USDA Withdraws Biotech Regulation Proposal

  • As previously covered on this blog, on January 19, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) published a proposed rule to update its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms in response to advances in genetic engineering and the Agency’s understanding of the plant pest and noxious weed risk posed by genetically engineered organisms.  These requirements have not been comprehensively revised since they were established in 1987.
  • On November 7, 2017, APHIS published a notice in the Federal Register (82 Fed. Reg. 51582) announcing its withdrawal of the January 19th proposed rule.  In withdrawing the proposed rule, APHIS cited stakeholder feedback critical of the proposed revisions.  As previously covered on our blog this summer, in comments submitted to APHIS, industry stakeholders applauded the Agency’s proposed rule as underscoring the need to promote innovation in biotechnology and for proposing to ease regulation of gene-edited products.  But at the same time, industry called out a number of proposed revisions as improperly expanding USDA’s review process in certain respects which could effectively hamstring developers before they can even begin testing products.
  • In its November 7th withdrawal of the proposed rule, APHIS stated that it is committed to exploring “a full range of policy alternatives” and that the Agency will “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.” Now that APHIS has decided to go back to the drawing board, industry has an opportunity to work with APHIS to develop revised requirements to facilitate a regulatory framework that promotes innovation in biotechnology.
This post was written by Food and Drug Law at Keller and Heckman of Keller and Heckman LLP., © 2017
For more Biotech, Food & Drug legal analysis, go to The National Law Review

GM Labeling Update: Ingredient Disclosure Debate

  • As previously reported on this blog, legislation requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018. On June 28, 2017, USDA’s Agricultural Marketing Service (AMS) posted a list of 30 questions to obtain stakeholder input to facilitate the drafting of mandatory disclosure requirements to implement the National Bioengineered Food Disclosure Law. One of those questions is:
    • “Will AMS require disclosure for food that contains highly refined products, such as oils or sugars derived from bioengineered crops?”
  • USDA has not yet posted the comments it has received, which were due by August 25, 2017; however, several organizations have posted the comments they submitted in response to the questions. Among the organizations supporting disclosure were the Grocery Manufacturers Assn. (GMA), the International Dairy Foods Assn. (IDFA)and the Consumers Union. Noting that excluding highly refined ingredients (HRI) from the scope of the mandatory disclosure standard would result in roughly 80% fewer products being subject to the disclosure requirements under the federal law, GMA wrote, “A clear, simple, and consistent mandatory disclosure standard that includes HRI will assist manufacturers in educating consumers about biotechnology as a safe and beneficial method of plant breeding.”
  • In contrast, the Information Technology & Innovation Foundation (ITIF) and The Biotechnology Innovation Organization (BIO) are opposed to mandatory disclosure of HRI. ITIF suggested that some refined products do not contain residual DNA sequences and that “[t]here are not analytical methods that would allow such products to be identified as coming from ‘GM’ plants or animals vs. others.”
  • While USDA develops mandatory disclosure requirements for bio-engineered foods, a number of class action laws suit have been filed suggesting that products containing GM ingredients are falsely labeled as natural. For example, last week, the U.S. Supreme Court refused to hear a bid by Conagra Brands Inc. to avoid a class-action lawsuit concerning cooking oil labeled 100% natural that contains GM ingredients (see S. News). And earlier this month, Frito-Lay North America agreed to not make any non-GMO claims on certain products “unless the claim is certified by an independent third-party certification organization”(see Food Navigator).
  • We will continue to monitor developments on the National Bioengineered Food Disclosure Standard and report them to you here.
This post was written by the Food and Drug Law at Keller and Heckman of Keller and Heckman LLP., © 2017
For more Biotech, Food & Drug legal analysis, go to The National Law Review

Chicago City Council Committee Approves Hands Off-Pants On Ordinance to Protect Hotel Employees

On October 2, 2017, the Chicago City Council Committee on Workplace Development and Audit approved an amendment to the Municipal Code (the “Ordinance”) that, if approved by the full City Council, will require hotel employers to equip hotel employees assigned to work in guestrooms or restrooms with portable emergency contact devices and develop and implement new anti-sexual harassment policies and procedures. The Ordinance is in response to multiple reports of sexual assault and harassment targeted at hotel employees by hotel guests.

The Ordinance in its current form will require hotel employers to (1) equip employees who are assigned to work in a guest room or restroom, under circumstances where no other employee is present in the room, with a panic button (at no cost to the employee) which the employee may use to summon help from other hotel staff if s/he reasonably believes that an ongoing crime, sexual harassment, sexual assault or other emergency is occurring in the employee’s presence; (2) develop, maintain and comply with a written anti-sexual harassment policy to protect employees against sexual assault and sexual harassment by guests; and (3) provide all employees with a current copy of the hotel’s anti-sexual harassment policy, and post the policy in conspicuous places in areas of the hotel where employees can reasonably be expected to see it.

With respect to the anti-sexual harassment policy mandates, employers must develop a policy that:

  • Encourages employees to immediately report to the employer instances of alleged sexual assault and sexual harassment by guests;
  • Describes the procedures that the complaining employee and employer shall follow in such cases;
  • Affords the complaining employee the right to cease work and leave the immediate area where danger is perceived until such time that hotel security or the police arrive to provide assistance;
  • Affords the complaining employee the right, during the duration of the offending guest’s stay at the hotel, to be assigned to work on a different floor or at a different station or work area away from the offending guest;
  • Provides the complaining employee with sufficient paid time to (a) file a complaint with the police against the offending guest, and (b) testify as a witness at any legal proceeding that may ensue as a result of such complaint;
  • Informs the employee that the Illinois Human Rights Act and Chicago Human Rights Ordinance provide additional protections against sexual harassment in the workplace; and
  • Informs the employee that it is unlawful for an employer to retaliate against any employee who reasonably uses a panic button or exercises any right under the Ordinance.

Employers in violation of the Ordinance would be subject to a fine between $250-$500 for each offense, and each day that a violation continues constitutes a separate and distinct offense.

Consequently, it is critical that Chicago hotel employers monitor the status of this Ordinance, which is now pending before the full City Council. If passed and signed into law, the Ordinance will take effect within 90 days of signature. Employers should consider preparations for providing panic buttons to those employees protected by the Ordinance and training hotel employees on their use, and revisiting anti-sexual harassment policies, whether stand-alone or included in employee handbooks, to ensure compliance with the Ordinance’s mandates. Additionally, employers should consider providing updated anti-sexual harassment and anti-retaliation training to all employees, including those who are assigned to work in guest rooms or restrooms, to ensure that all employees fully understand their employer’s policies and procedures.

This post was written by Shawn D. Fabian & Michael J. Roth of Sheppard Mullin Richter & Hampton LLP., Copyright © 2017
For more legal analysis go to The National Law Review

Court Approves $342,500 Settlement On Behalf of 82 Tipped Food Service Workers

In Surdu v. Madison Global, LLC, the Court approved a $342,500 settlement on behalf of approximately 82 current and former employees of Nello Restaurant, who had worked as servers, bussers, runners and bartenders. See No. 15-CIV-6567 (HBP) (S.D.N.Y. Sept. 1, 2017). The plaintiffs alleged violations of the FLSA and NYLL arising from allegedly unpaid minimum wages, misappropriated gratuities, uniform purchase and maintenance costs, and inaccurate wage statements.

After conditionally certifying a Rule 23 class for purposes of settlement, the Court addressed the “Grinnell” factors to assess whether the settlement was substantively fair, reasonable and adequate. Thus, the Court considered: (1) the complexity, expense and likely duration of the litigation; (2) the reaction of the class to the settlement; (3) the stage of the proceedings and the amount of discovery completed; (4) the risks of establishing liability; (5) the risks of establishing damages; (6) the risks of maintaining the class action through the trial; (7) the ability of the defendants to withstand a greater judgment; (8) the range of reasonableness of the settlement fund in light of the best possible recovery; (9) the range of reasonableness of the settlement fund to a possible recovery in light of all the attendant risks of litigation.

The Court found each of these factors satisfied. Of note, the Court found that it was reasonable for the class members to receive approximately 50% of their claimed misappropriated tips after service awards, attorneys’ fees, and costs were deduced from the gross settlement amount. The Court also found service awards in the amount $8,500 for each Named Plaintiff and attorneys’ fees in the amount of $114,166.66 to be reasonable.

This post was written by Brian D. Murphy of Sheppard Mullin Richter & Hampton LLP, Copyright © 2017
For more Labor & Employment legal analysis go to The National Law Review

Full Senate Set to Confirm Sonny Perdue as Agriculture Secretary

USDA Agriculture Sonny PerdueIt has been nearly 14 weeks since President Donald Trump nominated Sonny Perdue, former two-term governor of Georgia, to lead the U.S. Department of Agriculture (USDA). His long wait for formal confirmation is likely to come to an end this week. The Senate is scheduled to hold a confirmation vote late Monday afternoon, where Perdue is expected to receive bipartisan support.

Perdue easily secured the Senate Agriculture Committee’s support at its business meeting on March 30 by a 19-1 vote; Sen. Kirsten Gillibrand (D-NY) voiced her opposition to his nomination and Sen. David Perdue (R-GA) – cousin of Sonny Perdue – declined to participate because of their close connection. Senator Gillibrand requested her opposition be recorded, noting her disapproval of how certain Supplemental Nutrition Assistance Program (SNAP) issues in the State of Georgia were handled by then-Governor Perdue. However, Sonny Perdue is one of President Trump’s more uncontroversial Cabinet choices, and he notably boasts the support of the top Democrat on the Senate Agriculture Committee, Ranking Member Debbie Stabenow (D-MI), who has made clear her support for the Senate to swiftly confirm Perdue for the top USDA spot.

A formal swearing-in ceremony for Perdue, likely to be held later this week, will officially recognize Perdue as the 31st Secretary of Agriculture.

This Week’s Legislative Activities:

  • On Monday, April 24, the Senate will hold a vote on confirmation of the nomination of Sonny Perdue to be Secretary of Agriculture.

© Copyright 2017 Squire Patton Boggs (US) LLP

Grocery Manufacturers of America (GMA) and Vermont Agree to Drop GMO Lawsuit

GMO LawsuitThe food industry, led by the Grocery Manufacturers of America (GMA), and Vermont have agreed to dismiss a federal lawsuit that challenged a state law requiring the labeling of certain foods made with genetically modified organisms.

Vermont’s labeling requirements for genetically modified (GM) foods have been preempted by the recent enactment of federal GM labeling legislation which establishes a “National Bioengineered Food Disclosure Standard” and calls for the U.S. Department of Agriculture (USDA) to “establish a national mandatory bioengineered food disclosure standard”.  On August 11, 2016, Vermont’s Attorney General (AG) issued a formal memo stating that the AG’s office will no longer enforce the state’s requirements.  Still pending on appeal to the 2nd U.S. Circuit Court of Appeals in New York, however, was a federal court case filed by food industry groups against the state of Vermont challenging the state GMO labeling law.

Earlier this week, the parties to the lawsuit agreed the suit was no longer warranted because a new federal law preempted the Vermont law that took effect July 1, 2016.

The dismissal of the legal challenge to Vermont’s GMO labeling law represents the formal conclusion of a particularly controversial chapter in the GM labeling debate that involved sparring over the potential development of a patchwork of conflicting labeling requirements across the 50 states.  With the conclusion of the Vermont GMO labeling law saga, industry can now work with USDA to develop uniform federal regulation for labeling GMO foods.

Congress Passes GE Labeling Standard

GE Labeling Standard Genetically Engineered DNAOn July 14, 2016, the U.S. House of Representatives passed a genetically engineered (GE) labeling standard with bipartisan support. The bill is identical to S. 764, which passed the Senate last week, and represents a compromise brokered by Sens. Debbie Stabenow and Pat Roberts. The White House has indicated that President Obama will sign the legislation into law.

Significantly, the legislation sets a national standard that preempts current and future attempts by states to require labeling of foods containing genetically modified ingredients, including Vermont’s mandatory labeling standard that went into effect July 1.

The legislation establishes a mandatory disclosure standard that applies to all food products intended for human consumption containing bioengineered ingredients. Food companies may satisfy the disclosure requirement through text, a symbol, or by use of certain embedded electronic or digital links, such as a QR Code.

Animal-based products such as beef, pork, poultry, eggs and milk are prohibited from being considered bioengineered foods solely because the animal consumed feeds containing GE ingredients. The legislation does not require animal feed to comply with the disclosure requirement.

Under the legislation, the Secretary of Agriculture is required to promulgate rules that implement the national standard within two years. The legislation requires the Secretary to provide additional flexibility for small food manufacturers in the regulations, including additional disclosure options and more time to comply with the standard. Some very small food manufacturers will be exempt under the regulations.

White House press officials indicated that the administration was pleased with the Roberts–Stabenow compromise effort. “While there is broad consensus that foods from genetically engineered crops are safe, we appreciate the bipartisan effort to address consumers’ interest in knowing more about their food, including whether it includes ingredients from genetically engineered crops,” spokeswoman Katie Hill told reporters in an e-mail.

The federal standard comes just days after Vermont’s standard, passed in 2014, went into effect and follows failed attempts to mandate labeling in states such as Colorado, Oregon, and California. Food manufacturers expressed concern that a patchwork of state laws would make compliance difficult and potentially reduce consumer choice if manufacturers elected to pull products off store shelves rather than implement costly labeling requirements. After being signed into law, the focus will quickly turn to the U.S. Department of Agriculture’s implementation of the legislation and how the agency will define key terms that directly impact applicability (for example, the definition of “small” and “very small” food manufacturers).

© MICHAEL BEST & FRIEDRICH LLP