Mark Hackman Email & Phone Number

Boston, Massachusetts, United States (Working Remotely)

Greater San Diego Area

Provided expert regulatory guidance for the manufacture and shipment of four genetically modified microorganisms (GMM); successfully passed audits with CA Dept. of Food & Agriculture and USDA.Wrote and reviewed Standard Operating Procedures (SOPs) for receipt, shipment and use of 2000+ biological samples. Wrote Microbial Commercial Activity Notice (MCAN) for two GMMs, resulting in their approval.Discovered an exemption to market GMM without need to file a full MCAN, saving the company $500,000 and six months of time.Designed multi-step regulatory license strategy for using GMMs in Brazil. Led training for 100+ employees in regulatory compliance, cGMP, Global Harmonization for the Classification and Labeling of Chemicals (GHS), Movement of Plant Material in Interstate Commerce, Toxic Substance and Control Act regulations, and biosafety training.Petitioned and received 30+ USDA/APHIS and USDA/BRS permits as a Level II USDA Permit User for moving various plants, plant pests, and GMMs via interstate commerce.

Identified 150+ regulatory cases of FDA violations including complex sterile dosage form inspections, illegal sales of prescription veterinary drugs, illegal drug residue in animals intended for human consumption, pet food labeling claims, and imported and domestic veterinary devices resulting in numerous awards including the Center Directors Award for sustained and superior performance.Selected for group to develop precedent-setting regulations to establish registration of food manufacturing facilities. Prepared responses for five Congressional inquiries on high profile issues such as new animal drugs and their labeling, unapproved new animal drugs, and policy interpretation of federal regulations. Presented at five conferences on topics such as internet enforcement strategies, First Amendment interpretation, and US food import regulations.