The Food Safety Modernization Act (FSMA) Calls for stricter FDA - - PowerPoint PPT Presentation

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

• r 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

• fficials.

• 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 Hazard Analysis Critical Control Points Critical Limits Monitoring Corrective Actions Verification Record-Keeping FDA--PCHF Hazard Analysis Preventive Controls Parameter & Values Monitoring Corrective Actions or Corrections Verification Record-Keeping

Hazard Analysis

Supply-Chain Management Prerequisite Programs Good Manufacturing Practices Process Preventive Controls Allergen Preventive Controls Sanitation Preventive Controls Supply-Chain Preventive Controls

Food Safety Plan (including procedures for monitoring, corrective action and verification)

• 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,

• r 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).

Prevent Contamination

Ingredients People Environment

Potential Controls For Biological Hazards

Kill Them

Spores are harder to kill than vegetative cells of bacteria, viruses and parasites

Control Growth

(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)

Allergen Preventive Control

• Ingredient Allergen Identification--must contain “allergens in

ingredient formulation” and “allergens in precautionary labeling”.

• Allergen Label Declaration--all finished product must declare the

allergens present in the formula per listing and have correct labeled package or carton.

• Allergen Scheduling And Cleaning Assessments--no allergens at

beginning of shift; most allergens at end of shift. A full allergen clean is required after production of each product that contains a different (unique) allergen.

Sanitation Preventive Control

• Hygienic Zoning: To minimize the potential of recontamination with

environmental pathogens.

§ Air flow Control --- A positive air balance (i.e., air flows out of the area) is maintained between primary pathogen control processing areas and

• ther areas of the factory.

§ Dedicated personnel in sensitive areas --- properly gowned employees, designated foot covers, hand-washing provisions, etc.

• Environmental Monitoring: To verify the effectiveness of sanitation

and hygiene zoning procedures

§ Microbiological sampling/testing for Salmonella and/or Listeria.

Supply-Chain Preventive Controls

If ingredient history or raw-material history suggests potential

• ccurrence of a hazard, you have three choices:

a) no need for Supply-Chain PC if you will exercise a process control at your facility b) using a third-party to verify that a Supply-Chain PC is used by the Supplier or Customers (Further Processor.) c) notify Further Processor “not processed to control x .” Supply-Chain = Your Supplier

• f ingredients
• r raw material

Your Facility Your Customer

(the Further Processor)

• Manufacturer
• Food service
• Restaurant

Components of Good Manufacturing Practices (GMPs)

• The regulation of (21CFR§117) lists these components that

establish the conditions and practices the food industry must follow for processing safe food under sanitary conditions:

§ Personnel § Plant and grounds § Sanitary operations* § Equipment and utensils § Processes and controls* § Warehousing and distribution § Defect action levels

*Some components may be Preventive Controls based on Hazard Analysis

Recall Plan Requirements (PCHF)

• Required for any food with a Hazard requiring a Preventive

Control.

• Must be written.
• Must describe steps to take and assign responsibility to:

§ Notify regulators, direct customers, consignees, and, when appropriate, the public. § Record lot identification and Verification information. § Conduct effectiveness-checks procedures during a recall. § Execute disposition of food (reconditioning, reworking, relabeling, diverting, destroying).

What Are Parameters & Values

• Parameter: A characteristic, feature or measurable factor that can

help in defining a particular system.

• Value: An assigned numerical quantity.
• Parameters & Values: In PCHF, this term supports identification of

a frequency or other metric to assess compliance—rather than a min/max value--to which a parameter must be controlled (thereby, it is comparable to a “Critical Limit” in a HACCP Plan).

Definitions (PCHF)

Corrective Action

• Procedures that must be

taken if Preventive Controls are not properly implemented. 21CFR§117.150(a)(1) Correction

• An action to identify and correct a

problem that occurred during the production of food, without other actions associated with a Corrective Action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce). 21CFR§117.3

Efforts Are Underway To Recognize Private Certification Schemes Like GFSI As Equivalent To Compliance With FSMA

SOURCE: Ted Agres, Food Quality & Safety, March 2017.

• The US, China, Canada and Mexico are seeking to strengthen

and streamline their inspection activities by leveraging private- sector audit and certification activities.

• The presumption is that private certification schemes, such as

those recognized by GFSI and/or ISO (e.g., SQF, BRC, FSSC 22000) are highly likely to be in compliance with governmental food safety rewuirements.

• Canada will give facilities credit for a successful audit in assessing

risk.

• Cargill is working with the Acheson Group, GFSI and FDA to gain

approval of compliance for both domestic and foreign suppliers of raw materials, ingredients and final products.

• In January 2017, FDA published a document “Control of Listeria

monocytogenes in Ready-To-Eat Foods: Guidance for Industry”

• It describes FDA’s expectations for food safety controls related to

Listeria monocytogenes in ready-to-eat (RTE) and ambient at-risk production systems.

• It appears that all plants (except “Qualified”, very small

businesses) will need to comply with the PCHF Final Rule by September of 2017.

• The risk will be significant (and could result in regulatory, civil and

criminal charges) if plants have not also addressed practices suggested in the LM controls Guidance Document.