Produce Safety Challenges & Opportunities Jim Gorny, Ph.D. Vice President of Food Safety & Technology
Produce Marketing Association 2,500 member companies in 45 countries Members represent the entire produce supply chain: o Seed Companies, o Financial Institutions, o Growers/Shippers, o Importers/Exporters, o Processors, o Promotional Organizations, o Foodservice Distributors, o Government Agencies, o Supermarket Retailers, o Educators & Students, o Restaurant Chains, o Suppliers.
CPS is an industry, government & academic partnership that is: creating targeted produce safety research; streamlining costs and translating research into action.
Challenges Foodborne Illnesses, Sample Positives & Recalls Opportunities Routes of Contamination Research Pathogen Sources How Pathogens Get on Produce Preventive Controls Mitigation Policy Informed, Science & Risk-based: On-Farm Best Practices Regulations (FSMA) Guidance Preventive Controls Implementation Reduction In: Foodborne Illnesses Sample Positives Recalls
Produce Safety Research: Building a Knowledge Base Basic Science Applied Produce Research Research Academic & Govt Research CPS Programs Private Company Data Informed, Science and Risk-based: Regulations Guidance Programs Routes of Contamination Starting point Game changer
Produce Safety Research Investment: $1,027,053 8 $1,547,592 12 $543,777 6 $1,153,744 7 $1,836,107 10 Risk Compost Animal Vectors Irrigation water Harvest practices $1,905,331 11 Testing methods Postharvest $626,292 6 $487,817 3 $1,436,593 7 Wash water Pathogen studies
Produce Rule Alternatives & Variances Alternatives: Farms may establish alternatives to certain requirements related to water and biological soil amendments of animal origin Variances: A state or foreign country may petition FDA for a variance from some or all provisions if deemed necessary in light of local growing conditions. Alternatives & Variances: Must be scientifically established to provide the same amount of public health protection as the requirement in the proposed rule without increasing the risk of adulteration.
Produce Rule Alternatives & Variances Issues Practical Use of Alternatives & Variances How does one know when you have achieved the same amount of public health protection. Use of alternatives and variances is limited e.g. not allowed for ag water testing frequency. Proposed Solutions: o Allow expanded use of alternatives and variances. o FDA must provide guidance as to what is meant by the same amount of public health protection. o Increased produce safety research and financial support to develop the science needed to support alternatives and variances. (e.g. CPS) o Peer review is needed.
FSMA Opportunities Produce Rule Alternatives & Variances Research Frameworks Published for o Agricultural Water and o Soil Amendments FDA IRisk Model is Publicly Available Pooling limited public and private research resources stretches limited resources. An existing produce safety model that provides rapid, cost effective, actionable research results exists at CPS. FDA needs to opine as to what demonstrates an equal level of public health protection.
Produce Rule Coverage: Issues Produce Rule / Preventive Controls Regulatory Lines Mixed-type facility = Farm + FDA Registered Food Facility Farm (Produce Rule) + Pack house (PC Rule) Farm (Produce Rule) + On Farm Pack house (Produce Rule) Proposed Solution: Produce Rule Compliance = PC Compliance
Produce Rule Compliance & Enforcement Issues No Farm Food Safety Plan is Required If it isn t written down it didn t happen! Growers need written information to manage on-farm food safety. Paper audit trails are already required for GAP audits. A food safety culture starts with a written plan. Proposed Solutions: o Written on-farm food safety plans which include an operational assessment of risk should be required of all farms. o Written food safety plans should be simple, functional, easy to use and facilitate the implementation of on-farm food safety preventive controls. o Plans should NOT have to be submitted to FDA but available during inspections and during any foodborne illness outbreak investigation.
Produce Rule Compliance & Enforcement Issues Training & Implementation How will FDA train all their inspectors? How will industry train farmers? How will FDA inspectors understand farm practices and culture? Is this an aggressive or not aggressive enough implementation time frame? Should everyone irrespective of enterprise size comply at the same time? Proposed Solutions: o Need better industry and government cross training. o Need detailed compliance and policy guides (commodity specific and enterprise size specific). o Need an efficient, fair way to adjudicate issues.
Education Outreach: Local Grower Training Objectives 1. Assist produce buyers (retailer and food service) identify qualified local produce suppliers, 2. Provide sales opportunities to local growers by informing them of buyer produce safety needs and, 3. Provide growers with access to resources to meet buyer requirements. Next Offering: 13 November 2013 Raleigh, NC
cps.ucdavis.edu Thank You JGorny@pma.com www.pma.com cps.ucdavis.edu