Breaking News

Error rendering macro 'rss' : java.io.IOException: Failed to recover from an exception: http://environmentalhealthnews.org/archives_rss.jsp?sm=&tn=1title%2Clede%2Cdescription%2Ctext%2Csubject%2Cpublishername%2Ccoverage%2Creporter&tv=toxicology&ss=1

Introduction

On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, a set of amendments to the Toxic Substances Control Act (TSCA) of 1976. The product of several years of initiatives in Congress, the amendments are a step toward increasing public health protections from toxic chemical exposures. While it makes some significant changes, many health and environmental advocates claim it is a compromise bill that is too lenient on the chemical industry. Specifically, the pace of chemical safety review is slow, state laws may be preempted in some cases, and the funding is likely insufficient for carrying out the provisions.

Toxic Substances Control Act

TSCA was widely considered to be failed legislation for various reasons, including:

  • it did not evaluate the safety of the majority of about 60,000 chemicals already in use at the time the Act went into effect ("grandfathered," or automatically authorized, these chemicals)
    • while EPA had the authority to require manufacturers to test existing chemicals, in each case EPA had to make several formal findings and determine that the chemical "may present an unreasonable risk," which was difficult given that it required data that EPA could not access or cause to be generated without first making the determination
    • as of 2015 only 250 of the more than 60,000 existing chemicals had been directly tested by EPA: 140 of those were tested by regulatory order and 60 were tested only after voluntary consent by the manufacturer
  • it did not require safety reviews of new chemicals before they went on the market unless "unreasonable risks" were suspected, but as stated by EPA, "almost 90 percent of Premanufacture Notices submitted to EPA complete the review process without being restricted or regulated in any way"
    • EPA evaluation found that 85 percent of PMN data on health effects is deficient, and 67 percent of PMNs contain deficiencies on health or environmental effects of any kind
    • EPA had only 90 days after receiving a PMN to make a determination, and as a result only 40 percent of acute toxicity and mutagenicity testing is ever completed, even less data on long-term effects or specific endpoints (including subchronic, neurotoxicological, developmental, reproductive, and chronic) is ever generated
  • ultimately it addressed the production, importation, use, and disposal of only five chemicals/products: polychlorinated biphenyls (PCBs), asbestos, radon, and lead-based paint
  • in the case of asbestos, a 1989 ban by EPA was overturned by the Fifth Circuit Court of Appeals in 1991: EPA was accused of not choosing the least economically burdensome approach to reducing risks from exposure, and also of not being able to adequately prove the benefits of banning asbestos-containing products, which exposed serious weaknesses in TSCA's ability to ban chemicals

It is important to note that pesticides are regulated by a separate law, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, 1910). Drugs, cosmetics, food additives, and food packaging are regulated by FDA.

Key Provisions of the Lautenberg Amendment

Below are details on the key provisions, as described by EPA:

Existing Chemicals

  • Chemical Assessments
    • Prioritization
      • EPA must establish a risk-based process to determine which chemicals it will prioritize for assessment, identifying them as either “high” or low” priority substances.     
        • High priority – the chemical may present an unreasonable risk of injury to health or the environment due to potential hazard and route of exposure, including to susceptible subpopulations
        • Low priority – the chemical use does not meet the standard for high-priority
    • Risk Evaluations
      • High priority designation triggers a requirement and deadline for EPA to complete a risk evaluation on that chemical to determine its safety
      • Low priority designation does not require further action, although the chemical can move to high-priority based on new information
      • Assessment pipeline
        • First 180 days – EPA must have 10 ongoing risk evaluations
        • Within 3.5 years – EPA must have 20 ongoing risk evaluations
    • New Risk-Based Safety Standard
      • Chemicals are evaluated against a new risk-based safety standard to determine whether a chemical use poses an “unreasonable risk”
        • Risk evaluation excludes consideration of costs or non-risk factors 
        • Must consider risks to susceptible and highly exposed populations
    • Action to address unreasonable risks
      • When unreasonable risks are identified, EPA must take final risk management action within two years, or four years if extension needed
      • Costs and availability of alternatives considered when determining appropriate action to address risks
      • Action, including bans and phaseouts, must begin as quickly as possible but no later than five years after the final regulation
    • Manufacturer-requested assessments
      • Manufacturers can request that EPA evaluate specific chemicals, and pay the associated costs as follows:
        • If on the TSCA Workplan, manufacturers pay 50% of costs
        • If not on the TSCA Workplan, manufacturers pay 100% of costs
      • These assessments must account for between 25-50% of the number of ongoing risk evaluations for high-priority chemicals, but do not count towards the minimum 20 ongoing risk evaluation requirement
  • Chemical Testing Authority
    • Expands authority to obtain testing information for prioritizing or conducting risk evaluations on a chemical, and expedites the process with new order and consent agreement authorities
    • Promotes the use of non-animal alternative testing methodologies
  • Persistent, Bioaccumulative, and Toxic (PBT) Chemicals
    • New fast-track process to address certain PBT chemicals on the TSCA Workplan
      • Risk evaluation not needed, only use and exposure to chemical needed
      • Action to reduce exposure to extent practicable must be proposed no later than three years after the new law and finalized 18 months later.
      • Additional requirements for PBTs in the prioritization process for assessments

New Chemicals

  • Pre-Market Review of New Chemicals
    • New requirement that EPA must make an affirmative finding on the safety of a new chemical or significant new use of an existing chemical before it is allowed into the marketplace
      • EPA can still take a range of actions to address potential concerns including ban, limitations, and additional testing on the chemical

Confidential Business Information

  • Establishes new substantiation requirements for certain types of confidentiality claims from companies 
  • Requires that EPA review and make determinations on all new confidentiality claims for the identity of chemicals and a subset of other types of confidentiality claims
  • EPA must review past confidentiality claims for chemical identity to determine if still warranted

Source of Sustained Funding

  • Allows EPA to collect up to $25 million annually in user fees from chemical manufacturers and processors when they:
    • Submit test data for EPA review
    • Submit a premanufacture notice for a new chemicals or a notice of 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
  • New fees will defray costs for new chemical reviews and a range of TSCA implementation activities for existing chemicals

Federal-State Partnership

  • Preservation of State Laws
    • States can continue to act on any chemical, or particular uses or risks from a chemical, that EPA has not yet addressed
    • Existing state requirements (prior to April 22, 2016) are grandfathered
    • Existing and new state requirements under state laws in effect on August 31, 2003, are preserved
    • Preserves states environmental authorities related to air, water, waste disposal and treatment
    • States and federal government can co-enforce identical regulations
  • Preemption of State Laws
    • State action on a chemical is preempted when:
      • EPA finds (through a risk evaluation) that the chemical is safe, or
      • EPA takes final action to address the chemical’s risks
    • State action on a chemical is temporarily “paused” when EPA’s risk evaluation on the chemical is underway, but lifted when EPA:
      • completes the risk evaluation, or
      • misses the deadline to complete the risk evaluation
  • Exemptions
    • States can apply for waivers from both general and “pause” preemption
    • If certain conditions are met, EPA MAY grant an exemption from general preemption, and MUST grant an exemption from pause preemption

 

Criticism of the Lautenberg Chemical Safety for the 21st Century Act

The Lautenberg Amendment is facing criticism from health and environmental advocates for various reasons, including these:

  • the timeline for conducting risk assessments is too slow: in addition to an overall slow pace starting with 20 risk assessments in process within 3.5 years, it can take up to 9 years for action to be taken on chemicals once they are evaluated as posing "unreasonable risk"
  • the $25 million annual funding collected from industry is inadequate for EPA to be able to implement the provisions
  • risk evaluations do not consider issues of cost, but subsequent risk management assessments do consider cost
  • state laws restricting chemicals under EPA review may be preempted in some cases
  • while EPA must substantiate confidential business information ("trade secrets") in some cases, the provisions fall short of implementing a right-to-know policy for the public
  • manufacturers may abuse the ability to request reviews of specific chemicals under the manufacturer-requested assessments provision

 

Conversely, it has been endorsed by these organizations:

  • Environmental Defense Fund
  • The Humane Society of the United States
  • International Association of Machinists and Aerospace Workers
  • March of Dimes
  • Moms Clean Air Force
  • National Wildlife Federation
  • North America's Building Trades Unions
  • Physicians Committee for Responsible Medicine

More Information and Opinion

Bauers, Sandy. Five questions: what chemical safety update means for public health. The Inquirer (Philadelphia). July 1, 2016 (accessed July 5, 2016)

Brattleboro Reformer. Our opinion: A slightly less toxic system to protect our health. June 23, 2016 (accessed July 4, 2016)

EPA: The Frank R. Lautenberg Chemical Safety for the 21st Century Act (accessed July 4, 2016)

EPA: Essential Principles for Reform of Chemicals Management Legislation (accessed July 4, 2016)

Environmental Defense Fund Blog: Historic deal on TSCA reform reached, setting stage for a new law after 40 years of waiting (May 23, 2016)

Environmental Defense Fund, Chemicals Policy Reform: A strong new chemical safety law (accessed July 4, 2016)

Environmental Working Group: Asbestos: Think Again: Asbestos Is Still Not Banned. March 4, 2004. (accessed July 12, 2016)

Environmental Working Group: Is TSCA Rewrite Better than Current Law? (accessed July 4, 2016)

Environmental Working Group blog: What Would It Take for the EPA to Test Every Major Chemical for Safety? (April 15, 2015, accessed July 4, 2016)

Grossman, Elizabeth. Reformed Chemical Safety Law Doesn’t Eliminate Need for Public Vigilance. Earth Island Journal. June 23, 2016 (accessed July 5, 2016)

Lowell Center for Sustainable Production, University of Massachusetts-Lowell. What Is Chemicals Policy? (accessed July 5, 2016)

Mapes, Lynda. Environmental groups criticize revisions to toxics-control act. Seattle Times. May 25, 2016. (accessed July 5, 2016)

Safer Chemicals, Healthy Families: An Abbreviated Guide to the Frank R. Lautenberg Chemical Safety for the 21st Century Act (accessed July 4, 2016)

Safer Chemicals, Healthy Families: Key Takeaways from the Passage of TSCA Reform (accessed July 4, 2016)

Physicians for Social Responsibility: TSCA Reform: What does it mean? (accessed July 4, 2016)

Wikipedia: Toxic Substances Control Act of 1976 (accessed July 12, 2016)

 

  • No labels