science, fsis food safety risk assessments

Office of Public Health Science, FSIS

Food Safety Risk Assessments

Janell Kause, DirectorRisk Assessment Division

Office of Public Health ScienceFood Safety and Inspection Service, USDA

2009 Meat Industry ConferenceTechnical Developments: The New Economic Reality

Chicago, IL, October 27, 2009


• Public health agency in USDA- considers entire food safety system (from production to table)- collaborates with FDA, APHIS, and other food safety agencies

• Ensure meat, poultry and processed egg products are safe, wholesome, and correctly labeled and packaged

• Statutory requirements- Federal Meat Inspection Act, Poultry Products Inspection Act, and the Egg Products Inspection Act

• Scientific tools to guide food safety decisions- data & understanding: epidemiology (risk factors/attribution), food

testing (identification of hazards – chemical, microbial, etc.)- prediction & prevention: risk assessment

Food Safety and Inspection Service


Annual estimates of foodborne disease*• 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths

Emerging concerns• STECs (non-O157), Clostridium difficile, norovirus, specific sub-types of

known pathogens• nanotechnology, GMOs, allergens, antimicrobial resistance

• dioxin, melamine, other chemical contaminants

Cross-cutting issues• safety & freshness associated with locally grown; direct farm-to-market

• globalization: equivalence (WTO/SPS Agreement)

• effectiveness/consistency in labeling: nutrition/food safety

• food safety interventions: nutrition, quality, acceptance; risk trade offs

Public Health Context

* Centers for Disease Control and Prevention (Mead et al., 1999); updated estimates expected CY 2010

Lm

Campylobacter

Salmonella

E. coli O157:H7


• Cornerstone of our food safety

program– safety of meat, poultry, and egg products

– entire food safety system

– partnership with other agencies (FDA, APHIS, EPA, CDC), states, and academia

• Powerful tool to guide the development of food safety policy– current and emerging food safety issues

– transparency and stakeholder involvement to

ensure credibility and scientific accountability

Risk Analysis at USDA/FSIS

FSIS Risk Analysis Standard Operating Procedures: www.fsis.usda.gov/oppde/rdad/frpubs/rasops.pdf

Risk Assessors

Risk Managers

Risk Communicators

Inform risk management options

Effective decisions to improve food safety


What is Risk Assessment?

• Scientific process for estimating the probability of exposure to a hazard and the resulting public health impact (risk); consists of the following components:

• Predicts public health benefits of changes in policies, practices, and operations (and includes the certainty of these predictions).

• It is used to facilitate the application of science to policy (the “bridge between data and decisions”).

1. hazard identification2. hazard characterization 3. exposure assessment 4. risk characterization


• Regulatory Requirements (Public Law 103-354) – The Federal Crop Insurance Reform and Department of

Agriculture Reorganization Act of 1994 requires that any regulation published by USDA concerning human health, human safety or the environment and having an annual economic impact of at least $100 million in 1994 dollars contain a risk assessment and cost-benefit analysis.

• World Trade/SPS Agreements (equivalency)

• Presidential Executive Order 12866, significant regulatory actions– http://www.whitehouse.gov/omb/inforeg/eo12866.pdf

Regulatory Requirements for Risk Assessment


ExplicitObjective

QuantitativeMore Data

More ResourcesBroad Scope

ImplicitSubjectiveQualitativeLess Data

Fewer ResourcesNarrow Scope

Qualitative Quantitative

Types of Risk Assessments

The “best” risk assessment is the one that most directly informs the risk management issue.

ScreeningRisk profile

Categorical Scoring

Systems modelsStochastic models

Uncertainty Analysis

High/Medium/Low


8

Codex process for microbial risk assessment (RA)

• Hazard Identification• In-depth literature review

• Hazard Characterization• Dose-response

• Exposure Assessment• Likely intake of pathogen

• Risk Characterization• Consequences, given the above

National Resource Councilprocess for chemical RA

• Hazard Identification

• Dose-Response

• Exposure Assessment

• Risk Characterization

Risk Assessment Process


Overview: Risk Assessment Applications

Examineinterventions

Examineinterventions

Developperformance

standards

Developperformance

standards

Food Safety Risk Assessment: Bridge Data and DecisionsFoodborne

illnesses data &Laboratory

studies

Foodborne illnesses data &

Laboratorystudies

Scien

tific

D ata

Risk

Ass

essm

ent Hazard

IdentificationHazard

IdentificationHazard

Characterization(Dose-Response)

HazardCharacterization(Dose-Response)

Risk Characterization

Slaughter &Processing

Slaughter &Processing

FarmProduction

FarmProduction RetailRetail HomeHome

Exposure Assessment

PredictLikelihood of Illness

Identifycritical control

points

Identifycritical control

points

Environmentalconditions (time,

temp., pH, interventions)

Environmentalconditions (time,

temp., pH, interventions)

Consumerfood handling behavior & diet

Consumerfood handling behavior & diet

Amount of hazard (PBPK modeling;

predictive microbiology)

Amount of hazard (PBPK modeling;

predictive microbiology)

Testing data (chemicals and

microbes)

Testing data (chemicals and

microbes)

Evaluatechanges in practices &

policies

Evaluatechanges in practices &

policies

Determine equivalenceDetermine

equivalenceAppl

icatio

ns Prioritize food safetyresearch

Prioritize food safety

researchAllocate

resourcesAllocate

resources

Quantitative risk assessment integrates a wide variety of science and data to provide a comprehensive understanding of the food safety system.


Current• Establish food safety policies (policy development)• Allocate inspection resources to verify industry controls (assurance)• Measure federal performance in achieving public health goals (evaluation)

Future• Standardize and harmonize risk assessment methodology• Establish measurable performance objectives for industry based on national

public health goals (risk management metrics)• Address both chemical and microbial hazards simultaneously in assessing risk

from foods• Apply probabilistic approach to address chemical food safety risks• Integrate multiple environmental exposure routes of a hazard into food safety

system in determining food safety risk

Risk Assessment Applications at USDA/FSIS


• Systematically address food safety issues

• Formal and transparent conceptual framework that integrates data and information to guide decisions

– logical– science based – transparent– holistic

• Evaluate public health benefits associated with policy options (“what if” scenarios)

• Focus finite resources on the greatest risk (foods, hazards, process, and/or practices)

• Several applications for public health professionals, food safety managers, and other stakeholders

Why is risk assessment used to guide decisions?


Questions Involving the Use of Risk Assessment

How do you determine if there is an emerging food safety issue?

How are risk assessments developed to guide food safety policies?


Evaluating Emerging Food Safety Issues & Developing Risk Management Strategies

1. Evaluate Food Safety Problem 2. Public Health Goals

- Healthy People 2020- Risk management objectives

4. Identify Viable Policy Options

- cost-effectiveness- legal constraints- technically feasible

- Identify emerging issues/ improve understanding of existing issues

- Develop Risk Profile

6. Select Food Safety Policy

- Balance public health benefits (risk reduction) with societal costs

5. Regulatory Impact Analysis

- Conduct a risk assessment- Conduct a cost-benefit analysis

7. Implement Food Safety Policy

- regulation - guidance

- training - outreach

- allocate resources

8. Evaluate Effectiveness of Food Safety Policy

- inspection - FSAs- verification sampling- attribution data (trend analysis)

3. Formulate Various Policy Options

- Agency-wide input- External (Stakeholder) Input


Which ready-to-eat foods pose the greatest risk of listeriosis?

• FDA-FSIS Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods (2001, updated 2003)

Which industry practices effectively control Lm?• FSIS Risk Assessment for Listeria monocytogenes in Deli Meat (2003)

How can FSIS target its inspection resources to ensure industry controls Lm?

• FSIS Risk Based Verification Sampling for Listeria monocytogenes in Ready-to-Eat Meat and Poultry Products (2005)

Where should FSIS focus its efforts to further to reduce listeriosis?

• FSIS Comparative Lm Risk Assessment: Pre-packaged vs. Retail-sliced Deli Meat (2009)

Managing the Risk of Listeriosis: Use of Various Types of QMRAs


• FDA/FSIS Listeria risk

assessment identified deli

meats as posing the greatest

risk of listeriosis

• Action: Lm Food Safety

Action Plan

• Caveat: Predicted deli meat

posed greatest risk prior to

foodborne outbreaks

beginning in Fall 2002

-5.00

-4.00

-3.00

-2.00

-1.00

0.00

1.00

2.00

3.00

4.00

Tota

l Cas

es L

iste

riosi

s pe

r Ann

um (l

og s

cale

)

DM

PM

HFD

FNR

SU

C P

CRUM

SSF

FRV

DFS

FSC

SS

CS

RC

DS RS

PF IC PC

CD

HC

Deli meats Frankfurters (heated)

23 Categories of Ready-to-Eat Foods

Which foods pose the greatest risk of listeriosis?


• FSIS Listeria risk assessment

identified post-lethality

interventions and use of

antimicrobials were

substantially more effective

than sanitation measures

• Action: Interim Final Rule for

Lm (2003)

• Caveat: Changed FSIS risk

management strategy to focus

beyond testing/sanitizing

Source: http://www.fsis.usda.gov/PDF/Lm_Deli_Risk_Assess_Final_2003.pdf

Which industry practices effectively control Lm?


• FSIS’ risk-based Lm sampling

allocated FSIS verification sampling

resources among establishments

predicted to pose the greatest risk

each month (10,000 samples/year)

• Result: industry adopted more

effective Lm control measures

• Caveat: first risk-based food safety

inspection program in U.S. using

QMRAs

AlternativeSampling PP GI PP&GI

Frac

tion

of R

TE D

eli

Mea

t Pro

duct

ion

0.0

0.2

0.4

0.6

0.8Pre regulationCurrent

Industry adoption of Lm controls

How can FSIS effectively allocate its inspection resources to ensure Lm controls?

Source: http://www.fsis.usda.gov/PDF/RBVS_Risk_Assess_Jun07.pdf


Why a plateau in listeriosis?

FSIS Regulatory Testing for Lm in RTE Products by Calendar Year 1990-2008

(All Years All Projects)

4.60%

4.03%

3.61%3.44%

2.90% 3.02% 2.91%

2.25%2.54%

1.91%

1.45% 1.32%1.03%

0.76%0.55% 0.64% 0.61%

0.43% 0.42%

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

3.5%

4.0%

4.5%

5.0%

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Calendar Year

Perc

ent P

ositi

ve

Incidence of Foodborne Illnesses 1996-2008: Listeria

Preliminary FoodNet data on the incidence of infection with pathogenstransmitted commonly through food … 10 States, 2008

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Calendar Year

Inci

denc

e pe

r 10

0,00

0

National Health Objective:0.24 Cases per 100,000

Percent Positive Listeria in Product1990-2008

Incidence of Foodborne Listeriosis1996-2008

Reduction in Lm Contamination and Listeriosis in the U.S.


• FSIS comparative Lm risk assessment evaluated the risk of listeriosis from prepackaged vs. retail-sliced deli meat

• Finding: approximately 83% of listeriosis cases attributed to deli meat were associated with those sliced at retail (growth inhibitors significantly reduce risk overall)

• Action: FSIS and FDA focus on retail Lm contamination --developing a new risk assessment to evaluate retail cross-contamination and Lm controls

Source: http://www.fsis.usda.gov/PDF/Comparative_RA_Lm_Report.pdf

2009 FSIS Comparative Lm Risk Assessment: Pre-packaged vs. Retail-sliced Deli Meat

Where should we focus our efforts to further reduce listeriosis?


• Tiered approach to understanding and controlling Lm– Identify which food vehicle posed the greatest risk (Lm Action Plan)– Identify which processing intervention would best control Lm (FSIS Listeria Rule)– Identify where to focus inspection efforts among processors (FSIS risk-based

sampling)– Identify where further reductions in listeriosis can be realized (e.g.,

retail/sanitation) – Understand how cross-contamination occurs to effectively control Lm at retail

• Risk assessment findings guided Agency and industry efforts to successfully reduce Lm contamination in meat and poultry products

• RA: identified and provided basis for implementing better Lm controls

Using RA to Successfully Mitigate Listeriosis in the U.S.


• Must have well defined risk management questions

• RAs are not a “one size fits all”

• Complexity of the RA depends on the purpose for developing the risk assessment

• Risk assessors and risk managers are independent, but interdependent

• Risk profiles are essential for characterizing the current public health risk for emerging hazards (tiered approach to risk assessment)

Lessons Learned


• Involve stakeholders early in the process• RA models can be modular and built more

quickly using prior risk assessment models • Integrating economics and risk assessment

into a single model saves time in decision-making

• Use risk assessments as a predictive tools -conduct scenario analyses

• Characterization of certainty of risk estimates is important for decision makers

• Rigorous peer review is essential

Lessons Learned


• Broader food safety perspective and use of risk assessments

• Food safety risks will be “food-based” (multiple hazards) rather than traditional product-hazard based

• Risk management metrics: predict which performance objectives will meet established public health goal

• Increasing interagency collaboration & consideration of cross-cutting issues

• Evaluation of risk-risk trade offs

• Greater focus on emerging issues and prevention

Future Direction


FSIS Risk Assessment Website: www.fsis.usda.gov/Science/Risk_Assessments/index.asp

Janell Kause, DirectorRisk Assessment Division

Office of Public Health ScienceFood Safety and Inspection Service

U.S. Department of Agriculture

E-mail: [email protected]

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science, fsis food safety risk assessments

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