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DTSC Requests Public Comment on Scientific Peer Review of Green Chemistry Regulations

California Green Chemistry Regulations:

Yesterday, the Department of Toxic Substances Control (DTSC) notified the public that the agency is adding two external scientific peer review reports to the Safer Consumer Products rulemaking, which was published in the California Regulatory Notice Register (Z-2012-0717-04)on July 27, 2012.  A public comment period for the external scientific peer review reports will commence on November 30, 2012, and close at 5 p.m. on December 30, 2012.

According to the notice, DTSC has complied with Health and Safety Code section 57004 regarding submission of the scientific portions of the proposed safer consumer product regulations to an external scientific peer review. Documents were submitted to scientific peer reviewers through the University of California. Their written reports, which contain an evaluation of the scientific basis of the regulations, have been added to the rulemaking file.  (If truly independent and objective, these comments should make interesting reading, potentially providing ammunition for the legal challenge that seems likely.)

Comments may be submitted by e-mail to gcregs@dtsc.ca.gov, by fax to  (916) 324-1808, or by mail to:

Ms. Krysia Von Burg

Regulations Coordinator

Department of Toxic Substances Control

 P.O. Box 806

 Sacramento, CA 95812-0806

 Tel: (916) 324-2810

 Fax: (916) 324-1808

 The external scientific peer review reports are available at http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm or  http://www.dtsc.ca.gov/SCPRegulations.cfm and for public inspection between 8:00 a.m. and 5:00 p.m. at the Regulations Section located at 1001 I Street, 22nd Floor, Sacramento, California. Requests and inquiries concerning this matter may be directed to Ms. Krysia Von Burg at the address indicated above or by telephone at (916) 324-2810. If Ms. Von Burg is unavailable, please call Ms. Jacqueline Arnold at (916) 322-2004.

Inquiries regarding technical aspects of the external scientific peer review report should be directed to Mr. Jeff Wong at (916) 322-2822. If Mr. Wong is unavailable, please call Ms. Odette Madriago at (916) 323-4927. However, such oral inquiries are not part of the rulemaking record.

FTC Publishes Revised Green Guides

Green Marketing:

On October 2, 2012, the Federal Trade Commission (FTC) published long-awaited revised guidelines, known as the Green Guides, to aid marketers in properly making environmental benefit claims.   The FTC released its final revisions after a multiyear investigatory process, which included marketing surveys as well as reviewing comments from companies, trade organizations, government entities and individuals.  The the Green Guides lack the force of law, they provide guidance on how to avoid false or misleading environmental marketing claims in violation of Section 5 of the FTC Act, which prohibits unfair or deceptive acts or practices.

Below is a short summary of some of the major changes contained within the final revisions.

Highlights of the Newly Revised Green Guides

General Environmental Benefit Claims: The Green Guides caution against making general environmental benefit claims, such as using the words “green” or “eco-friendly,” without stating the basis for and qualifying these terms. The qualifying information must be clear, prominent and available at the point of sale—so consumers are able to see it before making their purchasing decisions.

Carbon Offsets: Marketers should use competent and reliable scientific evidence and comprehensive accounting methods to support their claims. However, an offset claim is inappropriate if the activity that makes the basis of the claim is required by law. If the offset purchase will pay for an emission reduction that will not occur for at least two years, then marketers are encouraged to disclose this information.

Certifications and Seals of Approval: The Green Guides also make recommendations for certifications and seals of approval used for endorsements. Marketers are encouraged to use environmental certifications or seals that convey the basis for the certification, but if these are not available, then they should clearly identify the product’s specific environmental benefits. Marketers are also encouraged to disclose their material connections with certifying organizations and must verify all express and implied claims when using third-party certification.

Compostable or Degradable:   “Compostable” claims must be based on competent and reliable scientific evidence, showing that product or packaging materials will become usable compost. Marketers should qualify if the product is not able to be composted in a safe or timely fashion. “Degradable” claims do not have to be qualified if the product or package can completely break down within a reasonably short amount of time, typically one year.

“Free-Off”:  “Free-of” claims can be made if the product contains trace amounts, background levels or less of the substance; the substance was not intentionally added to the product; and the amount contained with the product will not cause the type of harm linked to the substance.  The final revision differs from the standard articulated in the draft revision, and it will certainly create challenges for marketers.

 Non-Toxic:  For “non-toxic” claims, marketers should employ competent and reliable scientific evidence showing that the product is safe for people and the environment, unless otherwise qualified.  A product might be considered “non-toxic” under certain agency regulations designed to protect human health, but those regulations might not ensure protection for the environment.

Ozone-Safe:  Marketers are cautioned against misrepresenting that a product is safe for the atmosphere or ozone layer because the FTC finds that these can be unqualified general environmental benefit claims.

Recyclable and Recycled Content: The Green Guides also provide guidance regarding “recyclable” and “recycled content” claims. Recyclable claims should be qualified if recycling facilities are unavailable to 60 percent of consumers or communities to whom manufacturers sell a product. Recycled content refers to material recovered or diverted from waste during manufacturing or post-consumer use. Marketers are advised to qualify claims for products or packaging constructed partly from recycled material and specify the amount of partly recycled material contained therein. In addition, qualified claims should be made for products containing used, reconditioned or remanufactured parts.

Refillable: Marketers should not make unqualified “refillable” claims unless they identify a method to refill the product.

Renewable Materials and Energy : With claims like “made with renewable materials or energy,” the guides provide that marketers should qualify claims with specific information about the renewable materials used, such as what the renewable material is, how it is sourced and what qualifies it as renewable. Also, the Green Guides specify that marketers should qualify claims of renewable energy by specifying the source (e.g., wind or solar). If the power used to manufacture the product or any component of the product comes from fossil fuels, a renewable energy claim is inappropriate unless renewable energy certificates are purchased to link with energy use.

Source Reduction:  Finally, “source reduction” claims should be qualified with the amount of reduction and the basis for comparison from which the claim is made (e.g., “30 percent less runof f than our earlier model”).

 “Sustainable” and “Organic” Are Not Addressed:   The final revisions offer no guidance on claims regarding “sustainability” and whether a product is “organic.” The FTC claims that it lacks a sufficient basis or context to provide guidance on these claims because these terms have numerous meanings among consumers. However, the Green Guides caution marketers from making these types of claims without impunity.

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The complete final revisions to the FTC’s Green Marketing Guides are available here.   Additional information is also available on the FTC’s dedicated website

CBO Estimates Senator Lautenberg's TSCA Reform Bill Would Cost $128 Million over the Next Five Years

TSCA Reform:

On Tuesday, October 2, the Congressional Budget Office published its evaluation of the costs of implementing the amended version of S.847, The Safe Chemicals Act of 2011, which is Senator Lautenberg’s latest attempt to amend the federal Toxic Substances Control Act (TSCA).  Readers will recall that the Senate Committee on Environment & Public Works passed the amended bill on July 25, sending it to the full Senate for a vote.  Our blog post on that version of the bill is available here.

The CBO press release says the following:

“S. 847 would modify the Toxic Substances Control Act (TSCA), the law that regulates the manufacture, importation, and processing of chemicals, with the aim of shifting the burden from the Environmental Protection Agency (EPA) to chemical manufacturers to prove that substances are safe before they enter the marketplace. This new responsibility for chemical manufacturers would be accomplished primarily by increasing the amount of information about chemical toxicity and usage that they would be required to submit to EPA. Enacting this legislation also would require EPA to undertake other activities that would encourage and support the development of safer alternatives to existing hazardous chemical substances.

CBO estimates that implementing this legislation would cost $128 million over the next five years, assuming appropriation of the necessary amounts, as EPA would incur additional administrative costs to meet the new requirements imposed by S. 847.

Enacting S. 847 could affect direct spending and revenues because the bill would increase some existing civil and criminal penalties for violations of TSCA, establish some new civil and criminal penalties for violations related to that act, and authorize EPA to charge fees to chemical manufacturers. Therefore, pay-as-you-go procedures apply to S. 847. CBO estimates that any changes in revenues and direct spending would not be significant.

A copy of the CBO report is available here.

EPA Undertakes FIFRA Enforcement Initiative Against Companies Selling Alleged Plant Growth Regulators

FIFRA Enforcement:

On September 13, 2012, EPA issued a press release announcing three enforcement actions the agency recently settled against Missouri pesticide distributors under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  EPA alleged the distributors violated FIFRA by selling and distributing unregistered and misbranded pesticides. All three cases involved the sale and distribution of “plant growth regulators,” which are regulated as “pesticides” under FIFRA.  (Readers are forgiven for not knowing that plant growth regulators, several of which are natural and found in seaweed, are pesticides under FIFRA.)  Although the agency’s press release doesn’t mention it, the enforcement actions appear to be part of a broader, “under-the-radar” initiative against companies producing growth regulators, many of which are marketed as “biostimulants” or “fertilizers,” and not “pesticides.”

FIFRA defines plant growth regulators as substances intended to accelerate or retard the growth of plants.  Among other things, substances considered to be plant regulators may include hormone additives intended to stimulate plant root growth or fruiting, such as gibberellins, auxins, and cytokinins derived from seaweed. Products containing these additives are often marketed as fertilizers or biostimulants, but EPA says such claims do not exempt the products from regulation as pesticides.

The three settlements are summarized below, but others are pending within EPA and we suspect the agency is pursuing investigation of still more.

  • On June 14, 2012, FIFRA-07-2012-0015, Mayberry Seed Company of Essex, Missouri, agreed to pay a $17,160 penalty to resolve violations of FIFRA. EPA alleged that Mayberry distributed or sold an unregistered plant growth regulator and fungicide on at least 14 occasions between April 1, 2010, and August 25, 2011.

  • On July 5, 2012, Southeast Cooperative Service Company, Inc., of Advance, Missouri, agreed to pay a $12,000 civil penalty to resolve multiple sales of an unregistered plant growth regulator and fungicide to at least four individuals between April 1, 2010, and August 21, 2010.

  • On Sept. 4, 2012, FIFRA-07-2012-0029, AgXplore International, LLC, of Parma, Missouri, agreed to pay a $237,573 civil penalty to resolve violations of FIFRA, including 212 counts for the sale or distribution between May 7, 2009, and March 25, 2012, of 19 different unregistered pesticide products, including plant regulators, insecticides, and fungicides. AgXplore International, LLC has informed its customers and distributors of its violative products.

Under FIFRA, distributors of pesticides must ensure that pesticides intended for distribution within the U.S. are registered both if the distributor claims the substance can be used as a pesticide or if the product is intended to be used for a pesticidal purpose, including as a plant regulator.

Many plant growth regulator products are properly registered with EPA. Companies which comply with pesticide registration requirements must pay registration fees and may also incur significant costs in ensuring their products are correctly formulated, perform as intended, and are properly labeled. Accordingly, entities which produce, sell or distribute unregistered pesticides place themselves at an economic advantage relative to their competitors who comply with the law.

EPA registration requirements also protect consumers by ensuring that products are formulated in accordance with the product label. Without proper registration and labeling on pesticides (including required safety information), users may unintentionally misapply pesticides and cause damage to crops or non-target areas and may lack adequate first aid information in the event of an accident.

As part of their respective settlements with EPA, each of the three companies has certified that it is presently in compliance with FIFRA and its regulations. 

Stay tuned for future postings regarding this development.

EPA Levies Record-Setting Penalties under FIFRA

FIFRA Enforcement:

On September 7, 2012, EPA and the Department of Justice announced criminal and civil settlements with the Scotts Miracle-Gro Company for alleged violations of  the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the federal law governing manufacture, distribution, and sale of pesticides.  Scotts produces pesticides for commercial and consumer lawn and garden uses.  The case levied the largest criminal penalty, and the largest civil settlement, ever sought under FIFRA.  According to the EPA’s press release, Scotts had sold more than 70 million units of bird food illegally treated with pesticide that is toxic to birds.   The settlement leaves one asking:  “How did this happen at such a well-known and respected company?”

Criminal 

Scotts was sentenced in federal district court in Columbus, Ohio.   Scotts must pay a $4 million fine and perform community service for eleven criminal violations of FIFRA.   In addition to the $4 million criminal fine, Scotts will contribute $500,000 to organizations that protect bird habitat, including $100,000 each to the Ohio Audubon’s Important Bird Area Program, the Ohio Department of Natural Resources’ Urban Forestry Program, the Columbus Metro-Parks Bird Habitat Enhancement Program, the Cornell University Ornithology Laboratory, and The Nature Conservancy of Ohio to support the protection of bird populations and habitats through conservation, research, and education.

Scotts pleaded guilty in February 2012 to illegally applying insecticides to its wild bird food products that are toxic to birds, falsifying pesticide registration documents, distributing pesticides with misleading and unapproved labels, and distributing unregistered pesticides. 

In the plea agreement, Scotts admitted that it applied the pesticides Actellic 5E and Storcide II to its bird food products even though EPA had prohibited this use.  Scotts purportedly had done so to protect its bird foods from insect infestation during storage.  The company admitted that it used these pesticides contrary to EPA directives and in spite of the warning label appearing on all Storicide II containers stating, “Storcide II is extremely toxic to fish and toxic to birds and other wildlife.” Scotts sold this illegally treated bird food for two years after it began marketing its bird food line and for six months after employees specifically warned Scotts management of the dangers of these pesticides.

Scotts also pleaded guilty to submitting false documents to EPA and to state regulatory agencies in an effort to deceive them into believing that numerous pesticides were registered with EPA when in fact they were not. The company also pleaded guilty to having illegally sold the unregistered pesticides and to marketing pesticides bearing labels containing false and misleading claims not approved by EPA. The falsified documents submitted to EPA and states were attributed to a federal product manager at Scotts.

The criminal case was investigated by EPA’s Criminal Investigation Division and the Environmental Enforcement Unit of the Ohio Attorney General’s Office, Bureau of Criminal Identification & Investigation. It was prosecuted by Senior Trial Attorney Jeremy F. Korzenik of the Justice Department’s Environmental Crimes Section of the Environment and Natural Resources Division, by Michael J. McClary, EPA Criminal Enforcement Counsel and Special Assistant U.S. Attorney and by Assistant U.S. Attorney J. Michael Marous.

Civil 

In a separate civil agreement with EPA, Scotts agreed to pay more than $6 million in penalties and spend $2 million on environmental projects to resolves additional civil pesticide violations. The violations include distributing or selling unregistered, canceled, or misbranded pesticides, including products with inadequate warnings or cautions.

At the time the criminal violations were discovered, EPA also began a civil investigation that uncovered numerous civil violations spanning five years. Scotts’ FIFRA civil violations included the nationwide distribution or sale of unregistered, canceled, or misbranded pesticides, including products with inadequate warnings or cautions. As a result, EPA issued more than 40 Stop Sale, Use or Removal Orders to Scotts to address more than 100 pesticide products.

In addition to the $6 million civil penalty, Scotts will complete environmental projects, valued at $2 million, to acquire, restore and protect 300 acres of land to prevent runoff of agricultural chemicals into nearby waterways.

The civil case was investigated by U.S. EPA Region 5’s Land and Chemicals Division and Office of Regional Counsel, and the U.S. EPA Headquarters Office of Civil Enforcement, assisted by the Office of Pesticides Program.

Agency Press Statements

According to EPA’s press release: “The misuse or mislabeling of pesticide products can cause serious illness in humans and be toxic to wildlife,” said Cynthia Giles, assistant administrator for EPA’s Office of Enforcement and Compliance Assurance. “Today’s sentence and unprecedented civil settlement hold Scotts accountable for widespread company noncompliance with pesticide laws, which put products into the hands of consumers without the proper authorization or warning labels.”

“As the world’s largest marketer of residential use pesticides, Scotts has a special obligation to make certain that it observes the laws governing the sale and use of its products. For having failed to do so, Scotts has been sentenced to pay the largest fine in the history of FIFRA enforcement,” said Ignacia S. Moreno, assistant attorney general for the Environment and Natural Resources Division of the Department of Justice. “The Department of Justice will continue to work with EPA to assure that pesticides applied in homes and on lawns and food are sold and used in compliance with the laws intended to assure their safety.”

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More information about the civil settlement and recalled products: http://www.epa.gov/compliance/resources/cases/civil/fifra/scottsmiraclegro.html  

 

EPA to Post List of Chemicals Acceptable for DfE-labeled Products

Design for the Environment (DfE) / Green Chemistry:

EPA’s Design for the Environment (DfE) team announced today that, in September, it will post on the agency’s website a list of chemicals that are acceptable for use in DfE-labeled products.   Questions or comments about the proposal should be submitted to EPA by August 24, 2012.  The contact at DfE is Bridget Williams (williams.bridget@epa.gov).

As readers know, over the years many DfE stakeholders have requested that EPA issue a list of safer chemicals.  According to the agency’s press release, EPA’s intent is for the list to serve as a resource for product formulators and consumers, to increase understanding of the DfE Safer Product Labeling Program and the types of chemicals in DfE-labeled products.  The list is also intended to enhance the dialogue on safer chemicals and products.  

EPA is compiling its list from the ingredients in DfE-labeled products, as well as from chemicals eligible for use in labeled products – i.e., chemicals that meet the DfE criteria. The chemicals will be identified by their specific chemical name and Chemical Abstract Service (CAS) number and grouped by functional class—surfactants, solvents, etc. (chemicals with more than one common functionality may be listed in multiple classes).

A color code will appear next to each chemical to indicate its safer chemical status.  A green circle will appear next to chemicals that have met the DfE component-class criteria; a green/yellow square next to chemicals that have met the DfE criteria as adapted for their necessary functional characteristics, but are missing some experimental data on potential hazards; and a yellow triangle next to chemicals that have met the DfE criteria as adapted for their necessary functional characteristics, but have unresolved hazard profile issues.

No other information about the chemical—not its source, manufacturer, or use; association with a trade name product, percentages in formulation, etc.—will appear in the listing. EPA intends to include on this list the ingredients in third-party formulations sold by manufacturers to DfE participants, and will likewise not associate those ingredients with specific products. Also, no chemicals on the confidential portion of the Toxic Substances Control Act Inventory will be included in the listing.

According to the agency’s press release, the DfE list will complement the Green-Blue Institute’s CleanGredients database (www.cleangredients.org), which will continue to serve as a marketplace for chemicals that are acceptable for use in DfE-labeled products and provide trade name chemicals, physical-chemical and functional properties, hazard information, vendor contacts, and other information.

TSCA Reform Bill Headed to Full Senate

TSCA Reform:

On July 25, the U.S. Senate Committee on Environment & Public Works passed a 174-page, substantially revised version of Senator Lautenberg’s 2011 Safe Chemicals Act (S.847).  The bill was approved along party lines, with all Republicans voting against it.  It will now move to the full U.S. Senate for consideration.  Since the bill moved out of committee, we are aware of no meaningful progress toward passage of the bill on the floor of the full Senate.  Moreover, it is unlikely that a companion bill will be passed in the U.S. House of Representatives prior to the November election.  Therefore, we continue to anticipate meaningful TSCA reform efforts in 2013, but not before then.  We also expect this amended bill to remain a focal point of future negotiations in both houses.

  • Summary of Proposed Changes – Although the bill would make significant revisions to the current TSCA statute, the law’s scope would remain largely unchanged in terms of persons and chemicals subject to regulation, as well as the range of risk management measures available to EPA.  Compared to the existing statute, the bill would increase the regulatory burden of “processors,” making them subject to requirements similar to those imposed on manufacturers (e.g., notifications, risk management).  Compared to the prior version of the bill, this version places greater reliance on existing information before requiring new data and information to be generated in a targeted manner as part of a tiered evaluation process.  It limits the number of substances that must undergo a full safety determination.  It also provides greater protection for confidential business information than the last version.  Below is a short summary of some of the more noteworthy changes.
    • Inventory Reset – Manufacturers and processors would submit declarations of current or potential commercial interest in “existing” chemical substances (i.e., those on the current TSCA Inventory), and EPA would use the declarations to establish an “Active” and an “Inactive” Inventory.  The Active Inventory would list substances for which EPA received declarations of current commercial interest (basically manufacturing/ processing at the time of the new law’s enactment).  The Inactive Inventory would list substances that might be used as a substitute for a substance currently manufactured or processed.  Substances would be eliminated from the Inventory if no declaration was submitted.
    • New Chemicals Notification and Categorization – Pre-manufacturing notices (PMN) would be required for substances not on either the Active or Inactive Inventory.  (Certain exemptions would be available, but it does not appear the “articles” exemption would be based on its absence in the prior version or the current amendment.  Many of the exemptions would require some form of notification to EPA.)  More substantial data and information requirements would apply than under the current statute, even though “existing information” would be used initially.  EPA would “categorize” substances and impose data generation requirements on substances in some of the categories. The five categories are listed below.
      • Substances in the “SVHC category” would be PBTs and those that are “highly hazardous.”  They could not be manufactured or processed except under very limited circumstances requiring an exemption application (e.g., critical uses).  These would not be added to the either Inventory.
      • “Substances to Undergo a Safety Determination” would be set into one of three “Priority Classes” and then undergo a risk assessment to confirm that their manufacturing, processing, use (including in articles), etc., would meet the safety standard discussed below.  Risk management measures could be imposed in order to meet the standard.  These substances would be added to the Active Inventory while awaiting assessment because it’s anticipated that they would satisfy the standard.
      • “Substances of Very Low Concern” are not subject to risk management, and would not undergo further evaluation unless new information arose indicating a change was necessary.  They would be added to the Active Inventory.  They would be considered to have “intrinsic low-hazard properties.”
      • “Substances with Insufficient Information” would need certain data submitted and could not be manufactured or processed until the EPA had re-categorized the substance into one of the other categories.
      • “Substances Unlikely to Meet the Safety Standard” could not be manufactured or processed except under very limited circumstances requiring an exemption application. These would not be added to the either Inventory.
    • Existing Chemicals Notification Requirements – Existing chemicals would be subject to certain advance notification requirements.  Again, the “articles” exemption appears unavailable.
      • Substances on the “Inactive Inventory” would require certain limited data and other information to be submitted before manufacturing or processing could occur. 
      • Substances on the “Active Inventory” that had not undergone a safety determination would require advance notification before (1) engaging in a use not ongoing at the time of the law’s enactment or (2) substantially increasing the volume of a substance.  A submission akin to the current significant new use notification (SNUN) would be required – again certain existing data, etc., would be provided to EPA beforehand. 
      • Substances on the “Active Inventory” that had undergone a safety determination would require advance notification before undertaking a use that was not included in the determination.  The applicant would have to establish with data that the use would also comply with the standard.  EPA would impose any new risk management measures that might be necessary to meet the standard.
    • Existing Chemicals Categorization – Every five years, EPA would select a “batch” of approximately 6,000 existing chemicals.  It would then place them into “categories” very similar to the ones identified above for new chemicals.  Substances identified for safety standard determinations would be placed into one of three different “priority” classes and then reviewed. EPA might require data generation to categorize or a substance or to conduct the safety standard determination.  Risk management measures could result – again, SVHCs would be subject to expedited and highly restrictive risk management, but certain limited exceptions would be available.  Other substances unable to meet the safety standard would be banned except for under limited circumstances (e.g., critical uses).
    • Safety Standard – The safety standard proposed remains very rigorous and controversial.  It’s the same standard found in the Food Quality Protection Act.  Based solely on considering human health and the environment, including vulnerable populations, EPA must determine whether “there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance.”  The burden of proof rests on the company, however.  Use in “articles” must meet the standard as well.
    • Confidential Business Information – EPA would place information into one of three categories – (1) always eligible for protection, (2) never eligible, and (3) sometimes eligible.  Most eligible information would be protected for 5 years, with a possible extension for another five years.  Certain sensitive information would receive indefinite protection.  Severe penalties would be imposed for release of protected information or for claiming protections that were unwarranted.
    • Preemption of State Laws – the bill does not include a robust preemption provision. 

A copy of the amendment to the bill is available here Final-Amendment-to-S.-847[1].  The original version is available here BILLS-112s847is.  Senator Lautenberg’s summary is available here.  And a webcast of the committee hearing is available here.

Verdant Chosen for ABA Team Reviewing Moldova's Draft Chemicals Law

Moldova:

Verdant is pleased to announce that it was selected by the American Bar Association (ABA) to be part of a small team that will provide a legal review of Moldova’s draft law on chemicals, and provide guidance on drafting related legislation.

Verdant founder Philip Moffat said “We are pleased to have the opportunity to assist Moldova’s effort.  Our attorneys are experienced in working with the chemical control laws in most of the major markets around the globe, as well as many smaller ones.  Catherine Lin, who will be Verdant’s leading contributor, is a recognized expert in the field having previously served as in-house counsel at Pfizer on global chemical control and supply chain management issues.”

Background

The growing world-wide commitment to protect human health and the environment from dangerous chemicals and wastes has been a catalyst for action in many countries and sectors. Due to the cross sectoral nature of chemicals and waste management and the interests of various government ministries and other stakeholders in this area, well-coordinated and integrated management approaches at the national level will achieve maximum impact for the limited resources available worldwide, inclusively in the Republic of Moldova. This includes much improved links to the development planning agenda of the country. The analysis of existing mechanisms for inter-ministerial coordination in the sphere of sound management of chemicals reveals a fragmentary approach to chemicals management in different economic branches, which is an issue that will be directly addressed in this project. In this context, the UNDP “Mainstreaming of Sound Management of Chemicals in National Development Planning Processes” project aims to achieve the mainstreaming SMC priorities into national developments plans in order to strengthen country’s foundational capacities for chemicals and waste management thus minimizing the significant adverse effects of these on human health and the global environment.

Aiming at building capacities for formulation and implementation of SMC policies and fostering sustainable forms of development, the project will achieve its objective through the following outputs referring at:

  • Baseline analysis and identification of sound management of chemicals and hazardous waste priorities
  • Economic valuation of selected priorities and designing policy instruments supporting the priority SMC issues
  • Identification of opportunities for integration of SMC within national plans and subsequent mainstreaming of national SMC priorities into national development programs and plans.

The project will build-upon the UNDP-UNEP Partnership Initiative methodology to Integrating sound management of chemicals into MDG-based development planning which is a comprehensive approach to mainstreaming environmental sustainability.

National priority issues in the sphere of chemicals management in the Republic of Moldova were identified and reflected in the First National Profile on Chemicals Management in the Republic of Moldova (2008). The National Program on Sound Management of Chemicals was approved and establishes the main objectives of the sound chemicals management system to 2020. The overall aim of the program lies in developing an integrated system of chemicals management being efficient from technical, economic, social and environmental points of view.

The program further envisages harmonization of national legislations with EU legislations and sets up the necessary legal and institutional framework for establishment of Chemicals Agency in the Republic of Moldova (hereinafter referred to as the Agency). The draft Law on Chemicals will develop an integrated approach for chemicals management including import, production, processing, storage, transport, use, disposal/treatment and recycling and will be in line with the relevant international treaties. In this context, UNDP Moldova seeks to hire an international consultant (hereinafter referred to as the “consultant”) to provide legal support for revision of the draft Law on Chemicals and recommendations on relevant secondary legislation in line with EU Directives in the respective area.

EPA Announces More Muscular Use of TSCA Section 6

TSCA/Section 6 restrictions:

June 7, 2012 Jim Jones, Acting Administrator, Office of Chemical Safety and Pollution Prevention, announced that EPA plans to use TSCA §6 to ban or restrict the use of chemicals that pose an unreasonable risk.  This is an extension of the Administrator’s 2009 Comprehensive Approach to Enhance the Agency’s Current Chemical’s Management Program.  At that time, the Agency announced a renewed focus on identifying chemicals of concern and initiating appropriate risk management, including regulatory action to restrict or ban chemicals.  Jones’ Office explained that the agency intends to use its existing authority to the best of its ability until Congress enacts TSCA reform.  It noted that TSCA reform is one of the Administrator’s highest priorities.

Jones statement was made at the Environmental Council of the States’ State Environmental Protection in 2012 forum.  He spoke extemporaneously.  For further information, Jones’ Office recommends reviewing the Comprehensive Approach and the Administrator’s Essential Principles for Reform of Chemicals Management Legislation.  See also the Administrator’s September 2009 remarks announcing both efforts.

EU Member State Committee Identifies 5 More SVHCs

REACH/SVHCs/Authorization

During meetings held from June 6 – 8, 2012, the EU’s Member State Committee (MSC) unanimously agreed on the identification of five substances of very high concern (SVHCs).  SVHCs are thought to have serious and often irreversible effects on human health and the environment.  The five substances identified by the MSC are diborontrioxide and the following four dyes:  C.I. Basic Violet 3; C.I.Basic Blue 26; C.I. Solvent Blue 4; and 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol.  The listing for the four dyes will clarify that the substances will only be identified as SVHCs when the concentration of the impurities Michler’s ketone or Michler’s base is equal to or higher than 0.1%.

SVHCs include substances that have one or more of the following hazard characteristics: Carcinogenic, Mutagenic or Toxic for Reproduction (CMR 1,2); Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB); or cause probable serious effects to human health or the environment (e.g. Endocrine Disruptors).  REACH, the primary regulation for industrial chemicals, aims at ensuring that the risks resulting from the use of SVHCs are controlled and that the substances are replaced where possible.

The five substances will be added to the Candidate List and may subsequently become subject to authorization under REACH Title VII.  When an SVHC becomes subject to authorization, persons using or making it available on the EU market must apply for authorization within a prescribed deadline (i.e., the “sunset date”), seeking approval of nonexempt uses while also including an analysis of possible substitutes.  If they can show that the risks from their uses are adequately controlled (except non-threshold CMRs and PBTs/vPvBs), or that the socio-economic benefits outweigh the risks and no suitable alternatives exist, then their uses of the SVHC are “authorized” to continue.

Even without being selected for authorization, inclusion of substances on the Candidate List immediately triggers certain regulatory obligations. 

  • EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request. This information must contain as a minimum the name of the substance.
  • EU and EEA producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).
  • EU and EEA suppliers of substances on the Candidate List have to provide their customers with a safety data sheet.
  • EU and EEA suppliers of mixtures not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet if the mixture contains at least one substance on the Candidate List and the individual concentration of this substance in the mixture is ≥ 0.1% (w/w) for non-gaseous mixtures if the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

More information about the MSC is available here, and information about the process for identifying SVHCs is available here.