EPA Expands List of Safer Chemical Ingredients.

This week, the U.S. Environmental Protection Agency (EPA) added more than 130 chemicals to its Safer Chemical Ingredients List, which contains chemicals that meet the criteria of EPA’s Design for the Environment (DfE) Safer Product Labeling Program. For the first time, 119 fragrance chemicals for commercial and consumer cleaning products have also been added to the list.

Fragrance, although still thought to be a relatively low safety hazard compared to other chemicals, has become a health concern because of its unlisted ingredients. A study by the consumer advocacy groups Environmental Working Group and the Campaign for Safe Cosmetics tested 17 popular fragrances and found that the average fragrance product contained 14 undisclosed chemicals. Among them were phthalates, which are used to soften plastic and belong to the class of endocrine-disrupting chemicals that may affect the body’s hormone system.

With the addition of the new chemicals, the Safer Chemical Ingredient list now contains 602 chemicals. Established in September 2012, it serves as a resource for consumers, product manufacturers, and environmental and health advocates interested in the use of safer chemical ingredients in products. Product manufacturers can also use the guide to identify chemical ingredients that meet the DfE program’s rigorous scientific standards for protecting human health and the environment. More than 2,500 products are certified under the DfE Standard for Safer Products including all-purpose cleaners, laundry and dishwasher detergents, window cleaners, car and boat care, and many other products.

Chemical Safety Improvement Act May Be Overhauled in Senate Hearing Next Week.

Since its introduction in late May, the bipartisan Chemical Safety Improvement Act of 2013 (“CSIA,” S. 1009) has already had an eventful history which looks like it will get even more interesting next week when the Senate Environment and Public Works (“EPW”) Committee holds a day-long hearing on reforming federal chemical law. The hearing, scheduled for July 31, will focus on the CSIA but also consider other proposals to reform the 1976 Toxic Substances Control Act (“TSCA”) – the only major environmental statute that hasn’t been updated since its initial passage.

The CSIA, introduced by Senator David Vitter (R-LA) and the late Senator Frank Lautenberg (D-NJ), has already been the subject of two House committee hearings. The bill was introduced just weeks before the death of Sen. Lautenberg, who was known for his dedication to pollution protection and public health, and some have called for its passage as a tribute to his legacy. The CSIA is backed by industry and some environmental groups, but has been criticized by other environmental groups and consumer and health advocates who argue that the bill is critically flawed; for example, if passed, the law might override state consumer safety laws like California’s Proposition 65, which require warnings on products that contain certain chemicals. In California, Attorney General Kamala Harris and the state’s Department of Toxic Substances Control have expressed concern that the bill could not only preempt Prop. 65 but also derail the state’s nascent green chemistry regulations.

Senator Barbara Boxer (D-CA), who chairs the Senate EPW Committee and co-sponsored some of Sen. Lautenberg’s previous TSCA reform proposals, is reportedly planning a major overhaul of the bill “that would amount to starting over.” Sen. Boxer’s goal is to combine parts of the Chemical Safety Improvement Act with parts of the Safe Chemicals Act of 2013 (S. 696). The Safe Chemicals Act was introduced by Sen. Lautenberg in April 2013 without Republican support, and mirrors legislation that passed the Senate EPW committee last year. Details on the hearing, including the witness list, are not yet available.

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

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.

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.

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.