FSMA s Foreign Supplier Verification Program
|
|
- Claude Patrick
- 6 years ago
- Views:
Transcription
1 Understanding the Proposed Rule: FSMA s Foreign Supplier Verification Program FDA s proposed rule creates a fundamental shift in oversight of imported foods from that of inspection/examination at the port of entry to responsibility placed in the hands of the foreign supplier and importer. BY CLIFF PAPPAS 6 SEPTEMBER/OCTOBER 2013 AIB UPDATE
2 An FDA consumer safety officer working at the border crossing prepares tomato samples for testing by the FDA mobile laboratory unit. On July 29, 2013, the FDA released its proposed Foreign Supplier Verification Program (FSVP) rule. This proposed rule falls under section 301 of the Food Safety Modernization Act (FSMA) and impacts food facilities worldwide that export food to the United States. It is available for comment until November 26, Under the proposed rule, all importers of food for human and animals, unless exempt or subject to modified requirements, would be required to develop, maintain, and follow a FSVP. This is a fundamental shift in oversight of imported foods from one relying on inspection/examination of imported foods at the port of entry to a system that places the responsibility for food safety on the foreign supplier and importer. FDA maintains that the proposed rule represents a flexible, risk-based approach to foreign supplier verification that is intended to be sufficiently general and flexible to apply to a variety of circumstances without being unduly burdensome or restrictive of trade. AIB UPDATE SEPTEMBER/OCTOBER
3 WHO IS THE IMPORTER? An importer is defined as the person in the U.S. who purchased the food. If the food has not been sold to a person in the U.S., it would be the U.S. consignee. If there is no owner or consignee, this is the U.S. agent or representative of the foreign supplier. WHO IS THE FOREIGN SUPPLIER? A foreign supplier is defined as the farm that raised the animal or harvested the imported food or the last foreign establishment that manufactured or processed the imported food in more than a minimal manner. (Examples of minimally processed are adding a label, packing, or holding.) KEY FEATURES For each imported food, unless otherwise exempt or subject to modified requirements, the importer would be required to maintain and follow an FSVP with certain standard requirements, including: 1. A qualified individual as defined in the proposed rule would be required to develop the FSVP and perform most verification activities. A qualified individual is someone with the necessary education, training, and experience to perform each of the activities within the FSVP, including on-site auditing. This person would perform verification activities related to preventive controls and must have training or experience in preventive controls. The qualified individual is not required to be an employee of the importer. These requirements are similar to those proposed in the preventive controls rule. 2. A list of its foreign suppliers. 3. A review of the compliance status of the food and supplier. 4. A hazard analysis to determine the hazards reasonably likely to occur in the imported food. This evaluation would include: Ingredients of the food. Condition, function, and design of the foreign supplier s establishment and equipment. Transportation practices. Harvesting, raising, manufacturing, processing, and packing procedures. Packaging and labeling activities. Storage and distribution. Intended or foreseeable use of the food. Sanitation, including employee hygiene. Any other relevant factors, such as a natural disaster, affecting the foreign supplier facility. 5. Determine and document appropriate Foreign Supplier Verification (FSV) activities to provide adequate assurances that the hazards identified as reasonably likely to occur are adequately controlled: Verification Option 1. For any hazard that has a reasonable probability of causing serious adverse health consequences of death to humans or animals (SAHCODHA), the importer would be required to conduct or obtain documentation of an on-site audit before importing the food and at least annually thereafter. For all other 8 SEPTEMBER/OCTOBER 2013 AIB UPDATE
4 FDA consumer safety officers work at the border crossing preparing samples for testing by the FDA mobile laboratory. At left, officers prepare samples of yellow squash. At right, the officer prepares pepper samples. hazards (food), the importer would be able to choose from a series of verification activities that include on-site audits, periodic or lot-by-lot sampling and testing, periodic review of the foreign supplier s food safety records, and/or other appropriate practices (not defined). The on-site inspection goes beyond the requirements for seafood and juice, both of which are considered high risk foods. Verification Option 2. For any hazard the importer could choose from the verification activities identified above for non-sahcodha hazards and establish written procedures for conducting FSV activities. For thermal processed low-acid foods packaged in hermetically sealed containers, the importer would have to have a FSVP. If the food is produced in accordance with 21 CFR 113, then biological verification can be through the supplier s compliance with A review of all complaints, instances of adulteration, or misbranding, and associated appropriate corrective actions, which could include discontinuing the use of a foreign supplier. 7. A reassessment of the FSVP at least once every three years and upon becoming aware of new information about potential hazards associated with the imported food. 8. The Dun and Bradstreet Data Universal Numbering System (DUNS) number for each foreign supplier when filing entry with Customs and Border Protection (CBP). 9. Record retention in English for at least two years, making records available to FDA upon request, and sending records electronically in response to a written request. VERIFICATION DETAILS The importer would be required to verify only its foreign supplier. The importer would not be required to verify any entities before the foreign supplier. The importer would only have to verify those issues identified in the importer s hazard analysis as reasonably likely to occur. In instances where there are other FDA regulations (produce standards), these could take precedence over control of the hazard. Where a hazard is controlled by the importer s customer, FSVP may not be required. The importer would be required to provide documentation, at least annually, that the importer or customer is following procedures that adequately control the hazard or obtain at least annually written documentation from the customer they are following procedures that adequately control the hazard. MODIFICATIONS AND EXEMPTIONS Modified requirements would apply to dietary supplements components, including direct contact packaging or if the importer s customer is required to meet Part 111. The importer must verify the dietary supplement is produced in compliance with 21 CFR Part 111. If the importer is in compliance with Part 111 (determine such requirements have AIB UPDATE SEPTEMBER/OCTOBER
5 been met), then the importer would only be required to: Maintain all records in English for at least two years, make records available to FDA upon request, and send records electronically in response to a written request. Modified requirements would apply to finished dietary supplements, in which the importer must: Develop, maintain, and follow a FSVP. Have a qualified individual develop the FSVP and complete the verification activities. Complete a compliance review. Review complaints, instances of adulteration, instances or misbranding, and associated corrective actions. Reassess the FSVP as required. Follow written procedures for conducting foreign supplier verification, including on-site audits; periodic or lot-by-lot sampling and testing; periodic review of the foreign supplier s food safety records; and/or other appropriate practices (not defined). There may be an exemption where the importer is the same corporate family as the foreign supplier. Since both parties could be subject to a single company-wide approach to food safety in which hazards are controlled and verified by a common supply chain management system. FDA is seeking comment on this exemption. Similar requirements would be in place for food from a very small supplier. There are some modified rules for very small importers with annual sales less than $500,000. These include: Document annually they still meet the definition. Develop, maintain, and follow a FSVP. Have a qualified individual develop the FSVP and complete the verification activities. Complete a compliance review. Obtain written assurance (brief description of the foreign supplier s processes and procedures) before FDA mobile lab analysts prepare to test produce crossing the border for Salmonella and E. coli. Mobile laboratories help FDA quickly test food and drugs for contaminants. When not deployed, the mobile labs are stationed at FDA s Jefferson, Arkansas Regional Laboratory. importing the food and every two years thereafter. Promptly take and document corrective action if it is determined that a foreign supplier is not producing food in compliance with the appropriate standard or is adulterated under section 402. Maintain all records in English for at least two years, make records available to FDA upon request, and send records electronically or by mail in response to a written request. There also are modified requirements for foods from countries whose food safety systems have been officially recognized by FDA as comparable or equivalent to that of the U.S. New Zealand is currently the only country with this designation; however, FDA has initiated systems recognition assessment with Canada. COMPLIANCE Importation of certain foods: juice and seafood produced in compliance with juice/ seafood HACCP regulations, alcoholic beverages, food imported for research or evaluation, food for personal consumption, and food transshipped through the U.S. or imported for export are exempt. An article of food offered for import would be subject to refusal if it even appears that the importer is not in compliance with the FSVP requirements. Generally compliance would be 18 months after publication of the final rules. However, FDA recognized that an importer cannot be expected to verify its foreign supplier s compliance with preventive controls before the foreign supplier is required to comply with the preventive controls. Therefore, FSVP will be required six months after the date that the foreign supplier of the specific food is required to comply with the relevant preventive controls rule. If the food is a raw agriculture commodity (RAC), compliance will be 18 months after the date of publication of the FSVP rule or six months after required compliance to the produce safety rule, whichever is later. AIB The author is Senior Advisor, Quality Systems and HACCP for AIB International. 10 SEPTEMBER/OCTOBER 2013 AIB UPDATE
Food Safety Modernization Act (FSMA) & Imports of Food Products. August 9 th, 2016 Russell Statman, Registrar Corp
Food Safety Modernization Act (FSMA) & Imports of Food Products August 9 th, 2016 Russell Statman, Registrar Corp Background TIMELINE OF U.S. FOOD REGULATION Until 1906 The Jungle Background TIMELINE OF
More informationForeign Supplier Verification Programs: The Final Rule.
Foreign Supplier Verification Programs: The Final Rule http://www.fda.gov/fsma 1 Background FSMA Sec. 301 requires importers to have FSVPs and FDA to issue regulations. Proposed rule: July 29, 2013 Supplemental
More informationThe Food Safety Modernization Act: What Exporters to the U.S. Need to Know. Erik R. Lieberman Prepared for AgroBalt 2014 April 4, 2014
The Food Safety Modernization Act: What Exporters to the U.S. Need to Know Erik R. Lieberman Prepared for AgroBalt 2014 April 4, 2014 Food Marketing Institute Trade association for the supermarket industry
More informationBy Dr. Ramakrishnan Nara
A By Dr. Ramakrishnan Nara s the population of the U.S. becomes ethnically value of imports from the top 10 importing more diverse and their appetite for a variety countries and the value of food product
More informationWhitepaper April 2014 UNDERSTANDING THE US FOOD SAFETY MODERNIZATION ACT 2011
Whitepaper April 2014 UNDERSTANDING THE US FOOD SAFETY MODERNIZATION ACT 2011 Its Implications and Impacts on Suppliers, Producers and Exporters in Europe If your company exports food to the US or you
More informationThe Food Safety Modernization Act and Its Implications for USDA and Dual Jurisdiction Establishments
The Food Safety Modernization Act and Its Implications for USDA and Dual Jurisdiction Establishments April 6, 2016 Jolyda Swaim Principal Attorney Olsson Frank Weeda Terman Matz PC jswaim@ofwlaw.com 1
More informationAnalysis. Domestic Supplier Verification FDA Position in Proposed FDA Position in Supplemental
To: Stephanie Barnes, Food Marketing Institute From: Erik R. Lieberman Date: Re: FSMA Final Preventive Control for Human Food -Comparison with s and Proposed and Proposed s You asked us to draft a memorandum
More informationUS FOOD SAFETY MODERNIZATION ACT (FSMA) IMPACTS ON GLOBAL FOOD TRADE, CAPACITY BUILDING AND TRAINING
US FOOD SAFETY MODERNIZATION ACT (FSMA) IMPACTS ON GLOBAL FOOD TRADE, CAPACITY BUILDING AND TRAINING Katherine M.J. Swanson and Robert E. Brackett 4 th Asia-Pacific International Food Safety Conference
More informationU.S. FSMA Seminar: Practices
U.S. FSMA Seminar: Practices Case Studies 1 Q1 Registration of Food Facility Company A contracts out production to Company B and Company C. 1. Which company is responsible for applying to a facility registration?
More informationFinal Rule for Preventive Controls for Animal Food
Final Rule for Preventive Controls for Animal Food http://www.fda.gov/fsma THE FUTURE IS NOW 1 Background Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food
More informationSupplement FSSC & FSMA for Human Food FOOD SAFETY SYSTEM CERTIFICATION Supplement FSSC & FSMA for Human Food
Supplement FSSC & FSMA for Human Food FOOD SAFETY SYSTEM CERTIFICATION 22000 Supplement FSSC 22000 & FSMA for Human Food Version 1.0: September 2017 Supplement FSSC 22000 & FSMA for Human Food Contents
More informationDRAFT: FSSC FSMA Comparison
http://www.achesongroup.com jennifer@achesongroup.com 301-551-3601 December 2013 DRAFT: FSSC 22000 FSMA Comparison Scope of Evaluation and Summary This evaluation was done to demonstrate how FSSC 22000
More informationFSMA Food Safety Seminar Japan External Trade Organization
FSMA Food Safety Seminar Japan External Trade Organization U.S. Food and Drug Administration s Risk-Based Preventive Controls for Human Food & Supply Chain Preventive Controls January 2017 Jolyda Swaim
More information20 THINGS YOU NEED TO KNOW ABOUT FSMA
FreshTech Learning Center 20 THINGS YOU NEED TO KNOW ABOUT FSMA Learning Center Sponsored by: Top 20 Things You Need To Know About the Five FSMA Rules David L. Durkin OFW Law June 22, 2016 With special
More information3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series
3M Health Care Academy 3M Health Care Academy SM 3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series Host Kevin Habas, 3M Food Safety Active in the Food Safety market for
More informationMoving from HACCP to HARPC Practical Steps to Compliance
Moving from HACCP to HARPC Practical Steps to Compliance March 19, 2016 Overview What s FDA Up To? Where do you fall? Training Programs Evaluate & update GMPs Establish Preventive Controls Implement verification
More informationFSMA Final Rules: Foreign Supplier Verification, Accredited Third Party Certification, and Produce Safety
FSMA Final Rules: Foreign Supplier Verification, Accredited Third Party Certification, and Produce Safety Webinar for the American Frozen Food Institute Elizabeth Barr Fawell, Counsel Maile Gradison Hermida,
More information3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series
3M Health Care Academy 3M Health Care Academy SM 3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series Host Kevin Habas, 3M Food Safety Active in the Food Safety market for
More information3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series
This image cannot currently be display ed. 3M Health Care Academy 3M Health Care Academy SM 3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series Host John Wadie, 3M Food Safety
More informationFood Safety Modernization Act (FSMA): FDA Proposed Animal Feed Rule Florida Overview. Susan Caime Mardenborough September 18, 2014
Food Safety Modernization Act (FSMA): FDA Proposed Animal Feed Rule Florida Overview Susan Caime Mardenborough September 18, 2014 Agenda Background on FSMA Highlights of Proposed Animal Feed Rule Coverage
More informationSUPPLIER AUDITS AND FSMA CERTIFICATION. Hank Karayan, SGS Global FSMA Program Director May 24, 2018
SUPPLIER AUDITS AND FSMA CERTIFICATION Hank Karayan, SGS Global FSMA Program Director May 24, 2018 1 FSMA RULES & THEIR APPLICABILITY 7 Rules of FSMA Manufacture, Processing, Dist n Centers & Warehouses
More informationFSMA Ready? Here s Your List of To-dos
FSMA Ready? Here s Your List of To-dos March 14, 2016 Hilary Thesmar, PhD, RD, CFS, VP Food Safety Programs, FMI Questions/Answers Q: It seems the vast majority of the training sessions from FSPCA are
More informationFDA FSMA Timeline. July 29, 2009 House version passed. Nov. 30, 2010 Senate version passed. Dec. 19, 2010 Senate revised version passed
Food Safety Modernization Act (FSMA) FDA FSMA Timeline July 29, 2009 House version passed Votes 283-142 Nov. 30, 2010 Senate version passed Votes 73-25 Dec. 19, 2010 Senate revised version passed Unanimous
More informationFSMA FACTS. Final Rule on Preventive Controls for Human Food
FSMA FACTS Final Rule on Preventive Controls for Human Food Summary The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses
More informationFood Safety Modernization Act (FSMA) Key Points for Warehouses. June David Hakes-Regulatory Manager
Food Safety Modernization Act (FSMA) Key Points for Warehouses June 2013 David Hakes-Regulatory Manager Agenda Presentation Objective Why FSMA History & Leadership What is Congress & FDA trying to do Components
More informationFDA Publishes Final Rule on CGMPs, Hazard Analysis, and Preventive Controls for Human Food
FDA Publishes Final Rule on CGMPs, Hazard Analysis, and Preventive Controls for Human Food September 17, 2015 Food & Drug Today, the Food and Drug Administration (FDA) issued its long-anticipated final
More informationNovember 15, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852
November 15, 2013 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 RE: Proposed Rule - Current Good Manufacturing Practice and Hazard
More informationFood Safety Modernization Act An Industry Perspective
Food Safety Modernization Act An Industry Perspective JIFSAN Feeding the World Population May 16, 2012 Peggy Rochette Senior Director, Global Strategies GMA Member Companies *Represents a sample of GMA
More informationPRIOR NOTICE OF IMPORTED FOOD SHIPMENTS
U.S. Food and Drug Administration Protecting the U.S. Food Supply U.S. Department of Health and Human Services What You Need to Know About PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS The Public Health Security
More informationWhat a Preventive Controls Facility Looks Like. FSMA-HARPC vs. HACCP
What a Preventive Controls Facility Looks Like FSMA-HARPC vs. HACCP VS. COMPLIANCE WHAT S THE BEST APPROACH? CCPs HARPC GMPs GLOBAL FOOD SUPPLY THE FOOD SUPPLY NOW IS A GLOBAL ENTERPRISE! GLOBALIZATION
More informationFDA Publishes Final FSMA Preventive Control Rules
Sept. 18, 2015 Dave Fairfield, NGFA Vice President of Feed Services FDA Publishes Final FSMA Preventive Control Rules The U.S. Food and Drug Administration (FDA) on Sept. 17 published its final rules mandated
More informationFDA Issues Supplemental Preventive Controls Proposed Rules Under FSMA
Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 T +1 202 637 5600 F +1 202 637 5910 www.hoganlovells.com MEMORANDUM From: Joseph A. Levitt Elizabeth Barr Fawell Date:
More informationWhat 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
More informationCOMPLIANCE DATES. Preventive Controls. CGMP Compliance Date. Business Size. Business other than Small and Very Small employees
COMPLIANCE DATES Business Size CGMP Compliance Date Preventive Controls Compliance Date Business other than Small and Very Small 500 + employees Sept. 19, 2016 Sept. 18, 2017 Small Business Sept. 18, 2017
More informationFSMA and Grain Handlers
FSMA and Grain Handlers Regulatory Obligations and Supplier Expectations 2016 NGFA Country Elevator Conference David Fairfield NGFA Senior Vice President FDA Regulatory Authority U.S. Law: Grain and Feed
More informationJuly 26, Brian Pendleton Office of Policy Food and Drug Administration New Hampshire Avenue Silver Spring, MD
July 26, 2016 Brian Pendleton Office of Policy Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Dear Mr. Pendleton: The Food Marketing Institute (FMI) appreciated the
More informationAPPENDIX K. HACCP PROGRAM
APPENDIX K. HACCP PROGRAM I. THE HACCP SYSTEM INTRODUCTION HISTORY OF HACCP: The use of the HACCP System is not new to the dairy industry. HACCP is a logical, simple, effective, but highly structured system
More informationThe Impact of FSMA on Manufacturers. Peter Begg, Sr. Director, Global Quality Programs, Mondelēz International and GFSI Board Member
The Impact of FSMA on Manufacturers Peter Begg, Sr. Director, Global Quality Programs, Mondelēz International and GFSI Board Member Fast Facts about Mondelez International Created in October 2012 with
More informationFDA Publishes Final Rule on CGMPs, Hazard Analysis, and Preventive Controls for Animal Food
FDA Publishes Final Rule on CGMPs, Hazard Analysis, and Preventive Controls for Animal Food September 18, 2015 Food & Drug Yesterday, the Food and Drug Administration (FDA) issued its long-anticipated
More informationFood Fight: FSMA and the FDA s New Era of Enforcement. July By Sandra J. Wunderlich
Food Fight: FSMA and the FDA s New Era of Enforcement July 2017 By Sandra J. Wunderlich Panelists: Michael Landa, Retired Director, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
More informationJanuary 2015 Time Sensitive Material WHAT YOU NEED TO KNOW ABOUT THE FOOD SAFETY MODERNIZATION ACT. Rev. 1/7/
January 2015 Time Sensitive Material WHAT YOU NEED TO KNOW ABOUT THE FOOD SAFETY MODERNIZATION ACT Rev. 1/7/15 15-004 WHAT YOU NEED TO KNOW ABOUT FSMA January 2015 - Time Sensitive Material 1. What is
More informationFSMA Regulations for Ethanol Co-Products
FSMA Regulations for Ethanol Co-Products Kelly Davis Director of Regulatory Affairs Renewable Fuels Association October 2015 About the Renewable Fuels Association Founded in 1981 National Trade Association
More informationWhile comprehensive, this document does not replace a thorough review of the Rule to assure proper compliance.
Introduction A documented and implemented SQF System goes a long way in preparing certified sites for enforcement. The FDA Produce Safety Rule (or Rule) has specific requirements that may go beyond what
More informationFSMA Information & Compliance for Fuel Ethanol Producers
FSMA Information & Compliance for Fuel Ethanol Producers Compli Associates 605.254.1077 compli@compliassociates.com www.compliassociates.com About Compli Associates Compli Associates specializes in developing
More informationFood Safety Modernization Act Info Session Revised Handout August 1, 2013 at SOREC
Extension Small Farms Program 107 Crop Science Building, Oregon State University, Corvallis, Oregon 97331-3601 T 541 737 1569 http://smallfarms.oregonstate.edu Food Safety Modernization Act Info Session
More informationKill-Step Validation for Food Safety
Kill-Step Validation for Food Safety Kantha Channaiah, Ph.D. Director of Microbiology AIB International Copyright AIB International May not be reproduced without written permission. Agenda Food safety
More informationFDA s Final Rule for Preventive Controls for Human Food
FDA s Final Rule for Preventive Controls for Human Food IAFP November 18, 2015 http://www.fda.gov/fsma THE FUTURE IS NOW 1 What does PCHF do? Revises the farm definition Modernizes longstanding current
More informationHACCP audit checklist
Requirement HACCP audit checklist Prerequisite Program Management Commitment 1. Senior management ensures that the responsibilities and authorities are defined and communicated within the company Internal
More informationQuality Agreements with CMO s. Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals
Quality Agreements with CMO s Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals FDA Guidance Contract Manufacturing Arrangements for Drugs: Quality
More informationMEMORANDUM Via
1001 G Street, N.W. Suite 500 West Washington, D.C. 20001 tel. 202.434.4100 fax 202.434.4646 MEMORANDUM Via Email TO: RE: Clients and Other Interested Parties April 11, 2016 Overview of FDA s Final Rule
More informationThe Red Seal Your Road to FSMA and Quality Compliance
The Red Seal Your Road to FSMA and Quality Compliance Thomas Vogel Director, Food Safety DFA of California Jeremiah Szabo Director of Operations, DFA of California Our Presenters Today Thomas Vogel Auditor,
More informationPreventive Controls & cgmp s for Animal Food Industry Perspective Michele M. Evans, Ph.D. Diamond Pet Foods
Preventive Controls & cgmp s for Animal Food Industry Perspective Michele M. Evans, Ph.D. Diamond Pet Foods November 3, 2015 Preventive Controls Mini Conference: Is Small Industry Exempt from FSMA Preventive
More informationFood Safety Pest Management & Fumigation Services. Regional Companies Nationwide Service Global Network
Food Safety Pest Management & Fumigation Services Regional Companies Nationwide Service Global Network FPA is an organization of Regional companies formally organized to provide National capabilities of:
More informationThe Proposed Safe Food for Canadians Regulations (SFCR) Information Session
The Proposed Safe Food for Canadians Regulations (SFCR) Information Session 2011 Her Majesty the Queen in Right of Canada (Canadian Food Inspection Agency), all rights reserved. Use without permission
More informationFDA-2011-N-0920; RIN 0910-AG36;
December 15, 2014 By Electronic Submission Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Re: Current Good Manufacturing Practice
More informationPRINCIPLES FOR FOOD IMPORT AND EXPORT INSPECTION AND CERTIFICATION
SECTION 1 INTRODUCTION PRINCIPLES FOR FOOD IMPORT AND EXPORT INSPECTION AND CERTIFICATION CAC/GL 20-1995 1. Official and officially recognized inspection and certification systems are fundamentally important
More informationGuidance Document. Meeting Requirements as a Registered Food Importer. A guidance document issued by the Ministry for Primary Industries
Guidance Document Meeting Requirements as a Registered Food Importer. 23 February 2016 A guidance document issued by the Ministry for Primary Industries Title Meeting Requirements as a Registered Food
More information1
ISHS III International Conference on Fresh cut Produce 15 September 2015 Corrective Action FSMA Final Rule for Preventive Controls for Human Food 1 Sept. 2015 Current Good Manufacturing Practice and Hazard
More informationFeed Quality Assurance and Certification Programs. Representing the Total Feed Industry
Feed Quality Assurance and Certification Programs Quality Programs ISO 22000 Food Industry HAACP System Certification Program Comprehensive Quality Assurance Programs New US Food Safety Laws Animal Feed
More informationFDA Food Safety Modernization Act. C. Stewart Watson, R.E.H.S. Commander, U.S.P.H.S. Public Affairs Specialist Florida District FDA
FDA Food Safety Modernization Act C. Stewart Watson, R.E.H.S. Commander, U.S.P.H.S. Public Affairs Specialist Florida District FDA How Much Do You Know About FDA? Which item is not under the jurisdiction
More information1/29/2016. IFVGA 2016 FSMA Produce Rule Summary FDA FOOD SAFETY MODERNIZATION ACT FSMA FDA: FSMA PRODUCE SAFETY REGULATIONS
IFVGA 2016 FSMA Produce Rule Summary Dr. Angela Shaw Assistant Professor and Extension and Outreach in Food Safety FDA FOOD SAFETY MODERNIZATION ACT FSMA The FDA Food Safety Modernization Act (FSMA) was
More informationFSMA Compliance 2016 Carrier Concerns
FSMA Compliance 2016 Carrier Concerns DOJ and FDA Say Criminal Prosecution of Food Companies is a Priority The Department of Justice (DOJ) has formally announced that it has partnered with FDA and has
More informationPGA Update: Reporting Process in ACE (FDA, CPSC, etc.)
PGA Update: Reporting Process in ACE (FDA, CPSC, etc.) Russell K. Statman, Esq. Executive Director, Registrar Corp Tom Kuerbs, LCB Descartes Systems Group Craig Seelig, Product Manager Customs & Government
More informationCFIA Food Regulatory Modernization
CFIA Food Regulatory Modernization Saskatchewan Green Trades Conference November 7, 2014 2011 Her Majesty the Queen in Right of Canada (Canadian Food Inspection Agency), all rights reserved. Use without
More informationLessons from USDA s Mandatory HACCP Rule for Meat and Poultry
Lessons from USDA s Mandatory HACCP Rule for Meat and Poultry Mary K. Muth August 7, 2013 Presented at the Post-AAEA Workshop, Economic Analysis and Food Safety: the Food Safety Modernization Act Washington,
More informationGAPS, FSMA and the Produce Rule
GAPS, FSMA and the Produce Rule Erik Schellenberg Food Safety Resource Educator February 2016 Erik Schellenberg Food Safety Resource Educator ENYCHP jk2642@cornell.edu 845-344-1234 Third Party Audits Buyer-driven
More informationMFA Inc Compliance with the Food Safety Modernization Act. Jim S White PhD Director, Livestock Nutrition MFA Inc Columbia, MO
MFA Inc Compliance with the Food Safety Modernization Act Jim S White PhD Director, Livestock Nutrition MFA Inc Columbia, MO MFA Inc MFA Feed Division, 6 feed mills all licensed with the FDA 1 EPA registered
More informationFSMA S PRODUCE SAFETY RULE
FSMA S PRODUCE SAFETY RULE And How to Comply March 2017 Our Learning Goals What is the Food Safety Modernization Act (FSMA)? What is FSMA s Final Rule on Produce Safety? Is my farm covered under the regulations?
More informationFSMA Human Food Audit Checklist Iowa State University Extension and Outreach Department of Food Science and Human Nutrition
FSMA Human Food Audit Checklist Iowa State University Extension and Outreach Department of Food Science and Human Nutrition The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011.
More informationWhite Paper: Food Safety Enforcement and Inspection Actions and Terminology
USDA-FNS White Paper: Food Safety Enforcement and Inspection Actions and Terminology MULTI-AGENCY TASK FORCE FOR USDA FOODS USDA, Food and Nutrition Service This document provides an overview of basic
More informationSQF 2000 Code. 6th Edition AUGUST A HACCP-Based Supplier Assurance Code for the Food Manufacturing and Distributing Industries
SQF 2000 Code A HACCP-Based Supplier Assurance Code for the Food Manufacturing and Distributing Industries 6th Edition AUGUST 2008 Safe Quality Food Institute 2345 Crystal Drive, Suite 800 Arlington, VA
More informationFSMA Information & Compliance for Fuel Ethanol Producers
FSMA Information & Compliance for Fuel Ethanol Producers Chad Poppe Compli Associates 605.254.1077 compli@compliassociates.com www.compliassociates.com About Compli Associates Compli Associates specializes
More informationTransformation Agenda Update August 2014
Transformation Agenda Update August 2014 2011 Her Majesty the Queen in Right of Canada (Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited. CFIA Transformation
More informationSpringfield, Illinois June 18 20, 2015
Jason Young jason.young@okstate.edu GFSI Specialist/ Quality Management Specialist Robert M. Kerr Food & Agricultural Products Center http://www.fapc.biz/ Springfield, Illinois June 18 20, 2015 Retail
More informationDriving the Fox from the Henhouse Improving Oversight of Food Safety at the FDA and USDA September Survey Essay Excerpts
Driving the Fox from the Henhouse Improving Oversight of Food Safety at the FDA and USDA September 2010 Survey Essay Excerpts Special-Interest Pressure The use of 'risk' and 'economic impact' as factors
More informationSUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule to establish
This document is scheduled to be published in the Federal Register on 04/06/2016 and available online at http://federalregister.gov/a/2016-07330, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationUnderstanding Organics and the Regulations Governing this Market By Brad Rush, Briess Malt & Ingredients Company, Chilton, Wisconsin
Understanding Organics and the Regulations Governing this Market By Brad Rush, Briess Malt & Ingredients Company, Chilton, Wisconsin Abstract Once available only through specialty outlets, organic products
More informationFood and Feed Safety: What Grain Operators Need to Know NICK FRIANT CARGILL 2012 NGFA / GRAIN JOURNAL SEMINAR KANSAS CITY, MO WEDNESDAY, AUGUST 1
Food and Feed Safety: What Grain Operators Need to Know NICK FRIANT CARGILL 2012 NGFA / GRAIN JOURNAL SEMINAR KANSAS CITY, MO WEDNESDAY, AUGUST 1 1 Agenda Overview of Food Current Legislation New Legislation
More informationEXAMPLE OF VENDOR QUALIFICATION FOR IMMUNE EFFECTOR CELL PRODUCT MANUFACTURER
EXAMPLE OF VENDOR QUALIFICATION FOR IMMUNE EFFECTOR CELL PRODUCT MANUFACTURER Disclaimer: This example is just one potential example of a vendor qualification form to verify the adequacy of the internal
More informationFood Beverage COMPLIANCE READINESS
Food Beverage COMPLIANCE READINESS CONTENTS Government Agencies FSMA Safety Inspections Compliance Training Industry Knowledge Technology for Traceability Documentation MILAN Commitment Why Us? About MILAN
More informationRecords Required by the FSMA Produce Safety Rule K. Woods, D. Pahl, D. Stoeckel, B. Fick, G. Wall, and E.A. Bihn
Records Required by the FSMA Produce Safety Rule K. Woods, D. Pahl, D. Stoeckel, B. Fick, G. Wall, and E.A. Bihn *This publication has not been approved by the FDA and should not be considered legal guidance.
More informationFSSC Version 3.2 to Version 4.1 Key Changes Document
to Version 4.1 All changes from version 3.2 to version 4 are highlighted in yellow. i 3.2 Prerequisite programmes 2.1.3 Prerequisite Programs (PRP) When establishing, implementing and maintaining the Prerequisite
More informationISO 22000:2005 SYSTEMKARAN ADVISER & INFORMATION CENTER SYSTEM KARAN ADVISER & INFORMATION CENTER FOOD SAFETY MANAGEMENT SYSTEM ISO 22000:2005
SYSTEM KARAN ADVISER & INFORMATION CENTER FOOD SAFETY MANAGEMENT SYSTEM ISO 22000:2005 WWW.SYSTEMKARAN.ORG 1 www.systemkaran.org Foreword... 6 Introduction... 7 Food safety management systems Requirements
More informationUSDA-FSIS Recall Procedures
USDA-FSIS Recall Procedures Midwest FDC Conference April 28, 2010 Lisa Volk Recall Management Staff Recall A firm s voluntary removal of distributed meat, poultry, or egg products from commerce when there
More informationFSMA: Understanding FDA s New Food Safety Rules
March 2016 FSMA: Understanding FDA s New Food Safety Rules Sophia Kruszewski, National Sustainable Agriculture Coalition About NSAC NSAC is an alliance of grassroots organizations that advocates for federal
More informationWHOLE FOODS MARKET GMO Labeling Policy
WHOLE FOODS MARKET GMO Labeling Policy VERSION 4.1 NOVEMBER 3, 2017 As of September 1, 2018, Whole Foods Market will require suppliers of food products to label products that contain genetically modified
More informationBRC GLOBAL STANDARD FOOD SAFETY ISSUE 7 FSMA PREVENTIVE CONTROLS PREPAREDNESS MODULE AND GUIDANCE FOR BRC-CERTIFIED FACILITIES
BRC GLOBAL STANDARD FOOD SAFETY ISSUE 7 FSMA PREVENTIVE CONTROLS PREPAREDNESS MODULE AND FOR BRC-CERTIFIED FACILITIES LIABILITY The BRC publishes information and expresses opinions in good faith, but accepts
More informationVerification: Can Your Food Safety Plan Meet the Rigors of FSMA s Proposed Preventive Controls?
November 2014 In cooperation with Verification: Can Your Food Safety Plan Meet the Rigors of FSMA s Proposed Preventive Controls? Key Words FSMA, foreign material detection, verification, validation, preventive
More informationHazard Analysis and Critical Control Point The Almond Board of California. Overview. Definitions
Hazard Analysis and Critical Control Point The Almond Board of California Overview Hazard Analysis Critical Control Point (HACCP) is the final stage of an integrated, proactive food safety program targeting
More informationPresentation Proposal Guidelines
Presentation Proposal Guidelines We are accepting your presentation ideas to share insights, best practices, emerging trends, groundbreaking research and critical industry updates in the area of food safety
More informationBest Practices in the Herbal Ingredient Supply Chain
ACI s 4 th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements June 27-28, 2016 Best Practices in the Herbal Ingredient Supply Chain Michael McGuffin President American Herbal Products
More informationModerator: Rob Long, Long s Family Farm and Orchard, Commerce Township, MI
Great Lakes Fruit, Vegetable & Farm Market EXPO Michigan Greenhouse Growers EXPO December 6-8, 2011 DeVos Place Convention Center, Grand Rapids, MI Sweet Cider Where: Gallery Overlook (upper level) Room
More informationSQF 2000 Food Safety Management System Implementation Workbook
This comprehensive SQF 2000 Food Safety and Quality Management System package contains everything you will need to achieve SQF 2000 Certification. We have written this workbook to assist in the implementation
More informationBRC Food Safety and Quality Management System
This is an ideal package for Food Manufacturers looking to meet BRC Global Standard for Food Safety (Issue 7 published January 2015) for Food Safety Quality Management Systems. Our 2015 BRC Food Safety
More informationGFSI FSMA HARPC & FUTURE OF AUDITS
WWW.SGS.COM GFSI FSMA HARPC & FUTURE OF AUDITS Presented at the North American Millers Association May 14, 2015 Peoria, IL Walter P. Saraniecki, MS, LDN, LEHP, REHS/RS Food Safety Auditor, SGS North America
More informationBriefing Slides for Importers and Entry Filers
PREDICT and ITACS Briefing Slides for Importers and Entry Filers FDA Office of Regulatory Affairs Office of Regional Operations Division of Import Operations & Policy Systems Branch Revised June 23, 2009
More informationChain of Custody Standard. July, 2015
July, 2015 Copies of this document are available for free in electronic format at the following website: www.rainforest-alliance.org Please send your comments or suggestions concerning this document to
More informationFSMA AND ELECTRONIC RECORD KEEPING: MOVING BEYOND PAPER LOGS AND EXCEL. Room 314 December
FSMA AND ELECTRONIC RECORD KEEPING: MOVING BEYOND PAPER LOGS AND EXCEL Room 314 December 7 2017 AGENDA Rebecca Bailey, Almond Board of California, moderator Savy DiBenedetto, Savy Quality Review Tom Bergmann,
More informationFood Regulatory Guide
Food Safety & Compliance with High Performance Weighing & Inspection 2 Table of Contents Table of Contents Chapfer 1 Food Safety & Quality The Trend Towards Certification 06 Chapter 2 Traceability for
More informationFDA s Rule on Sanitary Transportation of Human and Animal Food
FDA s Rule on Sanitary Transportation of Human and Animal Food A. Horror Stories There have been horror stories of food contamination and spoilage of food being delivered to grocery stores and restaurants
More information