Nearly 3,000 Substances Registered by REACH Deadline.

/in

REACH passed its second registration deadline on May 31, with over 9,000 dossiers for almost 3,000 “phase-in” substances submitted to the European Chemicals Agency (“ECHA”). The deadline applies to those substances which have long been on the European market and which are manufactured or imported in the EU at a rate ranging from 100 to 1,000 tons per year. 2,344 of the substances have already been successfully registered, while pending cases are mostly awaiting collection of registration fees. Substances were registered by 3,215 companies, with 82% of substances registered as joint submissions.

Chemical Watch (sub. req’d) quotes Christel Musset, director of registration at ECHA, as noting discrepancies between the final number of registrations and the projected number as reported in a 2011 survey. The survey found that industry intended to register 3,103 substances in 2013, but 984 registrations were not pursued and a different set of 804 substances were registered. Musset said ECHA would investigate and determine “the reason for non-registration of those [984] substances.”

ECHA’s next steps will be to evaluate all testing proposals as well as 5% of dossiers in each tonnage band by June 2016.

More detailed statistics and other non-confidential information on the registration submissions will be available on ECHA’s website after all the dossiers are processed, which the agency projects will be in September. The final REACH deadline, for substances made or imported in the EU at a minimum of 1 ton per year, is scheduled for May 31, 2018.

Chemical Watch reports the chemical industry’s reaction to the deadline as “mixed” (sub. req’d). Industry representatives voiced general support for the REACH program, while also describing it as particularly burdensome for the growing portion of registrants that are small- and medium-sized businesses.

EPA Proposes Rules to Limit Formaldehyde in Wood Products.

/in

Last week, EPA released two new proposed rules to set and certify formaldehyde emissions standards in wood products. EPA developed the rules to implement the Formaldehyde Standards for Composite Wood Products Act (“the Act”), which added Title VI to the Toxic Substances Control Act (“TSCA”). The proposed rules would apply to domestic and imported hardwood plywood, medium-density fiberboard, particleboard, and finished goods – such as furniture – containing such products.

The emissions standards are established by the Act and match the limits already in place in California for wood products sold in the state. EPA’s proposed rules are designed to align with California’s program, but differ in how laminated products are defined and regulated. The proposal exempts laminated products “in which a wood veneer is attached to a compliant and certified platform using a [no-added formaldehyde-based] resin.”

The first proposed rule [PDF] requires that all wood products made in or imported into the U.S. be certified by a third party as compliant with the formaldehyde emission standards. The proposal imposes testing and product labeling requirements, a prohibition on product stockpiling, and provisions related to chain-of-custody documentation, recordkeeping, and enforcement. The proposed rule also provides incentives similar to the ones in place in California for the use of ultra low-emitting formaldehyde (“ULEF”) resins and no-added formaldehyde (“NAF”) resins.

The second proposed rule establishes a framework for third-party certification of compliant wood products, and is also meant to align with California’s existing requirements. Under the proposed rule, EPA-recognized accreditation bodies would evaluate and approve third-party certifiers (“TPCs”). Both the accreditation bodies and TPCs would be required to follow “voluntary consensus standards” established by the International Organization for Standardization (“ISO”) and International Electrotechnical Commission (“IEC”) related to assessing conformity, performing investigations, etc. The proposed rule requires that accreditation bodies conduct certain oversight activities, including recordkeeping, reporting to EPA, and auditing of TPCs and their testing laboratories. EPA could also independently oversee accreditation bodies and TPCs.

The proposed rules were released in pre-publication format and have yet to appear in the Federal Register. Once they are published, the proposed rules will also be accessible on Regulations.gov under the following docket numbers: EPA-HQ-OPPT-2012-0018 and EPA-HQ-OPPT-2011-0380.

DTSC: Cost of Safer Consumer Products Rules Is Unknowable.

/in , ,

The agency charged with implementing California’s Safer Consumer Products (“SCP”) regulations has concluded that the program’s costs cannot be determined until the rules are in place.

The Department of Toxic Substances Control (“DTSC”) released its Economic and Fiscal Impact Statement [PDF] for its proposed SCP regulations on May 22. DTSC cited the SCP program’s “number of unknowable factors” in explaining why the agency could not estimate the number of businesses affected or the total costs to the private sector.

The agency characterized the proposed rules as “process regulations” which would not directly affect any products or chemicals, and thus would not have any significant impacts on the private sector.

As we have previously discussed, the proposed SCP regulations create a system for prioritizing and evaluating chemicals in products with the goal of limiting exposure or reducing hazards posed by a chemical of concern.

DTSC noted that an Economic and Fiscal Impact Statement – along with other standard elements of the rulemaking process – would be completed for each product-chemical combination that the agency proposes to list as a Priority Product. Thus, specific costs and benefits would be identified and evaluated in a piecemeal, product-by-product manner.

The agency also argued that impacts could not be accurately estimated in part because of the flexibility built into the SCP program, which offers many options to both the regulator and the regulated community. For example, if a certain product is listed as a Priority Product, the manufacturer (or other responsible entity) may choose whether to conduct an Alternatives Assessment, stop using the chemical of concern, replace the product, or remove it entirely from the California market. DTSC will not be able to determine its own regulatory response – with its attendant costs – until after the manufacturer makes its “selection decision.”

The DTSC’s Economic and Fiscal Impact Statement did not provide an estimate for the number or percentage of impacted businesses which constitute small businesses; the agency explained that it had not determined the extent of information it needs to request from companies in order to implement the SCP regulations. Nevertheless, DTSC concluded that only “insignificant” costs would be incurred by those companies which choose to provide information requested by the agency.

Likewise, DTSC claims that no businesses or jobs would be created or eliminated by the proposed rules since they are “process regulations.” DTSC also asserts that the rules will not negatively impact California businesses’ competitiveness because the “process regulations” would not by themselves directly increase the cost of producing any particular product.

The 15-day comment period for the Economic and Fiscal Impact Statement is open through June 6, 2013. The agency’s public notice, containing additional details on commenting, is available online [PDF].

Senators Announce Bipartisan Bill to Modernize TSCA.

/in ,

The prospects for TSCA reform just improved considerably with Wednesday’s announcement of a bipartisan agreement to overhaul the chemical safety law.

Sen. Frank Lautenberg (D-NJ) and Sen. David Vitter (R-LA) led a group of 16 senators from both parties in unveiling the Chemical Safety Improvement Act of 2013 [PDF]. The compromise legislation has already been praised by industry groups, including the American Chemistry Council, as well as public health advocates like the Environmental Defense Fund.

The Act’s chief innovation is its framework for ensuring that all chemicals are screened for safety to human health and the environment. Under the new legislation, EPA would make safety determinations for chemicals based on intended conditions of use and a risk-based assessment integrating hazard, use, and exposure information.

New chemicals would have to first pass safety screening before entering the market. Chemicals already in commerce would also undergo safety evaluations, which would be prioritized based on the substance’s risk to human health and the environment, and high-priority chemicals would undergo further safety testing by EPA. In an effort to reduce duplicative testing, EPA would be authorized to rely on existing information as well as to collect safety data from chemical manufacturers. In addition, EPA would be required to evaluate risks to vulnerable populations, like children or pregnant women, in assessing the safety of each chemical.

The bill also authorizes EPA to employ a wide range of risk management measures on unsafe chemicals, from ordering additional labeling requirements to imposing an all-out ban.

As we previously reported, Sen. Lautenberg introduced a similar bill to modernize TSCA in April, but it only won support among his fellow Democrats. The new compromise bill was criticized by the Environmental Working Group as “unacceptably weak,” but its bipartisan support means it likely has a better chance at approval in the Senate.

USDA and EPA Report: Honey Bee Decline Caused By Multiple Factors

/in

Earlier this month, the EPA and USDA, along with beekeepers and academic researchers, released a report attributing the recent sharp decline in U.S. honey bee colonies to multiple factors, including pesticides, parasites, viruses and malnutrition. The report, summarizing the proceedings of the National Honey Bee Health Stakeholder Conference held in October 2012, stated that commercial honey bee colonies lost 31 percent of their population last winter, more than double the historical rate of loss (about 10 to 15 percent), and in line with rates documented since the start of Colony Collapse Disorder (CCD) in 2006. Because many agricultural crops depend on pollination by bees, CCD threatens crop yields and thus, food prices and food security. The report synthesizes the current state of knowledge of CCD and factors affecting honey bee health for the purpose of better developing research priorities and best management practices for beekeepers and the agricultural community.

The report identified pesticide effects on honey bees as “a primary concern,” and called for further research on the risks to honey bee decline associated with pesticide exposure. Based on current research, it is “not clear” whether pesticide exposure is a major factor in the deterioration of honey bee health, or if it specifically affects honey production or pollination. On the other hand, the report states that it is clear “that in some instances honey bee colonies can be severely harmed by exposure to high doses of insecticides” used on crops. Studies have also shown that sublethal doses of pesticides can increase susceptibility to a gut pathogen.

Overall, the report emphasizes that there is no “single silver bullet” to alleviating CCD and instead recommended a mix of strategies including habit enhancement, better-targeted pesticide use, and breeding bees for disease- and pest-resistance.

The report was released just days after the European Union voted to partially ban neonicotinoids, following a European Food Safety Authority finding that the pesticides posed an “acute risk” to honey bees. EPA stated that it has accelerated the registration review process for neonicotinoid insecticides, citing concerns over the pesticides’ potential effects on bees, and would require the completion of new field studies on oral toxicity, contact exposure, and toxicity to larvae.

EPA’s Acting Administrator Bob Perciasepe said the agency’s guidance document for improving “bee kill” investigations will be released this month. The preparers of the report, the National Honey Bee Health Stakeholder Conference Steering Committee, will next prepare an Action Plan in late 2013 or early 2014.

TSCA Reform Debuts in the 113th Congress.

/in ,

Last week, Sen. Frank Lautenberg (D-NJ) and Sen. Kirsten Gillibrand (D-NY) introduced the Safe Chemicals Act of 2013, which would overhaul the Toxic Substances Control Act (“TSCA”). The Safe Chemicals Act is identical to legislation approved last year by the Senate Environment and Public Works Committee.

The Safe Chemicals Act grants greater authority to the EPA to:

  • evaluate the safety of chemicals based on risk;
  • update EPA’s TSCA Inventory, first focusing review on priority chemicals;
  • order additional testing of chemicals when existing health and safety data is inadequate;
  • require regular use reporting;
  • impose a broad range of risk-management controls for chemicals that fail to meet safety standards; and
  • establish a public database of safety determinations and health and safety data.

The legislation’s focus on risk combines both hazard- and exposure-based methods of safety assessment. Under the bill’s new safety standard, EPA must determine that there is “reasonable certainty that no harm will result to human health or the environment from aggregate exposure” to evaluated chemicals. Such safety determinations must also follow recommendations on “best available science” from the National Academy of Sciences. EPA would evaluate and make safety determinations for all chemicals in the TSCA Inventory based on a priority classification scheme which uses existing data and considers the following factors: potential impacts on human health and the environment; hazard potential, including “designations of hazard characteristics by other authoritative entities”; potential for exposure; and measurements of exposure for any given pathway, if available. For chemicals that do not meet the safety standard, EPA would be able to implement controls ranging from requiring warning labels to imposing an outright manufacturing ban.

The proposed regular use reporting would apply to manufacturers and processors, and is similar to the existing Chemical Data Reporting rule. The bill also incorporates amendments made in committee to last year’s bill which aim to better protect manufacturers’ confidential business information, including specific protections applicable to certain types of information, like “[p]recise information describing the manufacture, processing, or distribution of a chemical substance or mixture” or marketing and sales data.

Lautenberg, who has announced he will retire in 2014, has introduced several TSCA reform bills during his career, and hopes to make the Safe Chemicals Act his “signature legislation for his final term in office.” Twenty-seven other members of the Senate’s Democratic caucus have joined Lautenberg and Gillibrand in sponsoring this bill. Sen. David Vitter (R-LA) has already announced his intention to introduce a competing bill for this Congress; he led Republican efforts on TSCA modernization in the 112th Congress.

The full text of the Safe Chemicals Act is available on Sen. Lautenberg’s website.

California’s New Revisions to Proposed Safer Consumer Products Regulations Released.

/in , ,

Last week, California’s Department of Toxic Substances Control (“DTSC”) released the revised proposed regulations implementing the Safer Consumer Products law. The 15-day public comment period for the revised proposed regulations is open through April 25, 2013. The revised text, as well as an underline/strike-out version showing changes from the January 2013 version, is available online.

Notably, the revisions contain several changes affecting Alternatives Analysis. The definition of “Alternatives Analysis Threshold” now means the Practical Quantitation Limit or another applicable concentration limit which DTSC may specify. Under the new provision at §69503.5(c), DTSC may set a threshold concentration in a proposed or final Priority Products list for any Chemical of Concern that is an “intentionally added ingredient.” Under this provision, DTSC may also specify a threshold concentration higher than the Practical Quantitation Limit for any Chemical of Concern that is a contaminant. In addition, the revised regulations move the requirement for identifying factors relevant to comparing a Priority Product and alternatives (such as adverse public health impacts or physical chemical hazards) from the second to the first step of the Alternatives Analysis process. The new § 69505.8 provides that Final Alternatives Analysis Reports will now be subject to a public comment period, instead of the Preliminary Alternatives Analysis Report. The responsible entity will not be required to respond to all public comments, but instead will only have to address issues identified by DTSC upon review of the comments in an “AA Report Addendum.”

The revised proposed regulations change the definitions of several other key terms. The definition of “assemble” was revised to clearly specify repair and maintenance activities, and “manufacturer” now means anyone who “specifies the use of chemicals to be included in the product,” rather than anyone who has the capacity to do so. “Reliable information” has been re-defined to include only information that could be considered “scientific.” The definition also now specifies that the information must meet certain criteria – such as publication in a scientifically peer reviewed report or by a government agency “that implements laws governing chemicals” – which under the previous version were only considered as indicators of a study’s trustworthiness.

In addition, the revisions removed the provision requiring manufacturers to compensate retailers participating in any end-of-life collection program. In its summary of changes [PDF], DTSC states that these costs will instead be addressed by agreements between manufacturers and retailers.

For more information about California’s Safer Consumer Products Regulations, contact Verdant Law.

Verdant Proudly Sponsors Prop.65 Clearinghouse's Green Chemistry Conference

/in , , , , , , , ,

Green Chemistry:

Verdant is pleased to announce its sponsorship of the Prop.65 Clearinghouse Green Chemistry Annual Conference.  This year’s conference will be held on Tuesday, April 9, 2013, at the The City Club of San Francisco, 155 Sansome Street.

  • Verdant attorney, Philip Moffat, will present on “REACH 2013.”
  • Verdant attorney, Catherine Lin, will present on “Supply Chain Management.”

More information about the conference is available here and an agenda is available here.   A copy of Mr. Moffat’s presentation is available here [PDF].

IC2 Releases Draft Risk Reduction/Safer Alternatives Guidance

/in

The Interstate Chemicals Clearinghouse (IC2) has released a draft guidance document for alternatives assessment and risk reduction.  The public comment period continues through Friday, May 3, 2013.

The IC2 is an association of state and local governments working together to coordinate inter-agency efforts promoting the use of safer chemicals and products.  Of the member states, only California currently has a robust green chemistry program. The draft Guidance for Alternatives Assessment and Risk Reduction was developed with technical support from EPA’s Design for the Environment and Clean Production Action.

The Guidance is designed to meet the needs of a wide range of users.  Principles instrumental to developing the Guidance include:

  • reducing risk by reducing hazards,
  • transparency, and
  • life cycle thinking.

The IC2 emphasizes that through life cycle thinking, users can avoid merely shifting impacts from one aspect of the product life cycle to another.  The Guidance observes that only in rare instances will no safer alternatives be available.

The Guidance includes four scoping modules to help users set parameters for the scope of the alternatives assessment process and seven decision modules to evaluate criteria, ranging from performance to hazard and materials management to cost and availability.  Within each module, users can select the level of complexity and corresponding data requirements appropriate to their needs and capabilities.  For example, criteria in the performance module include measures that test whether potential alternatives are technically feasible.  The Guidance also provides mechanisms to identify uncertainties and consider them in the decision-making process.

California’s Updated Plastic Packaging Regulations – More “Clamshell” and Other Plastic Containers Now Regulated

/in

Major updates to California’s rigid plastic packaging container (“RPPC”) regulations went into effect at the start of the new year, adding over 500 million plastic containers to the program’s regulatory reach.

The California Rigid Plastic Packaging Container Act was first passed in 1991 to encourage recycling and reuse and to reduce the amount of virgin resins used in product packaging. The Act has three  compliance options available for product packaging: manufacturers can  (1) ensure that their packaging is made of at least 25% post-consumer material, (2) choose packaging that is reusable or refillable at least five times, or (3) “source-reduce” the packaging weight by 10% within one year after the product is placed on the market in California. A fourth compliance option, based on the rate at which containers were recycled, was removed by statute in 2004 because of difficulties with accurately calculating the recycling rate on a timely basis.

According to CalRecycle, the state agency responsible for recycling and waste management, the RPPC regulations were amended to remove obsolete provisions, ensure consistency with statutory changes, and otherwise improve clarity and make it easier for product and packaging manufacturers to comply. For example, the updates aim to clarify the law while evening the regulatory playing field by making its application consistent across virtually identical types of packaging. The revisions broaden the definition of RPPC to include containers with non-plastic “incidental packaging elements,” such as non-plastic hinges or handles. In addition, an RPPC no longer must be capable of multiple re-closures, thus bringing all “clamshell” packaging within the meaning of the definition. Under the old regulations, RPPC regulations only applied to clamshell packages which could be reclosed – like those used for salad greens in the supermarket, while heat-sealed packages meant to be opened only once – like those containing small electronics – were not covered.

The revised regulations also significantly modify some aspects of the RPPC program’s various compliance options. The RPPC program’s reusable compliance option now specifically excludes containers meant to house a product permanently. In addition, resin-switching – substituting a lighter-weight plastic resin for a heavier one – is no longer an acceptable source reduction compliance option. The revised regulations also clarify that the post-consumer material compliance option cannot be met through the use of post-industrial material. The RPPC program’s definition of post-consumer material now covers obsolete and unsold products when used as feedstock, as well as rejected finished plastic packaging that has been disposed.

Another significant part of the update is a new three-step notification system for product makers, which CalRecycle developed to reduce companies’ regulatory burden. After receiving notice from CalRecycle, product makers can (1) register with the agency, which will (2) conduct pre-certification evaluation to determine if product packaging is compliant. Finally, (3) compliance certification is completed one year after pre-certification. Manufacturers have two years from initial notice before certification is due, which the agency hopes will provide more opportunities for manufacturers to resolve any compliance issues.

The process of amending the RPPC regulations began in 2007 and concluded when the revised regulations became effective on January 1, 2013. Information on the extensive rulemaking process is available on CalRecycle’s Rulemaking archive.