Tag Archive for: Transparency

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].

EPA Announces Proposed Revisions to FIFRA Minimum Risk Exemption

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FIFRA:

In a December 31, 2012 Federal Register notice, (77 Fed. Reg. 76,979) EPA announced a new proposed rule that would revise the labeling requirements for minimum risk pesticide products. The proposed rule affects section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) by changing how minimum risk pesticides are identified on product labels as well as the way ingredient lists are organized in the implementing regulations. In addition, producer contact information will be required on product labels.

Under FIFRA’s § 25(b) minimum risk exemption, pesticides with active and inert ingredients which are demonstrably safe do not need to be registered with EPA. These permitted ingredients are listed in 40 CFR 152.25(f), but because of ambiguities across the various ingredient lists, confusion remains as to which ingredients are covered and how they should be labeled, leading to increased regulatory burden and inefficiencies for state regulators. Many chemicals may be known by producers, regulators, and consumers by different names; for example, soybean oil may be described on a product label as “Glycine Soja Oil.”

EPA’s new proposed rule is intended to make clear which active ingredients are permitted in exempted pesticide products, and does not add or remove any ingredients from the list. Instead, EPA will identify permitted active ingredients by re-organizing them in tables including the chemical’s “Label Display Name” (e.g., “Citric Acid”), “Chemical Name” as determined by the Chemical Abstract Services (“CAS”) (e.g., “2-Hydroxypropane-1,2,3-tricarboxylic acid”) and “CAS Registry Number,” a unique identifier which is easy to use for consumers and widely accepted by industry and regulators alike. In addition, the table will include a “Specifications” column which will be empty for most ingredients, but will indicate the United States Pharmacopeia (“USP”) standard for “approximately 20 of the active ingredients.”

Inactive ingredients will also be re-organized into a table similar to the one proposed for active ingredients. This table will codify “List 4A,” the list of chemicals currently maintained on EPA’s website. In addition, EPA proposes to incorporate references to other CFR sections which describe which chemicals may be used as inert ingredients for the purpose of the minimum risk exemption. In the case of pesticides that may come in contact with foods, for which there are no federal tolerance levels or tolerance exemptions, EPA proposes to amend the text of the exemption to direct users to an EPA website for more information on which of the listed chemicals may be used in food-use pesticide products.

Finally, EPA proposes that exempted product labels must use the “label display name” in the product’s ingredient listing. The proposed rule also requires that producers of minimum risk pesticide products must include their company’s contact information (address and telephone number) on the product label. In the case of a product label which includes the name of a company that is not the producer, EPA proposes that the label text should clarify that the product was “packed for,” “distributed by,” or “sold by” the non-producer company.

EPA is requesting comments on various topics related to this proposal, including: the format and information to be included in the new tables; whether reference to an online resource with more information on food-use pesticide tolerance requirements would provide clarity for stakeholders; impacts on state and local agencies; and whether products would need to be reformulated as a result of the changes. The comment period for this proposed rule ends on April 1, 2013.

FTC Publishes Revised Green Guides

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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. 

Environmental Advocates Want Disclosure of Chemicals in Consumer Products

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Chemicals in Consumer Products:

Researchers at the Silent Spring Institute argue that the findings of their consumer product evaluation illustrate the need for full disclosure of ingredient information. The Institute tested consumer products — ranging from toothpaste to laundry detergent — for compounds identified as either endocrine disruptors or asthma-related. Most products evaluated by the Institute included one or more “chemicals of concern.”  In their report, the researchers emphasize that current chemical testing and product labeling requirements do not prevent the use of hormone disruptors or asthma-associated chemicals in products or provide enough information for consumers to avoid them. Silent Springs published its findings in the March 8, 2012 issue of the National Institute of Environmental Health Sciences’ Environmental Health Perspectives.  The report has proven highly controversial and been severely criticized by industry for a flawed methodology and equating the mere presence of a chemical in a product with a lack of product safety.

The Institute, and other environmental and public health advocates, clearly plan to use the report to support their arguments for robust reforming of TSCA, the primary federal statute for regulating chemicals in the United States.  Such advocates argue that many consumer products contain chemicals known to adversely affect human health. They note that for numerous common commercial chemicals, information about their presence in consumer products is limited. In particular, little information is available about hazardous chemical exposures from personal care and cleaning products.

The Institute found 55 chemicals of concern in conventional and “green” consumer products. The evaluation assessed consumer products for the presence of 66 known endocrine disruptors and asthma causing chemicals. Tested consumer products ranged from toothpaste to laundry detergent. The researchers found bis-2-ethylhexyl phthalate, diethanolamine, and glycol ethers in high concentrations. They found phthalates, monoethanolamine, alkylphenols, parabens, and cyclosiloxanes in many of the products.  Sunscreens and scented products such as air fresheners and dryer sheets contained both the largest number of target chemicals and some of the highest chemical concentrations. However, the Institute did not report whether these chemicals were present above limits setting safe levels of exposure.  For example, the National Institute for Occupational Safety and Health recommends diethanolamine exposure be limited to 3 parts per million.

The researchers allege that regulations require only limited product labeling, thereby limiting the information available to consumers.  Personal products such as sunscreens, deodorants, and anti-bacterial hand soaps are largely regulated as over-the-counter drugs by the FDA. FDA regulations mandate only that “active” ingredients be identified on product labels.  The Institute asserts that EPA has primary regulatory oversight of cleaning products, and only when these products are pesticide products (e.g., products that will kill bacteria and viruses) is active ingredient labeling required. Many consumer products call themselves “natural,” “non-toxic,” and “green;” however, the Institute contends that these terms are unregulated and the chemical contents of such products do not necessarily differ from comparable products.

The Institute also argues that gaps in ingredient information are also problematic for regulators.  It argues that EPA, for example, relies on ingredient concentrations in products for exposure modeling. 

And lastly, the researchers conclude that further study of the risks posed by the types of chemical mixtures that are found in personal care products, cleaning products, etc. are needed to understand their effects on human health.

US News, Forbes, Consumer Reports, and many other news outlets have published stories on this report.

France to require mandatory reporting of nanoscale materials in 2013

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Nanotechnology:

France will implement a compulsory declaration scheme for the quantities and uses of nanoparticle substances or nanomaterials produced in, distributed in, or imported to France January 1, 2013. Information about material identity, quantity, uses, and users will be required from all companies producing, distributing and importing nanomaterials, and public and private research laboratories. The declaration scheme will be implemented by the Ministries of Ecology, Sustainable Development, Transport and Housing; Economic, Financial and Industrial Affairs; Labor, Employment and Health; and Agriculture, Food, Fisheries, Rural Affairs and Planning. Detailed information on reporting requirements will be published in the Official Journal of the French Republic.

The reporting mandate was published February 19, 2012 in Decree 2012-232 (available in French only) (the December 2011 draft decree is available in English). The decree explains that the purpose of the scheme is to improve knowledge of nanomaterials and their uses, to monitor the channels of use, to improve knowledge of the market and the volumes sold and to collect available information on toxicological and eco-toxicological properties.  Data on 2012 nanomaterial use must be submitted by May 1, 2013.

Reporting requirements affect materials that are at least 50 percent comprised of particles with one or more external dimension between 1 nm and 100 nm. When any such material is produced, imported or distributed in quantities of 100 grams, the user must declare identity of the producer, importer, or distributor; identity of the nanomaterial; quantity of nanomaterial produced, distributed or imported; intended uses, and identifying information about the professional users to whom the material has been distributed. Specifics of the reporting requirements include:

  • Identity of the producer, importer, or distributor:
    • business name, official address, VAT number; and
    •  apacity (manufacturer, importer or distributor) and field of activity.
  • Identity of the nanomaterial:
    • chemical identification of the substance,
    • potential presence of impurities,
    • average particle diameter and particle size distribution,
    • specific surface,
    • surface coating, and
    • surface charge.

 

California DTSC Releases Public Comments on Informal Draft Green Chemistry Regulations

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Green Chemistry Regulations:

The public comment for the latest informal draft version of California’s “Safer Consumer Product Regulations” closed on December 30, 2011.   On January 20, 2012, the implementing agency, the California Department of Toxic Substances Control (DTSC), posted the comments on its website.  DTSC received ninety submissions from a range of stakeholder interests.  More information about the regulations is available here.

Phil Moffat Will Participate on ABA Panel Concerning California's Green Chemistry Regulations

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Green Chemistry Regulations:

Verdant is pleased to announce that Philip Moffat will participate on a “quick teleconference” program sponsored by the American Bar Association (ABA) Section of Environment, Energy, and Resources, titled “California Dreaming, Reality, or Nightmare?  California’s New Paradigm in Chemicals and Products Regulation Is Coming to a Store Near You.”  The December 13, 2011, teleconference will discuss the substantially revised regulations recently proposed by the California Department of Toxic Substances Control (DTSC) to implement AB 1879, a new California Green Chemistry Initiative law designed to “accelerate the quest for safer products” in the state.  In addition to discussing the law’s requirements and its implementation, the teleconference will provide both industry and public health perspectives. 

Other speakers include:

  • Philip Crowley, Assistant General Counsel, Johnson & Johnson, New Brunswick, NJ
  • Dr. Joseph Guth, UC Berkeley Center for Green Chemistry; and the Science and Environmental Health Network, Berkeley, CA
  • Dr. Jeff Wong, Chief Scientist, DTSC, Sacramento, CA
  • Ann Grimaldi, McKenna Long & Aldridge LLP, San Francisco, CA

There are two ways to participate in this program, either attending a host site location or individual dial-in.  Participation at a host site location is free of charge for ABA members, and $110 for non-members.  Registration with the host site contact is required, however.  The host sites are:

  • San Francisco, CA
    McKenna Long & Aldridge LLP, 101 California St., # 41
    RSVP: Cynthia Kelly, (415) 267-4051 or ckelly@mckennalong.com
  • Washington, DC
    McKenna Long & Aldridge LLP, 1900 K Street, NW
    RSVP: Debbie Leitner, (202) 496-7372, dleitner@mckennalong.com

The teleconference will begin promptly at 1:00 pm EasternTime, Tuesday, December 13, 2011, and last for 105 minutes.

  • 1:00 p.m. – 2:45 p.m. Eastern Time / 12:00 p.m. – 1:45 p.m. Central Time
  • 11:00 a.m. – 12:45 p.m. Mountain Time / 10:00 a.m. – 11:45 a.m. Pacific Time

Additional information about the teleconference is available here.

Reminder: Upcoming Meeting of California's Green Ribbon Science Panel

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Green Chemistry Regulations:

California’s Green Ribbon Science Panel (GRSP), the expert body established to advise the Department of Toxic Substances Control (DTSC) on green chemistry and the regulation of consumer products, will convene in Sacramento on November 14 (all day) and 15 (morning only) to discuss the latest informal draft of the so-called Safer Consumer Product Alternatives (SCPA) Regulations.  No agenda or other meeting materials have been publicly released at this time, but a copy of the informal draft regulations and related information is available here.

California Releases Informal Draft of the Revised Green Chemistry Regulations

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Green Chemistry Regulations:

On Monday, October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an informal draft of its revised green chemistry regulations, the so-called “Safer Consumer Product Alternatives (SCPA) Regulations.”  DTSC spent the last year further revising the regulations after some stakeholders decried the proposed final version released for public comment over the Thanksgiving holiday in 2010.  Public comments on the lastest informal draft are due by December 30, 2011.  The formal rulemaking process will begin in 2012.

On Monday DTSC also released a document setting out the most significant changes from the November 2010 version of the regulations. (For purposes of comparison, a summary of the November 2010 version is available here.)  It is clear that DTSC is envisioning a more robust program with shorter timelines and fewer exemptions, ultimately requiring more agency and private resources to implement without a clear benefit from doing so. In light of the poor state of California’s economy, and the relative weakness of the U.S. economy as a whole, one has to wonder why DTSC has chosen its proposed path. According to DTSC, the following are the most significant changes found in the current informal draft. 

Timeframes

(1) Many timeframes have been shortened and/or made more specific.

(2) Timing of initial Chemicals of Concern (COC) list — effective date of the regulations.

(3) Timing of initial Priority Products list — 6 months for the proposed list.

(4) Both the chemicals and products lists will be reviewed at least once every 3 years.

Chemical / Product Prioritization

(1) The regulations will establish an immediate robust (~3,000) list of COCs (which DTSC can add onto later), based on work already done by numerous authoritative bodies.

 (2) The list of hazard traits has been expanded to include all hazard traits and environmental and toxicological endpoints specified by OEHHA. Additionally, the universe of chemicals considered to be carcinogens and reproductive toxins is no longer limited to only those chemicals listed on a short list of lists.

(3) The regulations no longer limit the product categories that DTSC can consider when listing Priority Products during the first 5 years.

(4) Worker exposure has been added as a prioritization factor.

(5) The requirement for responsible entities to provide chemical and product information during the prioritization process has been eliminated. (DTSC will request this information and list anyone who does not provide the information on a Failure to Respond list.)

Alternatives Assessments

(1) The regulations expand the primary responsibility for compliance beyond the product producer to also include: (i) the person who controls the product design; and (ii) the U.S. importer.

(2) The alternatives assessment (AA) process is more specific and structured, but allows for flexibility.

(3) There is no requirement to fill information gaps during the AA — instead DTSC has the option to require this as a regulatory response.

(4) The third-party verification requirement for AAs has been eliminated — instead AAs are required to be conducted by a certified assessor. Also, DTSC will play a greater role in auditing AAs.

Exemptions

(1) The default de minimis level is 0.01% for chemicals with one of 9 specified hazard traits, and 0.1% for all other chemicals — DTSC can set a lower or higher de minimis level.

(2) The exemption for unintentionally-added chemicals has been eliminated. However, these chemicals are a consideration for setting a higher de minimis level.

(3) The “no exposure pathway” exemption has been eliminated. However, exposure potential will still be considered during the chemical/product prioritization process.

Readers wanting more information should check back for future posts on this development, as well as visit the DTSC website. In addition, there will be a public workshop on the draft proposal on December 5, 2011 from 9:30 am to 3:30 pm in Sacramento. The Green Ribbon Science Panel also will dicuss the proposal at the Panel’s meeting on November 14 – 15, also in Sacramento.        

Japan Revises Its Annual Notification Requirements to Provide Greater Protection for Foreign Suppliers’ Confidential Business Information

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Japan/Chemical Notification and Reporting:

Early in June 2011, Japan’s Ministry of Economy, Trade, and Industry (METI) announced a revision to the process Japanese companies use to annually notify the agency about the chemical substances that they import.  Under the new process, a foreign supplier can provide certain confidential business information (CBI) directly to METI rather than to the Japanese customer, and the Japanese customer would submit the remainder of the notification.  This joint process is a welcome approach, and although it is not a complete solution, it is an encouraging signal that METI will adopt a practical approach to implementing the 2009 amendments to the Chemical Substances Control Law (CSCL).

The annual notification requirement was adopted as part of a series of amendments to the CSCL that the government enacted in 2009 to move the country toward a more risk-based approach to chemical regulation.  For readers less familiar with the CSCL, the law is Japan’s analogue to the U.S. Toxic Substances Control Act (TSCA).  Several agencies, including METI, administer the law.  The CSCL generally requires Japanese manufacturers and importers to notify the agencies and receive their approval before commencing manufacture or importation of “new” chemical substances that are not otherwise excluded or exempt.  The law also bans certain substances and imposes restrictions and reporting requirements on others.  The annual notification requirement adopted in 2009 is distinct from the new chemical notification requirement.  The annual requirement applies to substances already on the market, and it was designed to provide additional exposure-related information to the agencies so that they can identify those whose risks warrant further management through restrictions or other measures.

The annual notification requirement applies to two classes of chemical substances, “General Chemical Substances (GCS)” and “Priority Assessment Chemical Substances (PACS)” that are manufactured or imported at or above 1 metric ton during the previous fiscal year.  (There is a similar notification process for so-called Monitoring Chemical Substances (MCS) that are manufactured or imported at or above 1 kg per year.)  When a GCS is present in a mixture below 10%, or a PACS is present as an impurity at less than 1%, it is not counted toward the 1-ton threshold.  Japanese companies that manufacture or import a reportable substance above the threshold must submit a notification form to METI between April 1 and June 30 each year.  2011 is the inaugural notification year.  The prescribed form requires information about the quantity of the substance imported or manufactured, as well as information about its chemical identity and uses.  

Prior to the revision METI announced, foreign suppliers, especially of mixtures, faced a tough choice.  Basically, they would either need to disclose to their Japanese customers the identities and percentages of the substances in their mixtures, potentially losing CBI since many of the mixtures are proprietary, or lose the customers by not providing information necessary to fulfilling a compliance obligation.  Preferring neither option, suppliers in the United States and elsewhere began lobbying METI for an alternative.  METI announced the alternative earlier this month, issuing guidance that revises the annual notification process.  However, the revision is not as comprehensive as what was requested since it does not protect from disclosure information concerning PACs.

METI’s revision affects annual notification of General Chemical Substances, but not PACs.  METI issued a three-page guidance document explaining the revised notification process.  A copy of the guidance is available here.  In it, METI explains that a Japanese company could submit a joint notification with its foreign supplier when the foreign supplier claims as CBI the chemical identity or its concentration rate in a mixture.  The Japanese company would initially complete as much of the notification form as possible and submit it to METI along with a cover letter explaining the situation and identifying the foreign supplier.  The incomplete form would function as a placeholder while the supplier completed the final version.  The supplier would then submit the final form to METI and the notification process would be considered complete. 

METI’s revision is an improvement on the annual notification process.  How well it works remains to be seen.  Presumably, the agency will make an evaluation at the end of this first notification cycle.  Readers interested in Japanese chemical regulatory control matters should check back periodically for further updates on this development and others in Japan.