Although Congress has indisputably given OSHA the power to regulate occupational dangers, it has not given that agency the power to regulate public health more broadly. Requiring the vaccination of 84 million Americans, selected simply because they work for employers with more than 100 employees, certainly falls in the latter category.

It is important to note, however, that OSHA enforcement in this area is likely to continue under the guise of the "general duty clause," which requires employers to provide a workplace "free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees." Accordingly, companies need to assess whether they are, in light of OSHA and other public guidance, taking appropriate steps to protect their employees from the virus.

A copy of the Court’s opinion is available here: 21A244 National Federation of Independent Business v. OSHA (01/13/2022) (supremecourt.gov).

The consent decree follows litigation filed by the environmental groups in March 2019:

Plaintiffs allege that EPA had a duty under Clean Water Act (“CWA”) section 311 (j)(5)(A)(i), 33 U.S.C. § 1321(j)(5)(A)(i), to issue regulations that require an owner or operator of a non-transportation-related onshore “facility described in subparagraph (C) to prepare and submit to the President a plan for responding, to the maximum extent practicable, to a worst case discharge, and to a substantial threat of such a discharge, of . . . a hazardous substance” (the “Hazardous Substance Worst Case Discharge Planning Regulations”) by August 18, 1992.

Despite its duty to issue worst-case hazardous-substance spill regulations by August 1992, EPA missed its deadline. These regulations are now more than twenty-five years overdue. EPA's decades-long failure to issue worst-case hazardous-substance spill regulations therefore violates the Agency's nondiscretionary duty.

... leaves the communities closest to the most dangerous chemical facilities in the country without any assurance that those facilities are - as Congress mandated - adequately planning to prevent and respond to catastrophic chemical spills, including those caused by floods, fires, and hurricanes. These communities, which are disproportionately low-income or communities of color, are entitled to all the protections for public health, drinking water supplies, and the environment Congress mandated in the Clean Water Act.

The plaintiffs now are relying on a separate provision of the CWA that is the basis for the FRP program for oil, which applies to a smaller universe of facilities than does the SPCC program. While "hazardous substances" are mentioned in the same CWA provision, EPA has never established a hazardous substance-specific Clean Water Act spill response program.

Under the FRP for oil, facilities that could reasonably be expected to cause "substantial harm" to the environment by discharging oil into or on navigable waters are required to prepare and submit Facility Response Plans. "Substantial harm" is defined as a facility (1) with total oil storage capacity greater than or equal to 42,000 gallons and is involved in activities that transfer oil over water to/from vessels; or (2) with total oil storage capacity greater than or equal to 1 million gallons and meets one of the following conditions: (i) does not have sufficient secondary containment for each aboveground storage area; (ii) is located at a distance such that a discharge from the facility could cause "injury" to fish, wildlife, and sensitive environments; (iii) is located at a distance such that a discharge from the facility would shut down a public drinking water intake; or (iv) has had, within the past five years, a reportable discharge greater than or equal to 10,000 gallons.

While the settlement requires EPA to conduct a rulemaking, the direction and content of that rulemaking are not prescribed. EPA is taking comment on the draft settlement agreement until March 4, 2020.

In my experience, that is simply not the case. The status quo is mere kabuki theater, with government officials going through the bureaucratic motions to dismiss FOIA requests without providing the requested data, even in circumstances in which the release of such data is mandated and clear under existing FOIA guidelines. Increasingly, and particularly with the current Administration, career staff are using various FOIA exemptions, such as the requirement not to disclose "private patient information," to avoid disclosing critical data (from community studies and other scientific reports) that serve as a basis for regulatory or enforcement action. This is done to prevent third parties who may be affected by the given regulation or enforcement action from being able to undertake their own critical review of such data. This is the equivalent of requiring a defendant to accept at face value the testimony of a prosecutor's expert witness.

A recent experience highlights this charade rather well ... names have been scrubbed to protect the innocent (and the not-so-innocent too):

• Early 2017 - EPA files a complaint against an industrial facility alleging an imminent and substantial endangerment, relying on the results of EPA-funded community research to support their allegations.
• June 2017 - First FOIA request filed seeking all records pertaining to the EPA-funded community studies.
• Next 10 months - EPA staff and company representatives work to come to an agreement to narrow the FOIA request to the underlying raw data for the research program with appropriate redaction to maintain the confidentiality of the research participants.
• May 2018 - EPA nevertheless denies the narrowed FOIA request citing fear of potential disclosure of the personal health information of study participants. These fears were promoted by a federal agency researcher with a vested interest in the underlying data at issue (and her interpretation of that data).
• October and December 2018 - Second and third FOIA requests filed for the underlying raw data from the community research program.

These subsequent requests rely on guidance developed by the Department of Health and Human Services (“HHS”) to facilitate disclosure of research data -- guidance that is highlighted by EPA as part of its recent “strengthening transparency in regulatory science” proposed rule. If records are redacted pursuant to the guidance, the information is no longer considered protected personal health information and therefore subject to disclosure.

• EPA refuses to engage on questions regarding disclosure pursuant to the HHS guidance and how it could be used to facilitate release of the underlying raw data.
• November 2018 and March 2019 - EPA summarily denies the second and third FOIA requests without addressing the HHS guidance identified by the agency as part of its “transparency in regulatory science” proposal.
• July 2019 - A request for assistance is filed with the Office of Government Information Services (OGIS), which has a stated mission to assist the public and Federal agencies by helping them resolve their FOIA disputes. OGIS responds with a pro forma statement regarding the FOIA appeals process, recommending that "the best course of action is to wait until EPA adjudicates your appeal."
• All appeals remain pending ... which should come as no surprise to anyone who has ventured down the EPA FOIA rabbit hole.

This charade must stop.

Under the new disclosure program, manufacturers (with over 100 employees) of covered cleaning products are required to disclose by July 1, 2019, certain information regarding intentionally added ingredients (other than fragrance ingredients), and nonfunctional ingredients present above trace quantities. Compliance requires completion and submission to NYDEC of a Certification Form, as well as making the required disclosures on the company's website. Additional disclosure requirements are phased in over the next several years, including for manufacturers with less than 100 employees, and with respect to different types of ingredients and information pertaining to human health and environmental risks.

Cleaning products covered by the Program are defined as "soaps and detergents containing a surfactant as a wetting or dirt emulsifying agent and used primarily for domestic or commercial cleaning purposes, including but not limited to the cleansing of fabrics, dishes, food utensils and household and commercial premises.”

No reason was provided for the additional enforcement delay. However, lawsuits challenging the program remain pending.

Further information on the enforcement delay and disclosure program in general can be found at www.dec.ny.gov/chemical/109021.html.

In announcing the launch of the new campaign on May 15th, EPA declared the agency's “renewed emphasis on encouraging regulated entities to voluntarily discover, promptly disclose, expeditiously correct, and take steps to prevent recurrence of environmental violations.” This renewed emphasis is consistent with the current EPA's focus on improving compliance through mechanisms, including voluntary self-correction, that achieve environmental goals more quickly and in a less costly, adversarial and time-consuming manner than traditional enforcement means.

More specifically, in the months since the initiative was launched, EPA has sought to expand use of the Audit Policy by enhancing and promoting: → the online “eDisclosure” program; → the additional flexibility available to new owners who self-disclose violations ("the New Owner Policy"); and, → opportunities to increase compliance through use of existing self-disclosure policies or tailored audit programs.

In its May statement, EPA explicitly aimed to remind the regulated community that the Audit Policy offers significant benefits, including:

(1) elimination of 100% of the gravity-based civil penalty that otherwise might apply (in the vast majority of Audit Policy disclosures, EPA will only seek to recover the "economic benefit"portion of a potential penalty); (2) waiver of the economic benefit component of a potential penalty where EPA deems it insignificant; (3) does not require advance notice to EPA of an audit; (4) does not impose time limits on audit completion; and (5) can provide clarity by defining allowable violation correction time periods.

The New Owner Policy also provides significant potential benefits and incentives for companies that want to make a ‘‘clean start’’ at newly acquired facilities by addressing environmental noncompliance that began prior to acquisition. Some of the policy’s key incentives and areas of flexibility include:

(1) the ability of new owners to enter into audit agreements that incorporate disclosure reporting that is appropriate to their unique situation; (2) the waiver of economic benefit penalties that otherwise might apply to delayed expenditures; and (3) more generous treatment of violations discovered through already legally mandated monitoring, sampling or reporting that would not normally be considered “voluntarily discovered” (such as testing pursuant to a Title V permit).

The Audit Policy was used extensively during the Bush Administration, but was effectively discontinued during the Obama Administration. The move is an affirmative sign that this Administration is more amenable to penalty mitigation for voluntarily discovered and disclosed violations, and a tangible manifestation of recent pronouncements out of the Office of Enforcement and Compliance Assurance that the agency is focused chiefly on finding ways to improve compliance and less towards punishment of violators.

More info on the Audit Policy and and the New Owner Policy can be found at: https://www.epa.gov/compliance/epas-audit-policy.

Human epidemiological studies provide evidence that persistent night shift work is associated with an increased risk of breast cancer and mechanistic and other related studies provide evidence that circadian disruption plays a major role in the cancer pathway in humans.

A peer review public meeting will be held October 5th in Research Triangle Park, NC to review the Draft Report on Carcinogens Monograph on Night Shift Work and Light at Night (dated August 24, 2018). Public comments or requests to make an oral presentation at the public meeting must be submitted by September 21st.

****

The headlines read like something out of The Onion, but both the U.S. National Toxicology Program (NTP) and the International Agency for Research on Cancer (IARC) are undertaking reviews to assess whether working at night poses a cancer risk. Scientifically speaking, the agencies are examining whether practices that disrupt circadian rhythms, such as "light at night" (LAN), for which night shift work is viewed as a proxy, are associated with an increased cancer risk.

While neither NTP nor IARC have direct regulatory authority, both agencies often are cited as "authoritative bodies" for identifying carcinogens under regulations implemented by EPA, OSHA, and other agencies, as well as California Proposition 65.

In fact, this is IARC's second look at the issue in the last decade: in 2010, the Lyon, France-based organization classified “shift work that involves circadian disruption” as probably carcinogenic to humans (Group 2A). That conclusion was based on (1) "limited evidence in humans for the carcinogenicity of shift work that involves night work," and (2) "sufficient evidence in experimental animals for the carcinogenicity of light during daily dark period (biological night)." On August 14, IARC announced that it would once again examine the association between cancer and circadian disruptions caused by shift work, and has requested that relevant studies and other information be submitted by May 6, 2019.

Meanwhile, in May, NTP released a protocol outlining its approach to preparing the cancer hazard evaluation for a draft Report on Carcinogens (RoC) monograph on "Night Shift Work and Light at Night." The aim is to assess "whether scenarios associated with exposure to modern electrical light practices that lead to circadian disruption, including light at night (LAN), shift work at night, and transmeridian travel, are associated with cancer risk." Following a 2012 nomination for NTP to consider listing "shift work involving LAN" in the RoC, NTP convened an expert workshop in 2016 which recommended examining the “health consequences of electric lighting practices in the modern world." NTP explains in the protocol document that

The rationale for this recommendation was that electric light acts as both an effector (based on direct effects on circadian disruption and melatonin suppression, and animal models and human studies of light pollution and indoor light), and as an enabler, allowing what were once daytime activities to be conducted 24/7. And thus, electric light as both an effector and an enabler of additional activities or behaviors (e.g., shift work), may lead to circadian disruption.

• Do a significant number of people residing in the United States work night shifts? • Are a significant number of people residing in the United States exposed to LAN? • Should night shift work be listed in the RoC? If so, how should it be defined? • Can we define the underlying exposures related to circadian disruption? • Should LAN be listed in the RoC? If so, how should it be defined?

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."

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.

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.

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.

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.

• Implementation of the amended Toxic Substances Control Act (TSCA);
• California Proposition 65 and Safer Consumer Products programs;
• European Union regulations under REACH, CLP, and RoHS;
• State programs that identify and potentially restrict “chemicals of concern”;
• Pesticides and antimicrobial product regulations; and
• Classification and risk assessment/communication issues affecting industrial and consumer products.

We hope to provide updates that are current and informative, yet succinct and readable. The goal is not to provide a legal treatise or a comprehensive catalog of all developments, but, rather, to impart information and analysis that is thought-provoking or, at least, helpful to you in assessing whether the issue is one that merits closer examination. If there are any topics you would like us to cover, please don’t hesitate to reach out and let us know.

Finally, yes, the primary author of the blog in fact is named Joe Green. Accordingly, the title Kelley Green Law blog was irresistible. We hope you enjoy it!