Essay: FDA Food Safety Modernization Act (FSMA)

I. Key Definitions and Facts:
• Signed into law on January 4th, 2011 by President Obama
• Current Good Manufacturing Practices (CGMPs): current regulations enforced by the FDA
o Designed to be flexible to be applicable to different types of companies, technologies, etc.
• In 2013, 19% of our overall food supply was imported
II. Background/Purpose:
• “Up until now, everything has been reactive,” says Darin Detwiler, senior policy coordinator for the advocacy group STOP Foodborne Illness. ”This is the most sweeping food safety legislation passed within the last 70 years.”
• Foodborne illness causes annually in the U.S.:
o 48 million people (1 in 6) to become sick
o 128,000 hospitalizations
o 3,000 deaths
III. Five Major Elements of the Bill:
• Preventive Controls (see section IV, parts 1 and 2)
o Designed to prevent/significantly minimize the likelihood of issues arising
• Inspection and Compliance
o Holds the industry accountable
• Imported Food Safety
o Imported food must meet U.S. standards
o Importers with foreign suppliers must prove satisfactory preventive controls and will have foreign food facilities audited for compliance with U.S. safety standards
• Response
o FDA now has mandatory recall authority for all food products after giving opportunity for the responsible party to cease distribution and recall themself
o Suspension of a food facility’s registration is possible
• Enhanced Partnerships
o Ex: Enhanced training of federal, state, local, territorial, etc. food safety officials
IV. Implementation (7 foundational rules):
1) Preventive Controls for Human Food
a. Food facilities (with the exception of operations defined as “farms”) must have written safety plans for preventing and identifying potentially hazardous issues (to be reanalyzed at least once every 3 years) that must include:
• Hazard analysis
• Identify known/foreseeable hazards (of natural or artificial means)
• Preventive controls
• How will these identified hazards be minimized or prevented
• All employees who manufacture, package, hold, or process food must be qualified by management to perform their tasks. This includes mandatory training in food hygiene and safety, including employee health and hygiene.
• Ex:
o Steps to kill bacteria/prevent them from growing
o How and when equipment is cleaned
o Training of employees
o Etc.
• Oversight and management of preventive controls
• Monitoring
o Are preventive controls consistently performed?
• Corrective actions and corrections
o Pertains to minor, isolated incidents identified with preventive controls
o Corrective actions to reduce likelihood of reoccurrence and evaluate products for safety to enter market must be documented with records
• Verification
o Scientific evidence must be demonstrated to prove that preventive measures are capable of controlling identified hazards
o May need to be done periodically to ensure effectiveness does not falter
b. Note that facilities are not required to utilize a preventive control if a subsequent entity (such as another processor, distributor, or customer) will be in charge of controlling the hazard. This must be disclosed and agreed upon by that entity. (Ex: this product was not processed to control ‘identified hazard’)
c. Compliance Dates
• Very small businesses (averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale): Three years, except for records to support its status as a very small business (January 1, 2016).
• Businesses subject to the Pasteurized Milk Ordinance (compliance dates extended to allow time for changes to the PMO safety standards that incorporate the requirements of this preventive controls rule): Three years
• Small businesses (a business with fewer than 500 full-time equivalent employees): Two years
• All other businesses: One year
• Compliance dates after publication of the final rule for the requirements of the supply chain program:
• Receiving facility is a small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: Two years
• Receiving facility is a small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Two years or six months after the supplier is required to comply with the applicable rule, whichever is later
• Receiving facility is not a small or very small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: 18 months
• Receiving facility is not a small or very small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Six months after the supplier is required to comply with the applicable rule
2. Preventive Controls for Animal Food
a. Facilities have written safety plans for preventing and identifying potentially hazardous issues ((to be reanalyzed at least once every 3 years) that must include:
i. (See above: Preventive Controls for Human Food)
b. Production facilities must have a recall plan in place
3. Produce Safety
a. Establishes, for the first time, science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms for human consumption – AKA emphasis on safety at farms
b. Key Requirements:
i. Agricultural Water
1. Water Quality
a. Establishes criteria for microbial water quality, based in the average presence of potentially dangerous generic E. coli
2. Testing
a. Adopts general approach for testing untreated water, but varies based on water source (surface vs. ground)
ii. Biological Soil Amendments
1. Raw Manure
2. Stabilized Compost
iii. Sprouts
1. Seeds or beans used for growing
iv. Domesticated and Wild Animals
v. Workers Training and Health and Hygiene
1. Requires measures to prevent contamination of produce of food-contact surfaces by sick/infected persons
2. Utilizing hygienic practices (i.e. washing hands after using restroom)
3. Measures required to prevent visitors from introducing contamination (i.e. toilet and hand-washing facilities available)
vi. Equipment, Tools and Buildings
1. Establishes standards (i.e. appropriate storage, maintenance and cleaning) to prevent these sources from contaminating produce.
a. Includes green houses, restrooms, etc.
c. Exemptions
The rule does not apply to:
i. Produce that is not a raw agricultural commodity. (A raw agricultural commodity is any food in its raw or natural state)
ii. The following produce commodities that FDA has identified as rarely consumed raw: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts
iii. Food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g. cotton seed, flax seed, rapeseed, soybean, and sunflower seed)
iv. Produce that is used for personal or on-farm consumption
v. Farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less
4. Foreign Supplier Verification Program
a. Importers must verify that foreign suppliers meet U.S. food safety standards. This is accomplished through a FSVP that is developed and maintained for each specific supplier.
b. Responsibilities of Importers:
i. Hazard Analysis
1. Includes:
a. Biological hazards (i.e. parasites and diseases)
b. Chemical hazards (i.e. pesticide and drug residues, natural toxins, unapproved food or color additives, allergens, etc.)
c. Physical hazards (i.e. glass)
2. Mandatory factors to consider:
a. Formulation of food
b. Condition, function and design of the facility and production equipment
c. Raw materials and other ingredients
d. Harvesting, raising, manufacturing, processing and packing procedures
e. Packaging and labeling activities
f. Storage and distribution
g. Intended or reasonably foreseeable use
h. Sanitation, including employee hygiene
3. Note that another entity can conduct the analysis, so long as the importer reviews the documentation
ii. Evaluation of Food Risk and Supplier Performance
1. An importer must evaluate:
a. The hazard analysis
b. The entity in charge of preventing/minimizing the hazards (i.e. the foreign supplier, supplier’s raw material producer, etc.)
c. Applicable FDA food safety regulations and the supplier’s compliance
d. Supplier’s food safety history (including responsiveness to past problems)
e. Any other relevant factors (i.e. storage and distribution)
2. Note that another entity can conduct the evaluation, so long as the importer reviews the documentation
iii. Supplier Verification
1. Importer must establish and follow written procedures to ensure it only imports from approved foreign suppliers that pass appropriate supplier verification
2. Options for supplier verification (depending on the risks and supplier characteristics) include:
a. Annual on-site audits of the supplier’s facility
b. Sampling and testing
c. Review of the supplier’s relevant food safety records
3. Note that another entity can conduct the verification, so long as the importer reviews the documentation
iv. Corrective Actions
1. Depends on the circumstance but could include discontinuing use of the foreign supplier until the cause of the noncompliance is addressed
c. Exemptions to Imported Food:
i. Juice and fishery products subject to and in compliance with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for those products, and certain ingredients for use in juice and fish and fishery products subject to the HACCP regulations.
ii. Food for research or evaluation
iii. Food for personal consumption
iv. Alcoholic beverages and certain ingredients for use in alcoholic beverages
v. Food that is imported for processing and future export
vi. Low-acid canned foods (LACF), such as canned vegetables, but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards).
vii. Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture at the time of importation
5. Third Party Certification
a. Accredits third-party auditors to monitor food safety and issue certifications for foreign facilities
6. Sanitary Transportation
7. Intentional Adulteration
a. Facilities must identify and address any vulnerable processes that could be used to cause intentional wide-spread harm
Initial “Best Practices” Thoughts:
• Keep a paper trail. Keep good records and documentation that is easily produced for inspection.
• Appoint a designated person to guide FDA through the inspection.