EPA’s Backlog Stalls Regulation and Enforcement of Nearly 255 Chemicals

The United States EPA’s Integrated Risk Information System (IRIS) has often been criticized for lacking transparency in their evaluation processes, allowing influence from other governmental agencies, and unexplained delays in producing assessments. The latest condemnation comes from a report published by the Center for Progressive Reform, a nonprofit organization, which chastises EPA for falling behind in completing statutory mandates for 255 chemicals. As an example of the incompleteness of IRIS, the report notes that EPA has not developed inhalation reference concentrations (RfCs) for approximately 77 known hazardous air pollutants.

This is not the first time that the problems with IRIS have been reported. In 2008, the Government Accountability Office (GAO) published a report detailing that despite EPA’s efforts, the backlog on chemical assessments have not diminished. In fact, the GAO implied that Office of Management and Budget requirement of interagency review would only further hamper the assessment process and limit IRIS’s credibility. Some of the GAO recommendations included clearly defining and documenting the IRIS process to minimize the need for revision, setting defined time-limits for interagency review, and conducting assessment with available studies and only suspending assessments to await completion of scientific studies in exceptional circumstances.

In addition, a review of the IRISTrack website demonstrated the validity of this criticism. For example, the acrylonitrile and benzo[a]pyrene assessments began in January and December 1998, respectively, and the finalized assessments are still pending. However, the assessment for chromium VI was initiated in November 2008 and is scheduled to be finalized in the third quarter of FY11. While the quick turnaround of the chromium VI assessment is unusual for IRIS, the majority of the ongoing assessments are scheduled to be finalized sometime during FY11, so, perhaps, this is an indication that the IRIS process is improving with the recent revisions.

In 2009, EPA Administrator Lisa Jackson announced reforms to the IRIS process including a streamlined review process so that assessments are available within two years of the start date. The reform involved reducing the timeframes for assessment and making the written comments from other governmental agencies public. These revisions allowed the EPA to regain a stronger control over the IRIS process, while still providing transparency and integrity.

While the recent reform of the IRIS process is a step in the right direction, there will still be long delays in producing assessments because EPA is hindered by a lack of toxicity data for many of the chemicals yet to be assessed. However, this may soon change with the upcoming TSCA revisions placing the burden on industry to conduct studies to fill in data gaps on their products and chemicals. Whether EPA is prepared to handle the influx of data from various industries on numerous chemicals that will emerge after the TSCA revisions are finalized is still a question to be answered. Once EPA begins receiving the industry data, there will be an initial struggle to review and manage the incoming information until EPA learns to adapt, which will undoubtedly result in further delays in the IRIS assessment process. How long the period of adjustment will last will depend on how well the IRIS program is managed.

TSCA Legislation: A Short Phrase With Huge Implications

Section 6 of the House TSCA modernization bill (H.R. 5820) requires U.S. EPA to develop a priority list of 300 chemicals and to make safety determinations regarding them. The bill also directs the agency to develop guidance for making such safety determinations and that “in developing such guidance, the Administrator shall rely upon the recommendations of the National Academy of Sciences report entitled ‘Science and Decisions.’"

This routine-sounding phrase is of potentially enormous significance to the way that risk assessment and chemical regulation is conducted in this country. The referenced document is a 2009 National Research Council report that made controversial recommendations on how dose-response curves should be formulated. The NRC committee that prepared the report wrote that:

Non-cancer effects do not necessarily have a threshold, or low-dose nonlinearity…. Scientific and risk-management considerations both support unification of cancer and non-cancer dose-response assessment approaches. (Summary, p. 8)

The idea of “linearity” –that an extrapolation of data points along the dose-response curve should pass through the intercept of the x and y axes—makes sense from a statistical standpoint. Indeed, statisticians were well represented on the committee.

However, linearity of non-cancer effects departs from decades of accepted understanding of biological mechanisms and how those shape dose/response. Through the processes of detoxification and cell-repair, organisms respond to lower levels of toxic exposure without adverse health effects.

This phenomenon gives rise to the concept of a threshold of effect. Naturally occurring levels of numerous toxicants provide evidence of the threshold effect at work. Without the ability to respond to these exposures with detoxification and repair, human life would have long ago been extinguished on this planet.

Determining such thresholds in laboratory animals, where it is termed a “no observed adverse effect level” (NOAEL), and translating it to comparable human equivalent dose levels --a “reference dose (RfD)--has become a frequent product of the work of regulatory agencies and non-governmental organizations across the globe.

It allows them to establish and enforce protective yet workable exposure limits for chemicals in food, consumer products, occupational settings, and environmental media such as remediated soil.

Discounting the existence of a threshold, what the committee calls “non-linearity,” would introduce both theoretical confusion into the field of risk assessment and also practical difficulties into the work of regulators. Linearity implies that each incremental increase in dose above zero can be expected to produce health effects. If moving from zero to one part-per-trillion of a particular chemical carries a statistically calculated, theoretical risk, does that obligate a regulatory agency to address that level of exposure?

This question is especially pertinent for statutory frameworks that lack other standard-setting criteria, such as technical feasibility or a balancing of costs and benefits. The National Ambient Air Quality Standards (NAAQS) provisions of the Clean Air Act, for example, require EPA to set allowable levels for particulate matter, ozone and other pollutants at a level sufficient to “protect human health and the environment, with an adequate margin of safety.” In such a context, the question arises whether the legally required level is “zero,” and if so, how does EPA—and American society—get to that level?

TSCA 2.0: Are Comparisons to Pesticide Regulation Instructive?

There is a widely-shared criticism of how new chemicals are regulated under TSCA. TSCA Section 5 requires a Pre-Manufacturing Notice (PMN) for both new chemicals and proposed new uses of chemicals already on the market. The PMN need not be accompanied by comprehensive health data on the compound, merely that information already in the possession of the applicant. This leaves industry without a strong incentive to compile a robust data set, and the resulting information gaps impair EPA’s ability to make informed judgments about the safety of a given chemical.

Both the House and Senate TSCA bills would substantially toughen PMN and review, requiring applicants to provide a "minimum data set" about the chemical and potential health and environmental impacts. Manufacturers and processers would for the first time have the responsibility of identifying or generating research needed to complete this data set or risk losing access to the marketplace.

Proponents of the bill argue that stringent data collection and review of new chemical products have been features of federal pesticide regulation for decades, and that this has not unduly burdened the crop protection industry or the agriculture sector. This analogy was made by Rep. Frank Pallone (D-NJ) at the July 29 subcommittee hearing on H.R. 5820.

The pre-market screening of pesticides under the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) and related statutes is undoubtedly stringent. Registrants must be prepared to provide studies on carcinogenic, neurological, developmental and reproductive effects, as well as information on fate and transport, persistence, and metabolic byproducts. Another essential element of the petition is an assessment of exposure to humans and other non-target organisms.

In light of these requirements, the agency itself acknowledges that “depending on the class of pesticide and the priority assigned to it, the review process can take several years.” Despite this, U.S. regulation of pesticides is generally viewed as a success, a point often made by those drawing comparisons to TSCA modernization.

But is this comparison apt? Pesticides present a relatively contained range of exposure scenarios, including exposed agricultural workers, contaminated groundwater, and pesticide residues on crops.

In contrast, the chemicals that would be governed by a revised TSCA present multiple routes of exposure, and the interaction of these various exposures must be modeled and aggregated to make meaningful decisions about chemical use. Further, a reworked TSCA is virtually certain to require modeling of exposures by vulnerable populations such as children and the elderly, something that is not required for pesticides.

The net result could be a registration process with a complexity that resembles REACH rather than FIFRA, one that will delay market access for some chemicals by years, and discourage others from being commercialized at all. Such an outcome might be tolerable for some mundane products and uses. But for components of lifesaving technologies such as medical devices and time-to-market critical products like smartphones, is our society prepared to accept such a delay?

New TSCA Inventory Update Reporting Rule Proposed

Agency Continues Pattern of Deploying Existing Authority

On August 11, 2010, EPA proposed changes to its TSCA Inventory Update Reporting (IUR) rule that would increase the frequency and standards for reporting by IUR- covered facilities. First promulgated in 1986, the IUR rule is designed to provide the agency with the volume of chemicals produced, imported or processed, along with basic information on how those chemicals are used. The goal is to inform agency prioritization and safety determinations for chemical substances, and (consistent with confidentiality restrictions) to release relevant data to the public.

The IUR rule was revised in 2003 and again in 2005 to expand the range of reportable chemicals and plant sites, broaden the type of data reported, and lower the production volume thresholds that trigger reporting. The pending changes continue that trajectory, increasing the frequency of reporting, requiring electronic reporting and decreasing the reporting threshold for facilities processing and using chemicals from 300,000 pounds to 25,000 pounds. The criteria for asserting confidential business information (CBI) would be further tightened, more specific information required on downstream commercial and consumer uses of chemicals produced.

This proposal fits squarely within a pattern of more deliberative assertion by the agency of its TSCA authority in recent years. The agency has expedited the collection and review of data for chemicals under voluntary programs such as the Voluntary Children’s Chemical Evaluation Program (VCCEP), the Chemical Assessment and Management Program (ChAMP), and the High Production Volume (HPV) Challenge Program. More recently, a series of “action plans” utilizing TSCA Section 6 and Section 5(b)(4) authority have directed scrutiny onto chemicals suspected of properties such as persistence, bioaccumulation and endocrine disruption.

Some have speculated that the Fall elections and other legislative priorities will hinder if not prevent TCSA modernization for several years. Nevertheless, what is clear is that EPA will continue to push for more comprehensive, precise and transparent chemicals management with a renewed insistence on industry responsibility for these data. Furthermore, administrative agencies and legislatures around the globe mirror these objectives. Some may view this as yet another regulator burden; however, we believe that this creates a unique opportunity for the most proactive industries and companies to gain a competitive advantage. Efforts to address EPA’s administrative demands can be structured to give companies a head start compiling an understanding of their chemical use, potential health effects, exposures, and product life cycle that a revised TSCA and its overseas counterparts will ultimately require. In the process, they will distinguish their firms as responsible and forward-looking in the eyes of regulators, customers, and consumer advocates.

Regulating Hazard or Risk - The Debate Continues

Another observation from the July 29th hearing was the extent to which debate over chemicals managment is circumscribed by the concept of hazard as opposed to risk. The witness testimony, as well as the question/answer exchanges, stressed the need to find “safer chemicals” to replace “toxic, persistent, and/or bioaccumulative chemicals” currently on the market.

However, as any first year toxicology student can attest, “the dose makes the poison.” A chemical demonstrating toxic properties in the laboratory can nonetheless be used with minimum risk provided that exposures are controlled. For example, most of us readily accept the presence of cadmium and other metals in auto batteries because the sealed battery housing, coupled with deposit and recycling programs, minimize the potential for human and environmental exposure.

It would be unfortunate if legislators miss a chance to significantly improve how we manufacture, distribute, use, and dispose of chemicals by continuing to focus on toxicity (in the abstract) as opposed to risk (in real-world context). This is one of a number of areas where a more informed embrace of scientific principles could benefit the final legislative product.

TSCA: Innovation Through Stronger Regulation?

The House Subcommittee on Commerce, Trade and Consumer Protection held a hearing on July 29, 2010 on H.R. 5820, recently-introduced legislation to revamp the Toxic Substances Control Act (TSCA). One recurring theme at the hearing was the contention that fuller information about chemicals and their potential health effects would encourage the development and commercialization of safer alternatives. It was suggested that this in turn would advance the innovation and competitiveness of U.S. chemical producers. In recent years, similar arguments have been made about the innovation and job-creation potential of carbon regulation and other environmental initiatives.

Let's not reflexively reject the notion that public policies can promote economic growth and competitiveness. Consider the Interstate Highway System. Is the nation’s economy healthier and its standard of living higher by virtue of the massive federal program to construct our network or highways, bridges, and roads? Economists across the political spectrum say “yes,” citing increased safety, workforce mobility, just-in-time delivery of industrial inputs, and the resulting growth of cities in the Sun Belt.

Turing our focus on chemicals policy, one can envision a regulatory framework that might help bring newer, safer products into the marketplace. It would require, on one hand, a fairly burdensome regimen of testing and reporting for existing chemicals (particularly those with indicia of hazard), and greater transparency into chemical formulations and other information now deemed proprietary. This would have to be coupled by more lenient treatment of new chemical formulations, including a comparatively expeditious path to market for those that are likely free of health and environmental concerns.

But is this type of framework embodied in H.R. 5820? Some proponents argue that it is. Dr. Richard Denison of the Environmental Defense Fund said at the hearing that the bill would allow “safer” chemicals to enter the market with less burdensome safety determinations. Stated that way, the argument appears internally inconsistent, because it is safety determinations that are chiefly relied upon to distinguish between good and bad chemical actors. Denison’s written testimony more explicitly defines what he means by “safer”: H.R. 5820 would allow new chemicals to enter the market without safety determinations if they are intrinsically low hazard, are safer for particular uses than chemicals already on the market, or serve critical uses.

What types of chemicals could be considered “intrinsically low hazard”? This category would include substances whose biological action is acknowledged to be benign and compounds with extremely low toxicity. However, most of the promising chemicals that have not yet been commercialized would fall outside of these relatively narrow classes. For these, structure-activity relationship (SAR) analysis would be needed to establish “intrinsically low hazard.” This type of analysis comes with its own complexities, and may not represent a significant decrease in burden as compared with traditional safety determinations. As such, it is not clear that chemicals in this category would benefit from an expedited route to market to the extent that the bill would promote innovation.

TSCA: Pre-Manufacture Notification and Review

TSCA reform promises to significantly alter the chemical marketplace. Contemplated changes will have a profound impact on all industries that manufacture, distribute, modify or utilize chemicals, articles or mixtures. Recognizing the magnitude of this potential impact, Science News & Views intends to provide substantive monitoring and analysis as the legislative process proceeds. Today, we will examine the current and proposed system of pre-manufacture notification and review of chemicals, a controversial aspect of the existing statute.

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Section 5 of existing TSCA prohibits the manufacture, processing, or import of a “new chemical substance” or “significant new use” of an existing substance unless a pre-manufacture notification (PMN) is submitted to EPA at least 90 days in advance.

Section 5 does not currently require a submitter to conduct testing before submitting a PMN, but merely to provide any information on health or environmental effects that are in its possession. During the 90-day review period, EPA is to utilize this and other information to determine whether the chemical “may present an unreasonable risk of injury to health or the environment,” and if so, to request more data, prohibit or limit manufacture, or halt the review process. In practice, the dearth of data accompanying submissions impairs the agency’s ability to make informed judgments about the safety of a given compound. Reform advocates cite this as a key weakness of the existing statute.

The proposed bills would toughen the Section 5 PMN and review process. Both the House and Senate would subject new chemicals and uses under Section 5 (as well as existing chemicals under Section 6) to the requirement of a “minimum data set.” This data set would consist of the chemical’s identity, physical characteristics, toxicological properties, hazard, exposure and use, along with other information that EPA establishes by rule. Indications are that the agency will require data on both traditional endpoints such as carcinogenesis and mutagenicity, and also emerging concerns such as bioaccumulation, environmental persistence and endocrine disruption.

The current presumption that a chemical is appropriate for the marketplace in the absence of an “unreasonable risk” or “insufficient data” finding will be inverted. Instead, a six-month to one-year review of the application will be triggered unless EPA affirmatively finds that the chemical is “reasonably anticipated” to meet safety standards.

Manufacturers and processers will have the responsibility of identifying or generating research needed to complete the data set for a new chemical or new chemical use, effectively shifting the “burden of proof” to them. They would also be responsible for updating data submissions to reflect new information. Both bills would give EPA the power to compel testing by administrative order and to specify appropriate methodologies. The House bill would allow the agency to to assess fines for non-compliance.

The PMN and minimum data set provisions will likely be the subject of debate and modification, particularly the timetables for implementation. Recent changes to chemical regulation in Europe help illustrate this point. The REACH law imposed similarly aggressive benchmarks for generation and submission of test data. This approach has proved to be impractical, time-consuming and expensive to implement.

Are we on a similar path with a new TSCA?

Clearly early engagement with legislators to help craft a smart and effective chemical regulation, one that protects human health and the environment in a cost-effective, rational manner, is critical.

TSCA Reform--Moving Forward

In a move which may signal growing momentum for chemical regulation reform, leaders of the House Energy & Commerce Committee introduced TSCA modernization legislation (H.R. 5820) and scheduled a subcommittee hearing for July 29, 2010. We will continue to provide monitoring and analysis of this bill and its Senate counterpart as they move through the legislative process.