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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.

EPA released on June 1 the “problem formulation” documents for the first 10 chemicals for which risk evaluations are being conducted under the amended Toxic Substances Control Act (TSCA).  (See:  https://www.epa.gov/newsreleases/epa-takes-three-important-steps-ensure-chemical-safety-under-lautenberg-act-proposes.)  The documents describe the chemical use and exposure scenarios that the agency expects to examine, as well as the hazards, exposures, conditions of use, and exposed populations (e.g., workers, consumers, bystanders) that will be considered as EPA conducts the risk evaluations.  Companies that manufacture or use products containing these chemicals should review the scoping documents and assess whether the use and exposure scenarios identified by EPA are accurate with respect to the products that they make or utilize in their production processes.  EPA is taking comments for 45 days upon publication in the Federal Register.

For example, the scoping documents rely in part on 2012 and 2016 Chemical Data Reporting to identify potential consumer or commercial exposures for various uses of a chemical that may be outdated or which may have been phased out.  If so, companies may wish to submit comments to EPA clarifying the nature and extent (or lack) of exposure to the chemical of interest.  Such comments could help avoid any inappropriate or misleading associations of risk that could result from the EPA evaluation.

The 10 chemicals, for which risk evaluations must be completed by December 2019, are:  Asbestos, 1-Bromopropane, Carbon Tetrachloride, 1,4-Dioxane, Cyclic Aliphatic Bromide Cluster (HBCD), Methylene Chloride, n-Methylpyrrolidone (NMP), Perchloroethylene, C.I. Pigment Violet 29, and Trichloroethylene (TCE).