[This article originally appeared on Law360.com on June 23, 2015.]
On June 2, 2015, the Suffolk County Legislature became the latest county legislature in New York to pass a “toxic-free toys” act. About a week later, the New York City Council got in on the action and introduced a similar bill. Since the beginning of the year, five county legislatures in New York (Albany, Suffolk, Westchester, Dutchess and Onondaga) and the New York City Council have either passed, or are in the process of considering, laws to supposedly stem the flow of unsafe children’s products onto local store shelves. The actions of these localities raise the fundamental legal and policy question: do local governments, such as county legislatures or town councils, have a legitimate role in regulating consumer products, a role typically reserved for the federal, and in some instances, state governments? Clearly, these local governments believe that they do, as do the consumer and environmental organizations behind the effort. Yet the answer is not as simple as it may seem.
Every so often, frequently in response to sensationalized media reports regarding the prevalence of allegedly unsafe products getting into the hands of children, counties decide to legislate on matters involving consumer product safety, and a trend, similar to the recent one in New York, begins. Unfortunately, these laws introduced and considered by localities tend to be more about politics and headlines than safety and have little effect on actually improving the safety of children’s products. Continue Reading
On Wednesday of last week, the Department of Justice (DOJ) and Consumer Product Safety Commission (CPSC) announced that a complaint has been filed in federal court against Spectrum Brands, Inc. (Spectrum). Notably, this is the second case in the past three months brought by the government in federal court against a company for an alleged failure to timely report (see our earlier post on the Michaels Stores litigation). These cases are not typical because most companies settle civil penalty claims rather than litigate against the government. As a result, there is precious little case law precedent as to how these lawsuits might play out in court, and close attention is being paid to them in the product safety community.
In this case, the government alleges that Spectrum and a former subsidiary (Applica Consumer Products) failed to timely report under Section 15(b) of the Consumer Product Safety Act (CPSA) a hazardous defect relating to certain Black and Decker brand SpaceMaker coffee pot handles. Specifically, the Complaint claims that the companies knowingly violated the reporting requirements of the CPSA with respect to allegedly defective carafe handles that could detach and cause hot coffee to spill onto consumers and burn them. According to the government, over a three year period, hundreds of consumers reported incidents involving the detached handle to the CPSC before the companies notified the agency of the potential problem and later recalled the product. The Complaint alleges that the companies themselves received approximately 1,600 consumer complaints regarding the same issue over the three year period (early 2009 through April 2012). The Complaint further alleges that the companies distributed a small number of the allegedly defective coffee pots to retailers even after the recall was announced, which is also prohibited by the CPSA.
The government is seeking an undisclosed monetary civil penalty under Section 20 of the CPSA and injunctive relief, including the enactment of a stringent compliance program to ensure future compliance with CPSC reporting obligations.
Notably, in response to the filing of the complaint, Spectrum Brands has stated, in part, that “the Commission is taking a position that is inconsistent and irreconcilable with its conclusions concerning the nature and degree of risk associated with similar products and similar quality issues” and that it is “compelled to defend its conduct in court” in the face of the Commission’s “inconsistent positions and arbitrary civil penalty demand.” The Company further stated that that it “has a long history of proactive communications with the [CPSC]” including in this case after “Spectrum Brands determined that it had distributed a small number of recalled coffeemakers…”
As we have previously commented, we expect the Commission to remain active in brining enforcement actions against companies for violations of Section 15(b) of the CPSA and other provisions of the CPSA (and statutes enforced by the Commission). We will continue to follow this litigation, and the Michaels Stores case, and update our readers on notable latest developments given the importance of these recent cases.
Acting to finalize a tentative decision from 2013, FDA announced on June 15, 2015 that it was issuing a declaratory order that will require manufacturers to remove partially hydrogenated oils (PHOs) from processed foods over the next three years. PHOs in ready-to-eat foods like baked goods, snack foods, and frozen foods represent Americans’ major dietary source of industrially produced trans fat, which studies have found to be associated with coronary heart disease and other adverse health outcomes. Artificial PHOs have been used in human food since the 1950s to increase the shelf life and enhance the flavor stability of food products. Trans fats also are naturally occurring in meat and dairy products, and FDA’s action does not apply to naturally occurring trans fats. The action also does not apply to fully hydrogenated oils (FHOs), which contain no trans fat and in essence become saturated fats, or to PHOs that may be added to animal foods.
As many readers of this blog know, the start of 2011 saw the enactment of a massive bill aimed at overhauling the nation’s food safety system to become more preventive instead of reactive to safety problems and illness outbreaks. Among the numerous significant new regulations, requirements, and programs that are being implemented under the authorities granted by the FDA Food Safety Modernization Act (FSMA) is the so-called Voluntary Qualified Importer Program or VQIP. On June 4, 2015, FDA finally released a draft VQIP guidance document for industry that lays out the scope of VQIP, the criteria for participation and the application process, and the actions FDA will take if a participating importer is found to be out of compliance with the conditions of participation. Continue Reading
Earlier this year, we wrote about a far-reaching product safety ordinance enacted into law in Albany County, NY (the “County”) entitled “The Toxic Free Toys Act.” At the time, we expressed our concern that numerous issues would arise in the local law’s implementation and enforcement, particularly with respect to those provisions in direct conflict with the federal Consumer Product Safety Improvement Act of 2008. Not surprisingly, in mid-April, a coalition of consumer product associations filed a lawsuit in federal court to challenge the law.
The “Safe to Play Coalition” argued in its Complaint that the Albany County law is pre-empted by both the federal Consumer Product Safety Act (CPSA) and Federal Hazardous Substances Act (FHSA), which regulate the same children’s products that are covered by the ordinance. The coalition asserted that Congress enacted both of these federal laws to ensure nationwide, uniform standards would govern the safety of children’s products rather than a patchwork of state and local regulations.
Rather than answer or move to dismiss the Complaint, in mid-May, the County joined with Plaintiffs in seeking a stay from the court of the proceedings to allow the County time to promulgate regulations implementing the law. The County stated that it expected to complete the regulations by November 1, 2015, and the parties agreed not to litigate until Plaintiffs had a chance to review those regulations to determine whether they should continue with the lawsuit. In any event, the County agreed not to enforce the law (scheduled to take effect in January 2016) or any regulations implemented pursuant to it until six months after any court decision or order on the preemption issue or appellate order. On May 15, the Court granted the requested stay of the proceeding.
Despite this litigation and publicity surrounding the law, much of it negative, other New York counties including Suffolk, Duchess, and Onondaga continue to consider, and in the case of Westchester County enact, similar local “children’s product safety” laws. For the same reasons stated in our initial blog post on this subject, we believe that while the motive behind such laws is well-intentioned, these ordinances tend to create confusion and cause more harm than good, particularly adverse economic ramifications. Product safety regulation is best left to the federal government, and in some cases, state governments. Ironically, just a few months after Albany County had passed its ordinance, the New York State Assembly passed the “Child Safe Products Act” (A5612) which also seeks to regulate “toxic chemicals” in children’s products by requiring New York State to publish a list of toxic chemicals, require disclosure of their use in children’s products, and eventually ban their use. Should that state bill become law, the parties to the litigation may need to address that as well should the case proceed.
On Friday, Federal Magistrate Judge Mark D. Clarke partially dismissed a lawsuit brought by commercial alfalfa farmers seeking to overturn a Jackson County ordinance that banned the use of GMO seed stock (“It is a county violation for any person or entity to propagate, cultivate, raise, or grow genetically engineered plants within Jackson County.”). The farmers claimed that the anti-GMO ordinance, which voters approved overwhelmingly last May and is set to take effect on June 5th, was prohibited by Oregon’s Right to Farm Act because it violated their right to farm.
According to the Judge, while the state’s “right to farm” law prohibits ordinances and lawsuits that treat a common farming practice as a trespass or nuisance, it does not protect activities that harm commercial agriculture. The harm here, as argued by defendants, was the potential tainting of organic crops resulting from cross-pollination from nearby commercial GMO-crop farms. “While farming practices may not be limited by a suburbanite’s sensitivities, they may be limited if they cause damage to another farm’s crops,” Judge Clark said. “Farmers have always been able to bring claims against other farmers [under the Right to Farm Act] for practices that cause actionable damage to their commercial agriculture products,” and the Jackson County ordinance simply “serves to prevent such damage before it happens,” he said.
The judge also found that state lawmakers intended to permit the Jackson County GMO ban because they expressly excluded the ordinance from a 2013 statewide bill that preempted other local governments from regulating GMO crops and reserved such regulatory power for the state. Specifically, the GMO preemption bill–passed during a special session of the Oregon Legislature in September 2013–includes an exemption for any ordinance that had qualified for the ballot before January 2014 and would be voted on in May 2014, an exemption the Jackson County ordinance falls squarely within.
While Judge Clark’s ruling grants partial summary judgment as to plaintiffs’ “right to farm” law claims, their claim seeking $4.2 million in compensation from Jackson County–incurred as a result of the forced removal of about 300 acres of GMO-seed alfalfa crops–remains alive. (More later on the financial implications of GMO policy.)
Nevertheless, the anti-GMO faction views the decision as a big win, and is gearing up to defend the decision before the Ninth Circuit Court of Appeals upon plaintiffs’ likely appeal. The decision, though limited to a county-level ordinance, could have broader effects, as so many GMO-related laws are facing similar challenges in states and counties across the country (see, e.g., our post about the GMO legislation landscape from last week).
Joining the rising tide of local GMO legislation, last week voters in Benton County, Oregon defeated the Benton County Local Food System Ordinance, which would have prohibited the cultivation of GMO crops in the county. The proposed legislation follows on the heels of a Jackson County, Oregon GMO Ban, which passed in 2014 and is currently under legal challenge. It also follows Measure 92, Oregon’s initiative to require labeling on packaging, bins, and shipping containers of GMO foods and foods containing GMO ingredients, which failed by a narrow margin in the November 2014 elections.
The varied success of GMO legislation at the County (Maui County, HI and Humboldt County, CA) and State (Vermont, New York) levels mirrors the GMO debate occurring at the Federal level, where two GMO-labeling bills are competing in Congress:
- The first is Representative Mike Pompeo’s (R-KS) “Safe and Accurate Food Labeling Act” (R. 1599), which would establish a federal labeling standard for foods with genetically modified ingredients, giving sole authority to FDA to require mandatory labeling on such foods if they are ever found to be unsafe or materially different from foods not produced with GM ingredients. The intent is to preempt a patchwork of state regulations and to remove any push toward mandatory labeling of genetically modified foods. The bill also creates a mechanism, via USDA, for those who wish to label their products as non-bioengineered. It remains to be seen how this bill will be affected by USDA’s recent announcement of its Process Verified Program expanding to include a GMO-free certification.
- The second is Senator Barbara Boxer’s (D-CA) “Genetically Engineered Food Right-to-Know Act” ( 511), which would require clear labels for genetically engineered foods intended for human consumption, including whole foods, processed foods, seafood, and animal-based foods to provide consumers with material information about their food and to prevent consumer confusion. Under the bill, if a food has been genetically engineered (GE), it would be identified as a GE food in the ingredients list. Any product that has been genetically engineered would also be prohibited from identifying itself with a “natural” label.
Mintz Levin and its consulting affiliate, ML Strategies, continue to monitor the progress of both State and Federal GMO legislation, and we will post updates as they become available.
Written by: Michelle Gillette and Katherine Fox
Currently, FDA regulates cosmetics to ensure they are not adulterated or misbranded, but does not have the authority to order cosmetic recalls or require adverse event reporting. Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) seek to change that.
On April 20, 2015, they introduced the Personal Care Products Safety Act (S.1014). The Act, if passed, would modify Chapter VI of the Federal Food, Drug, and Cosmetic Act (FDCA) to strengthen FDA’s oversight of, and regulatory authority over, cosmetic products.
Title I of the Act (“Cosmetic Safety”) gives FDA authority to order cosmetic recalls, as well as require manufacturers to: Continue Reading
Written by: Katy E. Ward and Jo Anne Shatkin
In its first step towards regulating nanoscale materials, EPA plans to impose a one-time electronic reporting and recordkeeping requirement under TSCA on manufacturers, importers and processors of particles ranging from 1-100 nanometers and exhibiting unique characteristics due to their size. Until now, nanoscale versions of substances already on the TSCA Inventory have been exempt from reporting requirements.
A manufacturer, importer and processor should first assess whether they are subject to the Proposed Rule. A company handling a nanoscale material is exempt if that material is contained in an “article.” An article is something that has a specific shape and an end-use that is dependent on that shape. Anything that is intended to be removed is not considered part of the article and must be reported (e.g., ink from a pen).
A manufacturer, importer and processor may also be exempt from the Proposed Rule if: Continue Reading
As we wrote about earlier this month, on April 1, 2015, the U.S. Court of Appeals for the Tenth Circuit (“Tenth Circuit”) temporarily stayed the effective date of “the enforcement and effect” of the CPSC’s safety standard for certain high-powered magnet sets. Specifically, the Court stayed the safety rule pending consideration of the CPSC’s response to plaintiff Zen Magnets’ (“Zen” or “the Company”) motion to stay the rule pending judicial review. While the temporary stay ordered by the Tenth Circuit was widely reported in the media, what followed soon thereafter – the lifting of that stay – has received scant attention.
On April 14, CPSC Responded to Zen’s Stay Motion. The Government argued that the rule should not be stayed pending judicial review because Zen could not demonstrate: Continue Reading