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PHSC 2014 6/18/2014
Trevor Suslow Dept. Plant [email protected]
UC Postharvest Technology of Horticultural CropsJune 19, 2014
Principles of Food Safety:
Wholesomeness
Safety
Defense
Security
Federal Agencies
•U.S. Department of Agriculture’s •Agricultural Marketing Service (AMS):Fresh produce standards, safety audits, pathogen surveillance, PSA
• Food and Drug Administration’s (FDA) • Center for Food Safety and Applied Nutrition (CFSAN): Fresh and fresh cut produce safety
• Environmental Protection Agency • (EPA) Office of Prevention, Pesticides and Toxic Substances (OPPTS): pesticides, environmental toxins and hazardous substances, sanitizers
•U.S. Homeland Security U.S. Customs and Border Protection (CPB) • Border crossings and import inspections
•U.S. Centers for Disease Control and Prevention (CDC) • Food Safety Office: foodborne infections, surveillance, investigations
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State and local governments:Often in charge of on‐the‐ground inspections, especially of restaurants and food preparation sites, initiate local outbreak investigations.
• Prevention ‐ Promotion of improved food safety and defense capabilities throughout the supply‐chain
• Intervention ‐ Coordinate risk‐based interventions among federal, state, local and foreign agencies.
• Response and Recovery ‐Develop rapid and comprehensive methods to communicate with consumers and other agencies before, during and after an event.
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Chemical Physical BiologicalMicrobialAllergensToxins
Mycotoxins
1. Management Commitment2. Food Safety Program3. Risk Assessment4. Land Use Assessment5. Irrigation and Water Management6. Fertilizer, Soil Additives and Pesticide Use7. Personnel Hygiene…Training8. Equipment and Field Sanitation9. Field & Processing Foreign Material Control10. Traceability – Recall Plan
Season Site Selection Variety
Crop ManagementIn-season field
sanitation
Pre-season field sanitation
Pre-harvest sanitation
Harvest Logistics
Process ControlHandling and Treatment
Cold Chain and Distribution ControlCold Chain and
Distribution Control
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Signed by President Obama January 4, 2011
Aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it
Establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables where it is determined that such standards minimize the risk
Critical Reviews in Food Science and Nutrition
Pre‐ and Post‐harvest Preventive Measures and Intervention Strategies to Control Microbial Food Safety Hazards of Fresh Leafy Vegetables
Pre‐FarmGate Risks
Maria I. Gil, Maria V. Selma, Trevor Suslow, Liesbeth Jacxsens, Mieke Uyttendaele & Ana Allende August 2013 DOI: 10.1080/10408398.2012.657808
Prior Use and Adjacent Land Use
Assessments
PreplantWater
System and Field Risk
Assessments
Crop Input, Management Controls, and Production Assessments
Preharvest
Pre‐Harvest Assessments
Site
Labor
Equipment
Implements
Postharvest Controls
Wash and Grade
Packing
Pre‐cooling
Shipping Dock
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If not controlled will cause illness Chronic or Acute Health Impacts Chemicals▪ Pesticides▪ Sanitizers▪ Lubricants and Fuels
Allergens▪ Undeclared ingredients▪ Cross contaminants
Unapproved additives▪ Includes packaging and consumer exposure
(e.g. , microwave impacts) Mycotoxins▪ e.g., aflatoxin, ochratoxin, patulin
• Long established regulatory and enforcement schemes• Extensive health and environmental risk assessment tools and models • Highly sensitive analytical tools (ppb)• Higher confidence in residue testing statistical validity
Toxins produced by fungi May be rot or dry‐decay Primarily Aspergillus spp.,
Penicillium spp., and Fusarium spp.
May have acute toxicity High doses impact infants < 10 µg/L for juices and foods destined for babies
and young infants Also concern in animal feed
Long‐term chronic toxicity of concern Negative immunological, neurological and
gastrointestinal outcomes Can be carcinogenic
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Foreign objects capable of injuring the consumer
Glass
Wood
Stones
Hard plastic
Metal shards
Ugh‐factor (bugs, animal parts)
Metal Detection is a (the) Critical Control PointDifficult to screen other types of physical hazards
Finger‐Bobs Cover BandageMetal Detection in Salad Plant
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Laser and X-ray Detection• Wire• Pebbles• Pen caps • Cigarette buds• Bottle caps
Chlorophyll-based defect removal• Decayed pieces more likely to
harbor human bacterial pathogens
Estimated 250 foodborne pathogens
Bacteria most common cause
Viruses, parasites
How Big Is A Cell?How Big Is A Cell?
Virus 1/10 micron
Salmonella 1.1 micron
Toxoplasma Cyst 3.5 micron
Human Red Blood Cell9 micron
Average Human Cell25-30 micron
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ANIMALS, BIRDS PRODUCE HUMANSWater
feces insects
sewage
soil
meat, milk, eggssilage, feedplants
(cross contamination)
harvesting, handling,processing
environments
Beuchat, 1996
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Salmonella spp. E. coli O157:H7 Pathotoxic E. coli Shigella species Aeromonas spp. Listeria monocytogenes Klebsiella spp. Citrobacter freundii Campylobacter spp. Vibrio cholera
Hepatitis A virus Norovirus Assort. Enteric viruses
Bacteria Viruses
• Cyclospora• Cryptosporidium• Giardia• Toxoplasma• Helminths ‐Ascaris
Parasites
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Pathogens: The Invisible Enemy
Inspections of product have limited impact on food safetyInspections and audits of facilities may tell a different story
CDC ESTIMATES (Scallan et al., 2011) Major foodborne pathogens (31 organisms)
9.4 million cases/year (6.6 to 13 million)
56,000 hospitalizations (40,000 to 76,000)
1,200 deaths (710 to 2,300)
Unspecified illness
20 to 61 million cases/year
Combined about 1 in 6 ill every year – most very mild but many severe
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70.1%
17.5%
4.1%
4.3%4.0%
Bacterial
Chemical/Toxin
Parasitic
Viral
Unknown
Source Credit FDA/CFSAN 2011
Source Credit FDA/CFSAN 2011
Source Credit FDA/CFSAN 2011
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2000‐2010 Produce Outbreaks Top 5 groups (79%)
Lettuce / Leafy Greens
Tomatoes
Cantaloupe
Herbs (Basil,parsley,cilantro
Green Onions
Image available athttp://www.fda.gov/Food/guidanceregulation/FSMA/ucm334114.htm
Why is the focus more on risks and practices than commodities?
Lettuce/Romaine 25Spinach 3Cabbage 1Tomatoes 20Cantaloupe 10Melons 3Honeydew 2Squash 1Cucumber 2Raspberries 6Strawberries 3Blueberries 1
Basil 5Basil or mesclun 3Cilantro 4Celery 2Parsley 2Green onions 2Mango 3Table grapes 2Jalapeño/Serrano 1Snow Peas 1Snap Peas 1Papaya 1
Source: FDA CFSANSprouts 37
Almond, Hazel, Pine Nuts, Pecan, Walnut
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1. Changes in the food system – How food is produced and consumed. What we eat, how we eat it, and how it is produced.
2. Increased surveillance3. Improved detection technologies4. Improved trace‐back of products5. Increased public health reporting 6. Global sourcing of product – food safety standards
are not universal7. Changing pathogens and associated microbes8. An aging or increasing ‘at‐risk’ population9. More media attention10. Consumer awareness – power of the bloggers
Donna Wells Lloyd & Clarence Wells Jr.
Juanita and Caesar Gomez
Herb and Elaine StevensPenny Hauser with Mike Hauser
Michelle Wakley‐Paciorekwith David, Madison, and premature Kendall
Paul Schwarz and wife
William and Monette Beach
Clarence Wells Sr.
Jeni Exleywith father Herb
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Food Safety Depends on Prevention Programs with Multiple Hurdles
Preharvest Postharvest
In all operations there exists the potential for shifting levels of risk inadvertently, by indifference or by ignorance, from routine and safe to beyond the boundaries of our control.
The approach to setting Produce Safety Standards is often…
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5. Review & Adjust
1. Identify Hazard
4. Effectiveness
4. Monitor Effectiveness
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Available data from many labs points towards HIGH RISK POTENTIAL
The general conclusion is ……
Environmental, Biological, and Control Measures create natural and applied hurdles and barriers
that result in a very low RISK EXPOSURE
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Hazard Analysis and Critical Control Points
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A point, step or procedure at which control can be applied and is essential to prevent or eliminate a hazard or reduce it to an acceptable level
Requirements:
Conduct hazard analysis, develop and implement preventive controls, and monitor the control’s effectiveness
Develop a written plan for controlling hazards
Reanalyze for potential hazards at least every three years
Verify the effectiveness of the controls
Maintain records of the verification process
Listeria continues to grow
What happens to E. coli or Salmonella?Cyclopsora? Hepatitis virus A?
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Benchmarked schemes, standards, and harmonized GAPs are great, but beyond record‐keeping and passing audits…
Risk reduction depends on ▪ Intimate regional and commodity knowledge
▪ Details….Details….Details
However… • Illness to Total Servings per Year ratio is staggeringly small •Consuming fresh produce remains the right message• Prevention across the supply‐chain is needed
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Prevention
Inspections, Compliance, and Response
Import Safety
Enhanced Partnerships
New FDA Authorities / Tools Mandatory Recall Administrative Detention Withdrawal of Facility Registration
FSMA Basics
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FDA Burden
Reasonable probability the food is adulterated or misbranded by failing to disclose major food allergens
Reasonable probability the food will cause serious adverse health consequences or death
Biennial registration requirements: Now every 2 years instead of “once for all time” (Must re‐register by Dec. 31)
Additional information required with registration: New Mandatory Food Categories
FDA Authority To revoke registration
Require declaration of more information in registration
Domestic Food Facilities High Risk Facilities: Once by January 2016
(then every three years)
Non‐High Risk Facilities: Once by January 2018(then every five years)
Foreign Food Facilities 600 inspections by January 4, 2012 19,200 inspections by January 4, 2017 FDA can consider requiring records be submitted for review instead of an inspection
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Seven “foundational” FSMA Rules, that are intended to function and coordinate together
FDA has been publishing these proposed FSMA Rules for comment
Lawsuit in 2013 resulted in court order to issue all regulations by June 30, 2015
On appeal, FDA obtained and agreed to extensions ranging from August 2015 to May 2016
Over 18,000 comments received
Second round of public comment pending
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• Produce Safety Standards • Preventive Controls for Human Food • Foreign Supplier Verification Program• Preventive Controls for Animal Food• Accredited Third Party Certification• Sanitary Transportation• Traceability
1. Produce Rule: science‐based minimum standards for the safe growing, harvesting, packing and holding of produce on farms addressing biological routes of potential hazards
2. Preventive Controls Rule – Humans: applies to facilities that manufacture*, process, pack or hold food for human consumption to implement “Hazard Analysis and Risk‐Based Preventive Controls (HARPC)” and updated CGMPs.
a. Generally applies to facilities that are required to register with the FDA under Section 415 of the Bioterrorism Act
3. Preventive Controls Rule – Animals: Regulates domestic and imported pet food and animal feed with new CGMPs for animals and preventive controls similar to that for human food
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* Manufacture includes farming/crop production (definition dependent)
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4. Foreign Supplier Verification Program: Requires importers to have a FSVP that ensures the imported food meets the same standards as that produced domestically. For produce, must consider chemical, physical and radiological risks in addition to microbiological risks covered under the Produce Rule
5. Accreditation of 3rd Party Auditors: FDA accredits Certification Bodies/Auditors to perform audits of foreign suppliers’ facilities under VQIP or food if designated by FDA as high risk
6. Sanitary Transportation: Establishes requirements for Shippers, Carriers by motor vehicle and rail, and receivers engaged in transportation of human and animal food for sanitary conditions and temperature control for certain foods
7. Intentional Adulteration: Addresses acts of terrorism intended to cause massive public health harm. Larger domestic and foreign food businesses (>$10 Million), must have a written food defense plan that identify vulnerable activities (actionable process steps) and implement focused mitigation strategies to address them. Focus is on liquids, secondary ingredients and mixing and similar activities.
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Pre‐legislation work
FSMA signed
Proposed Rules
CommentsFDA
reviewFinal Rules Compliance
We Are Here; Proposed Rules
Large Operations
Small Farms
Proposed effective date of the FSMA Rules is 60 days after publication of the final rule in the Federal Register
Varies by Rule, but generally, compliance is required: 1 year after effective date (Produce Rule 2 years, water 3 years; FSVP 18 months)
2 years after effective date for small businesses (PR 3 years)
3 years after effective date for very small businesses (PR 4 years)
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• FDA to work with USDA to establish standards for safely producing and harvesting raw agricultural products
• Prioritize for agricultural commodities that have been associated with food borne illnesses in the past
Primary focus is on practices not commodities
Science‐ and Risk‐based…sort of
Focus on identified routes of microbial contamination
Excludes certain produce rarely consumed raw Excludes produce to be processed
Flexible Extended timeline for small farms compliance Variances from regulations possible Alternatives for some provisions
Focus on long‐identified routes of microbial contamination
Domesticated and wild animals
Equipment, tools, buildings and sanitation
Worker health and hygiene
Agricultural water
Growing, harvesting, packing and holding activities
Biological soil amendments of animal origin
Specific requirements for sprouts
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Exemptions:
Facilities subject to HARPC requirements
Directly from farm to –
▪ Consumers, or
▪ Restaurant or retail food establishments (in the same state or within 275 miles)
Extra time to comply allotted to:
Small businesses (given 1 extra year)
Very small businesses (given 2 extra years)
Compliance roll‐out is defined by gross income level
Compliance Dates
o Very small farms ($25K‐$250K): 4 – 6 years (water)
o Small farms ($250K‐$500K): 3 – 5 years (water)
o Large farms (>$500K): 2 – 4 years (water)
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Produce Rule vs. Preventive Controls Regulatory Lines
• “Mixed‐type” facility = Farm + Registered Facility• Farm (Produce Rule) + Pack house (PC Rule)• Farm (Produce Rule) + On‐Farm Pack house (Produce Rule)• Farm (Produce Rule) + On‐Farm Pack house (handles
another farm product =PC Rule)• What about next year (no other farm product)?
Receiver
Owned Land
Leased Land
Grower & Shipper
Grade PackShip
ReceiverReceiver
Pre‐FarmGate
Receiver
Full or Partial Crop Ownership
Contract Grower 1, 2,3, …n
Grower & Handler
Grade PackShip
ReceiverReceiver
Pre‐FarmGate
What it says:
‘‘The owner, operator, or agent in charge of a facility shall (1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including (A) [bio][chem][phys][radiol] hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved or color additives; and (B) hazards that occur naturally , or may be unintentionally introduced ; and
(2) Identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and
(3) Develop a written analysis of the hazards
DevelopVALIDATED PREVENTIVE CONTROLS
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Facilities Exempt from HARPC Requirement:
Facilities only subject to Standards of Produce Safety
Facilities subject to the HACCP requirement and low‐acid canned food standards
Facilities subject to dietary supplement cGMPs
Most facilities will not be exempt from HARPC
Every importer must establish a plan that verifies:• That the foreign supplier complies with HARPC or Standards for Produce
Safety• That the food is not adulterated or misbranded by failing to disclose major
food allergens
Importer must maintain records for no less than 2 years
Noncompliance is grounds for refusal of an imported article (Beginning Jan 4, 2013 – or when regulations issued)
Grounds for criminal enforcement
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• FDA must establish voluntary program in order to expedite importation of safe and secure food.
• Eligibility is determined by overall safety of food offered for import by the specific importer.
• Importers must obtain certification by third‐party auditors (designated by FDA)
• FDA to review importers eligibility no less than once every three years.
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Pathogens are carried and spread by many hosts Survival in the environment and on produce varies Infectious dose (how many cells) can be very low Despite our best efforts to date…contamination and
outbreaks still happen Lessons learned from outbreak investigation help
identify or confirm hazards along the supply‐chain New and evolving federal regulations will redefine food
safety expectations, audits, and enforcement across the whole marketing chain\
International reciprocal food safety and trade responses are likely