U.S. FDA’s Food Safety Modernization Act (FSMA)mhaia.org/wp-content/uploads/FSMAFSPCAOutreach.pdf2...
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U.S. FDA’s Food Safety Modernization Act (FSMA) Kelly J. McCormick International Policy Analyst International Affairs Staff, Office of the Center Director Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration
U.S. FDA’s Food Safety Modernization Act (FSMA)mhaia.org/wp-content/uploads/FSMAFSPCAOutreach.pdf2 Food Safety Modernization Act 1. Food Safety Modernization Act signed January 2011
International Affairs Staff, Office of the Center Director Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
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Food Safety Modernization Act
1. Food Safety Modernization Act signed January 2011 by President Obama
2. Listening sessions 3. FDA drafted proposed rules based on the new law, as
well as input from public meetings and listening sessions
4. FDA published proposed rules for comment 5. Comments were considered and changes integrated
into proposed rules 6. Final Rules were published
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Why did we feel we needed modernized food safety legislation??? Regulatory Challenges in a Globalized World: Greater volume of imported products Greater number of foreign facilities supplying the United States Increased complexity of products, manufacturing methods and supply chains Greater opportunities for economic fraud Data/information gaps Continued migration of research & development, clinical trials & manufacturing outside U.S. borders Strategic and efficient use of limited resources and better leveraging of external resources Creating harmonized standards Some regulatory counterparts have an economic promotion mission that may conflict with FDA’s public health mission Cultural / linguistic / national differences Our solution? The FDA Food Safety Modernization Act (FSMA), which became law when President Obama signed it January 4, 2011, will be fully implemented over time, and the public, including companies affected by the new law, will have many opportunities to participate in the implementation process. FSMA is the most sweeping reform of FDA’s food safety authority in more than 70 years, and a law of this scope and complexity often comes with direction from Congress for the federal agency responsible for implementing it to go through a process called rulemaking. The new food safety law called for a number of rules (also called regulations) and guidances. This did not happen overnight and did not happen in a vacuum.
Food Safety Modernization Act FSMA’s Main Themes
Prevention
Inspections, Enhanced Compliance, Partnerships and Response
Import Safety 3
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The FSMA Mandate So as you can see, the FSMA mandate is broad and challenging. FSMA instructed FDA to overhaul its food safety program, with major new directions: Prevention: Shifting from an old, antiquated system of chasing after problems once they occur to a new focus on prevention. Move food system from reaction to prevention. For the first time FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. Risk-based: Improving resource management to improve food safety through risk-based priority setting and resource allocation. Inspection Compliance & Response: The law specifies how often FDA should inspect food producers. For the first time FDA will have mandatory recall authority for all food products. Increased, targeted inspections: Increasing the frequency of inspections and enhancing the targeting of inspections based on food safety risk and performance through modernized data collection and information systems. Key Principles: Focus on gaining industry compliance and reducing the risk of foodborne illness Not a “One Size Fits All” approach Recognition that not all situations are equal relative to risk and potential for public health impact Interactive, cooperative inspections Encourage industry to comply and make corrections on its own Regulatory strategy that is dynamic Imported Food Safety: FSMA’s most ground-breaking shift FDA has new tools to ensure that imported foods meet US standards and are safe for our consumers. Modernized and expanded import oversight: Implementing an entirely new import oversight program that relies on importers taking greater responsibility for the foods they bring into the U.S., enhances FDA’s risk-based import screening program, expands foreign inspections and collaboration with foreign governments, and facilitates trade in safe food. U.S. importers now responsible for ensuring that their foreign suppliers meet U.S. safety standards Can require mandatory certification for in certain limited circumstances Voluntary qualified importer program (VQIP) expedited review Can deny entry if FDA access for inspection is denied Requires food from abroad to be as safe as domestic Enhanced Partnerships: The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies, to achieve our public health goals. Critical role of partnerships Other federal agencies Integrated food safety system Foreign partnerships
Seven Foundational Final Rules
• Preventive Controls for Human Food • Preventive Controls for Animal Food • Produce Safety • Foreign Supplier Verification Program • Accredited Third-Party Certification • Sanitary Transportation • Intentional Adulteration
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Preventive Controls for Human Food: Sets safety requirements for facilities that process, package or store human food. Preventive Controls for Animal Food: Aims to protect animal food and feed from contaminants. Produce Safety: Sets science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. Foreign Supplier Verification Program: Makes importers responsible for ensuring that foreign food suppliers provide the same level of public health protection as is required of U.S. food producers. Third Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities and the foods they produce. Sanitary Transportation: Would require the use of sanitary transportation practices to ensure food safety. Intentional Adulteration: Would require facilities to implement a food defense plan to prevent actions intended to cause large-scale public harm.
FSMA – Section 305 “Building Capacity of Foreign Governments with Respect to Food Safety”
• Directs FDA to: …develop a comprehensive plan to expand the technical, scientific, and regulatory food safety capacity of foreign governments and their respective food industries, from which foods are exported to the United States.
• FDA’s Capacity Building Plan – Element 4 Train foreign governments and food producers on US requirements for safe food
It is important to note FSMA Section 305: “Building Capacity of Foreign Governments with Respect to Food Safety” directs FDA to develop a comprehensive plan to expand the technical, scientific, and regulatory food safety capacity of foreign governments, and their respective food industries, from which foods are exported to the United States. The Capacity Building Plan (Element 4) aims to train foreign governments and food producers on US requirements for safe food. Key actions of the Plan include: coordination with other U.S. agencies; development of training materials through partnerships; prioritization of training and capacity building efforts through risk assessment and needs assessments; and provision of support to FDA’s foreign offices on technical assistance. --this is the first time capacity building has been identified by statute. It is important to note that FDA has engaged in food safety capacity building efforts for many years. International Communications and Engagement Overarching Goal Support high rates of compliance with new FSMA rules Purpose Support the overarching goal by addressing a continuum of information needs of international stakeholders Furthermore, an International Communications & Engagement Plan developed by FDA supports high rates of compliance with new FSMA rules and by addressing a continuum of information needs of international stakeholders. The FDA is working to prepare partners and key stakeholders, conduct outreach on the final rules, provide training and education, and to promote sustainability of adoption of a preventive food safety focus.
International Communications and Engagement
• Key Implementation Principle: Facilitate industry compliance with prevention-oriented standards through guidance, developing tools/resources for education, outreach and technical assistance Guidance Documents
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GUIDANCE DOCUMENTS Preventive Controls Human Food Hazard Analysis and Preventive Controls: Draft Published 8/16 Listeria in RTE Food: Draft Published 1/17 Classification of Activities for Farms and Facilities: Draft published 8/16 Small Entity Compliance Guide: Published 10/16 Planned Guidances include: Supplier Controls, Validation of Process controls, Food Allergens Preventive Controls Animal Food CGMP: Draft published 8/16 Human Food By-Products for Use as Animal: Draft published 8/16 Small Entity Compliance Guide: Published 10/16 Planned guidances include: Hazard Analysis and Preventive Controls, , Supplier Controls Produce Sprouts: Draft published 1/17 Planned guidances include: Updated GAPs, Compliance Guide, Small Entity Compliance Guide FSVP, Intentional Adulteration, Sanitary Transport Planned Guidances include: Compliance Guide, Small Entity Compliance Guide
International Communications and Engagement
• Use of Regulatory Tools: Systems Recognition, bi/multilateral agreements, etc
• Partnerships: STDF, FAO, APEC, GFSP, WHO
• FSMA Outreach: FDA Outreach Meetings, Public Hearings, Presentations, and Webinars
• Interagency Collaboration: Food and Agriculture Sustainability Training (FAST), Food Safety Network
• Alliances: Food Safety Preventive Controls, Produce Safety, and Sprout Safety
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FDA undertakes a variety of efforts to collaborate with the International Community…. Regulatory Tools – SR….. FDA has established and maintains partnerships with many international organizations. These partnerships enable the agency to leverage the greater bodies of work being undertaken by these entities, thus enabling us to maximize influence while minimizing the taxation of our resources. Examples of these partnerships include our work with: STDF, FAO, APEC, GFSP, WHO… The FDA is also conducting FSMA Outreach through meetings and webinars. Cadres of FDA experts will be making a series of visits to various partner countries and regions, to meet with government, industry, and academic stakeholders to discuss FSMA and its impact. Additionally, as resources are limited, FDA has and will continue to hold conference calls and webinars to share FSMA presentations with the international community. Many of these presentations, webinars, and recordings are available on the FSMA website. FDA is also engaging in Risk-Based Food Safety Capacity Building Initiatives, such as the Food and Agriculture Sustainability Training (FAST). We are collaborating with the USDA’s Foreign Agricultural Service, the U.S. Agency for International Development, Texas Tech University, and Inter-American Institute for Cooperation on Agriculture (IICA) to implement FSMA-readiness outreach and capacity building in many countries in Latin America and the Caribbean. Success with FAST encouraged involvement in another tri-agency effort: the Food Safety Network, which supports activities geared toward building global SPS capacity. And perhaps MOST important for both domestic and foreign industry is FDA’s work through the Alliances: the Food Safety Preventive Controls, the Produce Safety, and the Sprout Safety Alliances.
International Communications and Engagement: ALLIANCES
• Food Safety Preventive Controls Alliance (FSPCA) o Curricula to train those that manufacture, process, hold,
and distribute human and animal food o Curriculum to train importers subject to the FSVP rule
• Produce Safety Alliance (PSA) o Curriculum to train the farming community
• Sprout Safety Alliance (SSA) o Curriculum to train sprout growers
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And perhaps MOST important for both domestic and foreign industry is FDA’s work through the Alliances: the Food Safety Preventive Controls, the Produce Safety, and the Sprout Safety Alliances. Links to the Alliance webpages can be found on the FDA FSMA page. The FDA has teamed the Illinois Institute of Technology and Cornell University to establish these public-private entities. They were formed to support safe food production by developing core curriculum, training and outreach programs to assist stakeholders to become and maintain prepared to adhere to modernized food safety regulations. For example, the FSPCA’s outreach goals and objectives aim to: increase industry awareness about the FSPCA education, outreach, and TA programs…..we have used mechanisms to communicate the Alliance’s training and technical assistance efforts including quarterly webinars like this one; develop a comprehensive network of lead instructors interested in participating in the FSPCA training program designed to help the food industry understand the PC requirements. The Alliance is in the process of recruiting educators that can help provide the training to industry; identify and develop relevant technical information and educational resources useful especially for the small food companies. The FSPCA draft course curriculum contains a chapter that provides a list of technical resources to assist in the development and modification of a food safety plan. This chapter contains a list of publications such as the FDA hazard guides, peer reviewed literature, and trade association publications and links to numerous credible websites that contain technical information; and establish a network of technical experts that would be available to assist the industry with technical questions that they may have subsequent to the training.
FSMA Technical Assistance Networks • To submit a FSMA regulatory interpretation
question, visit www.fda.gov/fsma • Scientific and technical questions can be
submitted to the FSPCA TAN: https://fspca.force.com/FSPCA/s/?language=en_US
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We are engaging both the domestic and international audiences through development of a FDA FSMA Technical Assistance Network. The TAN is meant to provide technical assistance to industry, regulators, academia, and consumers regarding FSMA by addressing questions related to FSMA rules, programs, and implementation. In September 2015. the TAN became operational to receive internal and external stakeholder inquiries regarding the preventive controls human food and animal food rules as well as questions about the other FSMA rules, programs, and implementation. Questions are reviewed by “administrators” who identify the appropriate subject matter expert to answer the inquiry. We have Subject Matter Experts available to answer questions related to all foundational Final Rules. TAN inquiries may be submitted through a web form or by mail. The web-form can be accessed on the FDA website’s main FSMA page, www.fda.gov/FSMA: scroll down to the bottom of the FSMA page to “Contact us” and click on “How to Contact FDA on FSMA”. FDA’s “subject matter experts” from our four offices/centers (CVM, CFSAN, ORA and OIP) will answer questions received via a web form regarding FSMA regulation interpretation, policy, and implementation. You will see a “KMS in the center of the FDA network. KMS stands for Knowledge Management System and is an IT system FDA has put into place to track and trend FSMA queries and serve as a repository for Q&As. In the bottom left corner is a diagram depicting how the FDA FSMA TAN will interface with Food Safety Preventive Controls Alliance TAN. The FSPCA network of “food safety experts” will be available to answer scientific and technical questions from the human and animal food industry. Questions will be received via a web form. These networks will work together – with FDA addressing answers to regulation and policy interpretation questions, FSPCA addressing scientific and technical questions, and interaction, as appropriate. In the event that the FSPCA network receives regulation interpretation questions the FSPCA has a mechanism to refer those questions to FDA.
FOOD SAFETY PREVENTIVE CONTROLS ALLIANCE INTERNATIONAL SUBCOMMITTEE
• In 2011, the FDA helped to establish a public-private partnership called the Food Safety Preventive Controls Alliance (FSPCA), created to provide Food Safety Modernization Act (FSMA) technical assistance and training programs. o The FSPCA is managed by the Illinois Institute of Technology (IIT).
IIT partners with the International Food Protection Training Institute (IFPTI) and the Association for Food and Drug Officials (AFDO) for training implementation.
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WHO is the FSPCA? In 2011, the Institute for Food Safety and Health at Illinois Institute of Technical was asked by FDA to establish the FSPCA. The FSPCA is a broad-based public-private alliance consisting of key industry academic and government stakeholders. FSPCA’s mission is to support safe food product by developing core curricula and associated training, outreach, and technical assistance programs, to help companies producing and / or importing human and animal food to comply with the FSMA regulations. The FSPCA is managed by the Illinois Institute of Technology (IIT). IIT partners with the International Food Protection Training Institute (IFPTI) and the Association for Food and Drug Officials (AFDO) for training implementation.
Who is FSPCA?
• The FSPCA developed core curricula, training, and outreach programs to assist stakeholders to be prepared to adhere to the following FSMA final rules: o Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventive Controls for Human Food; o Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventive Controls for Animal Food; o Foreign Supplier Verification Programs (FSVP) for Importers of Food
for Humans and Animals; and o Mitigation Strategies to Protect Food Against Intentional
Adulteration for Human Food (in-progress)
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WHO is the FSPCA? The FSPCA developed core curricula, training, and outreach programs to assist stakeholders to be prepared to adhere to the following FSMA final rules: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Animal Food; Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals; and Mitigation Strategies to Protect Food Against Intentional Adulteration for Human Food that is in-progress (on-line and instructor led training).
Training Technical Assistance Networks FSMA Rules and resources Alliance Committees Quick links – application process for LIs, course advertising recommendations, Bookstore for course materials including translated materials, e.g. Spanish, FSPCA metrics, list of Trainer the Trainers and Lead Instructors. Stay Connected – FSPCA quarterly webinars / presentations / subscription to FSPCA update list serv Info on Sister Alliances.
Who is FSPCA?
• Food Safety Preventive Controls Alliance (FSPCA) o FSPCA Community, an interactive portal where users can ask
questions of Alliance Food Safety Experts (FSEs), find a list of Lead Instructor (LI) trainers, and locate technical resources: https://fspca.force.com/FSPCA/s/?language=en_US
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Quick look at websites…
FSPCA Community, an interactive portal
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FSPCA Community is an interactive portal featuring knowledge articles, course listings, list of FSPCA Lead Instructors by experience and geographic travel range (NA or international); info on the sprout safety alliance, produce TAN, and info on how to become a lead instructor (application process).
WHAT does the FSPCA do?
Alliance outreach goals and objectives aim to: • increase industry awareness about the education, outreach, and
technical assistance programs; • identify and develop relevant technical information and
educational resources useful especially for the small food companies;
• establish a network of FSPCA FSEs that would be available to assist the industry with technical and scientific questions that they may have subsequent to the training; and
• ensure opportunities and educational materials are available to international audiences in a manner that is appropriate and sensitive to various cultures, religions, political situations, languages, and development levels.
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The Alliances Outreach Goals and Objectives are four-fold: #1 is to increase industry awareness about the FSPCA education, outreach, and TA programs…..we have used very mechanisms to communicate the Alliance’s training and technical assistance efforts including quarterly webinars like this one. The Second outreach goal is to develop a comprehensive network of lead instructors interested in participating in the FSPCA training program designed to help the food industry understand the PC requirements. As Jerry mentioned, the Alliance is in the process of recruiting educators that can help provide the training to industry. Our third goal is to identify and develop relevant technical information and educational resources useful especially for the small food companies. The FSPCA draft course curriculum contains a chapter that provides a list of technical resources to assist in the development and modification of a food safety plan. This chapter contains a list of publications such as the FDA hazard guides, peer reviewed literature, and trade association publications and links to numerous credible websites that contain technical information. And the fourth objective is to establish a network of technical experts that would be available to assist the industry with technical questions that they may have subsequent to the training.
WHY seek this training?
PCHF & PCAF -Require that certain activities must be completed by a “preventive controls qualified individual (PCQI).” The participant course, developed by FSPCA, is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet the requirements for a “PCQI.” Individuals can also be qualified through job experience.
FSVP -In contrast to the PC rules for human or animal food, the FSVP rule does not require an FSVP “qualified individual” to attend a training program following a “standardized curriculum” recognized by FDA. Completing the FSVP participant course is not mandatory. Attending the FSVP course, however, will help course participants understand the FSVP requirements and how those requirements can be met in their circumstance.
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WHY seek this training? The two Preventive Controls rules require registered facilities that manufacture, process, pack or hold human or animal food have one or more “Preventive Controls Qualified Individuals(PCQI)”. September 1, 2017 Both domestic facilities and foreign food processors exporting food intended for sale in the U.S. must comply with the Preventive Controls regulations unless an exemption applies. Each facility, unless covered under an exemption or modified requirement, will be required to implement a written food safety plan that focuses on preventing hazards in the food. The “PCQI” will be responsible for performing or overseeing the implementation of the facility’s food safety plan, namely: preparation of the food safety plan, validation of the preventive controls, review of records and reanalysis of the food safety plan. The Preventive Controls rules require that a “PCQI” must have either successfully completed training in the development and application of risk‐based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. In contrast to the Preventive Controls (PC) rules for human or animal food, the FSVP rule does not require an FSVP “qualified individual” to attend a training program following a “standardized curriculum” recognized by FDA. The FSPCA has developed an FSVP curriculum which was designed by regulatory, academia, and industry professionals and developed with funding from FDA as part of the FSPCA. While FDA assisted in the preparation of the FSVP course materials, the materials have been written and produced by the Alliance and are not official FDA materials. Completing the FSVP participants course is not mandatory. Attending the FSVP course, however, will help course participants understand the FSVP requirements and how those requirements can be met in their circumstance.
FSPCA Metrics
15,233 240
Total
FSPCA Courses Registered
Human Food Animal Food FSVP
3,872 311 230
FSPCA Certificates Issued
Human Food Animal Food FSVP
Domestic 32,999 4,425 1,884
International 259
48,232 4,665 2143
As of September 25, 2017
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FSPCA metrics are generated weekly and can be found on FSPCA’s website. Go through metrics by curriculum.
FSPCA Human Food International Information
FSPCA Human Food International Information As of 8-7-2017
Number of Lead Instructors Number of approved HF canidates not trained Number of HF course held
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For PCHF here is an international snap shot showing number of lead instructors by country; number of approved lead instructor candidates, and number of PCHF course deliveries.
WHERE, WHEN, & HOW can the public access FSPCA training and resources?
• How to find an FSPCA Participant Course: ohttps://fspca.force.com/FSPCA/s/courselist?
language=en_US
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Go through process on website.
FSPCA Participant Courses:
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Screenshot from FSPCA’s website showing upcoming PCHF courses offered across the world.
FSPCA Metrics - Lead Instructors
Human Food LIs 1,333 (368 international)
Animal Food LIs 202 (15 international)
FSVP LIs 211 (31 international)
As of September 25, 2017
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FSPCA metrics as of Sept 25 showing the number of trained Lead Instructors for human food, animal food, and FSVP.
WHERE, WHEN, & HOW can the public access FSPCA training and resources?
• How to become an FSPCA Lead Instructor: ohttps://fspca.force.com/FSPCA/s/li-public-g
uidance?language=en_US
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Explain below while going through process in real time… How to become an FSPCA Lead Instructor: PCHF – To become a Preventive Controls Lead Instructor (LI), an individual must apply via the FSPCA Community portal (https://fspca.force.com/FSPCA/s/li‐public‐guidance?language=en_US). o Applicants must have the adequate education, work experience, and food safety training experience detailed on the website. They also need to have successfully completed a PCHF participant course before applying to be approved by the FSPCA LI Selection Committee. More information on pre‐requisites can be found here: https://www.ifsh.iit.edu/fspca/fspca-preventive-controls-human-food. o LIs then independently market and offer courses per Alliance administrative requirements. o To register courses after completing the LI course, LIs can log in to their Community account, select the Course Registration tab, and click on “New” to open the registration form. PCAF – In order to become a Preventive Controls LI, an individual must apply via the FSPCA Community portal (https://fspca.force.com/FSPCA/s/li‐public‐guidance?language=en_US). o The process is the same as PCHF, as detailed above. FSVP – Current LIs or approved candidates for FSPCA’s Human or Animal Food courses already meet the criteria to qualify as a candidate to become an FSVP LI. Next steps are: 1. Updating your profile in the FSPCA Community indicating interest (see instructions below), and 2. Completing an FSVP LI course. To update your LI profile: 1. Log into your FSPCA Community account at: https://fspca.force.com/FSPCA/s/ 2. Click on your name to the right of the Search bar and a menu will open 3. Select “My Profile” on the menu 4. Click the edit button to the right of your name 5. Scroll down and check the box “Consider for FSVP LI” 6. Scroll down and Save o FSVP LIs independently market and offer courses, per Alliance requirements, as well as register courses using the normal FSPCA registration procedures (by logging in to your Community account, selecting the Course Registration tab, and clicking on “New” to open the registration form). o New LI Applicants ‐ Those who are not existing LI must complete a FSVP application, which can be found here: https://docs.google.com/forms/d/e/1FAIpQLSc6UkW6G‐GrTC5yGy88T7qAvQGYdPhoWzZAwk4KLCjV0c‐pww/viewform o For a few months at the beginning of the FSVP rollout, FSPCA will be offering combined courses (a Lead Instructor course coupled with a participant course) since a prerequisite of the Lead Instructor course will be a participant course. IA ‐ LIs will be sought in the future; a process has yet to be defined.
Preventive Controls Scientific & Technical FSMA Regulation & Policy Interpretation Questions from Industry – a web form at: Questions – a web form at:
www.iit.edu/ifsh/alliance www.fda.gov/fsma
ORA
CVM
OIP
CFSAN
KMS
Extension Specialists
Land Grant Universities
International Partners
iTAN
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And to reiterate what was presented in the FDA presentation earlier on the webinar….Here is a diagram depicting how the FDA FSMA TAN will interface with Food Safety Preventive Controls Alliance TAN. After explaining the info below, follow the link to the FSPCA TAN to go through how to submit a Q live…. FDA’s “subject matter experts” from our four offices/centers (CVM, CFSAN, ORA and OIP) will answer questions received via a web form regarding FSMA regulation interpretation, policy, and implementation. You will see a “KMS in the center of the FDA network. KMS stands for Knowledge Management System and is an IT system FDA has put into place to track and trend FSMA queries and serve as a repository for Q&As. The FSPCA network of “food safety experts” will be available to answer scientific and technical questions from the human and animal food industry. Questions will be received via a web form. In the event that the FSPCA network receives regulation interpretation questions the FSPCA has a mechanism to refer those questions to FDA. These networks will work together – with FDA addressing answers to regulation and policy interpretation questions, FSPCA addressing scientific and technical questions, and interaction, as appropriate.
FSPCA Community, an interactive portal
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Screenshot of FSPCA TAN – PC questions
FSPCA Technical Assistance Network
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Screenshot of FSPCA TAN – PC web form AND buttons to ask sprout and produce related scientific/technical questions.
Engagements • Work with FDA Office of International Programs • E-mail “opt-in” through FDA outreach to registered
food facilities
Current Activities • Collateral Materials
• Compliance date handout • Currently in English and Spanish then Chinese and other languages as
needed • FSPCA one-pager • Also utilizing FDA materials on FSMA that is already in
multiple languages • Materials already used at international conferences in
Mexico and Thailand. • Trade Shows and Conferences
• Booths at in US Food Safety Summit, IAFP, IFT and Fancy Food Show
• China Food Safety Conference in November, 2017 • Germany in November, 2017, GFSI Tokyo in March, 2018 • SIAL Paris in October 2018
Current Activities, cont. • Work with FDA
• Meet with FDA’s International Affairs Staff and Office of International Programs to coordinate the promotion of FSPCA awareness among FDA and USDA/FAS overseas staff.
• FSMA and FSPCA awareness webinar (this call) • Follow up will include an FSPCA “packet” for them to utilize
• Targeting based on numbers of registered food facilities
• Build Database of Registered Food Facilities through “opt-in” email plan
• Working with FDA CFSAN Office of Compliance to send out communications to all registered food facilities; they will then opt-in to receive information from FSPCA
Registered Food Facilities Top 10 Countries: Japan France Italy China Mexico Canada Spain South Korea India Germany
