The Food Safety Modernization Act (FSMA), a sweeping food safety legislation amending the Food, Drug and Cosmetic Act of 1938, was enacted on January 4, 2011.  It aims to ensure the United States food supply is safe by shifting the focus from responding to contamination to preventing it. As required by FSMA, the FDA implemented the HARPC (Hazard Analysis and Risk-Based Preventive Controls) regulation (also referred to as the “Preventive Controls Rule”) for the food industry on September 17, 2015.  Compliance dates were extended for small and very small businesses:

 September 18, 2017: Small businesses (with fewer than 500 full-time employees)

September 17, 2018: Very small businesses (businesses averaging less than $1 million per year (adjusted for inflation) in annual sales 

HARPC is similar to HACCP (Hazard Analysis and Risk-Based Preventative Controls) which is mandatory for certain food categories such as seafood, juice, meat/poultry (USDA) but includes planning for potential terrorist acts or intentional adulteration requiring facility registration with the FDA, controls on transportation inbound/outbound, facility visitor access, etc.

HARPC requires virtually every food manufacturer, processer, packer, and storage facility to:

  • identify food safety and adulteration hazards associated with their foods and processes,
  • implement controls to minimize the hazards,
  • verify that the controls are working, and
  • design and implement corrective actions to address any deviations from the controls that might arise in a food safety plan.

Everything in a HARPC plan must be properly documented and must conform to FDA’s standards and definitions surrounding facilities, controls, hazards, and the adulteration of foods.  HARPC requires each food facility to document all aspects of its plan, periodically review it, constantly maintain it, and document its verification steps.

HARPC represents a substantial new regulatory requirement with an unprecedented level of coverage for the industry that must be taken seriously.  Companies must create their unique food safety plan compliant with HARPC, update it, and produce the documentation to FDA upon request or inspection.

Facility Registration

Domestic and foreign facilities that manufacture, process, pack, or hold food/beverages for human or animal consumption in the US are required to register with the FDA and renew every even-numbered year. Registration is easy and free. Follow the prompts at the link below to register your facility. Registered facilities may be subject to random inspections. 

http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006831.htm

Registration is not required for AP5 Kombucha products (aka Hard Kombucha) as the FDA does not regulate alcoholic beverages.

Current Good Manufacturing Practices (cGMP’s) – Preventative 

Controls (Critical components of Step 2 in HARPC)

Plant and Grounds

Facility exterior

  • Shouldn’t harbor pests
    • Grass/weed control
    • No stored equipment within immediate parameter
  • Protected points of entry
    • Sealed, self-closing doors
    • Screened vents at all intakes
    • Walls, roof, foundation must prevent entry of water and pests

Facility Interior

  • Walls, floors ceilings should be durable, impervious,smooth, cleanable, white or light-colored 
  • Adequate floor drainage
  • Screened windows
  • Adequate lighting and shielded bulbs
  • Adequate ventilation
  • Proper waste containment and disposal
  • Handwashing stations with dispensable soap, single-use towels, direct connection to drain, waste receptacles, signage
  • Washrooms, lunchrooms should not open directly to processing areas; negative air pressure in washrooms
  • Plumbing must have backflow devices between potable water systems and sewage lines

Receiving and Storage

  • Transportation inbound – inspect truck and materials for damage or contamination, improper temperature controls
  • Ensure Certificate of Analysis (CoA) if required or conduct inspection/testing to verify ingredients and packaging meet specifications
  • Storage
    • Insure ingredients, packaging materials, product in process, and finished product are properly stored to prevent contamination – proper temperatures, 18” from wall, 6” off floor
    • Chemicals in isolated storage – properly labeled and accessible safety data sheets (SDS)

Equipment

  • Designed, constructed and installed to be accessible for adequate cleaning, sanitation, and maintenance
  • Product contact surfaces should be smooth, non-corrosive, food-grade, non-absorbent, non-toxic, and free from cracks, crevices, and pitting
  • Must have adequate drainage
  • Establish a preventable maintenance program

Personnel

  • Establish and implement training programs for all new employees; 
    • Provide refresher training
      • Personal Hygiene
      • Allergen Standard Operating Procedures (SOP’s)
      • Product and Material Safety
  • Maintain a personal hygiene policy and enforce 
    • Hair and beard restraints
    • Clean clothing and footwear (closed-toe only)
    • Eating, drinking, and smoking in designated areas only (includes gum)
    • No jewelry, watches, earrings; no fingernail polish or artificial nails
    • Proper handwashing practices and signage
  • Only authorized personnel on-site; visitors and contract employees to sign-in
  • Employee health 
    • Inform management of any communicable disease or potential for contamination
      • Diarrhea, vomiting or other gastrointestinal illness
      • Jaundice
      • Open, blistered or infected cuts, wounds, abrasions, or burns

Sanitation and Pest Control

  • Establish procedures for cleaning and sanitation of premises, production areas, equipment, and storage areas.  
    • Document procedures, chemicals used/usage levels, and maintain a log of pre-op, periodic, and post-op sanitation.
  • Interior pest control devices must not contain bait of any kind
  • Exterior pest control devices must be tamper-resistant, locked, labeled, and secured
  • Maintain
    • List of chemicals and pesticides used (including SDS and copies of labels which includes usage/application rates)
    • Schedules/frequency
    • Usage log that lists when and where used, concentration, how it was applied and by whom
    • Location map of devices
    • Activity reports/records for findings and actions
    • Corrective action records

Traceability and Recall Protocol

  • Traceability
    • Maintain documented procedures to ensure all raw materials, product, and packaging materials can be traced to usage dae and/or lot identification
    • Finished products should carry a “use by” or “best by” date and lot number (if multiple lots per code date)
  • Consumer Complaint Log
    • Outlines how complaints are processed, evaluated and investigated
    • Document customer name, contact information, current date, name of item, a description of the product safety and/or quality complaint, the purchase date of item and possible receipt 
  • Recall Protocol
    • Document what is to be done in the event product must be recalled from the distribution system and/or shelf
    • This will allow tracing and accounting for all identified defective products in a quick and efficient manner; managing communications in the event of a recall, and assisting outside agencies by having a predetermined plan and information-gathering mechanisms

KBI will be providing checklists and templates for some of these documents – stay tuned for more resources available in the Member Forum

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