introduction to risk analysis

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