By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2020, that the Integrated Risk Information System (IRIS) Program released the ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) for public comment. EPA states that the IRIS Handbook provides operating procedures for developing IRIS assessments, including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values. The IRIS Handbook notes that it does not supersede existing EPA guidance and does not serve as guidance for other EPA programs. EPA will publish a Federal Register notice announcing the beginning of a 90-day public comment period on the IRIS Handbook and on the draft charge questions for reviewers in advance of a National Academies of Sciences, Engineering, and Medicine (NASEM) peer review. EPA will summarize comments received and provide them to the committee conducting the peer review. EPA has posted a pre-publication version of the Federal Register notice.
By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
On March 27, 2019, the House Science, Space, and Technology Subcommittee on Investigations and Oversight and Subcommittee on Environment held a hearing on “EPA’s IRIS Program: Reviewing its Progress and Roadblocks Ahead.” The hearing focused on issues with the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program, as described in two recent reports issued by the U.S. Government Accountability Office (GAO), Chemical Assessments: Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act (Chemical Assessments Report) and High-Risk Series: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas (High-Risk Report). Please see our full memorandum for more information on what transpired at the hearing, including some background and commentary.
By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
GAO released on March 6, 2019, a report entitled High-Risk Series: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas. GAO’s high-risk program identifies government operations with vulnerabilities to fraud, waste, abuse, and mismanagement, or in need of transformation to address economy, efficiency, or effectiveness challenges. GAO’s report describes the status of high-risk areas and outlines actions necessary to assure further progress. GAO states that in the two years since its last high-risk report, three areas, including “Transforming EPA’s Process for Assessing and Controlling Toxic Chemicals,” have regressed in their ratings against GAO’s criteria for removal from the High-Risk List. GAO notes that since adding this area to its High-Risk List in 2009, it has made 12 recommendations to EPA related to the IRIS Program and TSCA. According to GAO, while EPA has taken steps to manage chemicals that pose risks to human health and the environment, leadership and implementation challenges remain. More information is available in B&C’s March 8, 2019, memorandum, “EPA’s Process for Assessing and Controlling Toxic Chemicals Remains on GAO’s High-Risk List.”
By Lynn L. Bergeson, Charles M. Auer, Oscar Hernandez, Ph.D., Richard E. Engler, Ph.D., and Carla N. Hutton
On March 4, 2019, the U.S. Government Accountability Office (GAO) published a report titled Chemical Assessments: Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act. The report describes the extent to which the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has demonstrated progress implementing the Toxic Substances Control Act (TSCA). GAO reviewed documents from the National Academy of Sciences (NAS) and EPA and interviewed EPA officials and representatives from two environmental and two industry stakeholder organizations. GAO found that while EPA made improvements in the IRIS Program, between June and December 2018, EPA leadership directed the Program to stop the assessment process during discussions about program priorities. GAO states that while EPA has responded to initial statutory deadlines in TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), challenges remain. Read the full memorandum for more information on the report including why GAO did the study, GAO’s findings, and an insightful commentary.
By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Oscar Hernandez, Ph.D.
The U.S. Environmental Protection Agency’s (EPA) release of its Toxic Substances Control Act (TSCA) Section 5(a)(3)(C) determination for P-16-0510 represents a significant step in EPA’s implementation of the New Chemicals Program under new TSCA. The substance is a polymer (a copolymer of ethylene glycol and propylene glycol end-capped with acrylamide groups). It is intended to be used as a deodorizer in a variety of products, including floor cleaners, cat litter, fabric freshener sprays, and other consumer products.
Notably, EPA’s determination document specifies the conditions of use that are intended, known, and reasonably foreseen. EPA states that there are no known or reasonably foreseen conditions of use other than those intended by the submitter. This may appear to be a controversial statement. Based on EPA’s interpretation of “conditions of use,” it would not pass legal muster to speculate that “anybody could manufacture or use it for anything” and, hence, impose use restrictions to prevent purely speculative applications with no basis in fact or reality. EPA has repeatedly stated that it would base what is reasonably foreseen on information, knowledge, or experience, not on any conceivable condition of use.
EPA identifies the new chemical’s potential health hazard endpoints based on the acrylate/acrylamide category. The concerns are based on acrylamide itself and some low molecular acrylamide analogs and include mutagenicity, developmental toxicity, reproductive effects, neurotoxicity, and a “marginal potential” for oncogenicity. This too may sound alarming. The real question, however, is how toxic is the new chemical and are exposures expected to exceed a “safe” level.
In this case, EPA specifically considers the low-molecular weight (LMW) components of the polymer (i.e., the “worst case”) in its assessment and identifies two analogs of the LMW components. Both analogs have similar structural features (they are end-capped with acrylates), so both are expected to share the same mode of action, and have similar molecular weights as the LMW components of the premanufacture notification (PMN) substance. EPA states that it also considered the toxicity of acrylamide in its assessment. We note, however, that acrylamide is not a good analog because it is substantially lower molecular weight than the LMW components of the PMN substance. Based on the identified analogs, EPA set a no observable adverse effect level (NOAEL) of 250 mg/kg/day for systemic toxicity based on a combined repeat dose/reproductive/developmental toxicity screening test (OECD 422). This study tests for a chemical’s potential to cause toxicity and the primary endpoints of concern relevant to the category (developmental, reproductive, and neurotoxicity). This NOAEL would put the substance in the low-to-moderate toxicity category. Note that despite the nominally alarming set of health endpoints identified in EPA’s category assessment, the 422 study shows the analog is not especially toxic to mammals. By way of contrast, EPA’s most recent Integrated Risk Information System (IRIS) assessment of acrylamide identified a NOAEL of 0.5 mg/kg-day.
EPA also identifies ecotoxicity concerns. Using its predictive models, EPA predicts toxicity levels for both acute and chronic effects to aquatic species and sets concentrations of concern (CoC) at 425 ppb for acute exposures and 43 ppb for chronic exposures. These levels put the substance in the “moderate” category for environmental hazard.
EPA then applies exposure modeling to predict exposures to workers, the general population, and consumers. EPA found that predicted exposures are sufficiently below EPA’s concern level to not present an unreasonable risk to workers, the general population, or consumers. EPA even found that at the “worst case” of 100 percent PMN substance, exposures would still be sufficiently below EPA’s concern level. EPA also evaluated surface water concentrations and found that the estimated maximum acute and chronic concentrations did not exceed the CoCs.
EPA reviewed the PMN, reviewed likely and potential exposures to workers, the general population, consumers, and aquatic species, and did not identify any foreseeable conditions of use that would lead EPA to predict that unreasonable risk was likely.
This is a marked and welcomed departure from previous TSCA Section 5(a)(3)(C) decisions. In nearly all cases in the past, EPA only made a not likely determination if it identified a low hazard for both health and ecological effects (“low/low” cases). Absent a low/low finding, EPA seemingly believed that there could be some conditions of use that could contribute exposures that could exceed EPA’s concern levels. Based on our review, EPA did not explain how it differentiated between “any possible/foreseeable” and “reasonably foreseeable” conditions of use. Instead, if EPA could imagine a set of circumstances that could elicit an exceedance, EPA was of the view that new TSCA precluded it from making a Section 5(a)(3)(C) finding. (While some stakeholders might applaud an approach based on concepts such as the European Union’s Precautionary Principle, this is not how new TSCA, or U.S. environmental legislation more generally, is structured.)
In the case of P-16-0510, EPA more carefully applied new TSCA as written when it identified a low/moderate health concern and a moderate eco concern, and nevertheless took a reasonable approach grounded on the law to go beyond mere consideration of potential hazard and to interpret the “reasonably foreseen” conditions of use and assess unreasonable risk as new TSCA requires. We support this more measured approach and believe it better meets the statutory intent and requirements. As we have written previously, in our view, a “not likely” finding is not limited to cases in which toxicity is so low that exceedances are unimaginable. Rather, EPA must limit its consideration to those conditions of use that are reasonably likely to occur and must evaluate unreasonable risks, not merely hazard, and regulate to protect to the “extent necessary” to protect against such unreasonable risks.
We applaud EPA’s more measured approach that likely indicates a maturation of its understanding of what is needed to meet a not likely determination. We urge EPA to articulate its thinking on what is and is not “reasonably foreseeable” and what PMN submitters can do to help EPA understand not only what is intended, but what might be reasonably foreseen to occur.
By Lynn L. Bergeson and Carla N. Hutton
The National Academies of Sciences, Engineering, and Medicine released a new report on April 11, 2018, that finds that the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has made “substantial progress” in implementing recommendations outlined by the National Academies in previous reports. According to the April 11, 2018, press release, the transformation of IRIS began several years ago, after the release of a 2011 National Academies report that provided suggestions for creating a more systematic and transparent IRIS process. In a 2014 report, the National Academies reviewed the changes implemented by EPA since 2011 and concluded that the improvements were considerable. Under the Program’s new leadership, EPA asked the National Academies to review again its progress toward addressing past recommendations. The press release states that the National Academies’ latest review, Progress Toward Transforming the Integrated Risk Information System (IRIS) Program, finds that the IRIS Program has made substantial progress in incorporating systematic-review methods into its process and assessments. The IRIS Program has also established a systematic-review working group and engaged subject-matter experts. According to the report, these groups should increase efficiency and consistency among assessments and improve the scientific rigor of the assessments. Although the National Academies Committee to Review Advances Made to the IRIS Process “offers some refinements and identifies a few possibilities for further development,” the report states that “its overall conclusion is that EPA has been responsive and has made substantial progress in implementing National Academies[’] recommendations.”
By Lynn L. Bergeson and Carla N. Hutton
On September 6, 2017, at 10:00 a.m. (EDT), the House Science, Space, and Technology Subcommittees on Environment and on Oversight will hold a joint hearing on “Examining the Scientific and Operational Integrity of EPA’s IRIS Program.” The following witnesses are scheduled to testify:
- Dr. Kenneth Mundt, Principal, Ramboll Environ;
- Dr. James Bus, Senior Managing Scientist, Exponent; and
- Dr. Thomas Burke, former Deputy Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) and EPA’s Science Advisor under former President Obama; Johns Hopkins University.
President Trump’s proposed budget request for fiscal year 2018 would have eliminated EPA’s Integrated Risk Information System (IRIS) Program, although the IRIS Program is included in the final budget request. The EPA Science Advisory Board’s (SAB) August 29-30, 2017, meeting included an update from ORD’s National Center for Environmental Assessment on the IRIS Program. According to the presentation, IRIS is working to increase transparency and full implementation of systematic review; modernize the IRIS Program; modularize product lines; and enhance accessibility. Other IRIS improvements include implementing “next generation IRIS” and improved management practices. During the meeting, the SAB agreed to send a letter to EPA Administrator Scott Pruitt in support of the IRIS Program.
By Christopher R. Bryant, Lynn L. Bergeson, and Margaret R. Graham
Facing a government shutdown, late on April 30, 2017, lawmakers reached agreement on a spending bill that funds the federal government through September 2017, which is the end of Fiscal Year (FY) 2017.
President Trump’s budget blueprint sought to slash EPA’s coffers by some 31 percent (and more if certain programs were eliminated from the base). The deal reached by lawmakers, however, would essentially fund EPA at its current levels and retain current staff levels. The bill appropriates $8.058 billion for EPA, paring a little over $80 million -- about one percent -- from EPA’s FY 2016 budget.
Programs targeted for elimination by President Trump remain funded, at least through September, when Congress will face another budget showdown. For example, the bill funds the Great Lakes Restoration Initiative, the Chesapeake Bay Program, and lead elimination programs.
While EPA’s budget is generally unchanged, the bill does contain several policy riders. It would require EPA to treat air emissions from forest biomass as carbon neutral. EPA also would not be allowed to regulate manure and similar agricultural byproducts as wastes under the Resource Conservation and Recovery Act (RCRA), and the bill would bar EPA from requiring Clean Water Act (CWA) permits for certain agricultural practices. The legislation also prohibits funding to regulate lead content of ammunition, ammunition components, and fishing tackle under the Toxic Substances Control Act (TSCA) or any other law.
Senate Report No. 114-281 on the pending FY 2017 budget deal and an accompanying explanatory statement also address specifically TSCA, the Integrated Risk Information System (IRIS), and nanomaterials. The specific language is below.
- Toxic Substances Control Act Modernization -- The Committee notes that legislation to modernize the Toxic Substances Control Act [TSCA] was recently approved by both the Senate and the House of Representatives. This bill includes language that will enable the EPA to collect and spend new fees to conduct additional chemical reviews, consistent with TSCA modernization legislation. Those fees are expected to be $25,000,000 per year once the program is fully implemented. The Congressional Budget Office estimates that in fiscal year 2017, fee collections will begin several months after the beginning of the fiscal year and will total $4,000,000. This bill also includes language ensuring that new fee collections will supplement, not supplant, appropriated resources for these activities.
- Integrated Risk Information System -- The Committee is aware of efforts by the Agency to implement the 2011 National Academy of Science’s [NAS] Chapter 7 and 2014 NAS report recommendations for the Integrated Risk Information System [IRIS] but remains concerned that the recommendations have not been fully implemented. In published appendices that accompany final IRIS assessments, EPA has detailed some of the Agency’s deficiencies in meeting the NAS high-priority reforms. The Committee directs the Agency to convene an interagency working group to be Co-Chaired with the Office of Information and Regulatory Affairs and to include relevant executive branch stakeholders to review compliance with the NAS recommendations in IRIS assessments issued since the 2014 NAS report. The working group shall focus specifically on transition from the use of single point estimates of hazard and exposure to presenting more complete information on the distribution of estimated hazards, exposures, and/or risks, including central tendency values; on processes for evaluating study quality, relevance, and risk of bias; the use of a transparent and reproducible weight-of-evidence process for applying scientific findings; the selection of an adverse outcome; and the use of default linear low-dose extrapolation and other default modeling approaches to hazard determinations. The Committee directs the Agency to issue a report to the Committees of Appropriations of the House and Senate on the findings of the working group and the implementation plans of its findings within 180 days of enactment of this act. The working group report shall also include a timetable for EPA’s full implementation of the NAS recommendations for all IRIS assessments issued since the 2014 NAS report.
- Nanomaterials Research -- The Committee notes the increased capabilities that the Food and Drug Administration [FDA] has developed to study environment, health, and safety of nanomaterials [nanoEHS] within FDA’s Jefferson Laboratory Campus, including the National Center for Toxicological Research, and its consolidated headquarters at White Oak, Maryland. The FDA can and should be more involved in nanoEHS research with other agencies, particularly in activities involving human health. Out of the amounts appropriated, the [EPA} Administrator shall seek to involve the FDA in nanoEHS research to the maximum extent possible, including participation in EPA funded research.
By Christopher R. Bryant and Lynn L. Bergeson
According to press reports, Nancy Beck, Ph.D., DABT has been hired as the Principal Deputy Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). Dr. Beck holds a doctorate in environmental health from the University of Washington. For the past five years she served as the Senior Director for Regulatory Science Policy at the American Chemistry Council (ACC). For a decade prior to ACC, she was an analyst within the White House’s Office of Management and Budget (OMB).
Despite Dr. Beck’s compelling credentials, the appointment has displeased some stakeholders. Dr. Beck has been a staunch critic of how EPA conducts chemical risk assessments and its Integrated Risk Information System (IRIS). President Trump is proposing to eliminate IRIS; it thus is unlikely that Dr. Beck would revive or rely upon it in implementing the recently revised Toxic Substances Control Act (TSCA). Less than two months ago, Dr. Beck provided testimony before the Senate Homeland Security and Government Affairs Subcommittee on Regulatory Affairs and Federal Management calling for changes to EPA’s risk assessment processes.