California AG Leads Attack on Lead in Infant Formula

Fresh off a victory in the CA primary, California Attorney General Xavier Bacerra filed suit on June 7, 2018 against Nutraceutical Corporation of Park City, Utah and Graceleigh, Inc. dba Sammy’s Milk of Newport Beach, CA, alleging violations of California’s Proposition 65 and California’s consumer protection laws.

At issue are Sammy’s Milk Free-Range Goat Milk Toddler Formula, made by Graceleigh, and Peaceful Planet Toddler Supreme Formula, a rice formula made by Nutraceutical. The complaint, filed in Alameda County, CA, alleges that the levels of lead in both products result in exposures above the Provisional Total Tolerable Intake level for lead of 6 micrograms per day (“ug/day”) applicable to children 6 years of age and younger, as set by the U.S. Food and Drug Administration. A statement issued by the AG asserts that State testing showed that the products actually cause lead exposure between 13 and 15 times the maximum allowable dose under California law. The AG’s office also advised that both companies have voluntarily agreed to stop selling the products at issue in California.

Prop 65 Claims

Lead was placed on the Prop 65 list on two occasions: on February 27, 1987 for reproductive toxicity and on October 1, 1992 for cancer.

Nutraceutical said it intends to vigorously contest the suit, which it said lacks merit. The company has reported that its Toddler Supreme protein supplement’s ingredient levels comply with applicable laws and regulations and don’t pose any safety risk to consumers, based on an opinion from a former FDA toxicologist. An issue will be if the levels meet the safe harbor provisions for lead, which would preclude the requirements for a Prop 65 warning. Prop 65 safe harbors do not always align with FDA standards.  The no significant risk level (“safe harbor”) for a cancer warning regarding lead is 15 ug/day (oral exposure). The maximum allowable dose level (“safe harbor”) for a reproductive toxicity warning regarding lead is 0.5 ug/day.

Claims Under CA Consumer Protection Laws

The complaint further alleges that due to the excess levels of lead, the products are adulterated within the meaning of the California Sherman Food, Drug and Cosmetic laws and therefore violates the unlawful prong of CA Bus. & Prof. Code section 17200. The false and misleading statements  of the two companies are alleged to also violate  CA Bus. & Prof. Code sections 17200 and 17500 in the following ways:

  • With respect to Graceleigh, by asserting that its ingredients in Sammy’s milk are “selected for purity” and provide “clean nutrition.”
  • With respect to Nutraceutical, by asserting that its Peaceful Planet product is “CLEAN” and “PURE.”

The State has requested that the court award both injunctive relief and civil penalties (Prop 65 statute calls for $2500 per violation).

We will continue to follow this case and other actions in California related to the continued assault on lead contamination of consumer and children’s products.

 

©1994-2018 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.
Read more on California legal updates on our California jurisdiction page.

President Trump Announces Tariffs on Canadian Steel and Aluminum, Canada Quickly Retaliates with Tariffs on U.S. Imports: An Unprecedented Trade War Looms

On May 31, 2018, by way of two Presidential Proclamations, President Trump imposed tariffs on Canadian exports of steel, which will be subject to a 25% tariff, and Canadian exports of aluminum, which will be subject to a 10% tariff. This move follows President Trump’s March 1, 2018 announcement that he intended to impose global tariffs on these products. The announcement stands in contrast with President Trump’s previous statements that Canadian products could remain exempt.

These Proclamations are:

  1. Presidential Proclamation Adjusting Imports of Steel into the United States; and

  2. Presidential Proclamation Adjusting Imports of Aluminum into the United States.

Canada’s Department of Finance has indicated that it will retaliate to President Trump’s Tariffs by imposing countermeasures against imports of steel, aluminum and other goods originating in the United States. Canada’s tariffs on U.S. goods will total up to $16.6 billion CAD ($12.8 billion USD) representing the value of the impact that President Trump’s steel and aluminum tariffs will have on Canadian exports. Canada will impose tariffs on U.S. steel at a rate of 25%, and aluminum and various other items at a rate of 10%.

In addition to the tariffs, Canada is launching disputes at the World Trade Organization and under Chapter 20 of the North American Free Trade Agreement (NAFTA).

How Did We Get Here

On May 31, 2018, President Trump unilaterally issued these two Presidential Proclamations under the authority of Section 232 of the Trade Expansion Act of 1962, as amended, section 301 of title 3, United States Code, and section 604 of the Trade Act of 1974, as amended. The measures were implemented directly from President Trump and are not considered to be safeguarding measures.

Products Affected

The Trump Steel Tariffs and Aluminum Tariffs cover a wide range of steel and aluminum products, defined on the Harmonized Tariff Schedule (HTS) (See (March 8, 2018) and ).

Canada’s retaliatory tariffs will affect steel and aluminum that originate in the U.S. Other goods that will be affected by retaliatory tariffs include plywood, veneer, boats, playing cards, beer kegs, whisky/bourbon, coffee, orange juice, strawberry jam, tomato ketchup, mustard, mayonnaise, maple syrup, licorice candy, soup, gherkins and cucumbers, toilet paper, dishwasher detergent, candles, hair lacquers, combined refrigerators/freezers, laundry-type washing machines, dishwashers, water heaters, mattresses, sleeping bags, lawn mowers, ballpoint and felt-tip pens, etc. (See ).

Canadian Foreign Affairs Minister Chrystia Freeland has said that “the list has been put together with a few considerations in mind. One has been to support and defend the Canadian steel and aluminum industries that are now facing unfair barriers in their exports to the United States. It is appropriate that their U.S. competitors face equivalent barriers in exporting to Canada.” The list of goods is also believed by some to be strategically targeting industries in states that voted for Trump’s protectionist message in 2016 during the election.

The Tariffs will impact products that originate in the United States. NAFTA Country of Origin Marking rules will be relied upon to determine this. These rules are used to clearly indicate to the ultimate purchaser of a product where it has been made. Under NAFTA, Canada, Mexico and the U.S. were permitted to institute their own country of origin marking rules applicable to goods imported from the other two trade agreement partners. The American NAFTA marking rules are set forth under 19 CFR Part 102 – Rules of Origin (19 U.S.C. 66, 1202).

Impact on Exporters and Importers

According to the U.S. Department of Commerce’s International Trade Administration, last year, U.S. steel imports from Canada made up 17% of total steel imports. Canada imports roughly half of U.S. steel and aluminum exports.

How Long Will It Last

Canadian retaliatory tariffs will begin on July 1, 2018. The countermeasures will remain in place until the U.S. terminates the Trump Steel Tariffs and Trump Aluminum Tariffs.

At present, President Trump has not stated a termination date for the Trump Tariffs.

How to Protect and Promote Interests

Canadian importers must closely consider the impact that both United States and Canadian tariffs will have on their products and should take several actions including:

  • Identifying which goods will be affected by the new tariffs;

  • Reviewing H.S. codes of imported items and certificates of origin for NAFTA goods (See: );

  • Reviewing existing purchase orders and supply contracts that are scheduled to come into effect after July 1, 2018;

  • Considering supply alternatives from other countries;

  • Reviewing increases in prices of goods sold in Canada and reflecting changes in pricing and contractual obligations.

United States exporters should take action by:

  • Reaching out to Canadian purchasers in order to encourage them to lobby the government to remove their products from the list of goods impacted by the countermeasures.

Recap: Previous Proclamations: new tariffs on steel and aluminum

Below are the links to two DW client alerts that have addressed the global Steel and Aluminum tariffs

Carly Walter contributed to this post.

© Copyright 2018 Dickinson Wright PLLC
This article was written by Brenda C. Swick of Dickinson Wright PLLC

Teamsters On The Hook For Full Back Pay, Says NLRB

The National Labor Relations Act protects the rights of employees with respect to both employers and labor organizations (i.e., unions). A recent decision by the National Labor Relations Board (NLRB) regarding the Teamsters is another reminder that unions – just like employers – can be held liable for damages stemming from labor law violations.

At issue in the case was the Teamsters’ unlawful operation of an exclusive hiring hall. Specifically, it was found that the union unlawfully refused to refer a specific employee for work opportunities. Based on that finding, the NLRB ordered the Teamsters to remit to the employee back pay for a three-and-a-half year period (March 2008 – August 2011). The Teamsters, however, resisted payment and argued that the employee’s back pay damages should be substantially reduced based on an alleged “failure to mitigate damages” defense. Under the law, employees have a duty to take reasonable measures to offset their damages, such as by trying to find subsequent, similar employment. The Teamsters went so far as to commission a report in an effort to show the employee did not avail herself of other work opportunities that were available in the area. The NLRB, however, rejected the union’s arguments, noting there were several deficiencies in the report (e.g., lack of essential details on whether the allegedly available jobs were comparable, etc.). Accordingly, the union was ordered to pay the employee full back pay for the three-year period.

While NLRB cases targeting unions are relatively rare as opposed to those against employers, this case demonstrates the agency does prosecute labor organizations’ violations when they occur. It also serves as a reminder that while a failure to mitigate defense can be useful in potentially reducing back pay exposure, a party must be sure to produce credible evidence that supports the defense.

© 2018 BARNES & THORNBURG LLP
This article was created by the Labor and Employment Law Department of Barnes & Thornburg LLP
Nick Seifer contributed to this post.

Blockchain Technology, Tax Attorneys, And The IRS

Blockchain could very possibly solve many difficulties that face the Internal Revenue Service (IRS). Blockchain, the underlying technology of bitcoin, could revolutionize how the IRS conducts business. In revolutionizing how the IRS conducts business, it stands to reason that how tax attorneys conduct business would also be revolutionized.

Blockchain Background

According to Deloitte, “it is clear that implementing Blockchain would require far-reaching changes to the legal system, reforming laws on databases, intellectual property, and legal identity.”

What is blockchain and how does it work? Cryptocurrency is an example of blockchain technology. This distributed ledger technology is the underlying force behind bitcoin, ethers and other blockchain projects. DLT is decentralized. Transactions are recorded onto a multitude of computers simultaneously. Each block of data is linked to a previous block of data, that is, “chained” together. The transaction is synchronized and all nodes reflect the updated figures as they occur. Once a transaction is validated and added to a blockchain, the transaction or asset is theoretically immutable.

An anonymous group or person called Satoshi Nakamoto introduced the first blockchain-based bitcoin in 2009. Blockchain has taken off in the last few years as both currencies and as a business tool. Meanwhile, the world’s legal and government sectors have been playing catch up.

There are both public and private blockchains. Both use decentralized ledgers, both use protocol consensus, and both ensure ledgers are immutable. While anyone can join a public blockchain, a private blockchain may only be joined by invitation or permission and must be validated by the network starter or by rules set up by the network starter. Today, many businesses are establishing private blockchains to help operate their systems.

Revolutionizing Tax Law

There are a number of situations where IRS complications could be smoothed out using private blockchain technology. There are several instances where the IRS must wait for lengthy periods before payments are settled or information is received. Blockchain could safely and securely speed the receipt of data from a mountain of forms. It could render payments settled in a matter of hours rather than days. Blockchain is an ideal tool for reducing taxpayer identity theft. It would also alleviate staff and budget reductions. Storing taxpayer information via blockchain would offer a groundbreaking approach to ensure security and maintain the accuracy of taxpayer data.

To properly and efficiently guide clients, tax attorneys will have to become well versed in blockchain technology and how it will affect the changed tax law landscape. A tax law attorney must understand, interpret and be able to use this technology in practical ways.

Implementation of Blockchain Technology

Other industries, including banking, insurance, real estate, and the arts, have begun capitalizing on blockchain capabilities. These and other clients will expect their attorneys to be able to understand and work with blockchain, including understanding its advantages and disadvantages. Attorneys who transform themselves into blockchain experts today will more than likely see enormous returns in the future.

Another area where blockchain could cause disruption is in the use of smart contracts. It is possible to create these limited, simple contracts with blockchain. The IRS could certainly put smart contracts to multiple uses.

A smart contract is a self-executing, self-enforcing program on a blockchain that, among other things, enables money or agreements to be exchanged. They are written in such a way that the rules are spelled out. Certain conditions must be met before the program will allow a party to proceed to the next step. Each time a criterion is met, the program will execute certain contract terms.

Using smart contracts would free up an enormous amount of time for the IRS and tax attorneys. Learning how to effectively use these contracts would help clients, attorneys, and the IRS. Eventually, tax attorneys who become blockchain wizards will work out how to use more complex contracts that will continue to bring huge changes to the tax law industry.

Conclusion

It is in all likelihood simply a matter of time before the IRS and many other government agencies adopt blockchain technology to provide a secure, speedy, efficient, and cost-effective manner to analyze, store, and transform data and currency. Forward-thinking tax attorneys will be at the forefront of this wave.

© Copyright 2018 PracticePanther
This article was written by Jaliz Maldonado of PracticePanther

Lawsuits Filed in Federal District Court Regarding WPS Training Delay

On May 30, 2018, two complaints were filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Southern District of New York.  Both of these suits concern a decision by EPA to defer publication of a notice of availability (NOA) of training materials prepared pursuant to the Agricultural Worker Protection Standard (WPS), 40 C.F.R. Part 170.  The WPS was originally promulgated in 1974, substantially amended in 1992, and then revised again in 2015.  Although the 2015 revisions to the WPS are currently in effect, employers are not required to adopt new training programs for agricultural workers and handlers until 180 days after EPA publishes the NOA announcing the availability of the new training materials in the Federal Register.

On December 21, 2017, EPA issued a Federal Register notice indicating that it “expects to publish a Notice of Proposed Rulemaking in FY 2018 to solicit public input on proposed revisions to the WPS requirements for minimum age, designated representative, and application exclusion zones.”  In this 2017 notice, EPA acknowledged that the WPS provisions it will propose to revise are already in effect and that training materials consistent with the 2015 rule have already been prepared, but stated that EPA does not expect to issue the NOA for these new training materials until after it completes a rulemaking concerning the proposed revisions to the 2015 WPS rule.  The plaintiffs in both of the new district court cases are challenging the decision of EPA to defer issuance of the NOA, which has delayed the timetable for expanded training for agricultural workers and handlers contemplated by the 2015 WPS rule.

The first of two complaints was filed by Rural & Migrant Ministry, et al. (RAM) v. EPA, Case No. 1:18-cv-04743.  RAM’s complaint’s includes four causes of action based on EPA’s failure to issue the NOA.  RAM alleges that this failure is “arbitrary and capricious,” constitutes “agency action unlawfully withheld and unreasonably delayed,” and violates the publication requirements of the Administrative Procedure Act (APA) and the Federal Register Act.  RAM requests a declaratory judgment that EPA has violated the APA and the Federal Register Act, and injunctive relief to require immediate publication of the NOA.

The second complaint was filed by the States of New York, California, and Maryland, New York v. Pruitt, Case No. 1:18-cv-04739.  These State plaintiffs also contend that EPA’s failure to publish the NOA is “arbitrary and capricious,” and constitutes “action unlawfully withheld or unreasonably delayed.”  Like RAM, the State plaintiffs seek a declaratory judgment and an injunction requiring that EPA immediately publish the NOA for the expanded training materials.  EPA will presumably seek consolidation of the two cases, which both challenge the same EPA actions and seek comparable relief.

The principal question presented by these two WPS cases is whether EPA can lawfully defer full implementation of the expanded training required by the 2015 WPS while it undertakes and completes a new rulemaking to revise certain provisions of the same rule.  Although EPA acknowledges that it has prepared the written materials needed to effectuate the expanded training required by the 2015 WPS, EPA will likely argue that it is both more efficient and less confusing for employers and workers to use the existing training materials until after EPA has finished revising the WPS.  In contrast, the plaintiffs in these two cases will argue that the 2015 WPS is already in effect, and that the protection for workers associated with the expanded training required by this rule has been improperly delayed by EPA without any prior notice and comment rulemaking.

The decision by EPA to defer full implementation of the 2015 WPS while EPA considers potential revisions to the WPS may be deemed analogous in some respects to other EPA actions that delayed the effective date for a rule expanding requirements for certified applicators who apply restricted use pesticides (RUP).  In a decision issued by the U.S. District Court for the Northern District of California on March 21, 2018, the court vacated several EPA actions that had delayed the effective date for the RUP rule, holding that EPA was required to provide notice and opportunity for comment before taking such actions and that EPA lacked “good cause” for acting without notice and comment.  See Order Granting Plaintiffs’ Motion for Summary Judgment, Pineros Y Campesinos Unidoa Del Noroeste v. Pruitt, Case No. 17-cv-03434-JSW.

The current cases may be distinguished from the actions EPA took to defer the effective date for the RUP rule because EPA has declined to take affirmative action to effectuate certain requirements in the 2015 WPS, rather than deferring the effective date for any of the requirements in that rule.  It remains to be seen whether the district court will consider this procedural distinction to warrant a different outcome.

©2018 Bergeson & Campbell, P.C.
This article was written by Timothy D. Backstrom of Bergeson & Campbell, P.C.

California Court of Appeal Enforces Delaware Forum Selection Clause Contained in Certificate of Incorporation

In Bushansky v. Soon-Shiong, 2018 Cal. App. LEXIS 493 (Cal. App. May 25, 2018), the California Court of Appeal, Fourth Appellate District, affirmed the dismissal of a shareholder derivative action brought in the Superior Court of California, San Diego County, on forum non conveniens grounds based upon an exclusive Delaware forum selection clause in the corporation’s certificate of incorporation. This decision interpreted for the first time a condition in a forum selection clause requiring that the Delaware courts have personal jurisdiction over all indispensable parties in order to trigger exclusive forum selection. The Court rejected plaintiff’s assertion that Delaware personal jurisdiction must exist at the time of the filing of the suit, and instead held that post-filing conduct by a defendant voluntarily accepting Delaware personal jurisdiction within a reasonable timeframe thereafter was sufficient. In so doing, the Court disagreed expressly with a decision from the Washington Court of Appeals. This decision reflects continued deference by the California courts to Delaware forum selection clauses in certificates of incorporation.

Plaintiff Steven Bushansky filed a shareholder derivative action purportedly on behalf of nominal defendant NantKwest, Inc., a Delaware corporation headquartered in San Diego County, California, alleging causes of action against its directors for breaches of fiduciary duty. Plaintiff also alleged accounting malpractice and aiding and abetting claims against Mayer Hoffman PC, an accounting firm that served as NantKwest’s auditor.

NantKwest moved to dismiss based upon forum non conveniens, arguing that the exclusive Delaware forum selection clause in its certificate of incorporation mandated dismissal of the action brought in San Diego. The clause in question designated Delaware as the “sole and exclusive forum” for any action brought, subject to the condition precedent that the Delaware courts have “personal jurisdiction over the indispensable parties named as defendants.”

The San Diego Superior Court enforced the forum selection clause and dismissed the case. Plaintiff appealed. Plaintiff argued that the forum selection clause was never triggered because the Delaware courts lacked personal jurisdiction over Mayer Hoffman — allegedly an indispensable party — at the time the action was filed. Although Mayer Hoffman consented to personal jurisdiction in Delaware less than two months after filing, plaintiff argued this was insufficient under a traditional minimum contacts analysis, under which personal jurisdiction is determined at the time of filing.

The Court of Appeal affirmed. First, the Court noted that plaintiff’s argument failed to account for a consent analysis, whereby personal jurisdiction could be established post-filing by a defendant’s voluntary consent to jurisdiction. The Court held that reading a rigid time limitation into the term “personal jurisdiction” was unreasonable, and declined to do so. Rather, the court held that where, as here, a condition precedent to a forum selection clause in a Delaware corporation’s certificate of incorporation was silent as to a timeframe for performance, it would be presumed that it was to be performed within a reasonable time. The two-month time period Mayer Hoffman took to consent was deemed reasonable, the Court held, and thus the condition precedent was thus effectively complied with.

The Court noted that its decision would not be read as endorsing gamesmanship, whereby parties could strategically delay consent to personal jurisdiction until it became “tactically advantageous” to give it. The Court held that Mayer Hoffman had not engaged in any gamesmanship, but rather specifically requested that its demurrer be heard after the motion to dismiss, filed only a few weeks later by NantKwest.

The Court concluded its analysis by elaborating on the shortcomings it saw in the Washington Court of Appeals’ decision in Shatas v. Synder, 2016 Wash. App. LEXIS 2517 (Wash. App. Oct. 17, 2016), a case factually similar to Bushansky. There, the Washington court held that post-filing consent was “irrelevant” in determining jurisdiction. The California Court took issue with (1) the fact that Shatas was unpublished, and thus questioned its persuasive value and (2) the logic underlying the Washington court’s assertion that post-filing consent was irrelevant, as it could not “invalidate properly invoked jurisdiction” (presumably referring to jurisdiction already invoked in Washington). The California Court held this to be a logical fallacy, reiterating that “parties may not deprive courts of their jurisdiction over causes by private jurisdiction.” The Court instead looked to the practicalities inherent in forum selection clauses, classifying them not as a weapon of gamesmanship, but rather, as a tool of efficiency.

The precedent set by Bushansky represents a meaningful affirmation of the principles underlying basic contract law between private parties reflected in a certificate of incorporation, as well as continued deference to Delaware exclusive forum selection clauses.

Copyright © 2018, Sheppard Mullin Richter & Hampton LLP.

EPA Takes “Three Important Steps” Intended to Ensure Chemical Safety

On June 1, 2018, the U.S. Environmental Protection Agency (EPA) announced that it took “three important steps” intended to ensure chemical safety under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), which amended the Toxic Substances Control Act (TSCA).  EPA released the following for public comment:  (1) the first ten problem formulation documents, (2) EPA’s systemic review approach document, and (3) a significant new use rule (SNUR) proposal enabling EPA to prevent new uses of asbestos, “the first such action on asbestos ever proposed.”  As noted below, the due dates for public comments on the documents will be available when EPA publishes them in the Federal Register.

Problem Formulation Documents

On December 19, 2016, EPA published a list of the first ten chemicals selected for review under the Lautenberg Act — asbestos, 1-bromopropane (1-BP), carbon tetrachloride, 1,4-dioxane, cyclic aliphatic bromide cluster (HBCD), methylene chloride, n-methylpyrrolidone (NMP), perchloroethylene, C.I. Pigment Violet 29, and trichloroethylene (TCE).  In June 2017, EPA published the scope of the risk evaluations to be conducted for these first ten chemical substances, including the hazards, exposures, conditions of use, and potentially exposed or susceptible subpopulations (PESS) that EPA expects to consider.  In May, EPA published a response to comments document (Response to Comments) that addresses cross-cutting comments submitted in response to the scope documents for these ten chemical substances.  It addresses comments that may be applicable to issues impacting all ten chemicals.  EPA notes that the responses in the document represent its “preliminary reactions to some of the comments received, as the Agency has not reached final decisions on the approaches to the 10 risk evaluations.”

EPA describes the problem formulation documents released on June 1, 2018, as “an important interim step prior to completing and publishing the final risk evaluations by December 2019.”  The problem formulation documents clarify the chemical uses that EPA expects to evaluate and describe how EPA expects to conduct the evaluations.  Comments on the problem formulation documents will be due in 45 days upon publication in the Federal Register.

Each of the problem formulation documents notes that TSCA Section 6(b)(4)(D) requires EPA to publish the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use and PESS that the Administrator expects to consider.  Each of EPA’s scope documents published in June 2017 explains that because there was insufficient time for EPA to provide an opportunity for comment, as EPA intends to do for future scope documents, EPA is publishing and taking public comment on the problem formulation documents to refine the current scope, as an additional interim step prior to publication of the draft risk evaluations.  Comments received on the problem formulation documents will inform development of the draft risk evaluation.

Asbestos

According to the problem formulation document for asbestos, EPA has identified the ongoing use of chrysotile asbestos in:  industrial processes in the chlor-alkali industry; asbestos sheet gaskets for use in equipment used in the manufacture of titanium dioxide; and asbestos brake blocks in oilfield equipment and aftermarket asbestos brake linings.  In addition, certain asbestos-containing products can be imported into the U.S., but the amounts are not known.  These products are mostly used in industrial processes (e.g., cement products) but could also be used by consumers, and include woven products and automotive brakes and linings.  EPA is excluding legacy uses, associated disposals, and legacy disposals from the problem formulation and risk evaluation, as it did in the scope document.  EPA states that it is excluding these activities “because EPA generally interprets the mandates under section TSCA § 6(a)-(b) to conduct risk evaluations and any corresponding risk management to focus on uses for which the manufacture, processing or distribution is intended, known to be occurring, or reasonably foreseen, rather than reaching back to evaluate the risks associated with legacy uses, associated disposal, and legacy disposal, and interprets the definition of conditions of use in that context.”

In previous Integrated Risk Information System (IRIS) assessments, EPA identified asbestos as a carcinogen causing both lung cancer and mesothelioma from inhalation exposures and derived a unit risk to address both cancers.  According to the problem formulation, “[g]iven the well-established carcinogenicity of asbestos for lung cancer and mesothelioma, EPA decided to limit the scope of its systematic review to these two specific cancers with the goal of updating, or reaffirming, the existing cancer unit risk.”  EPA will evaluate the inhalation hazards based on the specific exposure scenarios identified for workers, consumers, and the general population where applicable.

EPA has created a web page regarding its risk evaluation of asbestos.  Materials are available there and in Docket EPA-HQ-OPPT-2016-0736.

1-BP

The problem formulation document for 1-BP states that 1-BP is primarily used as a solvent cleaner in vapor and immersion degreasing operations to clean optics, electronics, and metals, but it has also been reported to be used as an alternative to ozone-depleting substances and chlorinated solvents, as a solvent vehicle in industries using spray adhesives such as foam cushion manufacturing, and in the dry cleaning industry.  Information from the 2016 Chemical Data Reporting (CDR) for 1-BP indicates the reported production volume is 25.9 million pounds per year (manufacture and import).  According to EPA, exposures to workers, consumers, and/or the general population may occur from industrial, commercial, or consumer uses of 1-BP and industrial releases to air, water, or land.  Workers and occupational non-users (ONU) (i.e., workers who do not directly handle the chemical but perform work in an area where the chemical is used) may be exposed to 1-BP during a variety of conditions of use such as manufacturing, processing, distribution, repackaging, spray adhesives, dry cleaning (including spot cleaning), and degreasing (vapor, cold cleaning, and aerosol).  Consumers and bystanders (non-product users that are incidentally exposed to the product) may be exposed to 1-BP from various consumer uses such as aerosol and spray adhesives, aerosol spot removers, and aerosol cleaning and degreasing products.  For 1-BP, EPA states that it considers workers, ONUs, consumers, bystanders, and certain other groups of individuals who may experience greater exposures than the general population due to proximity to conditions of use to be PESS.  Exposures to the general population may occur from industrial and/or commercial uses; industrial releases to air, water, or land; and other conditions of use.  EPA will evaluate whether groups of individuals within the general population may be exposed via pathways that are distinct from the general population due to unique characteristics (e.g., life stage, behaviors, activities, or duration) that increase exposure and whether groups of individuals have heightened susceptibility and should, therefore, be considered PESS for purposes of the risk evaluation.

EPA plans to analyze further inhalation exposures to vapors and mists for workers and ONUs and dermal exposures for skin contact with liquids in occluded situations for workers in the risk evaluation.  EPA plans to analyze further inhalation exposures to vapors and mists for consumers and bystanders and dermal exposures for skin contact with liquids in the risk evaluation.  According to the problem formulation, for environmental release pathways, EPA does not plan to analyze further surface water exposure to aquatic invertebrates and aquatic plants in the risk evaluation.

EPA has created a web page regarding its risk evaluation of 1-BP.  Materials are available there and in Docket EPA-HQ-OPPT-2016-0741.

Carbon Tetrachloride

According to the problem formulation document for carbon tetrachloride, currently it is used as a feedstock in the production of hydrochlorofluorocarbons (HCFC), hydrofluorocarbons (HFC), and hydrofluoroolefins (HFO).  EPA has identified information on the regulated use of carbon tetrachloride as a process agent in the manufacturing of petrochemicals-derived and agricultural products and other chlorinated compounds such as chlorinated paraffins, chlorinated rubber, and others that may be used downstream in the formulation of solvents for degreasing and cleaning, adhesives, sealants, paints, coatings, rubber, cement, and asphalt formulations.  The use of carbon tetrachloride for non-feedstock uses (i.e., process agent, laboratory chemical) is regulated in accordance with the Montreal Protocol.

Recent data on environmental releases from the Toxics Release Inventory (TRI) indicate that approximately 153,000 pounds of carbon tetrachloride were released to the environment in 2015.  Most of the reported environmental releases for carbon tetrachloride were air emissions (fugitive and point source air emissions).

EPA states that exposure may occur through inhalation and oral and dermal pathways “due to carbon tetrachloride’s widespread presence in a variety of environmental media such as air, drinking water, groundwater, and surface water.”  Exposures to the general population may occur from industrial, and/or commercial uses; industrial releases to air, water, or land; and other conditions of use.  Workers and ONUs may be exposed to carbon tetrachloride during a variety of conditions of use, such as manufacturing, processing, and industrial and commercial uses, including manufacturing of refrigerants and other chlorinated compounds.  According to EPA, it expects that the highest exposures to carbon tetrachloride generally involve workers in industrial and commercial settings.  EPA considers workers and ONUs to be PESS.  EPA will evaluate whether groups of individuals may be exposed via pathways that are distinct due to unique characteristics that increase exposure and whether groups of individuals have heightened susceptibility and should, therefore, be considered PESS for purposes of the risk evaluation.

EPA has created a web page regarding its risk evaluation of carbon tetrachloride.  Materials are available there and in Docket EPA-HQ-OPPT-2016-0733.

1,4-Dioxane

The problem formulation document for 1,4-dioxane states that it is currently used in industrial processes and for industrial and commercial uses.  Industrial processing uses include use as a processing aid and in functional fluids in open and closed systems.  1,4-Dioxane has uses as a laboratory chemical reagent, in adhesives and sealants, and several other identified uses.  Historically, 90 percent of 1,4-dioxane produced was used as a stabilizer in chlorinated solvents such as 1,1,1-trichloroethane (TCA).  Use of 1,4-dioxane has decreased since TCA was phased out by the Montreal Protocol in 1996.

The most recent data on environmental releases, according to TRI, indicate that approximately 675,000 pounds of 1,4-dioxane were released to the environment in 2015.  Releases are reported to all types of environmental media:  air, water, and land.  The environmental fate of 1,4-dioxane is characterized by partitioning to the atmosphere, surface water, and groundwater, and degradation by atmospheric oxidation or biodegradation.  It is expected to be moderately persistent in the environment and has a low bioaccumulation potential.

Workers and ONUs may be exposed to 1,4-dioxane during industrial and commercial conditions of use such as manufacturing, processing, distribution, use, and disposal.  EPA plans to analyze further inhalation exposures to vapors and mists for workers and ONUs and dermal exposures for skin contact with liquids in occluded situations for workers in the risk evaluation.  For environmental release pathways, EPA plans to include surface water exposure to aquatic vertebrates, invertebrates, and aquatic plants, exposure to sediment organisms, and exposure to 1,4-dioxane in land-applied biosolids in the risk evaluation.

EPA has created a web page regarding its risk evaluation of 1,4-dioxane.  Materials are available there and in Docket EPA-HQ-OPPT-2016-0723.

HBCD

According to the problem formulation document for HBCD, its primary use is as a flame retardant in expanded polystyrene (EPS) foam and extruded polystyrene (XPS) foam in the building and construction industry for thermal insulation boards and foam insulation panels.  HBCD also has limited use in replacement parts for automobiles.  Past uses of HBCD have included use in HIPS (high impact polystyrene) and textiles.  EPA states that information gathered from research, industry, and consumer product organizations, however, led it to conclude that those past uses are not ongoing; there is no longer manufacture, processing, or distribution of HBCD for HIPS or textiles; therefore, those uses are not included in the scope of the risk evaluation of HBCD.

With the listing of HBCD as a persistent organic pollutant under the Stockholm Convention in 2013, industry began to phase out the manufacture and use of HBCD.  In recent years, domestic manufacture of HBCD has ceased.  Some HBCD was imported in 2017, and EPA states that it believes that a small amount of import may be ongoing.  Use of stockpiles and exportation from the U.S. was completed at the end of 2017.  EPA concluded that the import and processing of HBCD for use in EPS and XPS in buildings may be ongoing.

According to EPA, the conditions of use of EPS and XPS building insulation are within the scope of the evaluation and are anticipated to continue to contribute to exposures in indoor environments.  In indoor environments, there may also be exposures resulting from legacy uses of HBCD in articles (textiles, electronics, and electrical products) containing HBCD.  EPA expects these exposures to decline over time as use of these articles is phased out.  The time scales for this are dependent on the age of the products, their useful service lives, and time lines for replacement.

While EPA expects environmental exposures to decline as the importing and processing of HBCD are phased out, based on past production volumes (millions of pounds per year) and the only recent cessation of domestic manufacturing, EPA states that “reductions in environmental concentrations will occur gradually over a period of time for this persistent and bioaccumulative compound.”

According to EPA, exposures to workers, consumers, and/or the general population may occur from industrial, commercial, and consumer uses of HBCD and releases to air, water, or land.  Workers and ONUs may be exposed to HBCD during conditions of use such as import, processing, distribution, repackaging, and recycling.  Consumers and bystanders may also be exposed to HBCD via inhalation of particulates, dermal contact with HBCD in articles, and oral exposure via ingestion of settled dust.  Exposures to the general population may occur from industrial releases related to the import, processing, distribution, and use of HBCD.  For HBCD, EPA considers workers, ONUs, consumers, bystanders, and certain other groups of individuals who may experience greater exposures than the general population due to proximity to conditions of use to be PESS.  EPA states that it will evaluate whether groups of individuals within the general population may be exposed via pathways that are distinct from the general population due to unique characteristics that increase exposure and whether groups of individuals have heightened susceptibility and should, therefore, be considered PESS subpopulations for purposes of the risk evaluation.

For aquatic ecological receptors, EPA states that it expects sediment-dwelling benthic species to be exposed to HBCD.  Exposures to pelagic species are also expected from HBCD present in surface water.  Trophic magnification may result in greater exposure following bioaccumulation.  According to EPA, it expects that aquatic and terrestrial species will be exposed to HBCD through the dietary exposure pathway.  EPA will consider which aquatic and terrestrial species are related via the food chain.

EPA has created a web page regarding its risk evaluation of HBCD.  Materials are available there and in Docket EPA-HQ-OPPT-2016-0735.

Methylene Chloride

The problem formulation document for methylene chloride states that methylene chloride, also known as dichloromethane and DCM, “is a volatile and high production volume (HPV) chemical that is used as a solvent in a wide range of industrial, commercial and consumer applications.”  In 2015, more than 260 million pounds of methylene chloride was reported to be manufactured (including imported) in the U.S.  The primary uses for methylene chloride are paint stripping and removal (30 percent), adhesives (22 percent), pharmaceuticals (11 percent), metal cleaning (eight percent), aerosols (eight percent), chemical processing (eight percent), flexible polyurethane foam (five percent), and miscellaneous (eight percent).

Exposures may occur to workers, ONUs, consumers, bystanders, and the general population through inhalation, dermal, and oral pathways.  Workers and ONUs may be exposed to methylene chloride during a variety of conditions of use, such as manufacturing, processing, and industrial and commercial uses, including uses in paint removal, adhesives, and degreasing.  EPA states that it expects that the highest exposures to methylene chloride generally involve workers in industrial and commercial settings.  Methylene chloride can be found in numerous products and can, therefore, result in exposures to commercial and consumer users in indoor or outdoor environments.  For methylene chloride, EPA considers workers, ONUs, consumers, bystanders, and certain other groups of individuals who may experience greater exposures than the general population due to proximity to conditions of use to be PESS.  Exposures to the general population may occur from industrial and/or commercial uses; industrial releases to air, water, or land; and other conditions of use.  EPA will evaluate whether groups of individuals within the general population may be exposed via pathways that are distinct from the general population due to unique characteristics that increase exposure and whether groups of individuals have heightened susceptibility and should, therefore, be considered PESS for purposes of the risk evaluation.  EPA plans to analyze further inhalation exposures to vapors and mists for workers and ONUs and dermal exposures for skin contact with liquids in occluded situations for workers in the risk evaluation.  EPA plans also to analyze further inhalation exposures to vapors and mists for consumers and bystanders and dermal exposures for skin contact with liquids in the risk evaluation.  For environmental release pathways, EPA plans to analyze further surface water exposure to aquatic invertebrates and aquatic plants in the risk evaluation.

EPA has created a web page regarding its risk evaluation of methylene chloride.  Materials are available there and in Docket EPA-HQ-OPPT-2016-0742.

NMP

The problem formulation document for NMP states that it is an HPV chemical that is widely used during the manufacture and production of polymers, pharmaceuticals, agrichemicals, and petroleum products.  In 2015, more than 160 million pounds of NMP was reported to be manufactured (including imported) in the U.S.  According to a recent EPA market report, the primary uses for NMP include petrochemical processing, engineering plastic coatings, electronics, pharmaceutical and agrichemical manufacturing, and solvent cleaning.

Exposures may occur to workers and ONUs, consumers, bystanders, and members of the general population.  Workers and ONUs may be exposed to NMP during various conditions of use (e.g., manufacturing, processing, and industrial/commercial uses).  General population exposures may result from industrial and/or commercial uses; industrial releases to air, water, or land; and other conditions of use.  EPA states that it expects the highest exposures will generally involve workers in industrial and commercial settings.  EPA notes that NMP occurs in numerous consumer products, however, and can result in exposures outside the occupational setting.  EPA considers workers, ONUs, consumers, bystanders, and certain other groups of individuals who may experience greater exposures than the general population to be PESS.  During the risk evaluation, EPA expects to analyze further inhalation exposures to NMP vapor and mist (for workers, ONUs, consumers, and bystanders).  EPA also expects to analyze dermal exposures from direct contact with NMP-containing liquids (for workers and consumers) and indirect exposure from vapor-through-skin contact (for workers, ONUs, consumers, and bystanders).

EPA has created a web page regarding its risk evaluation of NMP.  Materials are available there and in Docket EPA-HQ-OPPT-2016-0743.

Perchloroethylene

According to the problem formulation document for perchloroethylene, perchloroethylene is an HPV solvent.  According to the 2016 CDR, more than 324 million pounds of perchloroethylene were manufactured (including imported) in the U.S. in 2015.  Perchloroethylene is primarily used to produce fluorinated compounds, such as HFCs and HCFCs (65 percent) followed by dry cleaning (15 percent) and vapor degreasing solvents (ten percent).  Other uses can be quite varied, including:  adhesives; degreasing; brake cleaner; laboratories; lubricants; mold cleaners, releases, and protectants; oil refining; sealants; stainless steel polish; tire buffers and cleaners; and vandal mark removers.

Exposures may occur to workers, ONUs, consumers, bystanders, and the general population through inhalation, dermal, and oral pathways.  Workers and ONUs may be exposed to perchloroethylene during a variety of conditions of use, such as manufacturing, processing, and industrial and commercial uses, including uses in degreasing and adhesives.  EPA states that it expects that the highest exposures to perchloroethylene generally involve workers in industrial and commercial settings.  Perchloroethylene can be found in numerous products and can, therefore, result in exposures to commercial and consumer users in indoor or outdoor environments.  For perchloroethylene, EPA considers workers, ONUs, consumers, bystanders, and certain other groups of individuals who may experience greater exposures than the general population due to proximity to conditions of use to be PESS.  Exposures to the general population may occur from industrial and/or commercial uses; industrial releases to air, water, or land; and other conditions of use.  EPA states that it will evaluate whether groups of individuals within the general population may be exposed via pathways that are distinct from the general population due to unique characteristics that increase exposure and whether groups of individuals have heightened susceptibility and should, therefore, be considered PESS for purposes of the risk evaluation.  EPA plans to analyze further inhalation exposures to vapors and mists for workers and ONUs and dermal exposures for skin contact with liquids in occluded situations for workers in the risk evaluation.  For environmental release pathways, EPA plans to analyze further surface water exposure to aquatic vertebrates, invertebrates, and aquatic plants and exposure to sediment-dwelling organisms.

EPA has created a web page regarding its risk evaluation of perchloroethylene.  Materials are available there and in Docket EPA-HQ-OPPT-2016-0732.

C.I. Pigment Violet 29

The problem formulation document for C.I. Pigment Violet 29 states that it is an organic pigment found in the following uses:  (1) colorant primarily in paints and coatings, plastics, and rubber products, and merchant ink for commercial printing; (2) intermediate to create or adjust the color of other perylene pigments; (3) formulation, mixture, or reaction product; and (4) consumer watercolor and artistic color.

According to EPA, analysis of manufacturing conditions, uses, and engineering controls of C.I. Pigment Violet 29 indicates that releases from manufacturing, processing, distribution, use, and disposal are expected to be limited.  Physical-chemical characteristics (i.e., low vapor pressure, low water solubility, high sorption to organic matter, high molecular weight, high Log Kow) indicate exposures would be limited if C.I. Pigment Violet 29 is released to the environment.

EPA states that based on limited releases, low potential for environmental and human exposures, and a low toxicity profile for mammals and aquatic species, it concludes that further analysis of these exposure pathways to workers, consumers, the general population, and environmental receptors is not warranted for C.I. Pigment Violet 29.

EPA has created a web page regarding its risk evaluation of C.I. Pigment Violet 29.  Materials are available there and in Docket EPA-HQ-OPPT-2016-0725.

TCE

According to the problem formulation document for TCE, TCE is a volatile organic liquid that is classified as a human carcinogen.  In the 2014 TCE risk assessment, EPA assessed inhalation risks from TCE in vapor and aerosol degreasing, spot cleaning at dry cleaning facilities, and arts and craft uses, and also completed four supplemental analyses.  Based on these analyses, EPA notes that it published two proposed rules to address the risks presented by TCE use in vapor degreasing and in commercial and consumer aerosol degreasing and for spot cleaning at dry cleaning facilities.

Information on domestic manufacture, processing, use, and disposal of TCE is available to EPA through CDR and TRI.  In 2015, approximately 172 million pounds of TCE was manufactured or imported in the U.S.  An estimated 83.6 percent of TCE’s annual production volume is used as an intermediate in the manufacture of HFC-134a — an alternative to the refrigerant CFC-12.  Another 14.7 percent of TCE production volume is used as a degreasing solvent, leaving approximately 1.7 percent for other uses, including consumer uses.  Based on 2015 TRI data, most reported environmental releases of TCE are to air, with much lower volumes disposed to land or released to water.  According to EPA, TCE is expected to be moderately persistent in the environment and has a low bioaccumulation potential.

Exposure may occur through inhalation, oral, and dermal pathways, due to TCE’s widespread presence in a variety of environmental media.  Exposures to the general population may occur from industrial and/or commercial uses; industrial releases to air, water, or land; and other conditions of use.  Workers and ONUs may be exposed to TCE during a variety of conditions of use, such as manufacturing, processing, and industrial and commercial uses, including uses in paint and coatings, adhesives, and degreasing.  EPA states that it expects that the highest exposures to TCE generally involve workers in industrial and commercial settings.  TCE can be found in numerous products and can, therefore, result in exposures to commercial and consumer users in indoor or outdoor environments.  For TCE, EPA considers workers, ONUs, consumers, bystanders, and certain other groups of individuals who may experience greater exposures than the general population due to proximity to conditions of use to be PESS.  EPA will evaluate whether groups of individuals within the general population may be exposed via pathways that are distinct from the general population due to unique characteristics that increase exposure and whether groups of individuals have heightened susceptibility and should, therefore, be considered PESS for purposes of the risk evaluation.  For environmental release pathways, EPA plans to analyze further surface water exposure to aquatic species (i.e., aquatic plants) in the risk evaluation.

EPA has created a web page regarding its risk evaluation of TCE.  Materials are available there and in Docket EPA-HQ-OPPT-2016-0737.

Systemic Review Approach Document

EPA states that its systematic review approach document will guide its selection and review of studies in addition to providing the public with continued transparency regarding how EPA plans to evaluate scientific information.  The internal guidance document sets out general principles to guide EPA’s application of systematic review in the risk evaluation process for the first ten chemicals, as well as future evaluations.  Comments on the systematic review approach document will be due in 45 days upon publication in the Federal Register.

The Office of Pollution Prevention and Toxics (OPPT) plans to implement a structured process of identifying, evaluating, and integrating evidence for both the hazard and exposure assessments developed during the TSCA risk evaluation process.  As OPPT expects that new approaches and/or methods will be developed to address specific assessment needs for the relatively large and diverse chemical space under TSCA, OPPT intends to document the progress of implementing systematic review in the draft risk evaluations and through revisions of this document and publication of supplemental documents.

The systematic review approach document provides only the general expectations for evidence synthesis and integration.  Additional details on the approach for the evidence synthesis and integration will be included with the publication of the draft TSCA risk evaluations.  EPA states that “[‌u]ltimately, the goal is to establish an efficient systematic review process that generates high-quality, fit-for-purpose risk evaluations that rely on the best available science and the weight of the scientific evidence within the context of TSCA.”

EPA intends the information and procedures set forth in the document to be a technical resource to those conducting TSCA risk evaluations for existing chemicals.  EPA notes that non-mandatory language such as “should” provides recommendations and does not impose any legally binding requirements.  Similarly, “statements about what EPA expects or intends to do reflect general principles to guide EPA’s activities and not judgments or determinations as to what EPA will do in any particular case.”  According to EPA, the document is not necessarily applicable to risk assessments developed to support other EPA statutes or programs.  EPA expects to make changes to the living document at any time and, therefore, may periodically revise the document.

EPA described its initial work on systematic review in the supplemental files for each TSCA scope document, which included the Strategy for Conducting Literature Searches and the Bibliography for each chemical.  EPA has posted its Response to Commentsreceived on these supplemental documents.

Proposed Asbestos SNUR

For asbestos, EPA will propose a SNUR for certain uses of asbestos (including asbestos-containing goods) that would require manufacturers and importers to receive EPA approval before starting or resuming manufacturing and importing or processing of asbestos.  This review process would provide EPA with the opportunity to evaluate the intended use of asbestos and, when necessary, take action to prohibit or limit the use.  EPA has published a pre-publication version of the Federal Register notice.  Comments on the proposed SNUR will be due in 60 days upon publication in the Federal Register.

The notice states that the proposed significant new use of asbestos (including as part of an article) is manufacturing (including importing) or processing for certain uses identified by EPA as no longer ongoing.  According to the notice, EPA has found no information indicating that the following uses are ongoing, and therefore, the following uses are subject to the proposed SNUR:  adhesives, sealants, and roof and non-roof coatings; arc chutes; beater-add gaskets; extruded sealant tape and other tape; filler for acetylene cylinders; high-grade electrical paper; millboard; missile liner; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; and any other building material (other than cement).

Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing (including importing) or processing of asbestos (including as part of an article) for a significant new use.  The required notification initiates EPA’s evaluation of the conditions of use associated with the intended use within the applicable review period.  Manufacturing (including importing) and processing (including as part of an article) for the significant new use may not commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.

Commentary

In EPA’s cross-cutting Response to Comments, EPA makes a number of key points that apply across all ten problem formulation documents and that we expect will inform future TSCA existing chemicals risk evaluation work.  EPA acknowledges that the ten scoping documents were not as detailed as expected, largely due to the very short timeframe available to complete each.  As such, EPA is refining the scope of each in the problem formulation documents.  EPA expects future scoping documents to be more robust, necessitating less revisions of the scope in future problem formulation documents.

EPA responds to comments related to conditions of use by reiterating that it will generally not consider misuse and off-label uses or “legacy” uses as conditions of use.  EPA points to the legislative history and the statutory language to support its view that conditions of use are “intended, known to be occurring, or reasonably foreseen to occur (i.e., is prospective or on-going).”  EPA also states that it will consider exposures from legacy uses on a case-by-case basis.  For example, EPA is excluding past use as a fuel additive from the conditions of use evaluated in the 1,4-dioxane risk evaluation.  1,4-Dioxane was used as a fuel additive in the past and EPA only found evidence that it was phased out from that use and no evidence of on-going use as a fuel additive.  Similarly, EPA found no current consumer uses of 1,4-dioxane, so is excluding consumer exposures from the risk evaluation.  While these uses will not be considered in the risk evaluation, EPA may opt to issue a SNUR banning such uses absent submission of a significant new use notice (SNUN) and EPA taking the necessary action under TSCA Section 5(e) or 5(f).  According to EPA, it can better focus its effort on active uses and protect against unreasonable risk in other potential uses during a review of a potential new use just as if 1,4-dioxane were a new chemical.Some stakeholders argue that EPA is not permitted to omit such a use from its risk evaluation, and that promulgating a SNUR prohibiting a use that is not on-going, but is otherwise reasonably foreseeable, effectively makes that use not reasonably foreseeable. The SNUR would prohibit that use just as a TSCA Section 6 risk management might.  In this way, EPA can effectively limit its risk evaluation and simultaneously be fully protective against future uses that were outside the scope of the risk evaluation.  This strikes us as an effective way for EPA efficiently to manage potential risks without undue effort evaluating speculative uses.

EPA also reiterated its view that it may exclude risks that are appropriately and adequately regulated under other authorities administered by either EPA or other Departments or Agencies.  Along the same vein, EPA responds to a comment related to ozone depletion potential (ODP) by pointing out that ODP is evaluated and effectively managed under the Clean Air Act.  In the 1,4-dioxane problem formulation document, EPA states that it views commercial and industrial air emissions of 1,4-dioxane as adequately managed as a Hazardous Air Pollutant under the Clean Air Act and will exclude risk to the general population from such emissions from the TSCA risk evaluation.  Similarly, because 1,4-dioxane concentrations are already being monitored under the Safe Drinking Water Act, EPA will exclude general population exposures via drinking water from its risk evaluation.  On the other hand, because EPA has yet to develop an ambient water quality standard for 1,4-dioxane under CWA 304(a), EPA will include risk to aquatic life in its risk evaluation.  EPA also stated that it may exclude presence as an impurity from the scope of the risk evaluation if EPA has a basis to foresee that the risk from the impurity would be de minimis or otherwise insignificant.

EPA states that it will describe whether aggregate or sentinel exposures were considered and will include its explanation in the risk evaluation.  In conducting an aggregate exposure, EPA may include exposures from non-TSCA uses.  For example, in the 1,4-dioxane problem formulation, EPA included uses that are regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA).  EPA also intends to evaluate uses of 1,4-dioxane that might otherwise be eligible for the TSCA Research and Development (R&D) exemption.  EPA will also include potential exposure to 1,4-dioxane from volatilization that might occur during showering or bathing.

In referring to the scope of the risk evaluation, EPA uses some language that may be somewhat confusing.  For example, in Section 2.5.3.1 of the 1,4-dioxane problem formulation document, EPA states that there are “no environmental release and waste pathways for the environment or general population that EPA plans to include and further analyze in the risk evaluation.”  Given that EPA specifically states that it will evaluate general population and environmental effects elsewhere in the document, we interpret the statement in Section 2.5.3.1 to mean that there are no additionalpathways that EPA intends to include.  Similarly, in Section 2.5.3.2, EPA states that “[t]he pathways that EPA plans to include in the risk evaluation but not further analyze are ambient water exposures to aquatic vertebrates, invertebrates and aquatic plants, sediment and land-applied biosolids.”  Although EPA states that it does not intend to “further analyze” such exposures, EPA must mean that it is satisfied that the conceptual model that has already been identified is sufficient for the risk evaluation.

EPA does a good job in striking an excellent balance between the evaluation of all possible hazards and exposures to health and the environment and those for which (1) there is not otherwise adequate control; and (2) that are reasonably likely to occur above negligible levels.  In this way, EPA will make the most efficient use of its effort and limited resources under TSCA to protect health and the environment and avoid extensive time and resources to collect and analyze information that will be, at best, of marginal use in informing a risk decision.  EPA seeks input from stakeholders on all ten risk evaluations.

©2018 Bergeson & Campbell, P.C.
This article was written by Lynn L. Bergeson of Bergeson & Campbell, P.C.

Needless Gamble: Eleventh Circuit Uses Exceedingly Broad Language to Address Narrow Issue of Arbitration in TCPA Text Suit

In Gamble v. New Eng. Auto Fin., Inc., No. 17-15343, 2018 U.S. App. LEXIS 14608 (11th Cir. May 31, 2018) the Eleventh Circuit upheld denial of arbitration of a TCPA claim involving text messages offering a consumer a new auto finance contract. While the Eleventh Circuit used unnecessarily broad language–discussed below– the holding is actually quite narrow; calls made to offer a consumer a second finance agreement do not arise out of a first finance agreement for arbitration purposes. The panel’s decision to reach this narrow conclusion through the vehicle of broadly-worded analysis might mean trouble for defendants seeking to compel future TCPA cases to arbitration in the Eleventh Circuit, however.

The arbitration clause at issue  in Gamble required arbitration of any “claim, dispute or controversy whether preexisting, present or future, that in any way arises from or relates to this Agreement or the Motor Vehicle securing this Agreement.”  The contract also contained a separate provision with a separate signature line appearing below the signature line for the auto loan agreement relating to consent to receive texts.  This separate provision was not signed by Plaintiff.

Defendant apparently emphasized the unsigned text message consent provision as the crux of its legal position. By offering Plaintiff the right to opt-in to text messages in the contract–the argument goes–the resulting text messages must have arose out of that contract. That’s a terrible argument, of course, and the Eleventh Circuit made short work of it concluding roughly that “no agreement regarding text messages exists between the parties.”

Unfortunately the Court did not stop there–although it could have–and used unnecessarily broad language in passing on the dispute before it. For instance, the Court made the express finding that the Plaintiff’s claim “does not arise from any right implicated by the Loan Agreement nor from the parties contractual relationship.”  While that is undoubtedly true, the reason that is the case is because the texts at issue were unrelated to this contract and pitched a wholly different contract. Yet the Court’s failure to emphasize this critical fact makes it seem as if TCPA cases–which almost never arise from a right implicated in a loan agreement–are per se non-arbitrable.

Complicating matters further, the Court also emphasized, in seemingly gratuitous fashion, that TCPA claims arise “from post-agreement conduct that allegedly violates a separate, distinct federal law.”  Again, this is undoubtedly true, but that is not a predicate basis for denying arbitration–claims related to purported statutory violations are commonly compelled to arbitration, including by the Eleventh Circuit. See generally Walthour v. Chipio Windshield Repair, LLC, 745 F. 3d 1326 (11th Cir. 2014). And texts often arise out of contracts–such as where a consumer goes into default under the terms of a loan agreement resulting in text messages from a servicer seeking to collect. The loose language in Gamble needlessly implies, therefore, that claims related to such text messages are not subject to arbitration merely because the underlying right being enforced is a federal statutory right, rather than a contractual right. That’s an unnecessary–if not dangerous–implication, and surely not one that comports with the Congressionally-mandated policy favoring arbitration.

It remains to be seen exactly what district courts in the Eleventh Circuit do with Gamble, but one thing is for sure– Gamble just made defense efforts to compel arbitration of TCPA cases there a whole lot less certain. Care to roll the dice?

 

Copyright © 2018 Womble Bond Dickinson (US) LLP All Rights Reserved.
This post was written by Eric Troutman of Womble Bond Dickinson (US) LLP.

A Rundown of Recent State Action Relating to Medicaid Expansion

To date, 34 states (including D.C.) have adopted Medicaid expansion. Of the remaining 17 states, some are considering expanding Medicaid. States with recent activity relating to Medicaid expansion include Florida, Idaho, Maine, Missouri, Nebraska, New Hampshire, North Carolina, Utah, and Virginia.  Last week, Virginia became the latest state to expand Medicaid and also tied a Medicaid work requirement to the expansion. California is also exploring expanding Medicaid to undocumented adults.

Below we have highlighted recent state grassroots, legislative, and executive action to expand Medicaid.

Approved Medicaid Expansion:

Maine

On November 7, 2017, Maine became the 33rd state (including D.C.) to expand Medicaid and the first state to do so through a citizen’s initiative. The State legislature has previously voted on Medicaid expansion on five occasions. However, Governor LePage has repeatedly vetoed legislation expanding Medicaid.

Maine Question 2 requires the State to provide Medicaid through the State’s MaineCare for the new expansion population. The provision expands Medicaid to persons under the age of 65 with incomes equal to or below 138% FPL. The Maine Department of Health and Human Services has 90 days after the effective date to submit a State Plan Amendment to the HHS. The Governor has failed to meet the April 3rd State Plan Amendment submission deadline. On April 30, the Maine Equal Justice Partners filed suit against the State claiming, “The failure to expand Medicaid is harming low-income Mainers who by law should be eligible to receive Medicaid insurance this year.” On Thursday May 24, 2018, Kennebec County Superior Court Justice Michaela Murphy said, “Governor Paul LePage’s administration has a duty to enforce a voter-passed law.” According to local news, Judge Murphy did not indicate when she would issue a ruling.

Virginia

Introduced March 21, 2018, HB 5001 and 5002 expand Medicaid eligibility to 138% FPL. The Virginia Department of Medical Assistance is required to submit an amendment to the Medicaid State Plan and 1115 waiver to CMS no later than 45 days upon the passage of the bills from the Senate. Further, the proposed legislation establishes the Training, Education, Employment, and Opportunity Program (TEEOP). TEEOP will be required for all able-bodied working-age adults enrolled in the Medicaid program, ages 19 through 54. TEEOP requirements will gradually escalate, beginning at 20 hours per month, three months after enrollment, and increasing to 80 hours per month, 12 months after enrollment. With the exception of defined exemptions, enrollees shall be ineligible to receive Medicaid benefits if, during any three months of the plan year, they fail to meet the required engagement hours.

On April 17, 2018, HB 5001 and 5002 passed the House and was referred to the Senate. On May 30, 2018, HB 5001 and 5002 passed the Senate with substitute, a 23-Y, 17-N vote. Four Republicans crossed party lines to vote with the Democrats. Later that day (May 30, 2018) the House passed the Senate-passed version. Governor Northam is expected to sign the bills. Virginia will be the 2nd state under the Trump Administration to expand Medicaid. (Virginia is the 34th state to expand Medicaid.)

Considering Medicaid Expansion:

Idaho

Advocates are currently collecting signatures for an initiative that would place a Medicaid expansion measure on the November Ballot. According to a local grassroots advocacy group, Reclaim Idaho, the group turned over more than 60,000 valid signatures to the State Clerk by the May 1, 2018 deadline. On Thursday May 24, 2018, officials confirmed the proposal passed the signature threshold needed. However, officials stated further review is required before the initiative may be included on the November ballot.

Reclaim Idaho cites that 62,000 Idaho residents currently do not qualify for Medicaid or exchange subsidies. The state’s gubernatorial primary was May 15, 2018, with incumbent Governor Little winning the Republican ticket, and running against Democratic winner, Paulette Jordan, in November. The ballot initiative received mixed reviews from candidates; however, Lt. Governor Little recently stated that he would “adhere to the will of the voters.”

Nebraska

Led by The Fairness Project, Nebraska health care associations and advocacy groups are currently collecting signatures for an initiative that would place the Medicaid expansion measure on the November Ballot. Advocacy groups have until July 6, 2018, to submit the required 85,000 valid signatures. Governor Ricketts strongly opposes the initiative, stating, “Expanding Medicaid in Nebraska is a risky proposition for taxpayers not only because of the expense but also because we cannot trust the federal government’s long-term financial commitment to state programs.”

New Hampshire

New Hampshire’s current version of Medicaid Expansion, the New Hampshire Premium Assistance Program, is set to exhaust at the end of the 2018 fiscal year. SB 313 passed the House Committee on Health, Human Services and Elderly Affairs, with an adopted amendment May 3, 2018; the legislation is currently in the House Finance Committee. On May 10, 2018, the Senate approved SB 313, 16-6. If signed into law, the legislation replaces the New Hampshire Health Protection Program, establishing the Granite Advantage Health Care Program. Under the program, eligible individuals will choose coverage offered by one of the Medicaid contracted managed care organizations.

Additionally, the legislation establishes the Granite Workforce Pilot Program. The pilot program will utilize federal funds available from the TANF program for the purpose of job placement. Granite Workforce eligibility is contingent upon income, not to exceed 138% FPL; parents, or noncustodial parents, ages 18 through 64 with a child 18 and under in the household; and childless adults at least 18 years of age and under 25. New eligible adults the Department of Health and Human Services is required to apply for necessary waivers and state plan amendments to implement the 5-year demonstration program beginning January 1, 2019.

North Carolina

H.B. 662- Carolina Cares” was introduced April 6, 2017, and referred to the Committee on Health Care Reform; it was last amended April 17, 2017. This bill, “Carolina Cares,” governs the components of the Carolina Cares program, outlined in the State’s 1115 waiver amendment submitted November 20, 2017. Under the proposed legislation, the population covered by the Carolina Cares program includes residents not eligible for Medicaid under the current Medicaid program criteria, individuals with a modified gross adjusted income not exceeding 133% FPL, residents not entitled to Medicare Part A or B, and residents between the ages of 19 and 64. Failure to complete premium contributions within 60 days of the due date will result in termination from the program, absent proof of any accepted exemptions.

Utah

Governor Herbert signed H.B. 472 March 27, 2018. The legislation expands Medicaid coverage to include those at or below 100% FPL and not eligible for enrollment in the Medicaid program, with the exception of the Primary Care Network Program. The Department of Health is required to submit a Waiver request to HHS by January 1, 2019. CMS to date has not approved waivers that provide the enhanced match rate unless a state implements the full expansion of 138% FPL. Under H.B. 472 a trigger clause is included that would scale back or sunset Medicaid expansion if the 90% enhanced federal match rates is reduced. The State further maintains the ability to cease new enrollment if the projected expansion costs exceeds the state appropriations for the fiscal year. Additionally, the HB 472 includes a work requirement provision for the new expansion population. (This is in addition to the 1115 waiver amendment Utah has submitted to CMS to include Medicaid work requirements for the non-expansion Medicaid population.)

In the 2018 November primary, Utah residents may vote to expand Medicaid to the ACA’s full FPL. The measures would require the State to provide Medicaid to persons under the age of 65 and with incomes below 138% FPL. To finance the State’s portion of the costs associated with expanding Medicaid, the initiative increases the sales tax to 4.85%, currently set at 4.7%. The advocacy group, Utah Decides Healthcare, submitted more than 165,000 valid signatures before the April 6th deadline. Utah requires roughly 113,000 valid signatures for the inclusion of ballot initiatives.

The State’s Lieutenant Governor announced on May 29, 2018 that there are enough signatures to include the measure on the upcoming November election ballot. As of May 30, 2018, the initiative surpassed the 147,280 valid signatures needed in 26 of the 29 state Senate Districts.

Failed Medicaid Expansion:

Florida

SJR 1136 and HJR 911, Expansion of Medicaid Coverage, were introduced to the Florida House and Senate December 6, 2017. After referral and introduction within respective health subcommittees, SJR 1136 and HJR 911 were indefinitely postponed and withdrawn from consideration March 10, 2018.

Missouri

At the state legislative level, two bills (SB 713 and SB 731) that would expand Medicaid were under consideration. Introduced January 16, 2018, SB 713 would require the state to expand Medicaid to persons under the age of 65 and with incomes equal to or below 138% FPL by January 2019. After referral to the Committee on Seniors, Families, and Children, the proposed legislation ultimately failed on May 18, 2018. During this same period, SB 731 included the same Medicaid expansion language as SB 713; however, the legislation would require the measure to be included on the November 2018 ballot. The legislation failed in committee the same day at SB 713.

Separately, a citizen led initiative, The Missouri Medicaid Expansion Initiative, was filed September 6, 2017. The initiative received signature clearance in October; however, at the time of the May 6, 2018 deadline, signatures for the initiatives had not been filed.

Medicaid Expansion to Undocumented:

California

The California state legislature is considering two sister bills, SB 974 and AB 2965. The proposed bills expand the full scope of Medi-Cal benefits to undocumented adults over the age of 19 who, with the exception of their immigration status, would otherwise be eligible for Medicaid benefits. These individuals would be required to enroll into Medi-Cal manage care health plans. In addition, individuals will be required to pay copayments and premium contributions, to the extent required of otherwise eligible Medi-Cal recipients who are similarly situated.

The Legislature’s Analyst Office (LAO) estimates the total net state cost of expanding coverage is approximately $3 billion for 2018-2019. Approximately 3 million individuals living in California remain uninsured. The same report details nearly 60% of those uninsured lack legal status; of this population, approximately 1.2 million individuals would qualify for benefits through Medi-Cal. Governor Brown has not committed to either proposal, despite approval of SB 4 in 2015; the enacted legislation expands the full scope of Medi-Cal benefits to individuals under 19 years of age whom do not have, or are unable to establish , satisfactory immigration status. Governor Brown is set to leave office later this year.

©1994-2018 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.
*Nicole Meyerson was the lead contributor to this post.

The Tail of a Dog with Two Hats: Fifth Circuit Upholds “Golden Share” Held by Creditor Affiliate

On May 22, 2018, the United States Court of Appeals for the Fifth Circuit issued its decision in Franchise Services of North America v. United States Trustees (In re Franchise Services of North America), 2018 U.S. App. LEXIS 13332 (5th Cir. May 22, 2018). That decision affirms the lower court’s holding that a “golden share” is valid and necessary to filing when held by a true investor, even if such investor is controlled by a creditor.

The backdrop of mergers and acquisitions leading up to this case need not be retold in detail to understand the holding’s significance, but some context is helpful. Franchise Services of North America, Inc. (“FSNA”), one of North America’s largest car rental companies, filed for chapter 11 bankruptcy without the required consent of its sole holder of preferred stock, Boketo, LLC (“Boketo”). Boketo was a minority shareholder that had invested $15 million in FSNA  making it FSNA’s single largest investor. Boketo is a wholly-owned subsidiary of investment bank Macquarie Capital (U.S.A.) (“Macquarie”), an unsecured creditor of FSNA’s by virtue of an alleged $3 million claim for fees incurred in connection with the aforementioned transactions. When Boketo invested $15 million in FSNA, it required FSNA to re-incorporate in Delaware and add a “golden share” provision to its corporate documents, i.e. Boketo’s affirmative vote of its preferred share was required for certain corporate events, such as filing bankruptcy. Nonetheless, FSNA eventually filed for chapter 11 in the Southern District of Mississippi without seeking Boketo’s consent, fearing that shareholder Boketo—controlled by creditor Macquarie—would not consent to filing.

Macquarie and Boketo filed motions to dismiss the case for a lack of corporate authority under FSNA’s amended corporate charter. In doing so, Macquarie donned two hats—that of a shareholder through Boketo and that of an unsecured creditor with a $3 million claim. FSNA asserted that Macquarie used Boketo as a “wolf in a sheep’s clothing” to equip a creditor with shareholders’ blocking rights under an allegedly unenforceable “blocking provision” or “golden share.” FSNA implied the tail had been wagging the dog—that Macquarie made the $15 million investment through Boketo to avoid the cost and inconvenience of trying to collect some portion of its $3 million claim in FSNA’s bankruptcy. The bankruptcy court denied Macquarie’s motion because case law and public policy forbid a creditor from preventing a debtor’s bankruptcy filing. However, it granted Boketo’s motion, given its status as a voting shareholder. The Fifth Circuit affirmed, and found FSNA’s theory that Macquarie chased $3 million with $15 million “strain[ed] credulity.”

FSNA’s various legal arguments each fell flat. First, FSNA sought a ruling that “blocking provisions” or “golden shares” (similar, but not identical, concepts), in general, are unenforceable under Delaware law. The Fifth Circuit declined to offer such an advisory opinion. Second, FSNA contended that even if Delaware law allowed these types of provisions, federal policy forbids them. This, too, failed to move the court, since the corporate charter did not eliminate FSNA’s ability to file bankruptcy. Instead, it specified which parties’ consent was necessary to authorize a bankruptcy filing, placing the decision with shareholders. Third, because authority to file bankruptcy is a matter of state law, FSNA argued that Boketo could not exercise its blocking right under Delaware law, and that Boketo had owed a fiduciary duty to facilitate the filing. The Fifth Circuit held that Delaware law, flexible by nature, allows a corporate charter to assign rights to shareholders that would ordinarily be assigned to directors/management, but declined to go so far as to determine whether such provision was valid under Delaware law. In addition, the court refuted FSNA’s fiduciary duty argument because only controlling minority shareholders owe fiduciary duties, and here, Boketo was a non-controlling minority shareholder. The court explained that the standard for minority control is a “steep one,” and that courts focus on control of the board—i.e., whether the minority shareholder can exert actual control over the company. While Boketo made a sizeable investment in FSNA, it only had the right to appoint 2 out of 5 directors and therefore could not exert actual control over the board. FSNA pointed to Boketo’s hypothetical ability to prevent bankruptcy as evidence of actual control, but the court distinguished such theoretical control from actual exertion thereof. The court keenly noted that FSNA defeated its own control argument when it filed bankruptcy without Boketo’s consent—if Boketo was a controlling shareholder, then once again the tail must have been wagging the dog.

Franchise Services highlights the potential for a creditor to essentially step into a shareholder’s shoes and assert shareholder rights pursuant to a corporate charter’s blocking provision or “golden share” by virtue of wearing two hats through a parent and subsidiary.

© 2018 Bracewell LLP.

This post was written by Logan Kotler and Jason G. Cohen of Bracewell LLP.