Wal-Mart Bans PBDEs

Polybrominated diphenyl ethers (PBDEs) are used as flame retardants in various consumer products from electronics to textiles. Scientific studies have been published that suggest a link between PBDEs and human health effects (i.e., thyroid, liver and reproduction), while other studies indicate that PBDEs are safe. With the conflicting scientific results, PBDEs are a controversial subject. Acknowledging consumer concern about PBDEs, United States producers have either voluntarily phased out or are in the process of phasing out production of PBDEs. However, PBDEs can be still found in products imported from other countries. Currently, there is no federal ban on PBDEs, but a number of states have banned penta- and octa-BDEs, and some have issued regulations on deca-BDEs. Wal-Mart reacted to the lack of a federal ban and presence of patchwork regulations across the states by banning PBDEs from their stores.

The decision to ban PBDEs from their stores was first issued a couple of years ago, but has not been fully enacted. Recently, Wal-Mart notified their suppliers that as of June 1st 2011, they will begin testing all products for the presence of polybrominated diphenyl ethers (PBDEs). If PBDEs are detected, Wal-Mart will not allow the product to be sold in their stores.

This is not the first time that retailer have felt it necessary to restrict specific chemicals from their stores. Bisphenol A has been banned from Wal-Mart, Toys R Us and Whole Foods for a number of years.

Retailers enacting bans of specific chemicals are further proof of the need for revisions to chemical regulation in the United States. It is difficult enough for industry to properly comply when regulations vary from state to state. When nationwide chain retailers begin to produce their own bans, industry is forced to either pull their products or completely alter their formulations. In addition retailer restrictions on chemicals often are in response to consumer perceptions of risk and not actual risk proven by science. Federal regulators need to be aware and responsive to consumer concerns, whether it is enacting a ban, conducting a risk assessment, or issuing an assurance of safety, so that retailers do not feel it necessary to take action in lieu of the government.

Confidentiality Claims Denied Under TSCA

In May 2010, the US EPA proposed changes to their policy on Confidential Business Information (CBI) to improve transparency with TSCA submissions. New CBI claims would undergo more rigorous evaluation and claims of confidentiality will be denied unless the chemical identity contains mixture information specifically protected by law. In addition, EPA Administrator Lisa Jackson promised to review many of the past CBI claims and declassify chemicals when individually cited in health and safety studies. The declassification of the chemical identity would make the information

available to the public.

On February 10th, the implication of this new directive was immediately apparent when five companies were notified by the US EPA that the identities of 14 chemicals were not eligible for confidential treatment under TSCA. The companies have until the 31st day after the notification to challenge the order in federal court or the chemical identities will be disclosed.

This action has sparked new opposition from industry and trade associations. In the past, many have claimed that industry has been guilty of overusing claims of CBI for many of their chemicals and products, which is why the policy revisions are necessary. However, others contend that releasing too much information could negatively impact innovation within the chemical industry by endangering proprietary secrets and formulations to competitors.

Revising TSCA policy to increase the public’s knowledge is a good step, but a proper balance between secrecy and transparency is needed to ensure that actual trade secrets remain confidential while the public is still made aware of chemicals that have been linked to health and safety concerns.

State Legislators Announce Chemical Safety Laws

Back in December, Science News & Views discussed how the delay in chemical regulation reform, primarily TSCA, due to the shift in power in House of Representative could result in numerous different state regulations. Less than two months after that discussion, a press release by the non-profit organization, Safer Chemicals Healthy Families, announced the introduction of new chemical regulations by 30 states and the District of Columbia in response to the sudden governmental roadblock.

As discussed in the press release, nine states will introduce general chemical regulation state policies, approximately 17 states will announce restrictions or bans on bisphenol a in certain products, 8 states will introduce policies to ban cadmium in children’s products, 3 states will announce policies to reduce exposure to decabromodiphenyl ethers, and 11 states will be calling on Congress to overhaul the federal chemicals policy and TSCA.

State chemical regulation is nothing new. Over 70 chemical regulations have been passed in 18 states, ranging from laws concerning the ban of bisphenol A in consumer products to the concentration of contaminates in drinking water. When there is a deficit in federal chemical regulation in response to new science and emerging contaminants, States will fill in the gaps themselves. However, many of the State laws or guidelines are directly in response to public perception of the risks, despite if the science establishes that a risk actually exists.

The existence of laws concerning the same chemical or contaminant in different states makes it very difficult for industries with nationwide production to properly comply. Federal laws are needed to create uniform chemical regulation, which would decrease compliance confusion and create more realistic guidelines based on science and not perceived risk. The first step in more unified chemical regulation would be the overhaul and revision of TSCA. Hopefully, Congress will take note of the sudden influx of state chemical regulations and take chemical regulation reform off the back-burner and allow it to move forward.

Study That Linked Autism and Vaccines Now Determined to be Fraud

Back in September, Science News & Views discussed the retraction of the original 1998 article by Wakefield et al. that linked autism to the MMR vaccine and how despite the overwhelming evidence to the contrary, this article managed over the next decade to instill a fear in parents causing them to turn away from standard vaccinations. After the article was retracted and the medical license of Andrew Wakefield, the main researcher behind the study, was revoked, a United Kingdom journalist, Brian Deer, continued the investigation. His analysis was published in the British Medical Journal and provided details on the deliberate falsification of data used in the study for the purpose of suing the vaccine manufacturer.

Deer’s investigation showed that the errors in the Wakefield study were not the result of incorrect statistics, faulty analysis, or poor design. No, this study was a clear case of fraud. It is unsettling that one fraudulent study could have such an impact on the scientific world. When the study was published, the results were circulated by the media and parents understandably became alarmed. The number of children being vaccinated declined, resulting in resurgence in cases of measles and mumps. Despite Wakefield and his study being discredited, the belief that there is a link between the MMR vaccine and autism is so strong that the controversy has continued. The strength of this erroneous conviction is in part due to the media coverage of the issue.

It is the media’s job to report on new science, and they cannot be faulted for reporting Wakefield’s results when they were released in 1998. However, when the weight-of-evidence backed by numerous studies strongly began to favor the lack of an association between vaccines and autism, many of the media still reported on the supposed link citing Wakefield’s results and quoting activists with no scientific background who still claimed to be authorities on the subject and declared that there was ‘proof’ of the link. This is undoubtedly due to the reporters trying to provide a balanced story with viewpoints from both sides. While the media cannot have known that Wakefield falsified his data, the fact that this vaccine scare has lasted over a decade and negatively impacted the health of children proves that scientific news reporting should consider employing a weight-of-evidence approach and not allow another publicity-seeking fraud to cause an unnecessary and harmful health scare.

Bisphenol A Found on Money

A recent report published by the non-profit, advocacy groups Washington Toxics Coalition and Safer Chemicals Healthy Families stated that 21 out of 22 dollar bills tested contained small concentrations of bisphenol A (BPA). In addition, receipts collected across the country were also tested and found BPA concentrations on 50% (11 out of 22) of them. According to the report, normal handling of the receipts resulted in transfer of BPA from the paper to skin. The new data on BPA are used by the authors to illustrate the need for TSCA revisions.

By itself, a report like this sounds alarming, but it becomes less worrisome when certain factors are considered. While there have been many scientific articles suggesting a possible association between BPA and adverse health effects, there are also many others that do not find any significant health consequences to the public, especially at low concentrations. In addition, regulatory agencies in the United States and Europe have not deemed BPA to be a health threat under conditions of intended use.

Another important consideration is that this report was published by the non-profit groups themselves and not in a scientific journal, which means that it did not undergo an independent peer-review process. In particular, there is information in the report which is puzzling. For example, the statement that one receipt contained 2.2% BPA by weight is difficult to believe given the molecular weight of BPA. The report also indicated that people are being exposed from handling the receipts and currency, but only very small amounts of BPA are presumably absorbed through the skin. The hypothetical absorbed concentration would then be converted to a biologically inactive metabolite and eliminated from the body. Therefore, no adverse health impacts would have occurred. Finally, the CDC has conducted biomonitoring surveys of the United States and found that consumer exposure (which would include all potential exposure routes including receipts and currency) to BPA is low.

While it is interesting to learn that small amounts of BPA can be found on thermal paper products and dollar bills, the new information should not change the current regulatory viewpoint that BPA is not a public health threat given the biological insignificance of the concentrations. However, the authors’ call for revisions to TSCA legislation, no matter how unrelated it may be to the substance of their article, is still a necessary step for modernizing chemical regulation given the increased need to understanding of exposure and risk as they relate to chemicals in consumer products.

Chemical Regulation Overhaul May Hit Roadblock

According to a recent article published by Chemical & Engineering News, the shift in power in the House of Representatives from Democrat to Republican will greatly impact proposed chemical regulations and reform. Along with clean air and climate change regulations, the belief is that the TSCA reform will not be a high priority in the upcoming year. One Republican, Rep. Joseph L Barton (R-Texas), who is making a bid to head the House Energy and Commerce Committee, was quoted as saying that TSCA is “working well” in its current format. The Society of Chemical Manufacturers and Affiliates (SOCMA) and the American Chemistry Council responded by stating that they will continue to meet with legislators in the hope of convincing them to introduce the revised TSCA regulations in 2011.

Saying that TSCA is “working well” has been argued against by both non-profit groups and the chemical industry. The numerous hearings during 2009 provide support that revisions to 34-year old TSCA should be considered a priority and should not be delayed. As chemical regulations in the European Union and Canada continue to change and modernize with the advancement of science and technology, the United States runs the risk of falling behind in scope and relevancy. In addition, individual states, such as California, are developing their own regulatory initiatives which could result in a patchwork of regulations across the United States and cause enormous difficulties with compliance for industries with nationwide production and distribution.

Many of the Chemicals in Fragrance Products Are Not Listed on Labels

A recent article published by DiscoveryNews reported that “toxic or hazardous chemicals” have been identified in commonly used scented products, including dishwashing detergents, deodorants, baby shampoos, fabric softeners, and cleansing products. Many of the products tested were labeled as “organic” or “natural” and the majority of the chemicals detected were not listed on the product labels.

The debate over the toxicity of unlisted chemicals in scented products is not new. A number of non-profit groups have rebuked companies, often in the cosmetics industry, for not disclosing the entirety of their ingredients claiming that their products negatively impact public health. Industries that produce fragrances and International Fragrance Association have responded that their products are safe and that the fragrances are within acceptable limits.

Presently, fragrance formulations are protected as trade secrets or Confidential Business Information, but this may soon change as one of the goals of the proposed TSCA revision is to increase transparency. Therefore, claims of Confidential Business Information will be denied if the chemical is already on the publicly available TSCA Chemical Substances Inventory or is submitted under TSCA Section 8(e) as part of a health and safety study. Full chemical disclosure on product labels is also being discussed by many campaigns. While not all industries will be affected by the TSCA revisions (e.g., cosmetic are regulated by the FDA), many companies will find themselves burdened with providing in-depth toxicity data on their chemicals and the development of more detailed labels.

It is true that some people are sensitive to certain smells, not necessarily only artificial fragrances, and may develop headaches or other mild, temporary effects. Generally, this occurs when exposed to a high concentration of a scented product and not with normal application. However, the fact still remains that unlisted chemicals in scented products are an issue in the media and in legislation. As suggested by the proposed TSCA revisions, the chemical regulation landscape is changing. Whether it is Confidential Business Information or product labels, companies need to (1) have a full appreciation of the potential health impacts of the chemicals in their products, (2) stay informed on the changes to these regulations, and (3) learn how to comply with the regulations relevant to their industry.

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

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

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

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

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

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

Gas Production Technique Under Scrutiny

Controversy Over Whether Drilling Fluids are Contaminating Groundwater

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

REACH Right-to-Know Provisions: More Thoughts

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

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

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

Retailers May be Violating REACH Right-to-Know Provisions

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

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

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

Compliance Challenges for Chemical Companies

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

TSCA Legislation: A Short Phrase With Huge Implications

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

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

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

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

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

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

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

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

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

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

Autism “Debate” Reveals Media’s Misplaced Quest for Balance

An recent article from CNN.com suggests that suspected links between childhood immunizations and autism have finally been dispelled. Twelve years ago, the publication of a single journal article originally advanced the hypothesis that multiple vaccines (i.e, MMRs) were linked to autism. Subsequent research, including over a dozen epidemiological studies, showed no link between vaccines and autism. Further, the journal that published the original article retracted it, and its author was stripped of his medical license as a result of ethical questions pertaining to his publication. Unfortunately, the media has appeared to reach this consensus over a decade too late.

Furthermore, the CNN piece leaves readers with the impression that a debate in the scientific community is still ongoing. Undoubtedly this is the result of the reporter's desire to apply the practice of "balanced journalism" (e.g., quoting one expert on each side of a story line) to scientific controversies, even when the weight of evidence tilts emphatically in one direction.

In this case, parents across the globe were unnecessarily alarmed, immunizations were curtailed, and outbreaks of measles and other diseases resulted. In fact, to this day there are parents who are dangerously neglecting their responsibilities to protect their children's health by following the advice of a discredited study and uninformed celebrities. One would hope that in the future, the media would rely on more rigorous application of scientific principles, particularly the weight-of-evidence in the scientific community, rather than lessons learned during Journalism 101.

Bed Bugs and Pesticide Regulation

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

TSCA 2.0: Are Comparisons to Pesticide Regulation Instructive?

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

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

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

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

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

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

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

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

New TSCA Inventory Update Reporting Rule Proposed

Agency Continues Pattern of Deploying Existing Authority

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

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

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

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

Aggregate and Cumulative Exposures

An understanding of the various routes of exposure for chemicals in products, as well as their interaction with similar chemicals, are an important element of REACH and will likewise be central to a reformed TSCA. In combination with data on health effects, this information will allow authorities to make required safety determinations. Reliable modeling of exposure scenarios will also equip companies to persuasively defend their products against unfounded accusations in the media, the internet and the courts.

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An influential 1994 National Academy of Sciences report called Science and Judgment in Risk Assessment was one of the first voices citing aggregate and cumulative chemical exposures as critical to understanding real-world risk. Aggregate and cumulative exposures are related concepts concerning the potential impact of a given chemical through multiple routes of exposure, as well as the possibility that multiple chemicals might interact to produce additive or synergistic effects. For example, a person might be exposed to mercury from a smelting plant, but also in the fish he consumers. The same person might be exposed to different substances that share mercury’s neurotoxic effects, for example in pesticides he uses in the garden.

The Lautenberg bill directs EPA to “consider” the work of the Academy in this area. H.R. 5820 goes further, directing EPA to incorporate aggregate exposures in its determination of “reasonable certainty of no harm” (RCNH) for a particular chemical. At the July 29 hearing, there was some disagreement among witnesses and subcommittee members whether EPA or the chemical manufacturer or processor bore the ultimate responsibility for examining and making judgments on these complex issues.

Several lawmakers, including Rep. Diana DeGette (D-CO) noted that a recent modification to the bill agreed to by its drafters would make the company responsible only for providing information on exposure related to the chemical’s “intended use.” The agency would then amalgamate company submissions on various uses and exposures and incorporate these into its safety determination. However, other sections of the bill make clear that the agency’s failure to make timely determinations can have the effect of keeping a chemical out of the marketplace. Consequently, if EPA is thwarted in its efforts by the complexity of the analysis, by resource constraints or other factors, producers, formulators and commercial users may well have to undertake this effort themselves in order to keep the substance in use.

Regardless of what TSCA eventually requires, we believe there are compelling reasons for companies involved in the production and use of chemicals to take a proactive approach to exposure modeling and life-cycle analysis. Exposure data is a necessary complement to data on human and ecological toxicity in the realm of product stewardship and defense. Given the ready access to information from a variety of media sources and the ease with which this information can be distorted or misunderstood, a company’s ability to substantiate its exposure, hazard and disposal findings will prove critical in defending a product, company or industry. The groundswell of toxic torts cases, along with state-initiatives to restrict or eliminate chemicals based on inaccurate data, further support the wisdom of building a baseline understanding of exposure. We believe there’s no need to wait for legislation, news coverage or litigation to begin assembling one's product defense arsenal.

Regulating Hazard or Risk - The Debate Continues

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

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

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