Posted on January 29, 2021 by Ronald R. Janke

In the twilight of the Trump Administration, the Environmental Protection Agency issued an internal procedural rule entitled “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”  The rule which is focused on EPA’s consideration of dose-response data, is widely predicted to have a limited shelf life.  Congressional veto under the Congressional Review Act; EPA reconsideration, revocation and amendment or successful court challenges in already pending litigation can be anticipated.  Nevertheless, the goals enunciated in the rule are worth pursuing, as they point the way to better EPA decision-making through greater science transparency.  As the references cited and listed in the preamble reflect, the call for greater science transparency pre-dates the Trump Administration and extends well beyond EPA and the federal government.

The rule establishes how EPA will consider dose-response data that are crucial to decisions in issuing significant regulatory actions and influential scientific information, such as Integrated Risk Information System (IRIS) profiles, which characterize hazards from chemical exposures.  The most vehement and widely-cited criticism of the rule is that it will prevent EPA from considering important dose-response studies because they cannot be made publicly available or submitted for independent validation due to  privacy considerations preventing human health data from being shared.  In the rulemaking, EPA responds to this concern initially by stating that all relevant scientific studies are in the scope of its review.

The rule identifies nine non-exclusive factors EPA will  take into account when evaluating the consideration to afford studies with underlying dose-response data unavailable for independent validation.  EPA’s rule calls for giving “greater consideration to pivotal science where the underlying dose-response data are publicly available in a manner sufficient for independent validation.”  The preamble notes that if based on these factors two studies are “relatively equal,” both may be considered; but “other things being equal” greater consideration should be given to the one whose underlying data and models are publicly available and can be independently validated.  Even this requirement is flexible in that the rule authorizes the EPA Administrator to grant on a case-by-case basis an exemption from any part of the rule if any of five listed circumstances exists.  Furthermore, the rule requires EPA, whenever it does make available to the public dose-response data, to do so in accordance with legal protections on privacy, confidentiality and confidential business information and with a sensitivity to national security. Lastly, human health privacy concerns are irrelevant to a vast quantity of non-human dose-response data, such as animal feeding or aquatic toxicity studies, on which EPA bases IRIS toxicological profiles, water quality criteria and standards, drinking water standards and other decisions.         

While the rule may encourage the public sharing of data by researchers, the rule does not necessarily result in disclosure of dose-response data to the public.  The rule requires EPA to ‘identify the science that serves as the basis for informing a significant regulatory action and to make it “publicly available to the extent permitted by law.” However, as EPA notes in the preamble, “the rule does not obligate it to “collect, store or publicly disseminate dose-response data underlying pivotal science.”   

Making scientific data publicly available lies at the core of the science transparency movement, and it is unfortunate the rule does not do more to make data publicly available.  To a large degree, EPA has not analyzed data when issuing rules and influential scientific information.  Rather, it relies on studies by researchers who summarize their methodology, data and analysis and who present their conclusions.  Published, peer-reviewed studies are regarded as the gold standard, but a peer-reviewed study is not necessarily pure gold.  Researchers rarely submit the underlying data with their manuscripts and these data are not seen by peer reviewers. 

As the preamble notes, “Peer review does not typically include reanalysis of the underlying data . . . and thus peer review is not considered a replacement for the data availability requirements of this rule.”    Moreover, as good as peer review may be, something more can be gained when any interested person can review data, replicate the researcher’s analysis or conduct additional analysis.  This process may lead to greater confidence in the researcher’s own conclusions, produce additional findings or present a new hypothesis and additional research.  Especially where data are generated with EPA’s funds, EPA should make data publicly available.  Other federal and state research-funding agencies should do the same in the ordinary course.  “Data,” according to Lawrence Summers, former Secretary of the Treasury and president of Harvard University, “is the ultimate public good.”  If the public paid for the data, they should be able to see it when a public agency uses it. 

TSCA Implementation: A Catalyst for Litigation

Posted on May 22, 2018 by Lynn L. Bergeson

Extensive revisions to the Toxic Substances Control Act (TSCA) were signed into law almost two years ago and the U.S. Environmental Protection Agency (EPA) has been extraordinarily busy implementing the many Congressional mandates set out under the law that amended it, the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The new law was one of the last acts of Congressional bipartisanship and, given the rancor that is now rooted in our hyper-partisan Congress, agreement on environmental legislation this sweeping is not expected again anytime soon.

Unsurprisingly, the three core rules outlining critically important aspects of the revised law, referred to as the TSCA “framework rules,” have all been judicially challenged.  In August 2017, Safer Chemicals, Healthy Families and 11 other organizations sued EPA in the U.S. Court of Appeals for the Ninth Circuit challenging the Risk Prioritization and the Risk Evaluation final rules.  Other organizations similarly filed suit over the same rules in the Second Circuit (Environmental Defense Fund (EDF) in New York) and in the Fourth Circuit (Alliance of Nurses for Healthy Environments in Virginia).  The challenges to the Risk Prioritization rule were consolidated in the Ninth Circuit on November 27, 2017 (Safer Chemicals, Healthy Families v. EPA, Nos. 17-72260, et al.) and the challenges to the Risk Evaluation rule were consolidated in the Ninth Circuit on December 11, 2017 (Alliance of Nurses for Healthy Environments v. EPA, Nos. 17-73290, et al.).  Industry trade association and other chemical interests motioned to intervene in these challenges, which the Ninth Circuit granted.  The remaining framework rule, the Inventory Notification rule, was judicially challenged by EDF last September in the U.S. Court of Appeals for the D.C. Circuit (EDF v. EPA, No. 17-1201).  Industry trade groups and others have been granted leave to intervene in the case.

Of particular note is another challenge filed on January 5, 2018, by the Natural Resources Defense Council (NRDC) in the U.S. Court of Appeals for the Second Circuit (Second Circuit) of what it characterized as an EPA “final rule” that was released on November 7, 2017, titled “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  The draft Framework Document, as it has come to be called, is the final rule at issue and was posted in EPA’s docket opened for comments related to its two TSCA public meetings that took place last December.  It is reasonable to assume that the Framework Document is decidedly not referred to by EPA as a final rule and was not published in the Federal Register as a final rule because EPA believes it is a document that outlines a “conceptual approach” to how EPA may go about making decisions on new chemicals.  The document appears in the “supporting & related material” section of the meeting notice.  EPA specifically states that the document, referred to as a “draft” in the Federal Register notice that announced the two public meetings, “outlines EPA’s approach to making decisions on new chemical notices submitted to EPA under TSCA section 5, as amended,” and includes EPA’s “general decision framework for new chemicals” and a breakdown of how EPA “intends to approach each of the five types of new-chemical determinations required under the statute.”

NRDC’s opening brief was submitted on May 1, 2018.  It is an excellent read on the topic of why NRDC believes the draft Framework Document is actually a final rule in disguise that EPA implemented without the requisite process required under the Administrative Procedure Act.

The law suit raises novel and interesting procedural issues.  Is the draft Framework Document a final, reviewable rule amenable to judicial appeal as final agency action?  If the Court chooses to address the substantive TSCA issues, a key one relates to how EPA interprets “not likely to present an unreasonable risk” in reviewing TSCA Section 5 new chemical notifications, and what exactly Congress meant by “the circumstances … under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”  Is EPA misapplying the new language in Section 5 that NRDC claims is mandatory, or is EPA properly exercising its authority under Section 5 in identifying conditions of use as outlined in the Framework Document in conducting its Section 5 reviews?

These are hard questions and much depends on their outcome.  For TSCA new chemical aficionados, understanding “conditions of use” is the Holy Grail, and any judicial gloss a reviewing court offers is expected to have a profound impact on how EPA reviews new chemicals and, thus, how and when new chemicals will be commercialized in the U.S.

Finally! OSHA Revises Hazard Communication Standard

Posted on April 11, 2012 by Earl Phillips

OSHA recently announced its final rule final rule revising the Hazard Communication Standard (HCS). Originally promulgated in 1983, the HCS is based on workers' "right to know" about the hazards they face in the workplace. The intent of the revised HCS is to clarify the information provided to workers, based on an employee's "right to understand" workplace hazards. Click to view OSHA's press release, "US Department of Labor's OSHA revises Hazard Communication Standard: Regulation protects workers from dangerous chemicals, helps American businesses compete worldwide."

The revised HCS reflects the United Nations' Globally Harmonized System of Classification and Labeling of Chemicals (GHCS), which was negotiated by a variety of stakeholders around the world. Because American workers may use chemicals made abroad (and workers abroad may use US-produced chemicals), a consistent labeling standard around the world will enhance worker safety by making labels easier for everyone to understand.

The revised HCS makes three primary changes from the current standard:

Hazard Classification
Chemical producers and importers still bear the responsibility for classifying hazards presented by chemicals. The revised HCS provides detailed criteria for classifying the type and severity of hazard presented. The intent of the new information on hazard class and severity category is to efficiently provide guidance on the appropriate response to exposure.

Chemical Labels
The new rule requires a standardized label design that includes the use of pictograms, shown on the Hazard Communication Standard Pictogram Quick Card, which depict the type of hazard presented. Labels are also required to include a "signal word" ("danger" for more severe hazards and "warning" for less severe hazards) and a precautionary statement suggesting safety measures. A sample Hazard Communication Standard Label is available on the OSHA website. 

Safety Data Sheets
OSHA will now require a standardized 16-section format for Safety Data Sheets (SDSs), formerly known as Material Safety Data Sheets or MSDSs. This is expected to enhance ease of use, especially in an emergency, by ensuring that key information (for example, spill response procedures) can be quickly found within the document. The new SDS format is shown on the OSHA website. 

Chemical producers and importers are required to implement the revised label and SDS formats in 2015. As the GHSC labels are phased in around the world, American workers may start to receive labels and SDSs in the new format before the labeling rule goes into effect in the US. Therefore, to ensure that employees understand the new labels, OSHA requires US employers to train employees on the new label elements and SDS format by December 1, 2013.


Posted on March 2, 2012 by Michael Hardy

Attorneys, environmental professionals and regulators understand the importance of the Integrated Risk Information System, known as IRIS.  In rule-making, permitting, or remediation, the IRIS provides the EPA’s assessment of the health effects possibly resulting from exposure to chemicals in the environment.  Whether trying to determine the hazard index, reference dose, cancer slope factor, or other critical toxicological end-point, the IRIS assessment of a specific chemical constitutes an important first step.  Currently, the EPA has completed risk assessments of approximately 550 chemicals  in the IRIS, and reports that another 55 are on-going. 

But there have been numerous, long standing and wide-ranging criticisms of the IRIS process.  For example, the National Academy of Sciences criticized the EPA’s IRIS assessment for formaldehyde because it failed to explain its criteria for: identifying epidemiologic and experimental evidence, assessing the weight of the evidence, and characterizing uncertainty and variability. The NAS noted that these criticisms applied with equal force to other IRIS chemical  assessments as well.

More recently, in December, 2011, the U.S. Government Accountability Office issued a report to a House subcommittee crediting EPA for making some improvements in the process since earlier criticisms by the GAO in 2008, but noting recurring and new issues remain.  The GAO previously noted the IRIS data base faced a serious risk of becoming obsolete because EPA could not keep pace with the pace of needed assessments.  Even now, the GAO reported, the IRIS continues to suffer from problems with timeliness and productivity and “issues of clarity and transparency.”  The GAO called on EPA to develop a better system to apprise stakeholders of the status of IRIS assessments.  As an example, the GAO suggested a minimum of a two year notice of intent to assess a specific chemical, coupled with annual Federal Register reports on the status of on-going and proposed assessments.

To improve the credibility of the risk assessments, the GAO recommended the agency heed the recommendations of the National Academies.  The National Academies proposed improvements such as standardized approaches to evaluate and describe study strengths and weaknesses and the weight of the evidence.  Additionally, to restore scientific and technical credibility, the National Academies suggested the agency should involve independent expertise like the EPA’s Board of Scientific Counselors.

The GAO reports EPA has been receptive to its constructive criticisms and suggestions.  But the GAO and the trade press observe it is unclear how the EPA will actually implement the various suggestions from the GAO and the regulated community.

California Revives Its “Green Chemistry” Initiative

Posted on January 10, 2012 by Robert Falk

After a failed attempt at the end of the Schwarzenegger Administration, under current Governor Jerry Brown, California is now pushing forward with its new “green chemistry” approach to the regulation of chemicals in consumer products.  These regulations are likely to be formally unveiled early this year and will require extensive risk and life cycle analyses for prioritized products, which are likely to initially include children’s products, personal care products, and household cleaning products. 

The Envisioned Process
The revised California green chemistry regulations will establish a four-step process to identify safer consumer product alternatives.

1.  Chemicals:  The State will publish an initial list of Chemicals of Concern (COCs), likely involving close to 3,000 substances. 
2.  Priority Products:  Next, it will develop a list of Priority Products based on its evaluation of products that contain the identified COCs, as well as the distribution, use, and disposal patterns.
3.  Business Duty to Notify and Evaluate:  Responsible entities will be required to notify the State when their product is listed as a Priority Product and to perform an Alternatives Assessment. 
4.  Product/Chemical Limits/Regulations:  California will identify and impose a “Regulatory Response” to limit potential adverse public health and environmental impacts.

As drafted, the regulations will eventually apply to all consumer products containing a COC that are sold, offered for sale, supplied, distributed, or manufactured in California.  There are limited exemptions for:

•    Products exempted by law (specified medical and dental devices, “dangerous” prescription drugs, food, and pesticides) and products used solely to manufacture a product exempted by law;
•    Products manufactured, stored in, or transported through, California, solely for out-of-state use; and
•    Products regulated by other federal or California state regulatory programs or international trade agreements, where the program or agreement provides an equivalent or greater level of protection of public health and the environment than would be provided if the product were listed as a Priority Product (no examples are specified, but EU programs seem likely candidates).

There are de minimis exemptions for products with COCs at concentrations equal to:

•    0.01% by weight for chemicals exhibiting one of nine specified hazard traits (carcinogenicity, developmental toxicity, reproductive toxicity, endocrine toxicity, genotoxicity, immunotoxicity, neurotoxicity, bioaccumulation, or environmental persistence);
•    0.1% by weight for chemicals that do not exhibit any of the nine specified hazard traits and environmental and toxicological endpoints; or
•    A lower or higher concentration if specified by DTSC in the Priority Products list.

The regulations apply to any “responsible entity,” which includes the manufacturer, or, if the manufacturer does not comply, the importer or retailer. 

Alternatives Assessment
This assessment remains at the heart of the Green Chemistry regulations.  Each must be conducted in two stages, with a report sent to State regulators at the end of each stage.

Necessity/Identification of Alternatives:  In the first stage, product criteria are identified (e.g., by function, performance, technical, and legal requirements).  A statement must be provided on whether the COC or a substitute chemical is necessary to meet the product’s requirements.  Next, alternatives to the usage of the COC must be identified and screened, and a work plan proposed for the second stage.   
Detailed Assessment of Alternatives:  The second stage requires a more detailed assessment of alternatives.  The product and each alternative must be evaluated with respect to relevant factors and associated exposure pathways and life cycle segments.  At this stage, the responsible entity selects an alternative that will replace or modify the Priority Product or decides not to modify the Priority Product (or discontinue the distribution of the product in California). 

Regulatory Responses
At a minimum, product information will be required to be provided to consumers if a Priority Product contains a COC above the de mimimis level. Additional possible regulatory responses include mandating implementation of engineered safety measures designed to control access or limit exposure to the COC in a Priority Product and, at the extreme, a potential prohibition on sale of the Priority Product within California. 

With reform of the Toxic Substances Control Act stalled in Congress, Governor Brown’s Administration appears more determined than its predecessor to take the lead in product stewardship and chemical regulation through California’s so-called “green chemistry” initiative.