Rachael Dettmann Spiegel

Regulatory & Transactional

Rachael counsels food, feed and agribusiness clients on regulatory compliance and business transaction matters to mitigate client risk throughout their supply-chain. Rachael’s experience includes:

• Utilizing her in-depth knowledge of Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) requirements to provide practical compliance advice, including advising on compliance with FSMA’s Preventive Controls, Current Good Manufacturing Practices (CGMPs) and Foreign Supplier Verification requirements for food and feed manufacturers and importers.
• Drafting FSMA compliance programs for animal feed and human food manufacturing facilities.
• Advising clients through foodborne illness outbreaks, product recalls, FDA inspections and enforcement actions, counseling client teams regarding communications with FDA and subsequent litigation risks.
• Counseling fresh produce clients regarding compliance with the Perishable Agricultural Commodities Act (PACA), including PACA licensing and contracting requirements, advising on the PACA trust provision and securing PACA payments through bankruptcy proceedings.
• Collaborating with the firm’s corporate attorneys in M&A due diligence and agreement drafting, advising on any food regulatory and litigation issues that may impact a food or animal feed transaction.
• Drafting supply agreements and contract manufacturing agreements to address issues related to food safety, marketing, regulatory compliance, indemnification, import/export issues, inspections and recalls.