ASTA 2021 Regulatory Workshop

 

 

 

 

 

 

 

The ASTA 2021 Regulatory Workshop is scheduled to air live on August 4, 2021, 10:00am-4:30pm ET.

Registration is open to ASTA members and non-members. Below is the full agenda with session descriptions, speakers, sponsors, and more. Don’t miss this informative and engaging virtual event.

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Please make sure you login as an ASTA member to receive the member rate. Non-members, contact ASTA for a login user name to register online. Only confirmed registrations will receive online access. Questions? Please call (202) 331-2460 or send inquiries to [email protected] for assistance.

*  Schedule is tentative and subject to change

Wednesday, August 4, 2021

10:00am-4:30pm ET – Agenda

10:00-10:05am ET
Welcome and Introductions

ASTA President, Larry Lichter

10:05-10:55am ET
New Developments in U.S. Allergen Policy and Regulations
This session includes an update on the latest developments in U.S. allergen policy. It will be followed by a live Q&A with Alaura Ervin of Senator Scott’s office and Joe Baumert of FAARP. FDA will not be available for live Q&A during this session, but ASTA will follow up on questions for the agency after the event.  

Passage and Implementation of FASTER Act: Adding Sesame as a Major Allergen


The Food Allergy Safety, Treatment, Education and Research (FASTER) Act of 2021 represents the first law to designate a new major food allergen since 2004. Under the FASTER Act, sesame is now a major food allergen. Hear from the Senator’s office that sponsored the legislation, including the impetus behind it and their thoughts on future allergen designation.

About the Speaker: Alaura Ervin, Office of Sen. Tim Scott (R-SC)

Update on Food and Drug Administration (FDA) Compliance and Enforcement Activities


Allergens continue to be the leading cause of FDA recalls. In response to this ongoing issue, FDA has been increasing its enforcement of allergen mislabeling over the last year by sending warning letters to food facilities. Hear from FDA about allergen priorities and how to avoid enforcement action.

About the Speaker: Stefano Luccioli

Future of Allergen Regulations


A leading allergen expert from the Food Allergy Research & Resource Program (FARRP) will present on the efforts and implications of an FAO/WHO expert consultation on food allergen risk assessment, including the expert panel’s recommendations on evaluation of priority allergens.

About the Speaker: Joseph L. Baumert, Ph.D., Professor of Food Science, Director – Food Allergy Research & Resource Program, University of Nebraska-Lincoln
Joe L. Baumert, Ph.D., currently serves as a Professor in the Department of Food Science & Technology and Director of the Food Allergy Research & Resource Program (FARRP) at the University of Nebraska. Dr. Baumert maintains active national and international research and extension programs. His research interests include identification and characterization of novel food allergens, development and improvement of analytical methods for detection of allergenic food proteins, and development of quantitative risk assessment models for food allergens. Extension activities include outreach and training for the food industry on allergen control solutions and processing plant sanitation, expert consultation to help minimize the risk of allergen cross-contact, and quantitative risk assessment consultation.

10:55-11:00am ET – Break

11:00am-12:30pm ET
A Global View on Reducing Heavy Metal Limits in Spices
This session will provide updates on state, federal, and global regulatory activity related to heavy metals in spices, followed by a live Q&A with all of the speakers. 

New Limits on Heavy Metals in Spices in New York State


The New York State Department of Agriculture recently announced updates to recall action limits on heavy metals in spices that will go into effect 18-months after this research is published in the Journal of Regulatory Science. Hear the background and basis for this determination by the New York State Department of Agriculture & Markets.

About the Speaker: Jennifer Trodden MS, CSP, Deputy Commissioner,  NY State Department of Agriculture
Jennifer is a Deputy Commissioner with the New York State Department of Agriculture and Markets. As Deputy Commissioner, Jennifer oversees three of the Department’s largest Divisions – the Divisions of Food Safety Inspection, Milk Control & Dairy Services, and the NYS Food Laboratory.

Jennifer has an extensive compliance and policy background that closely aligns with the Department’s work on the newly launched New York State Grown & Certified program and work performed at the Department’s Food Laboratory.   New York plays a prominent food safety role at the national level and as the top key food safety advisor for the department, Jennifer is integrally involved in issues of prominence for New York State. Jennifer serves on the NASDA – FDA Implementation Group for the Produce Safety Rule and, because of her Deputy Commissioner’s role, is also intimately aware of the policy and programmatic issues affecting the broad areas of food safety across the United States.

Prior to joining the Department Jennifer worked as the New York Health, Safety, and Environment Manager at PepsiCo, spent more than 10 years at the State University of New York’s Poly-Technical Institute as their Health, Safety and Environment Manager, was an environmental & safety consultant to General Electric, was the Quality Control Manager at SCILAB, and was a health inspector at the Department of Health in Dublin, Ireland.

Jennifer has been executing public policy for over 20 years; holds a master’s degree in Environmental Health from Trinity College in Dublin, Ireland, is a Certified Safety Professional and is an advisory member on numerous boards across New York State. Jennifer is also a member of the American Society of Safety Engineers, the Board of Safety Professionals, and the State Academy for Public Administrators.

California Prop 65: Breaking Developments Involving Heavy Metals in Spices


This session will explore the latest updates on California Proposition 65 litigation and other matters related to heavy metals in spices: recent court decisions, the status of pending litigation, and more. 

About the Speaker: Gary M Roberts, Partner, Dentons US LLP
A member of Dentons’ Litigation and Dispute Resolution practice and Environmental and Natural Resources practice, Gary Roberts has extensive complex litigation, administrative advocacy, and counseling experience regarding environmental law, product liability, and false advertising matters. His experience includes state and federal litigation, as well as administrative advocacy before a wide range of state and federal regulators.

Gary consistently has represented Fortune 500 companies and their trade associations in California Proposition 65 litigation matters for more than 30 years. His representative litigation matters include cases involving a wide variety of food products (including spices), hardware, plumbing products, health care products, clothing, consumer goods, furniture, adhesive products, over-the-counter and prescription medicines, nutritional products, children’s products, various plastics, air emissions issues, and water discharge issues. In addition to litigation under Proposition 65, Gary has defended related failure to warn and failure to disclose allegations of individual plaintiffs and proposed class representatives under California’s Unfair Business Practices Act and California’s Consumers Legal Remedies Act.

The state of California appointed Gary to a working group tasked with revising Proposition 65 warning regulations. He has successfully advocated amendments to Proposition 65 regulations on a number of occasions. Gary maintains strong relationships with the public officials who implement and enforce Proposition 65. Gary is active in the Chamber of Commerce and other efforts regarding revisions to Proposition 65 and its regulations.

Gary graduated from Stanford Law School and obtained his undergraduate degree from Princeton University. He clerked for David R. Thompson, US Ninth Circuit Court of Appeals.
 

FDA’s “Closer to Zero” and the Future of Federal Heavy Metal Regulation


This session will explore the latest updates on California Proposition 65 litigation and other matters related to heavy metals in spices: recent court decisions, the status of pending litigation, and more. Get an update on the recent flurry of activity surrounding heavy metals in foods at the federal level – from congressional activity to FDA’s recently announced “Closer to Zero” initiative. This presentation will provide an overview of what to expect in the coming years on heavy metal regulation and how to prepare to navigate these dynamic developments.

About the Speaker: Elizabeth Fawell, Partner, Hogan Lovells
Successfully navigating the detailed and often complex regulatory issues confronting the food industry, Elizabeth Fawell helps companies understand both the rules and various risks involved to make the most informed and strategic decisions.

Elizabeth has worked with every segment of the food industry, including manufacturers, distributors, retailers, restaurants, and foodservice operators, as well as their trade associations.

Her work on behalf of food industry clients with the Food Safety Modernization Act (FSMA) since its inception and her understanding of Hazard Analysis Critical Control Point (HACCP) systems provides her with the experience and perspective needed to counsel clients on how to comply with new requirements under the law. Elizabeth is also a Preventive Controls Qualified Individual (PCQI) and has completed the FSPCA PCQI training.

Elizabeth understands how laws, regulations, and guidance documents are developed, interpreted, and enforced. Her extensive knowledge enables clients to prevent or respond to enforcement actions such as Warning Letters, Import Alerts, and agency investigations. She helps clients in determining whether an RFR report is necessary and whether a recall is warranted. If so, she helps manage the recall to minimize business impacts.

Elizabeth provides real-time advice during factory inspections, helps clients prepare 483 responses, and drafts inspection manuals. She assists clients in lawfully and creatively promoting their products; such as the development of labels, claims, and website and promotional campaigns. Elizabeth also supports clients in advertising disputes and with responses to FTC and Attorney General investigations.

Elizabeth helps clients stay informed of and ahead of public policy issues and develops strategies for effective advocacy before regulators. She also counsels clients on compliance with Consumer Product Safety Commission (CPSC) safety standards, testing and certification requirements, and reporting obligations.

Elizabeth is also a member of the Food and Dietary Supplements Committee of the Food and Drug Law Institute.

Update on Proposed Codex Limits for Lead in Spices


This session will provide an update on developments at the Codex Committee on Contaminants in Foods (CCCF) concerning lead in spices. A summary of recent activity will be discussed, including plans for ongoing work by the committee on lead in spices.

About the Speaker: Eileen Abt, Sc.D.  Office of Food Safety, Center for Food Safety and Applied Nutrition of the U.S. Food and Drug Administration (FDA) 

Eileen Abt, Sc.D. is a senior technical expert for the U.S. delegation to the Codex Committee on Contaminants in Foods. She is a Chemist within the Plant Products Branch within the Office of Food Safety, Center for Food Safety and Applied Nutrition of the U.S. Food and Drug Administration (FDA) where she is engaged on scientific and policy issues relating to chemical contaminants. Prior to coming to the FDA, Eileen was a Senior Program Officer for the National Research Council’s Board on Environmental Studies and Toxicology, where she directed toxicology, exposure, and risk-related studies. Eileen received her master’s and doctoral degrees from the Harvard School of Public Health.

12:30-1:30pm ET  – Lunch Break

1:30-2:30pm ET
Industry Strategies to Promote Compliance with U.S. Agricultural Chemical Regulations
Hear about what ASTA is doing to promote compliance with U.S. agricultural chemical regulations and an update on recent hot topics in pesticide regulation. Join the speakers for a live Q&A after the session.  

Updates on Spice Tolerance Applications


ASTA is continuing to work to obtain new U.S. pesticide tolerances for spices to reduce regulatory risk for importers. A new tolerance for difenoconazole on black pepper has now been successfully established based on ASTA’s petition. ASTA’s pending tolerance petitions and future work on behalf of the spice industry will be discussed.

About our Speaker: Lois Rossi, Retired EPA
After completing a full career (30 years) with the Office of Pesticide Programs, U.S. Environmental Protection Agency in September 2014, Lois decided to continue on with work in the pesticide regulatory area. She formed Rossi Regulatory Consulting Group in October 2014.

She has been working as a consultant on various pesticide regulatory issues including with WHO in the area of vector control products, on a project to increase JMPR capacity, and many MRL-related issues. Other projects have involved establishing import tolerances for a variety of commodities and MRL harmonization issues and working on pesticides undergoing registration review in the US and other countries.

While at EPA she was the Director of the Registration Division in the Office of Pesticide Programs for 11 years. From 2004-2014 she served as the U.S. delegate to the Codex Committee on Pesticide Residues (CCPR). Also, she was the head of the U.S. delegation to the Working Group on Pesticides and the Registration Steering Group, OECD.

Ms. Rossi has a Bachelor of Arts degree in Zoology from the University of New Hampshire, Durham, New Hampshire, and a Master of Science degree in Biostatistics and Epidemiology from Georgetown University. She is a native of Rhode Island.

Scaling Responsible Agrochemical Management and Sustainable Production of Vietnamese Black Pepper


ASTA has been collaborating with the Sustainability Spice Initiative (SSI), IDH, the European Spice Association (ESA), and the Vietnamese Pepper Association (VPA) on a multi-year joint project in Vietnam to promote the sustainable supply of black pepper. Learn about the project goals to promote compliance of Vietnamese black pepper with standards for agricultural chemical residues in importing countries.

About our Speaker: Jan Gilhuis, SSI
 

Chlorpyrifos: History and the Path Forward


Chlorpyrifos has been subject to repeated regulatory and legal challenges over the last 10 years. Hear an update regarding the latest developments and a discussion of possible paths forward.

About our Speaker: Manojit Basu, Ph.D., Managing Director Science Policy, Crop Life America (CLA)
Dr. Manojit Basu is the Managing Director of Science Policy at CropLife America, the U.S. national trade association representing manufacturers, formulators, and distributors of pesticide products. His primary areas of responsibility include advocating for science-based policies and regulations for approval and support of pesticide products and technologies.

Prior to joining CLA, Dr. Basu was the Vice President, Product Safety at the Grocery Manufacturers Association representing the food and beverage industry in Washington DC. He also holds an adjunct professor position at the Johns Hopkins University and has received his B.S. in Agriculture, M.S., and Ph.D. in Molecular Biology.

2:30-2:45pm ET – Break 

2:45-3:30pm ET
Ask the Expert: FDA Regulations
Elizabeth Fawell, Hogan Lovells
ASTA’s popular “Ask the Expert” series returns. This session is an informal opportunity for members to raise questions and discussion topics of interest related to FDA regulations and topics. Elizabeth Fawell of Hogan Lovells will be available to answer questions and engage in dialogue with attendees about hot topics related to food safety regulations. Come prepared with specific questions on FDA regulations, including FSMA, traceability, and inspections.

3:30-4:00pm ET
Tech Enabled Traceability in the New Era of Smarter Food Safety

About this session and speaker


This presentation will focus on the three sub-elements within Tech-Enabled Traceability and what are the activities in the works.

(1) Develop Foundation Components – speak the same traceability language,

(2) Encourage and Incentivize Industry Adoption of New Technologies – hosting a challenge to encourage food traceability technology providers to develop affordable traceability technology solutions,

(3) Leveraging the Digital Transformation – discuss what are the expected benefits from the first two sub-elements.

Speaker will be available for live Q&A after the session. 

About our Speaker: Andy Kennedy, New Era Technology Team Leader, U.S. Food and Drug Administration, Office of Food Policy & Response

Andy Kennedy is the Co-Leader of FDA’s New Era of Smarter Food Safety, Core Element 1, Tech Enabled Traceability. Also, he heads up the New Era Technology Team (the NETT) in the FDA Office of Food Policy and Response (OFPR). Mr. Kennedy started working with OFPR in October 2019 as a Subject Matter Expert in Food Traceability.

The FDA launched the FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge on June 1, 2021. Mr. Kennedy developed the concept for the challenge and led the team that brought it to life. The primary goal of this challenge is to encourage stakeholders, including technology providers, public health advocates, entrepreneurs, and innovators from all disciplines to develop traceability hardware, software, or data analytics platforms that are low-cost or no-cost to the end-user.

Mr. Kennedy led the design and development of 21 FORWARD for FDA’s Office of Food Policy and Response. The platform was developed in a joint effort by the FDA’s Office of Food Policy and Response, Center for Food Safety and Applied Nutrition, Office of Regulatory Affairs, and Center for Veterinary Medicine to help the FDA identify where risks for interruptions in the continuity of the food supply may be the greatest because of the COVID-19 pandemic. Data from 21 FORWARD is also being made available to assist states with their planning efforts for vaccine distribution. Link

Prior to his work at the FDA, Mr. Kennedy led IFT’s Global Food Traceability Center and co-founded FoodLogiQ, a leading Food Traceability platform for restaurant operators, food companies, and retailers. He co-convened traceability standards development working groups for GS1, the Produce Traceability Initiative, and the Global Dialogue on Seafood Traceability.  With Jennifer McEntire, Mr. Kennedy edited “Food Traceability from Binders to Blockchain,” published by Springer in 2019.

Mr. Kennedy holds an MBA from Duke’s Fuqua School of Business and an A.B. in Economics from Lafayette College.

4:00-4:30pm ET
ASTA Advocacy Initiatives (Members Only)
Laura Shumow, ASTA Executive Director
This members-only session will include updates on ASTA’s recent advocacy initiatives on food safety and chemical regulations. Learn about what ASTA is doing to influence state and federal regulations on behalf of the spice industry and how your company can get involved.

4:30pm
Closing Remarks