Leigh Barcham

Associate, Washington, DC

Leigh Barcham provides business-oriented legal and policy solutions to food and agriculture companies and trade associations. She advises clients on state and federal regulatory issues that may arise throughout the entire food production line from farm to table. Leigh also guides clients in consumer products industries as they navigate federal advertising laws and regulations.
When she joined Hogan Lovells, Leigh brought with her more than five years of public policy experience. A part-time student by night and a law clerk by day, Leigh worked throughout law school at a firm in Washington, D.C., focusing on legislation and federal regulation affecting the energy industry. Before law school she served as a policy analyst for international affairs and climate change at the White House Council on Environmental Quality.

Firm/Organization: Hogan Lovells

Blogs: A Seat at the Table, Global Media and Communications Watch

Latest Articles

A Seat at the Table

Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions

By Maile Hermida, Elizabeth Fawell & Leigh Barcham on June 12, 2019

The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). The consent order, which was approved by the district court judge on June 11, 2019, establishes a timeline for FDA to publish a list of high-risk foods and engage in rulemaking setting forth additional traceability recordkeeping…

A Seat at the Table

FDA Announces Produce Safety Rule Enforcement Discretion Policy for Almonds, Pulse Crops, Wine Grapes, and Hops under FSMA

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on April 3, 2019

The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise enforcement discretion for the requirements of the Produce Safety rule as they apply to entities growing, harvesting, packing, and holding almonds, pulse crops, wine grapes, and hops. FDA received feedback from these entities that they should be exempt after it issued the final Produce Safety rule, and FDA is exercising enforcement discretion while it considers pursuing rulemaking to address the…

A Seat at the Table

FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule

By Joe Levitt, Elizabeth Fawell, Maile Hermida & Leigh Barcham on March 14, 2019

The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food facilities must develop and implement a food defense plan that identifies their significant vulnerabilities and mitigation strategies to address those vulnerabilities, and…

A Seat at the Table

FSIS Releases Draft Guideline on Complaint Handling and Foreign Materials

By Gary Kushner, Brian Eyink & Leigh Barcham on March 12, 2019

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a Draft Guideline detailing the Agency’s expectations of companies that identify foreign material in their meat and poultry products and more generally providing recommendations for how establishments should craft their complaint handling policies. FSIS states that it developed the document in response to an increase in the number of recalls of meat and poultry products adulterated with foreign materials, many of which…

A Seat at the Table

Produce Safety Rule Inspections Will Begin Soon

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on February 14, 2019

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow more time for farmers and state regulators to receive training on the rule. Routine inspections for large farms (i.e., farms with more than an average $500,000 in produce sales during the previous 3-year period) were delayed until spring 2019, and routine inspections…

A Seat at the Table

FDA Finalizes Guidance on Public Warning and Notification of Recalls

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on February 13, 2019

The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was issued in January 2018. The Guidance outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a…

A Seat at the Table

California Amends Slack-Fill Law to Include Additional Safe Harbors

By Steve Steinborn & Leigh Barcham on December 19, 2018

The California legislature has passed a law amending the state’s slack-fill statute for food containers subject to the Federal Food, Drug and Cosmetic Act (FFDCA). Assembly Bill 2632 (AB 2632), which Governor Jerry Brown signed into effect on September 19, 2018, revises the slack-fill statute by creating four new so-called “safe harbor” provisions, under which empty space in a container is not considered nonfunctional slack-fill. These new safe harbor provisions provide additional clarity on the…

A Seat at the Table

OMB Releases Fall 2018 Unified Agenda of Regulatory Actions

By Joe Levitt & Leigh Barcham on November 13, 2018

The Office of Management and Budget (OMB) recently released the Fall 2018 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA) and the United States Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS), Animal and Plant Health…

A Seat at the Table

FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on October 25, 2018

The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first document is for farms covered by the Produce Safety Rule (PSR). The second document is for facilities subject to FDA’s Preventive Controls for Human Food (PCHF) rule and that manufacture, process, pack, or hold fresh-cut produce. The deadline for comments on both guidance…

A Seat at the Table

Lawsuit Seeks to Compel FDA to Implement FSMA Traceability Provisions

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on October 23, 2018

Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA to meet its obligation under FSMA to establish and publish a list of high-risk foods and engage in rulemaking setting forth additional traceability record keeping requirements for facilities that manufacture, process, pack, or hold those foods. The lawsuit was brought in…

Leigh Barcham

Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions

FDA Announces Produce Safety Rule Enforcement Discretion Policy for Almonds, Pulse Crops, Wine Grapes, and Hops under FSMA

FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule

FSIS Releases Draft Guideline on Complaint Handling and Foreign Materials

Produce Safety Rule Inspections Will Begin Soon

FDA Finalizes Guidance on Public Warning and Notification of Recalls

California Amends Slack-Fill Law to Include Additional Safe Harbors

OMB Releases Fall 2018 Unified Agenda of Regulatory Actions

FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors

Lawsuit Seeks to Compel FDA to Implement FSMA Traceability Provisions

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