Category: Biotech & Cleantech

Preparing for the Repeal of Cook County’s Beverage Tax: Requesting Credits and Refunds

Earlier this fall, the Cook County Board voted to repeal its constitutionally suspect, politically unpopular one cent per ounce sweetened beverage tax (Tax). The short-lived Tax will expire at the end of the County’s fiscal year on November 30, 2017.

Having been tasked with implementing the Tax, the Cook County Department of Revenue (Department) is now charged with unwinding it. Distributors and retailers who have paid the Tax are entitled to credits or refunds on their unsold inventory at month’s end. The Department recently issued guidance on the credit/refund procedure.

Retailers that have paid Tax to their distributors may claim a credit/refund from their distributors for Tax paid on their unsold inventory by completing the Department form entitled “2017 Sweetened Beverage Retailer Inventory Credit Request Form and Schedule A.” Retailers should complete and submit the form to their distributors, not the Department.

Distributors must file a final Tax return with the Department on or before December 20 (Final Return). To the extent a distributor already has refunded or credited Tax to its retailers, the distributor may claim a credit for the amount refunded on the “other deductions” line of its Final Return. Distributors must file the Department’s standard refund application, found on the Department’s website, to claim refunds for amounts refunded or credited to retailers after December 20. The Department has issued a new form (the “Sweetened Beverage Tax Distributor Credit Form Schedule”) to be submitted by distributors to the Department in support of any credit or refund claims. The form requires distributors to identify the retailers to which it has provided credits/refunds and the amounts thereof.

Retailers who self-remit the Tax may take a credit on their Final Return with supporting documentation. In addition, retailers that have unsold inventory as of December 1, on which they previously remitted floor tax, may obtain a refund of the floor tax through the Department’s standard refund procedure.

Practice Notes:

  1. To the extent possible, Taxpayers should take advantage of the opportunity to claim a credit on their Final Returns in order to avoid the time and expense associated with the County’s standard refund procedure.
  2. Since the Tax was repealed, enthusiasm has waned for various Illinois House Bills (HB 4082-84) proposing to limit the authority of localities to impose beverage taxes. It’s difficult to predict whether the bills will be enacted.
  3. However, the State of Michigan has passed legislation, signed into law by Governor Snyder on October 26, 2017, which prohibits municipalities from levying local taxes on food or beverages.
This post was written by Lauren A. Ferrante & Mary Kay McCalla Martire of McDermott Will & Emery., © 2017
For more legal go to The National Law Review

Mild Traumatic Brain Injury and the Pupillary Light Reflex

According to a recent review study of Pubmed Central/National Library of Medicine databases, the pupillary light reflex provides an optimal opportunity to investigate mild traumatic brain injury (mTBI).

Based on the findings of the review, the pupillary system may provide a noninvasive “window” to mTBI, in terms of documenting its existence and the often-accompanying symptom of photosensitivity. When an individual experiences mTBI, visual dysfunction may occur, and the pupillary light reflex may be affected. Pupils are routinely assessed for abnormal size and responsivity to determine the neural integrity of the visual system. Investigating pupillary light reflex in the mTBI population, researchers found that pupillary response was significantly delayed, slowed, and reduced, symmetrically, with a smaller baseline diameter. These findings may indicate dysfunction of the pupillary pathway.

Several objective biomarkers for the presence of mTBI and photosensitivity provide further insight into neurological dysfunction. In mTBI, photosensitivity may be due to dysfunction in the baseline neural sensor. Photosensitivity as a perceptual phenomenon can be confirmed through objective, noninvasive, rapid, vision-based, pupillary biomarkers.

Pupillary light reflex in mTBI may be investigated with pupillometers to assess subtle abnormalities in pupil size as well as pupillary responses. The resulting information can provide diagnostic or prognostic indicators relating to the extent of the injury, and neurophysiological linkages. Pupillometers offer precise and extensive pupillary testing for the mTBI population, especially those individuals who experience photosensitivity. The major drawback is cost. Development of a more inexpensive hand-held pupillometer would help with diagnosis of mTBI and improve patient care.

With such instrumentation, pupillary light reflex could be used to investigate the possibility of a very early, acute-stage mTBI/concussion in emergency rooms, in the workplace, and even on the sideline of sports games. Such information can be relevant to a worker’s compensation determinations, social security disability determinations, and return-to-play/work/learn standards for both adults and children.

This post was written by Bruce H. Stern of STARK & STARK., COPYRIGHT © 2017
For more Biotech legal analysis, go to The National Law Review 

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

EPA Approves Flint Hills Resources’ Plant For Cellulosic Ethanol Production

On October 12, 2017, Edeniq, Inc., a leading cellulosic and biorefining technology company, announced that Flint Hills Resources, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), received approval from EPA for cellulosic ethanol production at its Iowa Falls ethanol plant.  The 100 million gallons per year plant will use Edeniq’s Pathway technology to produce the cellulosic ethanol and will be eligible to qualify its cellulosic gallons for generating D3 Renewable Identification Numbers (RIN).  Iowa Falls is the second Flint Hills Resources plant, and the fifth overall, to receive approval for cellulosic ethanol production using Edeniq’s technology.  Edeniq announced in December 2016 that EPA approved Flint Hills Resources’ registration of its Shell Rock ethanol plant for cellulosic ethanol production.  According to Edeniq, its Pathway technology “remains the lowest-cost solution for producing and measuring cellulosic ethanol from corn kernel fiber utilizing existing fermenters at existing corn ethanol plants, and has already proven cellulosic ethanol yields of up to 2.5% or higher, as a percentage of its customers’ total volume output.”  Additionally, the technology allows for increases in corn oil production and greater overall ethanol yields.

This post was written by Lauren M. Graham, Ph.D. of Bergeson & Campbell, P.C., ©2017
For more legal analysis go to The National Law Review

DOE Announces $8.8 Million In Funding For Algae Technology Innovation Projects

On September 8, 2017, the U.S. Department of Energy (DOE) selected an additional four Productivity Enhanced Algae and Toolkits (PEAK) projects to receive up to $8.8 million.  The projects aim to develop high-impact tools and techniques that will increase the productivity of algae organisms to reduce the costs of producing algal biofuels and bioproducts.  In total, DOE has awarded over $16 million in funding to the initiative.

The project winners include:

  • Colorado School of Mines, in partnership with Global Algae Innovations, Pacific Northwest National Laboratory, and Colorado State University, which will use advanced directed evolution approaches in combination with high-performance, custom-built, solar simulation bioreactors to improve the productivity of robust wild algal strains;
  • University of California, San Diego, which will work with Triton Health and Nutrition, Algenesis Materials, and Global Algae Innovations on the development of genetic tools, high-throughput screening methods, and breeding strategies for green algae and cyanobacteria, targeting robust production strains;
  • University of Toledo, in partnership with Montana State University and the University of North Carolina, which will cultivate microalgae in high-salinity and high-alkalinity media to achieve productivities without needing to add concentrated carbon dioxide, and deliver molecular toolkits, including metabolic modeling combined with targeted genome editing; and
  • Lawrence Livermore National Laboratory, which will ecologically engineer algae to encourage growth of bacteria that efficiently remineralize dissolved organic matter to improve carbon dioxide uptake and simultaneously remove excess oxygen.
This post was written by  Kathleen M. Roberts of Bergeson & Campbell, P.C. ©2017
For more Environmental & Energy legal analysis go to The National Law Review

Bioplastics Industry Responds To Revised European Parliament Report On Waste Legislation

European Parliament EU BioplasticsOn June 9, 2016, European Bioplastics (EUBP) announced the support of a European Parliament (EP) report emphasizing the role of bioplastics in the creation of a circular bioeconomy. The report, produced by Italian MEP Simona Bonafè¨, outlines legislation that is needed to use waste more efficiently to create bio-based materials. Increasing the value of waste by promoting its use to create other bioproducts will help shift the linear bioeconomy to a circular, more efficient, bioeconomy. The report suggested defining composting and anaerobic digestion of organic waste as recycling, and requiring the collection of biowaste by 2020 in order to increase organic recycling of biowaste to 65 percent by 2025. On June 15, 2016, the EP debated possible new definitions of litter, with the intent of reducing both land and marine based litter by 50 percent by 2030.

ARTICLE BY Kathleen M. Roberts of Bergeson & Campbell, P.C.

©2016 Bergeson & Campbell, P.C.

Swiss Researchers Develop Model to Assess How Nanoparticles “Flow Through the Environment”

Swiss NanoparticlesThe Swiss National Science Foundation issued a May 12, 2016, press release announcing that researchers from the National Research Program “Opportunities and Risks of Nanomaterials” have developed a new model to track the flow of the “most important nanomaterials in the environment.”  To assess how man-made nanoparticles make their way into the air, earth, or water, researchers developed a computer model to determine the environmental accumulation of nanosilver, nanozinc, nano-titanium dioxide, and carbon nanotubes.  The press release notes that knowing the degree of accumulation in the environment is only the first step in the risk assessment of nanomaterials.  This data must be compared with ecotoxicological test results and the statutory thresholds.  According to the press release, in the case of nanozinc, “its concentration in the environment is approaching the critical level.”  The press release states that it “has to be given priority in future ecotoxicological studies — even though nanozinc is produced in smaller quantities than nano-titanium dioxide.”  Furthermore, according to the press release, ecotoxicological tests have until now been carried out primarily with freshwater organisms.  The researchers conclude that complementary investigations using soil-dwelling organisms are a priority.

Article By Lynn L. Bergeson & Carla N. Hutton of Bergeson & Campbell, P.C

©2016 Bergeson & Campbell, P.C.

Biomass Research And Development Initiative Provides Seven Projects With Up To $10 Million In Funding

On May 9, 2016, the U.S. Department of Energy (DOE), the U.S. Department of Agriculture (USDA), and the National Institute of Food and Agriculture (NIFA) announced the recipients of up to $10 million in funding through the Biomass Research and Development Initiative (BRDI). BRDI is a joint program through DOE and USDA that helps develop sustainable sources of biomass and increase the availability of biobased fuels and products. DOE selected two of the grant winners to receive between $1 million and $2 million: the Ohio State University (OSU) project is “Biomass Gasification for Chemicals Production Using Chemical Looping Techniques,” and the Massachusetts Institute of Technology (MIT) project is “Improving Tolerance of Yeast to Lignocellulose-derived Feedstocks and Products.”

USDA then selected five grant winners to receive a total of $7.3 million in funding:

  • University of California-Riverside, to convert poplar to ethanol and polyurethane via pretreatment and lignin polymer synthesis;

  • University of Montana, to quantify ecological and economic opportunities of various forest types and to quantify benefits of replacing fossil fuel with forest-based bioenergy;

  • North Carolina Biotechnology Center, to optimize production of educational resources on biomass sorghum production in the Mid-Atlantic region;

  • Dartmouth College, to overcome the lignocellulosic recalcitrance barrier; and

  • State University of New York College of Environmental Science and Forestry, to provide life cycle understanding for the production of willow and forest biomass to mitigate investment risk.

Article By Kathleen M. Roberts of Bergeson & Campbell, P.C.

©2016 Bergeson & Campbell, P.C.

Six Biofuel Trade Associations Write Congress To Extend Advanced Biofuel Tax Credits

On April 5, 2016, the biofuel trade associations Advanced Biofuels Business Council, Algae Biomass Organization, Biotechnology Innovation Organization (BIO), Growth Energy, National Biodiesel Board, and Renewable Fuels Association sent a letter to House and Senate Leaders asking for a multiyear extension of advanced biofuel tax credits. The six organizations are specifically asking that the Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, the Alternative Fuel and Alternative Fuel Mixture Excise Tax Credit, and the Alternative Fuel Vehicle Refueling Property through the Protecting Americans From Tax Hikes Act of 2015 are extended before they expire at the end of 2016. Other energy production tax credits have been extended, and the biofuel trade associations argue that extending certain energy tax provisions and not others creates investment uncertainty across the energy sector, and puts biofuel producers at a disadvantage.

Article By Kathleen M. Roberts of Bergeson & Campbell, P.C.

©2016 Bergeson & Campbell, P.C.

Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

BullmonLast November, we posted that the Food and Drug Administration (FDA) had approved a genetically engineered (GE) salmon: AquaBounty Techonologies’ AquAdvantage Salmon. This approval marked the first time that the FDA authorized selling a genetically engineered animal for human consumption.

Immediate backlash followed the FDA’s November 19, 2015 announcement from environmental and consumer advocacy groups. On March 31, 2016, environmental and food safety groups, as well as fisherman trade associations, sued the FDA and related agencies in federal court in California. The suit seeks to reverse the FDA’s approval of the fish for human consumption.

The complaint alleges that the FDA failed in its statutory duty to take a “hard look” at how GE salmon will impact the environment. The plaintiffs warn that the FDA did not appreciate the risk that the farmed salmon would inevitably escape, “interbreed with wild endangered salmon, compete with them for food and space, or pass on infectious disease . . . .”

The plaintiffs also take aim at the FDA’s authority to regulate GE animals under the Federal Food, Drug, and Cosmetic Act (FFDCA), arguing that, back in 1938, Congress did not expect the FDA to regulate genetically engineered animals for human consumption: “GE animals present enormously different risks and impacts than drugs, requiring different expertise, analyses, and regulation than were contemplated when Congress enacted the FFDCA.”

Whether additional lawsuits will follow this one remains to be seen. In our November post, we predicted that consumers could sue to challenge the labeling of the GE fish. Although the FDA initially determined that AquaBounty would not need to label its salmon as GE, a provision in December’s 2016 Omnibus Appropriations Bill required the FDA to ban GE salmon imports until it published labeling guidelines for the fish. In February, the FDA issued that ban and announced its plans to establish labeling guidelines.

Even if AquaBounty puts FDA-approved labeling on its product, consumers still may sue under failure to warn and related legal theories. The food industry has had some success defending state law food labeling claims based on federal preemption. But the federal Nutrition Labeling and Education Act exempts claims based on the adequacy of safety warnings unless the FDA has actually considered a risk and determined that no warning is necessary. So, the key question in any consumer personal injury suit involving GE salmon likely will be whether the FDA considered the risk of the alleged harm in implementing its new labeling guidelines.

Article By Amy M. Rubenstein & Katia Asche of Schiff Hardin LLP

© 2016 Schiff Hardin LLP