OEHHA to Hold Public Workshop on Potential Regulation Addressing Proposition 65 Warnings.

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On July 30, 2013, California’s Office of Environmental Health Hazard Assessment (OEHHA) will hold a public pre-regulatory workshop in order to gather input from interested parties on potential rulemaking to modify Proposition 65 warnings. If formally proposed and adopted, the regulation would either supplement or replace existing OEHHA regulations governing Proposition 65 warnings and conform to any statutory changes that may be enacted, such as the legislative reform package currently championed by Governor Brown.

Proposition 65 currently requires businesses to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to listed chemicals that are known to cause cancer, birth defects and other reproductive harm. This warning can be given by a variety of means, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper. However, with more businesses posting blanket warning signs in attempting to comply with Prop. 65, many are concerned that the signs have become meaningless to the public and a source of frivolous litigation. In response to these concerns, Governor Brown announced in May that he was seeking reform of Proposition 65 in order to end frivolous lawsuits and improve warning signs.

According to OEHHA, the potential rulemaking would provide for more informative and meaningful warnings to individuals concerning exposures to carcinogens and reproductive toxicants. The regulation would offer a variety of options for businesses that are required to provide these warnings, and would provide businesses with greater certainty that their warnings comply with Prop. 65.

At this time, OEHHA believes the regulation should include the following:

  • A requirement that a warning inform consumers that they will be exposed to a listed chemical;
  • The minimum information that must be included in all warnings, such as the health effect of exposure, how a person will be exposed, or how to avoid or reduce exposure to a listed chemical
  • Approved warning methods and content regarding exposures to listed chemicals in consumer products and in foods, including those sold at retail establishments and via the Internet;
  • Approved warning methods and content for environmental exposures, including for some common scenarios such as parking lots, hotels, apartments, and other businesses;
  • Requirements and approved methods for providing additional contextual information concerning exposures to listed chemicals. This information would not have to be available to the public before exposure, but must be available on a website or other generally accessible location;
  • Reasonable transition times for businesses to come into compliance with this regulation and recognition of existing warnings that are included in court-approved settlements.

Written comments are due August 30, 2013. The workshop will take place from 10 am to 3:30 pm in the Coastal Hearing Room at the Cal/EPA Headquarters Building, 1001 I Street, Sacramento, CA, and the agenda is now available online [PDF]. The workshop will be webcast at http://calepa.ca.gov/Broadcast. OEHHA notes that if it decides to formally propose a Proposition 65 warning regulation, it will provide additional opportunities for public input.

Senate Bill Would Require Warning Labels for BPA on Food Containers.

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On July 10, 2013, Senator Dianne Feinstein (D-Calif.) introduced legislation (S. 1124) that would require manufacturers to include warning labels on consumer food packaging containing bisphenol A (BPA). The bill, titled the “BPA in Food Packaging Right to Know Act,” would require such packaging to state “this food packaging contains BPA, an endocrine-disrupting chemical.” It would also direct the Department of Health and Human Services (HHS) to conduct a safety assessment within 180 days from passage of the bill to determine the effect of long-term low-dose exposure and high-dose exposure.  Based on the results of this assessment, HHS is to then develop a safety standard for BPA and to use that standard to evaluate possible alternatives.

BPA, which is used in epoxy resins that are used to line some metal food and drink containers and in the manufacture of some clear plastics, exhibits hormone-like properties that have raised concerns about its safety. Feinstein said in a statement that more than 200 scientific studies that have linked BPA exposure to certain types of cancer, reproductive disorders, cardiac disease, diabetes, and other problems. She said that the growing scientific evidence about BPA’s health effects makes it “essential that consumers know what chemicals are in the products they purchase.”

The American Chemistry Council (ACC), who recently obtained a court order to remove BPA from California’s Proposition 65 list of potentially dangerous chemicals, called the bill “unnecessary” because government agencies worldwide support the safety of BPA in food contact materials. The U.S. Food and Drug Administration (FDA) considers BPA to be safe at the low levels that occur in some foods, although the agency said it had concern “about the potential effects of BPA on the brain, behavior and prostate gland in fetuses, infants and young children.” The FDA is currently conducting additional research with its National Center for Toxicological Research to further determine the safety of BPA as it is used in food packaging.

The new bill is Feinstein’s latest attempt at legislation aimed at limiting the use of BPA. She had previously introduced legislation in 2009 that would have banned BPA from reusable food containers. She also tried to amend the Food Safety Modernization Act in 2010 to ban BPA from baby bottles and sippy cups. The amendment failed, although the FDA later used its authority to implement the same ban in 2012. On July 12, 2013, in response to a petition introduced by Senator Edward Markey (D-Mass.), the FDA also abandoned the use of BPA in packaging for infant formula. In both cases, the FDA took action after determining that manufacturers in the industry had already phased out BPA for those uses.

Currently, thirteen states currently have pending legislation that would ban BPA from children’s products and food containers. Two other states, South Dakota and Connecticut, have legislation similar to the Feinstein bill, which would require BPA warning labels on food and drink packaging.

New EU Cosmetics Regulation To Take Effect in July 2013.

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On July 11, 2013, the new European Union (EU) cosmetics Regulation (EC 1223/2009) will fully replace the existing cosmetics Directive (76/768/EEC) that has applied since July 27, 1976.  Unlike the previous EU cosmetics Directive, the self-executing Regulation unifies the cosmetics requirements of the European Economic Area (EEA) into a single law and eliminates ambiguities that may occur among EU member states during the enforcement process. The new Regulation, which applies to all EU cosmetics companies, is intended to ensure that consumers’ health is protected and that they are well informed by monitoring the composition and labeling of cosmetic products.

The Regulation is focused on simplifying procedures, streamlining terminology, and strengthening certain elements of the regulatory framework for cosmetics. The main changes it introduces include:

  • creating a new, electronic, centralized system that will replace the current national competent authority notification process
  • clarifying the format and content of the product information file (PIF) to be used in conducting a product safety assessment; particularly, the PIF must include data to support any claims made about a product
  • narrowing the “exceptional cases” when substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMRs) can be used
  • requiring the presence of nanomaterials in cosmetic ingredients be clearly indicated by the word “nano” in brackets
  • requiring cosmetics companies to designate a legal or natural person within the EU—known as a “responsible person”—whose role will be to ensure certain safety requirements for each cosmetics product introduced on the market

The Regulation also continues the previously established ban on animal testing, which came into full force through the Cosmetics Directive on March 11, 2013. Although the inclusion of the ban has been applauded by many consumers and animal welfare groups, it has also raised some concerns in the cosmetics industry about the potential negative impact on innovation due to the inability to fully test new ingredients as well as potential conflicts arising from the testing requirements imposed by other regulations. The European Commission has posted an impact assessment [PDF] online that discusses the various effects of the ban.

Notable milestone reached by the Regulation en route to becoming applicable, exclusively, to cosmetics placed on the EU market include: prohibiting use of CMR 1A/1B/2 substances in cosmetics, although certain CMR 2 substances may be exempted by the EU Scientific Committee of Consumer Safety (SCCS) after assessment; submission of all cosmetics through the new centralized notification system; commencing the  notification process  for nanomaterials already on the market.  All cosmetics are expected to be fully compliant with the new Regulation by July 11, 2013.

Prop. 65 Reform on California’s Agenda.

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Last month, California Governor Jerry Brown unveiled his proposed reforms to Proposition 65, the 27-year-old law passed by voter initiative to protect Californians from harmful chemicals. Gov. Brown directed the California Environmental Protection Agency (“Cal/EPA”) to work with the legislature to improve the law and put an end to the proliferation of abusive “shakedown” lawsuits. Prop. 65 is best known for requiring clear warnings about chemicals known to the state to cause cancer or reproductive harm, often seen in retail stores and restaurants and on many consumer products. Like several other landmark environmental laws, Prop. 65 permits private citizens acting in the public interest to enforce the law by suing violators. Under the current law, unscrupulous lawyers are incentivized to bring Prop. 65 lawsuits because they may be able to recover all attorneys’ fees plus damages of up to $2,500 per day, or otherwise extract settlements with little proof of a meritorious claim.

The governor’s reform package includes:

  • capping attorney’s fees;
  • requiring plaintiffs to make a stronger showing of a violation before bringing suit, as well as other disclosures;
  • limiting the amount of money from an enforcement action that can go into settlement funds (as opposed to penalties);
  • authorizing the state to adjust the level at which warnings about reproductive harm are required; and
  • making more useful information available to the public on chemical exposure and protection.

The governor’s announcement adds to growing momentum in the legislature to reform Prop. 65. Assemblyman Mike Gatto introduced legislation this session which would allow business owners to avoid a costly lawsuit or settlement by paying a $500 fine and correcting the violation within 14 days after receiving a notice of violation. The bill, AB 227, has passed the state Assembly and this week was approved by the Senate committee on environmental quality; the Senate judiciary committee will consider it on Tuesday, June 25.

Nearly 3,000 Substances Registered by REACH Deadline.

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REACH passed its second registration deadline on May 31, with over 9,000 dossiers for almost 3,000 “phase-in” substances submitted to the European Chemicals Agency (“ECHA”). The deadline applies to those substances which have long been on the European market and which are manufactured or imported in the EU at a rate ranging from 100 to 1,000 tons per year. 2,344 of the substances have already been successfully registered, while pending cases are mostly awaiting collection of registration fees. Substances were registered by 3,215 companies, with 82% of substances registered as joint submissions.

Chemical Watch (sub. req’d) quotes Christel Musset, director of registration at ECHA, as noting discrepancies between the final number of registrations and the projected number as reported in a 2011 survey. The survey found that industry intended to register 3,103 substances in 2013, but 984 registrations were not pursued and a different set of 804 substances were registered. Musset said ECHA would investigate and determine “the reason for non-registration of those [984] substances.”

ECHA’s next steps will be to evaluate all testing proposals as well as 5% of dossiers in each tonnage band by June 2016.

More detailed statistics and other non-confidential information on the registration submissions will be available on ECHA’s website after all the dossiers are processed, which the agency projects will be in September. The final REACH deadline, for substances made or imported in the EU at a minimum of 1 ton per year, is scheduled for May 31, 2018.

Chemical Watch reports the chemical industry’s reaction to the deadline as “mixed” (sub. req’d). Industry representatives voiced general support for the REACH program, while also describing it as particularly burdensome for the growing portion of registrants that are small- and medium-sized businesses.

EPA Proposes Rules to Limit Formaldehyde in Wood Products.

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Last week, EPA released two new proposed rules to set and certify formaldehyde emissions standards in wood products. EPA developed the rules to implement the Formaldehyde Standards for Composite Wood Products Act (“the Act”), which added Title VI to the Toxic Substances Control Act (“TSCA”). The proposed rules would apply to domestic and imported hardwood plywood, medium-density fiberboard, particleboard, and finished goods – such as furniture – containing such products.

The emissions standards are established by the Act and match the limits already in place in California for wood products sold in the state. EPA’s proposed rules are designed to align with California’s program, but differ in how laminated products are defined and regulated. The proposal exempts laminated products “in which a wood veneer is attached to a compliant and certified platform using a [no-added formaldehyde-based] resin.”

The first proposed rule [PDF] requires that all wood products made in or imported into the U.S. be certified by a third party as compliant with the formaldehyde emission standards. The proposal imposes testing and product labeling requirements, a prohibition on product stockpiling, and provisions related to chain-of-custody documentation, recordkeeping, and enforcement. The proposed rule also provides incentives similar to the ones in place in California for the use of ultra low-emitting formaldehyde (“ULEF”) resins and no-added formaldehyde (“NAF”) resins.

The second proposed rule establishes a framework for third-party certification of compliant wood products, and is also meant to align with California’s existing requirements. Under the proposed rule, EPA-recognized accreditation bodies would evaluate and approve third-party certifiers (“TPCs”). Both the accreditation bodies and TPCs would be required to follow “voluntary consensus standards” established by the International Organization for Standardization (“ISO”) and International Electrotechnical Commission (“IEC”) related to assessing conformity, performing investigations, etc. The proposed rule requires that accreditation bodies conduct certain oversight activities, including recordkeeping, reporting to EPA, and auditing of TPCs and their testing laboratories. EPA could also independently oversee accreditation bodies and TPCs.

The proposed rules were released in pre-publication format and have yet to appear in the Federal Register. Once they are published, the proposed rules will also be accessible on Regulations.gov under the following docket numbers: EPA-HQ-OPPT-2012-0018 and EPA-HQ-OPPT-2011-0380.

DTSC: Cost of Safer Consumer Products Rules Is Unknowable.

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The agency charged with implementing California’s Safer Consumer Products (“SCP”) regulations has concluded that the program’s costs cannot be determined until the rules are in place.

The Department of Toxic Substances Control (“DTSC”) released its Economic and Fiscal Impact Statement [PDF] for its proposed SCP regulations on May 22. DTSC cited the SCP program’s “number of unknowable factors” in explaining why the agency could not estimate the number of businesses affected or the total costs to the private sector.

The agency characterized the proposed rules as “process regulations” which would not directly affect any products or chemicals, and thus would not have any significant impacts on the private sector.

As we have previously discussed, the proposed SCP regulations create a system for prioritizing and evaluating chemicals in products with the goal of limiting exposure or reducing hazards posed by a chemical of concern.

DTSC noted that an Economic and Fiscal Impact Statement – along with other standard elements of the rulemaking process – would be completed for each product-chemical combination that the agency proposes to list as a Priority Product. Thus, specific costs and benefits would be identified and evaluated in a piecemeal, product-by-product manner.

The agency also argued that impacts could not be accurately estimated in part because of the flexibility built into the SCP program, which offers many options to both the regulator and the regulated community. For example, if a certain product is listed as a Priority Product, the manufacturer (or other responsible entity) may choose whether to conduct an Alternatives Assessment, stop using the chemical of concern, replace the product, or remove it entirely from the California market. DTSC will not be able to determine its own regulatory response – with its attendant costs – until after the manufacturer makes its “selection decision.”

The DTSC’s Economic and Fiscal Impact Statement did not provide an estimate for the number or percentage of impacted businesses which constitute small businesses; the agency explained that it had not determined the extent of information it needs to request from companies in order to implement the SCP regulations. Nevertheless, DTSC concluded that only “insignificant” costs would be incurred by those companies which choose to provide information requested by the agency.

Likewise, DTSC claims that no businesses or jobs would be created or eliminated by the proposed rules since they are “process regulations.” DTSC also asserts that the rules will not negatively impact California businesses’ competitiveness because the “process regulations” would not by themselves directly increase the cost of producing any particular product.

The 15-day comment period for the Economic and Fiscal Impact Statement is open through June 6, 2013. The agency’s public notice, containing additional details on commenting, is available online [PDF].

Senators Announce Bipartisan Bill to Modernize TSCA.

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The prospects for TSCA reform just improved considerably with Wednesday’s announcement of a bipartisan agreement to overhaul the chemical safety law.

Sen. Frank Lautenberg (D-NJ) and Sen. David Vitter (R-LA) led a group of 16 senators from both parties in unveiling the Chemical Safety Improvement Act of 2013 [PDF]. The compromise legislation has already been praised by industry groups, including the American Chemistry Council, as well as public health advocates like the Environmental Defense Fund.

The Act’s chief innovation is its framework for ensuring that all chemicals are screened for safety to human health and the environment. Under the new legislation, EPA would make safety determinations for chemicals based on intended conditions of use and a risk-based assessment integrating hazard, use, and exposure information.

New chemicals would have to first pass safety screening before entering the market. Chemicals already in commerce would also undergo safety evaluations, which would be prioritized based on the substance’s risk to human health and the environment, and high-priority chemicals would undergo further safety testing by EPA. In an effort to reduce duplicative testing, EPA would be authorized to rely on existing information as well as to collect safety data from chemical manufacturers. In addition, EPA would be required to evaluate risks to vulnerable populations, like children or pregnant women, in assessing the safety of each chemical.

The bill also authorizes EPA to employ a wide range of risk management measures on unsafe chemicals, from ordering additional labeling requirements to imposing an all-out ban.

As we previously reported, Sen. Lautenberg introduced a similar bill to modernize TSCA in April, but it only won support among his fellow Democrats. The new compromise bill was criticized by the Environmental Working Group as “unacceptably weak,” but its bipartisan support means it likely has a better chance at approval in the Senate.

USDA and EPA Report: Honey Bee Decline Caused By Multiple Factors

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Earlier this month, the EPA and USDA, along with beekeepers and academic researchers, released a report attributing the recent sharp decline in U.S. honey bee colonies to multiple factors, including pesticides, parasites, viruses and malnutrition. The report, summarizing the proceedings of the National Honey Bee Health Stakeholder Conference held in October 2012, stated that commercial honey bee colonies lost 31 percent of their population last winter, more than double the historical rate of loss (about 10 to 15 percent), and in line with rates documented since the start of Colony Collapse Disorder (CCD) in 2006. Because many agricultural crops depend on pollination by bees, CCD threatens crop yields and thus, food prices and food security. The report synthesizes the current state of knowledge of CCD and factors affecting honey bee health for the purpose of better developing research priorities and best management practices for beekeepers and the agricultural community.

The report identified pesticide effects on honey bees as “a primary concern,” and called for further research on the risks to honey bee decline associated with pesticide exposure. Based on current research, it is “not clear” whether pesticide exposure is a major factor in the deterioration of honey bee health, or if it specifically affects honey production or pollination. On the other hand, the report states that it is clear “that in some instances honey bee colonies can be severely harmed by exposure to high doses of insecticides” used on crops. Studies have also shown that sublethal doses of pesticides can increase susceptibility to a gut pathogen.

Overall, the report emphasizes that there is no “single silver bullet” to alleviating CCD and instead recommended a mix of strategies including habit enhancement, better-targeted pesticide use, and breeding bees for disease- and pest-resistance.

The report was released just days after the European Union voted to partially ban neonicotinoids, following a European Food Safety Authority finding that the pesticides posed an “acute risk” to honey bees. EPA stated that it has accelerated the registration review process for neonicotinoid insecticides, citing concerns over the pesticides’ potential effects on bees, and would require the completion of new field studies on oral toxicity, contact exposure, and toxicity to larvae.

EPA’s Acting Administrator Bob Perciasepe said the agency’s guidance document for improving “bee kill” investigations will be released this month. The preparers of the report, the National Honey Bee Health Stakeholder Conference Steering Committee, will next prepare an Action Plan in late 2013 or early 2014.

TSCA Reform Debuts in the 113th Congress.

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Last week, Sen. Frank Lautenberg (D-NJ) and Sen. Kirsten Gillibrand (D-NY) introduced the Safe Chemicals Act of 2013, which would overhaul the Toxic Substances Control Act (“TSCA”). The Safe Chemicals Act is identical to legislation approved last year by the Senate Environment and Public Works Committee.

The Safe Chemicals Act grants greater authority to the EPA to:

  • evaluate the safety of chemicals based on risk;
  • update EPA’s TSCA Inventory, first focusing review on priority chemicals;
  • order additional testing of chemicals when existing health and safety data is inadequate;
  • require regular use reporting;
  • impose a broad range of risk-management controls for chemicals that fail to meet safety standards; and
  • establish a public database of safety determinations and health and safety data.

The legislation’s focus on risk combines both hazard- and exposure-based methods of safety assessment. Under the bill’s new safety standard, EPA must determine that there is “reasonable certainty that no harm will result to human health or the environment from aggregate exposure” to evaluated chemicals. Such safety determinations must also follow recommendations on “best available science” from the National Academy of Sciences. EPA would evaluate and make safety determinations for all chemicals in the TSCA Inventory based on a priority classification scheme which uses existing data and considers the following factors: potential impacts on human health and the environment; hazard potential, including “designations of hazard characteristics by other authoritative entities”; potential for exposure; and measurements of exposure for any given pathway, if available. For chemicals that do not meet the safety standard, EPA would be able to implement controls ranging from requiring warning labels to imposing an outright manufacturing ban.

The proposed regular use reporting would apply to manufacturers and processors, and is similar to the existing Chemical Data Reporting rule. The bill also incorporates amendments made in committee to last year’s bill which aim to better protect manufacturers’ confidential business information, including specific protections applicable to certain types of information, like “[p]recise information describing the manufacture, processing, or distribution of a chemical substance or mixture” or marketing and sales data.

Lautenberg, who has announced he will retire in 2014, has introduced several TSCA reform bills during his career, and hopes to make the Safe Chemicals Act his “signature legislation for his final term in office.” Twenty-seven other members of the Senate’s Democratic caucus have joined Lautenberg and Gillibrand in sponsoring this bill. Sen. David Vitter (R-LA) has already announced his intention to introduce a competing bill for this Congress; he led Republican efforts on TSCA modernization in the 112th Congress.

The full text of the Safe Chemicals Act is available on Sen. Lautenberg’s website.