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Consumer Product Matters

A product safety and consumer related regulation and litigation blog

Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety, Uncategorized

After launching with an ambitious agenda fourteen months ago (as we wrote about here), last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks.  The Working Group has proposed an Update to the Coordinated Framework for the Regulation of Biotechnology, and it also completed work on a National Strategy for Modernizing the Regulatory System for Biotechnology Products. Together, these documents clarify the authority that Federal administrative agencies have to regulate certain products of biotechnology and they establish goals to ensure the proper use of those authorities in the future.

First, the Working Group’s proposed Update to the Coordinated Framework outlines the specific roles that FDA, USDA, and EPA serve to regulate biotechnology-derived products and the ways in which the agencies work together when those roles overlap. The Coordinated Framework, as noted in the Administration’s corresponding blog post, presents this information in three forms:

  • “graphics that illustrate agency-specific overviews of regulatory roles;
  • case studies that demonstrate how a product developer might navigate the regulatory framework; and
  • a comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.”

The Administration is soliciting public comment on its proposed Update. The deadline for submitting comments will be forty days after the Update is published in the Federal Register.

Second, the Working Group’s National Strategy dovetails with the Coordinated Framework, by listing a number of objectives related to the agencies’ use of their regulatory authorities. It groups these objectives under three overarching goals: “increasing transparency, increasing predictability and efficiency, and supporting the science that underpins the regulatory system.”

EPA, FDA, and USDA have agreed to report annually to the White House on their progress in meeting these three goals for at least the next five years. In addition, sometime soon, the Working Group plans to release a study on the future of biotechnology, the one item remaining on the group’s to-do list announced at its inception last year.

Consumer Product Matters will continue to follow the waning days of the Obama Administration and the transition to the next Administration – when the updated Coordinated Framework and the National Strategy ultimately will be put to the test.

Hot CPSC Jurisdictional Issues: Does the CPSC Have Regulatory Authority Over Amusement Park Rides and Guns?

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Product Recalls, Federal Regulations, State Product Safety Laws, State Regulations, U.S. Congress

In the wake of two tragic amusement park ride accidents in Kansas and Tennessee, and the ongoing political debate in America over gun safety issues, we felt it timely to help answer a question that continues to be asked in the media: does the U.S. Consumer Product Safety Commission (CPSC) have the authority to address the safety of amusement park rides and guns?

amusement-park-guns-cpscAmusement Park Rides.  Every time there is a tragedy on a ride at an amusement park, the nation turns its attention and scrutiny on the CPSC as the nation’s safe products regulator.  However, and crucially, the CPSC does not have jurisdiction over the safety of “fixed site” amusement park rides.  In 1981, the Congress stripped the CPSC of its jurisdiction over these rides through an amendment to the Consumer Product Safety Act (CPSA).  As a result, rides that are “permanently fixed to a site” (such as the ones at the Kansas and Tennessee parks) are subject to voluntary standards written by the ASTM F-24 Committee on Amusement Rides and Devices and state and local regulations.

The CPSC does have jurisdiction over “mobile” amusement rides (those transported from location to location).  The agency also acts as a clearinghouse for safety information on ride incidents identified by Commission investigators and state and local ride officials.  The following 2012 CPSC Directory of State Amusement Ride Safety Officials provides a helpful introductory overview of the CPSC’s activities with respect to amusement park rides and a directly of the relevant state and local officials dedicated to ride safety.

Read our previous post about this jurisdictional issue here.

Gun Safety.  Like fixed amusement park rides, firearms and ammunition are excluded from the definition of a “consumer product” in the CPSA.  As a result, the CPSC does not regulate the safety of guns, shells and cartridges (the Bureau of Alcohol, Tobacco, and Firearms does).

guns-amusement-park-cpscNote: CPSC Commissioner Marietta Robinson recently issued a thoughtful perspective describing how she believes the CPSC can make guns safer and help bring down the number of accidental incidents involving firearms.  According to Robinson, “guns should be defined as the consumer products they are so that we may do our job of protecting the American consumer.”

Despite its lack of jurisdiction to regulate the safety of guns and ammunition at present, the CPSC does have authority to regulate the safety of some products and accessories related to gun use.  For example, the CPSC has asserted its jurisdiction over separate firearm trigger locking devices.  Additionally, the CPSC has recalled previously gun storage boxes, handgun vaults, and gun holsters, thus all squarely falling within the regulatory authority of the agency.  In fact, as recently as 2013, the White House requested the CPSC to “review and enhance as warranted safety standards for gun locks and safes” as a measure to improve gun safety.

Without a further act of Congress, the CPSC’s activities with respect to fixed amusement park rides and gun safety will not likely change.

 

E-Cigarette Makers Contending with New CPSC and FDA Regulations

Posted in Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA), Federal Regulations, Food & Drug Administration (FDA)

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other interested parties, including dozens of plaintiffs in lawsuits stemming from battery explosions and other injuries.  Newly enacted Federal requirements for ENDS and their components and parts show that such scrutiny sometimes leads to legislative or administrative actions.  Indeed, Summer 2016 could down in infamy for manufacturers, distributors, and retailers of this category of consumer products due to its confluence of new regulations from two major Federal agencies – CPSC and FDA.

We previously reported on the  Child Nicotine Poisoning Prevention Act of 2015, introduced last year by Senator Bill Nelson (D-Fla.) and signed into law in January.  It requires liquid nicotine to be packaged in accordance with the Poison Prevention Packaging Act and CPSC’s standards child-resistant packaging and containers (children are those under age five).   Continue Reading

CPSC Chairman Kaye and Commissioner Adler: Current Civil Penalties Approach Works

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Civil Penalties, CPSC Enforcement Actions, Federal Regulations, Litigation, U.S. Congress

Yesterday, CPSC Chairman Elliot Kaye and Commissioner Robert Adler issued a lengthy joint statement vigorously defending the Commission’s current approach to civil penalties against various criticisms voiced by Commissioners Joe Mohorovic and Ann Marie Buerkle as well as stakeholders in the business community.  Their overarching message: such criticisms are without merit and are, in reality, a call for lesser penalties; there will be no change in the Commission’s current approach.

Over the past few months, we have written extensively about the Commission’s approach to seeking civil penalties against companies for failure to report violations—and the ongoing debate surrounding that process.  Chuck Samuels even testified on the subject last month at the CPSC’s Annual Priorities Hearing (watch here).

According to Kaye and Adler, “agency critics have urged an enormous undertaking by the Commission to prioritize exploring and redesigning its civil penalty system, effectively displacing work intended to save lives and prevent injuries.”  They expressed disappointment at the “distortion” of Chairman Kaye’s remarks at the ICPHSO conference last year, and pushed back at the idea that the Commission somehow operates without transparency when assessing civil penalties.  Specifically, Kaye and Adler assert the following points in their joint statement against the common civil penalty criticisms:

  • critics of the Commission’s current policy want more information shared related to the facts and factors that enter civil penalty valuations, but hamstring the agency in doing so by seeking (or supporting) stringent Section 6(b) confidentiality protections;
  • there is ample regulatory guidance to determine when to file a Section 15(b) report;
  • both the Commission and companies need flexibility when negotiating a civil penalty settlement, thus counseling against a matrix or formulaic approach to applying the civil penalty factors;
  • companies are afforded full due process protections and procedures when the Commission seeks civil penalties including the opportunity to be heard; and
  • the Commission carefully tracks the information available to firms at each and every step in time and does not rely on hindsight regarding companies’ obligation to file.

While many could find much to dispute in the joint statement, the Commission’s majority has made their view clear.

Companies should take a very close read of this policy statement.  It is now evident that the Commission will not change—or even revisit—its current approach to civil penalties in the coming fiscal year, as urged by some stakeholders in the product safety community.  Barring a change in CPSC personnel, Congressional action, or judicial involvement through the litigation process, the ongoing “debate” over civil penalties has effectively ended for now.

House Passes GE Labeling Bill; Obama Expected to Sign

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, U.S. Congress

As a parting act before its seven-week recess, the House last Thursday passed by a vote of 306-117 Senator Pat Roberts’s (R-KS) legislation (S.764) requiring the labeling of genetically engineered foods.  Already approved by the Senate last week, the bill is now expected to be signed into law by President Obama, according to a White House spokeswoman.

The bill directs the Department of Agriculture to set a standard within two years that would apply to all food labels in the U.S. The standard would permit three types of labels: a USDA-designed symbol; a written statement noting the presence of GE ingredients; and a QR code for smartphones to scan. The standard would preempt state law, including Vermont’s Act 120, which took effect July 1st. Continue Reading

Eighth Circuit Issues Decision Significant for All Executives of FDA-Regulated Businesses

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Litigation, Manufacturer Product Safety

On July 6, 2016, the Eighth Circuit Court of Appeals issued its ruling in United States v. DeCoster, in which it upheld prison sentences for two executives under the “responsible corporate officer” (RCO) doctrine of liability, also called the Park doctrine, for their role in introducing into interstate commerce eggs that had been adulterated with Salmonella.  The two executives were sentenced last year for strict liability violations of the Federal Food, Drug, and Cosmetic Act (FDCA). Continue Reading

Senate Passes Bill Requiring Labeling for Genetically Engineered Foods

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, U.S. Congress, Uncategorized

Four months after the Senate defeated a GE labeling bill (S.2609) introduced by Agriculture Committee Chairman Pat Roberts (R-KS), the upper chamber Thursday night passed, 63-30, a compromise measure (S. 764) that Roberts co-wrote with Senator Debbie Stabenow (D-MI), the Ag Committee’s Ranking Member.

Unlike Roberts’s original bill, he and Stabenow’s version would mandate the labeling of food with genetically engineered ingredients (i.e., ingredients that have been altered such that they could not be reproduced through conventional breeding). The bill requires that labels appear either as an on-pack, USDA-created symbol or a QR or bar code that smartphones could read.

In a disappointment to some labeling advocates, the bill would preempt state laws, including Vermont’s Act 120, which took effect July 1st.  The bill has fewer exemptions than the Vermont law, which does not require labeling for tens of thousands of processed food products. However, it does exempt foods in which meat, poultry, or egg products are the main ingredient.

Critics also complain that the definition of “bio-engineering” under the bill is too narrow and would allow certain products to be excluded , e.g. canola oil and high fructose corn syrup due to the manner in which they are processed.

The bill does call for the USDA, rather than the legislature, through the rulemaking process, to permit stakeholders to determine the foods, ingredients, and processes that should be included or excluded from the labeling requirements

After the Senate voted to invoke cloture, Roberts conceded his bill is “not the best possible bill” but insisted that “it’s the best bill possible under the difficult circumstances we find ourselves in today.” Vermont Senators Patrick Leahy and Bernie Sanders took to the floor to argue otherwise (though they were overshadowed by a protestor in the gallery who threw $2,000 on to the Senate floor amid shouts of “Monsanto Money”).

Although the bill garnered strong bipartisan support and was co-authored by Ag Committee leaders, its future is uncertain. While Secretary of Agriculture Tom Vilsack has called for a national uniform labeling standard, President Obama has been noticeably tight-lipped. In the end, he may not have to take a position: Given long-standing opposition among House Republicans to mandatory labeling, a bill may not land on the President’s desk.

But with the clock ticking – Congress adjourns at the end of this week for its summer recess – and the prospect of Vermont’s law becoming the de facto labeling standard, skeptics of mandatory GE labeling may hold their nose and back the bill. It might their best choice, as the bill, according to Roberts, is the “last train that is leaving town.”

We will continue to monitor the fate of the labeling of GMO/GE foods, as we have done, here, here, and here.

Chuck Samuels, Mintz’s Product Safety Regulatory Co-Chair, Provides Testimony to CPSC at Annual Priorities Hearing

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Civil Penalties

On June 15, Chuck Samuels, Co-Chair of Mintz Levin’s Consumer Product Safety Regulatory Practice Group, provided testimony to the U.S. Consumer Product Safety Commission (CPSC) at the Commission’s Meeting on its Agenda and Priorities for FY 2017 and 2018.  Chuck’s testimony focused on the Commission’s increasing imposition of heightened civil penalties for alleged violations of statutes and regulations enforced by the CPSC, including Section 15(b) of the Consumer Product Safety Act.  We have previously written about this important issue.

The following summary of Chuck’s remarks can be found here within the full briefing package for the Commission and are as follows:

“Critical to effective operation of our federal product safety regulatory regime and to consumer protection is a robust system of Section 15 reporting by regulated entities and appropriate penalties for late or no reporting.  The system is under stress in an era of both heightened penalties and increasing scrutiny of less obviously and more minor hazardous patterns of product failures…Fortunately, actions can be taken to improve the CPSC’s transparency and ability of the regulated community to understand the reporting and civil penalty regimes without constraining the CPSC from carrying out its critical mission.  Use of standard government and stakeholder communication techniques should be explored (e.g., workshops, advisory committees, hearings, outside neutral expert input).  This would possibly lead to enhanced guidance and/or new methods consistent with the law and more effectively promoting compliance with the law.”

Chuck’s full remarks to the Commission can be found here around the 12:25 time marker.  The Q & A portion of the testimony can be found between the 1:00:00 and 1:17:00 time marker.

 

 

 

 

Massive CPSC Recall Leaked to the Press by “CPSC Source” Prior to Official Agency Announcement

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Enforcement Actions, CPSC Product Recalls, Federal Regulations

Today the U.S. Consumer Product Safety Commission (“CPSC”) and Health Canada announced a massive joint recall with IKEA involving over 35 million pieces of furniture that can pose a tip over hazard to small children. While we would normally write about the recall itself, a troubling development has caught our attention.  A CPSC employee prematurely leaked the recall to staff reporter Tricia Nadolny at the Philadelphia Inquirer.

The CPSC and IKEA officially announced the recall this morning, but the Philadelphia Inquirer prematurely broke the story yesterday afternoon. The reporter confirmed in the story that her source works for the CPSC and did not have clearance to discuss the recall publicly. Additionally, the story included quotes from consumer advocates and other interested parties reacting to the recall—indicating that the reporter had the information for a decent amount of time prior to publishing the story.

After the Inquirer article was published, multiple other media outlets began reporting the recall. This likely put IKEA (and the CPSC) in an incredibly difficult situation of having to quickly make decisions about the release of information about the recall. For companies and legal counsel negotiating a recall—especially one of this magnitude—this is a nightmare scenario.

Even if a company has a contingency plan in the event a recall is leaked early (something we usually recommend for higher profile recalls), the carefully negotiated messaging and CPSC agreed rollout of the recall will have been thrown out the window and replaced by the leaked information. The company will be forced to scramble to respond to media questions while also not spoiling the originally planned announcement.

Additionally, and even more problematic, consumers who may have recalled units will start calling and emailing the company before they know the company’s official 800 number to call and before the company has sufficient staff to start fielding those calls. With over 29 million units involved in this specific recall, that could add up to quite a lot of phone calls and emails.

There are many compelling reasons why the CPSC and companies agree to not only the content of a recall, but also its timing. For a recall of this magnitude to be leaked to the media is a very troublesome precedent and cause for concern to companies negotiating higher profile recalls with the CPSC. Companies have not historically had much to fear in terms of recall information leaking from the agency, but this development potentially calls that into question.

Not only is it a violation of CPSC’s own statutes and regulations for recall information to be prematurely leaked to the press (and potentially could lead to employee sanctions), but it is also potentially disruptive to the effectiveness of the recall itself. The CPSC should take steps to ensure such leaks do not occur in the future.

 

 

The Last Set of Major FSMA Regulations Are Done!

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety, Supply Chain Risk Management

The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency when it settled a lawsuit related to its implementation of FSMA (our posts on the previous six FSMA rules are here, here, and here). The newest Final Rule, titled Mitigation Strategies to Protect Food Against Intentional Adulteration, has an effective date of July 26th. Responding to calls from affected stakeholders that a one-year compliance deadline from the effective date, as proposed originally, would not be enough time for companies to meet these significant and brand-new obligations, FDA has increased the compliance dates to 3 years for most businesses (along with 4 years for “small” and 5 years for “very small” businesses, as those terms are defined in the Final Rule).

The purpose of these new regulations, according to FDA, “is to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm,” and they establish requirements for covered food facilities to implement various food defense measures. Food defense consists of efforts to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means.  Continue Reading