Tag Archive for: Right to Know

DTSC Requests Public Comment on Another Draft of the Green Chemistry Regulations

California Green Chemistry Regulations:

The saga of California’s nascent Green Chemistry program continues. Last week, the Department of Toxic Substances Control (DTSC) released the revised text (PDF) of its proposed Safer Consumer Product Regulations. The comment period for the revisions started on January 29 and closes on February 28, 2013.

Notably, the revised rules significantly pare down the list of potential Chemicals of Concern (COCs), which are now referred to as “Candidate Chemicals,” from over 3,000 to approximately 1,200. The Candidate Chemicals  are drawn from lists of substances which exhibit one or more hazard trait. The revisions also clarify that the list of Priority Products to be regulated will be developed and updated through the Administrative Procedure Act rulemaking process.

In addition, DTSC modified the applicability of upfront exemptions for certain products, providing an exemption for products already regulated by other laws that provide comparable health and environmental protections. However, products which are manufactured, stored, or transported through California solely for use outside of the state, or used in California solely for the manufacture of non-consumer products will no longer be exempted, although these factors will be considered in the product prioritization process.

Requirements for the certification and accreditation of assessors involved in developing Alternatives Analyses (AA) have been relaxed in favor of a public review and comment process for AA reports, a choice that seems likely to increase the administrative burden and place confidential business information at greater risk. The scope of evaluating economic impacts for AA reports has also been limited to “a monetized comparison of public health and environmental costs, and costs to governmental agencies and nonprofit organizations that manage waste, oversee environmental cleanup and restoration efforts, and/or are charged with protecting natural resources, water quality, and wildlife.”

Finally, DTSC’s ability to make regulatory responses has been further refined and clarified. For example, the revised proposal requires DTSC to provide notice (with accompanying public comment period) of its proposed regulatory response determination no later than 90 days after it issues a notice of compliance or disapproval for a submitted AA report. The revised proposal also limits the agency’s ability to impose certain regulatory responses on manufacturers only, and not on retailers or importers.

More details on the revised proposed regulations, including how to submit comments and a comprehensive summary of changes from the agency’s last proposal, are available on the DTSC’s website.

EPA Announces Proposed Revisions to FIFRA Minimum Risk Exemption

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.

New EPCRA TRI Website

EPCRA Toxics Release Inventory (TRI):

On November 19, 2012, EPA rolled out a new website to provide information on how industrial facilities are preventing releases of chemicals. The site shows how industry is making progress in reducing releases reported under Section 313 of the Emergency Planning and Community Right-to-Know Act (ECPCRA).  The site and additional information about the TRI program is available  here

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

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.

OSHA Requests Public Comment on Extending the Information Collection Requirements in the Cadmium in General Industry Standard

OSHA:

On March 6, 2010, the Occupational Safety and Health Administration (OSHA) published a Federal Register notice (77 FR 13359), requesting public comments concerning its proposal to extend the Office of Management and Budget’s (OMB) approval of the information collection requirements set out in the Cadmium in General Industry Standard (29 CFR 1910.1027).  The proposal would extend current requirements into 2015.  According to OSHA, the industries likely to be effected include chemical mixers, utilities, and electroplaters.  OSHA estimates that nearly 50,000 facilities are covered by the rule.  The agency is requesting public comments to ensure that information collection occurs in a way that minimizes paperwork and related burdens on employers.  The docket includes both the FR notice and OSHA’s Information Collection Supporting Statement.  

Requirements Proposed for Extension

According to OSHA, the information collection requirements in the Cadmium General Industry Standard  protect workers from the adverse health effects that result from their exposure to cadmium.  The major information collection requirements of the Standard include:  

  • conducting worker exposure monoring,
  • notifying workers of their cadmium exposures,
  • implementing a written compliance program,
  • implementing medical surveillance of workers,
  • providing examining physicians with specific information,
  • ensuring that workers receive a copy of their medical surveillance results,
  • maintaining workers’ exposure monitoring and medical surveillance records for specific periods, and
  • providing access to these records by OSHA, the National Institute for Occupational Safety and Health, the worker who is the subject of the records, the worker’s representative, and other designated parties.

Topics for Public Comment

OSHA is particularly interested in public comments on the following topics:

  • whether the proposed information collection requirements are necessary for the proper performance of the agency’s functions, including whether the information is useful;
  • the accuracy of OSHA’s estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
  • the quality, utility, and clarity of the information collected; and
  • ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.

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Additional information on OSHA general industry requirements and guidance materials may be found on OSHA’s website.

Environmental Advocates Want Disclosure of Chemicals in Consumer Products

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

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.

 

US EPA and California DTSC Form Green Chemistry Partnership

Sustainable Products/Green Chemistry:

On January 12, 2012, the US Environmental Protection Agency (EPA) and the California Department of Toxic Substances Control (DTSC) announced their Green Chemistry Partnership.  The agencies’ agreement is memorialized in a Memorandum of Understanding (MOU) that outlines principles by which the agencies will cooperate to reduce toxic chemicals in consumer products, create new business opportunities in the emerging safer consumer products economy, and reduce the burden on consumers and businesses struggling to identify what’s in the products they buy for their families and customers.

The agrement supposedly will allow DTSC and EPA to minimize duplication of effort and promote consistency in their assessment methodologies, potentially providing increased environmental protection. The agreement sets up a framework for the agencies to collaborate on Green Chemistry issues so that California’s innovative “Green Chemistry” program can grow.

Jim Jones, EPA’s acting assistant administrator for the Office of Chemical Safety and Pollution Prevention said:  “This partnership will build and harmonize common tools and practices used to conduct alternative assessments to promote safer products ….  These alternative assessments inform and speed the adoption of safer chemicals for use in products, homes, schools, and workplaces, which produce significant environmental and economic benefits.”

In its press release, EPA said:  “The agreement represents a major advance for Californians looking to buy safer children’s toys, personal care products, household cleaners and other products. By shifting the question of an ingredient’s toxicity to the product development stage, concerns raised by … consumers can be addressed early on. The approach results in safer ingredients, and provides an opportunity for California industry to once again demonstrate its innovative spirit by making products that meet consumer demand throughout the world.”

EPA and DTSC signed the agreement in a ceremony at California’s Kaiser Permanente Sidney R. Garfield Health Care Innovation Center in San Leandro. Kaiser Permanente is nationally recognized as an industry leader in safer products, using its purchasing power and a sustainability scorecard to press suppliers for safer chemicals in medical products. 

Department of Interior to Issue Rules Requiring Disclosure of Chemicals Used in Fracking

Right-to-Know/Transparency:

According to Reuters, on Monday, October 31, 2011, Deputy Secretary of the Department of the Interior (DOI), David Hayes, told the Department of Energy’s shale-gas advisory panel that DOI will issue rules “in a couple of months” requiring the disclosure of the chemicals used in hydraulic fracturing or “fracking” on federal lands.  Fracking is the controversial technique that involves injecting a mixture of water, sand, and chemicals into shale formations at high pressures to extract oil and gas.  Recent technological advances have facilitated greater use of the technique leading to concerns about potential water contamination and air pollution.  The well-known documentary, “Gasland,” purported to document some of the environmental harm resulting from improper use of the technique.  DOI hopes that greater transparency will increase accountability while fostering public confidence.  The Department’s decision is consistent with other initiatives the Obama Administration, particularly through EPA, has undertaken to increase public access to information on chemicals, placing confidential business information at risk.

Reuters reports that about 14 percent of all U.S. natural gas production occurred on federal land during the last fiscal year. DOI supposedly estimates that fracking is used for about 90 percent of gas wells drilled on public lands.  Accordingly, only a fraction of wells in the U.S. would be affected by the rules.   Implicit in the Department’s decision to require disclosure is the reasonable assumption that the same chemicals will be used on both public and private lands subsequent to the rule’s implementation.  By disclosing those used on federal lands, stakeholders will have insight into those used on private lands thereby gaining confidence in the fracking process.  Moreover, several states have disclosure rules in effect or under development.

According to Reuters, DOI’s announcement is part of a larger effort by the Obama Administration to regulate hydraulic fracturing in a way that instills confidence without over-burdening the industry.  Last week, EPA announced that it will promulgate rules for disposing of wastewater from shale gas wells.  Additional information about the Administration’s initiatives is available here and here.  Information from the American Petroleum Institute and others is available here.