Regulatory Developments

2010 Predictions

January 7, 2010

As is our custom, The Acta Group, L.L.C. is pleased to forward our thoughts on what may be in store this year from the U.S. Environmental Protection Agency's Office of Prevention, Pesticides, and Toxic Substances. In light of the significant chemical management developments underway in the European Union, we are pleased that Ruxandra Cana and Koen Van Maldegem from the Brussels office of Field Fisher Waterhouse LLP have contributed their thoughts on what may be headed our way in the EU.

As always, we hope this information is useful, and would be pleased to expand upon any topic upon request.

The Acta Group, L.L.C. Field Fisher Waterhouse

2010 Predictions
January 7, 2010

Our thoughts are below on what may be headed our way in 2010 from the U.S. Environmental Protection Agency's (EPA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS). In short, the momentum and positions that the Obama Administration took in 2009 are likely to become greater and more solidified in 2010 as a number of key issues are addressed.

"Not Bush"

EPA as a whole continues to exhibit a desire to be the "un-Bush." That is, decisions or policies that originated with Bush Administration appointees appear to be regarded as presumptively inadequate. Administrator Jackson's repeated statements that "the cop is back on the beat" are one indication of this bias. The Office of Pollution Prevention and Toxics' (OPPT) statement last September to take a fresh look at EPA's policy on how nanomaterials should be treated under the Toxic Substances Control Act (TSCA) and the "superseding" of the Chemical Assessment and Management Program (ChAMP) are other examples. The Office of Pesticide Programs' (OPP) review of atrazine is yet another. Another clear indication of this is in the air area, namely Administrator Jackson's signing of the two endangerment findings under the Clean Air Act on December 7, 2009, though this initiative is not discussed further given the focus of this memo on toxics issues.

The desire to be "un-Bush" may be relevant for some programs, but it has led to actions in OPPTS that some believe are without scientific basis or need, such as the atrazine review, since OPPTS was not significantly partisan over the past eight years. Some may dispute that characterization, but the repeated rhetoric about the past "do-nothing" Bush era may take a significant toll in a number of areas within OPPTS. For example, morale of the career staff, who have been responsible for many decisions and activities during the Bush period, can be expected to suffer. Similarly, chemical and agrochemical manufacturers can be expected to resist the characterization that the past eight years reflect some sort of "do nothing" mentality, particularly in light of the completion of pesticide reregistration and tolerance review as required by the Food Quality Protection Act (FQPA), an initiative of the Clinton Administration.

Administrator Priorities

Administrator Jackson has often emphasized her priorities, which include chemical reform, environmental justice, and transparency, in speeches and writings since her confirmation last January. We can expect OPPTS initiatives in 2010 to promote these priorities in significant ways.

Administrator Jackson's issuance on December 30, 2009, of new regulatory risk management chemical action plans on certain chemical substances is a reflection of the Administration's commitment to overall domestic chemical management. Our December 31, 2009, memorandum, available online, reviews the action plans in some detail and offers a number of observations regarding the significance of the action plans and their role within the ongoing and broader chemical policy debate. What process is followed in refining the action plans in response to public comment and how these plans are implemented will be a test of Administrator Jackson's commitment to transparency.

Most recently, the announced policy of subjecting certain new Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration decisions to public comment before making a final determination may prove controversial. This will be especially so if the policy has a significant impact (as it may well) on the ability of the pesticide program to meet its Pesticide Registration Improvement Act (PRIA) deadlines.

Also, enhancement and expansion of the Worker Protection Standards will be a higher priority as part of an emphasis on environmental justice. Enhanced protection of agricultural workers may also drive revisions to the way occupational risk assessments are conducted (as announced on December 8, 2009), including perhaps the addition of an additional ten-fold safety factor for certain occupational assessments, which could have a drastic effect on the necessary mitigation requirements for some pesticides.

Continued emphasis on transparency is also likely to lead the program to review policies that underpin confidential business information (CBI) claims in one or both OPPTS programs. Renewed concerns about the scope of CBI claims asserted under TSCA by proponents of TSCA reform will almost certainly play out in legislative actions intended to limit the ability to assert CBI protections. EPA also recently announced on December 22, 2009, the beginning of a rulemaking process to require disclosure of inert ingredients in pesticide formulations -- historically a very controversial issue, and a topic on which there is likely to be significant dispute.

Endocrine Effects

The pesticide program has issued, and continues to issue, endocrine effect test orders for certain pesticides. The program now will soon face both the question of what any newly developed test results from these lower-tier tests mean, and whether any results can obviate the conclusions reached previously by the program on the basis of more advanced tests (e.g., the multi-generation reproductive toxicity tests).

Potentially with even larger programmatic implications would be any determination that for endocrine effects, there is a greater effect at lower doses of certain compounds. This is a long-debated concept with as yet no clear scientific conclusion. If EPA were to reach such a conclusion, it could call into question hundreds of other risk assessment conclusions reached over the past decades of toxicology testing. Presumably there would be an elaborate and lengthy scientific and deliberative process before reaching any such groundbreaking conclusions. Any such conclusion, either for or against the idea of a "low dose" effect, will involve many programs across EPA. As such, it will also involve the direct involvement of the senior leadership of EPA's Office of Research and Development (ORD), which until very recently did not have a new Assistant Administrator in place. Dr. Paul Anastas was confirmed for this position on December 24, 2009.

FIFRA Autonomy and FIFRA Process

In recent years, the general standing of FIFRA and its requirements as the virtually sole driver of pesticide regulatory decisions has been under assault. The now almost routine challenge to pesticide approvals under the Endangered Species Act (ESA) will continue. The larger question is whether EPA's new leadership and its sister agencies can devise a way to comply with ESA with something resembling a timely and predictable process. Prospects at this time remain grim for achieving this goal.

Even more important may be the evolution of EPA's approach to National Pollutant Discharge Elimination System (NPDES) permits for certain pesticide uses. To impose and implement permit requirements for each application of certain pesticides without a significant disruption to current agricultural practices will be a goal difficult if not impossible to meet. Nonetheless, EPA continues to devote significant resources to complying with the current court-ordered requirements, although grower and industry trade groups continue to seek a reversal of the current situation through a currently pending petition for Supreme Court review.

TSCA Reform and EPA's Enhanced Chemical Management Program

As one of the short list items on Administrator Jackson's list of priorities, TSCA reform will be a dominant part of OPPTS' activities in 2010. The release in September 2009 of a set of Administration principles for reform of TSCA was a significant development that lends credence to future Congressional efforts to reform TSCA. At the same time, the Administrator announced a comprehensive approach to enhance the Agency's current chemicals management program within the limits of existing authorities. Developing new legislative proposals while also attempting to be more active under current law, will consume the time and attention of EPA's senior leadership like no period since TSCA's earliest history over three decades ago. If legislation is enacted, any new requirements, as well as simply ramping up the revised program, will also be a consuming activity for both the Agency and the regulated industry.

Because the release of the new and improved Kid-Safe Chemicals Act (KSCA) has taken longer than expected, it is difficult to speculate when legislative efforts will be undertaken in earnest. If the bill is released in February as is rumored, further hearings and counter proposals could be ramped up fairly quickly. Even so, however, TSCA reform could take a back seat to climate change or other major legislative initiatives, further delaying meaningful legislative action until later in the year.

Ironically, while the relative failure of the recent climate change meetings in Copenhagen may reduce the probability of domestic climate change legislation in 2010, it may enhance the chances of TSCA legislation moving forward. The legislative Committees responsible for TSCA are the same ones deliberating climate change proposals. If climate change debate is stalemated, then these Committees may seek some victories or achievements in other arenas, such as chemical reform legislation. As the 2010 elections approach, the current Congress will likely face potential criticism as long on promises and short on achievements -- which could then induce calls for action on less controversial proposals. That is not to say that TSCA reform will be easy, but it does start with more conciliatory rhetoric and a relatively smaller set of issues. Some may recall that in 1996, FQPA "came out of nowhere" as an achievement of the newly minted Republican majority in part seeking to allay criticism about its environmental accomplishments.

EPA's release of the first four action plans announced by Administrator Jackson on September 29, 2009, was a promise kept on December 30, 2009. The first plans cover phthalates, long-chain perfluorinated chemicals (PFCs), polybrominated diphenyl ethers (PBDEs) in products, and short-chain chlorinated paraffins (SCCPs). They set the stage for how EPA envisions this process will work in general, and invite vigorous discussion among the stakeholders immediately impacted by their release and chemical stakeholders in general given their precedential impact. EPA has also stated its intention to take TSCA regulatory risk management actions on a number of additional chemicals, including, among others, lead, mercury, formaldehyde, and two "glymes." The nature of the regulatory measures identified in the action plans is unprecedented -- EPA has never previously announced so many actions under TSCA nor has it ever cited the use of Section 6 so widely. Moreover, that the action plans were issued in this form after being reviewed by the Office of Management and Budget (OMB) is significant and portends potentially great and largely unfettered EPA activity in the months to come. Finally, EPA's ability to implement the regulatory actions will be a test of Administrator Jackson's commitment to using existing TSCA authorities and her clout within the Administration. If EPA acts according to plan, the second wave of action plans can be expected in March, with more to follow regularly thereafter.

EPA has committed to issue its action plans as a way of signaling its intent to use current law notwithstanding any legislative attempts to modify TSCA. These action plans may inform at least two aspects of any future TSCA legislative debate: (1) EPA's thinking about how to evaluate and possibly control chemical risks are belied by elements of these plans, which may serve as a template for how to structure future Administration proposals for reform; and (2) EPA's rhetoric is not as shrill as some may have feared, although this may further develop as EPA continues to implement these plans and roll-out future ones.

Even if critics of the current law and program lament the ambitions and timeframes proposed in the action plans, the obvious possible "fix" is to accelerate a review and control process, while EPA has laid out a standard risk assessment approach. If these plans, or something like them, are eventually seen as a reasonable method of assessment and control, albeit with accelerated processes or timeframes, they would be less radical than other proposed schemes. They also indicate that however crippled some may view past TSCA implementation, reform, not revolution, may be sufficient to meet the needs of a modern chemical control law. Lastly, in selecting these action plans, EPA has both explicit and implicit risk criteria that may help inform the debate about how many of the existing universe of 80,000 chemicals are of possible concern. The specter of "80,000 unregulated chemicals" provides a different political momentum than "100-1000 suspect chemicals" -- which may help move any eventual discussion of amendments towards the political center and facilitate something resembling a dialogue process as proposed by various players in the current debate.

EPA had intended to "reset" the TSCA Inventory under ChAMP. Now that ChAMP has been superseded by the enhanced chemical management program reforms discussed above, the future of the Inventory reset concept is in doubt. During the recent Congressional hearings regarding TSCA, witnesses testified that the Inventory includes over 80,000 chemicals, with some using this fact as a scare tactic while others attempted to put it into context by noting that the precise number of those chemicals actually in commerce today is unknown. Most agree that EPA has stepped away from the Inventory "reset" and it is, regrettably, questionable whether EPA will pursue what is otherwise seen as an initiative with value for EPA, industry, and the environment.

EPA is expected to issue proposed revisions to the Inventory Update Rule (IUR). According to the December 2009 Regulatory Agenda, revisions under consideration include eliminating the upper threshold to collect processing and use data for all reported chemicals, collecting multi-year production volume information, returning the frequency of reporting to every four years from every five, triggering reporting based on the annual production volume since the last IUR, and requiring electronic reporting. Other changes include modifications to specific data elements such as the production volume, types of industrial and commercial/consumer uses, requiring an indication of consumer or commercial use and, if commercial, the number of workers, changes to CBI claims, and other modifications.

EPA is reportedly working on a proposed rule, which may be issued in March if OMB review is relatively speedy. Prompt promulgation of proposed changes will be essential if the June-September 2011 IUR reporting period is not to slip.

EPA will also have to address in 2010 petitions for partial exemptions from reporting the IUR processing and use information where the chemical is of "low current interest" -- EPA's response to such petitions will provide additional insights into its thinking, particularly if the petitions involved chemicals identified as "low priority" under ChAMP. Stakeholders with credible bases to claim partial exemptions from IUR reporting are well advised soon to begin preparing and submitting them to EPA.

Nanomaterials

2010 promises to be a busy year for OPPT in the nano area. Importantly, the Nanoscale Materials Stewardship Program (NMSP) concludes in early 2010. EPA will issue a "detailed final report," reportedly later this month. The report may not be all that flattering as far as industry is concerned and is not expected to report much more than the Interim Report issued in January 2009. EPA is already working on "risk management actions" with respect to carbon nanotubes, as stated in Administrator Jackson's September 29 announcement. EPA reportedly will initiate a "significant new use" rule (SNUR) under TSCA Section 5(a)(2) to "require protective measures to limit exposure or otherwise mitigate the potential unreasonable risk presented by two carbon nanotube chemical substances (P-08-177 and P-08-328)."

EPA also noted in its Interim Report that environmental health and safety data gaps exist and that EPA is considering how best to use its authorities under TSCA Sections 4 and 8(a) to address the "data gaps on existing chemical nanoscale material production, uses and exposures." According to an item in EPA's December 7, 2009, Regulatory Agenda, EPA believes that a TSCA Section 4(a) test rule "may be needed to determine the health effects of certain multi-wall carbon nanotubes and nanosized clays and alumina." EPA states that the results of the tests that could be required would assist it in understanding the health effects of the substance to manage and/or minimize any potential risk and exposure, and "could also help with establishing a correlation between the chemical/physical properties and health effects needed to protect the health of workers handling the substance." The notice states that EPA intends to issue a notice of proposed rulemaking in November 2010.

Consistent with the Interim Report, EPA's December 7, 2009, Regulatory Agenda confirms that EPA is working on a proposal for a TSCA Section 8(a) rule to establish reporting requirements for "certain nanoscale materials." The rule is likely to include "existing chemical nanoscale materials" and, if so, would represent the first attempt to impose reporting requirements on other than new chemical nanoscale materials. The rule would propose that manufacturers notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. According to EPA, the proposed reporting would provide it "with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment." While EPA continues to consider this option, its appeal is diminished due to the "small business" exemption under TSCA Section 8(a) that could effectively exclude a potentially large portion of the nano industry.

Although not included in the Regulatory Agenda, EPA is also reportedly considering issuing a SNUR for nanoscale chemical substances in general. Support for this approach seems to be growing and would round out EPA's information gathering efforts when viewed in tandem with a TSCA Section 8(a) rule. A SNUR would also greatly increase the regulatory implications insofar as significant new uses, however they are defined in the rule, of existing chemical nanoscale materials would be subject to notification and review by EPA using TSCA Section 5 authorities. At the same time, such a measure would go a long way to closing the perceived gap in oversight of existing chemical nanoscale materials and would likely affirm EPA's policy interpretation on new versus existing chemical nanoscale materials. That said, and as noted above, Assistant Administrator Owens last September publicly announced EPA's intent to take a fresh look at EPA's policy on how nanomaterials should be treated under TSCA so it remains to be seen what the outcome of that review will be.

Additional Discrete Issues/Decisions Expected in 2010

Atrazine -- The call for a series of Scientific Advisory Panel (SAP) reviews of the science underpinning the current regulatory position on atrazine is seen by some as a prelude to more stringent regulation. The meeting process alone will take some significant amount of time and program resources, and may raise both expectations and suspicions among environmental groups and growers, respectively.

Pesticide Drift -- The program will continue to struggle with how best to address the issue of pesticide drift. The current proposal is effectively to disallow drift to happen, which is reasonable as a policy goal but has proven difficult to enforce. The enforcement of any "no drift" scheme will be the key element of any scheme -- which may mean the controversies about this issue will vary by individual state (since states have the primary enforcement authority for FIFRA). If the drift policy is used to fashion mandatory across-the-board requirements for buffer zones around certain facilities (e.g., schools), the size of any buffer zone requirement could prove controversial as either too small for some and for others as nonsensical "one-size-fits-all" requirements created by "far away bureaucrats in Washington."

Public Availability of the Identity of Inert Ingredients in Pesticides -- In September, EPA announced it was proceeding with a plan to disclose the identities of all inert ingredients in pesticides, including those that are potentially hazardous. According to EPA, the increased transparency "will assist consumers and users of pesticides in making informed decisions and will better protect public health and the environment." EPA followed through with this commitment with the issuance of an advanced notice of proposed rulemaking (ANPR) in mid-December. This issue quickly entwines sensitivities about CBI and the "public right-to-know" -- tradeoffs which historically have been proven difficult to resolve. As an ANPR, this suggests a multi-year process to reach a conclusion, a timeframe which will likely prove unsatisfactory to proponents of more public disclosure. This could result in "interim" policies that the program seeks to impose by Pesticide Registration Notices or other avenues outside of or parallel to the rulemaking process.

NPDES -- In addition to the comment above, the specific logistical requirements of any NPDES requirements will prove daunting. EPA will have to devise some kind of system to attempt to comply with the court's ruling, but it will involve regions and states in pesticide application issues like never before. "Just doing it" will prove difficult, since it technically could require some kind of scheme to request, approve, and monitor thousands of "permits." It is uncharted territory in simply how to do it, separate from any policy implications or stringency of the requirements. It will also prove politically controversial almost regardless of how it is fashioned, which may consume a significant amount of senior leadership's time and attention.

ESA -- Similarly, attempting to sort out and comply in any way with the ESA will continue to consume large amounts of leadership time and attention. Assistant Administrator Owens has already stated that he expects personally to attempt to coordinate how to fix the problem with the sister agencies. At the same time, he has little control over how those other agencies allocate their resources or drive their own internal policy development process. The problem has been the regional staff resources and conclusions -- which will be difficult to influence.

Agenda Overload

As the above outline suggests, like the larger rhetoric of some critics who see the Obama Administration as taking on too much at one time, there may become a situation of agenda overload for EPA as well. That a new team has ambitious intentions is only to be expected, but as the issues evolve and the particular related dramas unfold, the organizational capacity limits may be reached. The new leadership is indeed eager to lay out a large and ambitious agenda, and they have done much already in 2009. During 2010, there may become a kind of natural selection process taking place due to inherent time and resource constraints.

The European Union

 

Biocides

The European Union (EU) Biocidal Products Directive 98/8 is currently being reviewed and revised. The new regulation is expected to be adopted toward the middle to end of 2010.

The proposed regulation is currently being discussed in the Council of the EU and the European Parliament, the two EU legislative bodies, and the European Parliament is expected to adopt its first reading resolution in May 2010.

There is ongoing debate as to the status of treated articles, in particular articles treated outside the EU. Currently, articles can be treated outside the EU with biocides unauthorized in the EU, if the biocides do not have an external effect. EU Member States support the position of the European Commission to impose EU approval of biocides used to treat products made outside the EU.

The European Commission proposal to fast-track "low" risk products is also under discussion, and EU Member States remain divided on this issue.

Finally, whether the approval of biocides will be centralized with the European Chemicals Agency (ECHA) in Helsinki remains undecided, and the European Commission has indicated such centralization may impose too heavy a workload for ECHA.

Pesticides

In 2009, the new EU regulation concerning the placing of plant protection products on the market, and the EU Directive on the sustainable use of pesticides were published in the EU Official Journal. Member states must implement the Directive on sustainable use of pesticides by early 2011.

In 2010, the responsibility for pesticides (and genetically modified crops) will shift from the European Commission's Environment Directorate General (DG) to the Health and Consumers DG, DG SANCO, under plans unveiled for the new European Commission.

Nanomaterials

On December 22, 2009, the European Commission opened a public consultation on the strategic nanotechnology action plan for 2010-2015. The consultation closes on February 19, 2010. Further, in 2011, the Commission intends to publish information related to types and uses of nanomaterials, including safety aspects, to provide a "better and more accurate overview" of nanomaterials in the EU market.

REACH

A number of important items on the international front are expected in 2010. The first registration deadline for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) occurs in December 2010. Unless otherwise exempt, phase-in substances that are manufactured and/or imported into the European Community in excess of 1,000 metric tons per annum (high production volume chemicals); and/or are considered to be a carcinogen, mutagen, and/or toxic to reproduction in accordance with Directive 67/548/EEC at a volume greater than 1 metric ton per annum at least once after June 1, 2007; and/or are considered to be very toxic to aquatic organisms (R50/53) in accordance with Directive 67/548/EEC at a volume greater than 100 metric tons per annum are required to be registered by December 2010. In practice, because of additional obligations and deadlines, registration dossiers should be submitted to ECHA by September 1, 2010, at the latest.

This timeframe means that potential registrants have to agree on the data to be jointly submitted during the coming spring, so that the Lead Registrant is able to submit the joint registration dossier and obtain the token to be provided to the other joint registrants.

The capacity and flexibility of ECHA's IT system, REACH IT, will be tested in 2010 and some question whether the system has the horsepower to manage the large number of registrations requiring ECHA processing. The system is being re-evaluated and modified, in part to address the large number of registrations anticipated and, in part, to improve core functionalities and utilities.

According to ECHA, 143,000 substances were notified during the initial pre-registration period (prior to December 1, 2008) by 65,000 companies. There are no definitive numbers available now on how many Late Pre-registrations were notified. The list of pre-registered substances can be searched via the following link on ECHA's website, available online. It is unclear as of this date how many registrations will actually be performed. The number of Substance Information Exchange Forums (SIEFs) that have been formed (2,195) is considerably less than the number of substances that have been pre-registered. There is no indication whether a Lead Registrant has been nominated and agreed upon by each of the substance SIEFs. ECHA continues to receive consultations on test proposals in which the first agreed upon proposal was recently published. Consultation on three test plans has been completed in which comments on four proposed studies for two substances is still underway. We anticipate that additional consultations will be sought in 2010, and it is difficult to speculate on how many test plans will be accepted as ECHA's track record is evolving.

We anticipate that Member States will continue to nominate substances for inclusion on the Candidate List of substances requiring authorization (Annex XIV). Substances included on Annex XIV cannot be placed on the market or used without obtaining an authorization for uses not otherwise exempt.

To date, Germany and France appear to have nominated the most substances. As a result, industry stakeholders may wish to be especially mindful of the domestic priorities in each of these countries as it is likely that both will keep up a brisk nominations pace.

Despite the lengthy registration guidance documents ECHA has issued, ECHA received numerous substance dossiers that did not pass the quality check phase of review. The ability to resolve any discrepancies with ECHA following an informal manner is currently not part of the process ECHA follows, nor is such a process identified in the REACH legislation. As a result, the first appeal for a rejected dossier was filed in 2009 by Field Fisher Waterhouse, with technical support offered by The Acta Group EU, Ltd, an affiliate of Bergeson & Campbell, P.C. (B&C). The appeal was successful (see our memorandum online). The appeal has clarified some key issues arising in connection with rejected dossier submissions. Many questions and uncertainties remain, however, regarding REACH implementation, and the need for greater guidance will continue.

2010 may also be relevant for those companies that notified "new" substances under the previous EU chemicals legislation -- so-called "NONS" substances. ECHA indicated in December 2009 that it has started checking the compliance of these dossiers, which were transferred automatically as registrations under REACH.

In terms of amendments to the REACH regulation, it is understood that Annex II (related to safety data sheets) will be revised twice, once in December 2010 and once in 2015. More generally, the EU Environment Ministers have agreed that the European Commission should be "invited" to act to review whether the "combined effects" of chemicals are adequately addressed in EU legislation. This review has been scheduled for "early 2012 at the latest" rather than 2011, and, importantly, the Ministers' conclusions do not indicate that cumulative effects must be addressed under REACH.

Classification, Labeling, and Packaging of Substances and Mixtures

The Classification, Labeling, and Packaging (CLP) of Substances and Mixtures, Regulation EC No. 1272/2008, was published at the end of 2008. The CLP is a slight modification to the United Nations Globally Harmonized System of Classification and Labelling. Although CLP implementation and wholesale replacement of existing European Commission Directives is not anticipated for a few years, some industry stakeholders are already reviewing and implementing CLP for certain substances. Article 40 of the CLP regulation confirms that classification and labeling designations that are submitted as part of REACH registration dossiers need not be separately notified under the CLP regulation. With the fast-approaching deadline of January 3, 2011, for the notification of substances placed on the market on or after December 1, 2010, some industry stakeholders are consolidating their notification activities with a view toward discharging their CLP regulation obligations through their REACH registration obligations. Nonetheless, there is considerable anxiety over the crush of notifications expected by the January 2011 deadlines, which some estimate to be as high as 20 million.

Propagation of REACH-Like Laws

In 2009, authorities began to adopt and/or expand upon chemical programs and looked to REACH as a template. Turkey enacted REACH-like legislation at the end of 2008. Notification under this legislation was required by December 26, 2009. An amendment issued on November 10, 2009, extended the notification date for certain substances to be June 30, 2010. There remains a general lack of knowledge and guidance on the new law, however, and confusion abounds. Industry should continue to seek as much information as possible to ensure compliance with this program.

RoHS

The RoHS Directive 2002/95 (Restrictions of Hazardous Substances in Electrical and Electronic Equipment) is currently being revised and it is being reviewed in the European Parliament. A vote in the Parliament's Environment Committee has been scheduled for April 2010. One of the amendments proposes the inclusion of all halogenated substances in electrical and electronic equipment, but the fate of this proposed amendment is not yet known. The final text of the revised law is expected late 2010.

In this regard, the EU Member States are also discussing the overlap between RoHS and REACH, and potential ways to address redundancies and inefficiencies caused by this overlap.

The Lisbon Treaty

The Treaty of Lisbon (replacing the previous founding treaties, as amended since 1958) came into force on December 1, 2009. The Treaty sets out clear definitions for sustainable development and environmental protection, and finds that sustainable development is one of the fundamental objectives of the EU in its relations with other global entities. Combating climate change on an international level is also becoming a specific objective of EU environmental policy.

The Stockholm Convention

The Stockholm Convention on Persistent Organic Pollutants (POPs), after adding nine chemicals to the control annexes in 2009, is poised to continue its work in 2010. As part of an effort to build "synergies" among chemicals conventions, there will be a simultaneous meeting of the Conferences of Parties (COPs) to the Basel, Rotterdam, and Stockholm Conventions in Bali, Indonesia, in February 2010. The POPs Review Committee will meet in October 2010 and likely recommend additional chemicals for listing to the next Stockholm COP scheduled for May 2011.

Finally, the recent report that a group of almost 50 non-governmental organizations (NGOs) had written to the Administration seeking its support for Congressional action on toxic chemicals, including ratification of the Stockholm Convention, may improve the prospects for Congressional action. The letter is available online. The NGO letter is important as it signals a shift in the NGOs' political views to one of supporting development of implementing legislation and ratification.


 
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