fda food safety modernization act (fsma) january 4, … act.pdf · fda food safety modernization...
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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 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
-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
Food Safety Preventive Controls Alliance (FSPCA)
-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
Food Safety Preventive Controls Alliance (FSPCA)
-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
Food Safety Preventive Controls Alliance (FSPCA)
- 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.
Food Safety Preventive Controls Alliance (FSPCA)
The Outline of the Course Hazard Analysis
and Preventive Controls
for Human Food
Food Safety Preventive Controls Alliance (FSPCA)
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
Food Safety Preventive Controls Alliance (FSPCA)
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
Food Safety Preventive Controls Alliance (FSPCA)
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
Food Safety Preventive Controls Alliance (FSPCA)
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
Food Safety Preventive Controls Alliance (FSPCA)
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
Food Safety Preventive Controls Alliance (FSPCA)
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
Food Safety Preventive Controls Alliance (FSPCA)
HACCP Focuses on the Process
A
Hazard Analysis
Critical Limits
CCPs
Monitor
Corrections/ Corrective Actions
Verification and Recordkeeping
Food Safety Preventive Controls Alliance (FSPCA)
HACCP Focuses on the Process
A
Hazard Analysis
Parameters and Values
Preventive Controls (CCPs and others))
Monitor
Corrections/ Corrective Actions
Verification and Recordkeeping
Food Safety Preventive Controls Alliance (FSPCA)
Not Required by FSMA But Useful Information:
- Food Safety Team - Product Description - Flow Diagram - Process Narrative
Food Safety Preventive Controls Alliance (FSPCA)
Required Written Elements:
- Hazard Analysis - Preventive Controls - Monitoring Procedures, Including Frequency - Corrective Action or Correction Procedures - Verification Procedures - Recall plan
Food Safety Preventive Controls Alliance (FSPCA)
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
- 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
Title I Section 105 Standards for
Produce Safety
- Hygiene - Packaging - Temperature controls - Animal in growing areas - Domestic - Wild
Title I Section 105 Standards for
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
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
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 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)
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)
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