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9/25/2013
1
Trevor Suslow
Department of Plant Sciences
FCQSW Sept 25, 2013
National GAPs Program at Cornell University
Wholesomeness
Safety
Defense
Security
Pesticide residues Pesticide degradation products Naturally occurring toxins Toxic heavy metals Radionuclides Pathogens and parasites Decomposition contaminants Food allergens
Federal Agencies
•U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS): meat; poultry; frozen, dried & liquid eggs.
• Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN): covers everything else.
• Environmental Protection Agency’s (EPA) Office of Prevention, Pesticides and Toxic Substances (OPPTS): pesticides
•U.S. Centers for Disease Control and Prevention’s (CDC) Food Safety Office:
foodborne infections
Food industry sector:GrowersHandlers/ShippersProcessorsPreparers
Consumers
State and local governmentsOften in charge of on‐the‐ground inspections, especially of restaurants and food preparation sites
If not controlled will cause illness 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
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013
9/25/2013
2
• 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.
Long‐term chronic toxicity of concern
Can be carcinogenic
Influence immune response
Foreign objects capable of injuring the consumer
Glass
Wood
Stones
Hard plastic
Metal shards
Ugh‐factor (bugs, animal parts)
Woody seed stalk not decomposed
Banding and strappingIrrigation parts
Pathogens: The Invisible Enemy
Inspections of product have limited impact on food safetyInspections and audits of facilities may tell a different story
Estimated 250 foodborne pathogens
Bacteria most widely recognized
Viruses & Parasites
Norovirus may be > 50% of cases
E. coli O157:H7 Salmonella Cryptosporidium Norovirus
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013
9/25/2013
3
13
ANIMALS, BIRDS PRODUCE HUMANSWater
feces insects
sewage
soil
meat, milk, eggssilage, feedplants
(cross contamination)
harvesting, handling,processing
environments
Beuchat, 1996
70.1%
17.5%
4.1%
4.3%4.0%
Bacterial
Chemical/Toxin
Parasitic
Viral
Unknown
Source Credit FDA/CFSAN 201116
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
Source Credit FDA/CFSAN 2011 Source Credit FDA/CFSAN 2011
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013
9/25/2013
4
Source Credit FDA/CFSAN 2011
65.5 %
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
Signed into law Jan 2011
Prevention
Inspections, Compliance, and Response
Import Safety
Enhanced Partnerships
Considers risk posed by practices first
Commodity traits and risk‐ranking secondary
Science & Risk‐based Focus on identified routes of microbial contamination Excludes certain produce rarely consumed raw Excludes produce to be commercially processed
▪ NOT Fresh Cut ▪ Process documentation required
Flexible Additional time for small farms to comply Variances Alternatives for some provisions
FDA has legislative mandate to require science‐based preventive controls across the food supply
Mandatory preventive controls (implementation of a written preventive control plan)
Hazard evaluation
Preventive steps or controls to minimize or prevent the hazards
Monitoring and verification of preventive controls
Specify corrective actions
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013
9/25/2013
5
• Produce Safety Standards
• Published Jan. 2013• Preventive Controls for Human Food
• Published Jan. 2013• Foreign Supplier Verification Program
• Published July 26, 2013• Preventive Controls for Animal Food• Accredited Third Party Certification
Farms that grow, harvest, pack or hold most produce in raw or natural state (raw agricultural commodities)
Farms and “farm” portions of mixed‐type facilities
Domestic and imported produce
Farms with annual sales > $25,000 per year
Limitations on who is covered proposed
Farms may establish alternatives to certain requirements related to water and biological soil amendments of animal origin
Specific metrics
Proposed frequencies
Some confusion within FDA
Alternatives must be scientifically established to provide equivalent protection
A state, region, or foreign country may petition FDA for a variance from provisions if warranted in light of local growing conditions and practices.
Some inconsistent messaging from FDA
Practices under the variance would need to provide the same level of public health protection as the proposed rule without increasing the risk of adulteration.
Harris, L.J., J. Bender, E. A. Bihn, T. Blessington, M.D. Danyluk, P. Delaquis, L. Goodridge, A. M. Ibekwe, S. Ilic, K. Kniel, J.T. LeJeune, D.W. Schaffner, D. Stoeckel, and T.V. Suslow.
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013
9/25/2013
6
Linda J. Harris, Elaine D. Berry, Tyann Blessington, Marilyn Erickson, Michele Jay‐Russell,Xiuping Jiang, Karen Killinger, Fredrick C. Michel, Jr., Pat Millner, Keith Schneider,Manan Sharma, Trevor V. Suslow, LuxinWang, and Randy W. Worobo
General Effective Date: 60 days after final rule is published
Small farms- Average annual value of food sold > $250,000 and ≤ $500,000
- Would have three years after the effective date to comply
- Would have five years for some water requirements
Very small farms
- Average annual value of food sold >$25,000 and
≤$250,000
- Four years after the effective date to comply
- For some water requirements, six years
Not covered: Farms with sales ≤$25,000/year
Other covered farms- Other covered businesses would have to comply two years after the effective date
- Would have four years for some water requirements
Draft Prepared by Jim Hollyer, University of Hawaii
http://producesafetyalliance.cornell.edu/psa‐mat.html
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013
9/25/2013
7
Hazard Analysis and Risk‐Based Preventive Controls Each facility would be required to implement a written food safety plan that focuses on preventing hazards in foods
Updated Good Manufacturing Practices
Facilities that manufacture, process, pack or hold human food
All fresh‐cut processors
In general, facilities required to register with FDA under sec. 415 of the FD&C Act
Bioterrorism Act
Applies to domestic and imported food
Some exemptions and modified requirements are being proposed
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
Process controls Validation
Verification
Food allergen controls Sanitation controls Recall plan Supplier approval & verification program
Verification of effectiveness of controls
Not simply that an SOP is followed
Calibration
Review of records
Possible final rule inclusion of
review of complaints
finished product testing
environmental testing
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013
9/25/2013
8
“Qualified” facilities: Very small businesses (3 definitions being proposed—less than $250,000, less than $500,000 and less than $1 million in total annual sales)
OR Food sales averaging less than $500,000 per year during the last three years AND Sales to qualified end users must exceed sales to others
Effective date: 60 days after the final rule is published
Compliance Dates Small Businesses—a business employing fewer than 500 persons would have two years after publication.
*
* Foreign Supplier Verification Program
OPTION 1 ‐ Very Simple…Right???
*Acronyms Run‐Amok – “serious adverse health consequences or death to humans or animals”
*
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013
9/25/2013
9
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013
9/25/2013
10
Third‐Party Accreditation Program
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013
9/25/2013
11
http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm
Suslow, Trevor 2013 Microbial Food Safety & FSMA Update Fresh-cut Products: Maintaining Quality & Safety Workshop Postharvest Technology Center, UC Davis http://postharvest.ucdavis.edu Section 9a
(c) UC Regents 2013