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FSMA What a Retail Supply Chain Executive Needs to Know
Food Safety Modernization Act
• Signed January 4, 2011 • P.L. 111-353 • Most expansive changes to Food Drug and
Cosmetic Act since 1938 – New enforcement authorities – New program activities – Increased inspections
Federal Regulatory Process Legislative • Congress passes laws directing agencies to regulate on specific issues
(e.g. FSMA statutory mandate)
Regulatory • First Step: Pre-rulemaking: Agencies may open docket or publish advanced notice of
proposed rulemaking requesting information needed to develop final rule • Second Step: Proposed Rule published in Federal Register; Notice and comment period
(typically 60 days but can be longer and is often extended) • Third Step: Preparation of final rule
– FDA must consider comments received in drafting final rule – The Office of Management and Budget reviews proposed and final rules prior to
publication if “economically significant” – Final Rule: Published in Federal Register and carries the force of law
Regulatory Process
Congress passes law
Federal Agency has authority
to regulate
Pre-rulemaking
Proposed Rule Final Rule
Public Comment Effective Immediately
Intro to Federal Agencies with oversight of food safety
Food and Drug Administration (FDA)
• Everything else including • Shell eggs • All other fish
US Department of Agriculture (USDA)
• Meat • Poultry • Egg Products • Catfish
Which regulations apply to which facilities?
• FSMA – FDA Registered Food Facilities
• Distribution Centers • Manufacturing/Central
Kitchens – Transportation – Imports – Farms – Recall notification (15 stores
or more)
• FDA Food Code – Retail Stores – Home Delivery
FDA Authority • Increased Inspections
– Depends on appropriations • Increased Records Access • Mandatory Recall Authority • Import Certification Authority • Fees for Reinspection • Administration Detention • Facility Registration and Suspension of
Registration
Rules that immediately went into effect
• Inspection of records • Suspension of facility registration • Expanded administrative detention • Authority to require import certificates • Mandatory recall
FSMA objectives
FSMA
Prevention Increased Inspection Enhanced Responses
Focus on prevention rather than cures
Apply domestic standards to imported food
1
3
2
4
Ensure compliance, contain crises
Import Safety Build a global system of food safety
Enhanced Partnerships
FSMA Status Summary - “The 7 Pillars”
Proposed Rule Final Rule Published
PC- Human Food-Final September 17, 2015
PC- Animal Food-Final September 17, 2015
Produce Safety November 27, 2015
FSVP November 27, 2015
Third Party Accreditation November 27, 2015
Sanitary Transport March 31, 2016
Food Defense May 31, 2016
Retail Store Only
Retailer: central
kitchen, or off-site
production
Any facility who
Imports (retail,
wholesale, production)
Retailer/ wholesaler:
With DC
Retailer/ wholesaler: DC & truck
fleet
Produce safety
Preventive Control Plan
Food Defense Plan
Sanitary transportation
Foreign supplier verification
FSMA compliance requirements by facility type
TODAY
Jan. 4, 2011 FSMA was signed into law by President Obama
Sep. 17, 2015 • Preventive
Controls: Human Food
• Preventive Controls: Animal Food
Nov. 13, 2015 • Produce Safety • Foreign Supplier
Verification Program
• Accreditation of Third Party Auditors
Sept. 17, 2016 • Preventive
Controls: Human Food
• Preventive Controls: Animal Food
Q2 2016 • Sanitary
Transportation • Food Defense
Expected Compliance Deadline
Final Regulation published
Q2 2017 • Sanitary
Transportation • Foreign Supplier
Verification Program
• Accreditation of Third Party Auditors
• Food Defense
Q4 2017 • Produce Safety
Preventive Controls for Human Food
Impacts: DCs
Manufacturing, processing
Preventive Controls for Human Food Who? • FDA Registered Facilities
– Pack, process, manufacture or hold food Requirements • cGMPs (good manufacturing practices) • Hazard Analysis • Food Safety Plan • Supply chain program (DC’s exempt) • Training
Qualified Individual • All employees engaged in cGMPs or Preventative Controls must be a
“Qualified Individual” – a person who has the education, training, or experience or
combination of same, to properly manufacture, process, pack, or hold clean and safe food as according to their job description
– All, including supervisors, must receive training in in principles of food hygiene and food safety, including employee health and personal hygiene
– Records of same to be kept, frequency of training is up to the facility • Training is now required for first time by regulation -
documentation becomes critical
Preventive Controls Qualified Individual
This is a “qualified individual who has 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 is otherwise qualified through job experience to develop and apply a food safety system.”
• This is the person deemed qualified to write the food safety
plan, oversee verification/validation, etc. • Training and documentation again is critical • Look for training from the FSPCA
Foreign Supplier Verification Program
Impacts: Imports
Importer: Definition
• The US owner or consignee of an article of food that is being offered for import into the US. If there is no US owner or consignee of an article of food at the time of US entry, the importer is the US agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under this subpart.
Foreign Supplier Verification Program (FSVP)
• Intent – Imported foods must be produced in compliance with the preventive controls and produce safety rules, not be adulterated or mislabeled
• Importers must develop, maintain and follow a FSVP • Importer definition different than Customs and
Border Patrol (CBP) importer definition
FSVP - Requirements • Qualified Individual develops FSVP and performs FSVP activities • Hazard Analysis
– Known or reasonably foreseeable hazards in each food – biological, chemical and physical
• Evaluation of risk based on history and other factors • Verification activities
– Use of approved foreign suppliers – written procedures – Onsite audits – Food safety records – Sampling and testing
Still to come…
• Sanitary Transportation March 31, 2016 – Trucks
• Intentional Adulteration May 31, 2016 – Food Defense
Sanitary Transportation
Impacts: Shippers, Carriers. Receivers
Motor and Rail
Sanitary Transportation • Avoid contamination of food in vehicles and
transportation equipment • Procedures for information exchange
– Records
• Required training and documentation • Awaiting final rule…
Retail Store Only
Retailer: central
kitchen, or off-site
production
Any facility who
Imports (retail,
wholesale, production)
Retailer/ wholesaler:
With DC
Retailer/ wholesaler: DC & truck
fleet
Produce safety
Preventive Control Plan
Food Defense Plan
Sanitary transportation
Foreign supplier verification
FSMA compliance requirements by facility type
FDA is not done yet…
• High risk foods list • Traceability • Reportable Food Registry
– Consumer notification of recalls for retailers with 15 stores or more
