IC2 Releases Draft Risk Reduction/Safer Alternatives Guidance

The Interstate Chemicals Clearinghouse (IC2) has released a draft guidance document for alternatives assessment and risk reduction.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 The draft Guidance for Alternatives Assessment and Risk Reduction was developed with technical support from EPA’s Design for the Environment and Clean Production Action.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

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



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.