Food Regulations Unit 3- FSMA &HACCP

Why does low-acidic canned food and acidic food need special rules?

1. Clostridium botulinum, can form spores capable of surviving under adverse conditions and can produce botulinum toxin. 2. Botulinum toxin, causes botulism- paralytic illness which can be fatal. 3. 1973- FDA issued a rule designed to control the primary factors that determine the formation and growth of Clostridium botulinum in canned food. Making sure they hit a a targeted heat inside a can in order to kill off the spores and forms of Clostridium botulinum.

What are the 3 benefits of HACCP?

1. Creates a complete system to ensure safety- Corrective actions, verifications, record keeping, potential risks 2. Clearly recognizes that the responsibility of ensuring safe food rests on the food industry- Puts problem solving and prevention at facility level and not defined by periodic regulatory inspections. 3. Allows traditional inspections to be more productive- HACCP record keeping improves ability of food managers and regulators to ensure that the food workers consistently implement traditional sanitary practices.

What must the written Food Safety Plan Requirements include?

1. Hazard Analysis 2. Preventative Controls 3. Supply-chain program 4. Recall Plan 5. Procedures for monitoring the implementation of the preventative controls 6. Corrective action procedures 7. Verification procedures 8. Records

What are the 7 principles of HACCP?

1. Hazard and risk assessment 2. Determine the critical control points (CCPs) to control the identified hazard 3. Establish critical limits for the preventative measures 4. Establish procedures to monitor the critical control points 5. Establish corrective actions to be taken when monitoring shows that critical limit has been exceeded (or other deviation occurs in CCP monitoring) 6. Establish effective recordkeeping systems that documents the HACCP system is working correctly 7. Establish procedures for verification that the HACCP system is working correctly

List the 8 food safety rules

1. Low-acid canned food 2. Acidified foods 3. Bottled Drinking water 4. Infant Formula 5. Fish and Fishery Products 6. Juice 7. Dietary Supplements 8. Refrigeration of shell eggs held for retail distribution

What are the 7 Final Rules of FSMA?

1. Preventative Controls for Human Food 2. Preventative Controls for Animal Food 3. Produce Safety 4. Foreign Supplier Verification Program 5. Third Party Certification 6. Sanitary Transportation 7. Intentional Adulteration

Why was FSMA created?

1. Response from a series of illness outbreaks and contamination incidents 2. Addresses food safety on a global scale 3. Scientific assessment of risk and implementation of controls 4. Focus is on being Proactive instead of Reactive 5. Amends the FD&C which now requires food facilities to implement a written hazard analysis and risk-based preventative control plan

What are chemical controls examples?

1. Thorough and comprehensive allergen-management program- Storage, cross contact, cleaning, and labeling 2. Only approved chemicals 3. Safety Sheets 4. Chemical Safety training for employees 5. Monitor ingredients from suppliers for potential allergens

What are physical control examples?

1. Thorough inspection of raw materials upon receipt 2. Equipment maintenance 3. Employees complying with cGMP's (Jewelry) 4. Improper storage 5. Metal detectors

What are the biological hazard controls?

1. Time/Temperature controls (thawing/tempering, cooking, freezing, storing, etc.) 2. GMP's- Employee Hygiene, Sanitation Programs 3. Packaging integrity 4. Preservation factors (pH and water activity) 5. Consumer directions for use (prevent abuse)

How does tracking FSMA success work?

1. Way to begin to evaluate and track the impact of the 7 rules of FSMA. FDA-TRACK 2. For each rule, the FDA has identified measures that will help where there could be room for improvement. 3. Metrics for evaluation the improvement areas as well as success areas

What is the foundation of the current Good Manufacturing Practices (cGMP)?

1. cGMP's were revised under FSMA and certain language was changed: "must" instead of "shall" 2. Revised to consider the threat of food-allergen cross contact 3. Emphasis on educating employees

What are the egg safety rules?

2000- FDA issued final rule on shell egg refrigeration regulation. Designed to prevent foodborne illnesses and deaths resulted from the contamination of shell eggs with Salmonella enteritidis (SE).

What is a known or reasonably foreseeable hazard?

A biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with the facility or the food.

What is an acidified food (AF)?

A low-acid food to which acid(s) or acid food(s) are added and which has a pH of 4.6 or below and a water activity (aw) greater than 0.85.

What is Hazard Analysis and Critical Control Point (HACCP)?

A prevention based food safety system. The risks from ingredients, process, and final food are analyzed. There are steps to control identified risks and monitor controls.

What is the definition of hazard?

Any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury.

What is a Low-acidic canned food (LACF)?

Any food (other than alcoholic beverages) with a pH greater than 4.6 and a water activity greater than 0.85, excluding tomato and tomato products with a pH less than 4.7.

What are the 3 types of hazard analysis and how may they occur?

Biological, Chemical (includes radiological), and Physical They may occur Naturally, Unintentionally introduced (cross contamination w/ an allergen), and Introduced for economic gain (substitute an ingredient that's more expensive and not inform consumer)

What are chemical hazards and give examples.

Chemicals that naturally occur (allergens, mycotoxins). Chemicals used in formulation (food additives, color additives, preservatives). Chemicals unintentionally or incidentally present (undeclared allergens, cleaning compounds, lead in candy)

Describe dietary supplement safety

Current GMP's to help maintain quality and overall safety of Dietary Supplements, Unique since they typically come in a capsule, gel cap, powder tablet, 2007 established GMP's for manufacturing, labeling, packaging, and holding of dietary supplements

What does FSMA stand for and what does its regulations recognize?

Food Safety Modernization Act. FSMA regulations recognizes the role of the food industry in food safety and gives the regulatory authority to the FDA

What are physical hazards?

Foreign objects (glass and brittle plastic that cause cuts, choking, etc.). Metal (cuts, broken teeth, choking, etc.). Wood and stones

What is the difference between HACCP and FSMA?

HACCP focuses on processing controls (CCP's). FSMA expands to include allergen preventative controls, sanitation preventative controls, and supplier controls

What is the 1875 final rule and requirements for bottled water?

In 1875 FDA issued a final rule to establish CGMP requirements for the processing and bottling of bottled water Requires that bottled water be safe and that it be processed, bottled, held, and transported under sanitary conditions; Also requires analytical testing

Why did HACCP implement meat and poultry?

In 1993 700 were sickened, 4 died, with E. coli from hamburgers from Jack in the Box. 1996 Final Rule

When and why was HACCP developed?

In the 1950s by the Pillsbury Company alongside NASA. Space food huge priority- food illness in space could potentially be catastrophic to entire mission. It was presented to the Conference for Food Protection in 1971. They started with low-acid canned foods in 1974, which was a success.

What are biological hazards?

Include pathogenic bacteria, viruses, and parasites. Biological agents cause more outbreaks. Depending on the hazard, it depends on kill them, control them, and prevent them. Ex: Salmonella as potential hazard

Describe infant formula safety rules

Infant Formula Act of 1980- Amended FD&C Act to include to included Section 412, to include protection of infants by establishing greater regulatory control over formulation and production of infant formula

Describe the 2009 final regulation for egg food safety

Production Storage and Transportation of shell eggs. 1. Prevent egg contamination on the farm level- farm biosecurity practices, rodent/fly pest prevention program 2. If possible present, prevent further growth in storage and transportation- washing and refrigeration 3. Shell egg producers must register with the FDA

Why was juice HACCP developed?

Resulted from a series of foodborne illness (E. coli) outbreaks associated with juice products (unpasteurized apple juice) in 1996. Final Rule in 2002 (small businesses in 2004)

Describe bottled water safety rules and the 1973 final rule

Resulted from field inspections and surveys of bottling plants not meeting regulatory criteria of chemical analysis and bottling under sanitary conditions. In 1973 FDA issued a final rule to establish quality standard regulations establishing allowable levels of microbiological physical, chemical, and radiological contaminants

True or False? In 1995, the FDA established HACCP requirements for the seafood industry because seafood presents a wide range of possible hazards.

True

What is Salmonellosis?

disease, diarrhea, fever, vomiting, headache, cramps, some it gets into bloodstream, most recover while some fall severely ill and can be fatal. Salmonella among the leading bacterial causes of foodborne illnesses and shell eggs are the prominent source of SE-related cases in the US

Where does contamination of food products typically come from?

ingredients, processing environment (including equipment), and people

What are the big 8 food allergens?

milk, fish, soybeans, tree nuts, peanuts, eggs, shellfish, wheat