Thursday, May 26, 2016

Finally, Chemical Safety Act Set to Pass

On Tuesday, May 24th by a vote of 403-12 the U.S. House of Representative passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act. This bill amends the Toxic Substances Control Act (TSCA), a 1976 law that provides the U.S. Environmental Protection Agency (EPA) with the limited authority they have to require reporting, record-keeping, testing, and restrictions on chemical substances, mixtures and compounds. Both the House and Senate passed different versions of this bill last year that have now been reconciled. The current version of the bill goes to the U.S. Senate where it is expected to pass this week.

Chemicals are everywhere, they exist in pharmaceuticals, household products, personal care products, plastics, pesticides, industrial chemicals, human and animal waste; they are in short, all around us. These chemicals include organics, inorganic, polymers, and UVCBs (chemical substances of Unknown or Variable composition, Complex reaction products, and Biological materials). Yet, very few of these chemicals have been evaluated for health risks under the existing TSCA law because the EPA can only require testing for existing chemicals when there is evidence of harm and this became a sort of Catch 22: you can’t require testing unless there is evidence of harm and you can’t prove evidence of harm without testing. Under TSCA, if a chemical is on the TSCA Inventory of over 80,000 chemicals, the substance is considered an "existing" chemical.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act would require the EPA to test chemicals using "sound and credible science" and impose regulations if they are shown to pose a health risk. The bill revises TSCA to create a safety standard to ensure that no unreasonable risk of harm to health or the environment will result from exposure to a chemical under the conditions of use. The standard includes the protection of potentially exposed or susceptible populations, but does not take cost or other non-risk factors into consideration. The bill repeals the requirement that the Environmental Protection Agency (EPA) apply the least burdensome means of adequately protecting against unreasonable risk from chemicals.

In addition, the bill revises the EPA's authority to require the development of new information about a chemical by establishing a risk-based screening process. By deadlines specified in the bill, the EPA must designate a certain number of existing chemicals as high- or low-priority for safety assessments and determinations and conduct safety assessments and determinations for high-priority chemicals.

The bill requires that the EPA prevent the manufacture, processing, use, distribution, or disposal of a new chemical, or a significant new use of an existing chemical, if the chemical is not likely to meet the safety standard, or additional information is necessary to make a safety determination. The bill requires manufacturers and processors to pay fees to defray the costs of this bill and establishes the TSCA Implementation Fund to receive such fees.

Out of thousands upon thousands of chemicals in commerce today, very few have been fully evaluated for potential health effects. Until recently when screening assays became available it was impossible. Now, with the analytical tools of the 21st century this has changed. Scientists can now use screening assays to evaluate the potential health effects of thousands of chemicals to choose the ones to look at further to consider regulating. This screening uses automated methods that allow for a large number of chemicals to be rapidly evaluated for a specific type of biological activity.

In anticipation of this regulation, EPA in conjunction with the National Institutes of has been trying to improve the data generated from the automated screening technology to incorporate chemical metabolism. Current technology would miss chemicals that are metabolized to a more toxic form in the body where impact could be magnified. EPA is working with the science community to find new ways to incorporate physiological levels of chemical metabolism into screening assays. Using both prestige and modest cash awards the EPA announced a new challenge that will award in total up to $1 million to improve the data generated from automated chemical screening technology used for toxicity testing

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