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.
** 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:
- 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.
Thousands of companies that sell chemical products online should pay close attention to a new EU enforcement initiative aimed at the apparent widespread failure to disclose health and safety hazard information to consumers making website purchases. EU member state enforcement authorities will focus on internet sales of chemical products, according to an announcement regarding the launch of the 8th REACH enforcement project. While details have yet to be defined, the initiative is expected to emphasize compliance with hazardous chemical restrictions and labeling requirements. Official launch will be in 2020, with preparation under way through 2019.
The EU action follows a 2017 pilot project that found over 80% of online advertisements for sales of hazardous chemical mixtures — including household cleaners, paints, hobby glues, solvents, bug sprays, motor fluids, garden fertilizers and others products — did not comply with the Classification, Labelling and Packaging (CLP) regulation, including online disclosure requirements. Substances for which restrictions have been adopted under REACH Annex XVII are expected to be a primary focus.
Similarly, compliance with REACH authorization requirements for hexavalent chromium, and other hazardous chemicals yet to be announced, will be the target of another enforcement initiative to be launched in 2020. Companies should ensure that their use of “substances of concern” are authorized and abide by any conditions imposed on the use. REACH also requires users of a chemical subject to authorization to notify ECHA within three months of their first supply of the substance. A recent EU review found unauthorized hexavalent chromium to be present in a wide range of products.
Reversing course from an Obama-era EPA agreement to initiate a rulemaking to impose spill prevention, countermeasure and control (SPCC) requirements for hazardous substances, EPA announced on June 19th that it believes that existing regulations are adequate to meet its obligations under the Clean Water Act (CWA) and no new regulatory program is needed:
Based on the reported frequency and impacts of identified CWA [hazardous substance] HS discharges, and the Agency’s evaluation of the existing framework of EPA regulatory requirements relevant to preventing CWA HS discharges, EPA has determined that the existing framework of regulatory requirements serves to prevent CWA HS discharges. Additionally, EPA identified relevant requirements in other Federal regulatory programs and determined that they further serve to prevent CWA HS discharges, providing additional support for this proposed action.
In an example of the “sue and settle” policy that the current Administration has sought to curtail, in February 2016, EPA agreed in a consent decree with environmental groups to initiate rulemaking to expand the SPCC program beyond oil to address other hazardous substances. The settlement established an aggressive schedule for EPA to issue regulations under CWA Section 311(j)(1) by mid- to late-2019.
The CWA contemplated the development of “hazardous substance SPCC” regulations over 40 years ago. The operative provision of the Act requires that, “as soon as practicable after October 18, 1972, and from time to time thereafter, the President shall issue regulations consistent with maritime safety and with marine navigation laws . . . establishing procedures, methods, and equipment to prevent discharges of oil and hazardous substances from vessels and from onshore facilities and offshore facilities, and to contain such discharges . . . .” While EPA did promulgate SPCC regulations addressing the storage of oil and petroleum products such as gasoline and diesel fuel, the Agency proposed (in 1978), but never finalized regulations applicable to the storage of hazardous substances.
The SPCC regulations for oil and petroleum products apply to facilities that have the capacity to store more than 1,320 gallons of oil above ground (or 42,000 gallons in underground tanks). They require the development of SPCC plans that include a description of containment, drainage control, and diversionary structures; proper liquid storage areas, container materials, and secondary containment; drainage for raw material storage areas; control for other site features that could produce runoff; secondary containment and treatment processes for truck and railcar liquid loading and unloading areas; and equipment that prevents discharges for in-plant transfer, processing, and materials handling areas. SPCC plans also must address preventative maintenance, facility security, and training. Plans must be reviewed and certified to by a registered professional engineer, and updated every five years, or more frequently, if material changes are made to the facility or its oil storage capacity.
In suing EPA over the failure to adopt a version of SPCC for hazardous substances, environmental groups cited a series of chemical spill incidents that gained widespread media exposure over the last decade. The groups’ alleged that not only are onshore hazardous-substance storage facilities “subject to neither state nor federal regulation,” there are also “thousands of self-reported hazardous-substance spills from onshore facilities each year,” hundreds of which reach waters subject to CWA jurisdiction. In addition, the complaint asserted that “hazardous-substance spills from non-transportation-related onshore facilities pose a disproportionate threat to low-income communities and communities of color.”
Environmental groups already are condemning the proposed decision not to proceed with a rulemaking, and litigation is highly likely to follow if the proposal is finalized.
A 60-day comment period will commence as soon as the proposal is formally published in the Federal Register.
Responding quickly to a landmark court ruling requiring coffee sold in the state to bear a Proposition 65 warning label, California has initiated a proposed rulemaking to clarify that exposure to acrylamide and other chemicals “created by and inherent in the roasting of coffee beans and brewing of coffee” do not pose a significant risk of cancer. Given the widespread criticism, and even outright mockery, of the need to place a cancer warning label on a product for which there is no evidence of increased cancer risk, the state’s action is a politically astute move. Arguably, it is a much needed regulatory adjustment to save the Prop 65 program from one of its worst public excesses, and the proposal explicitly recognizes the benefit of “helping to avoid cancer warnings for chemicals in coffee” that do not actually pose a risk.
In support of the proposal, posted today, the Office of Environmental Health Hazard Assessment (OEHHA) relies on the findings of the International Agency for Research on Cancer (IARC), the only Proposition 65 authoritative body to have evaluated coffee, that “coffee consumption is not classifiable as to its overall carcinogenicity and is associated with reduced risk of certain cancers in humans.” (For “IARC watchers,” there is some irony in California relying on the findings of that body, the subject of much deserved recent criticism, to take a deregulatory action.) While acknowledging that coffee is a mixture that contains a wide range of potentially carcinogenic substances, OEHHA finds that “abundant data on coffee show that the carcinogens in this particular mixture should be viewed differently” than other complex mixtures, such as cigarette smoke and diesel exhaust, for which warnings are required.
The proposed rule would adopt a new Section 25704 to the Prop 65 regulations, entitled “Exposures to Listed Chemicals in Coffee Posing No Significant Risk” and stating simply: “Exposures to listed chemicals in coffee created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.”
Of course, the regulation, if adopted, does not address exposures to chemicals that are intentionally added to coffee or are present as contaminants through a means other than the inherent process of roasting coffee beans or brewing coffee.
Comments on the proposal are due by August 30 and a public hearing will be held in Sacramento on August 16. Further information on the proposed rulemaking can be found at: https://oehha.ca.gov/proposition-65/crnr/proposed-adoption-new-section-under-article-7-no-significant-risk-levels-section.