chemicals will remain the same? There will be new categories of exempted chemicals?
5- What will be the new legal procedure to allow EPA to request assessment of a chemical? The agency is still obliged to prove that the chemical is hazardous?
6- Once the active chemicals list is composed, what will happen with the TSCA inventory? A chemical that is currently listed TSCA and that is classified high-priority, will remain listed as long as its assessment is not done yet or the TSCA inventory will be reseted?
7- The requirement of 25 high priority chemicals and 25 low priority chemicals in 5 years of enactment means that in 5 years only 50 chemicals will be evaluated ? And what will happen to the chemicals on the active chemicals list that have not been evaluated yet but were listed TSCA, they will be able to be put in market or we will be obliged to wait their assessment?
8- In which way the new procedure of assessment for new chemicals is different? Will it be more rigorous?
9- In the current TSCA bill is there any particularity on the assessment and notification of chemicals in articles?
10- The requirement of making a Chemical Data Reporting (CDR) every 4 years will be remained?

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