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Chemical management: Industry presses for TSCA reform

4:52 PM MST | December 16, 2013 | —Rebecca Coons

The introduction of a bipartisan bill to modernize the Toxic Substances Control Act (TSCA) earlier this year was an unlikely development given the discord surrounding chemicals management and the state of politics in America. Committee negotiations over state preemption rights and a short window of opportunity before the 2014 midterm elections threaten to derail industry’s opportunity for TSCA reform, although hopes remain high that a workable bill can emerge in time.

Industry and lawmakers are optimistic that the latest push to update and reform TSCA will remain viable throughout committee negotiations and pass a polarized legislature—and ultimately provide welcome relief to the decades-long deadlock over US chemicals management.

Boxer: Defending Prop 65 and state preemption.
Vitter: Committed to advancing TSCA reform.
Dooley: Room to compromise to keep bill on track.
Rosenberg: Goal is a credible federal program.

Introduced 22 May by the late Senator Frank Lautenberg (D., NJ) and Senator David Vitter (R., LA), S. 1009—The Chemical Safety Improvement Act (CSIA) of 2013—has been hailed by industry, lawmakers, and nongovernmental organizations (NGOs) as a solid compromise that addresses key TSCA inadequacies and can serve as an effective template for meaningful chemicals management reform.

The chemical industry has been an advocate for TSCA reform, as waning public confidence in the federal government’s ability to effectively regulate chemicals has given rise to increasing state, local, and retailer restrictions.

“We were obviously very delighted with the introduction of the CSIA by Senator Vitter and Senator Lautenberg earlier this year,” says ACC president Cal Dooley. “That was a significant development and the first time since TSCA was introduced that we had a bipartisan proposal to modernize and reform it in a way that certainly enhances EPA’s authority and ability to assess the safety of chemicals and makes an affirmative determination on the safety of chemicals in commerce but... in a balanced way that allows our member companies and the broader value chain to continue to assure that the United States has a regulatory construct through TSCA or through the CSIA that allows us to continue to be on the forefront of innovation and the development of new technologies.”

The bill addresses long-standing concerns about chemical regulation, including requiring a systematic evaluation of grandfathered chemicals for the first time, prioritizing chemicals for EPA review, giving EPA more authority to demand further testing and additional data from chemical manufacturers, and requiring EPA to make more information available to the public.

Ernie Rosenberg, president and CEO of the American Cleaning Institute (ACI), says the bill marks the first time since TSCA’s passage, in 1976, that there has been a reasonably good opportunity to strengthen TSCA. “This is something that we really need because we have to have a national chemical management system. Our distribution chains don’t allow us to have different products for different states. This is extraordinarily important to our members.”

Dooley says he is optimistic CSIA or a bill “similar in concept” can advance and be signed into law before the November 2014 midterm elections slam shut the window for complex legislation. “We’re dealing with a very polarized Congress that is approaching another election,” he says. “But, we’ve got a great start with the introduction of the bipartisan bill in Congress,” and hearings held by the House of Representatives indicate that the House is also considering similar legislation. “We have been meeting with a number of Democratic and Republican members in the House and are encouraged by their openness to consider TSCA reform.... [W]e’re optimistic that there is a real possibility that we could see action in the House in the first half of next year, which could lead to a joint Senate/House action and legislation signed into law prior to November elections.”

Industry watchers are currently awaiting a revised version of the bill after Senator Barbara Boxer (D., CA), chair of the Senate Committee on Environment and Public Works (EPW), indicated opposition to CSIA’s language surrounding state’s preemption rights. California’s Prop 65 law, which creates a list of substances the state has found to be carcinogenic or to cause reproductive harm, is considered the most far-reaching state-level regulatory effort. Under Prop 65, products including the listed substances must carry a label stating that they contain substances linked to cancer or reproductive harm in order to be sold in the state, unless a low risk—10-5 lifetime risk with daily intake—is made.

At a 31 July EPW committee hearing on chemicals regulation, Boxer said that, although it is clear TSCA is broken and reform is needed, “[w]hen people in our states vote for very specific protections from harmful toxins, their rights must not be preempted.” Boxer then added that, without language protecting states’ rights, “we’re not going to have a bill.”

Under CSIA, states would be blocked from regulating chemicals that EPA designates as low priority during safety evaluations. If a chemical is listed as high priority, then states must wait for EPA to take action. If EPA does take action, the state cannot take an inconsistent action; if EPA fails to act, then state action is allowed. Mike Walls, v.p./regulatory and technical affairs for ACC, says the perception that Prop 65 would be immediately preempted by CSIA is not accurate. “I think it’s clear that, on a close reading of the bill, even as introduced, that this is not the case, and its certainly not the intention.”

The authors of CSIA have tried to advance a preemption approach that is similar to what exists with the pharmaceutical and medical device industries, Dooley says. “They have tried to ensure that there is collaboration between the states and EPA in the assessment of safety of chemicals. But, I think they also believe that once EPA makes a safety determination that either affirmatively finds the safety of a chemical for a particular use or places restrictions on the use of that particular chemical, then that is final agency action that should be the law of the land and should preempt state action in that arena,” he says. “This is not too different from the preemption language that already exists in TSCA. The authors of the CSIA tried to build upon this while also ensuring that there would be greater opportunities for the engagement of the states.”

CSIA allows for states to request a waiver from EPA if they have local conditions of use that could merit a different restriction on use of a particular chemical in commerce, Dooley adds. “So, we think there’s a path forward there, but there are some constituencies that say there can be absolutely no preemption under CSIA. That, I think, is clearly something that will not be accepted by a lot of the Democratic and Republican cosponsors and certainly would be unacceptable to our industry, our members at ACC, and the large majority of the associations that are a part of the American Alliance for Innovation.”

Dooley says ACC is hopeful that Senator Tom Udall (D., NM), a cosponsor of CSIA; and Vitter, minority chair of EPW, can work with Boxer to update the state-preemption provisions in a workable way. “We are encouraged by the constructive conversations that are ongoing in the Senate to try to narrow some of the differences between Senator Vitter and Senator Udall in their conversations with Senator Boxer, who continues to have some concerns on how preemption would impact some of the California state laws,” he says. “We think that there’s a way that you can structure a preemption that is still consistent and similar to what we have with the pharmaceutical industry as well as in the medical-device industry that can be applied in an appropriate manner with TSCA reform.” Vitter and Udall are “absolutely committed to trying to find a path forward to resolve” this issue, he adds. “We continue to be optimistic that the work that Senator Vitter and Senator Udall are engaged in to try to respond to some of the outstanding concerns of Senator Boxer as well as some of the NGO community can be resolved in a way that will still lead to the successful passage of CSIA in the Senate.”

Lynn Bergeson, partner at law firm Bergeson & Campbell (Washington), estimates the chances of TSCA reform legislation being enacted in 2014 to be 10–15%. “[It’s] not impossible because Senators Vitter, Udall, and Boxer seem predisposed to making TSCA reform a reality—not inevitable because Senator Boxer’s insistence on significant changes to the preemption provisions could be a deal breaker and the legislative calendar offers only a narrow window of opportunity before all semblance of rationality is hijacked by midterm election partisan rhetoric. If Senator Boxer can extract a win and position herself as the successor in interest to Senator Lautenberg as the torchbearer of enlighten chemical management reform, S. 1009 or a successor version of it could be taken up by the Senate. The House could well use it as a template for its version, based on the most recent House hearing, and something could happen. It would require significant and demonstrable support from all stakeholders, most especially the business community, if the legislation has any chance of success. The key to success is Senator Boxer, and it is difficult to speculate, given staff changes in her office and other variables, how Senator Boxer will play her hand, whether a new and decidedly different version of S. 1009 will emerge and if so, what it will provide, and whether the House can commit to important and complicated environmental legislation in an election year.”

Rosenberg says that if a workable bill gets out of committee, there is “still a good chance of getting this done.” If not, the window for substantive deliberations is very small, given that election politics kick off in June, if not earlier. There is room for compromise if it helps keep the bill on track, Rosenberg adds. “We have been very clear that we don’t consider the original bill a take-it-or-leave-it proposition. However, if the [proposed] changes are in the direction of inhibiting innovation or otherwise too difficult to comply with the bill will lose a lot of support from the chemical industry.”

Calls for reform

Criticism of TSCA and calls for reform began within five years of the bill’s 1976 passage but kicked into high gear in 1991, when EPA lost its bid to ban asbestos. “I would say a lot of TSCA reform work has been done since the mid-90s, but, as far as significant legislative movement toward reform, [CSIA] is the first,” Rosenberg says. CSIA builds on Lautenberg’s Safer Chemicals Act, which never gained traction in the Senate. “It’s clear that [CSIA] is built on the old Lautenberg bill but that it makes very substantial changes,” Rosenberg says. “Those changes make it actually possible to pass it.”

CSIA strengthens EPA’s authority to regulate chemicals already in commerce—a key issue that contributed to the public’s lack of faith in TSCA—but does not mandate an extensive review of each, which would have been a Herculean task.

“A significant number of chemicals were grandfathered in when TSCA was enacted in 1976,” Dooley says. “Under CSIA, EPA will, for the first time, have the authority to do a safety assessment of these chemicals, which haven’t been subject to a comprehensive EPA assessment. We think that is something that is needed and is appropriate.”

CSIA requires all active chemicals in commerce to be evaluated for safety and labeled as either a high or low priority chemical based on potential risk to human health and the environment. For high-priority chemicals, EPA must conduct further safety evaluations. If a chemical is found to be unsafe, EPA has the necessary authority to take action, ranging from labeling requirements to the full phaseout or ban of a chemical.

CSIA also allows EPA to secure necessary health and safety information from chemical manufacturers while directing EPA to rely first on existing information to avoid duplicative testing and protecting trade secrets and intellectual property from disclosure. CSIA also requires EPA to evaluate the risks posed to particularly vulnerable populations, such as children and pregnant women, when evaluating the safety of a chemical—a provision not included in TSCA.

CSIA also changes how new chemicals are evaluated while ensuring that the process is not so burdensome that chemical industry innovation is hurt. Under TSCA’s new chemical approval program, EPA must be given at least 90 days to review a premanufacture notice (PMN) but can request an extension and more information. Companies have either honored such requests or withdrawn their PMNs. EPA does not have to make a determination on a PMN. “Essentially, the EPA has a mandate under TSCA to review new chemicals, but it does not have to take an action if it has no concerns,” Rosenberg says. CSIA, however, requires EPA, on the basis of the information that is available to the agency, to determine whether a new chemical or new use is likely to meet the new safety standard, not likely to meet it, or whether more data and information are needed to make this determination.

“[CSIA] also says that this doesn’t have to be done before the end of the review period,” Rosenberg says. “That is very important. If it is not done by the end of the review period, then that regulator doesn’t have to be looking over his or her shoulder about being attacked for the decision and won’t be subject judicial review. There is a provision in CSIA that is responsive to the desire to have EPA actually say something about a new chemical, but it doesn’t go all the way like [the earlier] Lautenberg bill did in requiring actual approval of every new chemical and every new use, which would be absolutely impossible. There are several thousand new chemicals submitted every year.”

Dooley believes some of the bill’s language could be clarified, however. “We think that the issue related to the EPA’s consideration of exposure to vulnerable populations, from our perspective, is adequately addressed in the legislation. Jim Jones[, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention] testified that he thought they have the authority to consider exposure to vulnerable populations under CSIA but if there is an opportunity to further clarify that we think that can be further achieved.”

Industry has also expressed concerns that CSIA places too few deadlines on EPA’s chemical safety assessments. “How much time does the EPA have to act or react to comply with these various regulations?” says Lawrence Sloan, Socma president and CEO. “And there is concern from our point of view as to whether or not EPA is staffed well enough to act within a prescribed amount of time.”

This issue is one that Socma and NGOs agree upon, says Bill Allmond, Socma’s v.p./government relations. “One of the biggest criticisms that environmentalists have of TSCA is that there is nothing that really compels EPA to make a decision to regulate a chemical within a certain amount of time. We feel like TSCA could be strenghtened to compel the agency to, for example, consider and take action on a limited number of chemicals annually and have deadlines in place for EPA to meet. They wouldn’t be arbitrary, but we feel that without those deadlines it really leaves TSCA open-ended for the agency to move at a snail’s pace.”

Clarifications as to how litigation would proceed under CSIA are also needed, Dooley says. “But, I think everything is pretty manageable if you have constituents that are committed to being constructive. ACC is certainly committed.... [T]his is our highest legislative priority.”

ACI hopes that, by strengthening EPA’s authority to regulate chemicals, public trust in the government’s ability to regulate chemicals will be reinstated. This change will help remove uncertainty for industry and free up resources for chemical innovation.

“The actual objective is a credible, federal program,” Rosenberg says. “Passing something that doesn’t really strengthen TSCA won’t help us. Passing something that still has insurmountable roadblocks for EPA to take the necessary actions won’t be credible. For the law to be credible, the changes to TSCA have to be practical, they have be achievable, and they have to be workable. If passed, it will be a question of over the coming few years whether EPA is able to take the actions that it wants to take,” Rosenberg says. “It might not be all the actions that the NGOs want EPA to take, but if EPA doesn’t initiate action [it’s] not because the law is weak; it will be because EPA did not agree that the chemical needed to be controlled. If EPA initiates action and fails in a manner that calls into question the strength of the law, that would be very bad.”

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