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.

Gas Production Technique Under Scrutiny

Controversy Over Whether Drilling Fluids are Contaminating Groundwater

About 90 percent of natural gas wells now employ hydraulic fracturing, a technique in which sand and fluids are pumped into wells to open seams within rock formations so that they release more methane. This practice, commonly called “fracking,” has allowed for the production of gas from formations one to two miles deep, and is credited with more efficient development of gas reservoirs with fewer wells. It is also considered critical to economical production from

shale formations, such as the Marcellus Shale region in the Eastern U.S., which tend to feature low porosity rock.

In fracking operations, wells are completed to the desired depth and the bottom portions of the well casing are punctured with explosive charges, releasing pressurized water and sand into resulting fractures in the rock. The water contains an estimated one percent drilling fluids, primarily lubricants and surfactants. The precise formulations of these fluids are proprietary, but constituent chemicals may include benzene, zetaflow ® (whose composition is not publicly known) and 2-butoxyethenol (2-BE).

It is these drilling fluids that have aroused complaints from neighboring landowners and environmental advocates, who claim that they are polluting groundwater near gas wells. These parties cite odors, coloring and sediments observed in tap water, as well as isolated cases of illness. They also call for the identity of the fracking fluids to be revealed, without which linkages to water contaminants will be difficult to establish.

A 2004 EPA study on coalbed methane production concluded that it was unlikely to impact groundwater because water tables resided hundreds or thousands of feet above the fractured portions of wells. Some advocates of further study and regulation acknowledge this, but theorize that imperfections in well structures may be allowing fracking fluids up into the well shaft and from there onto the surface and the groundwater beneath.

Based in part on EPA’s work, Congress in 2005 exempted fracking fluids from the Safe Drinking Water Act, which requires the disclosure of chemicals potentially released into groundwater. Legislation proposed by Rep. Diana DeGette (D-CO) and Charles Schumer (D-NY) would revoke that exemption and thereby shed light on the compounds being used. These bills are supported by the Natural Resources Defense Council (NRDC) and other public interest groups.

EPA has announced another review of the issue, and has asked nine leading drillers to voluntarily provide the agency with the formulations of their fluids. A coalition of state water regulators is also promoting voluntary disclosure of fluid components, which it plans to post on a website for the benefit of researchers.

Bed Bugs and Pesticide Regulation

A piece from today's Washington Post highlights the phenomena of countervailing risks and unintended consequences so common to chemicals management. DDT is long-acting and effective against a broad spectrum of insects. It has relatively low human toxicity, but high environmental persistence, manifested most vividly in the fragile eggshells of species such as bald eagles and brown pelicans that led to its ban in the U.S. The ban was subsequently extended worldwide, which some contend contributed to the death of millions from malaria and other insect-borne diseases. This argument is advanced by Robert S. Desowitz in The Malaria Capers.

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.

Pairing Risk Management and Communication

We welcomed, along with the rest of the country, encouraging news about the installation of the latest containment cap on the Macondo well. This development may represent an important step in controlling the Gulf oil spill. Currently, pressure readings are being gathered to demonstrate the structural integrity of the well and crude reservoir, which would allow the cap to remain sealed. Alternatively, the dome is equipped to vent up to 80,000 barrels per day to surface ships, which would eliminate most if not all of oil discharges into the Gulf.

Efforts to contain the Macondo well fostered a constructive debate on the concepts of hazard and risk, and on the phenomenon of comparative risk. As millions of barrels of crude flowed into the Gulf during the Spring and early Summer, response authorities were faced with an emotionally-charged decision about the use of chemical dispersants to mitigate the ecological impacts. Dispersants are typically mixtures of solvents and other compounds designed to separate oil into smaller globules, which are more likely to be diluted to safer levels by currents and broken down by bacteria. The public and the media directed a great deal of focus on the chemical properties and toxicity of the dispersants, and whether they were making an environmental tragedy worse. An estimated 800,000 gallons of dispersants had been employed by June, both on the surface and around the leaking wellhead and riser pipe.

The principal dispersant used in the Gulf has been several versions of Corexit ®, a product of Nalco Holding Company. These reportedly contain 2-butoxyethanol and a proprietary organic sulfonate, along with low levels of propylene glycol. On May 19, EPA directed BP to deploy less toxic alternatives, or to justify its choice of Corexit over those products. BP cited an inadequate supply of most alternatives, and noted toxicological concerns about a more widely available dispersant. That chemical, marketed by Alabaster Corporation as Sea Brat 4 was itself less toxic than Corexit, but BP noted the risk that it could degrade into nonylphenol, which is environmentally persistent and toxic to some marine life.

Based on this information, on May 26 EPA approved the continued use of Corexit, but directed responders to significantly decrease the overall volume used and to cease use of dispersant on the surface whenever mechanical controls such as booms and skimmers could be relied upon. EPA also began its own testing of eight dispersants on native shrimp and fish species. Initial peer reviewed results announced in July indicated that neither Corexit nor the alternative products studied displayed biologically significant endocrine disruption.

The Agency’s approach to dispersants, the assessment of their hazard, and the risk-benefit analysis of their continued use demonstrate the value of sound, risk-based decision-making. Unfortunately, this thoughtful and deliberative process was overshadowed by an ineffective communications plan which failed to reassure the media and public as to the need for dispersants. In general, the inherent toxicity of these chemicals is far outstripped by crude oil. And yet the Agency, in their most recent press briefing, devoted more time and effort explaining the toxicity testing performed on the dispersants and less on the known toxicity of oil and the ecological devastation which its unfettered spread would visit on the region’s estuaries and beaches.

In our experience, risk management is never as effective as when it is coupled with a sound communications plan. Going forward, one would hope that the Agency improve their ability to articulate the risks and benefits associated with their decision-making so that concern over the response to a problem does not hinder action against the primary threat.