Hearing Questions EPA Stance on Fracking

The House Subcommittee on Energy and Environment held a hearing earlier this week to review federal hydraulic fracturing research activities. The hearing examined research activities by the Environmental Protection Agency (EPA), Department of Energy (DOE) and the Department of Interior (DOI) in an inter-agency effort to “address the highest priority challenges” related to the production of domestic unconventional oil and natural gas resources.  Readers may recall we have posted about fracking issues before. 

Chairman Lamar Smith (R-Texas) noted a widely publicized handful of unsubstantiated charges that fracking pollutes ground water; the EPA is at the center of this debate, linking fracking to water contamination in at least three cases, only to be forced to retract their statements after further scrutiny.

Members questioned administration witnesses on the objectives of the interagency initiative as they relate to the administration’s regulatory intentions and track record of unsubstantiated attacks on the safety of hydraulic fracturing.  

Witnesses included:

Dr. Kevin Teichman, Senior Science Advisor, Office of Research and Development, Environmental Protection Agency
Mr. Guido DeHoratiis, Acting Deputy Assistant Secretary for Oil and Gas, Office of Fossil Energy, Department of Energy
Dr. David Russ, Regional Executive, Northeast Area, U.S. Geological Survey
Dr. Robin Ikeda, Acting Director, Agency for Toxic Substances and Disease Registry, Department of Health and Human Services

The hearing also noted the administration’s interagency working group had committed to release a draft of their research plan by October 2012 and complete the final plan by January 2013. The Administration has yet to even release a draft for public comment. 

Energy Subcommittee Chairman Cynthia Lummis (R-Wyo.) noted that her home state of Wyoming is at the center of this issue since the EPA put it in the national spotlight with a “draft” report implying that fracking was somehow responsible for the quality of the water. However, in the days and weeks that followed this announcement, the State of Wyoming, industry, and other federal agencies exposed EPA’s study as deeply flawed.

Environment Subcommittee Chairman Chris Stewart noted that largely as a result of the expanded use of cheap natural gas from 2005 to 2011, the U.S. has decreased its carbon dioxide output more than any other nation, including those countries that have implemented aggressive green energy agendas, such as Germany and Spain.  It is perhaps ironic that many of the most passionate advocates for action on climate change also oppose fracking.

TSCA "Reform" Bill Moves To Senate Floor

Over the past several years, Congress has wrestled with chemical safety and possible ways to modernize TSCA. Chemical business leaders, public officials, scientists, doctors, academics, and liberal environmental organizations have expressed support for varied methods of reforms to this principal toxic substance law. 

Recently, a U.S. Senate committee advanced yet another bill that would revise the decades-old  regulation for chemicals. The Senate Committee on Environment and Public Works voted 10-8 (along party lines) to move S. 847, the so-called Safe Chemicals Act, to the Senate floor.

The bill would require the Environmental Protection Agency to establish new minimum data sets for chemical substances; identify required testing of any chemical substances; create various hurdles for a manufacturer before making any new chemical substance;  update a list of chemical substances warranting placement within one of three priority classes regarding risk management; and, importantly, requires substance manufacturers and processors to bear the burden of proving that chemical substances meet applicable safety standards.  The bill would also establish an Internet-accessible, public database of information on the toxicity of, use of, and exposure to chemical substances.  The bill would also drastically narrow the conditions under which data about chemical substances may be treated as confidential business information.

The chemical Industry remains committed to working with the Senate Committee on Environment & Public Works to pursue reform of TSCA, but views this as a partisan markup of a bill that is inconsistent with balanced reform.  Specifically, the bill would establish an unworkable safety standard, and would require an enormous amount of additional government resources to implement. The bill would also dramatically increase the time it would take for EPA to review new chemicals and undermine long-standing protections of trade secrets, seriously hampering innovations in new products and technologies.

 

 

EPA Releases Draft BPA Report

Last week, the EPA released a draft analysis of chemicals that may substitute for bisphenol A's use in thermal paper -- that's the material often used in sales receipts, supermarket labels, parking tickets, airline tickets, and similar items.

Readers may recall that in 2010, EPA released a chemical action plan that summarized hazard, exposure, and use information on bisphenol A (BPA) and identified various actions EPA was considering.  Part of that action plan was to help industries consider alternative chemicals and provide a basis for informed decision-making by developing an in-depth comparison of potential human health and environmental impacts of chemical alternatives. Representatives from industrial, academic, governmental, and non-governmental organizations worked with EPA to select and evaluate alternatives to BPA in thermal paper and develop this report.

By way of background, BPA (a topic we have posted on before) is a high production volume (HPV) chemical with a U.S. volume estimated at 2.4 billion pounds in 2007 and an estimated value of almost $2 billion. It is a monomer used in manufacturing most polycarbonate plastics, the majority of epoxy resins, and other chemical products such as flame retardants.  Approximately 94% of BPA is used as a monomer to make polycarbonate plastic and epoxy resins. Although most human exposure to BPA is believed to come from food and beverage packaging made from these materials, less than 5% of the BPA produced is used in food contact applications.  BPA-based materials are also used in automotive and other transportation equipment, optical media such as DVDs, electrical/electronics equipment, construction, linings inside drinking water pipes, thermal paper coatings, foundry casting, and elsewhere.  It has been an extraordinarily useful product.

The BPA in Thermal Paper Alternatives Assessment is an evaluation of potential hazards associated with thermal paper developers that are likely to be functional alternatives to BPA. Thermal paper systems include a developer and other components such as dyes and sensitizers. (EPA recognized that a change in the developer may require additional adjustments to the system.) This draft report summarizes the outcomes of the alternatives assessment, and aims to improve understanding of the potential environmental and human health impacts of BPA and alternative developers in thermal paper throughout their life cycles. Importantly, this draft report does not identify functional chemicals with no or even low concern for all human health and environmental hazard endpoints; all of the alternatives are associated with some trade-offs. For example, a chemical may have a lower concern for human health but a higher concern for aquatic toxicity. Finding and choosing substitutes is not always as easy as plaintiff attorneys and advocacy groups try to suggest.

Comments on EPA's draft alternatives assessment are due Oct. 1, 2012, at baier-anderson.caroline@epa.gov.
 

House Subcommitee Chair Questions EPA Approach on Fracking

We have posted before about the tremendous economic promise of fracking technology, and the attempts of the plaintiffs bar to exploit this promise.  Another piece of the evolving puzzle has been the regulatory issues.

House Subcommittee on Energy and Environment Chairman Andy Harris (R.-Md.) earlier this month sent a long letter to Environmental Protection Agency (EPA) Administrator Lisa Jackson requesting information and documents related to the Agency’s activities with respect to hydraulic fracturing.
 

The letter expressed frustration with EPA's "lack of transparency and responsiveness" surrounding its fracking approach, and with the agency's "confusing and questionable" approach to fracking regulation.  The letter cites numerous examples of EPA "leaping to scientific conclusions before having all the facts."  These include claims that fracking operations in Parker County, Texas, had affected drinking water, later retracted; and alleged fracking contamination in Dimock, Pa. only later to conclude the water was safe to drink.

The letter worries that such examples, while individually very troubling, "collectively suggest EPA is not objectively pursuing an improved understanding of the relationship between hydraulic fracturing and drinking water, but rather is determined to find fault with the technology in order to justify sweeping new regulations.”

 

EPA Issues New Proposed HPV Chemical Rules

The U.S. Environmental Protection Agency issued two proposed rules last week that would require manufacturers and importers of dozens of high production volume chemicals to provide health, environmental and usage data.  EPA also issued  a final rule that requires manufacturers to test the health and environmental effects of 15 high production volume (HPV) chemicals

In 1998, EPA concluded that there were significant gaps in the basic data needed to understand and characterize the potential hazards associated with certain HPV chemicals. HPV chemicals are classified as those chemicals produced or imported in the United States in quantities of 1 million pounds or more per year.  In the High Production Volume (HPV) Challenge Program, companies were "challenged" by EPA to make health and environmental effects data publicly available on chemicals produced or imported in the United States in the greatest quantities.  As of June 2007, companies sponsored more than 2,200 HPV chemicals, with approximately 1,400 chemicals sponsored directly through the HPV Challenge Program and over 860 chemicals sponsored indirectly through international efforts.

One proposal would require manufacturers to test the health and environmental effects of an additional 23 HPV chemicals, and the other proposal would require companies to notify EPA prior to new uses of an additional 22 chemicals that are widely used in commerce. Both new rules would be issued under the Toxic Substances Control Act, which itself is the subject of Congressional scrutiny.

The 1998 High Production Volume Challenge did not provide adequate data for the 45 chemicals covered by the two proposed rules, according to EPA. Observers believe the proposed rules will likely affect chemical manufacturing and petroleum refineries.

Public comments must be received on or before January 19, 2012.
 

Medical Monitoring Claim Rejected in Rail Spill

The Sixth Circuit recently rejected the medical monitoring claims of a putative class of residents of a small Ohio town who alleged exposure to chemicals released after a CSX Transportation Inc. train accidentally derailed. Jonathan Hirsch et al. v. CSX Transportation Inc., No. 09-4548 (6th Cir. Sept. 8, 2011).

On October 10, 2007, thirty-one cars of a CSX train derailed and caught fire near the town of Painesville, Ohio. As a precaution, emergency personnel removed about 1,300 people from the surrounding half-mile radius. Most of what burned in this fire was non-toxic, but nine of the cars were carrying potentially hazardous materials. The plaintiffs claimed that 2,800 tons of burning material were sent into the surrounding atmosphere, and that, as a result, the level of dioxin in their town was significantly elevated.

While the fire was still burning, several residents of the town brought suit against CSX;  the district court did not allow the plaintiffs to pursue an independent cause of action for medical monitoring, but decided a court-supervised medical monitoring was available as an equitable remedy under Ohio law. See Wilson v. Brush Wellman, 817 N.E.2d 59, 63-65 (Ohio 2004); see also Day v. NLO, 851 F. Supp. 869, 880 (S.D. Ohio 1994).  Defendant then moved for summary judgment, which was granted. The district court held that the plaintiffs had failed to meet their burden to show that (1) the dioxin released into the air by the fire is a known cause of human disease; and (2) that the named plaintiffs were exposed to dioxin in an amount sufficient to cause a significantly increased risk of disease such that a reasonable physician would order medical monitoring. The plaintiffs timely appealed.

The court of appeals focused on the issues of causation and injury. Rather than traditional personal injuries, the alleged injuries consisted solely of the increased risk of—and corresponding cost of screening for—certain diseases that, according to plaintiffs, were more likely to occur as a result of the train crash. Assuming that Ohio would recognize such an injury, the remedy would be a medical monitoring program that would spare the Plaintiffs these expenses. But were plaintiffs actually at such an increased risk of disease that they were entitled to a medical monitoring program? Not every exposure, not every increased risk risk of disease warrants increased medical scrutiny. For the plaintiffs to prevail, there must be evidence that a reasonable physician would order medical monitoring for them.

Plaintiffs hired several experts to try to meet this burden. (No Daubert issue raised; the issue was sufficiency, not admissibility.). They offered a chemical engineer who tested the community for levels of dioxin. He assumed a normal background level of dioxin at 4 parts per trillion and took measurements around Painesville to compare with this baseline. His measurements
showed elevated levels near the crash site.  Plaintiffs had a chemist who speculated about train cargo, nature and amounts; then, a physicist who plotted the dispersion and concentration of the chemicals from the fire on a map for the purpose of showing which members of the community were exposed to what levels of dioxin. Then a medical doctor used this map to determine who in the community was likely exposed to levels of dioxin above what the EPA considers acceptable—levels at which the risk of cancer increases by "one case in one million exposed persons."

The court of appeals saw at least two problems with this offer.  One issue was the use of the regulatory level. The expert not only accepted the risk of one in a million as the threshold for monitoring, but appeared to have halved it. “One should be afforded the benefit of medical
monitoring, if one has sustained a dose equal to or in excess of 50% of the EPA maximum.” There was little explanation as to why he believed that reasonable physicians would order expensive and burdensome testing for such a small risk, but he explained he wanted "to err on the side of patient safety.”  However, a one-in-a-million chance is small. Indeed, it is proverbially small. If something has a one-in-a-million chance of causing cancer in an individual, then it will not cause cancer in 999,999. For some perspective, the National Safety Council estimates a person’s lifetime risk of dying in a motor vehicle accident as 1 in 88. The lifetime risk of dying in “air and space transport accidents” is roughly 1 in 7,000. The risk of being killed by lightning
is roughly 1 in 84,000, while the risk of being killed in a “fireworks discharge” stands at around 1 in 386,000. So, a small risk and no basis to say it called for medical monitoring.  Certainly the EPA didn't base its standard on any medical monitoring analysis.

Second, the doctor based based his assessment on the exposure map.  But the map was unreliable. The estimate of the total material burned was speculative. The expert admitted that “the fire temperature, particle size distribution, and fire area were not established.” And there were other sources of exposure not accounted for.

Plaintiffs thus alleged only a risk that bordered on legal insignificance, and failed to produce evidence establishing with any degree of certainty that they had even this hypothetical risk.

Summary judgment affirmed.

New Theory Emerges in Climate Change Litigation

Just as many eyes are focused on the climate change/global warming cases pending in the appellate courts, a group of activist environmentalists have enrolled new plaintiffs to bring an old legal theory into the climate change litigation mix. A case filed last week alleges that the atmosphere is a "public trust resource" and, as such, the government has a duty to act to protect it. See Loorz v. Jackson, No. CV11-2203 (N.D. Cal., 5/4/11).

Plaintiffs are youths, alleged to be "beneficiaries" of the "public trust," including the teenage head of the group, Kids v. Global Warming, which is also a named plaintiff. Defendants are the EPA and numerous federal agencies who allegedly could act to curb greenhouse gas emissions allegedly linked to global warming.

Plaintiffs' complaint contains the well-known litany of alleged effects of global warming, including rising seas, melting glaciers, warming oceans, changing precipitation, all as an alleged result of increasing CO2 levels.  It takes short term readings and phenomena and raises them to the level of global climactic changes, hypotheses into alleged scientific proof.

The plaintiffs seek declaratory and injunctive relief, on the theory that the atmosphere is a public trust; that under the public trust doctrine, the federal government has a fiduciary duty as trustee to protect the trust for the benefit of the benficiaries (plaintiffs); and that therefore the agencies should be ordered to act to reduce CO2 emissions by 6% a year beginning in 2013.

Thus, the claim moves beyond environmental statutes, such as the Clean Air Act, and tort doctrines such as public nuisance, both of which have been recognized as not applicable by most courts, to an even less applicable theory, the so-called public trust doctrine. This notion has a far more limited reach, with lakes and navigable streams being maintained for drinking, commerce, and recreation purposes under a public-trust doctrine -- or tidal and submerged lands not being given over to private ownership.

Media reports that similar lawsuits are being filed in several other courts, and that petitions for rulemakings by state administrative agencies will be filed in other states.

The cynical use of youthful plaintiffs (aren't we all "beneficiaries"?) may illustrate how clearly the environmental activists sees the challenges of persuading courts on the science and the law, that human emissions of carbon dioxide which comprises less than 0.04 percent of the atmosphere is somehow responsible for hurricanes and every other weather event we experience. 

Whatever the theory alleged, it seems likley that these cases will run headlong into the same issues that derail so much of the global warming agenda, the fact that these cases raise political questions that should be reserved for the political branches of government, not an inidvidual judge. Indeed, the legislative branch, acting within the confines of the common law public trust doctrine, is recognized in the calse law as the ultimate administrator of the trust and often is described as the ultimate arbiter of permissible uses of trust lands.


 

Showdown Over Regulation of Greenhouse Gas Looming in Congress

We have posted before about a number of issues related to greenhouse gas regulation and climate change litigation.  Now comes word that a potential showdown in the U.S. Senate over competing proposals to either strip the EPA of asserted authority to regulate greenhouse gas emissions or to delay the implementation of such rules has been put off until Senators return from their recess at the end of this month.

Earlier this month, Senate Republicans offered an amendment to the Small Business Reauthorization Act (S. 493) that would end all EPA authority to address emissions related to global climate change and block all current and future emissions rules. And the House Energy and Commerce Committee on March 15 approved an identical, stand-alone measure (H.R. 910), which we have posted on before.  The committee vote was along party lines. Also in play is an alternative offered by Sen. Jay Rockefeller (D-W.Va.) that would impose a two-year delay of enforcement of EPA's rules regarding power plants and other large emitting facilities. 

There is also speculation about other measures short of a complete ban on EPA regulation, including a  proposal to exempt the agricultural sector from EPA's greenhouse gas rules.   

All this may come to a head when the Senate reconvenes in April. Meanwhile in the litigation, New York Attorney General Eric T. Schneiderman filed a brief with the U.S. Supreme Court last week (on behalf of Respondents New York, Connecticut, California, Iowa, Rhode Island, Vermont, and the city of New York) asking the Court to  to recognize the right of states to sue various power companies as contributors to global warming. American Electric Power Co. v. Connecticut, No. 10-174 (U.S., brief filed 3/11/11).  The case is set for oral argument on April 19.

Legislation Proposed to Curb EPA Greenhouse Gas Authority

As we have noted in previous posts, one of the many important questions lurking in the climate change/global warning cases currently being litigated is whether the EPA will be the primary regulator of greenhouse gas emissions or whether private parties will be permitted to go directly to court. Should a single judge set emissions standards for regulated utilities across the country—or, as here, for just that subset of utilities that the plaintiffs have arbitrarily chosen to sue? Judges in subsequent cases could set standards for other utilities or industries, or even conflicting standards for these same utilities. At the sane time, many observers question whether the current EPA regulatory direction offers sufficient protection for the jobs and the still shaky economy.

A number of bills have been introduced that could affect this equation. The Chair of the House Energy and Commerce Committee, Fred Upton (R-Mich.), last week spoke of draft legislation that would prohibit the Environmental Protection Agency from regulating greenhouse gas emissions.  The Energy Tax Prevention Act of 2011 would bar the EPA from regulating the so-called greenhouse gases under the Clean Air Act by precluding the agency from taking into consideration the emission of a greenhouse gas due to concerns regarding possible climate change.

Joining in support of this approach were Sen. James Inhofe (R-Okla.), the highest ranking Republican on the Senate Environment and Public Works Committee, and Rep. Ed Whitfield (R-Ky.), chairman of the House Energy and Commerce Subcommittee on Energy and Power.
Senator Inhofe reportedly plans to introduce a Senate version of the bill soon. 

Already in the Senate, Sen. Jay Rockefeller (D-W.Va.) re-introduced the EPA Regulations Suspension Act of 2011 (S. 231) which would delay for two years EPA's greenhouse gas emissions rules covering stationary sources.  Co-sponsors include Democrats: Sens. James Webb (Va.), Claire McCaskill (Mo.), Tim Johnson (S.D.), Joe Manchin (W.Va.), Ben Nelson (Neb.), and Kent Conrad (N.D.).  Rockefeller's version would apparently continue to allow EPA regulation of vehicle greenhouse gas emissions.  Wyoming Republican Senator John Barrasso introduced a more sweeping Senate bill (S. 228) that would reduce federal authority to regulate such emissions under not just the Clean Air Act, but also the Clean Water Act, the National Environmental Policy Act, and the Endangered Species Act.

The White House announced last year that the President would veto efforts to curb EPA authority over these greenhouse gas emissions. But many have expressed concern that the EPA regulations could hurt job growth, particularly for heavy manufacturing states.
 


 

Update on Greenhouse Gas Emissions Reporting

The White House Office of Management and Budget has reportedly completed its review of the draft final rule to set greenhouse gas emissions reporting requirements for oil and natural gas wells and related equipment, as well as locations that produce fluorinated greenhouse gases. Completion of OMB review is typically the final step before a proposed rule is released by the Environmental Protection Agency for publication.

Readers may recall these rules were proposed in Spring, 2010, and would require oil and natural gas wells and related equipment that emit more than the equivalent of 25,000 metric tons per year of carbon dioxide to report their greenhouse gas emissions. EPA estimates that the proposal would apply to about 3,000 facilities, which would be required to begin collecting data on Jan. 1, 2011.  According to EPA, fluorinated gases account for about 2 percent of U.S. greenhouse gas emissions.

The proposed rule for oil and natural gas systems, like many related rules, seem to impose burdensome testing requirements on natural gas systems rather than calling for use of arguably more cost-effective estimating techniques.  Also controversial is EPA's effort to include smaller facilities by aggregating multiple facilities of a company in a region.

The Nov. 2 elections put Republicans in charge of the House and reduced the Democratic margin in the Senate; this may impact greenhouse gas regulation, and climate change legislation (such as cap and tax) is probably off the table for the next two years. Industry groups may seek to lobby for delay in EPA's greenhouse emissions rules through a variety of techniques, including via the EPA spending bill. Several top House Republicans have been quoted as saying such rules are a priority target.  On the Senate side, Sen. Jay Rockefeller (D-W.Va.) and a few other Democrats have favored a delay in implementing the EPA regulations for two years, so the new math there may also create road blocks.

Another aspect of this is seen in statements, such as those by Rep. Darrell Issa (R-Calif.), who may be in line to chair the House Oversight and Government Reform Committee; he has stated that he will call for oversight hearings on EPA activities, including in this area. Organizations such as the National Association of Manufacturers have argued that if the EPA is allowed to continue forward with an "overreaching agenda" on greenhouse gasses that puts additional and unnecessary burdens on manufacturers and drives up energy costs, it will cause economic harm and instill even more uncertainty into our already fragile economy, and will destroy jobs.

 

DTSC Green Chemistry Symposium

The California Department of Toxic Substances Control (DTSC) and the state's Department of Public Health (DPH) are hosting a brown-bag symposium, "Green Chemistry through the Lens of Public Health," next week.  The program will examine the potential and intended effects of Green Chemistry on public health. It is set for Monday, October 18, 2010, 10 a.m. – 3 p.m.
 

We have posted on the California Green Chemistry Initiative, from the introduction of legislation for the program, to the proposal of draft regulations, to the final rule making stages.  As readers know from previous posts, "green chemistry" is the state's effort to require that chemical products be designed in such a way as to reduce the use or generation of hazardous substances and reduce health and environmental risks, with a clear emphasis on finding alternatives to "chemicals of concern."  Two bills passed in 2008 by the legislature mandated that DTSC develop regulations for identifying and prioritizing chemicals of concern, to create methods for analyzing alternatives to existing chemicals, and to create a mechanism for regulatory response, including possible restrictions or bans on certain chemicals. The laws also created a Green Ribbon Science Panel to advise DTSC, and provided for a Chemical Information Clearinghouse that will make chemical risk information more accessible to the public.

The symposium is scheduled to feature interactive discussions with physicians, scientists and some stakeholders on the impact of the new chemicals policy on public health. The keynote speakers are Dr. Margaret Kripke, Ph.D., immunologist, and Steve Owens from the U.S. Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention.

The event is open to the public and is supposed to be accessible via a live webcast at www.dtsc.ca.gov/greenchemistry.
 

 

House Holds Hearing on Proposed Toxic Chemicals Safety Act

The Subcommittee on Commerce, Trade, and Consumer Protection  of the House Committee on Energy and Commerce held a hearing on H.R. 5820, the “Toxic Chemicals Safety Act of 2010,” last week.  The proposed legislation would amend the Toxic Substances Control Act of 1976 to deal with potential risks resulting from chemical exposure.

Witnesses included Steve Owens from the EPA; Calvin M. Dooley, President and Chief Executive Officer of the  American Chemistry Council; and Beth Bosley, Society of Chemical Manufacturers and Affiliates, Inc.

Any approach toward updating federal chemical regulation should balance safety issues with the need to preserve the ability of the United States to serve as the innovation engine for the world; and protect the hundreds of thousands of American jobs fueled directly and indirectly by the business of chemistry.  That is, reforming TSCA to enhance the safety assessment of chemicals while maintaining the ability of the U.S. chemical industry to be the international leader in innovation and manufacturing.

It is clear that the standards established in this bill sets an impossibly high hurdle for all chemicals in commerce, and are guaranteed to produce significant technical, bureaucratic and commercial barriers. For example, the bill requires that “aggregate exposure” to a chemical or a mixture meet the “reasonable certainty of no harm” standard. This apparently means that when a chemical or mixture is listed for a safety determination, the manufacturer carries the burden of showing with reasonable certainty not just that the company’s use of the chemical and any resulting exposures from those uses pose no significant risk of harm, but that all other aggregated exposures from all other uses of the chemical pose no harm. It is not clear to MassTortDefense how any company could actually do that in the real world.  TSCA regulates thousands of chemicals, many with hundreds of uses. TSCA chemicals have multiple important industrial applications and consumer product applications. It is totally unclear how industry or even the EPA would be able to gather enough information to meet this aggregate exposure standard for each and every regulated substance.

The proposed bill thus creates a burden that seems far out of proportion to its benefit. The onslaught of new regulations may simply force customers of the industry to relocate their factories and make the products at issue overseas, outside the EPA's jurisdiction.  The bill would also  discourage the introduction of new chemicals, including new greener chemicals, into commerce in the United States.  Congress, keep working at it.
 

EPA Issues Additional Greenhouse Gas Rules

Late last month, the Environmental Protection Agency signed off on a final rule requiring that  additional categories of sources begin to track and report greenhouse gas emissions under EPA's earlier GHG reporting rule.

Readers will recall the original rule, published in October, 2009, regulated 41 kinds of sources of methane, carbon dioxide, and nitrous oxide ,and other GHG emissions, requiring reporting when the rule becomes effective.  The new rule adds Magnesium Production, Underground Coal Mines, Industrial Wastewater Treatment, and Industrial Landfills, to the list of sources that have reporting requirements.  With this final rule the Agency has taken action on all outstanding source categories and subparts from the April 2009 original proposal for the greenhouse gas reporting program.

EPA promulgated the regulations to require monitoring and reporting of various major greenhouse gas emissions. In general, this national greenhouse gas reporting program is supposed to  provide EPA with accurate and timely GHG emissions data from facilities that emit 25,000 metric tons or more of carbon dioxide equivalent (CO2e) per year. This data is supposed to provide a better understanding of where GHGs are coming from and will guide development of the best possible policies and programs to reduce emissions, says the EPA.

Underground coal mines, magnesium production facilities, industrial waste landfills and industrial wastewater treatment facilities that meet the reporting threshold must begin monitoring GHG emissions on January 1, 2011 and must submit the first annual report to EPA by March 31, 2012. These GHG reporting rules are genearaly viewed as the first steps toward implementing GHG emissions limits and related climate change regulations. 

NRDC Sues FDA Over BPA

The Natural Resources Defense Council brought suit last week against the FDA for allegedly failing to take timely action in response to its petition asking the agency to ban the chemical bisphenol A. NRDC v. Sebelius, D.C. Cir., No. 10-1142 (filed 6/29/2010).

NRDC is one of a number of advocacy groups who allege that this important chemical, used to make polycarbonate plastics in water bottles and epoxy resins used to line cans containing food, causes harmful health effects, particularly to infants and children, including early puberty, reproductive abnormalities.

However, both the scientific process and the public interest are better served by allowing the FDA to complete its ongoing review of the science surrounding the safety profile of BPA -- at its own pace.  Just this January, the U.S. Department of Health and Human Services and the FDA made it clear that BPA has not been proven to harm children or adults.  EPA released its bisphenol A Action Plan in March 2010. Importantly, the agency clearly indicated that it does not intend to initiate regulatory action under TSCA at this time on the basis of human health concerns.

This observation is consistent with a draft assessment issued by FDA in 2008, and the scientific conclusions of many other government regulatory agencies around the world. In January 2010, the German Federal Institute for Risk Assessment (BfR, Bundesinstitut für Risikobewertung) wrote, “Following careful examination of all studies, in particular the studies in the low dose range of bisphenol A, BfR comes to the conclusion in its scientific assessment that the normal use of polycarbonate bottles does not lead to a health risk from bisphenol A for infants and small children. BfR is not alone in this assessment. The European Food Safety Authority (EFSA) and the U.S. Food and Drugs Administration (FDA) share this opinion. Japan, which has conducted its own studies on bisphenol A, does not see any need for a ban either.”
 

In January 2010, FDA Deputy Josh Sharfstein was quoted as noting the FDA does support the use of baby bottles with BPA because the benefits of sound infant nutrition currently outweigh the known risks from BPA. Nevertheless, and perhaps not surprisingly, the California Assembly passed legislation last week to ban the use of bisphenol A in children's food and drink containers beginning in 2012.  The bill passed by a vote of 43-31 vote. The Toxics-Free Babies and Toddlers Act (S.B. 797) moves to the state Senate for approval, since the Senate initially passed a different version early last month.

The bill provides that if the state Department of Toxic Substances Control begins to regulate the chemical through its “green chemistry’’ initiative, S.B. 797 would be repealed.  In the meantime, the law would would limit the level of BPA in baby bottles, toddlers' cups, and food and drinking containers.  Infant formula manufacturers would have until July, 2012, to stop using BPA in the coatings used to line their metal containers.

 

EPA Releases Draft Toxicology Assessment of Formaldehyde

The Environmental Protection Agency has released a draft toxicological review of formaldehyde, entitled "Toxicological Review of Formaldehyde Inhalation Assessment: In Support of Summary Information on the Integrated Risk Information System (IRIS).''  (EPA's IRIS is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to chemical substances found in the environment. )

EPA announced a 90-day public comment period and a public listening session for the external review draft human health assessment.  The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA said it was releasing this draft assessment for the purpose of pre-dissemination peer review.  Also, a committee of the National Research Council, acting under the auspices of National Academy of Sciences (NAS), will conduct an independent scientific peer review of the EPA draft human health assessment of formaldehyde. The peer review committee will hold meetings, some of which may involve public sessions. Public sessions will be announced before each meeting on the National Academies Web site.  The public comment period and NAS scientific peer review are separate processes that are supposed to provide opportunities for all interested parties to comment on the assessment.

Formaldehyde is present in a wide variety of products including some plywood adhesives, abrasive materials, insulation, insecticides and embalming fluids. The major sources of anthropogenic emissions of formaldehyde are motor vehicle exhaust, power plants, manufacturing plants that produce or use formaldehyde or substances that contain it (i.e. glues), petroleum refineries, coking operations, incinerating, wood burning, and tobacco smoke, says the EPA.  It is used in industry to manufacture building materials and numerous household products and consumer products, including some soaps, shampoos, and shaving cream. 

Of course, alleged exposure to formaldehyde has been involved in numerous toxic tort suits as well as consumer fraud actions.

The draft assessment found that formaldehyde could be more likely to cause cancer than in previous EPA calculations. In the draft, EPA now estimates there could be up to one case of cancer for every 1,000 people breathing formaldehyde at concentrations of 20 parts per billion over their lifetime.  The draft assessment also provides for the first time an agency estimate of a reference concentration (RfC). Lifelong inhalation of formaldehyde at concentrations up to that RfC would not be expected to cause breathing, immune, reproductive, and other non-cancer health effects.

At Section 4.5.4, the report concludes that human epidemiological evidence is sufficient to conclude there is a causal association between formaldehyde exposure and nasopharyngeal cancer, nasal and paranasal cancer, all leukemias, myeloid leukemia and lymphohematopoietic cancers as a group. But, for example, it is questionable whether there really is a demonstrable link between formaldehyde and leukemia.  And the evidence does not appear to support a causal link between formaldehyde and  upper-respiratory tract cancers. See the critical comments of other federal agencies.

Any regulatory decision on this important chemical based on incomplete information could cause significant harm to the economy, as many products critical to the home and commercial building, automotive and aerospace industries, as well as defense-related applications and vaccines used worldwide to prevent polio, cholera, diphtheria, and other major diseases, all use it.  All living things — including people — produce and process formaldehyde. It occurs naturally in the air we breathe and does not accumulate in the environment or in plants, animals or people.

Rep. Henry A. Waxman (D-Calif.) has stated that the draft report is another reason to reform the Toxic Substances Control Act.  He plans to introduce such a bill this Summer. Also, legislation that would amend TSCA to set formaldehyde emissions limits for plywood and other composite wood products was reported out last month by the House Energy and Commerce Committee.  See H.R. 4805, The Formaldehyde Standards for Composite Wood Products Act.

Update: and an alert reader points out that the Senate just this week passed its own version, S.1660, the Formaldehyde Standards for Composite Wood Products Act.  The Senate bill would make the formaldehyde emission standard contained in the California Code of Regulations (relating to an airborne toxic control measure to reduce formaldehyde emissions from composite wood products, as in effect on July 28, 2009) applicable to certain hardwood plywood, medium-density fiberboard, and particleboard sold, supplied, offered for sale, or manufactured in the United States, with certain exemptions, including for composite wood products used inside new vehicles, rail cars, boats, aerospace craft, or aircraft.

Safe Chemicals Bill Introduced in Senate

Sen. Frank R. Lautenberg, D-N.J., chair of the Senate Subcommittee on Superfund, Toxics
and Environmental Health, introduced this week the "Safe Chemicals Act of 2010," which would
amend the the Toxic Substances Control Act of 1976.

Over the last several months, Congress has held a series of hearings focusing on chemical safety and possible ways to modernize TSCA. Chemical business leaders, public officials, scientists, doctors, academics, and liberal environmental organizations have expressed support for varied methods of reforms to the principal toxic substance law. The “Safe Chemicals Act of 2010” comports with the reform principles laid out by the Obama Administration and groups such as the Safer Chemicals Healthy Families Coalition, and purports to address issues with TSCA identified by the GAO.

The bill (summarized here) is supposed to:

  • provide EPA with sufficient information to judge a chemical’s safety, by requiring manufacturers to develop and submit a minimum data set for each chemical they produce, while also preventing duplicative or unnecessary testing. EPA will have full authority to request additional information needed to determine the safety of a chemical.
  • Prioritize chemicals by having EPA categorize chemicals based on risk, and focus resources on evaluating those most likely to cause harm.
  • Place a new burden of proof on chemical manufacturers to prove the safety of their chemicals, including all foreseeable uses, before the chemical may enter the market or continue to be used.
  • Create more access to chemical information, by establishing a public database to catalog the information submitted by chemical manufacturers and the EPA’s safety determinations. The EPA will impose requirements to ensure the information collected is "reliable."
  • Promote innovation and development of green chemistry, through grant programs and research centers to foster the development of safe chemical alternatives, and bring some new chemicals onto the market using an expedited review process.


     

It is clear that safety must be the primary goal of chemical regulatory reform, and the scientific and technological advances made since the passage of TSCA should allow industry and the regulatory agency to achieve a high degree of safety.  Certainly,  the need to prioritize chemicals for evaluation, a proper risk-based approach to EPA safety reviews, and a reduction in animal testing, are all aspects that should generate bi-partisan support. However, the bill’s proposed decision-making standard may be both legally and technically impossible to meet. Readers know how the articulation and application of the burden of proof can be outcome determinative. It is impossible to prove that something is "safe,” if one means risk-free. Every substance, even water, is hazardous to health at some levels in some exposure contexts. It would be devastating for our economy if this bill was merely a back-door attempt to make the so-called precautionary principle the law in this country, as it is in Europe. It is simply scientifically false that every chemical that is dangerous at high doses is also hazardous at low doses;  it is patently false that every chemical that causes effects in lab animals will also cause those effects in human beings.

And the proposed changes to the new chemicals program could very well hamper innovation in new products, processes, and technologies. In addition, the bill undermines business certainty by appearing to allow states to adopt their own regulations and create a lack of regulatory uniformity for chemicals and the products that use them.

Congressmen Henry Waxman and Robert Rush have proposed a "discussion draft" on the House side, and that may afford an opportunity for a transparent and meaningful discussion by all key stakeholder groups to ensure that TSCA reforms are based on sound science and protect the safety of all consumers, while promoting jobs and innovation.  In these uncertain economic times, the last thing needed is another expensive government program that risks doing more harm than good.

 

Senate Hearing on TSCA Reform Featured Industry Experts

The Senate Subcommittee on Superfund, Toxics, and Environmental Health convened a hearing last week with leaders of businesses that manufacture or use chemicals to hear their business views on reforming U.S. chemical safety law. The hearing was the third in a series of oversight hearings leading up to the possible introduction of legislation to reform the Toxic Substances Control Act (TSCA). 

Entitled "Business Perspectives on Reforming U.S. Chemical Safety Laws," the hearing featured testimony from Charlie Drevna, President of the National Petrochemical and Refiners Association.  His remarks addressed the call from some observers for a European-style replacement regulatory regime. The European Union has started to implement new legislation – Registration, Evaluation and Authorization of Chemicals (REACH), but many of the perceptions of REACH are incorrect. For example, rather than relieving the government of the burden of chemical safety, REACH only increases the burden on industry while it does not reduce the burden on government. No government authority is going to receive a chemical dossier from industry and take it at face value. Furthermore, REACH places so much burden on industry that small- and medium-sized chemical manufacturers are already facing significant difficulties complying with the program. REACH, contrary to some commentary, is unlikely to spur innovation in safer chemicals. Innovation is a function of spending on research and development and ease of entry into the marketplace. Toxicity and other laboratory testing is considered part of research and development and typically comes out of R&D budgets. That leaves less money for new, and often safer, product development. REACH is a regulatory concept that has never been attempted anywhere in the world, at any time. Authorities in Europe have already been inundated with so much information that they simply cannot keep up.
 

Dr. Neil C. Hawkins, Vice President, EH&S and Sustainability  for The Dow Chemical Company testified that an ideal chemical safety program would base its decisions on a consistent scientific
evaluation of both hazard and potential exposure (an evaluation of risk), using a weight-of-evidence approach. A weight-of-evidence approach requires critical evaluation of the entire body of available data for consistency and biological plausibility. Studies conducted and funded by industry are necessary and valuable contributions to the understanding of potential public health and environmental effects related to the manufacture and use of its products. Industry scientists have expert knowledge of the chemicals they manufacture, especially as this relates to the development and interpretation of the science needed to comply with governmental requirements around
the world. Research should be judged on the basis of scientific merit, without regard for funding source or where the studies are conducted (e.g. academia, government, or industry). 

Also testifying was Linda Fisher, Vice President, Safety Health and the Environment for DuPont.  She stressed in her remarks that as the agency contemplates exposure reductions it is important that the EPA be required to take into account the societal benefits from the use of chemicals and the time and complexity of bringing substitutes to market. Congress should avoid presumptive bans or rigid phase-out schedules. Bans and deadlines for phase-outs or substitution that fail to account for the realities of transitioning to new ingredients, receiving needed customer and regulatory approvals, or modifying manufacturing facilities, are counter-productive. Such actions could lead to unnecessarily disrupting markets, reduce public access to valued products, and cede markets to global competitors.

The issue of confidential business information, or CBI, also needs attention. The ability to preserve legitimate CBI and prevent piracy of intellectual property is critical to U.S. competitiveness and innovation. If companies simply give innovation away there is little reason to innovate.  Intergovernmental sharing of CBI data with proper protections, whether between state and federal governments or nation to nation, should be facilitated.


 

More Groups Challenge EPA's "Endangerment Finding" in Climate Change Debate

A variety of business groups, including the National Association of Manufacturers (NAM), last week filed a petition in federal court challenging the U.S. EPA's decision to regulate greenhouse gas emissions through the Clean Air Act.  Also petitioning in this latest round of filings are the American Petroleum Institute, the National Petrochemical & Refiners Association, the National Association of Home Builders, the Corn Refiners Association, the Brick Industry Association, the Western States Petroleum Association, and the National Oilseed Processors Association.

The groups are challenging EPA’s "Endangerment Finding" determination, and asserting that EPA hasn't asked the right questions, or sought the right information, and hasn't met the government's burden under the standards set forth in the Clean Air Act.  The endangerment finding was based in large measure on the scientific findings of the U.N. Intergovernmental Panel on Climate Change. The IPCC findings have come under fire since e-mails were disclosed in November which seem to show that some scientists were trying to manipulate the data to falsely show that climate change is occurring.

Raising the slippery slope problem, the petitioners worry that if EPA moves forward and begins regulating stationary sources, it may open the door for them to regulate everything from industrial facilities to farms to even American homes. Such a move would further complicate a permitting process that EPA is not equipped to handle, while increasing costs to the manufacturing sector. According to some published estimates, the “Endangerment Finding” and subsequent regulations will trigger new permitting requirements for more than 6 million stationary sources. These 6 million sources may include 200,000 manufacturing facilities, approximately 20,000 farms, and another 200,000 other sources such as universities, schools and even American homes, impacting every aspect of the U.S. economy. These costly burdens and uncertainty, they observe, will stifle job creation and harm our competitiveness in a global economy.

The organizations note they support a comprehensive climate change policy that achieves real environmental results while also fostering continued economic growth – essential conditions for a healthy manufacturing sector in the United States.  The state of Texas has also joined the list of opponents of the EPA's finding. The U.S. Chamber of Commerce filed a petition already. 

EPA Administrator Lisa Jackson had announced the agency finding back in December that greenhouse gas emissions endanger public health and welfare and that cars and light trucks cause or contribute to the emissions. See 74 Fed. Reg. 66,496.  The agency is reportedly planning to take regulatory action in March, under the Clean Air Act.

The finding responded to a decision in 2007 by the U.S. Supreme Court saying that greenhouse gas emissions fall under the definitions of the Clean Air Act, but that EPA must make a finding on whether they endanger public health and welfare and justify its decision based on science. See Massachusetts v. EPA, 549 U.S. 497 (2007).

 

EPA Releases First Chemical Action Plan

The Environmental Protection Agency recently issued its first Chemical Action Plan (CAP).  The plan deals with  phthalates, which are found in some food packaging and cosmetics.  But anyone in the chemical industry should take notice, as this CAP comes as part of EPA’s efforts to enhance the existing chemicals program under the Toxic Substances Control Act. EPA has identified an initial list of widely recognized chemicals, including phthalates, for action plan development based on one or more of the following factors: their presence in humans; persistent, bioaccumulative, and toxic  characteristics; use in consumer products; or production volume.

Although many in industry support  EPA’s effort to update agency actions for prioritized chemicals under TSCA, there is much to question in this effort so far, including the fact that the initial set of chemicals seem to have been selected based on their current “high-profile” nature. EPA should prioritize chemicals for the CAP program based on scientific criteria that reflect available hazard, use, and exposure information.  Despite the new Administration's campaign promises, there has been little transparency, and in fact great uncertainty, over the scientific basis for the selection of these chemicals.  Unfortunately, the CAP process to date provides no evidence of a systematic, science-based approach to chemicals management.

A large body of scientific data already exists about phthalates, and these products have been subject to numerous government safety assessments.  Bio-monitoring data shows that exposure to phthalates in the general public are below safety limits established by the EPA and the European Union. In assessing potential future restrictions on certain phthalates, EPA plans to weigh the relative toxicity and feasibility of phthalate substitutes. Identification of safer and affordable non-phthalate substitutes will be an important consideration in any action that would restrict the use
of these chemicals.  EPA intends to conduct a Design for the Environment and Green Chemistry alternatives assessment by 2012. The information developed could be used to encourage industry to move away from phthalates in a non-regulatory setting to expand risk management effects beyond whatever regulatory action might be taken under TSCA, or could be used as input to a regulatory action. 

EPA also intends to lay the groundwork to consider initiating in 2012 rulemaking under TSCA section 6(a) to further regulate phthalates. Readers know how regulatory events can spawn and impact toxic tort litigation.  It should be noted  that an Action Plan is intended to describe the courses of action the Agency plans to pursue in the near term to address its concerns. The Action Plan does not constitute a final Agency determination or other final Agency action.

 

 

 

 

Senate Hearing on Toxic Chemicals Legislation

The Senate Committee on Environment and Public Works and the Subcommittee on Superfund, Toxics, and Environmental Health held a joint hearing yesterday, entitled “Oversight Hearing on the Federal Toxic Substances Control Act.”

The Senators heard testimony from Lisa Jackson, head of EPA; John Stephenson, Director of Natural Resources and Environment for GAO; and Linda Birnbaum, head of NIEHS and the National Toxicology Program.

Administrator Jackson argued that the Toxic Substances Control Act is in urgent need of reform because of "troubling gaps" in knowledge about many chemicals that have come into wide use since. She asserted that manufacturers of various “grandfathered” chemicals weren’t required to develop and produce the data on toxicity and exposure that are needed to properly and fully assess potential risks. [In a bit of drama, EPA’s Jackson was asked about some of the troubling emails recently disclosed about the apparent concerted effort of some to quash any scientific dissent to an aggressive view of global warming.]

The American Chemistry Council has noted that updating the legislation in certain respects made good sense, favoring a comprehensive approach, rather than the current patchwork of state and federal laws governing chemicals.

GAO’s representative testified that TSCA generally places the burden of obtaining data about existing chemicals on EPA rather than on chemical companies. For example, the act requires EPA to demonstrate certain health or environmental risks before it can require companies to further test their chemicals. As a result, EPA does not routinely assess the risks of the over 83,000 chemicals already in use. Moreover, TSCA does not require chemical companies to test the approximately 700 new chemicals introduced into commerce each year for toxicity, and companies generally do not voluntarily perform such testing.

Dr. Birnbaum encouraged Congress to call for utilization of the new kind of toxicological testing that is less expensive and also gives an improved understanding of the actual effects of chemicals on humans. Toxicology is advancing from a mostly observational science using disease-specific models, she said, to a better, predictive science focused upon a broad inclusion of target-specific, mechanism-based, biological observations. This means using alternative assays targeting the key pathways, molecular events, or processes linked to disease or injury, and incorporating them into a research and testing framework.

Democratic legislators, including Sen. Lautenberg (D-NJ) have called for increased requirements for chemicals testing, and that “It's time to sound the alarm.” In an attempt to respond to industry concerns, Lautenberg argued that stronger regulations would somehow protect chemical companies from product liability suits—an ironic assertion at best as Democrats actively work to overturn express preemption for medical devices and extol the Wyeth v. Levine decision restricting implied preemption of drugs.

Of particular concern to readers of MassTortDefense would be efforts to eliminate the current risk-based review system under TSCA and force EPA to use the so-called precautionary principle.

It seems more supportable that any overhaul of TSCA should include the notion that scientific reviews must use data and methods based on the best available science and risk-based assessment; must include cost-benefit considerations for the private-sector and consumers; must protect proprietary business information, and should logically prioritize reviews for existing chemicals.

 

Summary Judgment in Proposed Medical Monitoring Class Action

A federal court has granted defendant CSX Transportation, Inc.’s Motion for Summary Judgment in a medical monitoring case arising from a train accident. See Mann v. CSX Transportation, et al., NO. 1:07-cv-3512 (N.D. Ohio Nov. 10, 2009).

The case arises from the derailment of 31 rail cars, nine of which contained hazardous materials, and the subsequent fire that burned for around sixty hours. Ohio emergency personnel oversaw an
evacuation of a one half mile radius. The next day, plaintiffs filed a putative class action complaint in state court, which was removed to the Northern District of Ohio. Plaintiffs’ complaint, under
theories of strict liability and negligence, primarily sought the establishment of a judicially administered medical monitoring program.

After discovery had been completed, defendant filed its motion for summary judgment. The court began by noting that Ohio law recognizes medical monitoring as a form of remedy for an underlying tort. See Wilson v. Brush Wellman, 817 N.E.2d 59, 63 (Ohio 2004). (Readers will note some states consider it a separate cause of action.) Therefore, medical monitoring is only granted if a plaintiff is able to prove all the elements of the underlying tort and the elements of medical monitoring. On the first part, in order to avoid summary judgment, plaintiffs thus must make a showing of a genuine issue of material fact as to the elements of a negligence claim under Ohio law: (1) defendant had a duty to plaintiffs, (2) defendant breached that duty, and (3) plaintiffs suffered damages directly and proximately caused by defendant’s breach. See, e.g., Menifee v. Ohio Welding Products, 15 Ohio St. 3d 75, 77 (Ohio 1984).

The first two issues were not contested for purposes of the motion. On injury and causation, the court noted the overlap with typical medical monitoring requirements, such that to meet this aspect of their negligence claim plaintiffs must demonstrate a genuine issue of material fact that: (1) the chemicals (dioxins) released into the air by the fire are known causes of human disease; and (2) that the plaintiffs were exposed to the dioxins in an amount sufficient to cause a significantly increased risk of disease such that a reasonable physician would order medical monitoring.

Plaintiff experts relied on classifications of the chemicals as carcinogens as their only evidence that dioxins cause the various endpoint diseases for which they seek medical monitoring.  Plaintiffs’ experts also failed to provide an independent assessment of the causal link between dioxins and disease.  Instead they "parroted" the conclusions of other experts and cited to EPA, IARC and NTP documents labeling dioxins as known carcinogens. This was an insufficient showing, said the court.

But even if plaintiffs could demonstrate a causal relationship between dioxins and cancer, plaintiffs had failed to establish that they were exposed to dioxins in an amount warranting a reasonable physician to order medical monitoring. See Day v. NLO, 851 F.Supp.869, 881 (S.D. Ohio 1994).

Plaintiffs’ theory was that they were at an increased risk of disease because they lived for eighteen months with alleged contamination from the fire inside and around their homes. However, none of the named plaintiffs presented evidence that a physician has examined them or their medical records and opined that they are at an increased risk of disease. Similarly, plaintiffs’ experts had not conducted any measurement of dioxin inside or outside of the homes of five of the seven named plaintiffs. At least three of the seven had not even lived in their air dispersion modeling expert's "impact zone" long enough to qualify for his proposed medical monitoring program. Even for those that did, mere residence in the so-called impact zone is insufficient evidence of sufficient contamination and increased risk because it ignores any individual variables, including other sources, and most notably, at what level each of the named plaintiffs was actually exposed to dioxins. The Sixth Circuit has stated “generalized proofs will not suffice to prove individual damages.”  Sterling v. Velsicol Chem. Corp., 855 F.2d 1188, 1200 (6th Cir. 1988).

Again, even if plaintiffs had presented sufficient evidence of the amount of named plaintiffs’ dioxin exposure, plaintiffs did not demonstrate that a reasonable physician would order medical monitoring based on this exposure. Plaintiffs attempted to rely upon the EPA soil cleanup level after the accident as a basis for justifying medical monitoring. The court found two fatal defects in using this EPA soil cleanup level. First, demonstrating why regulatory guidelines are often not useful in the tort litigation context, see Rowe v. E.I. DuPont de Nemours & Co., 2008 WL 5412912 (D.N.J. Dec. 23, 2008); Redland Soccer Club, Inc. v. Dep’t of the Army, 55 F.3d 827 (3d Cir. 1995), the EPA soil cleanup level represented a threshold for the cleanup of contaminated soil, not a danger point
above which individuals would require medical monitoring. And even if government regulations were relevant to showing increased risk, a conservative soil cleanup level should not be used in place of a medically based risk assessment or evidence of the actual dose level at which dioxin truly causes cancer – the danger point critical to a medical monitoring determination.  Second, the EPA’s threshold soil cleanup level represents an increase in the risk of developing cancer from the baseline level for the general population of one in a million. Thus, even assuming there were a million members in this class who had been exposed to this level of dioxin over their entire lives, and assuming causation, only one of them would develop cancer because of the exposure. Plaintiffs thus sought to commence medical monitoring based on this one-in-a-million risk, but this risk and indeed risks higher, have been found insignificant as a matter of law.  Medical monitoring typically requires a significantly increased risk. Plaintiffs' expert opinion to the contrary was a legal conclusion, and thus it did not create a genuine issue of material fact.

In sum, the court concluded that the plaintiffs had not presented a genuine issue of material fact that the circumstances would warrant a reasonable physician to order medical monitoring. Medical monitoring in Ohio is a form of relief which should only be granted "with prudence."  Interestingly, the court concluded that plaintiffs’ proposed program would likely be extremely expensive, said the court, and inconvenience thousands of people for many years in the future. (Note to readers, the potential down-sides of medical monitoring must be explored in each case.) Plaintiffs had not presented enough evidence for a reasonable jury to conclude that such a burdensome program is warranted.

 

 

Chinese Drywall Update

On the eve of the 3rd biennial United States--China Consumer Product Safety Summit, to be held in China, the head of the Consumer Product Safety Commission reported she will press Chinese officials on whether new regulatory standards need to be set for drywall composition. CPSC Chairwoman Inez Tenenbaum said she also would inquire whether the Chinese were willing to provide compensation for the damage from tainted drywall.

In its latest status report on the Chinese drywall issues, the CPSC noted that it had received 1192 consumer complaints, from 24 different states. The majority of the reports continue to be from Florida, Louisiana, and Virginia. The focus of the federal drywall team has remained pursuing the scientific bases of the possible problems, and tracing the chain of commerce of the drywall.

CPSC reports it has completed principal field work for a 50 home indoor air sampling program, coordinated the state and federal response to allegations of radioactive phosphogypsum in Chinese drywall, and completed 75 in-depth site investigations, with another 20 in progress. Long-term air sampling tests will be completed later this month. The evaluation of the results is expected to be complete before November. (Phosphogypsum is a gypsum that has elevated levels of naturally occurring potassium, thorium and uranium radionuclides and decay products.) The CPSC coordinated testing and reporting results for radioactive phosphogypsum contamination in drywall with the Florida Department of Health and the EPA National Air and Radiation Environmental Laboratory. The results of the technical review showed that no radiological hazard was present. EPA is conducting elemental analyses of 15 drywall samples. EPA expects to complete its analyses of drywall samples in the next few weeks.

CPSC continues to analyze the information received from consumers, builders, importers, manufacturers, and suppliers of drywall to determine how much imported drywall may be affected and where that drywall has been installed. To date, CPSC staff has confirmed that during 2006, 6,997,456 sheets of Chinese drywall were imported into the U.S.

As readers of MassTortDefense know, litigation has been filed over the drywall issues, alleging that sulfur levels in the Chinese-made products are abnormally high, causing problems with air conditioning systems, appliances, internal wiring and other electrical systems.  Approximately 200 cases are pending in the MDL. In re: Chinese-Manufactured Drywall Products Liability Litigation, No. 09-md-02047 (E.D. La.).

In the MDL , the next status conference is scheduled for Thursday, November 19, 2009. Recently, the court  issued an order regarding a "Revised Exporter, Importer, or Broker Defendant Profile Form.”  All defendant drywall exporters, importers, or brokers must complete this Profile Form.  The form, inter alia, requires information on exemplar transactions concerning the exportation/importation/brokering of Chinese Drywall for import/export to the United States between 2001 and 2009, including but not limited to purchases, sales, consignments, shipments, transfers, deliveries, receipts, or other distributions.  The form requires information to identify any markings on the Chinese Drywall product (e.g., lot number, batch number, serial number, color markings, UPC codes, etc.) involved in this transaction; a list all trademarks of the product, and any markings or means of identification employed to track or identify the Chinese Drywall.

The issue of linking the specific product that allegedly harmed a plaintiff to the defendants who made and sold that particular product -- often termed "product identification" -- is an essential aspect of the cause in fact inquiry and is often problematic in toxic tort litigation.

 

 

EPA Finalizes Nano-technology Research Strategy

Many readers of MassTortDefense have wondered about the potential future litigation risks associated with nanotechnology. The U.S. Environmental Protection Agency has just finalized its new strategy to guide its research into how nanomaterials, used in a growing number of consumer products, might be studied for potential effects on human health and the environment. The Nanomaterial Research Strategy (NRS) describes the EPA's strategy for conducting and supporting research to understand the potential human health and ecological implications from exposure to manufactured nanomaterials, and how nanotechnology can be used sustainably in environmental protection applications.

EPA has written this document with three stated purposes:
(1) to guide its own researchers and managers as they conduct EPA’s research program,

(2) to assist scientists in other organizations and agencies as they plan research programs, and

(3) to inform the public of how EPA intends to generate scientific information to guide environmental decisions related to nanomaterials.

With the use of nanotechnology in the consumer and industrial sectors expected to increase
significantly in the future, nanotechnology offers society the promise of major benefits. The challenge for environmental protection is to ensure that, as nanomaterials are developed and used, unintended consequences of exposures to humans and ecosystems are prevented or minimized. In addition, knowledge concerning how to sustainably apply nanotechnology to detect, monitor, prevent, control, and clean up pollution is needed, says the NRS.

The strategy builds on the work of the Nanotechnology Environmental and Health Implications
Working Group (NSTC, 2008), and in the EPA’s Nanotechnology White Paper (EPA, 2007).

EPA’s strategy focuses on four areas:

􀂃 Identifying sources, fate, transport, and exposure
􀂃 Understanding human health and ecological effects to inform risk assessments and test methods
􀂃 Developing risk assessment approaches
􀂃 Preventing and mitigating risks
 

The key science questions described in the strategy document are intended to help decision makers answer the following questions:
􀂃 What nanomaterials, in what forms, are most likely to result in environmental exposure?
􀂃 What particular nanomaterial properties may raise toxicity concerns?
􀂃 Are nanomaterials with these properties likely to be present in environmental media or biological
systems at concentrations of concern, and what does this mean for risk?
􀂃 If we think that the answer to the previous question is “yes,” can we change properties or mitigate
exposure?

Readers of MassTortDefense know that nanotechnology is the process of manipulating materials 1 million times smaller than a millimeter. Nanomaterials, lighter and stronger than other materials, are used in hundreds of products already on the market, including many cosmetics and skin care products.  We have posted on this topic before.  Materials can take on new properties at the nano level, becoming stronger, better conductors of heat or electricity, for example.

The EPA's own office of research development is focusing its research on seven manufactured nanomaterial types: single-walled carbon nanotubes, multiwalled carbon nanotubes, fullerenes, cerium oxide, sliver, titanium dioxide and zero-valent iron. Carbon nanotubes are used in vehicles, sports equipment and electronics, while titanium dioxide is used in paints, cosmetics and sunscreens, as reported by EPA.  The Agency is also part of the government-wide National Nanotechnology Initiative.

Chamber of Commerce Requests Open Debate on Science of Global Warming

The U.S. Chamber of Commerce last week filed a supplemental request for an “on-the-record” hearing to debate the evidence behind the Environmental Protection Agency’s expected finding that greenhouse gases endanger the public health and welfare.

Readers of MassTortDefense may recall that in 2007, in Massachusetts v. EPA, 549 U.S. 497 (2007), the Supreme Court found that greenhouse gases could be regarded as air pollutants, and held that EPA must determine whether or not emissions of greenhouse gases from motor vehicles cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare, or whether the science is too uncertain to make a reasoned decision. In making these decisions, the agency is required to follow the language of section 202(a) of the Clean Air Act. The Supreme Court decision resulted from a petition for rulemaking under section 202(a) filed by more than a dozen environmental, renewable energy, and other organizations.

The EPA is proposing to find that the current and projected concentrations of the mix of six key greenhouse gases — carbon dioxide (CO2), methane (CH4), nitrous oxide (N2O), hydrofluorocarbons (HFCs), perfluorocarbons (PFCs), and sulfur hexafluoride (SF6) — in the atmosphere threaten the public health and welfare of current and future generations. This is typically referred to as an "endangerment finding."  EPA is further proposing to find that the combined emissions of CO2, CH4, N2O, and HFCs from new motor vehicles and motor vehicle engines contribute to the atmospheric concentrations of these key greenhouse gases and hence to the threat of climate change.  While an endangerment finding under the Clean Air Act would not by itself automatically trigger extensive regulation under the entire Act, many observers expect such regulations.  Moreover, the finding could prod the Congress to pass controversial climate legislation.  Finally, it may impact the pace and weight of climate change litigation.

The Chamber argues that the informal notice-and-comment process employed here has not worked to air the issues, and the only real solution is an on-the-record hearing for a transparent review of all the evidence.  Having reviewed the evidence in EPA’s endangerment docket, the Chamber observes flaws and omissions in the reasoning underlying the proposed endangerment finding. The Chamber is thus asking for more transparency in this process, as the ruling could ultimately cause a "regulatory train wreck" with inescapable economic consequences, as well as an impact on mass tort litigation. The agency has apparently ignored evidence contradicting its preliminary conclusions on a wide range of issues, such as the alleged effect higher temperatures will have on net mortality and on the levels of other pollutants.  Media reports have surfaced that EPA ignored a study by two members of its staff concluding that the agency had relied on outdated studies and that the current state of climate science refutes the proposed endangerment finding.



 

EPA Releases New Strategic Plan for Evaluating Potential Toxicity of Chemicals

The U.S. Environmental Protection Agency released a new strategic plan last week that is designed to allow it to better assess potential risks from chemicals by adopting new toxicity testing methods. The “U.S. Environmental Protection Agency’s Strategic Plan for Evaluating the Toxicity of Chemicals” outlines a new scientific approach that will allow EPA to assess risks from many chemicals and mixtures by adopting new toxicity testing methods that use recent advances in molecular biology, genomics, and computational sciences.

Readers of MassTortDefense who have an interest in toxic torts know the impact that government testing and evaluation of chemicals can have on litigation. Under the EPA's traditional risk assessment approach, the agency relied mostly on data generated through the intentional high dosing of experimental animals. While this approach has provided EPA a basis for much regulatory decision-making over the past several decades, such testing has known limitations arising from the dose-response concept and inter-species variations. Traditional testing also has been less useful on complex issues such as cumulative exposures, life-stage vulnerabilities and genetic susceptibilities.

The new approach is to focus more on identifying and evaluating cellular response pathways responsible for adverse health effects when sufficiently perturbed by environmental agents under realistic exposure conditions. The new Strategic Plan is centered on three interrelated components: (1) the use of toxicity pathways identification and use of this information in screening and prioritization of chemicals for further testing; (2) the use of toxicity pathways information in risk assessment; and (3) the institutional transition necessary to implement such practices across EPA.

In addition to the scientific bases, the new forms of testing, when fully implemented, will permit EPA to screen more environmental chemicals more quickly for potentially harmful effects. The strategic plan will also allow EPA scientists to look at how children may react differently to the same chemicals as adults, thus providing better health protection for children, says the Agency.

The EPA plan builds on the 2007 report, Toxicity Testing in the 21st Century: a Vision and a Strategy, of the National Research Council of the National Academies of Science, regarding toxicity testing and risk assessment.
 

Nanotechnology Update

Many readers of MassTortDefense know that nanotechnology refers to a new field of technology that seeks to manipulate and control products, really matter, on the atomic and molecular scale, typically 100 nanometers or smaller. To give some sense of scale, one nanometer is one billionth, or 10-9 of a meter. A nanometer compared to a meter is the roughly the same ratio as that of a baseball to the size of the Earth. Or another analogy, a nanometer is the length a man's whiskers grow in the time it takes him to lift his razor to his face to shave.

First, the European Food Safety Authority (EFSA) recently called for public comments on its draft scientific opinion document assessing the potential risks of engineered nanomaterials used in food and feed. EFSA opinions provide guidance for the European Commission and European Union member state food safety organizations.

EFSA has noted that complete information about engineered nanomaterials in food is lacking, leading to uncertainties in risk assessment. In particular, the agency said knowledge is limited about how engineered nanomaterials in food should be characterized, detected, and measured. It also said more information is needed on the toxicological and environmental impacts of using such nanomaterials.

The comment period on the draft opinion is open until Dec. 1, after which the scientific opinion will be revised and finalized, taking the comments into account.

Second, back in the US, the activist group Consumers Union released new product tests this week, claiming to show that some sunscreens claiming not to contain nanoparticles appeared to contain them.
 
The group is concerned because nano-size particles are known in some applications to have different properties than the conventional versions of these chemicals. Sunscreen manufacturers use nano-size particles of these ingredients for several reason, including because they help make the products clear rather than opaque, something consumers prefer. The European Union has required manufacturers to submit data on sunscreens containing nanoparticles.

Third, the EPA has issued an announcement intended to give notice of the potential application of the Toxic Substances Control Act (TSCA) requirements to carbon nanotubes (CNTs). Carbon nanotubes are generally made from sheets of graphite no thicker than an atom—about a nanometer, or one billionth of a meter wide—and formed into cylinders, with the diameter varying from a few nanometers up to tens of nanometers. They are excellent conductors of electricity. Carbon nanotubes can also be used to reinforce polymers to create very strong plastics. Carbon nanotubes show promise as building blocks for computer chips that are smaller and faster than those made of silicon. Economists predict that the market for carbon nanotubes will grow to more than $1 billion by 2014.

EPA generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon already listed on the TSCA Inventory. Many CNTs may therefore be new chemicals under TSCA. If a particular CNT is not on the TSCA Inventory, anyone who intends to manufacture or import that CNT is required to submit a premanufacture notice (PMN) at least 90 days before commencing manufacture. MassTortDefense has posted about carbon nanotubes before.

Apparently, inquiries to the Agency and questions in public forums indicated a lack of clarity on this issue. Some of the misunderstanding may be the result of an EPA communication to a chemical manufacturer a number of years ago pertaining to a substance the Agency now considers to be a carbon nanotube material. EPA understands that the earlier communication may have been misunderstood by some companies as a possible indication that all CNTs may be equivalent to other allotropes of carbon already on the TSCA Inventory. Hence the clarification.
 

FDA Meeting On Nano-Technology Spurs Debate

The FDA held a public meeting on September 8, 2008, to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report relating to the development of agency guidance documents concerning nanotechnology. In July 2007, FDA had issued a report analyzing scientific and regulatory considerations relating to the safety and effectiveness of FDA-regulated products containing nanoscale materials regulated by FDA, and making recommendations regarding these considerations. The Nanotechnology Task Force Report made recommendations which covered foods (including dietary supplements), food and color additives (including food contact substances), animal drugs and feeds, cosmetics, human drugs and biologics, and medical devices. Additionally, the Report summarized the state of the science for biological interactions with nanoscale materials.

The meeting included a plenary session led by Dr. Norris Alderson, head of the FDA Nanotechnology Task Force, followed by separate sessions for prescription and OTC drugs, cosmetics, medical devices, food additives, and others. FDA speakers reportedly were interested in comments on the circumstances under which the regulatory status of a product might change if nanoscale materials were utilized instead of the traditionally sized materials evaluated by regulatory officials when the product was first approved. 

Andrew Maynard, the chief science adviser for the Project on Emerging Nanotechnologies, told the FDA at the September meeting that they should view products containing nanomaterials as potentially "risk-added." Maynard said that materials with a dimension less than 100 nanometers exhibit unique properties due to their small size, and thus are “value-added." But, Maynard said, the unique properties exhibited by nanomaterials might also carry special risks. Francis Quinn, speaking on behalf of the Personal Care Products Council, offered a different perspective. For example, while nanoparticles are used in the early stages of developing sunscreens, by the time they are mixed with other ingredients they are no longer nanoscale and present no different risks than traditional sunscreens. Jay Ansell, senior director of the council, said no special labeling of nanoscale ingredients in cosmetics is needed.

But other speakers said the FDA needs to take a different approach as it contemplates regulating products containing nanoscale ingredients. The Conservation Law Foundation said that existing frameworks for assessing risks need to be updated to address nano-specific attributes such as particle characteristics. And a researcher from The George Washington University urged caution about the use of nanomaterials in dietary supplements.


As an aside, the latest report from the Project on Emerging Nanotechnologies addresses nano-scale silver. Silver Nanotechnologies and the Environment: Old Problems or New Challenges. The most common nanotechnology material currently used in the products is silver, which is mentioned in 235 product descriptions, such as silver-containing socks, baby carriages, air filters, coin-operated washing machines, and swimming pool treatments. 

The report asserts that widespread use of nanoscale silver will challenge regulatory agencies to balance important potential benefits against the possibility of significant environmental risk, highlighting the need to identify research priorities concerning this emerging technology. The issue of assessing the risks posed by nanoscale silver was highlighted after the Environmental Protection Agency’s (EPA) San Francisco office earlier this year imposed a fine of $200,000 on a California company selling computer keyboards and mouses coated with nanosilver. EPA issued the fine on the basis that the products should have been registered under federal pesticide law because of the company’s germ-killing claims. Due to its antibacterial properties, some have argued that the Federal Insecticide, Fungicide, and Rodenticide Act may be used to regulate many uses of nanoscale silver.

Nanosilver is a new challenge, says the report, a problem that fits poorly into the old boxes of the existing regulatory system. EPA is crafting a Federal Register notice that will invite comment on a citizen’s petition on nanoscale silver. EPA also has a 2007 white paper on nanotechnology.
 

Think Tank Releases Nano-Technology Report

A Washington, DC think tank last week released a new report with suggestions on how the next administration should approach regulation of nano-technology in products.  The Project on Emerging Technologies is based at the Woodrow Wilson Center in Washington. The Project was established in 2005 as a partnership between the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts. The Project is dedicated to helping ensure that as nanotechnologies advance, possible risks are minimized, public and consumer engagement remains strong, and the potential benefits of these new technologies are realized.

Nanotechnologies are hailed by many as the next industrial revolution. They promise to change everything from the cars we drive to the clothes we wear, from the medical treatments our doctors can offer to our energy sources and workplaces. Although focused on very small particles, nanotechnologies offer large potential benefits. From new cancer therapies to pollution-eating compounds, from more durable consumer products to detectors for bio-hazards like anthrax, from novel foods to more efficient solar cells, nanotechnologies are changing the way people think about the future.

The Project on Emerging Nanotechnologies collaborates with researchers, government, industry, NGOs, policymakers, and others to look long term, to identify gaps in knowledge and regulatory processes, and to develop strategies for closing them. The Project's stated mission is to try to provide independent knowledge and analysis that can inform critical decisions affecting the development and commercialization of nanotechnologies.

A source of uncertainty for nanotechnology is regulation. The Project released a 28-page regulatory agenda for the next administration, noting that whichever candidate wins is going to have to deal with this issue, probably sooner rather than later. The next president has the opportunity to ensure that nanotechnology’s benefits will be maximized and its risks identified and mitigated, says the group. 

The report, Nanotechnology Oversight: An Agenda for the Next Administration, calls for the White House and federal agency policymakers to maximize the use of existing laws to improve nanotechnology oversight. Such measures include defining nanomaterials as “new” substances under federal toxics and food laws, thereby enabling the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) to consider the novel qualities and effects of nanomaterials. The group addresses whether the Federal Food, Drug and Cosmetic Act, the Toxic Substances Control Act and the Consumer Product Safety Act need to be amended to cover nanotechnology.

The Project notes that more nanotech products are hitting the market. From March, 2006 to February, 2007, the number of manufactured goods using nanotech tripled to 600.  For fiscal 2009, the federal government has devoted $1.5 billion to nanotech, a sum split up between various agencies. Under the Bush administration, EPA has a Nanoscale Materials Stewardship Program, which is endorsed by the Synthetic Organic Chemical Manufacturers Association, the American Chemistry Council and the NanoBusiness Alliance. Some state governments, however, are pushing forward with their own rules on nanotech.

Coincidentally, consumer advocates said this week that food produced by using nanotechnology is quietly coming onto the market, and they want U.S. authorities to force manufacturers to identify them. New consumer products created through nanotechnology are coming on the market at the rate of 3 to 4 per week, according to The Project on Emerging Nanotechnologies.

MassTortDefense has posted on nanotechnology here and here.

 

2d Circuit Rejects Novel Mass Tort

Here at MassTortDefense, the focus is often on developments in ongoing mass torts and significant product liability litigation. How interesting to be able to report on the Second Circuit’s decision to reject plaintiffs’ attempt to create “in essence a mass tort for making inaccurate statements.” In Benzman v. Whitman, No. 06-1166, 2008 WL 1788401 (2d Cir. 4/22/08), the court ordered the dismissal of a putative class action seeking to hold the former EPA administrator liable for her erroneous reassuring statements about the health risks of the World Trade Center dust in the aftermath of the Sept. 11, 2001, attack.

Background
The class action lawsuit was brought on behalf people who lived, attended school, or worked in lower Manhattan or Brooklyn following the attack. The class alleged under a variety of theories that Christine Todd Whitman and EPA officials acting at her direction made statements regarding air quality  that failed to report health risks associated with WTC dust or misrepresented the nature of those risks, thereby violating the Plaintiffs' Fifth Amendment substantive due process right to be free from government-created health risks. The district court denied Whitman's motion to dismiss the claim against her as an individual for misleading the public about the air quality.

2d Circuit Reverses
The Second Circuit rejected any individual liability claim, pointing out that no court has ever held a government official liable for denying substantive due process by issuing press releases or making public statements. Such a suit against a federal official for decisions made as part of federal disaster response and cleanup efforts implicate the special judgment and policy factors that counsel against creation of a litigation remedy. Plaintiffs' allegations fell far short of showing either the type of special relationship between governmental actor and victim or a state-created danger arising from the relationship between the state and the private assailant.

The 2d Circuit noted the evidence “that the agency's performance in discharging its responsibilities in the aftermath of the 9/11 attacks, which involved an attack on America's largest city unprecedented in our history, was flawed. But legal remedies are not always available for every instance of arguably deficient governmental performance.” Id. at *11.

The nuances of a Bivens Fifth Amendment claim, and intricacies of the APA, are perhaps not frequent aspects of mass torts. But the 2d Circuit clearly recognized the potential impact of recognizing the claim alleged. Plaintiffs alleged a state-created danger, sufficient to impose liability, based on a senior official's public statements that offered assurances of environmental safety that turned out to be substantially exaggerated. The Court called this an attempt to create “in essence a mass tort for making inaccurate statements.” Id. at *5. The 2d Circuit would have no part of creating such a novel mass tort.

That type of policy hesitation ought to at least be part of the analysis of new causes of action (like medical monitoring), attempts to expand existing causes of action (CFA claims), and application of important legal defenses (preemption).

BPA Litigation Begins- But Why?

Bisphenol A (BPA) is in the news. This is a chemical produced in large quantities for use primarily in the production of polycarbonate plastics and epoxy resins. Polycarbonate plastics in turn have many important applications, including use in certain food and drink packaging, e.g., water and infant bottles, compact discs, impact-resistant safety equipment, and medical devices. Polycarbonate plastic can also be blended with other materials to create molded parts for use in mobile phone housings, household items, and automobiles. Epoxy resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants or composites contain bisphenol A-derived materials. U.S. manufacturers produce some 7 billion pounds of BPA annually, and business worldwide has been growing about 4 percent a year, driven by rising demand in Asia.


Recently, BPA has been in the news, with regulatory and legislative attention being applied, scientific data being generated, and litigation being brought. MassTortDefense questions those in the media suggesting this should be the “next mass tort.”

FDA Role

BPA has been in use for decades, and has been long regarded as safe by FDA. (Aside: Attacks on the FDA, and the alleged politicization of science is a favorite line of plaintiffs, and we will see it here. But, the agency relied in part on research backed by the American Plastics Council only because FDA had input on its design, monitored its progress, and reviewed the raw data. The fact is, it is industry's responsibility to demonstrate the safety of the products they sell; that industry generated data is used in looking at product safety is neither unusual or inappropriate. )

NTP Report
BPA received considerable recent attention due to widespread human exposures and concern for possible reproductive and developmental effects reported in laboratory animal studies. A recent draft report by the Center for the Evaluation of Risks to Human Reproduction (CERHR) of the National Toxicology Program (NTP) examined the Food and Drug Administration finding that bisphenol-A is safe when used to line infant formula cans.

The CECHR was established by the National Institute of Environmental Health Sciences (NIEHS) as part of the National Toxicology Program in 1998. CERHR convenes a scientific expert panel that meets in a public forum to review, discuss, and evaluate the scientific literature on a selected chemical. CERHR selects chemicals for evaluation based upon several factors including production volume, extent of human exposure, public concern, and the extent of published information from reproductive and developmental toxicity studies.

The CERHR/NTP draft report, issued April 15 for public comment, expressed "some concern" based on animal studies that the chemical might affect the neurological systems and behavior of fetuses, infants, and children.


Legislative Reaction

The legislative [knee jerk] reaction? Sen. Charles Schumer (D-N.Y.) and Sen. Dianne Feinstein (D-Calif.) announced recently that they have introduced legislation that would prohibit the use of bisphenol-A in all children's products. Canada recently proposed to ban bisphenol-A from polycarbonate baby bottles. Several states also are considering legislative bans or restrictions on the chemical. California legislators, for example, are considering a bill that would ban BPA in children's products.

Litigation?

And the litigation wasn’t far behind. A California woman has initiated a class action accusing Nalge Nunc International Corp. of suppressing key information about the potential health risks of its hard-plastic sports bottles containing bisphenol A. See Felix-Lozano v. Nalge Nunc International Corp., E.D. Cal., No. 08-cv-854, filed 4/22/08). Of course, the suit comes despite the fact the manufacturer already announced it was phasing out the production of bottles using the chemical within a few months. Plaintiff does not claim use of the bottles has harmed her or her children's health. As is typical with product claims in which the plaintiff was not injured by the product, the suit alleges fraud, and violations of consumer fraud laws, specifically the Unfair Competition Law, False Advertising Law, etc. Based on all available scientific evidence, the defendant in this case continues to believe that products containing BPA (bisphenol-A) are safe for their intended use.

However, plaintiffs will try to treat the product-line change/subsequent remedial measure as an admission of liability rather than a simple reflection of the fact that customers indicated they preferred BPA-free alternatives and the company acted in response to those concerns. U.S. retailers Wal-Mart and Toys 'R Us have already removed baby bottles containing BPA from store shelves. Playtex said it would offer free non-BPA bottles to parents and will stop using BPA in all products by the end of the year.

And a purported class action has been filed over the use of bisphenol A in plastic baby bottles and toddler training cups. The suit, Maria Sullivan et al. v. Avent America Inc. et al., 4:08-cv-00309 (W.D.  April 30, 2008), alleges that five baby bottle makers failed to disclose that BPA poses risks to an infant’s brain and sexual development. Plaintiffs allege that defendants continue to represent that their BPA-laced products are safe despite mounting evidence to the contrary. The suit is seeking to recover the amount plaintiffs spent to purchase the defendants’ products and the amount plaintiffs spent and will spend to replace the products.

Does the NTP draft report warrant all this?

The NTP Brief on Bisphenol A is not a quantitative risk assessment, nor is it intended to supersede risk assessments conducted by regulatory agencies. The NTP Brief on Bisphenol A does not present a comprehensive review of the health-related literature; it does not include a comprehensive analysis of the issues related to this chemical. The NTP report relies heavily on animal testing, rather than human epidemiology. Regarding the neural and behavioral effects reported in some studies of rats and mice at relatively low BPA doses, the Panel authoring the report also acknowledges that it is not even clear whether these effects should be construed as an adverse toxicological response. The draft report does not conclude that BPA is dangerous. It notes that further research is needed – that’s the right approach to new data or concerns about a product that has been in use for decades. And the key reported low-dose effects are not replicated or corroborated.

The report found that there was negligible danger in exposure to BPA for adults and pregnant women, and only minimal concern for adults exposed even to high levels of the chemical in an occupational setting. The CERHR Panel also noted the apparent scientific implausibility of any mechanism that would produce endocrine effects at low doses that are not also observed in well conducted studies at higher doses. Again, the need for more research. And the panel report documents that much of the sampling to date on possible migration of BPA into food has been done utilizing an approach subject to interference from substances naturally present in food products.

The American Chemistry Council has noted that the weight of scientific evidence, as assessed by Health Canada and other agencies around the world, provides reassurance that consumers can continue to safely use products made from bisphenol A. Consumer products made from polycarbonate plastic and epoxy resins, including products for infants and children, are accepted as safe for use, and used, around the world. But an FDA re-review of the safety of the chemical for additional reassurance to the public on the safety of consumer products makes perfect sense to industry.

Cure Worse Than Problem

Any wide-spread ban of the product – or litigation accomplishing the same result -- may risk the public safety more than enhance it. Epoxy resins derived from bisphenol A are used to manufacture protective polymer coatings for the inner surface of metal food and beverage containers. This critical technology protects the contents of these containers from aggressive food products, thereby assuring a safe, wholesome, and nutritious food supply. Compared to other coating technologies, coatings derived from epoxy resins provide superior adhesion to the metal surface, greater durability, and higher resistance to the wide range of chemistries found in foods and beverages. These attributes are essential to protect the packed food from microbiological contamination, which is a significant food safety issue.

Canning might be the single most important innovation in the preservation of food in history. More than 1500 food items are regularly packed in cans, making out of season foods globally accessible year-round. More than 90% of food and beverage cans use epoxy-based coatings because of their strength, adhesion, formability and resistance to chemical reactions in the food and drinks -- without affecting the taste or smell of the product. They protect the food from the container and from bacterial contamination. They give canned foods their long shelf-life.

State court jury rooms are a bad place to make policy decisions that can have far-reaching impact on public health.

EPA Revises Chemical Risk Information System

Readers of MassTortDefense who have an interest in toxic torts may wish to take note that the Environmental Protection Agency’s (EPA) Office of Research and Development recently announced revisions to the Integrated Risk Information System (IRIS).

What Is IRIS?

IRIS is a compilation of electronic reports on specific substances found in the environment and their potential to cause human health effects. IRIS was initially developed for EPA staff in response to a growing demand for consistent information on substances for use in risk assessments, decision-making and regulatory activities. For each chemical contained in IRIS,  the database contains summary information on the studies evaluated, any uncertainties or assumptions made in the studies, a statement of the level of confidence that EPA has in the study, the names of EPA scientists to contact for more information, and complete bibliographic citations. See Report of the IRIS Quality Action Team on External Peer Review and Public Involvement at 5 (July 1994).

IRIS provides human health risk information describing the potential adverse health effects that may result from exposure to over 540 environmental contaminants. IRIS includes descriptions of hazard identification and dose-response information, quantitative risk estimates for chronic non-cancer and cancer effects, and access to searchable scientific documentation.

Not Just Regulatory

While EPA often will base regulatory rules on IRIS evaluations, this is not just a regulatory issue. IRIS is generally accepted as a reliable source of information on the potential hazardous effects of those chemicals that are included in IRIS. See National Oilseed Processors Ass'n v. Browner, 924 F.Supp. 1193 (D.D.C.,1996). Thus, proffered experts in the toxic tort branch of products litigation may refer to and seek to rely on IRIS. E.g., Avance v. Kerr-McGee Chemical, 2006 WL 39124272 (E.D. Texas 1/1//07); Allgood v. General Motors, 2006 WL 2669337 (S.D. Ind. 9/18/06). And this is true of class actions, e.g., Pohl v. NGK Metals Corp., 2003 WL 24207633 (Pa. Com. Pl. 7/9/03)(rejecting medical monitoring class action), and mass toxic torts. E.g., In re Welding Fume Products Liab. Litig., 2006 WL 4507859 (N.D. Ohio 8/8/06).

The upcoming changes are to the process for developing chemical assessments, and will include an expanded process for recommending a substance be assessed; the earlier involvement of other agencies and the public; hosting “listening sessions” to allow for the broader participation and engagement of interested parties; and an even more rigorous scientific peer review of IRIS assessments.

How It Works And How It Will Change

On an annual basis, the IRIS Program requests nominations for new or updated IRIS assessments from EPA Program Offices and Regions and from the public. The IRIS process has started with the development of a draft Toxicological Review for the chemical.  A health scientist, referred to as a Chemical Manager, is assigned to each substance. The Chemical Manager is responsible for developing the draft assessment and shepherding draft documents though the review process. Development of a draft assessment consists of a literature search and preparation of a draft Toxicological Review and an IRIS Summary. The Chemical Manager may work with a team of toxicologists, epidemiologists, and statisticians in reviewing and analyzing the available literature. EPA’s risk assessment guidelines form the basis for the analysis. This work is often supported by an EPA outside contractor.

The next stage includes internal and external scientific reviews of the draft document, conducted in accordance with Agency guidance on peer review. These may include internal (EPA) peer review, a review by a standing group of senior health scientists representing EPA’s Offices and Regions and by selected senior health scientists with scientific expertise relevant to the substance, review by other federal agencies, and external peer review, typically via a panel meeting. Final steps are the EPA response to review comments, and development and posting on the IRIS web site of an IRIS Summary and final Toxicological Review. www.epa.gov/iris

The new steps in the process include increased participation by other federal agencies and the public in the development of the Toxicological Review and greater opportunities for other federal agencies to conduct research to fill data gaps. Together, these changes to the IRIS process are supposed to help create a more predictable, streamlined, and transparent process for conducting IRIS assessments. A major stated goal of the Agency is to define the important role that public and inter-agency comments and interactions play in the process, and to foster greater communication and sharing of relevant scientific information between experts, interested parties, and EPA.

Effects on Readers?

The revised procedure is not without controversy, as environmental groups and Democratic legislators – ironically those often calling for more public input and participation – have argued that chemical risk assessments will become a “special-interest scrum.”  But for clients of readers of MassTortDefense, it may offer increased opportunities to ensure their voice is at least heard.