The 1976 Toxic Substance Control Act (TSCA) was passed to protect the public from “unreasonable risk of injury to health or the environment” by regulating the manufacture and sale of chemical substances. Prior to this latest TSCA Reform Law, signed into law on June 22, 2016, the United States Environmental Protection Agency (EPA) had limited ability to protect the public from dangerous chemical substances.
This new TSCA Reform Law gives EPA the necessary tools to regulate chemical substances in commerce in a more efficient and effective manner, adds increased protection to consumers and the environment and provides industry with a more predictable regulatory program. EPA is required to publish a proposed rule by mid-December of 2016 and finalize it by mid-June of 2017. EPA has already developed timelines for its implementation. EPA is taking steps to identify existing chemical substances used in commerce, establish procedures to prioritize chemical substances, evaluate high priority chemical substances and is also working on a fee system to support its implementation.
This latest TSCA Reform Law allows EPA for the first time to evaluate existing chemical substances in commerce starting with those most likely to cause risk. Chemical substances—as defined under TSCA—do not include pesticides, food, drugs, cosmetics, medical devices and radioactive materials which are all regulated under other federal regulations. Aside from some article exemptions TSCA includes most chemical substances used in commerce. “Existing chemical substances” are those currently on the TSCA inventory. “New chemical substances” are not on the inventory. This new law requires EPA to evaluate new and existing chemical substances against a new risk-based standard that provides extra protection for vulnerable populations. Unlike in the past, EPA will now have enforceable deadlines ensuring timely review of prioritized chemical substances and timely action on identified risks. In addition, the restrictions on chemical substances confidentiality will be loosened, allowing more sharing of confidential information with States and health and environmental professionals.
Who Is Impacted by the TSCA Reform Law?
Traditionally domestic manufacturers (including distributors) of chemical substances have borne most of the requirements under TSCA. They are required to determine if the chemical substance that they are planning to manufacture is:
- – An “existing chemical substance” (currently on the TSCA Inventory);
- – Exempted from being on the list;
- – A “new chemical substance” (not on the TSCA Inventory); or
- – An “existing chemical substance” that has a significant new use.
If it is a new chemical substance or is an existing chemical that has a significant new use, the manufacturer must file a Premanufacture Notice (PMN) or a Significant New Use Notice (SNUN), respectively, to EPA. EPA then has 90 days to evaluate the chemical substance in its chemical review process.
Since under TSCA, an importer is included in the definition of a manufacturer, almost all of the requirements that apply to a domestic manufacturer of chemical substances apply to importers. Be careful as to how “importer” is defined under TSCA. It includes the first importer who identifies the chemical substance and total amount to be imported. It also includes the person who is primarily liable for the payment of duties, or an authorized agent, the consignee, the importer of record, in some cases the actual owner and transferee. This could be the importer’s customer (i.e., company who will be using the chemical substance) for whom the importer imported the chemical substance.
By mid-summer of 2017, EPA is expected to send a notification to companies (those who manufacture or use chemical substances) requesting a list of the chemical substances that they have manufactured and/or used within the last 10 years. Companies will have 180 days to respond. The results of this survey will be used to designate active and inactive chemical substances on the TSCA inventory of existing chemical substances. Companies (herein referred to as users) who purchase chemical substances directly from domestic manufacturers should make sure the manufacturer has followed the TSCA protocol for those chemical substances. If companies are importing chemical substances, they should ensure the chemical substances are being imported in accordance with TSCA.
Therefore, domestic manufacturers (including distributors) of chemical substances, importers and users of chemical substances could be impacted by TSCA.
Areas Immediately Impacted by This New Law
The new chemical substances review process has changed. EPA is now required to make an affirmative determination within 90 days of submittal of a PMN for a new chemical substance or a SNUN for an existing chemical substance before manufacturing can commence. If after 90 days EPA has not issued a decision on the chemical substance, EPA is required to return the review fee back to the company. Information on PMN and SNUN fees are provided below. The company cannot commence manufacturing until EPA’s review is completed.
The PMN and SNUN review process–which evaluates the hazards and exposure potential of the chemical substances–consists of four technical phase reviews:
- 1. The chemistry review phase;
- 2. The hazard (toxicity) evaluation phase;
- 3. The exposure evaluation phase; and
- 4. The risk assessment/risk management phase.
These phases were developed to drop chemical substances of low-risk from further assessment, and to focus on evaluating higher priority chemical substances. A chemical substance with a “high priority” rating is defined as having the potential to pose an unreasonable risk of injury to health or the environment due to a potential hazard or route of exposure including susceptible populations. A “low priority” chemical substance is defined as any chemical substance that does not meet the “high priority” rating.
EPA is now required to take expedited action on a risk evaluation of certain persistent, bioaccumulative and toxic (PBT) chemical substances. These PBT chemical substances will be pushed ahead of the chemical review line due to their increased toxicity hazards.
EPA has formed a new Science Advisory Committee on Chemical Substances. The purpose of this committee is to provide independent advice and expert consultation with respect to the scientific and technical aspects of risk assessments, methodologies and pollution prevention measures supporting the new TSCA law.
Risk Evaluations – For chemical substances with a “high priority” rating, EPA is required to complete a risk evaluation on that chemical substance to determine its safety, within a required deadline. No further action is required for chemical substances having a “low priority” rating. Within the first 180 days, EPA is required to have 10 ongoing risk evaluations. Within 3.5 years, they are required to have 20 ongoing risk evaluations. Chemical substances are evaluated against a new risk-based safety standard (which includes risks to susceptible and highly exposed populations) to determine if they pose an “unreasonable risk.”
Once an “unreasonable risk” is identified, EPA must take final risk management action within two years (four years with extension). When taking risk management action, EPA must consider costs and availability of alternatives. Risk management action (including bans and phase outs) must begin as soon as possible but no later than five years after the final regulation.
Manufacturers (or importers) can request an EPA evaluation of specific chemical substances but they must pay the associated costs. EPA is authorized to collect user fees up to $25 million annually from chemical substances manufacturers and importers when they:
- – Submit test data for EPA to review;
- – Submit a PMN for a new chemical substance or SNUN for a significant new use;
- – Manufacture or process a chemical substance that is the subject of a risk evaluation; or
- – Request that EPA conduct a chemical risk evaluation.
Under this reform law the fees have increased significantly for submitting a PMN or SNUN. The amounts have not been finalized, but the anticipated range is from $5,000 to $10,000 per submission.
The new TSCA reform law provides much-needed regulatory tools for EPA to carefully evaluate the hazards of chemical substances used within commerce and the impact their use has on people with careful consideration focused on susceptible populations. It also should slow down the creation of new state laws pertaining to toxic chemical substances which hopefully will eliminate the need for multiple and duplicative state and federal laws. Needless to say, EPA’s oversight of the usage of existing and new chemical substances is about to take on a whole new meaning.
For more information about the new TSCA Reform Law, contact Mike Rioux, CHMM at firstname.lastname@example.org