Food Safety Modernization Act - nyscheesemakers.com · •“The most sweeping reform of our food safety laws in more than 70 years.” •Refocus: reactive to preventive •Gave

Food Safety Modernization Act

NYS Cheese Manufacturers’ Association

7 March 2016

1

Agenda

• Overview of the Legislation

• Overview of FSMA Regulations

• NYS Role in FSMA

• Questions

2

Agenda




• Questions

3

FSMA: Legislative Overview

• “The most sweeping reform of our food safety laws in more than 70

years.”

• Refocus: reactive to preventive

• Gave new or expanded authority to FDA

• Standards for growing, harvesting, packing and holding produce on farms

• Require HACCP-like food safety plans for human food

• Require GMPs for animal feed

• Require HACCP-like food safety plans for animal feed

• Intentional Adulteration (Food Defense)

• Sanitary transportation of food

4

FSMA: Legislative Overview

• Authority to mandate recalls (and charge fees)

• Imported food: will be held to the same standard, ideally

• Foreign supplier verification program (FSVP)

• Third party accreditation

• Mandatory inspection intervals for domestic facilities

• Mandatory number of inspections for foreign food facilities

• Records, records, records

• High risk recordkeeping requirements

• Inspection of records authority

• Laboratory accreditation provisions

• Mandatory reporting to FDA for “food testing” results

5

Where are we now?

7

• September 17, 2015• Human Preventive Controls• Animal Preventive Controls

• November 27, 2015• Produce Safety• Third Party Accreditation• Foreign Supplier Verification

• March 31, 2015• Sanitary Transportation

• May 31, 2015 • Protection from Intentional Adulteration

Do you have a §415 food facility?

9

No. No registration.

Do you handle food?

Yes. Register unless an

exemption applies.

Any applicable exemption?

Retail food establishment

Farm

Foreign facility

Nonprofit food establishment

USDA regulated

Fishing vessel

Yes. No registration. No. Register as §415 Food

facility. Additional

standards apply.

Registered Facility Statistics Establishment Type (by activity)* Domestic Foreign

Facility Registrations (in total) 81,575 115,753

Warehouse/Holding Facility 237,845 101,982

Acidified/Low Acid Food Processor 4,703 16,845

Interstate Conveyance Caterer/Catering Point 8,760 11,863

Commissary 4,740 10,634

Contract Sterilizer 759 11,955

Labeler/Relabeler 22,396 55,995

Repacker/Packer 31,535 73,791

Manufacturer/Processor 35,466 98,157

Molluscan Shellfish Establishment 1,079 3,885

Salvage Operator (Reconditioner) 2,131 8,912

Animal Food Manufacturer/Processor/Holder 18,627 6,321

Other Activity Conducted (Animal consumption only) 2,720 8,121

15

NYS Registered Food Facilities

415 Facility Registrations (in total) 3,670

Manufactured Food Processors (20c) 1,560

Seafood and Juice HACCP 210

Warehouse/Holding Facility (28d) 1,400

Part 2 – Dairy 370

Grade A 50

Non-Grade A 320

Animal Manufacturing 130

16

Federal Inspection Frequency

• Registered food facilities & the primary function• First inspection (started in 2011):

• 7-years for “non high risk”

• 5-years for high risk

• Follow-up• 5-years thereafter

• 3-years thereafter

• Foreign food facilities: 600 per year, year following passage & inspection to double for the next 5 years

• 37,800 in six years had FDA met the 600 per year first year

17

Implementation Dates RegulationHuman Preventive Controls Very Smal l Faci l i ty (VSF) Option 3: <$1M^ human food 3 years*

Qual i fied Faci l i ty < $500K all food ^ + other

requirements

*

Smal l Faci l i ty Less than 500 employees 2 years

"Large" Faci l i ty None of the above 1 year

Animal Preventive Control Very Smal l Faci l i ty Option 3: <$2.5M^ animal food 3 years*

Qual i fied Faci l i ty QF < $500K^ animal food *



Produce Safety "Super" Smal l Bus iness Up to $25K^ value of produce Excluded Excluded

General Water

Qual i fied Exemption < $500K^ all food + other

requirements

N/A N/A

Very Smal l Bus iness $25K < VSF ≤ $250K^ value of produce 4 years* 6 years

Smal l Bus iness $250K < SF ≤ $500K^ value of produce 3 years* 5 years

"Large" Bus iness $500K+ value of produce 2 years 4 years

Business sizes Implementation

Poss ible 2-

s tage

phase

from GMP

21

Implementation Dates, cont’d.

22

RegulationForeign Supplier Verification

Proposed 21 CFR Part 1

Qual i fied < $500K all food ^ *

Very Smal l Option 3: <$1M^ all food 3.5 years*

Smal l Less than 500 employees 2.5 years

"Large" None of the above 1.5 year

Third Party Accreditation


N/A N/A N/A

Sanitary Transportation


Non-covered bus iness < $500K all food N/A

Smal l Bus iness < $25M (only carriers ); Less

than 500 employees (shippers ,

carriers , receivers )

2 years


Intentional Adulteration


Qual i fied Faci l i ty < $500K all food ^ + other

requirements

3 years*

Very Smal l Faci l i ty < $10M all food ^ 3 years*



Dairy Mi lk Farms UNKNOWN UNKNOWN

Business sizes Implementation

Agenda




• Questions

23

Agenda


• Human Preventive Controls

• Foreign Supplier Verification Program (FSVP)

• Third Party Accreditation

• Animal Preventive Controls

• Produce Safety

• Sanitary Transportation

• Intentional Adulteration

25

Preventive Controls Current Good Manufacturing Practices (cGMPs) and Hazard Analysis and Risk Based Preventive Controls (HARPC) for Human Food and Animal Feed

26

§ 103 Statutory Elements

• Applicable to § 415 registered food facilities

• Hazard analysis

• Preventive controls

• Monitoring preventive controls

• Corrective actions

• Verification & Validation of preventive controls

• Written plan of the above

• Recordkeeping (not less than 2 years)

• Requirement to reanalyze

• Recall plan

28

HPC Significant Features in the proposed regulation

• Written food safety plan for significant hazards & implement

preventive controls to ensure the hazard will be significantly

minimized or prevented

• Includes cross-contamination & food allergens

30

HPC Proposed Regulatory Structure

• Subpart A. General Provisions (Definitions)

• Subpart B. Current Good Manufacturing Practices

• Subpart C. Preventive Controls

• Subpart D. Modified Requirements for QF

• Subpart E. Withdrawal of Exemption Applicable to a QF

• Subpart F. Requirements Applicable to Records that Must be

Established and Maintained

• Subpart G. Supply Chain Program

31

Subpart A: Definitions & Applicability • Part 11 – Electronic records, doesn’t apply to part 117

• VSB: includes sales and processed food

• Hazards: any biological, chemical, physical, radiological

• Known or reasonably foreseeable hazard: known to be or potential to be associated with facility or

food

• Hazard requiring a preventive control: based on foreseeability, severity and probability of

occurrence

• Preventive controls qualified individual: completed training equivalent to the standardized curriculum

or job experience

• Qualified auditor: technical expertise through education, training or experience

• Qualified individual: education, training or experience necessary to manufacture, process, pack or

hold food

• Supplier: Manufacture, process, pack or hold food provided to a processing facility (not labeling)

• Supply-chain applied control: control applied before receipt by receiving facility

32

Exemptions & Modifications

• Small and very small businesses: Modified requirements

• Seafood (part 123) and Juice HACCP (part 120)

• LACF (part 113) with respect to microbial only

• Dietary Supplements (part 111)

• Farm mixed-type facility performing limited low risk packing &

holding / processing & manufacturing (117.5g & h)

• Solely the storage of packaged foods (117.7)

• Off farm holding of RACs (117.8)

33

Qualified Exemption for QFs

• VSB less than $1,000,000 sales of human food plus value of human

food manufactured processed, packed or held without sale

• Subpart C & G (Preventive Controls & Supplier Program) Exemption

• Qualified facilities, subject to modified requirements (not all modified

requirements created equally)

• Very Small Businesses

• Qualified facility requirements: Submit attestation information to FDA

(biennially)

• One of those evolving areas of analysis

34

Farm mixed type facility exemptions

• Small and very small businesses

• 117.5(h) Manufacturing and Processing if the only manufacturing and processing activities subject to registration

• Added product groupings to allow or disallow exemption

• Dried and dehydrated fruits (some)

• Other fruit and vegetable products

• Peanut and tree nut products

• Dried / Dehydrated herbs and spices

• Grains

• Milled grain products

• Other grain products

• Typical exempt foods

• Milling, baking, acidified fruits, coating some dried/dehydrated fruits and vegetables (not caramel apples), making jams and jellies with pH 4.6 or lower, packaging some foods, pasteurizing honey, roasting and toasting baked goods, sifting, salting some products, and more

35

Storage of packaged foods

• Subpart D – Modified Requirements

• Solely storage activities and food is unexposed to the environment, including packaged food requiring time/temperature controls

• Variation of modified requirements • Applies to packaged foods, including unexposed packaged foods that

require time/temperature control to significantly minimize or prevent the growth of pathogens

• Additional documentation regarding how to provide controls, monitoring, corrective action, verification, validation of temperature control

36

Hazards and Controls

• Hazard Levels • Hazard – potential to cause injury or illness• Known or reasonably foreseeable hazard – hazard known to be or

has the potential to be associated with facility or food• Hazard requiring a preventive control – known or reasonably

foreseeable hazard, reasonably knowledgeable person on the basis of hazard analysis (severity, probability) would establish 1+ preventive controls to significantly minimize or prevent

• Hazard Categories

• Controls• 6 types of controls • Waiver to Implement a preventive control

37

Subpart B: cGMPs

• Revise cGMPs currently at 21 CFR Part 110 and move to 21

CFR Part 117, Subpart B

• Language revisions and clean-up with minor changes

• Revising “shall” to “must”

• Phasing out Part 110

38

Subpart C: Hazard Analysis and Risk-Based Preventive Controls

• Written Food Safety Plan

• Hazard Analysis

• Preventive Controls

• Supply Chain Program

• Recall Plan

• Monitoring of Implemented Controls

• Corrective Actions

• Verification Procedures

39

Preventive Controls Process 1. Diagram Process Flow

2. Identify Hazards Requiring Significant Control• Identification (intentional and unintentional)

• Categorize (biological, chemical including radiological, physical)

• Determine significance (severity of illness and likelihood of occurrence)

• RTE Evaluation• i) Ready to eat food, ii) exposed to the environment, iii) prior

to packaging, iv) does not receive a treatment or include a control measure

40

Preventive Controls Process 3. Determine Preventive Controls or

Controlling Party • Categorize Controls

• Process (must validate)

• Food Allergen

• Sanitation

• Supplier

• Recall

• Other

• Controlled by other entity (customer, supplier)• Determine appropriate documentation to disclose or

maintain

41

Preventive Controls Process 4. Monitor

• Written procedures

• Exception records (for refrigeration)

5. Corrective Action • Anticipated

• Unanticipated

• Not applicable to: food allergen controls, sanitation controls, or minor/isolated problems not associated with food safety

43

Preventive Controls Process 6. Verification

• Written procedures • Includes calibration, environmental monitoring, product

testing, records monitoring, written procedures, etc.

7. Validation • Process controls only

8. Reanalysis• 3 years, when appropriate with significant change

44

Subpart D, E – Modified Requirements

• Available to Establishments based on size or limited activities • Affirmative submission of documents every other year

• Not required for non-QF establishments

• Procedures for withdrawing a modified exemption

46

Subpart F – Records

• Not subject to Part 11 – electronic records

• Owner must sign and date the food safety plan• On initial completion

• Upon modification

• Maintain for 2 years

• Maintain for 3 years if a Qualified Facility

• Original or true copy

• Off-site permitted if retrievable w/in 24 hours

47

Subpart G: Supply Chain Program

• Sophisticated, complicated, almost flexible

• Allows the use of approved and temporarily not approved suppliers

• Contemplates the use of: onsite audits, sampling, product testing, record review, written assurances of hazard controls, “other” methods

• Permits outsourcing of supplier program (including on-site audits), with appropriate receiving facility review

• May not: rely on supplier self-audit, supplier determined controls alone

• Contemplates receiving products from QF facilities and farms

48

Human Preventive Controls & Dairy

49

Grade A & Human Preventive Controls

50

Standards for Grade A IMS-Listed Dairy

Human PC

21 CFR part 117,

Subpart C

PMO

• Current structure• Regulated by the PMO

• State-Federal Cooperative Agreement

• Post Human PC• Existing PMO Model: will be

modified

• Human PC: not expecting an exemption for Grade A

• FSMA: Required an analysis of the PMO to Human PC

51

IMS Listed Facilities and Human PC

• Delayed implementation - September 17, 2018• Hazard identification for: physical, chemical, radiological, biological

• Environmental Monitoring

• Supplier Verification for risks controlled by the supplier

• Product Testing/Sampling (by the facility)

• What is the conversation? • Approach: Alignment through PMO Modification

52

Fed Reg. 55986 – PMO facilities

• we have extended the date for compliance with the requirements of subparts C and G in light of comments expressing an intent to revise the current requirements of a Federal/State cooperative program to incorporate the requirements of this rule. In other cases, a facility may determine and document through its hazard analysis that no preventive controls are necessary to prevent its food products from being adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act (see, e.g., Response 222, Response 226, Response 229, and the discussion of § 117.130 in section XXV). Such facilities, although not exempt, [PMO facilities] will have a reduced burden to comply with the rule, if the outcome of their hazard analysis is that there are no hazards requiring preventive controls.

53

Non-Grade A & Human Preventive Controls

56

Standards for Non IMS-Listed Dairy

State Standard

Federal cGMPs

21 CFR part 117,

Subpart B

• Current structure:• Most states have specialized

programs

• Federal cGMPs

57


Human PC

21 CFR part 117, Subpart C

State Standard

Federal cGMPs

21 CFR part 117, Subpart

B

• Post Human PC • UPDATED: Federal cGMPs

• NEW: Hazard Analysis and Risk-Based Preventive Controls

• State PMO-related provisions

• Other state standards

• Big Picture: Most other categories of food that had a pre-existing program were exempt from HPC, there is no applicable example.

58

Federal

Standards


Human PC

21 CFR part 117, Subpart C

State Standard

Federal cGMPs

21 CFR part 117, Subpart

B

• Current structure:• Most states have specialized

programs

• Federal cGMPs

• Post Human PC • UPDATED: Federal cGMPs

• NEW: Hazard Analysis and Risk-Based Preventive Controls

• NYS PMO-related provisions

59

Federal

Standards

Importer Regulation Foreign Supplier Verification Program

86

Foreign Supplier Verification Program

“Same level of public health protection as the preventive controls or produce

safety regulation”

• 6 months lag behind supplier controls requirements

• Requirement for importers to implement foreign supplier verification program or

comply with (human and animal) Preventive Controls and Produce Safety for

imported food.

• Importers: purchaser, consignee, or representative, not necessarily a registered

facility

• Foreign supplier: final manufacturer / processer before export

• Contemplates outsourcing FSVP procedures w/ appropriate review

87

FSVP, cont’d.

• Applies to food sales greater than $1 million for human food,

$2.5 million for animal food

• Exemptions & Modified Requirements• Seafood & Juice HACCP

• Food for research or

• Personal consumption

• Import / Processing and Export

• VSB (importer/supplier): All food sales <$1 million (3-year avg.)

88

Agenda




• Questions

106

Road to Compliance

• FDA

• FDA received $104.5 million dollars

• User fees for the remainder (imported food lines)

• Preventive Controls: no nationwide state cost estimate

• Alliances

• Produce Safety Alliance

• Preventive Controls Alliance

107

What about NYS and FSI?

• Departmental Impact / Changes

• Human Preventive Controls (3,700 facilities)

• 20-C facilities (not all); 28d Warehouses (1,400), Part 2 (370)

• Animal Preventive Controls (around 130)

• Produce Safety (500- 800 not eligible for size exemption)

• Modifying current inspections

• Training

• Alliance training

• Regulator training

108

Agenda




• Questions / Recommendations

109

Recommendations

• Attend the Preventive Controls Alliance Training

• Develop an internal FSMA committee

• Work with your state/national organizations to maintain

awareness

• Review existing food safety documents

• As a supplier: don’t anticipate being able to rely on an

exemption

110

Documents

Food Safety Modernization Act - nyscheesemakers.com · •“The most sweeping reform of our food safety laws in more than 70 years.” •Refocus: reactive to preventive •Gave