The Food Safety Modernization Act (FSMA) • Calls for stricter FDA oversight of the way agricultural commodities are grown, transported, stored, processed, tested and verified as fit for their intended use. • Marks a turning point in the FDA’s 110-year history by mandating proactive measures to prevent harmful substances from entering the supply stream. • Replaces FDA’s longstanding policy of responding to outbreaks of contamination after the fact, with a more assertive approach to stay ahead of a food-safety problem.
Impetus To Enact FSMA • A spate of highly-publicized foodborne illness outbreaks. • Continuing concerns of the risk of bioterror attacks on the food supply. • The challenges of maintaining safety and quality across an increasingly globalized supply chain . • Realization that adoption and implementation of the best approaches to mitigate risks of foodborne illness (e.g., HACCP) remained voluntary as did decisions to initiate recalls. • The fact that inspections of food facilities were infrequent and inconsequential for deviations from FDA guidelines.
• FSMA shifts FDA from reactive to proactive regulatory policies. • Increases FDA’s emphasis on inspection and enforcement. • Reshapes the food safety landscape (horizon scanning and GFSI). • Requires companies at every point in the supply chain to fortify their contamination-control strategies with extra measures of vigilance. • While the deadline for PCHF compliance has already passed for larger companies, small businesses must comply by August 2017, while very small businesses have an additional year.
The New Regulatory Scene: What To Prepare For • Legally binding “Preventive Controls For Human Food” rules . • More frequent, far-ranging and consequential inspections. • Expanded authority over the feed industry. • Mandatory recalls . • Stronger control of global supply-chain safety. • Enforceable safety standards for produce farms. • Tougher sanctions .
Legally Binding “Preventive Controls For Human Food” Rules • Must implement a Food Safety Plan that identifies all reasonably foreseeable Biological, Physical and Chemical Hazards. • Must stipulate appropriate Control measures (such as cGMPs, CCPs, Preventive Controls, ingredient specifications, and raw material and/or product testing) for each Hazard. • Must Monitor progress and keep Records of Control efforts and remedial Corrective Action measures--all of which are legally binding rules.
• Plant size classifications (original and extended implementation dates): § Very small businesses are those which average less than $1 million per year in both annual sales of human food plus the market value of human food manufactured, processed, packed or held without sale. (September 2018, or 2020) § Small businesses are those with fewer than 500 full-time equivalent employees. (September 2017, or 2019) § All other businesses . (September 2016, or 2018)
More Frequent, Far-Ranging And Consequential Inspections • In 2011, nearly twice the number of inspections and 52% more Warning Letters than in 2001. • FDA plans to visit food and feed processing plants plus farms, packing and shipping operations plus grain elevators and other storage facilities. • Frequency of inspections will be based on known food-safety risks in the facility’s purview plus that facility’s compliance history. Facilities deemed “High Risk” will be inspected at least every 3 years; others, every 7 years.
• Expanded Authority Over The Feed Industry-- FSMA requires feed and pet food manufacturers to comply with new cGMP rules and supply-chain controls. • Mandatory Recalls --FSMA authorizes FDA to require responsible parties to recall products suspected or proven to be contaminated. Companies with a Hazard requiring a Preventive Control must develop a Recall Plan. • Stronger Control Of Global Supply-Chain Safety-- Importers must verify that their foreign suppliers conform to the same safety standards--including Preventive Controls--as US food suppliers. Foreign Supplier Verification Programs (FSVPs) must be in place by April 31, 2017.
• Enforceable Safety Standards For Produce Farms --In place of recommended guidelines, mandatory science-based safety requirements will apply to all fruits and vegetables that are consumed raw and not destined for processing. Deadlines for compliance are December 31, 2017 (for “large”), December 31, 2018 (for “small”) and December 31, 2019 (for “very small”) businesses. • Tougher Sanctions - -FDA has obtained the clout to make sure regulations are followed. Breaches of the standards can result in financial and legal fallout including re-inspection fees, complete shutdowns of facilities, suspension of registration, revokation of license and potential fines and imprisonment of operatives and officials.
• With passage of the “Preventive Controls for Human Food” regulation in 2015, every FDA-regulated facility (except those that already have HACCP Plans), must have a “Food Safety Plan.” • If you currently have a HACCP Plan, it likely will be the part of your Food Safety Plan that addresses Hazard Analysis and Process Preventive Controls. • The Hazard Analysis may need adjustments to identify Allergen, Sanitation, Supply-Chain and potentially other Preventive Controls in addition to those addressed in a traditional HACCP plan.
USDA--HACCP FDA--PCHF Hazard Analysis Hazard Analysis Critical Control Points Preventive Controls Critical Limits Parameter & Values Monitoring Monitoring Corrective Actions Corrective Actions or Corrections Verification Verification Record-Keeping Record-Keeping
Food Safety Plan (including procedures for monitoring, corrective action and verification) Supply-Chain Management Prerequisite Programs Hazard Analysis Good Manufacturing Practices Process Preventive Controls Allergen Preventive Controls Sanitation Preventive Controls Supply-Chain Preventive Controls
• Changes in cGMPs: § Moved form 21 CFR Part 110 to 21 CFR Part 117 § “Recommended” practices have either become “Required” practices, or removed § The word “shall” has been replaced by “must” § Includes stricter requirements for allergen control.
Physical Hazards Examples (PCHF) • Foreign Objects --FDA has taken action against Physical Hazards that are hard, sharp and pointed and 0.3 inches (7mm) to 1.0 inches (25mm) in length. Physical Hazards include: § Glass hazards § Plastic (both brittle and soft) § Metal hazards § Stones § Choking hazards for young children (includes soft plastic and globular- shaped and dangerously sized portions of food) * objects like string and paper are unlikely health threats.
Economically Motivated Hazards (PCHF) • Limited to hazards with a pattern of economically motivated adulteration in the past. For example: § melamine in infant milk formula § lead-containing dyes in spices and candy § Sudan 1, a carcinogen, in chili powder • Include only those agents that can cause illness or injury. For example, do not include horsemeat for beef, corn syrup for honey, or peanuts for cumin. • When a Preventive Control is needed, a Supply-Chain Preventive Control program is typically used.
Radiological Hazards (PCHF) • A type of Chemical Hazard; includes “radionuclides such as radium-226, uranium-235, plutonium-239, strontium-96, iodine-131 and cesium-137. • The most common way these radionuclides are incorporated into foods is through use of water that contains them during food production. • In the US, certain locations have high concentrations of radium-226 and uranium-235 in water from private wells. • Milk, vegetables and seafood from areas contaminated by damage to nuclear facilities in Europe and Asia (e.g., Chernobyl; Fukushima).
Potential Controls For Biological Hazards Kill Them Spores are harder to kill than vegetative cells of bacteria, viruses and parasites Prevent Contamination Ingredients People Control Growth Environment (Bacteria Only) Use time, temperature, pH, water activity, atmosphere, competition, and preservatives
Preventive Controls May Include: • Process Preventive Controls • Food Allergen Preventive Controls • Sanitation Preventive Controls • Supply-Chain Preventive Controls • Recall Plan • other Preventive Controls
• A Process Preventive Control requires identification of a Critical Control Point and a Critical Limit (a min/max value), monitoring procedures, corrective action procedures and verification that the process is controlling the hazard. • Allergen , Sanitation and Supply-Chain Preventive Controls do not use the terms CCP or CL because they are not controlling a specific processing action . The focus is on “what must be done to control the hazard,” rather than “what a specific step is called.”
Process Preventive Controls--CCP and CL Food Allergen Preventive Controls --accurate labeling; cross-contact prevention Sanitation Preventive Controls --environmental pathogens control; cross-contact prevention; cross-contamination prevention Supply-Chain Preventive Controls --use of ingredient/raw material history to verify controls of your supplier or of your customer (the further processor)
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