Regulatory DevelopmentsJanuary 2, 2014
Bergeson & Campbell, P.C. (B&C®) outlines below thoughts on what may be headed our way in 2014 from the U.S. Environmental Protection Agency's (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). We also offer a few thoughts on European and Asian developments pertinent to chemical regulatory matters.
Although President Obama is well into his second term, the 2014 off-year elections, combined with the bitter partisan atmosphere in Washington, D.C., will result in a continuing use of environmental issues to make distinctions between the two parties. Closely contested races in the Senate may especially cause somewhat unusual alliances and/or emphasis on various environmental issues, as both parties seek to have majority control in the new Congress. Beyond the election-driven rhetoric, life at EPA will be driven by the typical demands of the discrete issues that come before program management on a daily basis. An added and complicating concern may be the impact on these and all issues of continued budget cuts that challenge EPA's ability to operate as it has in the past; even the simple ability to process approvals or conduct public meetings about non-controversial matters have become more difficult.
This memorandum outlines broadly many of the issues we expect to come before OCSPP in the coming year. For more detail on any issue or to review events as they occur, we invite you to review our website at www.lawbc.com. Our website has many substantive memoranda and information to access B&C webinars on a broad range of topics of interest to the chemical, pesticide, and chemical products communities. Some of these memoranda and webinars are specifically noted below for your convenience. As always, we would be pleased to expand upon any topic noted below upon request.
A Second Term for President Obama
2013 saw a new Administrator arrive at EPA, as Gina McCarthy was elevated from her former position as Assistant Administrator of EPA's Office of Air and Radiation (OAR). The fact that the then current Deputy Administrator, Bob Perciasepe, was passed over demonstrated the President's wish to stress the issue of climate change as part of his legacy. This emphasis was signaled early in the year when he made prominent mention of the issue, somewhat surprisingly, in his State of the Union Address. That EPA's top three priorities will be "climate, climate, and climate" will impact other federal agency operating programs; the new Administrator will be especially focused on delivering something resembling results to the President in a hostile political environment where there is little chance of any legislative success regarding climate issues. Any progress will have to come within current law; even with stretched or novel interpretations. This reality will leave less of Administrator McCarthy's time or capital to expend on other EPA programs, including budget priorities.
OCSPP also saw new leadership with a new Assistant Administrator, but not a new arrival, as Jim Jones finally received Senate confirmation on August 1, 2013. Jones had been Acting Assistant Administrator since December 2011, coming from the position of Deputy Assistant Administrator for OAR. Jones is a very familiar and comforting presence in OCSPP; he has been with EPA for over two decades, including serving four years as the Office of Pesticide Programs (OPP) Office Director (2003-2007) and four years as OCSPP Principal Deputy Assistant Administrator (2007-2011). His tenure also includes six months as OCSPP Acting Assistant Administrator in 2009 after the 2008 election.
Jones appears to maintain an excellent and direct relationship with Administrator McCarthy, which was likely fostered in part by Jones being her Deputy in OAR for a short period. Perhaps this relationship will help OCSPP priorities compete across other EPA program offices in the coming year.
Interaction with OMB
No longer facing re-election, the Administration can more fully pursue initiatives that otherwise may have been too sensitive or too ambitious before now. One indicator of such change will come in EPA interaction with the President's Office of Management and Budget (OMB).
OMB provides an important gatekeeper role through its Office of Information and Regulatory Affairs (OIRA). OIRA routinely reviews pending EPA regulations and significant policy initiatives. For many environmental advocates, OIRA is seen as a hindrance to EPA initiatives or attempts to pursue more forward thinking environmental policies. The OIRA function is both to coordinate rules across agencies and to comply with various Executive Orders mandating some examination of costs and benefits of rules and more generally to examine the reasonableness of EPA activities.
Before the 2012 election, there had been numerous pending matters at OIRA that many environmental advocates lamented the OIRA office was delaying or diluting. Many of these pending matters have now either been released or otherwise decided (some have been withdrawn) -- resulting in a mostly "clean slate." It remains to be seen how aggressive a second term EPA will be.
At present, only one Toxic Substances Control Act (TSCA) rule remains queued up at OMB. That rule, which was received by OMB in November 2010, concerns TSCA significant new use rule (SNUR) and Section 8(a) reporting requirements for nanoscale materials. During 2013, other TSCA matters were resolved or deferred. For example, the "chemicals of concern" (COC) list and a rule affecting confidential business information (CBI) claims on chemicals identified in health and safety studies submitted to EPA were withdrawn by the Office of Pollution Prevention and Toxics (OPPT). EPA's recently updated regulatory agenda for fall 2013 includes few new TSCA rules; projected deadlines for others have been delayed, as discussed below.
Along with the general budget debate about the "fiscal cliff" and any partisan maneuvering about taxes and spending is the cold reality that federal discretionary spending has seen a significant decline. The outstanding question is by how much, not whether, resources for programs such as EPA's will go down in both absolute and relative terms. Most of the cuts in the past few years have been met with a decline in program grant and contract dollars, though there have been personnel furloughs and freezes and reduced hiring to backfill retirements and attrition.
Even if President Obama is successful in the current clash with the Republican leadership of Congress, EPA resources are not expected to be robust. That will translate to further reductions in the operating programs such as OCSPP, and eventually (if it has not already) will translate into personnel, skills-mix, and salary impacts. For example, in the pesticides program, EPA reported that OPP saw 80 personnel leave in the past year, but was authorized to backfill only 30 of the 80 positions. If EPA has to implement another round of cuts, there will be at least another five percent cut to the program budgets. The budget situation will hinder the ability of both OCSPP programs to review submissions timely and meet other program objectives.
For the pesticide program, reauthorization of the Pesticide Registration Improvement Act (PRIA) fee legislation was expected to present some protection from more drastic program cuts. PRIA includes a "baseline protection" of a certain budget amount, which must be appropriated to keep the authorization to collect fees in place. The goal was to protect OPP from budget pressures to use PRIA fees simply to substitute for appropriated dollars The budgets imposed by sequestration, however, have waived the minimum baseline appropriations levels, leaving PRIA deadlines in some jeopardy. In addition, the pesticide program will be subject to Agency-wide policies such as hiring freezes, and current OCSPP leadership is directing some additional resources towards the toxics program, so even with PRIA fees, OPP might still suffer as it continues to contribute to resources made available to OPPT.
Farm Bill, EPA Oversight, TSCA Legislation
Divided government, especially in the current bitter partisan atmosphere in Washington, D.C., has made agreement on any legislative or major policy issue difficult at best. This will likely continue in 2014.
This often bitter partisan divide applies to legislation that historically has had relatively bipartisan support across many very diverse constituencies, namely the Farm Bill. Generally, the rural interests have focused mostly on issues affecting agricultural producers and urban interests have focused on government food programs such as nutrition assistance and food stamps. The current atmosphere may actually fracture the traditional coalition, which, at the end of the day, led to a Farm Bill reauthorization about every five years.
Both the House and Senate have passed Farm Bill legislation, and House and Senate conferees are struggling to find consensus on new five-year Farm Bill legislation. Just before adjourning for its winter recess, the House approved on December 13, 2013, by voice vote an extension of the 2008 Farm Bill through January 31, 2014. It is expected that Congress will pass a new five-year Farm Bill by the end of January 2014. Pesticide companies and grower groups have been supportive of language in the House-passed version of the Farm Bill that provides National Pollutant Discharge Elimination System (NPDES) permit relief for pesticide users. That provision would amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Clean Water Act (CWA) to prohibit EPA or a state from requiring a discharge permit under the CWA for applications into or over navigable waters of a pesticide labeled for such use, or the residue resulting from the application of such a pesticide. Although the Senate version does not contain such a provision, similar NPDES relief legislation was passed by the House authorizing Committee in late October, providing some bipartisan support for this provision before Farm Bill conferees.
The House legislation also contains provisions regarding pesticide registrations and the Endangered Species Act (ESA). In April 2013, the National Academy of Sciences (NAS) issued a report on how EPA and the Services (the Fish and Wildlife Service of the Department of Interior, along with the National Marine Fisheries Services of the Commerce Department) coordinate efforts to implement the ESA. The report was sought by Congress to help better coordinate agency activities and reduce the time, expense, and uncertainty of the current process (EPA's ESA program is discussed in more detail below). As part of the Farm Bill, the House bill has a provision seeking, among other requirements, to have EPA and the Services follow the recommendations of the April report.
It is not clear whether these amendments will be part of any final legislation, and there remain serious questions about whether any significant Farm Bill legislation will be successful in more than simply reauthorizing the current programs for some interim period if consensus on the major issues cannot be reached.
Partisanship between the House and Senate will also be found in the intensity and tenor of EPA oversight. The President has identified climate issues as a top environmental priority, and critics see this as proof that EPA is engaged in a "War on Coal." As a result, EPA can expect a continued stream of oversight hearings and information requests (including subpoenas) intended to produce data to show that EPA's efforts are unjustified or otherwise would lead to significantly higher energy prices. Also, as EPA may be more aggressive in pushing climate and other second term priorities, House critics can be expected to claim that EPA's initiatives across the board are unjustified "job-killers" impeding economic growth. Critics of EPA will certainly also be found in the Senate, but House critics will be able to convene hearings and move legislation through the authorizing Committees to make their points. For OCSPP, distrust of EPA and opposition to any expansion of EPA's authority will affect the chances of seeing any significant TSCA legislation, discussed in the next section.
In contrast, in the Senate, one can expect the Democratic majority to continue to press for expansion of various environmental programs generally, including support for EPA efforts to address climate change. As in the past, the Senate Democratic majority will be looked to for blocking or ameliorating some of the likely House Republican proposals, e.g., budget cuts or prohibitions blocking pending regulations. For OCSPP, in addition to any relevant House actions, the most visible efforts in the Senate will be an attempt to amend TSCA, an effort underway since the first year of the Obama Administration.
The future prospects for any new TSCA legislation appeared to be dim at the beginning of 2013. Then on May 22, 2013, S. 1009, the Chemical Safety Improvement Act (CSIA), was introduced by Senator Frank Lautenberg (D-NJ) and Senator David Vitter (R-LA). Senator Lautenberg at the time was Chair of the Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health, and Senator Vitter is Ranking Minority Member of the full Environment and Public Works Committee. That these two senior members of the Committee came to agreement was big news in itself; more remarkably, both members drew significant support from other Senators, making the legislation bipartisan and relatively widely supported. Some warm and openly supportive remarks were also offered by a number of stakeholders, including some, but by no means, all, of the environmental advocacy groups who have been actively working for TSCA reform. Also contributing to the legislation's development was the death of Senator Lautenberg in June, not long after introduction, with many remarks by colleagues that the legislation would be a fitting and deserved memorial to the Senator's tireless efforts to reform TSCA.
Efforts to revise TSCA have dramatically improved, so much so that some environmental groups seen as holding more extreme positions quickly mobilized significant opposition to the bill. Of particular concern was strong language in CSIA, which seemed designed to pre-empt virtually all state efforts to control separately toxic chemical uses. The issue of federal pre-emption, among other provisions, energized the Chair of the full Environment and Public Works Committee, Senator Barbara Boxer (D-CA), to oppose openly the newly introduced bill as she promised to address a number of issues she saw as shortcomings in CSIA.
Since introduction, the Senate has convened a hearing on the bill, and while no parallel legislation has been offered in the House, the Republican majority of the Energy and Commerce Committee has held a number of "informational" hearings on TSCA where the new legislation has been a backdrop to the Committee's work. Summaries of all such hearings are found online. The last House hearing, held on November 13, 2013, featured an explicit discussion of the Senate provisions and provided the first opportunity for EPA to appear as a witness at a TSCA hearing since the new bill was introduced (appearing for EPA was OCSPP Assistant Administrator Jones). House momentum appears to be picking up as of this writing, so on the whole prospects are improving.
As of this time, it appears that S. 1009 has both significant momentum and significant hurdles. The issues described as needing more work are substantive and among the most controversial (including pre-emption, confidential data claims, and the safety standard). At the same time, the bipartisan group of Senators who seem to be working to fashion a workable compromise includes the new Subcommittee Chair, Senator Tom Udall (D-CO). The most difficult rate-limiting factor may be the general calendar, since little legislation is expected to see significant action after mid-2014 as the next off-year elections draw near. That functionally leaves a mostly narrow window of time for any resolutions to be offered and agreed to given the number of significant issues needing resolution. But as mentioned, prospects have not been this positive since the issue was put on the Congressional and Administration agendas in 2009. For more information on S. 1009, including an analysis of its provisions, see the following.
TSCA Implementation and EPA's Enhanced Chemical Management Program
OPPT continued its efforts to make progress on Work Plan chemicals, including starting the peer review process for several chemicals during 2013. The October government shutdown affected a number of the peer reviews and EPA has rescheduled these to occur during the period after December 2013 and continuing into the early part of 2014. Big questions that remain concern OPPT's ability to conclude the peer review process satisfactorily given the variety and significance of the questions that have been raised during peer review (particularly those focusing on exposure aspects of the risk assessments), and then, more importantly, once the peer review step is behind them, how well (or if) OPPT will be able to use the risk assessments without additional revision/peer review to support regulatory actions where needed for the chemicals at play.
Related to this aspect are the possible impacts of the shuffle in organizational responsibilities and management that occurred in OPPT during the last quarter of 2013. Historically, exposure assessments for new and existing chemicals had been done by the Economics, Exposure, and Technology Division (EETD) in OPPT. This responsibility was moved to the Risk Assessment Division (RAD), which is now responsible for all aspects of risk assessment (i.e., hazard (health and ecotoxicity), exposure (occupational, general population, environmental, consumer, and environmental fate), and risk). This development represents an important shift to consolidate exposure/risk assessment responsibilities in one unit, but it will also present a potentially difficult cultural challenge in integrating the former EETD staff into RAD.
In addition, following the 2013 retirement of Dr. Oscar Hernandez, Dr. Tala Henry was named as the Director of RAD. Dr. Henry is an aquatic toxicologist by training and had previously worked in the National Program Chemicals Division in OPPT (as the Director), in RAD (as a Senior Advisor), and, earlier in her career, in the Office of Water and the Duluth Office of Research and Development (ORD) lab. While Dr. Henry seems well equipped to handle her new responsibilities (although seemingly she will need to learn more about exposure assessment), the sum total of these developments sets up 2014 as an important year for resolving the organizational and management challenges set in motion and in determining how the approach to handling risk assessment may evolve for both existing and new chemicals.
The fall 2013 Regulatory Agenda identified several new TSCA rulemakings, including a Section 8 reporting rule on chemicals used in "fracking," a rule to require assertion and periodic resubstantiation of CBI claims, and a SNUR for perfluorooctanoic acid (PFOA) and similar perfluorinated compounds (PFC). The last action seemingly relates to industry's decision to phase out a number of PFCs under EPA's 2010/2015 PFOA Stewardship Program, a voluntary program that has now been in play for about seven years and that, if phaseout is actually achieved, could be one of OPPT's more significant accomplishments. The Regulatory Agenda also pushed back the timelines for ongoing rulemakings, including certain regulatory requirements relating to formaldehyde in composite wood products, a SNUR and test rule for deca-brominated diphenyl ether (deca-BDE) and other polybrominated diphenyl ethers (PBDE), and several other SNURs relating to glymes, benzidine dyes, and toluene diisocyanate (TDI), among others, as well as a Section 8(d) rule on several diisocyanates (methylene diphenyl diisocyanate (MDI) and TDI). Background information on a number of these items can be found in the 2013 Predictions memorandum.
One of the important issues for several of the SNURs concerns the treatment of imported articles and whether the rules would lift the regulatory exemption that otherwise applies to imported articles. This has been proposed in the deca-BDE SNUR, for example, and has been identified as a component in other SNURs that are yet to be proposed. (It was also an issue for the long chain PFCs SNUR which issued in 2013 although that regulation had a narrow scope that involved use in an article (imported carpets), whereas the other SNURs at play have a broad scope of coverage.) There are several other significant regulatory issues at play in the deca-BDE SNUR, including the approach of combining a SNUR with a test rule (thus potentially squeezing companies between a "phase out" and a testing obligation) and how EPA will define or describe ongoing uses for the flame retardant chemicals. OPPT also has the challenge of getting this rulemaking through OMB/OIRA in relatively intact form despite the novel policy issues presented in finalization. Interestingly, the fall 2013 Regulatory Agenda did not include the combined SNUR and test rule on the 4th group of High Production Volume (HPV) Challenge chemicals, which raises the question of whether OPPT has dropped this action and what if anything it says about the approach of combining a SNUR with a test rule.
OPPT is thus continuing its efforts to use existing TSCA authorities to assess and regulate chemicals. EPA's initial effort to implement a list of COCs under Section 5(b)(4) was scuttled in 2013 and does not appear to be on the radar screen for 2014. This may in part be due to industry opposition to the creation of the list, which many feared would immediately identify chemicals to be deselected, resulting in commercial disruption and enhanced tort liability. Given the apparent forward progress on OPPT's other efforts to utilize available authorities, it would appear this effort is unlikely to be revisited in 2014.
At the same time, it is evident from this brief review of 2013 developments and 2014 prospects that OPPT has a number of significant questions that are yet to be answered concerning its Work Plan risk assessments and its ability to resolve the significant issues and concerns raised by several of its proposed SNURs. While OPPT is to be commended for its commitment to moving forward, it is useful to recognize that, unlike in the earlier years of the Obama Administration, OPPT is content to focus on completing its current commitments, rather than adding substantial numbers of additional commitments to its agenda. It is unclear how much of this is attributable to factors such as furlough days in 2013 and the continuing relatively bleak budget picture for 2014, and possibly to recognition by OCSPP senior management that with three years to go in the Administration, OPPT needs actually to complete key actions rather than make new commitments that may or may not be realized within the time available.
Regulation of Nanoscale Materials
According to EPA's fall 2013 Regulatory Agenda, EPA is developing a proposal to establish reporting and recordkeeping requirements under TSCA for chemical substances when manufactured or processed as nanoscale materials. This proposal includes a TSCA Section 5(a)(2) SNUR that would require persons who intend to manufacture, import, or process nanoscale materials for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.
In addition, according to the Regulatory Agenda, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a) that would require that persons who manufacture these nanoscale materials to notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. While the Regulatory Agenda states that EPA intends to issue a notice of proposed rulemaking in December 2013, EPA has yet to do so. In fact, EPA's proposed rule concerning TSCA Section 8(a) reporting, which EPA submitted to OMB in November 2010, remains under OMB review, as noted above.
Despite the lack of progress concerning broad rules under TSCA for nanoscale materials, in 2013, OPPT increased the number of SNURs issued for specific nanomaterials. OPPT's interest in obtaining data on existing nanoscale materials has not abated, and leadership can be expected to identify new opportunities to share these data with EPA. Industry will be expected to work with OPPT to identify acceptable means by which information can be shared.
Although EPA proposed in June 2011 several possible approaches for obtaining certain additional information on the composition of nanoscale pesticide products, EPA has not chosen a final approach, nor is it clear EPA will choose one any time soon. In its proposal, EPA focused particularly on information about what nanoscale materials are present in registered pesticide products, and defined "nanoscale material" as "an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm)." Under one approach, EPA would use FIFRA Section 6(a)(2) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B).
According to EPA's June 17, 2011, Federal Register notice, EPA believes FIFRA Section 6(a)(2) "is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach." The notice also proposed a "new approach" that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a "new" active or inert ingredient for purposes of FIFRA and PRIA, even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. More information is available in our June 10, 2011, memorandum.
On August 27, 2013, EPA announced its proposed decision to register "Nanosilva," a nanosilver-containing antimicrobial pesticide product. According to EPA, Nanosilva is a silver-based product "used as a non-food-contact preservative to protect plastics and textiles (e.g., in household items, electronics, sports gear, hospital equipment, bathroom fixtures and accessories) from odor and stain causing bacteria, fungi, mold and mildew." EPA states that it evaluated exposure to nanosilver from Nanosilva "using data showing that plastics and textiles treated with the product released, at most, exceedingly small amounts of silver." EPA also reviewed other information submitted by the applicant and used data from the scientific literature to evaluate the hazard of nanosilver. Based on its evaluation, EPA determined that Nanosilva "will not cause unreasonable adverse effects on people, including children, or the environment." As a condition of registration, EPA is requiring the company to generate additional data.
On November 7, 2013, a panel of the U.S. Court of Appeals for the Ninth Circuit issued a decision granting in part and denying in part the Natural Resources Defense Council's (NRDC) petition for review of EPA's 2011 conditional registration of HeiQ AGS-20 and AGS-20 U (collectively, AGS-20) pesticide products that EPA has determined contain nanoscale silver (nanosilver). The court vacated EPA's decision "insofar as it concluded that there was no risk concern requiring mitigation for short- and intermediate-term aggregate oral and dermal exposure to textiles that are surface-coated with AGS-20." The opinion by a majority of the appellate panel based this holding solely on EPA's failure to require risk mitigation after calculating a margin of exposure (MOE) for aggregate exposure to AGS-20 of exactly 1,000, and stated that this holding has no effect on "any portion of EPA's decision where the calculated MOE is greater than 1,000." The majority opinion also denied NRDC's other objections to the registration decision, holding that substantial evidence supported EPA's decision to use the characteristics of toddlers rather than infants in its risk assessment for AGS-20, as well as EPA's decision not to consider other sources of exposure to nanosilver in its risk assessment. In a dissenting opinion, one member of the panel disagreed with the decision by the majority to deny these other objections. The decision is available online. More information is available in our November 12, 2013, memorandum.
California Safer Consumer Products Regulations
2014 marks the year when implementation, and likely litigation, begins regarding the California Department of Toxic Substances Control (DTSC or Department) Safer Consumer Products Regulations (Regulations), which became effective on October 1, 2013. Memoranda providing background information on the Regulations are available online.
The Regulations impose requirements on "responsible entities" of "consumer products." Although responsible entities are defined to include manufacturers, importers, assemblers, and retailers, the requirements for responsible entities are tiered, such that primary responsibility plainly falls on product manufacturers.
The Regulations define a consumer product as it is defined in Health and Safety Code Section 25251: "a product or part of the product that is used, brought, or leased for use by a person for any purposes." The Regulations also state that a consumer product also means "[w]hen applicable, a component of an assembled 'consumer product.'" The Regulations apply only to consumer products placed into the stream of commerce in California and there are very limited exemptions (e.g., products exempt from the definition of "consumer product" as specified in California Health and Safety Code Section 25251, certain consumer products that DTSC determines are regulated by one or more federal and/or California State regulatory program(s), and/or applicable treaties or international agreements with the force of domestic law).
The scope of the Regulations includes four core elements of the Regulations -- Candidate Chemicals, Priority Products (PP), Alternatives Analysis (AA), and Regulatory Responses.
DTSC released the "Candidate Chemicals" List of approximately 1,200 substances on September 28, 2013 (see online). Prior to January 1, 2016, DTSC will consider a limited scope of Candidate Chemicals when reviewing product-chemical combinations. This Initial Candidate Chemicals List (see online) contains approximately 164 substances. Any potential responsible entity of a consumer product sold in California should review these lists to determine if any of its consumer products contain one of these substances. There are delisting proceedings potentially available to companies seeking to remove a chemical erroneously placed on the Candidate Chemicals List.
DTSC will evaluate and prioritize products that contain Candidate Chemicals to develop a list of PPs for which AAs must be conducted. To identify products of high priority, DTSC will evaluate the potential adverse health and environmental impacts posed by the Candidate Chemical(s) in each product based on several factors: potential adverse impacts and exposures during the life cycle of the product; product uses, discharges, or disposals; the extent and quality of information available to substantiate such impacts, exposures, and adverse waste; the extent to which other regulatory programs regulate the product; and "[w]hether there is a readily available safer alternative that is functionally acceptable, technically feasible, and economically feasible."
DTSC must release the Initial PP List -- limited to no more than five products -- by March 30, 2014. Within 60 days after a product-chemical combination is placed on the PP List, responsible entities will be required to provide a PP Notification to DTSC stating that they will conduct an AA unless they submit "alternative notifications." Alternative notifications to the PP Notification include: (1) Alternatives Analysis Threshold (AAT) Exemption Notification (where the COC is present only as a contaminant and the concentration does not exceed the Practical Quantitation Limit (PQL), or does not exceed the AAT established by DTSC); (2) Chemical Removal Notification (where the only change is the removal of the COC from the PP without use of a replacement chemical or otherwise adding other chemicals to the product); (3) Product Removal Notification (if the PP will cease to be sold or distributed in California); and (4) Product-Chemical Replacement Notification (where the COC is removed from the PP and any replacement chemical meets certain criteria).
Responsible entities (generally, manufacturers) must perform an AA for the listed COC-PP combination to determine how best to limit potential exposures or the level of potential adverse public health and environmental impacts posed by the COC in the PP. It will be important for companies with consumer products that may be identified as PPs to identify other entities similarly affected and determine the ability to consolidate efforts (e.g., through a consortium) in conducting AAs.
AAs will be conducted in a two stage process. The Regulations set forth the elements of each stage and the requirements of the AA Reports to be submitted to DTSC. At the end of the process, after the responsible entity has evaluated and compared the PP with each identified alternative with respect to each relevant factor and associated exposure pathways and life cycle segments, if applicable, identified, the responsible entity must select the alternative(s) that will replace the PP, unless the decision is to retain the PP. DTSC plans to release by January 2014 draft guidance to help chemical and product manufacturers, retailers, and importers evaluate different ways to make a product safer.
To provide a quality assurance mechanism for the AAs, DTSC will provide a public comment period for the Final AA Reports, review those comments, and then identify, no later than 30 days after the close of the public comment period, any issues that it determines need to be addressed by the responsible entity in an AA Report Addendum.
With respect to any documents or information submitted to DTSC, a person may assert a claim of trade secret protection. These claims will need to be substantiated by providing certain information to DTSC specified in the Regulations and by providing a redacted copy of the documentation being submitted with the trade secret information removed. There are very limited opportunities to claim a chemical identity as confidential "if that chemical is an alternative considered or proposed in an Alternatives Analysis, and a patent application is pending for the chemical or its contemplated use in the product."
After evaluating the Final AA Report, DTSC is required to consider the appropriate regulatory response. In selecting regulatory responses, DTSC shall seek to "maximize the use of alternatives of least concern when such alternatives are functionally acceptable, technically feasible, and economically feasible." Possible regulatory responses triggered by DTSC's findings and determinations include use restrictions, sales prohibitions, engineered safety measures or administrative controls, end-of-life management stewardship programs, and required research and development projects.
While there are indications that these Regulations may be litigated in the New Year, relying on a favorable outcome and doing nothing now is unwise. Companies doing business in California should instead be reviewing the chemical lists, determining if any of its consumer products contain one of those substances, reviewing and commenting on DTSC guidance (when available), identifying other entities similarly affected, and determining the ability to consolidate efforts (e.g., through a consortium) in conducting an AA.
2014 will likely see a continuation of issues that have dominated EPA's pesticide program during the past few years, such as implementation of the ESA and the CWA, and the impact of budget cuts. Added to the mix will be issues that have attained a higher profile in the last half of 2013, such as the impact of pesticides on pollinators (especially commercial honeybees), along with some long-developing initiatives that may now be deemed worthy of moving forward, such as revisions to the worker protection standards and release of a policy on off-target movement of pesticides (better known as EPA's "drift policy"). One can speculate about whether these more recent initiatives are partly due to the now comfortable time period since the re-election of President Obama -- but these policies have been long in development as they are inherently difficult issues.
The most contentious and difficult issue facing EPA's pesticide program remains implementation of the ESA. There remains a context of continued and repeated litigation by various parties over EPA compliance with the ESA in its pesticide approvals. Litigation continues by environmental advocates and pesticide companies and users over ESA requirements and how to manage the consultation process for endangered species between EPA and the Services regarding appropriate measures to protect species. During 2013, reports of new product registrations being delayed over ESA concerns presented a new element to the discussion, and these delays have the potential to impose significant and more immediate impacts on the availability of pesticides to agricultural producers.
Litigation will continue in 2014. Of particular note in the past few years has been the status of what is known as the ESA "mega-suit," which was originally filed in January 2011 by the Center for Biological Diversity alleging that EPA is out of ESA compliance on more than 300 pesticides on 214 endangered species (Center for Biological Diversity v. EPA, N.D. Cal., No. CV-11-0293, 1/20/11). This "mega" suit is national in scope and could affect agricultural producers across virtually all crops in all major growing regions. If ultimately successful, one result, at a minimum, would be to consume significant regulatory resources in OPP currently devoted to other programmatic activities.
There were repeated settlement discussions between the parties of the "mega" suit throughout 2012, and finally in November 2012, EPA and the industry intervenors filed motions to dismiss the case on various grounds. The court subsequently granted dismissal but the decision allowed the plaintiffs to refile the complaint if they met certain conditions, including identifying the agency actions under review and the affected species with more specificity. The environmental groups did refile a voluminous complaint for some of the pesticides, and EPA and the industry intervenors filed motions for a more definite statement. On November 25, 2013, the court issued a decision partially granting these motions, because the plaintiffs still did not allege sufficient facts concerning a specific failure to consult when they refiled their complaint. This new decision is limited to the facial sufficiency of the allegations in the new complaint, and it does not resolve some other long-standing objections by EPA and industry, including jurisdiction, application of the statute of limitations, and ripeness.
Litigation over ESA implementation has now been going on for at least ten years, and no easy resolution of these cases is expected anytime soon. Meanwhile, to attempt to break at least some of the stalemate, Congress directed NAS to conduct a study to better coordinate agency activities and reduce the time, expense, and uncertainty of the current process. The report, "Assessing Risks to Endangered Species from Pesticides," was released on April 30, 2013.
The report was requested by EPA and the other affected agencies in March 2011. The EPA position generally has been that its registration support analysis is more reliable than much of the criticism or otherwise vague assessments it has received from the Services (the Services may have a different opinion). A major goal of the NAS study was to define better, for all parties, what a reasonable assessment (or the components of assessments) should be, make recommendations that could lead to a more predictable pathway about how to conduct an ESA assessment, and offer comments on the current approach of EPA and the Services (including, for example, EPA's use of modeling as part of a registration decision, geospatial information, and the possible cumulative effects of pesticides).
In general, the report's recommendations are broadly supportive of EPA's assessment process and utilization of the registration data it has on hand. At the same time, the report was very critical of EPA's reluctance to utilize probabilistic risk assessment tools to frame many of the difficult issues that are part of an ESA assessment (for example, the appropriate way to evaluate the potential risk of pesticide mixtures or the fact that some number of different pesticides might be used in a specific cropping system). The report's impact appears to have made some significant headway in helping EPA and the Services come to agreement on a best, or at least better, path for coordinating data and assessments. The joint agencies held a briefing in November 2013 outlining what they described as the approach they will take in light of the report's recommendations, and some progress towards better coordination seems to have been made. Skeptics of the current process on both sides of the issue remain uncertain of whether the process outlined in the November briefing will truly make a difference in terms of either efficiency or protection of species. The briefing left many details vague with exhortations to the audience to "wait and see" how the agencies apply any new found epiphanies to the current procedural morass.
Lastly, as mentioned earlier, the Farm Bill may contain language related to the implementation of the report's recommendations, but it is not clear how direct or binding any legislation might be on the current plans of EPA and the Services.
On October 31, 2011, EPA issued a NPDES general permit to comply with what began as a January 2009 court decision that vacated an earlier EPA rule that had exempted pesticide users from needing a permit to apply pesticides in or near water bodies. This general permit covers only those states where EPA is the permitting authority, but the larger issue is the now effective requirement for water permits for many pesticide applications. To comply with the court decision, throughout 2012 states not covered by the general federal permit had to implement also a CWA permit program for certain pesticide applications. This has been and remains controversial, with concerns about the ability of pesticide users to comply either in terms of getting permits in time or otherwise following any subsequent requirements, and now facing citizen suit provisions available under CWA (unlike any similar provisions in FIFRA).
Generally, initial implementation of the requirements has not seen significant disruptions in most users' ability to use pesticide products. There have been reports, however, of some pesticide applicators (e.g., commercial applicators) that simply declined to offer certain pesticide services to avoid the possibility of needing a CWA permit or otherwise avoid certain liabilities. There have been reports of disease incidence (e.g., mosquito-borne West Nile virus) that ordinarily might have been reduced through mosquito abatement programs that were not available in some jurisdictions due to the CWA requirements (costs may have increased, certain product vendors may have curtailed their services, and related factors).
Fears of potential negative impacts, such as increased costs or reduced availability of products, has led to Congressional efforts to enact legislation that would generally remove the requirement for a water permit for FIFRA-compliant applications. As mentioned earlier, the pending Farm Bill legislation from the House Agriculture Committee has a legislative reversal of the CWA requirement. It remains uncertain whether any legislative change affecting the current rule will become law. Proponents of eliminating the rule remain fearful that critics of pesticide use will file citizen suits concerning compliance with the now-required CWA permits.
Another long-standing issue that will continue to be active in 2014 is EPA's proposal to initiate cancellation proceedings against certain rodenticide products, including consumer products containing the second generation rodenticides brodifacoum and difethialone. In May 2008, EPA announced its intention to restrict certain rodenticide active ingredients due to concerns for non-target wildlife and risks to children, and stated that, as of June 2011, it would consider those products misbranded. That approach was challenged by Reckitt-Benckiser Inc., maker of D-Con products, insisting that EPA should instead issue a cancellation notice to implement its decision and not rely on the threat of considering such products misbranded. In a court challenge to determine the issue, the court agreed with Reckitt (Reckitt Benckiser Inc. v. EPA, D.C. Cir., No. 09-1314), and so EPA in 2011 initiated the cancellation process. In November 2011, EPA released it draft Notice of Intent to Cancel, and began three days of meetings by the Scientific Advisory Panel (SAP) as required by the cancellation procedures outlined in FIFRA.
EPA finally issued its cancellation order in February 2013, which, as expected, was challenged when Reckitt filed a request for a cancellation hearing. A cancellation hearing is a potentially long and laborious evidentiary hearing concerning affected products before an Administrative Law Judge. In such a hearing, all evidence admitted into the record is typically sponsored by a witness subject to cross-examination, and affected parties may obtain pre-hearing discovery. EPA is required to present its basis for cancellation, but the hearing is de novo. New evidence is typically presented and new issues may be examined over the course of the hearing.
Although EPA could have issued its cancellation notice sometime in 2012, it appears that EPA decided to delay the hearing process until after the election. Now that a cancellation notice has been issued and challenged, it is not clear how much programmatic attention will have to be devoted to this proceeding during the year as the situation unfolds, but hearings can be very resource intensive and consume significant amounts of time and attention on the part of senior program managers. Taking place in an era of significant budget pressures will only exacerbate any resource effects of the cancellation process.
An issue that has been increasing concern in the world of pesticide regulation is the potential impact of pesticide use on pollinators. Many consider this an issue of how to avoid (or investigate) bee-kills, but the overall issue is more general than simply adding label language to reduce any impacts of pesticide use on bees. Pollinators/bees have been a subject of a sub-group of EPA's Pesticide Program Dialogue Committee (PPDC), and the pesticide program has been more active, devoting more time, attention, and regulatory concerns about the issue.
Much of the focus in recent years has been on the use of some newer chemistries, specifically the use of neonicotinoid compounds, that have replaced past applications of organophosphate and carbamate products. These newer compounds have a greatly improved mammalian hazard profile, but remain potent insecticides, and bees are insects. A key concern is that these neonicotinoid compounds, used as seed treatments, allow fugitive dust during application to contact pollinators and result in bee-kills. These compounds may also result in residues in nectar and other parts of the plant that could be a source of exposure to pollinators. Bee-keepers have been especially critical of what they see as a lack of attention paid to the issue of bee-kill incidents and the lack of label language that might help further prevent or mitigate possible exposure to pollinators.
EPA has become more concerned about the issue, and is considering what additional data requirements or specific label restrictions might be appropriate to address the issue. The pollinator issue is affecting more products and overall is receiving more program attention. This increase in program activity is expected to continue in the immediate future, and continued PPDC work group activity will further keep the issue before EPA. Meanwhile, the more general issue of "bee health" had become part of the conversation to broaden the possible solutions to include hive disease (mite control products), additional habitat, and general good hive management practices -- steps that could improve the situation beyond any particular label restrictions that may be appropriate for any specific product.
Endocrine Disruptor Screening Program (EDSP)
EPA has been implementing the endocrine effect testing requirements in the Food Quality Protection Act (FQPA) since 1996. After lengthy delays and difficulties in getting the program started, EPA is now planning to complete its review of the initial round of testing in the next year, and issue test orders for Tier 2 testing sometime in Fiscal Year 2014. Critics of the program argue that the program is requiring lower tier, less informative tests on many pesticide active ingredients that already have higher tier, multi-generation tests completed as part of existing FIFRA requirements. Further, EPA has not yet validated its Tier 2 studies, nor has it indicated how the results of any Tier 1 tests will be interpreted to lead to the requirement for any Tier 2 tests that will be eventually validated.
Along the way, in 2014, EPA will hold a FIFRA SAP meeting in January, and has indicated intention to complete the validation of its Tier 2 assays this year. Results of these efforts will also tie into the broader EPA effort to develop its 21st Century Toxicology strategy, where even more EDSP-like assays will be developed to make chemical testing less costly, quicker, and with reduced animal testing.
For those "phase-in" substances with a higher tonnage (≥100 tonnes) and those with certain classifications that are subject to the registration requirements under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), registration deadlines occurred in November 2010 and May 2013. The European Chemicals Agency (ECHA) is urging companies to begin preparing for the May 31, 2018, registration deadline (≥1 tonne per year and <100 tonnes), which is fast approaching. Registrations due in 2018 will see smaller, medium, enterprise (SME) businesses pursuing specialty chemical registrations. Many SMEs will need to develop a business strategy to ensure a successful registration or consider exiting the European Union (EU) marketplace prior to the 2018 registration deadline due to the cost of registration. ECHA has released information and guidance to promote the best practice in fulfilling the obligations and also to publicize the various services and tools that can help companies, of all sizes, comply with REACH registration requirements. More information is available on the ECHA website.
We anticipate that companies with significant registrations due in 2018 will develop a strategy to ensure that those substances requiring a registration in 2018 are evaluated and prioritized. In 2014, companies can be expected to begin to develop a subset of substances to register between the years 2014-2018 or initiate an exit strategy from the EU marketplace. For those substances deemed as key by a company and for which a Lead Registrant has not emerged, we anticipate interactions with the Substance Information Exchange Forum (SIEF) to begin and data gathering efforts to begin. In addition, we anticipate in 2014 that for key substances in which a Lead Registrant has emerged, companies will initiate studies necessary to produce the analytical data to support a joint submission. Companies should anticipate laboratories over the next several years to be extremely busy and thus should begin to secure laboratory space necessary to ensure a successful registration can be performed in advance of the 2018 deadline. This year will see increased activity in preparation for those substances subject to the 2018 deadline.
ECHA, as part of its Multi-Annual Work Programme 2014-2018, in 2014 is updating certain REACH guidance documents to improve the information submitted within registration dossiers for submission in 2018. This update will specifically consider companies identified as SMEs. ECHA identifies four areas for which additional support will be provided: substance identification, description of uses, chemical safety reports (CSR), and the harmonization of classification and labelling by industry. Additional information can be found online. In addition, due to the apparent lack of communication observed within supply chains, particularly regarding Exposure Scenarios, ECHA intends to provide additional guidance and workshops in 2014.
ECHA projects harmonizing the enforcement aims and priorities of EU Member States in 2014 via a two year joint enforcement program scheduled to launch in 2015. The enforcement program will focus on authorization and substances placed on the EU market illegally. Many EU enforcement agencies are enhancing their detailed review of Safety Data Sheets (SDS). Requests from enforcement agencies for updates, amendments, or improvements to SDSs are likely to become more common in 2014.
In March 2014, the Community Rolling Action Plan (CoRAP) will be updated to include new evaluations for years 2014-2016. The CoRAP includes substances that ECHA suspects could pose a risk to human health or the environment. As required annually, the update to the CoRAP list will be proposed and circulated to the Member State competent authorities and ECHA Member State Committee. The first CoRAP, in 2012, listed 90 substances for review under the REACH evaluation process; as of December 2013, the CoRAP listed 152 substances, with 79 evaluations listed as "Ongoing." The substances are divided for evaluation during 2012, 2013, 2014, and 2015.
For 2014, a total of 46 substances are scheduled for evaluation by various Member States. According to ECHA: "In many cases the initial concerns are related to PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive use or consumer uses. In general, the uses of these substances cover various areas and are not limited to particular industrial, professional or consumer uses." More information is available online.
Below we summarize key Asian chemical management developments anticipated in 2014. The Acta Group, B&C's consulting affiliate, has offices in China and addresses regulatory issues in virtually all Asian markets.
2013 saw new leadership in Beijing. This new leadership is expected to be more environmentally friendly and open to promoting environmental protection measures. We anticipate that the new leadership will direct increased governmental support and investment to protecting the environment. The much publicized deteriorating situation pertaining to air quality in China's major cities is prompting the government to take significantly more action to ensure the protection of the environment. We anticipate additional environmental protection regulations with emphasis on air quality to be promulgated in 2014.
In late 2013, the Ministry of Environment Protection (MEP)-Chemical Registration Center (CRC) merged with the Center of Solid Waste of the MEP, creating a new center, with the appointment of Mr. Lin as Director. The merger is viewed positively, and we expect in 2014 more efficient management of the new chemical registration and notification process.
The CRC is continually fine tuning the implementation of the Environmental Management of New Chemical Substances in China (Decree 7). To date, implementation has been largely regarded as successful. Although many of the available guidance documents remain vague in some areas or do not explicitly identify all situations, MEP-CRC appears to be receptive to understanding better the need for clarity and offering guidance on situations not addressed. The team at MEP-CRC is gaining much needed experience. Submission numbers for regular notifications in 2013 remained at levels similar to those in 2012, but we anticipate an increase in the regular notifications in 2014, as well as in technical reviews of substance specific issues, i.e., nuances, read-across, and Quantitative Structural Activity Relationship (QSAR). Many hope that 2014 will bring about a more consistent approach to enforcement at the provincial/local level. Nonetheless, MEP-CRC is expected to remain as supportive as possible to ensure the intent of the regulation is met.
In 2013, pharmaceutical companies in China -- multi-national or domestic -- were required to register all new chemicals pursuant to CRC-MEP requirements, except those in the form of finished products. We expect to see the full impact of this new development around mid-2014.
The demand for regulatory services in food contact, agrochemicals, and fertilizers is likely to increase in 2014, as food safety is increasingly becoming an important social and political issue in China. The strong demand for more crop yields incentivizes agrochemical and fertilizer companies to invest more on new chemical substances research and development (R&D). China is a top country of preference in terms of manufacturing intermediates.
As predicted last year, many regulations were modified and/or proposed to bring the program into alliance with the provisions outlined in China's Regulations on the Safe Management of Hazardous Chemicals and GHS implementation (Decree 591), which is considered a "keystone" legislation. 2014 is expected to be similar in that additional regulations are anticipated to continue alignment with Decree 591. The draft hazardous substance list was circulated in late 2013 and is anticipated to be issued in final in 2014.
Chinese Taipei (Taiwan)
In December 2013, revisions to Taiwan's Toxic Chemical Substances Control Act (TCSCA) were promulgated and are to take effect on December 11, 2014. Companies will need to remain informed and knowledgeable about the modifications, as they will greatly impact manufacturers and importers of chemical substances. As a result of the revisions to TCSCA, several other relevant regulations will need to be revised or drafted prior to December 2014 to align with the revised TCSCA. The TaiwanEPA plans to hold public hearings and seminars in the third quarter of 2014. Implementation regulations are anticipated in the first half of 2014.
The formation of the Ministry of Natural Resources and Environmental Protection (MNREP) is expected to coincide with the implementation of the revised TCSCA. The MNREP is to include a chemical and pollution control agency. The registration and evaluation of chemical substances is to fall within the scope of the MNREP. The MNREP will have upwards of 60 staff members and use the services of external experts as necessary.
In January 2013, four substances were added to the regulated toxic substances list with the classification of one substance being altered. The substances are: diarsenic pentaoxide (Classes 2 and 3); lead chromate molybdate sulphate red (CI pigment red 104)/molybdate orange (Class 2); lead sulfochromate yellow (CI pigment yellow 34) (Class 2); tris(2-chloroethyl)phosphate (TCEP) (Class 2); and di-iso-butyl phthalate (DIBP) (Class 4 to Classes 1 and 2).
Companies should pay particular attention to chemical control program developments in Taiwan throughout 2014.
Effective March 2013, Japan's Ministry of Economy, Trade and Industry (METI) published an updated version of its manual for chemical notification. A revised version of the manual is issued each year, which sets out the submission and documentation requirements for notifications. The manual addresses substances within the following lists/categories: General Chemical Substances; Priority Assessment Chemical Substances (PACS); and List of Monitoring Chemical Substances.
Chemical notification schedules for new chemicals in 2014 were unveiled in September 2013 by the Ministry of Health, Labour and Welfare (MHLW), METI, and the Ministry of Environment (MOE). From September 2013, manufacturers and importers of new substances must follow the revised requirements when submitting new chemical notifications. Notifiers are required to use the updated manual for new substance notification published in August 2013 to prepare their dossiers and notifications.
Japan released a PACS revision in 2013. Tier 1 risk assessments of 79 of the 95 PACS were designated in 2011. METI advises that eight PACS will undergo Tier 2 risk assessment in 2014. The assessment of PACS is anticipated to continue forward with additional substances being added as PACS as new information becomes available on substances. Hydrazine is scheduled to be assessed for human health and environmental effects, while the remaining seven substances are to be assessed for environmental effects only. These seven substances are: bromomethane; n,n-dimethyl formamide; 1,2,4-trimethyl benzene; naphthalene; alpha-(nonylphenyl)-omega-hydroxypoly(oxyethylene); hydrogen peroxide; and acrylic acid.
Based on the outcome of Tier 1 assessments, 62 substances are to have their prioritization order amended due to an indication either of health or environmental effects. An additional eight substances will have their tonnages monitored, and may be re-prioritized based on the outcome. Six of the eight substances currently have an estimated nationwide emission volume of less than one tonne, and two with less than ten tonnes.
Japan is expected in 2014 to continue with review of the Chemical Substances Control Law (CSCL) to streamline the process and timeline for bringing new chemical substances to market. Emphasis of the review is being placed on low volume and small quantity substances to reduce the notification requirements.
In March 2013, the EU and Japan began discussion and negotiations to establish a free trade agreement. This development is a result of several factors, but key is that trade volumes of chemical substances between EU and Japan are almost equivalent. Additional discussions are planned for early 2014. It is unlikely that a free trade agreement will be implemented in 2014, but significant progress is anticipated as the EU-Japan Business Round Table (BRT) desires an agreement be reached swiftly.
In late July 2013, Japan published its revised Globally Harmonized System (GHS) of classification and labelling Classification guidance in two separate versions. The revisions bring Japan's guidance in sync with the 4th revision of the United Nations (UN) GHS of classification and labelling, which was previously based on the 2nd revision.
On April 24, 2013, the South Korea National Assembly Environmental and Labor Committee passed the Act on Registration and Evaluation, Authorization and Restriction of Chemical Substances, commonly known as Korea REACH or K-REACH. On April 30, 2013, the National Assembly enacted K-REACH, and it is now scheduled to come into force on January 1, 2015. K-REACH will be the key regulation on new chemicals notification and toxic testing requirements. Additional chemical control program management provisions remain under the Toxic Chemicals Control Law (TCCL), which will be replaced by the Chemical Control Law (CCL) on January 1, 2015, to coincide with the implementation of K-REACH. Additional information on the adoption of K-REACH can be found online.
Since K-REACH's adoption, the Korean MOE and Ministries of Trade, Industry and Energy (MOTIE) have expressed their intent to assist/support SMEs in complying with the new regulations, which may include: financial support, training, information technology tools, and an assistance hotline.
The K-REACH task force, which is comprised of a diverse group of stakeholders including industry, government, non-governmental organizations (NGO), and regulatory experts, was launched in September and has met several times to discuss key issues related to K-REACH's implementation. The task force discussed key topics related to Articles 8, 10-17, 32-37, and the transition period from the old to new laws. The MOE is expected to hold a public hearing early in 2014.
Many K-REACH guidance documents and clarifications are expected to be released in 2014. Comparisons are frequently made between K-REACH and the EU's REACH regulation. Additional information of such analysis can be found online.
As a result of K-REACH's adoption, modifications to the TCCL are necessary to better align with K-REACH. In June 2013, Decree No 11862 was adopted to modify the framework of the chemicals management in Korea. The Decree now identifies the chemical management program as the CCL, which will take effect January 1, 2015. The new chemical notification provisions and toxic testing requirements now reside within the framework of K-REACH, while the remaining elements will transfer from the TCCL to the CCL, which includes licensing and chemicals risk management. Risk management efforts are further strengthened under the CCL.
Periodically in 2013, both the Toxic Chemicals Substance List (TCSL) and GHS Classification List were modified to include additional substances. Additions in 2014 are not highly anticipated, since focus will be on the implementation of K-REACH and the CCL.
2014 will prove to be a busy year for chemical control law modifications in Taiwan and South Korea. B&C is a proud sponsor of ChemCon Europe 2014. Lynn Bergeson and Leslie Scott MacDougall will present multiple topics at the conference, including sessions on China and Korean chemical programs. More information is available online.
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We hope you have found this forecast useful. As noted, B&C's website contains many more substantive memoranda on a wide range of subjects. Please go to www.lawbc.com and click "KNOWLEDGE & RESOURCES" and then click "Regulatory Developments" for more information.
We wish you all much good health, success, and happiness in the New Year.