Risk Evaluations

Screening Process No later than 1 year after the enactment of this new rule, the EPA must establish a risk-based screening process. This process must include criteria for designating chemical substances as either high- or low-priority, depending on the hazard and exposure potential of a chemical substance. High-priority chemicals must undergo a risk evaluation, while low-priority chemicals do not warrant a risk evaluation. The designation of low-priority chemicals may be revised at any point if the Agency receives sufficient information to do so. This screening process must take between 9 months and one year, and includes such requirements as:

• The EPA must request information from interested parties when a chemical is in the process of being designated into the high- or low-priority categories. 90 days must be provided to those submitting information.
• Once a chemical has been designated, the EPA must publish the designation, along with the information and analysis used to come to this determination. There must be a 90-day public comment period on each chemical designation.
• The EPA is given authority to extend the deadline for up to three months in order receive or evaluate information. If, at the end of this extension, the agency does not have sufficient evidence to designate the chemical as low-priority, then they must designate it a high-priority chemical.
• No later than 6 months after the initiation of a risk evaluation, the Agency must publish the scope of the evaluation to be conducted, including all information the Agency expects to consider.
• Risk evaluations must be completed within three years of initiating the evaluation. Prior to releasing a final risk evaluation, the Agency must publish a draft risk evaluation and provide no less than 30 days for comments.

These risk evaluations must begin on at least 10 chemical substances from the 204 inventory no later than 180 days after the enactment of this rule. While these risk evaluations are taking place, the agency must publish a list of such chemicals. Three and a half years after the enactment of the new rule, the Agency must be conducting risk evaluations on at least 20 high-priority substances and at least 20 low-priority substances. Risk evaluations may be requested for a fee. However, preference will not be given to such risk evaluations. Rulemaking After Risk Evaluations No more than one year after the publication date of a risk evaluation for a chemical substance, the EPA must propose a rule for the chemical substance, 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. The proposed rule must consider all reasonably available information on effects of the chemical, benefits, exposure levels, economic consequences, and whether any economically feasible alternatives are available. In determining any prohibitions on a chemical substance, the Agency may apply such regulations to articles or categories of articles containing the chemical substance. This excludes certain replacement parts designed prior to the date of the publication of the rule in question. When promulgating a rule regulating a chemical substance, the EPA must follow a certain procedure. Along with proscribing the rule, the Agency must also publish a notice of the proposed rulemaking stating the reasons for the rule and allow interested persons to submit publically accessible information and arguments.  Following this, a final rule must be promulgated and published. Upon promulgating any rule, the Agency must specify the date that it will take effect and should specify mandatory compliance dates for all requirements. As part of these rulemakings, the Agency can grant exceptions for the requirements for a specific use of the chemical – if the specific use is critical to a process, if compliance with the rule would disrupt the nation’s economy or security, or if the specific use of the chemical provides a benefit. Any exemptions must be made available to the public, along with an analysis on the determination. The agency must establish a time limit on these extensions, but may alter them on a case-by-case basis. For chemicals identified in the 2014 update of TSCA, and that the agency finds persistent, bioaccumulative, or toxic, rules must be proposed within three years of the Frank R. Lautenberg Chemical Safety for the 21^st Century Act, and must be promulgated within 18 months after that. Risk evaluations are not required in these cases. Any decisions made by the Agency regarding the risks of a chemical substance and the relevant legislation is considered final agency action.