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.

California "Safer Consumer Product Alternatives" Regulation Continues Trend Towards Greater Chemical Scrutiny

California is known for setting trends in this country related to music and entertainment. But it also serves as a bellwether for environmental regulation. This pattern may be continuing with the Safer Consumer Product Alternatives (SCPA) regulation, a measure under development by the California Department of Toxic Substances Control (DTSC) as part of the state’s Green Chemistry Initiative.

The SCPA, which does not require approval by the legislature, will direct state regulators to establish a priority list of chemicals of concern, and a corresponding list of products containing those chemicals. Businesses selling into the state—including manufacturers, distributors, retailers and licensees—will need to:

• Provide regulators with the name and contact info for all participants in the product’s supply chain;

• Conduct a life-cycle analysis of the product’s human health and environmental impacts, considering raw materials sourcing, manufacturing, transportation and disposal/recycling;

• Prepare a similar analysis of substitute chemicals, along with a proposal to redesign the product to reduce concentrations of chemicals of concern in favor of safer alternatives.

The process of establishing the priority chemicals and priority products list will consume the next three years, and compliance obligations under the regulation will commence in December 2013. A parallel proposal by Cal/EPA’s Office of Environmental Health Hazard Assessment (OEHHA) would require that data developed under these assessments be made available to consumers under the state’s Proposition 65 law. Currently, only cancer and developmental/ reproductive effects must be reported under Prop 65.

Taken together with activity under CPSIA, TSCA and REACH, the SCPA embodies a demand by decision-makers for a more comprehensive suite of data on the chemical content of products, exposures, and the potential for human and environmental harm as a condition of market access. The hazard traits that must be evaluated and under the draft law are quite extensive, and include neurotoxicity, endocrine disruption, epigenetic toxicity, ototoxicity and phtotoxicity.

Readers may wish to submit comments to the agency before the expiration of the comment period on November 1, 2010.

REACH Right-to-Know Provisions: More Thoughts

Retailers and their upstream suppliers should not be surprised to see a flood of such inquiries going forward. To help facilitate that result, at least one NGO has posted a sample letter for use by supporters.

The time and paperwork entailed in responding to these information requests will prompt many companies to view these inquiries as "a death by a thousand cuts." Some will simply abandon the market while others may reformulate to non-SVHC ingredients - which some would argue is the ultimate purpose of right-to-know legislation.

Regardless, chemical management by hazard in the absence of an appreciation of exposure and risk appears to be the modus operandi for regulators and NGOs for the foreseeable future.

Retailers May be Violating REACH Right-to-Know Provisions

One of the lesser-known provisions of the sprawling REACH law is the right of consumers to demand information on the chemical content of products they purchase. The Ecologist reports today that two major European retail chains are failing to meet these obligations.

Titles IV and V of the law require that sellers of products containing chemicals listed as substances of very high concern (SVHC) notify their customers of this (customers could be downstream producers utilizing a chemical in their own product, as well as retail consumers). Generally, the threshold for notification is the presence of an SVHC in a concentration of 0.1 percent. The reporting obligation can be triggered by the addition of a substance to the SVHC candidate list, which currently contains several dozen chemicals but is expected to grow exponentially in coming years.

Reporting duties can also be triggered by a customer request for such information. In this case, at least the name of the chemical and information allowing the safe use of the product must be provided to the customer within 45 days. In a recent investigation by the European Environmental Bureau (EEB), that NGO sent 158 information requests to 60 retailers and vendors in the EU. EEB contends that 50 percent of the requests were not answered at all, while 75 percent received legally insufficient responses. EEB goes on to recommend that companies selling into Europe establish electronic chemicals management systems, utilize third-party testing, and deliver certification manifests through the supply chain.

Compliance Challenges for Chemical Companies

An excellent article by James A. Kosch, partner at LeClairRyan, on the need for the chemical industry to adapt to a changing regulatory climate.

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?