Category: Biotech & Cleantech

Green Innovation Being Fast Tracked by USPTO

The USPTO now fast tracks applications involving greenhouse gas reduction technologies. The new Climate Change Mitigation Pilot Program targets impact on the climate by accelerating examination of patent applications for innovations that reduce greenhouse gas emissions. Qualifying applications may be advanced out of turn for examination (granted special status) until a first action on the merits—typically the first substantive examination—is complete. Advantageously, qualifying applications do not incur the petition to make special fee and is not required to satisfy the other requirements of the accelerated examination program.

The United States Patent and Trademark Office (USPTO) accept petitions to make special under this program until June 5, 2023, or the date when 1,000 applications have been granted special status under this program, whichever occurs earlier. “This program aligns with and supports Executive Order 14008, dated January 27, 2021, and supports the USPTO’s efforts to secure an equitable economic future, reduce greenhouse gas emissions, and mitigate the effects of climate change.” The new program takes steps toward working to incentivize and expedite clean energy technologies that will help reduce greenhouse gas emissions and mitigate the effects of climate change.

To qualify for the Program:

  • Patent Applications must contain one or more claims to a product or process that mitigates climate change by reducing greenhouse gas emissions, and be: (a) a non-continuing original utility non-provisional application; and (b) an original utility non-provisional application that claims the benefit of the filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) of only one prior application that is either a non-provisional application or an international application designating the United States. Note: Claiming the benefit under 35 U.S.C. 119(e) of one or more prior provisional applications or claiming a right of foreign priority under 35 U.S.C. 119(a)-(d) or (f) to one or more foreign applications will not affect eligibility for this pilot program.

  • The application or national stage entry and the requisite petition form must be electronically filed by use of the Patent Center of the USPTO, and the specification, claims, and abstract must be submitted in DOCX format.

  • Applicants must file the petition to make special with the application or entry into the national stage under 35 U.S.C. 371 or within 30 days of the filing date or entry date of the application. The fee for the petition to make special under 37 CFR 1.102(d) has been waived for this program.

  • Applicants must use Form PTO/SB/457—which contains the petition and requisite certifications—to request participation in this program.

  • Petition filing limitations: Applicants may not file a petition to participate in this pilot program if the inventor or any joint inventor has been named as the inventor or a joint inventor on more than four other non-provisional applications in which a petition to make special under this program has been filed.

In a recent blog post announcing the Climate Change Mitigation Pilot Program, USPTO Director Kathi Vidal said, “It’s essential to protect these transformative energy innovations with intellectual property (IP). Innovation is a primary driver of the U.S. economy, and IP is the bridge between an idea and bringing that innovation to market. Industries based on innovation and the protection of intellectual property generate almost $8 trillion ($7.8 trillion) in GDP, and account for 44% of all U.S. jobs. Workers in patent-intensive industries earn almost $1,900 per week. That is 97% higher than the average weekly wage of workers in non-IP intensive industries.”

Vidal also said, “Startup companies that have a patent are far more likely to be successful in raising funding than those that have not secured intellectual property protection. When used as collateral, a patent increases venture capital funding by 76% over three years, and increases funding from an initial public offering by 128%, the approval of a startup’s first patent application increases its employee growth by 36% over the next five years, and after five years, a new company with a patent increase its sales by a cumulative 80% more than companies that do not have a patent.”

Moving forward to protect essential green energy transition technology can be helpful for future corporate and strategic goals. This new Climate Change Mitigation Pilot Program opens the door to accelerating potential patent protection for many of these developing technological fields.

Article By Jeffrey S. Whittle,  Karthika Perumal, Ph.D., Christopher Kent, Kevin J. Davis, Ph.D., and Samuel A. Savanich of  Womble Bond Dickinson (US) LLP

For more environmental, energy, and resources news, click here to visit the National Law Review.

Copyright © 2022 Womble Bond Dickinson (US) LLP All Rights Reserved.

Senate Bill to Revise and Reassess GRAS Program

  • On May 27, Senator Edward J. Markey (D-Mass.), alongside Senators Richard Blumenthal (D-Conn.) and Elizabeth Warren (D-Mass)., introduced the Ensuring Safe and Toxic-Free Foods Act, which is described as “comprehensive legislation that ensures the Department of Health and Human Services (HHS) fulfills its responsibility to promote the health and well-being of American families by directing the Food and Drug Administration (FDA) to strengthen the Substances Generally Recognized as Safe (GRAS) Rule, which exempts companies from seeking pre-market approval for food chemicals.” A summary of the legislation is available here.
  • The legislation would prohibit manufacturers from independently designating substances as GRAS (or manufacturing or selling food containing those substances) without supplying notice and supporting information to the Secretary of HHS. Substances that are carcinogenic or that have evidence of reproductive or developmental toxicity would be prohibited from receiving a GRAS designation. Further, the legislation would require that a GRAS Notice and all supporting information be publicly available online and subject to a 90-day review period.
  • The legislation would also direct the Secretary to create an Office of Food Chemical Safety Reassessment within FDA’s CFSAN. The new office would be responsible for reassessing the safety of existing food additives, food contact substances, color additives, and substances that had already received GRAS status. The office would be required to reassess at least 10 substances (or class of substances) once every three years. As included in the bill, the first 10 substances to be reviewed would be:
    • Perfluoroalkyl substances and polyfluoroalkyl substances
    • Ortho-phthalates
    • The class of bisphenols
    • Titanium dioxide
    • Potassium bromate
    • Perchlorate
    • Butylated hydroxyanisole (BHA)
    • Butylated hydroxytoluene (BHT)
    • Brominated vegetable oil (BVO)
    • Propyl paraben
  • With regard to the legislation, Senator Markey has said “The FDA too often falls short on their responsibility to promote food safety, highlighted recently by the baby formula crisis where FDA’s deputy commissioner for food policy did not learn about the whistleblower complaint for four months. It is long past time we revise existing food safety measures and close the loophole allowing manufacturers to self-regulate what new substances can enter our food supply.”

Article By Food and Drug Law at Keller and Heckman of Keller and Heckman LLP

For more biotechnology, life sciences, food and drug law news, click here to visit the National Law Review.
© 2022 Keller and Heckman LLP

Phantom Participants with Real-World Ramifications: Clinical Drug Trial Data Falsification

As if medical-related disinformation was not pernicious enough, unscrupulous actors seek to enrich themselves from falsifying clinical drug trial data. A Florida-based clinical research firm project manager was sentenced to 30 months in prison because of his involvement in a conspiracy to falsify clinical drug trial data. Previously, the primary investigator, clinic owner, and another senior employee at Miami-based Tellus Clinical Research were charged with various counts of mail and wire fraud, money laundering, as well as making false statements to Food and Drug Administration (FDA) inspectors. A researcher or other employee of the medical clinic could have reported this conspiracy to the government and shared in 15-25% of the government’s recovery.

Pharmaceutical companies sponsor clinical research trials to gather data on the safety and efficacy of the drugs they manufacture. Prior to commencing research trials, pharmaceutical companies or “sponsors” must submit to the FDA their “study protocol,” which identifies who can participate, drug dosages and timing, and how the study’s performance will be measured. Sponsors engage contract research organizations (CROs) to perform the clinical trials, and the CRO must ensure compliance with the study protocol and FDA regulations. In this case, a clinical research firm contracted with pharmaceutical manufacturers to conduct trials related to an opioid dependency treatment, an irritable bowel syndrome drug, and diabetic nephropathy or kidney disease medication. The sponsors would reimburse the CRO a set amount per study participant and for some fees and Tellus would pay participants in accordance with the study protocol.

How the research firm gamed the system involved the eligibility requirements for the studies: each of these clinical trials required patients to meet certain requirements for participation. Instead of honestly recruiting patients with the diagnoses needed to participate in the program, the defendants enrolled people without applicable diagnoses and falsely claimed that study participants completed all the requirements in the study protocol, to garner more payments from the clinical trial sponsors. Several of the defendants enrolled friends and family members to bump up the research firm’s participation numbers, and other research firm employees went so far as to misappropriate personal information from third parties without their knowledge or consent. The co-conspirators also falsified clinical notes and medical records of these unwitting participants, claiming to have performed medical exams, drawn blood for testing, and made payments to participants. This elaborate conspiracy served to wrongfully enrich the research firm owner and senior management at the expense of pharmaceutical companies and ultimately patients.

Clinical research fraud is harmful to consumers. As the Assistant Commissioner for the FDA Office of Criminal Investigations (OCI) stated, “Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review.” Consumers could end up with unsafe medications due to fraudsters’ schemes.

A whistleblower could have reported this fraud to the FDA and ensured only drugs which perform well in clinical trials on real human beings make it to market. The Department of Justice needs whistleblowers to report fraud involving clinical drug trials.

© 2022 by Tycko & Zavareei LLP
For more content about the FDA and drug trials, visit the NLR Biotech, Food & Drug section.

“Key Legislative Limits to Nuisance-Based Attacks on the Right to Farm Live on.”

The North Carolina Chamber of Commerce, through its “Ag Allies: Landscape-Shifting Legal Developments” webinar on August 18, 2021, featured North Carolina’s Right to Farm Act (the “Act”), and appropriately so, as it has been at the forefront of North Carolina law and politics over the past few years.

Agribusiness is the backbone of the North Carolina economy, accounting for 17.5 percent of total jobs and having a total estimated economic impact of over 95 billion dollars in 2019 alone.  The evidence suggests that this impact has, despite recent challenges, only grown since then.  However, the agricultural operations that make up this market have a unique impact on the land and on their neighbors as noise, odor, storage, and dangerous equipment and structures are all unavoidable parts of agriculture.  These effects are compounded by the fact that many agricultural operations are located in rural areas in close proximity to residential zones.  This mix has long resulted in tensions, and those tensions can come to a head in lawsuits for nuisance.  “Nuisance” is a legal claim that allows for the recovery of damages for unreasonable interference with the use of one’s land.

This presented a particular problem for North Carolina agricultural operations, especially meat production.  These and other agricultural operations were deemed too valuable to be left subject to nuisance actions without some protections, and the North Carolina General Assembly sought to help by passing the Act in 1979.  Its stated objective was to decrease losses to the State of its agricultural and forestry resources by curtailing the situations in which agricultural and forestry operations could be deemed a nuisance.  The Act featured prominently in the recent mass nuisance litigation brought by over 500 plaintiffs against Murphy-Brown/Smithfield and the threat that future litigation like it presented for the State’s agribusiness industry.  Ultimately, the Act did not serve to protect the defendants from substantial jury verdicts, prompting the General Assembly to revisit and strengthen its protections.

The Act received boosts from the General Assembly through amendments in 2017 (capped recoverable damages to the fair market value of a plaintiff’s property) and in 2018 (narrowed who can bring a nuisance lawsuit against a farm and the time in which they can bring a nuisance suit).  But these boosts were not without opposition.  In 2019, three non-profit organizations filed suit challenging the 2017 and 2018 amendments.  The organizations argued that the amendments, on their face, violated North Carolina’s Constitution.  Facial constitutional challenges require proof that the law in question is unconstitutional in all of its applications.  A court cannot strike down the law if there is any “reasonable ground” to uphold it.  Finding the organizations had failed to state a claim, the trial court dismissed the organizations’ suit.  After their challenge was dismissed, the organizations appealed their case to the North Carolina Court of Appeals.  In upholding the trial court’s dismissal of the organizations’ suit, the Court of Appeals held that Plaintiffs’ had failed to state a legal claim and that the amendments in question do not violate North Carolina’s Constitution on their face.

Here are the highlights of the arguments presented in the appeal:

  • The organizations argued on appeal that the amendments violated private property rights under the Law of the Land Clause contained in the State’s Constitution, which prohibits a person from being deprived of life, liberty, or property except as allowed “by the law of the land.”  The Court disagreed.  It found the amendments to be reasonably necessary to promote a public benefit (through limiting nuisance claims against the State’s agricultural and forestry operations).  It also determined that the amendments’ interference on property use rights to be reasonable.
  • In response to the organizations’ argument that the amendments exceeded the authority of the State’s police power, the Court pointed to North Carolina’s historied interest in preserving and promoting agricultural and agricultural-related industries and found the amendments to be within the scope of the State’s police power.
  • The organizations also argued that the amendments violated the fundamental right to enjoy property.  In disposing of that argument, the Court noted the organizations had not alleged a taking by the government and reiterated its conclusions regarding the facial constitutionality of the amendments.
  • Another provision of the State’s Constitution at issue in the appeal was the prohibition on the General Assembly from enacting local, private, or special acts (as opposed to generally applicable laws) concerning the abatement of nuisances.  The organizations took the position that the amendments provide private protections to the hog industry.  The Court disagreed, noting that the amendments generally apply to the agricultural and forestry industries and are not limited to a particular subset of those industries or groups within them.
  • Finally, the organizations asserted that the 2017 amendment, which capped recoverable damages, violates the constitutional right to a trial by jury.  In rejecting their position, the Court cited the General Assembly’s power to modify the State’s common law by statute to define what remedies are recognized by law.  The Court then pointed to statutory caps on recoverable damages that the General Assembly had enacted for other civil torts.

In affirming the trial court’s dismissal of the organizations’ lawsuit, the Court delivered a “win” to the State’s agricultural and forestry industries by upholding the amendments’ limitations on nuisance claims.  Only time will tell whether the win it delivered will stay on the books.  The Court’s ruling was limited to considering the facial challenges the organizations had presented in attacking the amendments.  The Court was not tasked with evaluating whether the amendments would withstand an-as applied constitutional challenge, and it remains to be seen how the Court would rule if asked to consider an as-applied challenge.  Still, the ruling is an encouraging nod to the important role the agricultural and forestry industries play in North Carolina and the State’s interest in protecting those industries.

© 2022 Ward and Smith, P.A.. All Rights Reserved.
For more about North Carolina law, visit the NLR North Carolina jurisdiction page.

Senate Bill Would Amend FIFRA to Prohibit Dangerous Pesticides and Cancel Registrations of Organophosphates, Neonicotinoids, and Paraquat

On November 23, 2021, Senator Cory Booker (D-NJ) announced his intention to reintroduce the Protect America’s Children from Toxic Pesticides Act of 2021, that would amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) “to [protect fully] the safety of children and the environment, to remove dangerous pesticides from use, and for other purposes.” Similar legislation was introduced in the House (H.R. 7940) and Senate (S. 4406) in 2020, but the bills did not move out of committee.

Ending Indefinite Delays on Review of Dangerous Pesticides

The bill would amend FIFRA Section 2 to add a provision regarding registration review determination, defined as “the final decision to renew the registration of a pesticide product or active ingredient to authorize the use of the pesticide product or active ingredient” for an additional 15-year period from the date of the previous registration, reregistration, or registration review determination and in compliance with all applicable laws and regulations. Registration review determinations would not include any intermediate determination regarding the continued use of pesticide product or active ingredient.

The bill would allow an interested person to petition the U.S. Environmental Protection Agency (EPA) to designate an active ingredient or pesticide product as a dangerous pesticide, which would be defined as an active ingredient or pesticide product that may:

  • Be carcinogenic;
  • Be acutely toxic;
  • Be an endocrine disruptor;
  • Cause harm to a pregnant woman or a fetus; or
  • Cause neurological or developmental harm.

EPA would have 90 days after receiving the petition to make a finding as to whether the petition presents substantial scientific information indicating that the designation of the petitioned active ingredient or pesticide product as a dangerous pesticide may be warranted. If EPA fails to make a finding, the active ingredient or pesticide product would be deemed to be a dangerous pesticide. In making its finding, EPA “shall fully consider all relevant evidence,” including epidemiological studies or data; peer-reviewed literature; and data generated by a federal or state agency or an agency of a foreign government.

If EPA issues a finding that an active ingredient or pesticide product may warrant designation as a dangerous pesticide, the registration would be suspended immediately and remain suspended until EPA makes a registration review determination. The continued sale and use of existing stocks of a suspended active ingredient or pesticide product would be prohibited. If EPA fails to suspend the registration of an active ingredient or pesticide product that may warrant designation as a dangerous pesticide by no later than 60 days after any deadline described in this subsection, the registration of the active ingredient or pesticide product would be “immediately and permanently canceled” and the sale of existing stocks would be prohibited.

Emergency Review of Other Pesticides Banned in Other Nations

The bill would amend FIFRA Section 6 to require EPA to suspend immediately the registration of any active ingredient or pesticide product that is banned or otherwise prohibited from entering the market by the European Union (EU), one or more EU member states, or Canada. EPA would then complete an expedited review of the justification and rationale for the ban. Unless EPA determines that the decision was “clearly erroneous,” the suspended registration would be canceled not later than two years after the date of completion of the review. EPA “shall fully consider all relevant evidence,” including epidemiological studies or data; peer-reviewed literature; and data generated by a federal or state agency or an agency of a foreign government. In determining whether the ban was “clearly erroneous,” EPA would be prohibited from considering “any economic analysis of the benefits or costs of continuing to register the pesticide.” Before making a final determination, EPA would provide the draft determination for a comment period of not less than 90 days.

Ensuring Accountability in Conditional Registrations

The bill would amend FIFRA Section 3(c)(7) to provide registrants only two years to meet the terms and requirements of conditional registration. If a registrant fails to comply with the conditions by the earlier of the deadlines established by EPA or two years after the effective date of the conditional registration, EPA would cancel the conditional registration. Conditional registrations outstanding at the time the bill is enacted for which the registrant has not met the conditions would be canceled. The continued sale and use of existing stocks of a pesticide for which the conditional registration has been canceled would be prohibited.

Prohibition on the Sale or Use of Existing Stocks of Suspended or Canceled Pesticides

The bill would amend FIFRA Section 6(a) to prohibit the sale or use of existing stocks of a pesticide for which the registration is suspended or canceled, or vacated or set aside by judicial decree.

Amending Emergency Exemption Provisions

The bill would amend FIFRA Section 18 to limit emergency exemptions for the same active ingredient or pesticide product in the same location to two years in any ten-year period. EPA would no longer grant emergency exemptions to use an active ingredient or pesticide product that is not registered for any use or that is registered conditionally.

Adding Transparency for Inert Ingredients

The bill would amend FIFRA Section 2(n) to require that the ingredient statement include:

  • The name and percentage of each active ingredient in the pesticide product;
  • The name and percentage of each inert ingredient in the pesticide product;
  • If applicable, a statement that the pesticide product contains an inert ingredient determined by a state or federal agency, or the Administrator based on epidemiological data or peer-reviewed literature, to be likely:
    • To be carcinogenic;
    • To be an endocrine disruptor;
    • To be acutely toxic;
    • To cause harm to pregnant women or fetuses; or
    • To cause neurological or developmental harm.

The bill would amend FIFRA Section 3(c)(9) so that any required label or labeling must provide a complete list of inert ingredients.

Cancellation of Registration of Organophosphates

On the date of enactment, the bill would deem all organophosphate pesticides “to generally cause unreasonable adverse effects to humans,” and the registration of all uses of organophosphate pesticides would be “immediately and permanently canceled by operation of law and without further proceedings.” Tolerances and exemptions that allow the presence of an organophosphate or any pesticide chemical residue that results from organophosphate use in or on food would be revoked within six months of the date of enactment. The continued sale or use of existing stocks of organophosphate pesticides would be prohibited on the date of enactment. The bill would not allow any future organophosphate registrations and organophosphate pesticides would be ineligible for emergency use.

Cancellation of Registration of Neonicotinoids

On the date of enactment, the bill would deem all active ingredients and pesticide products containing one or more of the active ingredients imidacloprid, clothianidin, thiamethoxam, dinotefuran, acetamiprid, sulfoxaflor, and flupyradifurone (neonicotinoid pesticides) “to generally cause unreasonable adverse effects to the environment,” and the registration of all uses of neonicotinoid pesticides would be “immediately and permanently canceled by operation of law and without further proceedings.” Tolerances and exemptions that allow the presence of a neonicotinoid pesticide or any pesticide chemical residue that results from neonicotinoid pesticide use in or on food would be revoked within six months of the date of enactment. The continued sale or use of existing stocks of neonicotinoid pesticides would be prohibited on the date of enactment. The bill would not allow any future neonicotinoid registrations and neonicotinoid pesticides would be ineligible for emergency use.

Cancellation of Registration of Paraquat

On the date of enactment, the bill would deem paraquat “to generally cause unreasonable adverse effects to humans,” and the registration of all uses of paraquat would be “immediately and permanently canceled by operation of law and without further proceedings.” Tolerances and exemptions that allow the presence of paraquat or any pesticide chemical residue that results from paraquat use in or on food would be revoked within six months of the date of enactment. The continued sale or use of existing stocks of paraquat would be prohibited on the date of enactment. The bill would not allow any future paraquat registrations and paraquat would be ineligible for emergency use.

Empowering Communities to Protect Themselves from Pesticides

The bill would amend FIFRA Section 24 to extend the authority of a state to regulate the sale or use of any federally registered pesticide or device to “any political subdivision of a State.”

Protecting Farmworkers from Dangerous Pesticides

The bill would amend FIFRA Section 3(c)(9) to require that labels be printed in both English and Spanish. If a pesticide product is known to be used in agriculture by more than 500 individual persons or applicators who speak the same language other than English or Spanish, EPA will provide a translation of the label in that language on its website. The bill would amend FIFRA to include a section concerning farmworker safety. Employers of farmworkers would be required to report to EPA farmworker incidents, defined as exposure of a farmworker to an active ingredient, a pesticide product, a tank mixture of multiple pesticides, a metabolite, or a degradate that results in:

  • An illness or injury:
    • Requiring medical attention or hospitalization of the farmworker; or
    • That requires the farmworker to stop working temporarily or permanently;
  • A permanent disability or loss in function of the farmworker; or
  • Death of the farmworker.

The bill would require EPA to implement an online system to facilitate the reporting of farmworker incidents within 60 days of the bill’s enactment. The online system must allow for anonymous reporting to protect farmworkers from retaliation. Employers that fail to report a farmworker incident would be fined $1,000 per day beginning on the eighth day after the farmworker incident occurs. Employers that knowingly fail to report or that pressure or coerce a farmworker not to report would be liable for a criminal penalty of up to $100,000, six months in prison, or both. The bill calls for EPA to implement a reward system that provides a monetary award of not less than $25,000 per person per farmworker incident that leads to the identification of one or more employers that have failed to report a farmworker incident.

Within 15 days of receiving a report of a farmworker incident, EPA would transmit a report of the incident to the manufacturer of each involved pesticide product and the manufacturer of each involved active ingredient or ingredients. If a farmworker incident results in the death of a farmworker, the pesticide product or active ingredient that caused the death would be immediately suspended, pending a review. Pesticide product manufacturers who receive a farmworker incident report would have 60 days to provide EPA an assessment of the incident, including whether any changes to the label of the pesticide product or active ingredient are warranted at the time of the assessment to avoid future farmworker incidents. Active ingredient manufacturers who receive a report of a farmworker incident would have 60 days to provide to EPA an assessment of the farmworker incident, including whether any changes to the pesticide product or active ingredient are warranted at the time of the assessment to avoid future farmworker incidents.

No later than the earlier of 90 days after receiving an assessment from a pesticide product or active ingredient manufacturer or 180 days after the occurrence of the farmworker incident, EPA will make a draft determination as to whether a change in the label of an involved pesticide product is warranted. EPA will publish its draft determination in the Federal Register for a 30-day comment period. No later than 30 days after the close of the public comment period, EPA will make a final determination as to whether the label should be changed and publish its decision in the Federal Register.

If EPA makes a final determination that the label of the applicable product must be changed and the manufacturer of the pesticide product or active ingredient fails to do so, the pesticide product or active ingredient “shall be immediately and permanently canceled by operation of law and without further proceedings.” If a pesticide product or active ingredient is responsible for ten or more farmworker incidents of any type, or three or more incidents resulting in death, and the pesticide product or active ingredient has not received a final determination regarding a registration review during the preceding 15-year period, EPA will “immediately suspend the pesticide product or active ingredient until a final determination is made regarding the registration review of the pesticide.”

Authority to Bring Civil Action

The bill would amend FIFRA Section 16 to allow any person to bring a civil action where there is an alleged failure of EPA to comply with any of its provisions. The U.S. District Courts would have exclusive jurisdiction over such actions.

Employee Protection

The bill would amend FIFRA to add a section regarding employee protection. Employers would be prohibited from discharging or discriminating against an employee because the employee has commenced or is about to commence a proceeding under the Act, has testified in a proceeding, or has assisted or participated in a proceeding. Employees would have 30 days from the date of the alleged violation to file a complaint with the Secretary of Labor and the Secretary would have 30 days to conduct an investigation.

Commentary

This bill is unlikely to become law any time soon. This legislation, or anything like it in terms of its presumption that pesticides approved by EPA under current law are fundamentally flawed, would present a radical change to current EPA authority and procedures. Advocates of such change believe otherwise, and point to the fact that FIFRA has not been amended for 25 years. Whether this is sufficient to garner broad support of national environmental and consumer advocacy groups is unclear. Assuming it gains the support of at least a handful of Democrats in the Senate, along with a likely House companion bill, this legislation lays the groundwork for advocating eventual changes to FIFRA. This approach takes a page from the Toxic Substances Control Act (TSCA) reform playbook. Certain Members of Congress and TSCA stakeholders established policy positions for reform five or more years before reauthorization occurred. Similar to TSCA, the legislation is premised on the view that FIFRA is fundamentally flawed, a widely held view with TSCA reform. This view is not widely shared with regard to FIFRA, however. Critics of this proposed legislation will argue that EPA has been effective at implementing FIFRA driven by the requirements of the 1996 Food Quality Protection Act amendments, following a rigorous scientific process with various required safety factors to determine that pesticides used on food meet a “reasonable certainty of no harm” standard. In that view, this bill may be a solution in search of a problem. If this legislation is indeed used as a starting point for reform, there will be many more years before any common ground is found — and common ground likely will be essential for any kind of meaningful FIFRA “modernization.”

©2021 Bergeson & Campbell, P.C.
Article by Bergeson & Campbell, P.C.‘s Government Regulation practice group.
For more articles about toxic substance legislation, visit the NLR Biotech, Food & Drug section.

Justice Thomas Criticizes Federal Marijuana Policy, Questions Whether Prohibition Remains Necessary or Proper

U.S. Supreme Court Justice Clarence Thomas has issued an unexpected statement questioning whether the federal government’s continuing prohibition on marijuana is necessary or proper. His statement was made in conjunction with the denial of a writ of certiorari in the matter of Standing Akimbo LLC v. United States, which asked the court to address whether a medical marijuana dispensary could properly deduct ordinary business expenses in violation of section 280E of the federal tax code.

In his statement, Justice Thomas bluntly acknowledges that the reasoning behind the U.S. Supreme Court’s 2005 decision in Gonzales v. Raich ‒ which held that the power of Congress to regulate interstate commerce authorizes it to prohibit the local cultivation and use of marijuana ‒ has been “greatly undermined” by federal policies over the past 16 years. He characterized the federal government’s current approach as a contradictory and unstable “half-in, the half-out regime” that “strains basic principles of federalism and conceals traps for the unwary.”

Examples of the federal government’s mixed signals include the 2013 Cole Memorandum issued by the Department of Justice (DOJ) and Congress’s prohibition in place since 2015 that restricts the DOJ from spending funds to prevent states from implementing their own medical marijuana laws. These actions by the federal government have “broad ramifications” according to Justice Thomas, given that 36 states allow medical marijuana use and 18 of those states also allow adult use of cannabis.

Behind the Statement

In this environment, Justice Thomas rhetorically asks whether it is now reasonable for an ordinary person to think that the federal government “has retreated from its once absolute ban on marijuana,” and for cannabis business owners to think “that their intrastate marijuana operations will be treated like any other enterprise that is legal under state law.” He points out, however, that “legality under state law and the absence of federal criminal enforcement do not ensure equal treatment.”

Justice Thomas clearly is bothered by the strict enforcement of the federal tax code to the detriment of state-legal businesses and the simultaneous absence of federal enforcement in areas such as cultivation and distribution of marijuana that is legal under state law. He describes the federal government’s willingness to look the other way as “more episodic than coherent.” Justice Thomas identifies other harmful results caused by this schizophrenic federal approach, including federal prohibitions on financial institutions providing services to the cannabis industry, which has resulted in significant public safety issues, and civil lawsuits brought against individuals and businesses under the Racketeer Influenced and Corrupt Organizations (RICO) Act.

Justice Thomas concludes by noting that the federal government’s current approach to marijuana bears little resemblance to the uniform policy of prohibition upon which a closely divided Supreme Court based its decision in Raich 16 years ago. He warns that by allowing states to act as laboratories that try novel social and economic experiments, the federal government may no longer have authority to intrude on the states’ core police powers. “A prohibition on intrastate use or cultivation of marijuana may no longer be necessary or proper to support the Federal Government’s piecemeal approach.”

Marijuana Policy

Though Justice Thomas’ statement has no formal precedential value, it nevertheless represents the most explicit statement yet from a sitting – and conservative – Supreme Court Justice that questions the rationality of current federal marijuana policy. For court watchers, this represents a seismic shift on marijuana policy within the highest court of the land. Justice Thomas’s bold defense of federalism also should prove influential to members of the other branches of government who remain cautious on broad marijuana reform.

© 2021 Wilson Elser
For more articles on marijuana policies, visit the NLR Biotech, Food, Drug section.

Brain Interfaces Bring Us Closer to a Life of the Mind

As we learn more about the human brain, we can begin to wonder if the rest of the body is necessary. Improved brain-machine interfaces are showing us how much can be accomplished by tapping directly into our thoughts.

While brainwaves can be read and interpreted through electrodes placed on the scalp, this method lacks the spatial detail of implanted electrodes. The recent action in practical thought-to-action science has taken place with direct physical connections.

For example, last summer brain researchers in Australia and the U.S. showed promising results by mounting electrodes on an expandable stent and threading it through blood vessels that lead to the brain. The sensors in the stent could sense when people’s brains signaled an intention to move, the sensors wirelessly sent this information to a computer which interpreted the signals. The interface allowed ALS patients to combine use of an eye tracker to move a cursor plus a thought-controlled click, making their communication faster and easier without surgery to implant electrodes.

Electrode-based therapy is still the gold standard, and Elon Musk’s company Neuralink has announced testing of a wireless implant that could provide a broadly useful direct interface between human brains and computers. Neuralink’s small implants include more than 1000 electrodes designed to send wireless signals to anything digital, like prosthetic hands or automotive controls.  According to a story in Wired last year, “The reason that excites neuroscientists is that right now their tools are relatively crude. The standard is the “Utah array,” a single chip with 64 electrodes on it. Just putting it in or taking it out can damage the tissue around it, and it’s not good at isolating single neurons or covering a large area … At the Neuralink presentation, Musk said that his prototype included sensors for motion, temperature, and pressure and 1,024 thin, flexible wires to pick up the electrical signals neurons put out while they’re neuron-ing.” Currently, this array can be wirelessly connected to a computer to learn to associate outbound signals with specific intentions.

Computer-aided brain-driven prosthetics have been improving by adding an element of touch feedback to the process.  Until recently, a person using a brain-computer interface would use visual cues to pick up objects with prosthetic arms. However, according to this week’s Ars Technica, researchers working with people paralyzed from the neck down added tactile feedback to the systems, allowing the test participants to drastically improve performance. The biggest improvements involved tasks requiring grasping an object. “While we may not always be consciously aware of them, touch and pressure play a major role in everything we do with our hands. By targeting the right area of the brain, the implant takes advantage of the systems the brain already has for managing this kind of sensory input.” As we understand more about these regions of the brain, the Brain/computer/ prosthetic interaction becomes easier and more efficient.

One of the most impressive recent achievements arrives this month out of Stanford and Brown Universities allowing a paralyzed person to type out about 90 characters per minute by imagining that he was writing the characters out by hand. This drastically beats the efficiency of earlier efforts that involve virtual keyboards and cursors. As noted by Wired, “there are other possible routes to getting characters out of the brain and onto the page. Somewhere in our writing thought process, we form the intention of using a specific character, and using an implant to track this intention could potentially work. . . Downstream of that intention, a decision is transmitted to the motor cortex, where it’s translated into actions. Again, there’s an intent stage, where the motor cortex determines it will form the letter (by typing or writing, for example), which is then translated into the specific muscle motions required to perform the action. These processes are much better understood, and they’re what the research team targeted for their new work.”

By placing implants in the premotor cortex, researchers were able to capture the base intentions of the thinker at an earlier, clearer stage than simply the intentions of movement to effectuate the underlying ideas. Conceptually, this is an interesting advance. We had been focused on tapping into the same neurons that allow a person to type a message, but we are finding that, if we can catch the thought before the brain has converted it into a specific physical action, then we can skip a step in the brain’s process and make the brain-computer interface much more efficient. It makes one wonder whether stripping the process back even further, capturing thoughts of entire words, rather than letters, would create further efficiencies.  Right now we can turn intentions toward physical action into the actions themselves.  But this is an advance toward capturing the initial desire before it can be processed further by the action portions of the brain.

As the Wired article stated, “the system shows a very significant speed boost compared to previous implant-driven systems, and the accuracy is quite good. The system also has the potential to be similar to touch-typing, in that a user doesn’t have to actually visually focus on letter production, allowing more normal interactions with the user’s surroundings.” So we proceed closer to the holy grail of brain-computer interface: allowing a person’s brain to drive direct actions without involving the rest of the body at all.

This would be a clear victory for those with bodily impairments, but it also would be an excellent step toward systems that allowed us to manage all parts of our world without needed a body to manipulate our environment.  We could speak to our home temperature control system or direct our automobile without touching anything. Arriving in the midst of a pandemic, the possibility of touchless control of our environments has a special allure. Maybe someday in the not-so-distant future, all we will need is an operational brain to be a fully functioning human.

Copyright © 2021 Womble Bond Dickinson (US) LLP All Rights Reserved.

ARTICLE BY Theodore F. Claypoole of Womble Bond Dickinson (US) LLP

For more articles on the human brain, visit the NLRBiotech, Food, Drug section

Voters in Five States Approve Marijuana Ballot Initiatives on Election Day

Voters in Arizona, Mississippi, Montana, New Jersey, and South Dakota approved laws to legalize marijuana on Election Day 2020. Recreational marijuana was approved in Arizona, Montana, and New Jersey, while Mississippi voters approved medical marijuana. South Dakota voters approved both medical and recreational marijuana ballot initiatives.

Medical Marijuana

  1. Mississippi – Mississippi Ballot Measure 1 passed, with 68% voting “yes” and 32% voting “no.” Ballot Measure 1 asked voters to generally cast a vote for “either measure” Initiative 65 or Alternative 65A, or against both measures. Voters who cast a vote for “either measure” were then required to cast an additional vote for their preferred measure. Mississippi voters passed Initiative 65 with 74% voting for it and 23% voting for Alternative 65A.*

Initiative 65 allows the medical use of marijuana by patients who suffer from qualifying medical conditions. Qualified medical marijuana patients may possess up to 2.5 ounces of medical marijuana. The new law does not permit a qualifying patient to be “subject to criminal or civil sanctions for the use of medical marijuana.” However, it does not require “accommodation for the use of medical marijuana or require any on-site use of medical marijuana” in any place of employment. It also does not affect any “existing drug testing laws, regulations, or rules.”

The Mississippi State Department of Health has the authority to implement, administer, and enforce the law. It is required to issue final rules and regulations regarding medical marijuana by July 1, 2021. The Department must begin issuing medical marijuana identification cards and treatment center licenses no later than August 15, 2021.

  1. South Dakota – South Dakota’s Initiated Measure 26 passed, with 69% voting “yes” and 31% voting “no.” The new law allows the medical use of marijuana by patients who suffer from a debilitating medical condition. Medical marijuana card holders may possess up to three ounces of marijuana and cultivate marijuana plants. The law goes into effect July 1, 2021, but it may take up to a year before medical marijuana is available in the state.

Under the new law, medical marijuana cardholders are entitled to “all the same rights under state and local laws” as the person would be afforded if they were prescribed a pharmaceutical medication as it pertains to: (1) any interaction with a person’s employer; (2) drug testing by a person’s employer; and (3) drug testing required by any state or local law, agency, or government official.

The new law requires the South Dakota Department of Health to issue regulations regarding medical marijuana within 120 days after the law goes into effect (October 29, 2021) and to begin issuing registry identification cards to qualifying patients within 140 days after the law goes into effect (November 18, 2021).

The new law does not apply to employers to the extent it would conflict with the employer’s obligations under federal law or regulation or if it would disqualify an employer from a monetary or licensing-related benefit under federal law or regulation.

Although employers may discipline employees for ingesting marijuana in the workplace or for working while under the influence of marijuana, employers may not consider a qualifying patient to be under the influence of marijuana solely because of the presence of metabolites or components of marijuana that appear in “insufficient concentration to cause impairment.” Employers in South Dakota should take note of this language because there is no universally accepted concentration of marijuana that proves “impairment.”

Recreational Marijuana

  1. Arizona – The Smart and Safe Arizona Act passed with nearly 60% voting “yes” and 40% voting “no.” Under the Smart and Safe Arizona Act, individuals 21 years of age or older may lawfully use and purchase less than one ounce of marijuana (except, not more than five grams may be in the form of marijuana concentrate) and may cultivate up to six marijuana plants for personal use at the individuals’ primary residence (subject to certain restrictions). The new law does not include a delayed effective date, but it will likely be several months before Arizonans can purchase recreational marijuana.

The new law requires the Arizona Department of Health Services to begin accepting applications for marijuana establishment licenses from “early applicants” beginning January 19, 2021 through March 9, 2021. Licenses will be issued to qualified applicants within 60 days of receiving an application.

The new law does not restrict the rights of employers to “maintain a drug-and-alcohol free workplace” or prevent employers from having workplace policies “restricting the use of marijuana by employees or prospective employees.” It also does not require employers to “allow or accommodate the use, consumption, possession, transfer, display, transportation sale or cultivation of marijuana in a place of employment,” nor does it restrict employers from prohibiting or regulating marijuana use that occurs on or in their properties.

Arizona passed the Arizona Medical Marijuana Act in 2010, prohibiting employers from discriminating against medical marijuana patients. The recreational marijuana law expressly states that is it not intended to limit any privilege or right of a qualifying patient under the Arizona Medical Marijuana Act.

  1. Montana – Montana’s Initiative 90 and Constitutional Initiative 118 both passed with approximately 57% voting “yes” and 43% voting “no” for Initiative 90.  Effective January 1, 2021, individuals age 21 or older may possess, use, or transport one ounce or less of marijuana, and grow up to four mature marijuana plans and four seedlings on the grounds of a private residence. The Montana Constitution provides that a person 18 years of age or older is an adult for all purposes, except that a different legal age may be established for purchasing, consuming, or possessing alcoholic beverages. Effective October 1, 2021, the Montana Constitution will similarly permit a different legal age (i.e., 21 years of age or older) to be established for the purchase, consumption, or possession of marijuana.

Certain provisions of the new law go into effect on October 1, 2021, which is the deadline for the Department of Revenue to issue rules and regulations related to licensure of adult-use marijuana providers and dispensaries. The Department must begin accepting applications from dispensaries, providers, and manufacturers on or before January 1, 2022. However, for the first 12 months, the Department will only accept such applications from providers and dispensaries licensed under Montana’s medical marijuana statute.

The new law does not impose restrictions on employers. It states that is may not be construed to: (1) require an employer to permit or accommodate recreational marijuana use (or any other conduct permitted by the law) in any workplace or on the employer’s property; (2) prohibit an employer from disciplining an employee for violation of a workplace drug policy or for working while intoxicated by marijuana; (3) prevent an employer from declining to hire, discharging, or otherwise taking adverse action against an individual with respect to hire, tenure, terms, conditions, or privileges of employment because of the individual’s violation of a workplace drug policy or intoxication by marijuana while working.

Montana has had a medical marijuana law since 2004.

  1. New Jersey – New Jersey’s Question 1 passed with 67% voting “yes” and only 33% voting “no.” Effective January 1, 2021, the New Jersey Constitution will be amended to legalize recreational use of marijuana for adults ages 21 and older. The constitutional amendment provides for the Cannabis Regulatory Commission to regulate recreational marijuana and subjects all retail sales of recreational marijuana products to state sales tax.

The Cannabis Regulatory Commission and New Jersey lawmakers will address the regulatory issues that will determine the amount individuals can possess legally, the requirements for operating dispensaries for sale of cannabis, and taxation by state and local authorities. This process is expected to take up to approximately one year.

New Jersey has approved the use of medical marijuana since 2013. Under 2019 amendments to the Jake Honig Compassionate Use Act, employers are not permitted to discriminate against those who use cannabis for medical reasons.

  1. South Dakota – South Dakota’s Constitutional Amendment A passed with 53% voting “yes” and 47% voting “no.” Effective July 1, 2021, the new law permits individuals 21 years of age or older to possess and use one ounce or less of marijuana and to grow up to six marijuana plants on the grounds of a private residence.

No later than April 1, 2022, the South Dakota Department of Revenue is required to issue rules and regulations related to the commercial sale, cultivation, and testing of marijuana. The new law also directs the legislature to pass laws regulating the cultivation, processing, and sale of hemp and medical marijuana by April 1, 2022.

The new law does not require employers to permit or accommodate conduct authorized by it. It also does not affect an employer’s ability to restrict the use of marijuana by employees.

Next Steps

Employers should review their drug and alcohol policies – especially drug and alcohol testing policies – for compliance with applicable state laws.

While marijuana remains a Schedule I drug under the federal Controlled Substances Act, the trend in the courts over the last three years is to disregard marijuana’s status under federal law and to enforce state laws instead (with the exception of federally regulated employees such as those regulated by the U.S. Department of Transportation).

Employers must be familiar with the marijuana laws in the states where they operate before taking employment actions against those who use marijuana.

Jackson Lewis P.C. © 2020
For more articles on marijuana legalization, visit the National Law Review Biotech, Food, Drug section.

Japan Announces Process for Adding “Existing Substances” to PL

The Japanese Ministry of Health, Labour and Welfare (MHLW) has published a request for nominations for “existing substances” be included on the Positive List (PL) of “synthetic resins” for food-contact materials (FCMs) with corresponding submission forms. “Existing substances” include those marketed or used for food-contact utensils, containers and packages (UCP) in Japan prior to the effective date for the PL (i.e., June 1, 2020).  The deadline for filing such nominations is October 30, 2020.

For additional information on the PL system for “synthetic resins” that was MHLW published on April 28, 2020, see the PackagingLaw.com article, A Move to Mandatory: Japan Finalizes its Positive List for “Synthetic Resins”.)

As a component of MHLW’s process for nominating “existing substances,” the Ministry requires that companies include an attestation that such substances were marketed or used in food-contact UCP prior to June 1, 2020.  Submission forms are provided for each of the following materials:

  1. Base polymers (Plastics and Coatings);
  2. Minor monomers polymerized with base polymers; and
  3. Additives (including coating agents).

Additional information, including links to application form and submission instructions, is available here.

© 2020 Keller and Heckman LLP
For more articles on packaging law, visit the National Law Review Biotech, Food, Drug section.