suslow fcqsw 2013 overview microbial food …ucce.ucdavis.edu/files/datastore/234-2602.pdfincludes...

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Trevor Suslow

Department of Plant Sciences

[email protected]

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

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• 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


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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


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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


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• 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.


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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


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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


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“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”

*


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Third‐Party Accreditation Program


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http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm


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suslow fcqsw 2013 overview microbial food …ucce.ucdavis.edu/files/datastore/234-2602.pdfincludes...

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