fda food safety modernization act (fsma) january 4, … act.pdf · fda food safety modernization...

FDA Food Safety Modernization Act

(FSMA)

January 4, 2011

FDA Food Safety Modernization Act (FSMA)

The Most Sweeping Reform of

the U.S. Food Safety Laws in More than

70 Years

FDA Food Safety Modernization Act (FSMA)

The Goal of the Act is to ensure

the US food supply is safe by shifting focus from responding to

contamination to preventing it

Table of Contents - Introduction - History - Title I – Improving capacity to prevent food safety problems - Title II – Improving capacity to detect and respond to food safety problems - Title III – Improving the safety of imported food - Title IV - Miscellaneous provisions - HACCP and FSMA

Main Themes of FDA Food Safety Modernization Act

Science-Based,

Risk-Based Preventive Controls

Enhanced Partnership

Import Safety Inspection, Compliance and Response

- Introduction -

Strategic Communications & Outreach Team –

Prevention Standards

Inspection & Compliance

Imports

Importer Verification &

VQIP

Accredited Third- Party Certification

Lab Accreditation & Integrated Consortium /

FERN

Fees Federal/State

Integration

Reports & Studies

Operational Partnership

Capacity Building

Produce Safety Regulation

Produce Safety Guidance

Preventive Controls

Regulation

Preventive Controls Guidance

Mandatory Recall / Recall

Communications

Tracing

Inspection & Auditor Fees

Reports to Congress/

Studies

Comparability

Task A: Prior Notice

Training Frequency of

Inspection

Administrative Enforcement

Tools

Safe Food Transport

Food Defense

Contaminants

Import Certification

Registration

RFR Improvements

Manner of Inspection / Food Safety Plan Review

International Capacity Building

Implementation Executive Committee

History of Food Safety Agricultural Revolution and Food Safety

Scientific Revolution and Food Safety

Industrial Revolution and Food Safety

Codex Alimentarius Austriacus

The US Food, Drugs and Cosmetic Act of 1938

Space Age and Food Safety (HACCP)

The Codex Alimentarius of the United Nations

The FDA Food Safety Modernization Act of 2011

Title I

Improving Capacity to

Prevent Food Safety Problems

TITLE I Section 101. Inspections of records. Section 102. Registration of food facilities. Section 103. HAZARD ANALAYSIS AND RISK- BASED PREVENTIVE CONTROLS. Section 104. Performance standards. Section 105. Standards for produce safety. Section 106. Protection against intentional adulteration. Section 107. Authority to collect fees. Section 108. National Agriculture and food defense Strategy.

TITLE I Section 109. Food and Agriculture Coordinating Councils. Section 110. Building domestic capacity. Section 111. Sanitary transportation of food Section 112. Food allergy and anaphylaxis management Section 113. New dietary ingredients Section 114. Requirement for guidance relating to post harvest processing of raw oysters Section 115. Port shopping. Section 116. Alcohol related facilities

FDA FSMA Proposed Rule for Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

Title 21 Part 110 change to 117 cGMPs not revised since 1986

www.fda.gov/fsma

August 2015 - Final Rule

- The owner, operator, or agent in charge of

a facility shall: - Evaluate hazards that affect foods: - Manufactured - Processed - Packed - Held - Identify and implement preventive controls:

-

- Identify and implement preventive controls: - To significantly minimize or prevent the occurrence of such hazards - Assurance that food is not adulterated or misbranded - Monitor the performance of the controls - Routinely keep records of these monitoring activities

-The owner, operator, or agent in charge of a facility shall: - Perform Hazard Analysis to - Identify and evaluate hazards known or reasonably foreseeable that may be associated with the facility including: - Biological hazards - Chemical hazards - Physical hazards - Radiological hazards - Natural toxins

- Pesticides - Drug residents - Decomposition - Parasites - Allergens

-

- Unapproved food - Color additives - Naturally occurring - Intentional hazards - Food Defense

-The owner, operator, or agent in charge of a facility shall: - Develop a written analysis of the hazards - Identify and implement preventive controls - Including at critical control points (if any) To - significantly minimize or prevent the identified hazards - That the food is not adulterated - That the food is not misbranded

-The owner, operator, or agent in charge of a facility shall: - Monitor the effectiveness of the preventive controls that are implemented and insure safe food production - Establish Corrective Action procedures for ineffective or improperly implemented preventive controls to: - Reduce the likelihood of recurrence of implementation failure - All effected food are evaluated for safety - Ensure that adulterated or misbranded foods don not enter into commerce

-The owner, operator, or agent in charge of a facility shall: - Verify that implemented preventive controls are adequate to control the identified hazards - that monitoring and corrective actions are done - that preventive controls are effectively and significantly minimize or prevent the occurrences of identified hazards using product and environmental testing and other appropriate means - that periodically reanalyze and document the food safety plan for relevancy to raw material, new merging treats and conditions and processes

-The owner, operator, or agent in charge of a facility shall: - Document and keep records for not less than two years of: - Monitoring records of implemented preventive controls - Instances of nonconformance material to food safety - Results of testing and other appropriate means of verification - Instances of implemented corrective actions - Efficacy of preventive controls and corrective actions

-The owner, operator, or agent in charge of a food facility shall: - Prepare a written food safety plan that documents and describes the procedures used by the facility to comply with the Act including - Analyzing hazards - Identifying preventive controls - Documentation and records mentioned previously - The plan and related records and documents must all be promptly available to authorized representative of the Secretary upon oral or written request

-The owner, operator, or agent in charge of a food facility shall: - Conduct a reanalysis whenever: - a significant change is made that creates a potential for a new hazard - or significant increase in previously identified hazard OR - Not less than frequently once every 3 years whichever is earlier - New hazard, new scientific understanding or the order by the Secretary due to Risk assessment by the Department of Homeland Security (DHS)

- “This section shall not apply to a facility if the owner, operator, or agent in charge of this facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facilities: (A) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration. (B) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

This section shall not (C) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or successor standards) - The exemption under (C) shall apply only microbiological hazards that are regulated under LAFP and qualified facilities

Prevention:

For the First Time FDA Has Legislative Mandate

to Require

Science-Based Preventive Controls

Across the Food Supply Chain

Global Food Supply Chain

Production (Land and Water)

Manufacturing

Processing

Distribution

Consumption

Mandatory Preventive Controls for Food Facilities

- Food facilities are required to implement a Written Preventive Food Safety Plan that involves 1. Evaluating hazards that could effect food safety 2. Specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards 3. Specifying how the facility will monitor these controls to ensure they are working

Mandatory Preventive Controls for Food Facilities

4. Maintaining routine records of monitoring 5. Specifying the actions the facility will take to correct problems that arise

Food Safety Preventive Controls Alliance

(FSPCA) Established 2011 as part of grant by FDA to IFSH

- Broad-based public private alliance - Public – Key Industry – Academia - Illinois Institute of Technology Institute for Food Safety and Health (IFSH) - Mission:” to support safe food production by developing a nationwide core curriculum, training and outreach programs to assist companies producing human and animal food in complying with the preventive controls regulations that will be part of the Food Safety Modernization Act (FSMA).”

Food Safety Preventive Controls Alliance (FSPCA)

HAZARD ANALYSIS

AND PREVENTIVE CONTROLS

FOR HUMAN FOOD

Draft Training Curriculum


-The curriculum is - Standardized - Industry-oriented - Focused on food safety activities and documentation for implementation of a preventive controls food safety plan in compliance with:

Hazard Analysis And

Risk-Based Preventive Controls for

Human Food Rule


-The participants will learn how to develop -A Risk-Based Food Safety Plan and

Implement Preventive Controls - To meet the requirement for training under Title 21 Code of Federal Regulations Part 117.155 for the “qualified individual” - Class room setting (2.5 days) or - Self-guided internet version (Segment 1) plus - One day in person (Segment II) - A Certificate of Course Completion is Given


- The FSPCA course is standardized and recognized by FDA and against which other training courses will be evaluated. - Attending an FSPCA course is not mandatory, but provides assurance that the course content and resulting knowledge is consistent with regulatory expectations.


The Outline of the Course Hazard Analysis

and Preventive Controls

for Human Food


Chapter 1: Introduction to Course Chapter 2: Food Safety Plan Review Chapter 3: Good Manufacturing Practices and other Prerequisite Programs Chapter 4: Food Safety Hazards Chapter 5: Preliminary Steps in Developing a Food Safety Plan


Chapter 6: Hazard Analysis and Preventive Controls Determination Chapter 7: Process Preventive Controls Chapter 8: Food Allergen Preventive Controls Chapter 9: Sanitation Preventive Controls Chapter 10: Supplier Program Chapter 11: Recall Plan Chapter 12: Verification and Validation Procedures Chapter 13: Record-Keeping Procedures


Chapter 14: Regulation Overview – cGMP and Hazard Analysis and Risk-Based Preventive Controls for Human Food Chapter 15: Resources for Food Safety Plans Chapter 16: Preventive Controls for Human Foods Review


Appendix 1: FDA Regulation on cGMPs and Hazard analysis and Risk-Based Preventive Controls for Human Food (FSMA Sec. 103) Appendix 2: Food Safety Plan Worksheets Appendix 3: Food Safety Plan Example: Frozen Omelets Appendix 4: Foodborne Pathogen Supplementary Information Appendix 5: Sanitation Basics, Hygienic Zoning and Environmental Monitoring Supplemental Information


Appendix 6: Evolution of Risk-Based Food Safety Preventive Controls - History of HACCP - HACCP principles related to preventive controls - How a HACCP plan fits into a preventive controls Food Safety Plan

HACCP Plan VS

Food Safety Plan


FSPCA General Overview and Plans for

Implementation Katherine M.J. Swanson, Ph.D. President, KMJ Swanson Food Safety, Inc. FSPCA Curriculum Development Program Manager and Executive Editor 5 February 2015, 3M Food Safety Global Business Meeting, St. Paul, MN

Food Safety Preventive Controls Alliance (FSPCA) By Dr. Katherine M.J. Swanson, Ph.D.

Preventive Food Safety Systems

A

Food Safety Plan

- Water - Handwashing - Training - Pest control - Specifications - Equipment maintenance etc.

GMPs and Prerequisite Programs

Hazard Analysis

Recall plan

Process Control

Supplier Control

Sanitation| Control

Allergen Control


HACCP Focuses on the Process

A

Hazard Analysis

Critical Limits

CCPs

Monitor

Corrections/ Corrective Actions

Verification and Recordkeeping


HACCP Focuses on the Process

A

Hazard Analysis

Parameters and Values

Preventive Controls (CCPs and others))

Monitor

Corrections/ Corrective Actions

Verification and Recordkeeping


Components of a

Food Safety Plan


Not Required by FSMA But Useful Information:

- Food Safety Team - Product Description - Flow Diagram - Process Narrative


Required Written Elements:

- Hazard Analysis - Preventive Controls - Monitoring Procedures, Including Frequency - Corrective Action or Correction Procedures - Verification Procedures - Recall plan


Subsections for Procedures and Records

- Procedures and records are required for these elements: - Monitoring - Corrections or corrective actions - Verification including validation if appropriate - Recall plan

Title I Section 105

Standards for Produce Safety

Title I Section 105

Standards for Produce Safety

- FDA must establish science-based minimum standards for the safe production and harvesting of fruits and vegetables.

Title I Section 105 Standards for

Produce Safety

- Those standards must consider - Naturally occurring hazards - Intentional - Unintentional - Soil Amendment - materials added to the soil such as compost - Water


Produce Safety

- Hygiene - Packaging - Temperature controls - Animal in growing areas - Domestic - Wild


Produce Safety

- FDA Draft Environmental Impact Statement (EIS) for the Produce Rule: Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption

http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM429442.pdf

Title I Section 106

Protection Against Intentional Adulteration

- FDA must issue regulations to protect against the intentional adulteration of food, including establishment of SCIENCE-BASED MITIGATION STRATEGIES to prepare and protect the food supply chain at vulnerable points.

Title II

IMPROVING CAPACITY TO DETECT AND RESPOND

TO FOOD SAFETY PROBLEMS

.

TITLE II

Section 201. Targeting of inspection resources for domestic facilities, foreign facilities and ports of entry; annual report. Section 202. Laboratory accreditation for analysis of foods Section 203. Integrated consortium of laboratory networks Section 204. Enhancing tracking and tracing of food and recordkeeping. Section 205. Surveillance Section 206. Mandatory recall authority

TITLE II

Section 207. Administrative detention of food. Section 208. Decontamination and disposal standards and plans Section 209. Improving the training of State, local, territorial and tribal food safety officials Section 210. Enhancing food safety Section 211. Improving the reportable food registry

Improving Capacity to Detect and Respond

to Food Safety Problems The Food Safety Modernization Act (FSMA) provides FDA with important new tools for - Inspection and Compliance - Mandated Inspection Frequency - Record Access - Testing by Accredited Laboratories

Improving Capacity to Detect and Respond

to Food Safety Problems The Food Safety Modernization Act (FSMA) provides FDA with important new tools for - Response - Mandatory Recall - Expanded Administrative Detention - Suspension of Registration - Enhanced product tracing abilities - Additional Recordkeeping for High Risk Foods

TITLE III

IMPROVING THE SAFETY

OF IMPORTED FOOD

TITLE III

Section 301. Foreign supplier verification program. Section 302. Voluntary qualified importer program. Section 303. Authority to require import certifications for food Section 304. Prior notice of imported food shipments Section 305. Building capacity of foreign governments with respect to food facilities Section 306. Inspection of foreign food facilities

TITLE III

Section 307. Accreditation of third-party auditors Section 308. Foreign offices of the Food and Drug Administration Section 309. Smuggled food

Improving the Safety of Imported Food

The Food Safety Modernization Act (FSMA) gives FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. New authorities include: - Importer Accountability - Third Party Certification - Certification for High Risk Foods - Voluntary Qualified Importer Program - Authority to Deny Entry

TITLE IV MISCELANEOUS

PROVISIONS

Section 401. Funding for Food Safety. Section 402. Employee Protections. Section 403. Jurisdiction; Authorities Section 404. Compliance with International Agreements Section 405. Determination of Budgetary Effects

Risk Analysis

Codex Alimentarius Risk Analysis Model (Accepted by FDA)

Risk Assessment 1. Hazard Identification

2. Hazard Characterization

3. Exposure Assessment

4. Risk Characterization

Food Safety Risk is

Probability and extent of exposure during production, processing,

transportation, sale and consumption X

Probability and severity of consequences determined by

dose response, probability of illness and population health burden

(by FDA)

Variables Used in Determining Food Safety Risk

- Food - Hazard - Population - Process model - Production - Manufacturing - Transportation - Storage - Consumption pattern - Dose response - Health Effect (by FDA)

The Central themes of FDA Food Safety Modernization Act of

2011 is to protect public health by using a food safety system along the food supply chain that is

SCIENCE-BASED,

RISK-BASED, HAZARD ANALYSIS

AND PREVENTIVE CONTROLS

SCIENCE + PREVENTION

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