22 February 2013 10:29 [Source: ICB]
While waiting for reform of the Toxic Substances Control Act (TSCA) to take place, both industry and the US Environmental Protection Agency (EPA) have found opportunities to work within the framework of existing regulation. For the EPA, that has meant leveraging the full extent of its authority - and pushing the limit in some cases.
Both the Society of Chemical Manufacturers & Affiliates (SOCMA) and the American Chemistry Council (ACC) are taking proactive measures to help the EPA achieve the goal of TSCA - protection of public health and the environment - while also maintaining the chemical industry's ability to innovate and compete in the global marketplace.
During the first Obama administration, according to Mark Duvall, a principal with law firm Beveridge & Diamond, the EPA showed a lot of energy and ingenuity in stretching TSCA in order to get as much out of the flawed statute as it could. A number of proposals that the agency has submitted to the Office of Management and Budget (OMB) for review have been held up for extended periods. What will happen with these initiatives in 2013 remains unclear.
A BROADER VIEW
"The OMB takes a broader view and looks more closely at the potential impact of the EPA's proposed actions on the economy," Duvall says. "As a result, in some cases the EPA may be allowed to implement them with modifications, and in others they may be dead. The EPA must expect, however, that many will get approval from the OMB this year, because the agency has predicted their publication in the Federal Register as part of its regulatory agenda published in December."
One proposal currently at the OMB relates to CBI claims of confidential chemical identity for new chemicals that have not yet been manufactured or introduced in the marketplace and would prohibit the use of generic names in health and safety studies, except in very limited circumstances.
"Our members are very concerned about this EPA proposal," says Dan Newton, senior manager of government relations at SOCMA. "Their products are often highly specialised and much can be learned about the functionality and potential applications of such products from the chemical name. As a result, some have indicated that, if trade secret protection for chemical substance identification is lost that early in the product life cycle, they may choose not to invest in new chemical development in the US." He expects that this proposal will eventually move forward sometime this year.
"The EPA is trying to understand how business is impacted by the regulations the agency issues under TSCA"
The Council is also working on its own possible approaches, which it ultimately intends to propose to the EPA. Members of both SOCMA and ACC are working voluntarily with the EPA to review and update old CBI claims. Both groups have asked the EPA to require upfront substantiation of the need for CBI in order to prevent overuse of this important aspect of the TSCA regulations. In 2012, both associations worked with their members to ensure that the agency received the most accurate data possible in the first filing under the chemical data reporting (CDR) rule.
"It is very important for the EPA and industry to get the CDR data right," says Robert Kiefer, director of regulatory & technical affairs with ACC. "TSCA is currently limited with respect to its ability to track current chemicals in commerce. The CDR will provide the EPA with manufacturing and process data that it can use for prioritisation and risk assessments, such as for the workplan chemicals."
CHEMICALS UNDER REVIEW
With respect to its workplan approach, the EPA has kept fairly close to its proposed schedule. The agency initially identified 83 chemicals for review in the next several years. It selected seven for review in 2012 and an additional 18 for evaluation in 2013-2014, with the remainder to be completed by 2016. Based on the first five reviews, which were released in early January, it appears that the EPA is focusing on issues related to particular uses of the chemicals and providing an opportunity for public comment and peer review.
SOCMA approves of the agency's stepwise process, according to Newton, and ACC's Franz commends the EPA for assessments that target particular uses. However, ACC would like to see the EPA consider the assessments as highly influential rather than merely influential, which would require a more robust scientific approach and additional peer review.
Duvall also points out that the question of what will happen at the end of the process has not yet been answered. "Risk management primarily falls under TSCA Section 6, and there hasn't been any action by the EPA under this section since 1991," he says. "I expect there will be extensive discussion on what will be the most effective approach and what is possible under the current statute."
ACC is also hoping the EPA will hold another stakeholder meeting on prioritisation, which remains a key issue for the association. "The agency held a meeting in the fall of 2011 and really listened to industry; several recommendations were implemented," Franz says. "However, the EPA should be pursuing a more comprehensive prioritisation of chemicals in commerce." ACC has developed a comprehensive, scientifically-based prioritisation system that takes into account both hazard and exposure and has shared this tool with the agency and other stakeholders.
"Overall, the EPA is trying to understand how business is impacted by the regulations the agency issues under TSCA," Newton says. He tempers that statement, however: "EPA is under a lot of pressure from various angles in light of the lack of modernisation of TSCA."
SOCMA will continue to work with the agency and encourage the EPA to deal with all chemical risk management issues in a targeted fashion and avoid sweeping rules that do not apply to smaller companies and batch chemical manufacturers.
ACC, too, is committed to continually engaging the EPA so that TSCA can be as effective and efficient as possible. "We are working with our members to educate them and propose real solutions to the many issues faced under TSCA," says Scott Jensen, ACC's director of issues communication.
"We also want to ensure that the EPA gets quality data and is made aware of our members' concerns, and that we as an industry understand the agency's goals so that we can find ways to reach them without having a negative impact on the business of chemistry."
CONCERN OVER PBDE RULES
One rule that the Office of Management and Budget (OMB) has yet to review in 2013 has to do with a significant new use rule (SNUR) for polybrominated diphenyl ethers (PBDEs), which are flame retardants.
"EPA has taken a new tactic with this SNUR," says Sarah Brozena, senior director of regulatory and technical affairs with ACC. "For the most part, the agency previously did not regulate chemicals in articles [final products such as sofas], and if it did, it generally limited the SNUR to a specific article.
"It is very important for EPA and industry to get the CDR data right"
Mark Duvall, a principal with law firm Beveridge & Diamond, adds that SNURS have in the past been limited to new uses, but with the PBDE SNUR, the EPA appears to be trying to address ongoing uses that it would like to substantially reduce or eliminate.
"This idea is a challenging concept for the EPA to implement and a very troubling one for industry," he says. "It is interesting to note that the OMB allowed the draft proposed rule to go through. If the OMB approves the final rule, it may give new life to the EPA's use of SNURs."
Last year there was a greater number of SNURs, largely due to the EPA working through its backlog. Many of these rules were related to aquatic toxicity, according to Suzanne Hartigan, manager of PMNPro services at SOCMA. "SNURs are a concern because they can impact the entire supply chain," she says. "Many customers simply do not want to use regulated chemicals in their products, so sales can dramatically decline.
"SOCMA is working to educate the EPA about the consequences of these types of regulations and actively seeking more guidance with respect to aquatic toxicity and how to approach other difficult substances, such as chemicals that aren't very soluble but may still be subject to a SNUR," she adds.
ACC is also concerned that the EPA use its authority appropriately with respect to the issuance of SNURs, according to Christina Franz, senior director of regulatory and technical affairs with ACC. On a positive note, she says, the EPA has agreed to discuss with industry its decision-making process for SNURs. The agency is also working with industry to develop workshops to discuss its decision process for substances that are difficult to test, and for multi-component products, for which there have been misunderstandings in the past.
SOCMA would like the EPA to provide an online database to enable tracking of SNUR decisions. Through its PMNPro services, it helps members with filing of premanufacture notices (PMNs), including arranging upfront meetings with the EPA prior to filing in order to identify any potential issues that need to be addressed.
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