DTSC: Cost of Safer Consumer Products Rules Is Unknowable.

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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.

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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

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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.

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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.

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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

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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

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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

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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.

EPA Proposes Significant New Use Rules for 37 Chemicals and Nanomaterials

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TSCA/SNUR/Nanotechnology:

Background

Continuing its robust exercise of its expansive TSCA authority, EPA last week released proposed Significant New Use Rules (“SNURs”) under TSCA for 37 chemicals, including 14 nanoengineered carbon compounds. The SNURs cover a wide range of uses, including the manufacture, processing, and import of adhesives, coatings, colorants, lubricants, chemical intermediates, etc., and result from premanufacture notice (“PMN”) submissions from as long ago as 2000. For almost half of the affected chemicals, the SNURs essentially codify protective measures already required under existing consent orders; the rest are largely based on PMN use scenarios.

EPA has already determined that 17 of the substances addressed by the proposed rule “may present an unreasonable risk of injury to human health or environment” and thus are subject to risk-based consent orders under TSCA § 5(e). The proposed SNURs for these substances adopt certain safety precautions already required by the consent orders. For example, for certain chemicals, workers would be required to wear specified respirators unless air monitoring shows that the substance is actually present in concentrations lower than the New Chemical Exposure Limit (“NCEL”). The NCEL provisions, already incorporated in the § 5(e) consent orders, were established by EPA “to provide adequate protection to human health” and modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs). Users who wish to pursue the NCEL alternative to the respirator requirement would have to request permission to do so under 40 CFR § 721.30 (“EPA approval of alternative control measures.”) EPA anticipates approving such requests under the same conditions already present in the consent orders.

The other 20 substances covered by the new SNURs are not subject to § 5(e) consent orders. These “non-5(e) SNURs” cover certain changes from the use scenarios described in the PMNs which could result in increased exposure, per 40 CFR § 721.170(c)(2).

In addition to personal protective equipment, the SNURs impose various standard use restrictions on the chemicals, such as prohibiting manufacture in the U.S., limiting use to conditions specified in existing consent orders, and banning release to water. EPA also recommends various types of toxicity testing to better characterize the new chemicals’ environmental effects.

Regulatory actions flowing from SNURs

Upon promulgation of the SNURs, any users of the affected substances will be required to determine whether they must submit a Significant New Use Notification (“SNUN”) to EPA 90 days prior to engaging in one of the designated “new uses.” On receipt of the SNUN, EPA may take further regulatory action under TSCA § 5(e), 5(f), 6 or 7, or otherwise publish a notice in the Federal Register explaining its reasons for not taking action.

In addition, EPA’s proposal of the SNURs triggers export notification requirements under TSCA § 12(b). Any exporter or intended exporter of the affected chemicals must notify EPA of the first export or intended export to a particular country, unless the substance is present at certain low concentrations that qualify for the de minimus exemption. If and when the SNURs are finalized, importers of the affected substances must also certify their compliance the SNURs.

EPA is accepting comments on the proposed SNURs through April 26, 2013.

Naming nanoscale materials and other CBI concerns

In the proposed SNURs, EPA identifies nanoengineered carbon compounds based on generic structural terms in order to protect the confidential chemical identities of the substances. EPA uses terms like, for example, “single-walled carbon nanotube” (or “SWCNT”), along with PMN numbers to identify the substances for inclusion in the TSCA Inventory.

The nomenclature developed by EPA is further described in a document, “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature,” which should be available soon under the docket number EPA–HQ–OPPT–2012–0727. It is likely to be similar to or the same as the identically-named document published with the SNUR finalized in 2011 for a substance named as “multi-walled carbon nanotubes.”

If an intended user is uncertain whether its chemicals are subject to the new SNURs, EPA advises contacting the agency or obtaining a written determination under the bona fide procedures in 40 CFR § 721.11. Since production volume limits and certain other uses detailed in the proposed SNURs may also be claimed as CBI, users may not know whether their intended production volumes constitute a significant new use. The bona fide procedures also apply to such cases. If, after evaluating detailed submissions on the intended use, EPA finds that the user has a bona fide intent to manufacture, produce, or import the substance, the agency will advise whether the intended use would qualify as a significant new use.

Fourth Circuit overturns use restrictions on pesticides.

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Last week, the Fourth Circuit Court of Appeals handed down a unanimous decision vacating a 2008 Biological Opinion by the National Marine Fisheries Service (“NMFS”) that supported use restrictions on certain pesticides near the habitat of endangered Pacific salmon. In Dow AgroSciences v. National Marine Fisheries Service [PDF], the Fourth Circuit held that the Biological Opinion was arbitrary and capricious under the Administrative Procedure Act. The Biological Opinion, which concluded that the application of chlorpyrifos, diazinon, and malathion would jeopardize endangered and threatened salmonids, failed to adequately explain certain critical assumptions. The Fourth Circuit directed that the Biological Opinion be remanded to NMFS for further analysis and revision.

This decision may have sweeping effects on other pesticides subject to use restrictions recommended by NMFS Biological Opinions. The overturned Biological Opinion was the first issued as part of a 2008 settlement requiring the EPA to consult with NMFS on 37 pesticides, with eight more Biological Opinions forthcoming. NMFS may have to reevaluate their procedures in developing Biological Opinions, which would only worsen EPA’s backlog of pesticide consultations. This reversal exemplifies the overburdening of the NMFS (and Fish and Wildlife Service) under the Endangered Species Act’s protracted consultation process.