FDA Food Safety Modernization Act FSMA Regulatory Tidal

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FDA Food Safety Modernization Act FSMA Regulatory Tidal Powered By Docstoc
					     FDA’s Food Safety                                                 Allen R. Sayler    Background:
                                                                     President, Center    • 29 years in Dairy Industry as state, FDA
     Modernization Act                                                                      & USDA Regulator
          (FSMA)                                                      for Food Safety &
                                                                                          • 12 years w/IDFA serving as primary
                                                                         Regulatory         HACCP, SQF and food safety trainer,
                                                                          Solutions         advocating industry views with FDA,
 A Regulatory Tidal Wave                                                                    USDA and all state dairy regulatory
                                                                                            bodies and writing industry position
   Is Your Plant Ready?                                                                     papers
                                                                                          • Certified HACCP Trainer
                               Allen Sayler, Vice President,                              • SQF Trainer & Consultant
                           Center for Food Safety & Regulatory                            • 2009 IAFP Harold Barnum Award Winner
                                   Solutions, (CFSRS)
                                                                                          Education:
                                  Woodbridge, Virginia
                                                                                          BSc Biology & Human Physiology,
                            asayler@cfsrs.com 202-841-1029                                   University of Mary
                                     www.cfsrs.com                                        Additional Course Work in Civil
                                                                                             Engineering




     CFSRS Training Workshops:                                   FOOD SAFETY REALITIES
                                                                 •    Ground turkey
                                                                 •    Sprouts
• Food Safety Modernization Act Webinar: July 27th & Sept. 11    •    Pasteurized Milk (Yersinia)
  @ Noon (EDT)                                                   •    Raw Milk Cheese - Listeria
• Food Safety Modernization Act Workshop: Aug. 20-21 & Oct. 8    •    Raw Milk - ecoli O157H7, listeria
  – 9 (Mon. 1 p.m.- Tues. Noon CDT) @ Rosemont, IL               •    Ground beef - always??
• CFSRS's Practical Implementation: HACCP & Preventative         •    Undeclared Allergens - always??
  Measures Workshop: Aug. 21-22 & Oct. 9-10 (Tues. 1 p.m.-       •    Black Pepper & Other spices
  Wed. 5 p.m. CDT) @ Rosemont, IL                                •    Cleaning chemicals-school milk - MD & MN
                                                                 •    Hydrolized Vegetable Proteins (HVP)
• Practical Implementation Strategies: Converting to the 7th
                                                                 •    Instantized Milk Products
  edition of the SQF Code Workshop: Aug. 23-24 & Oct. 11-12
                                                                 •    Peanut & Peanut Products
  (Thurs. 8:30 a.m.- Friday 5 p.m. CDT) @ Rosemont, IL
                                                                 •    Cookie Dough
                                                                                                                                4




                                                                                                                                       1
             The Public Health Imperative
                                                                                             Figure 7 - Distribution of 229 Primary RFR Entries by
                                                                                                               Food Safety Hazard


 • Foodborne illness is a significant burden
      – About 48 million (1 in 6 Americans) get sick each
        year
      – 128,000 are hospitalized
      – 3,000 die
 • Immune-compromised individuals more susceptible
      – Infants and children, pregnant women, older
        individuals, those on chemotherapy
 • Foodborne illness is not just a stomach ache—it can cause
   life-long chronic disease
      – Arthritis, kidney failure
                                                                                                                                                     6




             FDA Reportable Food Registry – Sept.2009 – Sept. 2010
              E. coli    List.
                                            Staph.
                                 Salmonella aureus
                                                   Foreign
                                                           Allergens    Other
                                                           /Intoler- (including    Total
                                                                                           2011 Food Safety Modernization Act
             O157:H7    Mono.                      Object
                                                             ances chemical)
All Dairy       1         8          1        0       0        8         0         18
Dairy %       5.6%      44%        5.6%      0%      0%      44%        0%        100%
All Food        6        33         86       30    80      16                      229
All Food %    2.6% 14.4% 37.6% 0% 1.3% 34.9% 7.0%                                 100.0%
                  FDA Recall Database (Dec.2010 – Dec. 2011)
Cheese          0      7        1      1     0      2        0                     11
Drinking
                0      0        0      0     0      3        1                      4
Milk
Ice Cream       0         0          0        0       0        5         0          5
Other
                0         1          2        0       1        1         0          5
Dairy
Grand
                0         8          3        1       1       11         1         25
Total
    %          0%       32%        12%       4%      4%      44%        4%        100%                                                               8
                                                                                                                                                     8




                                                                                                                                                         2
                             Food Safety                        US Federal Rulemaking Process
                           Modernization Act
                                                           • FDA proposes a rule/regulation
                                (FSMA)
                                                           • Draft rules/regulations are published in the Federal
                            PL 111-353, 124
                                                             Register & http://www.regulations.gov
                              Stat. 3885
                                                           • Public comment period, then FDA collates and
                                                             consider public comments
•   Enacted January 4, 2011                                • FDA revises Rule/Regulation based on public comment
•   Most expansive changes since 1938 Act                    & final rule/regulation is issued with effective date
•   Sweeping new enforcement authorities                   • After a final rule is published, it may have an effective
•   Exacting new food import requirements                    date in the future
•   Major new program activities for FDA                   • FDA may issues guidance documents to better
•   Increased inspections                                    understand the rule/regulation




                 Who Will be Regulated Under                              FSMA Exemptions
                      This New Law??
                                                           a. Very Small Businesses (as defined by SBA)
                                                           b. Small business -less than $500,000 (3-year average)
    • All food products other than poultry, meat and          and majority of food distributed directly to consumers
      some egg products, which are regulated by the US
      Department of Agriculture (USDA).                       & restaurants, intrastate distribution only and all sales
    • All plants making food for human consumption shall      within 275 miles. Sales to "Qualified End Users"
      register with FDA in even numbered years (2012,         must exceed sales to others
      2014, etc.) starting in 2012.                        c. Warehouses for packaged food (maybe)
    • Introducing food into commerce without complying     d. Storage facilities for raw agricultural commodities
      is a “prohibited act”                                e. Seafood, juice beverages and low acid canned foods
    • Failure to comply with FSMA could result in your        (micro only) covered under existing FDA regulations
      registration being suspended.                        f. Dietary supplements (many parts of FSMA apply)
                     What does this mean?                  g. Alcohol-Related Facilities - covered by ATF




                                                                                                                          3
              Facility Registration
•   Facilities are required to register will have to re-
    register every 2 years, during the period beginning on
    October 1 and ending on December 31 in even
    numbered years. This will first occur in October-
    December 2012.
•   Only the Secretary of Health & Human Services can
    suspend registration of a facility registered in certain
    circumstances involving food manufactured,
    processed, packed, received or held by a registered
    facility that has a reasonable probability of causing
    serious adverse health consequences or death to
    humans or animals.
•   Battle in-progress on a registration fee ($500 per plant)




                                                                  Prevention Control Mandates
                                                                Sec. 103. Hazard analysis and risk-based
                                                                 preventive controls
                                                                 Requires human and animal food facilities to:
                                                                    • Evaluate hazards that could affect food safety;
                                                                    • Identify and implement preventive controls to
                                                                      prevent hazards;
                                                                    • Monitor controls and maintain monitoring
                                                                      records; and
                                                                    • Conduct verification activities.




                                                                                                                        4
                                                                                                                     Yogurt Process Flow
                             FSMA                                                                                                                                 Cup Set Yogurt

                                                                                                                                                                  Vat Set Yogurt


       Written “Preventative Controls”
                                                                                         Cow /              Cooling / On-             Transport /
               HACCP or Not?                                                             Milking            Site Storage              Dairy Receive
                                                                                                                                                                      Raw
                                                                                                                                                                      Silo



a. Hazard Analysis – reanalyze every 3 years, include
                                                                                      Pasteurize /                                                               Transport to
   biological, physical, chemical and hazards introduced                              Homogenize                Blend                 Pasteurize /
                                                                                                                                      Separate                   Processor

   by terrorism. Addressing radiological agents is a
   requirement under chemical hazards.                                                 Cool
                                                                                                                                                     Distribution Channels
                                                                                                                            Dry
                                                                                                                            Ingredients
                                                                                                                                                     Transportation
b. HACCP Plan Summary Table with CCP(s), critical
                                                                                      Ferment         Culture
   limit(s), monitoring records, corrective actions,                                                                                                 Finished Product Storage

   verification & validation plans & overall records                                                                         Fill
                                                                                                        Fruit /
   system. Verification activities include environmental                              Cool
                                                                                                        Flavor Add          Package
                                                                                                                                                                      Cool


   and end-product sampling records                                                                                          Label
                                                                                                                                                                      Ferment




                 Biological Hazards
                                                                                                Chemical Hazards:
Bacteria                                        Parasites / Protozoa
Vegetative Pathogens         Spore-forming       Cryptosporidium
                                                                                  • Allergens/Food Sensitivities:
 Corynebacterium spp.       Pathogens            parvum
 Coxiella burnetti           Clostridium       Cyclospora                          – ingredients, sub-ingredients, processing aids,
 Brucella                     botulinum         Entamoeba histolytica                   rework;
 Mycobacterium spp           Clostridium       Giardia lambia                      – product changeovers on common equipment
 Aeromonas hydrophilia        perfringens       Taenia solium                            with inadequate cleaning;
 Campylobacter jejuni        Bacillus          Taenia saginata
                               cereus            Trichinella spriralis               – wrong label
 Pathogenic E. coli
 Listeria monocytogenes      Bacillus          Toxoplasma gondii               •   Pesticides: ingredients, plant environment, pest control
 Salmonella spp.              anthracis
                                                                                 •   Drug residues: dairy ingredients
 Shigella                                      Viruses
 Yersinia enterocolitica                        Norwalk Virus                   •   Mycotoxins: ingredients, growth in product
 Staphylococcus aureus                          Rotavirus                       •   Sanitizers: CIP cross-connections: over application
 Streptococcus agalactiae                       Hepatitis A
 Streptococcus pyogenes
                                             Adapted from ICMSF, 1986; Jackson,   •   Preservatives / Additives / Vitamins: over addition
                                             1990.




                                                                                                                                                                                   5
                        Physical Hazards                                                                                                  Radiation Hazards
Foreign material such as metal, glass, wood splinters,
or plastic fragments that might cause injury or
present a choking hazard.
Sources:
                                                                                  Nuclear Explosion Hazards:
• Glass: bottles, jars, light fixtures, gauge                      covers        • Carbon-14
                                                                                 • Cesium-137
• Wood: field, pallets, boxes, building structure
                                                                                 • Zirconium-95
• Stones: field                                                                  • Strontium-90
• Metal: screens/sieves, employees, equipment
                                                                                 Luminous watches and clocks
• Plastic: field, packaging material, pallets,                                   contain Tritium or Promethium-147,                              What radionuclide
  employees, equipment covers (Plexiglas®)                                       and by far contribute the most dose                             concentrates in seafood?
                                                                                 from consumer products                                          a. Mercury     b. Thorium
* See Dairy Hazards & Controls Guide for more information
                                                                                                                                                 c. Lead         d. Iron




                                                                                 Hazard Analysis Summary Table
                        Hazard Matrix Tool                                       Product Name:_________________________________       Plant Name: ____________________________________________
                                                                                 Date:_____________________________________________   Plant Address:________________________________________________
                                Known          Could    Not      Practically
                                                                                                   Hazard –
FREQUENCIES              Common to Occur       Occur    Expected Impossible      Material /       Biological,                                                  Prerequisite Program,
                                                                                                                 Likeli-
                                                                                 Processing       Chemical,              Severity                            Operational Program, etc.         CCP
CONSEQUENCES                                                                                                      hood            Significance Score
                                                                                    Step         Physical, or             Score                             Identify & Brief Description
                                                                                                                 Score
Fatality                        1         2        4           7           11                    Radiological
                                                                                                B–
Serious Illness                 3         5        8          12           16                   C–
                                                                                                P-
                                                                                                R–
Product Recall                  6         9       13          17           20                   B–
                                                                                                C-
Customer Complaint             10        14       18          21           23                   P–
                                                                                                R–
Insignificant                  15        19       22          24           25                   B–
                                                                                                C–
                         Note: Highlighted area indicates the need for control                  P-
                         with either a CCP or Pre-Requisite Program.                            R–
                                                                                                B–
                                                                                                C-
                                    Hazard addressed by Prerequisite                            P–
                                                                                                R–
                                    Hazard addressed by CCP                                     B–
                                    Hazard addressed by either CCP                              C–
                                                                                                P-
                                    or Prerequisite depending on                                R–
                                    circumstances & operational                                 B–
                                                                                                C-
                                    conditions                                                  P–
                                                                                                R-




                                                                                                                                                                                                       6
 FSMA Written “Performance Standards?                                                  FSMA – Supply Chain Management
a. Supplier Management
b. Environmental Monitoring Program – as part of a plant’s
     verification program that could include finished product testing and a    a. Risk-based supplier verification to ensure
     consumer complaint program.                                                  compliance with FSMA
c. Allergen Control Program                                                    b. Ensure food produced in conformance with
                                                                                  plant’s Food Safety Plan
d. GMP Program as defined in 21 CFR 110                                        c. Ensure food produced in conformance with FDA’s
e. Product Traceability/Recall                                                    FSMA requirements
                                                                               d. Ensure food is not adulterated as defined under
f. Food Defense                                                                   section 403(w) of the Act
g. Employee Training (GMPs, HACCP, sanitation, allergens,
     environmental monitoring, food defense, food regulations, chemical use)
                                                                               What about ingredient & primary packaging brokers?
                                                                                                                                            26
h. Processing Equipment Cleaning & Sanitizing




                                FSMA FEES                                      How does FDA identify a high-risk (HR) facility?
                                                                               • Known safety risks of the food manufactured, processed,
                                                                                 packed, or held at the facility.
Fees – may start in 2011 (limited to $20 million annually for recall           • Compliance history of a facility, including recalls, foodborne
      expenses and $25 million for re-inspection related fees)                   illness outbreaks, and violations of food safety standards.
a.     No Registration or civil penalty fees
                                                                               • Effectiveness of the facility’s hazard analysis and preventive
                                                                                 controls. Establishment type / type of activity conducted at the
b.    Re-inspections & Recalls                                                   facility (manufacturer/processor, repacker/packer, etc.)
     • $224 an hour if no foreign travel is required                           • Years since last inspection.
     • $335 an hour if foreign travel is required                              • If imported food is manufactured, processed, packed or stored &
     • Effective: October 1, 2011 through September 30, 2012                     is sourced in manner leading to potential adulteration
d.     Processing fee for export certificates: food going “out”                • If imported food has received a certification under section
                                                                                 801(q) or 806 (voluntary qualified importer program)
e.     Extra fee for food imports using “fast lane” access to US               • Any other criteria deemed necessary and appropriate by the
       markets                                                                   Secretary for purposes of allocating inspection resources.




                                                                                                                                                    7
            FSMA – Inspection Frequency
                                                                                      FSMA – Mandatory Recall Program
                                                                             • Notification of recall to FDA
a. Domestically produced “High-risk” foods – every
   3 years                                                                   • Mandatory recalls if a voluntary recall is refused

b. Domestically produced “Low-risk” foods – every                            • Standard for mandatory recall would be tied to if food
   5 years                                                                     product “serious adverse health consequences or
                                                                               death.“
c. Imported food processing plants – increase total
   inspections from 600 – 9600 within 5 years of bill                        • Effective immediately and only authorized for the
   becoming law                                                                Commissioner of FDA. Note: failure to comply would
                                                                               trigger a $50,000 penalty per individual and a
                                                                               $250,000 penalty per company so the total would not
                                                                               exceed $500,000.                                  30




   FDA Admin. Detention: Effective July 3, 2011                                             FSMA – Records Access
Lower legal standard from “credible evidence or information indicating
[that the article of food] presents a threat of serious adverse health
consequences or death” to “reason to believe [that the article of food] is   • FDA Published the Interim Final Rule and Guidance on
adulterated or misbranded                                                      Records Access On February 22, 2012, under sec.414(a) of
– An officer or qualified employee of FDA may order the detention of           the FD&C Act, as expanded Section 101 of FSMA
  any article of food for up to 30 days if the officer or qualified
  employee has reason to believe that the article of food is adulterated
  or misbranded.                                                             • What are the record availability requirements (continued)?
– FDA decision to administratively detain food would be based on a             Such records and other information must be made available
  "case-by-case” basis using specific facts.                                   as soon as possible, not to exceed 24 hours from the time of
– FDA must issue the detention order in writing, in the form of a
  detention notice, signed and dated by the officer or qualified               receipt of the official request, from an officer or employee
  employee of FDA.                                                             duly designated by the Secretary of Health and Human
– FDA more likely to use administrative detention against articles of          Services who presents appropriate credentials and a written
  food where the use of or exposure to a violative product may cause
  temporary or medically reversible adverse health consequences or             notice.
  where the probability of serious adverse health consequences is
  remote, analogous to a Class II recalls.
                                                                     31                                                               32
– FDA has used this authority 3 times




                                                                                                                                              8
                  FSMA – Records Access                                                   Records Protected under FSMA
Under what circumstances may FDA access and copy records under
section 414(a) of the FD&C Act?                                              • Records from farms
FDA may access and copy records from domestic and foreign persons            • Records from restaurants
who manufacture, process, pack, transport, distribute, receive, hold, or     • Recipes, as defined in 21 CFR 1.328 - A “recipe" is the
import food if:
                                                                               formula, including ingredients, quantities, and instructions
 (1) FDA has a reasonable belief that the food, and any other food that
                                                                               necessary to manufacture a food. Because a recipe must
     FDA reasonably believes is likely to be affected in a similar manner,
                                                                               have all three elements, a list of the ingredients used to
       a) is adulterated, and                                                  manufacture a food, without quantity information and
       b) presents a threat of serious adverse health consequences or          manufacturing instructions, is not a recipe.
          death to humans or animals.
                                                                             • Financial data                  Pricing data
 (2) FDA believes that there is a reasonable probability that use of or
    exposure to the food, and any other food that the FDA reasonably
                                                                             • Personnel data                  Research data
     believes is likely to be affected in a similar manner will cause        • Sales data other than shipment data regarding sales
                                                                      33                                                                     34
     serious adverse health consequences or death to humans/animals.




                 FSMA – Imported Food                                                       FSMA – Imported Food
                   In 2010, FDA received 10,116,018 prior notices
                       from approximately 129,757 submitters.

                                                                             a. The requirements in this interim final rule effective on
• Section 301 – Foreign Supplier Verification Program
                                                                                July 3, 2011
• Section 302 – Voluntary Qualified Importer Program –
  “Green Light Program”                                                      b. Foreign food facilities must meet all requirements of US-
• Section 303 – Import Certifications of Food                                   based food processing facilities
• Section 304 – Prior notice of imports
                                                                             c. Compliance with prior notice under Bioterrorism Act of
• Section 306 – Inspection of Foreign Food Facilities                           2002.
• Section 307 – Accreditation of Third-Party Auditors
                                                                             d. Use of third-party certification to allow import
                                                                               –   Accreditation Bodies for recognizing laboratories and auditors
                                                                     35                                                                      36




                                                                                                                                                    9
                 Prevention Measures
                                                                                  FSMA – Traceability
                  for Imported Foods
                                                                  On September 7, 2011, FDA announced two product
Sec. 301 Foreign Supplier Verification Program (FSVP)             tracing pilot projects that will enhance the agency's
• Requires importers to conduct risk-based foreign                and industry's ability to trace products through the
  supplier verification activities to verify that food            food supply. These two pilot projects, one for
  imported into the United States is not adulterated              processed foods and one for produce, are being
  and that it was produced in compliance with FDA’s
  preventive controls requirements and produce                    conducted through an existing contract with the
  safety standards                                                Institute of Food Technologists (IFT). IFT will carry out
                                                                  the pilots at the direction of FDA, and the Agency will
Sec. 307. Third Party Auditor Accreditation                       retain the ultimate decision making authority
• Can be used by importers for supplier verification
  under FSVP                                                                                                           38




 FSMA Food Defense Requirements                                          FSMA – Miscellaneous Requirements
• Food Defense – FDA working with the Department of
  Homeland Security and USDA to perform food                      • Whistle-blower protection
  vulnerability assessments and publish regulations to
  prevent the intentional adulteration of food products.
• Regulations not issued                                          • Upgraded FDA Webpage on Status of
• FDA website on food defense: Good tools to evaluate
                                                                    On-Going Recalls
  your vulnerability and develop multi-layered program
  for food defense that relies on:                                • Grocery Store Posting of Recalls in
  – physical barriers (fences, locked doors & windows, etc.)        “Conspicuous Locations” for chains of 15
  – procedures (sign-in, visitor picture ID requirements, etc.)     or more stores. Must be in-place with 24
  – employee training & reporting suspicious activity
                                                                    hours of recall and remain for 14 days
• Challenge once per year                                                                                              40




                                                                                                                              10
                                   FDA                           Definitions
                               Regulations
                                 on Food          • IPS : immediate previous source
                                Transport
                                                  • ISR: immediate subsequent recipient




                                                                                          42




             Hauler Requirements                       Non-Transporters
1.   Temperature control
2.   Sanitation
3.   Loading & Unloading
4.   Segregation & Prior Cargo
5.   Training of transport staff
6.   Recordkeeping                                Non-transporters (e.g. manufacturers)
                                                  must establish and maintain records
                                                  that identify both the transporter and
                                                  non-transporter IPS and ISR (indicated
                                             43   with solid red arrows above)            44




                                                                                               11
Records Non-transporters Have To EstablishAnd Maintain
     to Identify the Immediate Previous Source (IPS)
                                                                 Snapshot of FSMA homepage elements
                                                                      at: http://www.fda.gov/fsma
Non-transporters have to establish and maintain records to
  identify the non-transporter and transporter IPS of all food
  you receive that include:
• Firm name and contact information of the non-transporter
  IPS (domestic or foreign)
• Description of the type of food received, including brand
  name and specific variety
• Date food was received
• For persons who manufacture, process, or pack food, the lot
  or code number or other identifier (to the extent the
  information exists)
• Quantity and how the food is packaged (e.g., 25 lb cartons)
• Firm name and contact information of the transporter IPS
  who brought the food to you
                                                          45




 Thank You, you are
     not alone

   Who has the first
     question?


Allen Sayler VP, CFSRS

   asayler@cfsrs.com




                                                                                                      12

				
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