With the biggest sales day of the year shortly upon us, a new wave of on-line shopping Americans likely will see Proposition 65 warning notices for the first time.  Though California’s notorious program technically only applies within the state’s borders, Prop 65’s impact stretches well beyond.  Non-California businesses long have had to deal with Prop 65’s requirements since it was adopted by voter referendum in 1986.  Now, however, non-California consumers will be introduced to the ubiquitous warnings (that many Californians simply ignore) thanks to recent amendments emphasizing the need to provide warnings for internet purchases.  (For more details on the recent amendments, including the requirements for internet sales, please see my prior blog post.)

With an exponential increase in recent months of such internet warnings (and the fact that most businesses do not maintain “California-only” websites), consumers across the United States will be seeing many more of these warnings, perhaps for the first time, as they start their holiday shopping.  This article from Yahoo News (Article) — “‘This product contains chemicals known … to cause cancer’: How to navigate Prop 65’s scary warnings while toy shopping” — gives a sense of how consumers may respond … and, more importantly, hints at how such warnings should be understood.

In particular, consumers should keep in mind:

→ There are over 900 chemicals listed by the State of California as potentially causing cancer or reproductive/developmental harm.  Many of these substances are listed based on exposures (usually to laboratory animals) at levels hundreds or thousands of times higher than the level to which a person ever would be exposed.

→ Because of the punitive enforcement mechanisms of Prop 65 … and the proliferation of plaintiff “bounty hunters” that enforce the law … many businesses choose to provide a warning (even when one is not necessary) rather than defend a determination (based on sound science and common sense) not to provide a warning in a lawsuit at substantial cost.

→ Most importantly, remember that it “the dose that makes the poison.”  The existence of a warning does not mean that the product actually poses any kind of meaningful risk.  In most cases, the presence of a warning only means that there may be some exposure to a listed substance, mainly due to the practicality of providing a warning even when one is not necessary.

Prop 65 is intended to force businesses to provide a warning if they choose not to reformulate listed chemicals out of their products.  For many products, reformulation is not an option.  Moreover, it may be impossible to avoid miniscule amounts of certain substances, such as lead, which are ubiquitous contaminants in many materials.  Hence, there is a proliferation of warnings on products that are provided simply out of an abundance of caution and serve no real risk-reduction purpose.  (Which is why they are routinely ignored by many Californians … unfortunately, the rest of the country is not nearly as familiar with them.)

Now these warnings are coming en masse to the Black Friday shopping website of your choice ….  something to consider while enjoying your turkey this Thanksgiving!

With Democrats now in control of the House, Congressional oversight of EPA’s implementation of the 2016 amendments to the Toxic Substances Control Act (TSCA) is set to ramp up.  The expected incoming chair of the House Energy & Commerce Committee, Rep. Frank Pallone (D-NJ), announced yesterday his intentions to hold a hearing early next year to address what he calls the agency’s “broad efforts to undermine” the revised TSCA.  Pallone was an early House sponsor of the bipartisan 2016 legislation that fundamentally revised TSCA and triggered a series of regulatory requirements that EPA must fulfill within a relatively aggressive timeframe.

While signed into law by President Obama, the major framework rules that govern how the agency moves forward with prioritizing, evaluating, and regulating existing and new chemicals has fallen primarily to the Trump Administration.  Like any major legislation, the “new TSCA” embodies a multitude of compromises, with differing interpretations competing to be codified in regulations.  Over the last several months, numerous controversies have arisen over how the Trump EPA is implementing the law’s new requirements, most notably with respect to how EPA defines the scope of uses (intended and reasonably foreseen) that must be evaluated in assessing the risks of a given chemical.

Rep. Pallone’s most recent statement, in fact, was issued in conjunction with the release by EPA of the first of ten draft risk assessments for existing chemicals.

“The new draft risk evaluation of [Pigment Violet 29] raises serious red flags about the Trump EPA’s commitments to scientific integrity and protecting the public health.  EPA appears to have purposely discounted known environmental hazards, numerous foreseeable uses, and all manufacturing below reporting thresholds for the Chemical Data Reporting Rule.  This is disturbing but falls in line with the Trump Administration’s ongoing attempts to weaken the updated TSCA law. We look forward to holding hearings on this draft and EPA’s broad efforts to undermine the Lautenberg Act early next year.”

The remaining draft assessments for the first wave of chemicals to be evaluated under the revised TSCA are scheduled to be issued by or soon after the new year.  Given the precedent that these initial risk assessments will establish for future chemical reviews, they are expected to be a key focus of oversight by House majority Democrats.

 

 

 

 

By November 2021, the European Union (EU) is requiring that clothing, accessories, footwear and other textiles (such as furniture upholstery and bed linens) be essentially free of 33 “CMR” substances, including lead, cadmium, arsenic, hexavalent chromium, formaldehyde, several phthalates, and certain azodyes, aromatic amines, and hydrocarbons, among other substances often found in a variety of dyes, flame retardants, and stain- and water-proofing agents.  The restrictions, adopted on October 10 under Annex XVII of the EU’s REACH legislation, apply to textile products sold in the EU that may come into contact with human skin (or be inhaled or ingested) and aim to reduce exposures to substances identified as carcinogens, mutagens, or reproductive toxins (so-called “CMR” substances).

The regulation specifies acceptable de minimis levels for the 33 substances, ranging from as low as 1 mg/kg to 3,000 mg/kg.  Amounts above these levels, whether present intentionally or as an impurity, would be prohibited.

The restrictions do not apply to (a) products made exclusively of natural leather, fur or hide; (b) non-textile fasteners and non-textile decorative attachments; (c) second-hand clothing or other products; (d) carpets, rugs, and other textile floor coverings; or (e) medical devices or personal protective equipment, as well as disposable (i.e., single or limited use) textiles.

While a two year phase-in is provided to allow for manufacturers to conform to the new restrictions, a number of companies reportedly already have reformulated away from the listed substances and adopted (supposedly) less hazardous alternatives or are on track to do so.

The full text of the new EU regulation can be found here:  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2018.256.01.0001.01.ENG&toc=OJ:L:2018:256:TOC.

 

 

 

A new framework of fees to cover the costs of implementing the provisions of the 2016 amendments to the Toxic Substances Control Act (TSCA) will go into effect October 1st, under a final rule issued yesterday by EPA.  The fees are designed to collect $20 million annually from chemical manufacturers, importers, and processors, or about 25% of the expected agency costs of implementing the new mandates of TSCA, including chemical prioritization and risk evaluation tasks, as well as review of toxicity and exposure data submitted under an EPA test order.

These fees are intended to achieve the goals articulated by Congress by providing a sustainable source of funds for EPA to fulfill its legal obligations to conduct activities such as designating applicable substances as High- and Low-Priority, conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, requiring testing of chemical substances and mixtures, and evaluating and reviewing new chemical submissions, as required under TSCA sections 4, 5 and 6, as well as and collecting, processing, reviewing, and providing access to and protecting information about chemical substances from
disclosure as appropriate under TSCA section 14.

Examples of some of the fees manufacturers (and sometimes processors) would pay include:

• $1.3 million for agency-initiated chemical risk evaluations;

• $2.5 million for manufacturer-requested risk evaluations for chemicals not on EPA’s 2014 TSCA Work Plan list, and $1.25 million for chemicals on the list;

• Between $9,800 and $22,800 for EPA review of toxicity, exposure, and other information companies submit in response to an EPA order, regulation, or negotiated agreement;

• $16,000 for EPA review of new chemicals (or certain new uses).

The final rule largely adopts the user fee program as proposed in February, with certain modifications to the procedures for identifying manufacturers subject to the fees, the fee calculation for chemical reviews requested by manufacturers (which are substantially higher than the fees for agency-initiated reviews), and the standard for identifying “small businesses” subject to fee reductions of approximately 80%.

The fee rule is the fourth and final of EPA’s “framework rules” for implementing the 2016 TSCA amendments.  The first three rules addressed chemical prioritization for risk assessment; the process for conducting risk evaluation; and update of the TSCA existing chemical inventory.

Further details and background information on the fee rule is available from EPA’s website:  www.epa.gov/tsca-fees.

** UPDATE 8/29/2018 ** NTP just released a draft report recommending that “frequent and long term night shift work … that causes circadian disruption is known to be a human carcinogen” based on human studies.  Continue Reading This is Not a Dream … Agencies Actually are Reviewing the Cancer Risks of Night Shift Work (UPDATED)

The European Union (EU) is about to dramatically expand the reach of mandatory chemical disclosure requirements for consumer products.  The European Chemicals Agency (ECHA) announced recently that it is preparing to launch, by the end of 2019, a new database on the presence of hazardous chemicals in articles.  The database will be populated with information submitted by companies  producing, importing or selling articles into the EU that contain REACH Candidate List substances (i.e., Substances of Very High Concern or “SVHC”).  Companies will be required to submit such information by the end of 2020.

The EU action joins and has the potential to greatly expand the burgeoning trend towards the identification and public disclosure of chemicals in consumer products.  More limited and product-specific disclosure requirements have proliferated in recent years, with, for example, numerous U.S. states now requiring disclosure or reporting for chemicals in children’s products and cleaning product disclosure requirements launching in California and New York.  The new amendments to California Proposition 65, as discussed elsewhere in this blog, now require identification of at least one chemical for which a warning is being provided, and also have spurred extensive discussions about the presence of listed chemicals among retailers, manufacturers, distributors, and anyone doing business in the state.  These are just a few of the more prominent examples of the growing interest, among consumers and regulators, in mandating that businesses publicly provide information about the chemicals in their products.

The new ECHA database is an outgrowth of both existing REACH requirements and implementation of a revised directive on waste that entered into force last month, which aims to enhance EU’s “circular economy” policy by “improv[ing] the risk management of chemicals during waste recovery and to promote non-toxic material cycles.”  ECHA explicitly recognizes that the “database aims to help consumers make informed choices for safer products” and “will also increase pressure to substitute substances of concern.”

Currently, REACH §33 provides consumers the right to request, and receive within 45 days, from a manufacturer information about the presence of SVHC ingredients in a product.  Supply chain communication of chemical information is another essential feature of REACH, but does not directly involve public disclosure. The new database, in contrast, compels disclosure of such information in a public forum.

In practice, the new disclosure requirements represent a significant expansion of the compliance obligations for businesses that sell consumer products in the EU.  Exporters of consumer products to the EU should engage with their European importers and distributors regarding compliance with the information submission requirements in preparation for the program coming online next year.  The EU action also underscores the need for every business to know information about the chemicals in their products and what, if any, hazards they may represent.

“Science and the scientific process must inform and guide decisions … The public must be able to trust the science and the scientific process informing public policy decisions.”

Former EPA Administrator Scott Pruitt introducing the 2018 proposal he championed on “Strengthening Transparency in Regulatory Science”?  Nope, this is the opening statement of President Obama’s 2009 memorandum on “Scientific Integrity.”  That Obama-era policy further instructed “[t]o the extent permitted by law, there should be transparency in the preparation, identification, and use of scientific and technological information in policymaking.”  These fundamental transparency issues, which were not particularly controversial when addressed by the prior administration (or in myriad other incarnations over the past 30 years), are at the core of EPA’s present efforts.

Who doesn’t agree with the assertion (this time from the current Science Transparency proposal) that “[e]nhancing the transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA’s regulatory actions and its obligation to ensure the Agency is not arbitrary in its conclusions”?  Indeed, this principle is neither controversial nor new.  Under the Administrative Procedure Act, as the D.C. Circuit held in 1973, “it is not consonant with the purpose of a rule-making proceeding to promulgate rules on the basis of inadequate data or data that [in] critical degree, is known only to the agency.” Likewise, a decade later the premier regulatory appellate court in the country stated:

In order to allow for useful criticism, it is especially important for the agency to identify and make available technical studies and data that it has employed in reaching the decisions to propose particular rules.  To allow an agency to play hunt the peanut with technical information, hiding or disguising the information that it employs, is to condone a practice in which the agency treats what should be a genuine interchange as mere bureaucratic sport.

To avoid the “hunt the peanut” game, guidelines adopted by EPA in 2002 to implement the Information Quality Act require that “influential information” be subject to a high degree of transparency, including that findings must be “reproducible” (within a reasonable degree of accuracy) by third parties.  Reproducibility by others is a critical check on the quality of the study process and reported data, as well as on the inherent bias (unintentional as it may be) of researchers to find “significant” results.

Curiously, the current EPA proposal omits discussion of the ample existing legal authority specifically related to the transparency and reproducibility of public health research sponsored by the Federal Government.  As set forth in OMB guidance for financial assistance to non-Federal entities, federal agencies have unfettered legal authority to “[o]btain, reproduce, publish, or otherwise use the data produced under a Federal award,” or to “[a]uthorize others to receive, reproduce, publish, or otherwise use such data for federal purposes.”  In addition, any public health research data (a) produced under a Federal award, and (b) used by the Federal Government in developing agency action that has the force and effect of law, must be released to the public if a request for the data is made pursuant to the Freedom of Information Act (FOIA).  (Of course, anyone who has sought such information under FOIA knows well the exemptions/excuses that often are employed to inhibit release of data to which the public has a fundamental right to access.  For more, see my previous post addressing privacy concerns: https://www.kelleygreenlawblog.com/2018/06/epa-science-transparency-policy-enable-stakeholder-access-study-data/.)

Because the federal government has sponsored a substantial majority of the public health research conducted in the United States over the past 50 years, the EPA and other agencies are well positioned, using existing legal authority, to facilitate release of public health research data if they are inclined to do so as a matter of policy.

The REACH Committee of the EU Commission agreed on July 11 to advance a proposal that would restrict the presence of four phthalates (DEHP, DBP, BBP, DIBP) in products placed on the market.   The proposed restriction would limit the amount of these common plasticizers, individually or in any combination, to a concentration below 0.1% by weight.

According to the Commission, consumers can be exposed to phthalates through a variety of sources, including ingesting food and dust, placing articles in the mouth, breathing in air and dust indoors, and by dust and articles getting in contact with mucous membranes and skin.  The phthalates previously were identified under REACH as substances of very high concern (SVHC) based on reproductive toxicity and endocrine disrupting effects.

The European Parliament and the Council now have 3 months to review the measure before it goes back to the Commission for final adoption. The restriction will then be published in the EU Official Journal and will apply 18 months after entry into force to products produced both in and outside of the EU.

We are seven weeks away from the California Proposition 65 amendments adopted in 2016 going into full effect, including substantial changes to the wording and format for providing warnings, new guidance on providing warnings for website purchases, and tailored warnings for certain exposure scenarios (such as restaurants), as well as important new provisions regarding the division of responsibility for providing warnings among retailers, manufacturers, distributors, and others in the supply chain.  August 30 marks the two year anniversary of issuance of the revised warning regulations and the end of a transition period during which either the prior or new “safe harbor” warning requirements could be utilized to ensure compliance.   As of August 30, only the new “safe harbor” warnings can be relied upon to avoid potential challenge for failure to provide a “clear and reasonable warning.”  Also on that date, for the first time, the new provisions addressing retailer liability, and the obligations of manufacturers and other suppliers seeking to pass on warning responsibilities, become effective.

To briefly recap, the major new provisions include:

(1) First and foremost, the familiar old Prop 65 signs (on right below) will give way to a more detailed warning, including the newly required posting of the yellow triangle “warning symbol,” identification of at least one specific chemical for which the warning is provided, a statement that the product “can expose” the consumer to the chemical (and not simply that the product “contains” a listed chemical), multi-lingual labeling, and reference to the Prop 65 website:

The soon-to-be “old” “safe harbor” Prop 65 warning
  • For exposure to carcinogens:  “WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.”
  • For exposure to reproductive toxins:  “WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.”
  • For exposure to both carcinogens and reproductive toxins: “WARNING: This product can expose you to chemicals including [name of one or more listed chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.”

(2) New abbreviated “on-product” warnings for consumer goods.

(3) Specific “safe harbor” warnings for the certain products or exposure scenarios:  Food; Alcoholic beverages; Restaurants; Prescription drugs; Dental care and emergency medical care; Raw wood; Furniture; Diesel engines; Passenger vehicles or off-road vehicles; Recreational vessels; Parking garages; Amusement parks; Petroleum products; Service stations and vehicle-repair facilities; and Designated smoking areas.

(4) For internet purchases, the safe harbor warning must be provided by including either the warning or a clearly marked hyperlink using the word “WARNING” on the website product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase.  Guidance from the Prop 65 implementing agency, the Office of Environmental Health Hazard Assessment (OEHHA), earlier this year clarifies that in addition to the website warning, the consumer also must be receive the warning through the traditional methods related to sale of consumer products (e.g., a warning also must appear on the product label or be provided in another format).

(5) In terms of clarifying retailer/manufacturer responsibility, the new provision provides manufacturers (and others in the supply chain) with two basic options: (1) affix an appropriate warning to the product; or (2) provide written notice to the retailer regarding the required warning for the product.  The manufacturer (or other suppliers) then must obtain confirmation of the retailer’s receipt electronically or in writing.  If a retailer fails to post or obscures or alters a warning when the manufacturer has provided it, only then will liability potentially fall on the retailer for failing to warn consumers.

Keep in mind that the amendments did not alter the more fundamental question of how a business decides whether to provide a warning, but rather only relate to how that warning is provided.

A detailed overview of the 2016 amendments is available here.  

In addition, OEHHA sent an email blast yesterday with a catalog of guidance materials available for businesses, including the agency’s own overview of the new regulations and links to informative FAQs and Q&As.