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Policy
GlobalChem In Briefs
Annual meeting gives chemical industry an opportunity to discuss key issues
by Cheryl Hogue
March 17, 2014
| A version of this story appeared in
Volume 92, Issue 11
International trade, new efforts in toxicology, reform of the Toxic Substances Control Act (TSCA), and sundry actions by the Environmental Protection Agency on commercial compounds are hot items for the chemical industry. These were among the issues probed at GlobalChem, the chemical industry’s annual conference on regulations. Two trade associations, the American Chemistry Council and the Society of Chemical Manufacturers & Affiliates, hosted the annual meeting held in Baltimore early this month.
Jump to Topics:
- EPA May Seek Toxicity Data Via Subpoena
- Transatlantic Trade Deal Wouldn’t Spread Or Rein In EU’s Reach
- Draft TSCA Reform Bill Would Eventually Preempt State Law On Chemicals
- ACC Not Happy With EPA’s Plans To Expand Design For The Environment
- Complaints About Cheap Chemical Imports Are On The Rise
- Evidence-Based Toxicology Explained
- Fractions Of Substances Get EPA Scrutiny
↑ Top
EPA May Seek Toxicity Data Via Subpoena
EPA recently ran into a brick wall when it asked some chemical manufacturers to share the toxicity data that they’d submitted to the European Union. Now, EPA is hoping to chart a path around that wall using its TSCA subpoena powers.
The toxicity data EPA is after were assembled by companies when they registered certain chemicals under the EU’s Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH) law.
For instance, EPA asked for REACH registration toxicity data to assess a handful of high-production-volume chemicals, which are made in amounts of at least 1 million lb per year. At least some companies, however, have refused to give the data to EPA. They formed consortia to split the costs of generating the information. The consortia members are contractually barred from sharing data for any purpose other than REACH registration. Furthermore, the European Chemicals Agency is bound by law not to share that data.
Wendy Cleland-Hamnett, director of EPA’s Office of Pollution Prevention & Toxics, told attendees at GlobalChem that some consortia agreements allow companies to provide data if a government authority formally demands it. As a result, EPA may issue subpoenas under TSCA to get data from U.S. companies that were part of consortia if they continue to turn down the agency’s requests, she said.
↑ Top
Transatlantic Trade Deal Wouldn’t Spread Or Rein In EU’s Reach
The U.S. and the European Union are hammering out a deal, known as the Transatlantic Trade & Investment Partnership, that is expected to boost trade. But unlike previous trade agreements, a major aim is to decrease the impacts of regulations on trade, including commerce in chemicals.
Some in the chemical industry were hoping that the new trade pact could lead to some changes in Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH) regulations, which they view as onerous.
But don’t expect any changes to the EU’s REACH law because of the new trade deal, an EU official told attendees at GlobalChem. “We’re not going to change REACH, and we’re not seeking to impose REACH on the U.S.,” Isabel Pastor Arenillas, an EU trade attaché, told the conference. Likewise, the transatlantic deal will not affect TSCA. Instead, the goal is to trigger future regulatory cooperation between the EU and U.S., she said.
For chemicals, this could mean that the U.S. and EU might work toward establishing similar systems for classifying commercial substances, said Jeff Weiss, senior adviser for standards and global regulatory policy at the U.S. Department of Commerce. It could also lead to common definitions of terms such as “nanomaterials,” he said.
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Draft TSCA Reform Bill
Would Eventually Preempt State Law On Chemicals
Draft legislation in the House of Representatives to overhaul TSCA would not immediately override state laws on chemicals, a Republican congressional aide told the GlobalChem conference. But that draft bill would eventually grant industry’s wish to do away with the growing assortment of state laws controlling chemicals and replace them with a single federal system, said David McCarthy, counsel for the House Energy & Commerce Committee. A major Republican goal for TSCA reform is to ensure the free flow of interstate commerce, he added.
The draft bill to reform TSCA, made public in late February but not yet formally introduced, would preempt state laws pertaining to a specific chemical only after EPA took action on that substance, McCarthy explained.
For instance, the draft would override state laws on a chemical if EPA deemed it a low priority for future scrutiny by regulators. Also, any regulation EPA finalized for the substance, such as requiring a warning label or a phaseout of its use, would then supersede state laws on that chemical.
Whether Congress should preempt existing state chemical laws is perhaps the most controversial aspect of TSCA reform—which lawmakers in both the House and Senate are working on.
Environmental and health advocates and many states, notably California, want to preserve these state laws. They say the draft House bill would prohibit states from collecting information on any chemical for any purpose. This would be the case even if states face an environmental emergency, such as the chemical spill that tainted the drinking water of Charleston, W.Va., earlier this year.
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ACC Not Happy With EPA’s Plans To
Expand Design For The Environment
EPA is working to improve and expand its ecolabeling effort, the Design for the Environment (DfE) program. Wendy Cleland-Hamnett, director of EPA’s Office of Pollution Prevention & Toxics, told GlobalChem attendees that the agency is working with a marketing firm to redesign its DfE logo within the next year.
What’s more, Cleland-Hamnett said, the agency hopes to expand the program to cover more consumer products. The goal is to better convey to consumers that a product contains safer chemicals than products without the label, she said.
Since 1990, companies have applied to use EPA’s DfE logo on qualifying products that contain ingredients that perform well, are cost-effective, and are less hazardous to the environment than ingredients often used in that type of product. It has been used most widely for products sold for institutional use, such as cleaning offices or schools, Cleland-Hamnett said.
But American Chemistry Council CEO Calvin M. Dooley is raising hackles over these efforts. ACC is a major chemical industry trade group. Dooley raised questions about the appropriateness of the government determining that one product is superior to another.
The agency should ensure that the DfE program complies with Federal Trade Commission requirements for green marketing, Dooley said. The commission’s guidelines apply to environmental marketing claims and are focused on ensuring that those claims do not deceive consumers.
“ACC looks forward to working with EPA to improve the DfE program so that it takes into account exposure and risk, not just the potential hazard of a chemical in a product,” he said. Dooley added that the DfE program “has value” and a lot of ACC member companies use the label, but he did not elaborate further.
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Complaints About Cheap Chemical Imports Are On The Rise
Although GlobalChem historically has focused on the regulation of chemicals, international trade concerns are getting increased attention at the conference. This year, an international trade attorney said a trend of interest for chemical makers concerns dumping. This is the practice of an exporter selling a commodity at a price lower than that it normally charges in its home market.
Companies around the world increasingly complain of economic harm from foreign competitors who dump low-cost chemicals and plastics into their domestic markets, said Jennifer A. Hillman, a partner in the Washington, D.C., office of the law firm Cassidy Levy Kent.
Nearly 22% of antidumping cases filed with national governments since 1995 have involved commodity chemicals, Hillman said. Another 12% of cases concerned plastics and resins.
Governments investigate the complaints filed by companies and may impose antidumping duties or fees on the imported product at issue, as allowed under international trade rules.
Antidumping cases concerning chemicals and plastics span the globe. Over the past two decades, Indian companies have led the world in initiating complaints involving chemicals and plastics. They have filed hundreds of cases against competitors in countries including the U.S., China, Kenya, Pakistan, Russia, and South Korea, Hillman said. Most of the chemicals- and plastics-related antidumping cases filed in the U.S. concern Chinese manufacturers, she added.
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Evidence-Based Toxicology Explained
A developing discipline called evidence-based toxicology drew plenty of attention from chemical company representatives at GlobalChem. The aim of the disciplines to establish a rigorous structure for transparent, objective, and replicable assessment of available scientific evidence about a chemical’s toxicity.
Also known as a systematic review, the discipline is gaining acceptance at the National Toxicology Program and in EPA’s chemical risk assessment efforts.
Evidence-based toxicology is modeled after evidence-based medicine, said Martin L. Stephens, a senior research associate at Johns Hopkins University Bloomberg School of Public Health. Evidence-based medicine is a structured way of assessing findings from multiple research studies about the impacts of therapies and the accuracy of diagnoses.
Evidence-based toxicology applies to reviews of scientific literature about the association between exposure to a chemical and an adverse effect. It sets a standard framework for identifying and scrutinizing studies detailed in the literature, Stephens explained.
Practitioners of evidence-based toxicology first establish a strategy for searching the literature for applicable studies. Next, they apply criteria, which are determined in advance, for either including or excluding studies from the analysis. Then they extract the data from included studies, often combining results of similar studies.
Finally, the practitioners apply another set of criteria, also determined in advance, to assess the methodological quality of the studies. This provides a confidence level for the overall conclusions of the analysis, Stephens explained.
↑ Top
Fractions Of Substances Get EPA Scrutiny
Commercial substances produced in the U.S. and regulated under TSCA often contain a number of discrete chemicals. The substances, with their mix of chemical components, or fractions, are legally sold because they appear on the TSCA inventory of chemicals in commerce. But the various fractions sometimes are not on that inventory and cannot legally be sold separately.
Now, EPA enforcement efforts, including inspections, are targeting companies that separate fractions of a substance and sell them as separate products, said Rosemarie Kelley, director of the agency’s Waste & Chemical Enforcement Division.
Any company that separates fractions from another substance is considered a chemical manufacturer under TSCA. That company is thus responsible for determining whether components are on the inventory before selling them, Kelley said. If a fraction isn’t on that list, the producer must submit a premanufacture notice to EPA, which will then review it, before commercializing the material.
Separated fractions that were subsequently marketed were the basis of a 2012 enforcement case against Dover Chemical. The company paid $1.4 million to resolve allegations that it made and sold short-chain, medium-chain, and long-chain chlorinated paraffins without first submitting a premanufacture notice to EPA.
Components may pose significantly greater risk to human health or the environment than the substance from which they were separated, Kelley said. EPA has found a number of cases, including the one involving Dover Chemical, in which a fraction wasn’t on the TSCA inventory—and thus never underwent premanufacture review—but was being sold.
Jump to Topics:
- EPA May Seek Toxicity Data Via Subpoena
- Transatlantic Trade Deal Wouldn’t Spread Or Rein In EU’s Reach
- Draft TSCA Reform Bill Would Eventually Preempt State Law On Chemicals
- ACC Not Happy With EPA’s Plans To Expand Design For The Environment
- Complaints About Cheap Chemical Imports Are On The Rise
- Evidence-Based Toxicology Explained
- Fractions Of Substances Get EPA Scrutiny
Chemical & Engineering News
ISSN 0009-2347
Copyright © 2024 American Chemical Society
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