Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

 
October 26, 2022
12:00 p.m. - 1:00 p.m. (EDT)

The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to outbreaks to preventing them. FSMA consists of seven major rules, each meant to improve the safety and sustainability of the nation’s food supply, regardless of its country of origin, and identify clear, specific actions to achieve enhanced food safety.

This webinar will focus on FSMA and discuss the incremental progress the law has achieved in assuring food safety.  In addition, the webinar will include a look at the New Era of Smarter Food Safety, a 2020 initiative meant to enhance FSMA, and improve food safety outcomes by leveraging technology. Register now to join Thomas J. Dunn, Karin F. Baron, and Lynn L. Bergeson for the Bergeson & Campbell, P.C. (B&C®) sponsored webinar, “Food Safety Issues in the United States.”
 
Topics Covered:

  • Review of FSMA
  • Discussion on food safety over the past decade
  • New Era of Smarter Food Safety

Speakers Include:
 
Thomas J. Dunn, Managing Director, Flexpacknology llc, has been an active practitioner in the flexible packaging industry since 1979, with significant responsibilities as an associate with the Flexible Packaging Association and Printpack Inc. He supplemented his professional accomplishments with leadership roles in industry associations (FPA, RadTech NA) and professional societies (TAPPI, SPE, IFT). Dunn has authored peer-reviewed papers, served on U.S. Department of Agriculture (USDA) grant proposal review panels, and contributed content to major technical publications in the industry.
 
Karin F. Baron, MSPH, Senior Regulatory Consultant, B&C, has more than 20 years’ experience developing, implementing, and managing complex chemical regulatory compliance matters for some of the largest industrial and specialty chemical companies in the world. Her primary areas of practice include hazard and risk assessment and communication, industrial hygiene and environmental health and safety (EHS) programs, FDA regulations pertaining to food contact materials, and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), including compliant safety data sheets (SDS).
 
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

REGISTER NOW


 

By Lisa M. Campbell and Lisa R. Burchi

 

On June 3, 2015, the General Court of the European Court of Justice issued a ruling in Luxembourg Pamol (Cyprus) Ltd. and Luxembourg Industries Ltd. (Luxembourg) vs. European Commission regarding the publication of information by the European Food Safety Authority (EFSA) in its peer reviewed draft assessment report of potassium phosphonate that Luxembourg claimed as confidential. 

 

The case was brought by Luxembourg after EFSA rejected Luxembourg’s claim that certain information be treated as confidential, and not included in the EFSA’s peer reviewed draft assessment report on potassium phosphonate.  The European Commission agreed with EFSA.  EFSA stated that under the Plant Protection Product Regulation No. 1107/2009 (and Article 14 of its predecessor Directive 91/414) and European Union (EU) Regulation No. 199/2011 setting forth procedures for reviewing certain active substances including EFSA’s peer review of draft assessment reports, confidential status cannot be extended to:  information on the composition of the substance at issue; the analysis method for that substance; the analysis methods for residues; the scientific information on the basis for the evaluation and risk assessments performed; and information already in the public domain.  After EFSA refused the confidentiality request, Luxembourg sought reconsideration by the European Commission, who found that the sanitization principles applied by EFSA “reflect a common understanding of EFSA and the Commission of the provisions of Article 14 of Directive 91/414/EEC.”

 

In its decision, the Court dismissed the lawsuit because Luxembourg brought the case against the European Commission when the appropriate party was EFSA.  The Court agreed with the Commission that the decision at issue was an act of and attributable to EFSA, stating that while the Commission “indicated to EFSA the legislation and principles applicable to the requests for confidentiality at issue, the fact remains that the Commission did not apply that legislation and those principles in order to determine those claims itself.”  The Court stated that Article 7(2) of Regulation No. 188/2011 grants EFSA to make confidentiality determinations “in its own right” and that Articles 12(1) and 60 of Regulation No. 1107/2009 show that EFSA is “competent to adopt a decision on a request for confidentiality.” 

 

While this decision does not provide certainty or guidance to industry regarding the type of information that can be claimed, and accepted, as confidential, it does add to a growing pool of cases addressing complex issues regarding the confidential treatment of information related to agrochemicals.  This includes, but is not limited to, the ongoing case following the European Court of Justice’s October 8, 2013, ruling that the European Commission erred by refusing access to documentation about the pesticide glyphosate.


 

By Lynn L. Bergeson and Timothy D. Backstrom

On December 16, 2014, the Center for Food Safety (CFS) and its affiliate the International Center for Technology Assessment (ICTA), along with a coalition of other non-governmental organizations, brought suit in the U.S. District Court for the District of Columbia. The suit concerns a May 1, 2008, petition by these organizations requesting that the U.S. Environmental Protection Agency (EPA) take regulatory action concerning nanoscale silver (nanosilver) products, including classifying nanosilver as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since receiving the CFS/ICTA petition, EPA has taken a number of incremental steps to regulate nanosilver. After inviting comment concerning the petition, EPA referred scientific issues concerning risks from and exposure to nanosilver to the FIFRA Scientific Advisory Panel (SAP), announced that it would treat nanoscale pesticides (including nanosilver) as a separate pesticidal active ingredient, established new registration requirements for several specific nanosilver products, and initiated the registration review process for registered nanosilver products.

Notwithstanding these actions, EPA has not formally responded to the 2008 CFS/ICTA petition, and the petitioners have characterized the steps taken by EPA to date as “toothless.” Rather than contesting the suit, EPA may seek an agreement requiring EPA to respond formally to the petition by a specified date. Perhaps EPA will characterize the regulatory actions taken to date as a partial grant of the petition. On the other hand, many of the nearly 400 nanosilver products that CFS/ICTA claim EPA should regulate under FIFRA have no pesticidal claims or purpose or are being sold and distributed outside of the U.S. With respect to these products, EPA will likely respond that it has no authority to provide the relief sought by the petitioners.