EPA Moves Forward With TSCA Implementation

On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act into law, amending the Toxic Substances Control Act (TSCA).  The original rule that was implemented in 1976 created an inventory of 62,000 chemical substances that were already in commerce. For any substances that were not in the inventory, pre-manufacture notification (and sometimes testing) were required. The thousands of chemicals already included were “grandfathered in” and considered safe, despite inadequate testing. Parts of the rule have been considered mostly unworkable for the past several decades; however, no changes to the rule have been made until now. The EPA has faced legal battles that have prevented the agency from regulating harmful chemicals, and meaningful evaluation of chemicals already in the inventory was simply not possible under the original rule. The new rule requires the EPA to test all chemicals — a large feat for the agency. These chemicals are used in a large variety of industries, and it will be important for businesses in every marketplace to pay attention to changes over the coming years.

• The amendments made a number of significant changes to the rule, including:
• The EPA will be required to evaluate the chemicals on the existing inventory, starting with the highest-risk substances.
• Both new and existing chemicals must be evaluated based on a risk-based safety standard, with consideration of vulnerable populations.
• The EPA will now have the authority to access and develop chemical information that may be necessary to complete risk evaluations.
• The EPA will have clear and enforceable deadlines to ensure timely review of prioritized chemicals and timely action on identified risks.
• Public transparency of chemical information will be increased by limiting unwarranted claims of confidentiality and allowing for the appropriate sharing of confidential information with states, as well as health and environmental professionals.
• EPA will have a source of funding to carry out the provisions of the rule.

For each chemical on the existing inventory, the EPA will now have to complete a “risk evaluation.” These evaluations will include considerations of exposure to workers, site-specific assessment of environmental and general population exposure, and consumer exposure. Evaluation of risks from new chemical substances are considered throughout their product lifecycle. The review process includes a chemical review and search strategy meeting; a structure activity team meeting to assess hazard and environmental fate; development of exposure and release assessments; a preliminary risk management decision meeting; further assessment (if needed); and a final risk management decision meeting.  There are several factors that may affect the length of a review process, and the efficiency of this process is highly dependent upon information received from interested parties. Upon completion of a risk evaluation, the EPA must propose a rule for the chemical substance within one year if it is found to present an unreasonable risk of injury to health or the environment. The Agency must then publish that rule no more than two years after the publication of the risk evaluation. If an extension is needed, the Agency may extend the deadlines for proposing and publishing a rule for no more than two years, with some exceptions. Chemicals found to have detrimental effects on the health of humans or the environment may be subject to harsher regulations, or even prohibition. Due to the EPA’s increased authority to review chemicals, it is expected that following the enactment of this legislation there will be in increase in the number of chemicals being regulated or even banned. Industry stakeholders may prepare themselves to present information on relevant chemicals to the EPA during the course of a risk evaluation on that particular chemical. Stakeholders are given many chances to influence the EPA in their decision-making process. Before a chemical is designated as high priority, for example, interested parties may submit relevant information to the EPA. Stakeholders may also comment on draft risk evaluations and proposed risk management rules. Parts of the new rule go into effect immediately, while others will be phased in gradually. Within six months of the law’s passing date in June 2016, the agency was required to choose 10 workplan chemicals on which to begin risk evaluations. On November 30, 2016, the EPA announced the first 10 chemicals that will undergo risk evaluations, listed below:

• 1,4-dioxane
• bromopropane (1-BP)
• asbestos
• carbon tetrachloride
• cyclic aliphatic bromide cluster (HBCD)
• methylene chloride
• n-methylpyrrolidone (NMP)
• pigment violet 29
• tetrachloroethylene (perc)
• trichloroethylene (TCE)

The bolded chemicals may be used in printing processes. 1,4-dioxane is used in a variety of applications including as a solvent for inks and adhesives. Methylene chloride is used in various industrial processes including metal cleaning and degreasing, adhesives manufacturing and use, solvent distribution and formulation, and textile spotting fluids. NMP may be used in solvents and screen printing. Within three years, the EPA must complete risk evaluations on all 10 of these chemicals to determine if the chemicals present an unreasonable risk of injury to health or the environment. The agency has gotten a quick start on evaluating these top 10, and is already in the process of making determinations on the regulatory status of these chemicals. On December 7, 2016, the EPA proposed a ban on certain uses of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities. The public is allowed a comment period after all proposed rules, and comments must be received no later than 60 days after publication in the federal register. The agency must start risk evaluations on the other nine chemicals listed and within six months must release a document detailing the scope of the evaluations for each chemical. These include hazard exposure information, conditions of use, and the potentially exposed or susceptible subpopulations the Agency plans to consider for the evaluation. The next few years will present key changes to industries that use chemicals in manufacturing or production, but this new legislation allows for a better working relationship between those industries and the EPA. Businesses are advised to access the TSCA chemical substance inventory (found at https://www.epa.gov/tsca-inventory) and to be prepared to collect data on relevant chemicals to share with the agency and make the risk evaluation process more efficient. SGIA will continue to monitor the implementation of this important piece of legislation. Sign up to receive the most up-to-date regulatory and legislative information about specialty imaging on SGIA.org/garment/FTK.