3/17/2015

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FSMA Implementation: Are You FSMA Ready?

The Nexus of Policy & Business

Jim Gorny, Ph.D.Vice President of Food Safety & Technology

When I say food safety and regulations

most…

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�

Pre-legislation workFSMA signed (1/4/2011)

Proposed Rules

Comments FDA review Final Rules ComplianceTraceability

(Pending)

“NOT so long way to go…”

Resources:

� FDA FSMA www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

�PMA FSMA www.pma.com/fsma

Mar‘15 Aug/Oct‘15

New FDA Authorities / Tools

� Mandatory Recall

� Administrative Detention

� Withdrawal of Facility Registration

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

FSMA

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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

Roles & Responsibilities

“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?

FSMA Compliant Market Access Audits Best of Class Operators

Understands/Implements:

� FSMA requirements

Understands/Implements:

� FSMA requirements

� B2B requirements

Produce Safety

Marketplace Snapshot

Understands/Implements:

� FSMA requirements

� B2B requirements

� In-depth understanding

� Incorporates new

science & technology.

FSMA Rules Coverage by Produce Supply Chain Segment

Grower

Domestic &

International

TransporterPacking

Off-Farm

Fresh-cut

Processor

Importer

Huller /

Sheller

Shipper Wholesale

Distributor Packing

On-Farm

Produce Rule*PC Rule*

SFTA Rule

Food Defense

Traceabilty

PC Rule*

SFTA Rule

Traceabilty

FSVP**

Produce Rule*

PC Rule*

SFTA Rule

VQIP**

Traceabilty

SFTA Rule

Traceabilty

FSVP**

PC Rule*

SFTA Rule

VQIP**

Traceabilty

Retailer /

Foodservice

* 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

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Excerpt from FDA Draft EIS, 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)

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 ControlsSupplier 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

• harvestsfood that is exported to the United States without further

manufacturing / processing by another establishment.

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Foreign Supplier Verification Programs

� Requires FSVP consisting of:

1. Compliance Status Review2. 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.

� FDA is Proposing (When Foreign Suppliers Control Hazards)

2 hazard classes: SAHCODA vs non-SAHCODA hazards, SAHCODA Hazards requires onsite audits.

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.

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).

1. Inspection Modernization and Training - $25 million

2. National Integrated Food Safety System - $32 million3. 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 million6. Risk Analytics and Evaluation - $4.5 million

7. FDA Infrastructure Improvements - $7 million

FDA FY ’16 Proposed Budget $109.5 M IncreaseBudget Authority

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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-private-academic 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 - $25.5M12M 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

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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

� 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.

Education:

FSMA Compliant Market Access Audits Best of Class Operators

The Education & Implementation Continuum

Understands/Implements:

� FSMA requirements

Understands/Implements:

� FSMA requirements

� B2B requirements

Understands/Implements:

� FSMA requirements

� B2B requirements

� In-depth understanding

� Incorporates new

science & technology.

Grower

Domestic &

International

TransporterPacking

Off-Farm

Fresh-cut

Processor

Importer

Huller /

Sheller

Shipper Wholesale

Distributor Packing

On-Farm

Retailer /

Foodservice

FSMA Education Outreach by Business Need

Level I

FSMA

Level II

FSMA

B2B

Level III

FSMA

B2B

Best of Class

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)

Individual Consultations

Planning:

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.)

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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

Whole Genome Sequencing

100K Genome Project

FDA Genome Trakr Network

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!

Impact of FSMA

� Hard to say definitivelyM.

• 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.

Rule2014

Dec 15

2015

2016 2017 2018 2019 2020 2021Aug 30 Oct 31

Produce

Safety

Preventive

Controls

Human

Preventive

Controls

Animal

FSVP

Suppl. Prop. Final Large Small V. Small Water

FSMA Compliance Dates by Business Size (anticipated)

Questions?

www.pma.com

Thank YouJGorny@pma.com

Reference Sheet for FSMA Compliance Dates General Compliance Period

FSMA Rule

Final Rule

Publication

(Anticipated)

Required Compliance

Compliance

Deadline

(Anticipated)

Preventive Controls for Human Food 8-30-15 1 year after final rule 8-30-16

Preventive Controls for Animal Feed 8-30-15 1 year after final rule 8-30-16

Produce Safety 10-31-15 2 years + 60 days from final rule* 12-31-17

Foreign Supplier Verification Program 10-31-15 18 months from final rule † 4-31-17

3rd

Party Accreditation and Certification 10-31-15 After Model Accreditation Standards‡ -

Sanitary Transportation 3-31-16 1 year from final 3-31-17

Food Defense 5-31-16 1 year + 60 days from final rule 7-31-17

Small Business Compliance Period (less than 500 employees business-wide)

FSMA Rule

Final Rule

Publication

(Anticipated)

Required Compliance

Compliance

Deadline

(Anticipated)

Preventive Controls for Human Food 8-30-15 2 years from final rule 8-30-17

Preventive Controls for Animal Feed 8-30-15 2 years from final rule 8-30-17

Produce Safety 10-31-15 3 years + 60 days from final rule* 12-31-18

Foreign Supplier Verification Program N/A§ N/A§ N/A§

3rd

Party Accreditation and Certification N/A§ N/A§ N/A§

Sanitary Transportation 3-31-16 2 years from final rule 3-31-18

Food Defense 5-31-16 2 years + 60 days from final rule 7-31-18

Very Small Business Compliance Period (annual business food sales below applicable limit)

FSMA Rule Limit Final Rule

Publication

(Anticipated)

Required Compliance

Compliance

Deadline

(Anticipated)

PC Food <$1M 8-30-15 3 years from final rule 8-30-18

PC Feed <$2.5M 8-30-15 3 years from final rule 8-30-18

Produce Safety <$250K 10-31-15 4 years + 60 days from final rule* 12-31-19

FSVP <$500K 10-31-15 18 months from the final rule† 4-31-17

3rd

Party Accreditation N/A§ N/A§ N/A§ N/A§

Sanitary Transport N/A§ N/A§ N/A§ N/A§

Food Defense <$10M 5-31-16 3 years + 60 days from final rule 7-31-19

* 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.

‡ 3rd 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.

• 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

A Brief History…

Laboratory Services

Laboratory Analysis

•Additives

•Pesticides

•Mycotoxins

•Microbiology

•Fumigation

Research

Fresno Laboratory

Food Additives

• Include preservative

compounds:

-Sulfates & sorbic acid

in dried fruits.

-BHT in nuts.

• Amounts are critical.

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).

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

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)

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!

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 AccreditationFresno (Pesticide Analysis).

• 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

Accreditations

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 17025-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!

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).

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…

FSMA Related Services

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.

Commodity Inspection

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

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

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

The FSMA Benefit

Sanitary Transportation of food

Staff training (customizable)

Facility / process inspection & audit

Questions?