When I say food safety and regulations

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3/17/2015 When I say food safety and regulations most FSMA Implementation: Are You FSMA Ready?

Food Safety Modernization Act FSMA marks the biggest change to our nation s food laws in more than 70 years. Prevention is the focus.

This is a process FSMA Mar 15 Aug/Oct 15 New FDA Authorities / Tools Mandatory Recall Administrative Detention Withdrawal of Facility

Traceability (Pending) FDA FSMA www.fda.gov/food/guidanceregulation/fsma/default.htm PMA FSMA www.pma.

1 3/17/2015 When I say food safety and regulations most FSMA Implementation: Are You FSMA Ready? The Nexus of Policy & Business Jim Gorny, Ph.D. Vice President of Food Safety & Technology FSMA Anxiety? What is FSMA? Food Safety Modernization Act FSMA marks the biggest change to our nation s food laws in more than 70 years. Prevention is the focus. Confirms industry s primary role on food safety. Science & Risk-based. This is a process FSMA Mar 15 Aug/Oct 15 New FDA Authorities / Tools Mandatory Recall Administrative Detention Withdrawal of Facility Registration Pre-legislation work Resources: FSMA signed (1/4/2011) Proposed Rules Comments FDA review Final Rules Compliance Traceability (Pending) FDA FSMA PMA FSMA FSMA Proposed Rules Final Rule (anticipated) Produce Rule 10/31/2015 Preventive Controls for Human Foods 8/30/2015 Preventive Controls for Animal Feed 8/30/2015 Foreign Supplier Verification Programs 10/31/2015 Sanitary Food Transportation 3/31/2016 Traceability Pending NOT so long way to go 1

3/17/2015 Roles & Responsibilities Food Industry is responsible for producing safe food.

that standards are met, and maintaining a strong enforcement program to deal with those who do not comply

Gov It is not the strongest of the species that survives, nor the most intelligent, but the one most

Charles Darwin How will you manage ever increasing food safety demands from regulators, buyers and consumers?

Understands/Implements: FSMA requirements Understands/Implements: FSMA requirements B2B requirements

Rule* PC Rule* PC Rule* SFTA Rule SFTA Rule SFTA Rule SFTA Rule SFTA Rule Food Defense VQIP** VQIP**

Transporter Wholesale Domestic & On-Farm Off-Farm Distributor International Retailer / Fresh-cut Foodservice

Produce Rule = FDA Produce Specific Implementing Regulation On-farm / Packing Houses.

2 3/17/2015 Roles & Responsibilities Food Industry is responsible for producing safe food. Government Agencies are responsible for: setting food safety standards, conducting inspections, ensuring that standards are met, and maintaining a strong enforcement program to deal with those who do not comply with standards. From: FoodSafety.Gov It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change. Charles Darwin How will you manage ever increasing food safety demands from regulators, buyers and consumers? Produce Safety Marketplace Snapshot FSMA Compliant Market Access Audits Best of Class Operators Understands/Implements: FSMA requirements Understands/Implements: FSMA requirements B2B requirements Understands/Implements: FSMA requirements B2B requirements In-depth understanding Incorporates new science & technology. FSMA Rules Coverage by Produce Supply Chain Segment FSVP ** FSVP** Produce Rule* Produce Rule* PC Rule* PC Rule* PC Rule* PC Rule* SFTA Rule SFTA Rule SFTA Rule SFTA Rule SFTA Rule Food Defense VQIP** VQIP** Traceabilty Traceabilty Traceabilty Traceabilty Traceabilty Grower Packing Packing Shipper Importer Transporter Wholesale Domestic & On-Farm Off-Farm Distributor International Retailer / Fresh-cut Foodservice Processor Huller / Sheller * Regulatory Requirement for Training ** Import related rules Produce Safety FSMA Produce Rule = FDA Produce Specific Implementing Regulation On-farm / Packing Houses. Raw Agricultural Commodities Multitude of commodities Multitude of production procedures, practices and processes. International in-scope Produce often consumed uncooked. Prevention based i.e. NO kill step. Produce Rule Coverage Establishes science-based standards focused on the production, harvest, packing and holding of produce on-farms. On-Farms On-farm Pack Houses Domestic and Imported Produce. Produce: Fruits, Vegetables, Mushrooms, Tree Nuts 2

3/17/2015 Produce Rule Exemptions & Exclusions Excluded Produce Rarely Consumed Raw (e.g.

(Tester/Hagen Amendment) Excerpt from FDA Draft EIS, 2015 Produce Rule Compliance & Enforcement Effective

(water) o Small farms ($250K-$500K): 3 5 years (water) o Large farms (>$500K): 2 4 years (water) Preventive

Requires written plans to: Identify hazards, Identify preventive controls to minimize or prevent identified

processors, Some Terminal Market Wholesalers Preventive Controls Rule Provisions 1) Environmental Testing 2)

Supplier Approval & Verification Process Buyers play an important marketplace gate keeper role.

verify that food imported into the US has been produced with the same food safety standards that are required

S. owner or consignee at the time of entry, the U.S. agent or representative of the foreign owner or consignee.

3 3/17/2015 Produce Rule Exemptions & Exclusions Excluded Produce Rarely Consumed Raw (e.g. potatoes) Produce that will Receive Commercial Processing Farms <$25K Sales/Yr Exempt Qualified Exemption (Tester/Hagen Amendment) Excerpt from FDA Draft EIS, 2015 Produce Rule Compliance & Enforcement Effective Date: 60 days after final rule is published 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) Preventive Controls Rule Sets standards for firms which manufacture, process, pack or hold human food. Requires written plans to: Identify hazards, Identify preventive controls to minimize or prevent identified hazards, Identify monitoring procedures, Record monitoring results and Specify corrective actions to correct problems. Produce businesses that will be affected Produce packing houses that are FDA registered facilities, Fresh-cut processors, Some Terminal Market Wholesalers Preventive Controls Rule Provisions 1) Environmental Testing 2) Product Testing (Raw Materials, In-Process, Finished Product) 3) Supplier Controls Supplier Controls = Supplier Approval & Verification Process Buyers play an important marketplace gate keeper role. Foreign Supplier Verification Programs Importers would be required to perform certain risk based activities to verify that food imported into the US has been produced with the same food safety standards that are required of US producers (Produce Rule & Preventive Controls Rule) An importer of food as per FSVP is: the U.S. owner or consignee of the food at the time of entry, or, if there is no U.S. owner or consignee at the time of entry, the U.S. agent or representative of the foreign owner or consignee. A foreign supplier of food as per FSVP is an establishment that: manufactures / processes, raises the animal, or harvests food that is exported to the United States without further manufacturing / processing by another establishment. 3

3/17/2015 Foreign Supplier Verification Programs Requires FSVP consisting of: 1.

Corrective Actions 5. Periodic Reassessment of the FSVP 6.

Recordkeeping Verification Activities: onsite auditing, sampling and testing, review of

Sanitary Food Transportation Requires certain shippers, receivers, and carriers who

the contamination of human and animal food during transportation.

non-sahcoda hazards, SAHCODA Hazards requires onsite audits.

equipment for transport and conduct the transport of foods.

Other forms of transportation not directly affected, Transport legs not in the United

Food Transportation A Shipper is a person who initiates a shipment of food by motor or rail

A Carrier is a person who owns, leases, or otherwise is ultimately responsible for the use

, the common carrier that physically ships the food).

represent the final point of receipt for the food (e.g., retail distribution center).

cleanable and maintained in a sanitary condition.

4 3/17/2015 Foreign Supplier Verification Programs Requires FSVP consisting of: 1. Compliance Status Review 2. Hazard Analysis 3. Verification Activities 4. Corrective Actions 5. Periodic Reassessment of the FSVP 6. Importer Identification: (DUNS) 7. Recordkeeping Verification Activities: onsite auditing, sampling and testing, review of supplier food safety records, or some other appropriate procedure. Sanitary Food Transportation Requires certain shippers, receivers, and carriers who transport food to be consumed or distributed in the United States, to take steps to prevent the contamination of human and animal food during transportation. Vehicles and transportation equipment, Transportation operations, Information exchange, Training and Recordkeeping. FDA is Proposing (When Foreign Suppliers Control Hazards) 2 hazard classes: SAHCODA vs non-sahcoda hazards, SAHCODA Hazards requires onsite audits. Sanitary Food Transportation Primarily addresses carriers, as they typically supply equipment for transport and conduct the transport of foods. Coverage Motor & rail vehicle transportation. Other forms of transportation not directly affected, Transport legs not in the United States are not covered by this rule. Covers direct transport of food into the U.S. Sanitary Food Transportation A Shipper is a person who initiates a shipment of food by motor or rail vehicle (e.g., food manufacturer who arranges for their food to be shipped). A Carrier is a person who owns, leases, or otherwise is ultimately responsible for the use of a motor or rail vehicle to transport food (e.g., the common carrier that physically ships the food). A Receiver is a person who receives food after transportation, whether or not they represent the final point of receipt for the food (e.g., retail distribution center). Sanitary Food Transportation Hazards Covered Transport must be suitable, designed to be cleanable and maintained in a sanitary condition. Refrigeration of food (TTCS and spoilage) Proper cleaning between loads and All forms of adulterations (allergens, contaminants and spoilage are to be considered). FDA FY 16 Proposed Budget $109.5 M Increase Budget Authority 1. Inspection Modernization and Training - $25 million 2. National Integrated Food Safety System - $32 million 3. Education and Technical Assistance for Industry - $11.5 million 4. Technical Staffing and Guidance Development at FDA - $4 million 5. New Import Safety Systems - $25.5 million 6. Risk Analytics and Evaluation - $4.5 million 7. FDA Infrastructure Improvements - $7 million 4

3/17/2015 Inspection Modernization & Training 1) New FDA Inspection Model

implementing systems that effectively prevent food contamination,

soundness and performance of a facility s overall food safety system, data

2) Training FDA Inspectors and Compliance Staff ( 2000) 3) IT systems

assistance to provide compliance support and oversight.

State Inspectors and Compliance Staff ( 1000) 5) Assure nationwide

6) Investing in state laboratory accreditation and Education & Technical

5M (Estimated 300,000 entities subject to the final FSMA rules) 1)

collaborations: Produce Safety Alliance Sprout Safety Alliance Food Safety

2) FDA Food Safety Technical Assistance Network 3) USDA NIFA FSMA mandated

and organic farmers and processors. New Import Safety Systems - $25.

50% of fruits, 20% of fresh vegetables, 1) Develop & Implement FSVP

2) FDA staffing & training including SME compliance support staff.

Analysis, Risk Evaluation, Appropriate selection of verification

Building FDA s Cadre of Food Safety Experts: 12 Preventive Controls SME s

Safety Technical Assistance Network technical assistance to industry,

Guidance Development PC: Hazard Analysis, Allergen Controls, Environmental

5 3/17/2015 Inspection Modernization & Training 1) New FDA Inspection Model from evidence of violations / enforcement cases to assuring firms are implementing systems that effectively prevent food contamination, specialized inspectors, supported by FDA technical experts, to assess the soundness and performance of a facility s overall food safety system, data to guide risk-based inspection priority, frequency, depth, and approach. 2) Training FDA Inspectors and Compliance Staff ( 2000) 3) IT systems Identify & track risk, Assess & track inspection efficiency and inspector competency. National Integrated Food Safety System: $32M 1) Education and technical assistance to provide compliance support and oversight. 2) Build state partnerships and capacity to provide education and technical assistance to growers. 3) Inspection grants, contracts, and cooperative agreements, 4) Training State Inspectors and Compliance Staff ( 1000) 5) Assure nationwide quality, consistency and efficiency. 6) Investing in state laboratory accreditation and competency. Education & Technical Industry Assistance: $11.5M (Estimated 300,000 entities subject to the final FSMA rules) 1) Financial support to state agencies and public-privateacademic collaborations: Produce Safety Alliance Sprout Safety Alliance Food Safety Preventive Controls Alliance. 2) FDA Food Safety Technical Assistance Network 3) USDA NIFA FSMA mandated compliance grants to provide technical assistance to small, sustainable, and organic farmers and processors. New Import Safety Systems - $25.5M 12M line-entries to 88k consignees receiving food shipments Imports: 50% of fruits, 20% of fresh vegetables, 1) Develop & Implement FSVP regulatory procedures & infrastructure. 2) FDA staffing & training including SME compliance support staff. 3) Guidance, outreach and technical assistance to industry Hazard Analysis, Risk Evaluation, Appropriate selection of verification activities Technical Staffing & Guidance Development at FDA - $4M 1) Building FDA s Cadre of Food Safety Experts: 12 Preventive Controls SME s 8 Produce Safety SME s 60 Compliance Support Staff SME s 2) FDA Food Safety Technical Assistance Network technical assistance to industry, technical support for FDA and state inspectors / compliance staff 1) Guidance Development PC: Hazard Analysis, Allergen Controls, Environmental Monitoring Produce: Packinghouse, Sprouts, Animal Intrusion, GAPs. Small Entity Compliance Guides Risk Analytics & Evaluation - $4.5M 1) Operations and Data Sharing (ERP) System to link FDA wide public health risk priorities to budgets, program performance, resource allocation data. 2) Data Structure & Gathering targeting data collection to make risk informed decisions and resource allocation 3) Data Analysis & Evaluation Risk ranking, prioritization, and attribution tools 5

3/17/2015 FDA FY 16 Proposed Budget $191.

Note: 1) Authorization of user fees would require that Congress amend the Federal Food Drug and Cosmetic Act. 2) FDA re-inspection fees are authorized in FSMA already.

Education & Implementation Continuum FSMA Compliant Market Access Audits Best of Class Operators Engage with FDA early and often. Put it in writing (i.e. comments) Don t assume FDA understands your business practices, procedures and processes.

Understands/Implements: FSMA requirements Understands/Implements: FSMA requirements B2B requirements Understands/Implements: FSMA requirements B2B requirements In-depth

FSMA Education Outreach by Business Need Planning: Level I FSMA Level II FSMA B2B Grower Domestic & International Packing Packing Shipper Importer Transporter Wholesale

Alliance (Cooperative Extension) State Departments of Agriculture PMA Guest Speaker / Supporting Role (TBD) Regional Trade Orgs, Commodity Boards, Marketing Agreements,

6 3/17/2015 FDA FY 16 Proposed Budget $191.8 M in User fees 1) Food Imports, 2) Food Facility Registration, 3) Food Facility Inspection, 4) Food Contact Substance Notifications, and 5) International Couriers. Note: 1) Authorization of user fees would require that Congress amend the Federal Food Drug and Cosmetic Act. 2) FDA re-inspection fees are authorized in FSMA already. How to Prepare for FSMA Implementation: Understanding Education Planning Validation Implementation Verification Understanding: Rule-Making is a Process Education: The Education & Implementation Continuum FSMA Compliant Market Access Audits Best of Class Operators Engage with FDA early and often. Put it in writing (i.e. comments) Don t assume FDA understands your business practices, procedures and processes. Provide alternatives to FDA proposed provisions that provide and equal level of public health protection. Understands/Implements: FSMA requirements Understands/Implements: FSMA requirements B2B requirements Understands/Implements: FSMA requirements B2B requirements In-depth understanding Incorporates new science & technology. FSMA Education Outreach by Business Need Planning: Level I FSMA Level II FSMA B2B Grower Domestic & International Packing Packing Shipper Importer Transporter Wholesale On-Farm Off-Farm Distributor Retailer / Fresh-cut Foodservice Processor Huller / Sheller Produce Safety Alliance (Cooperative Extension) Food Safety Preventive Controls Alliance (Cooperative Extension) State Departments of Agriculture PMA Guest Speaker / Supporting Role (TBD) Regional Trade Orgs, Commodity Boards, Marketing Agreements, Marketing Orders Retailer (e.g. Wegmans) and Foodservice (Sysco) Develop a systematic approach to food safety and a culture of food safety: HARPC Hazard Analysis Risk Based Preventive Controls Food Safety Plan / On-farm Food Safety Plan Resources Human Resources (Technical Resources) Capital Resources (Building, Equipment, etc.) Recurring Costs of Implementation (Recordkeeping, etc.) Level III FSMA B2B Best of Class Individual Consultations 6

3/17/2015 Validation: assuring that PC s work Invest and be aware of new and emerging science & technology.

Rapid detection & enumeration technologies Implementation: Set internal timelines for implementation.

Don t be lulled into complacency by extended compliance dates based on enterprise size. Just Do It!

Final rules pending. Process has to run its course What should I be doing now?

(Recordkeeping!!!!!!) Set internal timelines for implementation & don t wait to meet FDA timelines.

7 3/17/2015 Validation: assuring that PC s work Invest and be aware of new and emerging science & technology. Integrate new technologies into preventive control programs. Rapid detection & enumeration technologies Implementation: Set internal timelines for implementation. Don t wait to meet FDA timelines. Don t be lulled into complacency by extended compliance dates based on enterprise size. Just Do It! Whole Genome Sequencing 100K Genome Project FDA Genome Trakr Network Impact of FSMA Hard to say definitively. Final rules pending. Process has to run its course What should I be doing now? Understand Proposed Requirements Consider Needed Expertise Consider Capital Improvement Needs Consider Recurring Costs (Recordkeeping!!!!!!) Set internal timelines for implementation & don t wait to meet FDA timelines. Don t be lulled into complacency by extended compliance dates based on enterprise size. FSMA Compliance Dates by Business Size (anticipated) Rule Produce Safety Preventive Controls Human Preventive Controls Animal 2014 Dec Aug 30 Oct Questions? Thank You JGorny@pma.com FSVP Suppl. Prop. Final Large Small V. Small Water 7

General Compliance Period Reference Sheet for FSMA Compliance Dates FSMA Rule Final Rule Publication (Anticipated) Required Compliance Compliance Deadline (Anticipated) Preventive Controls for Human

8 General Compliance Period Reference Sheet for FSMA Compliance Dates FSMA Rule Final Rule Publication (Anticipated) Required Compliance Compliance Deadline (Anticipated) Preventive Controls for Human Food year after final rule Preventive Controls for Animal Feed year after final rule Produce Safety years + 60 days from final rule* Foreign Supplier Verification Program months from final rule rd Party Accreditation and Certification After Model Accreditation Standards - Sanitary Transportation year from final Food Defense year + 60 days from final rule Small Business Compliance Period (less than 500 employees business-wide) Final Rule FSMA Rule Publication (Anticipated) Required Compliance Compliance Deadline (Anticipated) Preventive Controls for Human Food years from final rule Preventive Controls for Animal Feed years from final rule Produce Safety years + 60 days from final rule* Foreign Supplier Verification Program N/A N/A N/A 3 rd Party Accreditation and Certification N/A N/A N/A Sanitary Transportation years from final rule Food Defense years + 60 days from final rule Very Small Business Compliance Period (annual business food sales below applicable limit) FSMA Rule Limit Final Rule Compliance Publication (Anticipated) Required Compliance Deadline (Anticipated) PC Food <$1M years from final rule PC Feed <$2.5M years from final rule Produce Safety <$250K years + 60 days from final rule* FSVP <$500K months from the final rule rd Party Accreditation N/A N/A N/A N/A Sanitary Transport N/A N/A N/A N/A Food Defense <$10M years + 60 days from final rule * All farms have an additional 2 years to comply with certain water-related requirements. All importers must comply with FSVP requirements 18 months after the final rule OR 6 months after their foreign suppliers reach their FSMA compliance deadlines, whichever is later. 3 rd Party Accreditation and Certification s provisions are effective immediately following the final rule, but can only be implemented after publication of Model Accreditation Standards, which are yet to be released by FDA. If there is no special compliance period noted, then follow the General Compliance Period rule. Disclaimer: This document is provided for informational purposes only and does not constitute legal advice. PMA does not advise on the application of law to individual or company specific circumstances. Although PMA goes to great lengths to assure that the information provide is accurate, we recommend you consult an attorney for professional assurance that this information, and your interpretation of it, is appropriate to your particular circumstances.

10 Laboratory Services A Brief History Started with micro-analytical (filth) analyses in the 1940s. Pesticide testing added in the 1960s. Currently have five locations: Fresno Yuba City Modesto Kerman Winters

11 Laboratory Analysis Fresno Laboratory Additives Pesticides Mycotoxins Microbiology Fumigation Research

12 Food Additives Include preservative compounds: -Sulfates & sorbic acid in dried fruits. -BHT in nuts. Amounts are critical.

13 Pesticide Analysis Current screening (GC-MS) - Detects approx. 300 compounds (Luke method). - Limit of Detection: 5-25 ppb range. Added HPLC MS/MS (2014). - Increased sensitivity & number of compounds detected. - Key for export markets (EU, Asia).

14 Microbiology Tests for bacteria, yeast & molds that can cause spoilage/illness. Pathogen testing: - Example is Salmonella in nuts. - We use PCR (DNA testing) and other AOAC approved methods

15 Mycotoxins Toxic by-products of mold growth. Insect damage increases mold contamination. Key mycotoxins of interest: -Aflatoxin (nuts,dried figs). -Ochratoxin (dried fruits). -Patulin (apples, pears)

16 Fumigation Research Dried fruits & nuts are routinely fumigated to kill insects. DFA conducts research on new fumigation methods & compounds. We even raise our own insects!

Fresno Yuba City Kerman Modesto ISO 17025:2005 Fresno (Chemistry & Microbiology) Kerman

17 Accreditations USDA Approved Voluntary Aflatoxin Sampling Plan (VASP) Certificate Laboratories. Fresno Yuba City Kerman Modesto ISO 17025:2005 Fresno (Chemistry & Microbiology) Kerman (Chemistry) Yuba City (Chemistry & Microbiology) Modesto (Chemistry & Microbiology) California State Environmental Laboratory Accreditation Fresno (Pesticide Analysis).

18 Accreditations USDA Approved Pistachio Aflatoxin Laboratory (Marketing Order & Export Program) Fresno Official Laboratory, Japanese Ministry of Health, Labor & Welfare Fresno FDA Partnership Agreement (PA-07) Lab Quality systems

19 FMSA & Lab Accreditation Section 202 (a) of FSMA: FDA to establish a program for the testing of food by accredited laboratories. Accreditation program not yet defined: Likely to be ISO based. FDA to create registry of accredited labs For regulatory testing on behalf of FDA. Identified/suspected food safety issue. Import issues (detention, alerts). DFA is awaiting further information!

20 FSMA Related Services Produce Safety Rule: Water quality standards for generic E. coli. Number of test samples specified: Establishing a baseline. Annual monitoring of results. New water quality profile as needed or every 10 years. We can help (sampling, testing, calculations).

21 FSMA Related Services Preventive Control Rules (Human/Animal Foods): Product testing, environmental monitoring proposed. Test for pathogens (Salmonella, Listeria) or indicators. Sampling products, swabbing & testing for microbes is our specialty! Training/consulting too

22 Commodity Inspection The Value: Third-Party Quality Certification Receiving Inspection (Raw Goods) Provides processing information for handlers and aids in product valuation Outbound Inspection (Finished Goods) To ensure quality to the customer and processing feedback to the handler. Red Seal Certificate (Finished Goods) Third-party C of A Stand out above your competitors Available to DFA of California members and recognized worldwide.

23 Commodity Inspection

24 Food Safety Services Food Safety Consulting and Training GFSI BRC & SQF Introductory & Advanced Custom Training DFA Member Food Safety Standard Other Audit Types (ABC DV Audits, (cgmp) Audits, Huller & Dryer Audits) DFA Global Certifications BRC, SQF, HACCP

25 The FSMA Benefit Preventive Controls (HARPC / HACCP) Training Public or on-site Custom training International HACCP Alliance Approval Consulting GMP, Pest Control Inspections DFA Global Certifications Recognized HACCP and GFSI audits

26 The FSMA Benefit Accredited Third-Party Certification DGC is currently ANSI Accredited (ISO 17065) Foreign Supplier Verification Supplier inspection Review of supplier verification programs Lab testing: verification

27 The FSMA Benefit Sanitary Transportation of food Staff training (customizable) Facility / process inspection & audit

28 Questions?

What s New with the FSMA Rules? Co-Sponsored by:

What s New with the FSMA Rules? Co-Sponsored by: What s New with the FSMA Rules David Gombas, Ph.D. June 12, 2014 Food Safety Modernization Act Fundamental changes in how FDA regulates food Generally supported