introduction to risk analysis
TRANSCRIPT
Bachelors Degree –
Agricultural Sciences
The Pennsylvania State University
Masters Degree –
Poultry Science
Texas A & M University
20 years of industry experience including regulatory, meat and poultry slaughter and processing, frozen food, bakeries, grain mills, pet food, distribution and retail
Formed in 1977
10,000 employees
Inspection services for meat, poultry, eggsproduced at approximately 6,200 facilities
Formed in 1906
9,300 employees
Inspection services for fruit, vegetables, grains, milk, tobacco, dietary supplements, pharmaceuticals and veterinary products produced at approximately 52,000 facilities
1880 – first bill introduced to legislature (defeated)
1906 – Pure Food & Drugs Act
1907 – First Certified Color Regulations
1927 – Food & Drug Administration founded
1938 – Federal Food, Drug & Cosmetic Act
1958 – First Generally Recognized as Safe (GRAS) list published
1969 – FDA begins sanitation oversight
1980 – Infant Formula Act
1990 – Nutritional Labeling & Education Act
1993 – Food Code model for foodservice & retail
1994 – Dietary Supplement Health & Education Act
1995 – Seafood HACCP
1998 – Juice HACCP
2000 – Safe Handling for Shell Eggs
2002 – Public Health Security and Bioterrorism Preparedness and Response Act
2006 – Food Allergen Labeling and Consumer Protection Act
2009 – Egg Safety Rule
10/2009 - Food Safety Modernization Act introduced
1/6/2011 – President Obama signs into law
1/16/2013 – First Rules Published
The Food Safety Modernization Act (FSMA) incorporates a prevention-based philosophy stressing Hazard Analysis & Critical Control Point principles
Do you feel the Food Safety Modernization Act will have a big impact on how you conduct business?
Globalization
◦ 15 percent of U.S. food supply is imported
Food supply more high-tech and complex
◦ More foods in the marketplace
◦ New hazards in foods not previously seen
Shifting demographics
◦ Growing population (about 30%) of individuals are especially “at risk” for foodborne illness
Involves creation of a new food safety system
Broad prevention mandate and accountability
New system of import oversight
Emphasizes partnerships
Emphasizes farm-to-table responsibility
Developed through broad coalition
Prevention
Inspections,
Compliance,
and Response
Import Safety
Enhanced
Partnerships
Importers now responsible for ensuring that their foreign suppliers have adequate preventive controls in place
FDA can rely on third parties to certify that foreign food facilities meet U.S. requirements
Can require mandatory certification for high-risk foods
Can deny entry if FDA access for inspection is denied
Requires food from abroad to be as safe as domestic
The Food and Drug Administration (FDA) is proposing to amend its regulation for Current
Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs)
to modernize it and to add requirements for domestic and foreign facilities that are required
to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and
implement hazard analysis and risk-based preventive controls for human food. FDA also is
proposing to revise certain definitions in FDA's current regulation for Registration of Food
Facilities to clarify the scope of the exemption from registration requirements provided by
the FD&C Act for “farms.” FDA is taking this action as part of its announced initiative to
revisit the CGMPs since they were last revised in 1986 and to implement new statutory
provisions in the FD&C Act. The proposed rule is intended to build a food safety system for
the future that makes modern, science-, and risk-based preventive controls the norm across
all sectors of the food system.
August 2012 14
• Creating a food safety culture starts with
every one of us
• As leaders, we must take accountability
for engaging our employees and
enhancing the food safety culture
How would you describe the Food Safety Culture
in your work environment?
16
PassiveOperate just to pass the “audit”
ReactiveFood Safety is important, we
address it after an event
CalculativeWe have systems in place to
manage all hazards
ProactiveWe work on problems
that we still find
GenerativeFood safety is built in the
way we work and think
Where is your facility / work environment
based upon the previous slide?
What steps need to be taken to continue to
evolve?
Mandatory Food Safety Programs (HACCP) for each
facility
FDA Authority for Recall
Implementation cost of $701 mil, annualized $472 mil
Still largely unknown due to delays in rulemaking
What do you think will be the biggest impact as
the law stands today?
Where would you focus your rule making?
Do you have a HACCP plan for your facility?
Do your customers already expect that you
do?
Risk management is defined for the purposes of the
Codex Alimentarius Commission as "The process,
distinct from risk assessment, of weighing policy
alternatives, in consultation with all interested
parties, considering risk assessment and other
factors relevant for the health protection of
consumers and for the promotion of fair trade
practices, and, if needed, selecting appropriate
prevention and control options.
Please give current examples of active risk
management within your organization.
The interactive exchange of information and
opinions throughout the risk analysis process
concerning risk, risk-related factors and risk
perceptions, among risk assessors, risk
managers, consumers, industry, the academic
community and other interested parties, including
the explanation of risk assessment findings and
the basis of risk management decisions.
Risk assessment is defined for the purposes of the Codex Alimentarius Commission as "A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization."
"The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods."
"The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable."
"The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant."
"The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment."
Biological◦ Bacteria
◦ Mold
◦ Viruses
◦ Prions
Chemical◦ Toxins◦ Pesticides◦ Drug Residues◦ Allergens
Physical◦ Metal◦ Stones◦ Jewelry◦ Glass
Break in small groups
Identify 2 instances where it may be beneficial to perform a risk assessment
Why