Joseph G. Allen, Harvard T.H. Chan School of Public Health
Lauren Kasparek, JD, MPH, Center for Health and the Global Environment
The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act or Act) contains major revisions of the Toxic Substances Control Act (TSCA), changing the process of chemical regulation in the United States.1 The Act regulates chemical manufacturers and processors, and the distribution, use and disposal methods.2 Although the Act preserves TSCA’s objectives, it changes chemical testing, notice and review processes, the chemical inventory, confidential information claims, and state oversight.3
The law covers chemicals and mixtures (naturally occurring and from chemical reactions), and explicitly excludes pesticides, unnatural mixtures that are not from a reaction, tobacco, food, makeup, and drugs.4 The law applies to chemical manufacturers and processors, and aims to evaluate and control manufacturing, processing, distribution, use, and/or disposal that poses an “unreasonable risk of injury to health or the environment.”5 The law applies to manufacturing, processing, and distribution in the U.S market; however, chemicals for export may be regulated if they pose an “unreasonable” health or environmental risk while in the U.S.6
If testing reveals the potential for “significant risk of serious or widespread harm to humans,” action must be taken to avoid or minimize the risk without considering costs.12 Possible actions include notice, rulemaking to reduce risk, or addressing an imminent hazard.12
All U.S. manufactured and processed chemicals are included in a chemical inventory; it does not contain chemicals made in “small quantities” for research.7 Inventory chemicals will be divided into “active” and “inactive.”8 Active substances include chemicals made for “nonexempt commercial purpose[s]” in the 10 years preceding the Lautenberg Act.8
Chemical testing produces information to determine whether a chemical “present[s] an unreasonable risk of injury to health or the environment.”9 Testing must occur in two situations: 1. Inadequate facts exist to determine if a chemical poses an unreasonable risk and 2. Inadequate facts exist on chemicals with exposure potential made in “substantial quantities.”9 Additionally, testing may occur to produce information for a notice, risk evaluation, or other actions under this law.10 Manufacturers and processors can be ordered to test chemicals, but they may opt for a 3rd party to do it for them.11 If testing reveals the potential for “significant risk of serious or widespread harm to humans,” action must be taken to avoid or minimize the risk without considering costs.12 Possible actions include notice, rulemaking to reduce risk, or addressing an imminent hazard.12
Manufacturers of new chemicals and manufacturers and processors of a chemical with a “significant new use” must give EPA “notice” 90 days before production; some chemicals may be exempt.13 The notice must include “reasonably ascertainable” information listed in section 2607(a)(2) and information on health or environmental effects.14 The Administrator has up to 90 days to make a decision.15 There are three possible outcomes of an evaluation, which does not consider costs but includes “subpopulations:” “unreasonable risk of injury to health or the environment,” not enough information, and no “unreasonable risk of injury to health or the environment.”16 If there is an unreasonable risk, the Administrator must take action to ban or limit the chemical, or other action listed under section 2605(f)(2).17 If information is lacking, the chemical must be banned or limited through an order; however, production may begin if parties follow the order.18 If there is no unreasonable risk, then production may begin.19
The Administrator will conduct “risk evaluations” on chemicals labeled “high priority.”20 A high priority chemical is one that “may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use.”21 Risk evaluations will begin on 10 chemicals from the 2014 TSCA Work Plan for Chemical Assessment (2014 Work Plan), and later expand to at least 20 high priority chemicals.22 The only requirement for setting high priority chemicals is to prioritize 2014 Work Plan chemicals that are persistent, bioaccumulative, “known human carcinogens[,] and have a high acute and chronic toxicity.”23 Although the risk evaluation process is yet to be determined, there is statutory guidance on factors to consider.24 Additionally, manufacturers may request chemicals for risk evaluation, but there are limits on the total number that the Administrator can consider.25 The goal of risk evaluation is to establish if a chemical’s conditions of use “present an unreasonable risk of injury to health or the environment;” subpopulations, not costs, must be considered.26 Any findings of unreasonable risk under this section (section 2605) and potentially sections 2603 and 2604 are subject to rulemaking; any rules to ban, limit, or affect manufacturing, processing, or distribution from these sections must consider the economic, environmental, and health effects of such action.12,17,27
Manufacturers and processors can assert confidentiality claims, but must substantiate it.28 The law delineates what the assertion must include for chemical identification and general claims.29 The Administrator will review all chemical identification claims and only 25% of general claims.30 Substantiated information receives 10 years of protection, at which time the claim must be reasserted and resubstantiated.31 Past and current claims can also undergo review; it is mandatory for a chemical that presents an unreasonable risk in risk evaluation, and at the Administrator’s discretion for a high priority or an active substance, or where a risk evaluation requires confidential information.32 There is a list of unprotected information including health and safety studies, general descriptions of manufacturing or processing, and information on banned chemicals.33 Additionally, even if a substance achieves confidential status, the information can be revealed in specific situations; these situations include health and environmental protection, federal or state law enforcement, and emergency circumstances.34
Additionally, even if a substance achieves confidential status, the information can be revealed in specific situations; these situations include health and environmental protection, federal or state law enforcement, and emergency circumstances.34
States cannot create or enforce any laws or actions for notice, restrictions, or information already covered under the Lautenberg Act.35 Additionally, a state may not take any action on a high priority chemical after performance of a risk evaluation; however, any action initiated prior to risk evaluation publication may continue.36 States may continue to enforce actions in effect before 4/22/16 and actions under state law before 8/31/03.37 States may apply for waivers that must be granted where a state has or proposes a statute or action to limit a chemical undergoing prioritization, or where action based on peer-reviewed science will not interfere with interstate commerce.38 Mandatory waivers only last until the Administrator completes the chemical’s risk evaluation.39 Additionally, states may establish identical requirements as the Act, but may not penalize parties more severely or duplicate assessed Federal penalties.40
The Lautenberg Act changes the evaluation of chemical risks to human health. When the Administrator decides whether an “unreasonable risk” exists for human health in a chemical notice or risk evaluation, the analysis explicitly excludes “costs or other nonrisk factors.”16,26 Additionally, chemical testing also explicitly excludes these factors in determining whether a chemical poses “significant risk of serious or widespread harm to humans.”12 The Act also takes subpopulations into account when evaluating notices and risk evaluations.16,26 Specifically, subpopulations include individuals at risk due to the exposure level or internal susceptibility.41 These alterations in both populations considered and focusing on risk in the analysis phase will likely afford stronger chemical regulation around human health.
The Act prioritizes human health over confidential information. Exceptions exist for both emergency and non-emergency health circumstances, allowing medical responders access to chemical information potentially vital for performing their duties.34 Furthermore, the Administrator may release confidential information to protect health or enforce other health laws.34 These measures ensure human health is protected in both foreseeable and unforeseeable situations over proprietary claims.
The Act sets the ceiling for most chemical regulation, barring states from playing a secondary role.35,36 This could be problematic for health because states may no longer legislate where federal chemical regulation fails. However, the Act does allow some loopholes for states to pursue action (i.e. – waivers, pre-existing actions, etc.) to protect human health if federal regulation fails.36,37,38
There are still shortcomings in the Lautenberg Act despite the overall improvement from TSCA. Four particular limitations standout in the Act: the current chemical inventory, the deadline for notice evaluations, states’ rights, and the cost-benefit requirement for rulemaking.
Initially, the Act ensures risk evaluations on 10 chemicals; however, there are approximately 1500 notices each year and currently 85,000 chemicals in the inventory.22,42,43 Although the processes for prioritization and risk evaluation are unknown, it is reasonable to assume it could take years to go through all the chemicals in commerce.44
The Administrator has no more than 90 days to make a decision on notices.15 Although section 2604 delineates the outcomes of a notice analysis, evaluation relies on receiving adequate manufacturer and processor data.14,16 Yet, one report notes only 33% of notices contain chemical properties data and another 15% contain health data, leaving EPA to fill the void.45 Although not enough information is an option when reviewing notices, a manufacturer or processor can still go forward with production as long as they follow the order.18
The Act also limits state action where federal action is occurring.35,36 This is problematic because states will be unable to act where the Act falls short. TSCA received a makeover because of its ineffectiveness in chemical regulation; only 5 chemicals have been restricted since TSCA’s inception.46 Despite loopholes available for state action, it remains concerning that states will be barred from effectively participating in chemical regulation, particularly given TSCA’s past.36,37,38,46
The Act’s language on rulemaking remedies one of the shortcomings of TSCA: the Lautenberg Act no longer requires EPA address risk with the “least burdensome requirements.”47,48,49 The goal of rulemaking is to ensure a chemical “no longer presents such risk,” but only “to the extent necessary.”49 Rulemaking requires an analysis of the economic, environmental, and health factors.50 These factors include available alternatives, the chemical benefits, “economic consequences,” and the health and environmental effects.50 Although there is no mandate to choose a specific course of action as in the past, these factors must be part of the Administrator’s rulemaking analysis. Future cases will likely flesh out EPA’s ability to use rulemaking to prevent risks associated with chemicals in commerce.