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 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.

TSCA: Pre-Manufacture Notification and Review

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

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

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

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

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

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

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

Are we on a similar path with a new TSCA?

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

Inaugural Post

Welcome to Science News & Views. This forum will explore how decisions concerning hazard, risk, human health and the environment shape modern life. We'll do this by highlighting news events, recent publications, and current trends in the scientific and policymaking communities. We believe this exercise will illustrate how business and consumers are impacted by good (and bad) policy and suggest how decision-making may be improved.

To kick things off, we'll take a look at a recent interview with Richard Hubner about product safety regulation. In this Q & A, Rich argues that elected officials and their staffs are ill-equipped to micro-manage regulatory decisions concerning risk. Instead, they should establish coherent legal frameworks and funding levels for regulatory agencies, put them to work developing risk-based performance standards, and hold them accountable. Rich also urges legislators to get back in the business of oversight, using hearings and subpoena power to monitor the work of regulators--in an ongoing fashion, not just when high profile events compel their attention and intervention.