Draft Risk Profile:

Pathogens and Filth in Spices

Center for Food Safety and Applied Nutrition 

Food and Drug Administration 

U.S. Department of Health and Human Services

2013

FDA Draft Risk Profile | i 

MAJOR CONTRIBUTORS

Risk Profile Team Leader and Project Manager

Jane Van Doren, FDA (April 2010 – completion) 

Sherri Dennis, FDA (January 2010 – April 2010)

Mary Brandt, FDA (July 2009 – January 2010)

Marianna D. Solomotis, FDA (February 2009 - July 2009)

Risk Profile Team Members 

Laura Gieraltowski, CDC

Vikas Gill, FDA

Thomas S. Hammack, FDA

Daria Kleinmeier, FDA

Martin Muckenfuss, FDA

Karen P. Neil, CDC

Obianuju Nsofor, FDA

Lori Papadakis, FDA

Mickey Parish, FDA

Jane Van Doren, FDA

Ann Westerman, FDA

Robin Woo, FDA * 

George C. Ziobro, FDA

Risk Management/Advisor Team

Nega Beru, FDA (Spice Risk Management Team Leader)

Vincent Bunning, FDA

Sherri Dennis, FDA

Kathy Gombas, FDA

Lane Highbarger, FDA

Henry Kim, FDA

John Sheehan, FDA

Jennifer Thomas, FDA

Donald Zink, FDA (Senior Science Advisor)

* Retired / Former Employee
FDA Draft Risk Profile | ii

ACKNOWLEDGEMENTS

The FDA Draft Risk Profile: Pathogens and Filth in Spices benefited from contributions, conversations and 

information provided by many individuals, organizations, and government officials listed below. We thank 

and acknowledge each one for their contributions. 

American Spice Trade Association, American Dehydrated Onion and Garlic Association, and the Indian 

Government (Indian Spices Board) for organizing and hosting site visits to spice production and processing 

facilities and to the employees of the companies visited, for providing information about spices, the spice 

supply chain, and common practices used in the spice industry. 

The spice and food industry for sharing and discussing industry guidance, best practices and common 

challenges through submission to the Federal Register in response to FDA’s call for data and information to 

support this risk assessment, presentation at scientific meetings, and discussions in meetings with FDA and 

the American Spice Trade Association for submitting microbiological sampling data to the Federal Register.

Food and Drug Administration scientists for sharing their data, expertise and information, especially Régis 

Pouillot and Robert Blodgett (modeling and statistics); Susanne Keller, Elizabeth Grasso, Lindsay Halik, 

Brenda Aloi, Yinqing Ma, Marilyn Balmer, Linda Fabbri, Kristin Kamas, Norman Fogg, Mercedes Loftis, and 

Office of Regulatory Affairs scientists & field personnel (special laboratory experiments and field 

assignments); Tracy DuVernoy, Erica R. Pomeroy, and Capt. Suzan Gordon (U.S. outbreaks); Michael DiNovi, 

Alison Edwards, Ewa Carlton and Karin Hoelzer (consumption); Nicole Nolan (RFR); Rosemary Gary and 

Martin J. Stutsman (U.S. regulations); Christine Keys, David Melka, Errol Strain, and Mark Allard (PFGE and 

NGS); John W. Larkin and Nathan Anderson (pathogen reduction treatment); Patrick McDermott , Maureen 

Davidson and Claudine Kabera (antimicrobial susceptibility); Marjorie Davidson (retail establishment and 

consumer guidance); Stephanie Briguglio and Mary Same (intern) (literature searches and document 

preparation), and Amy Miller and Lawrence D’Hoosteleare (filth adulteration).

Centers for Disease Control and Prevention (CDC) and state public health departments for their data, 

expertise and information regarding U.S. outbreaks, especially Shauna L. Mettee, Hannah Gould, and Ian 

Williams (CDC); Jeffrey Higa (California Department of Public Health); and Robert Ireland and Daniela 

Quilliam (Rhode Island Department of Public Health). 

International scientists Christine L. Little (while at Health Protection Agency, United Kingdom), Gilles Delmas 

(Institut de Veille Sanitaire, France), Andrea Altieri (European Food Safety Authority), Jordi Serratosa 

(European Food Safety Authority), and Tobin Robinson (European Food Safety Authority) for providing 

additional information about published reports of international outbreaks and spice contamination.

Versar, Inc. (David Bottimore, Kathy Coon, and Stephanie Sarraino) for organizing the External Peer Review 

of the draft report.

Larry R. Beuchat (University of Georgia), Linda J. Harris (University of California, Davis), Margaret Hardin 

(IEH Laboratories and Consulting Group), Jeffrey Lee Kornacki (Kornacki Microbiology Solutions), and 

Christine L. Little (independent contractor) for their peer review of the draft report.
FDA Draft Risk Profile | iii

TABLE OF CONTENTS

Major Contributors ................................................................................................................................................................................ i

Acknowledgements ..............................................................................................................................................................................ii

Table of Contents................................................................................................................................................................................. iii

List of Tables........................................................................................................................................................................................... v

List of Figures ...................................................................................................................................................................................... vii

Abbreviations and Acronyms........................................................................................................................................................ viii

Executive Summary.............................................................................................................................................................................. 1

1. Introduction........................................................................................................................................................................................ 7

1.1 Risk Profile objectives and Scope ................................................................................................................................... 7

2. Foodborne Illness Outbreaks from Microbial Contaminants in Spices, 1973-2010.................................................. 9

2.1 Summary of Outbreaks, 1973-2010............................................................................................................................... 9

2.2 Outbreaks in the United States ..................................................................................................................................... 16

2.3 Selected Non-U.S. Outbreaks......................................................................................................................................... 18

2.4 Public Health Burden....................................................................................................................................................... 19

2.5 Related Outbreaks – Spice ingredients used in non-spice capacities.............................................................. 20

2.6 General Observations Regarding Foodborne Illness Outbreaks Attributed to Microbial 

Contaminants in Spices.................................................................................................................................................... 20

3. Types of Pathogen and Filth Contamination Found in Spices ........................................................................................ 22

3.1 Microbial Pathogens Found in Spices......................................................................................................................... 22

3.1.1 Types of Microbial Pathogens Found in Spices...................................................................................... 22

3.1.2 Salmonella Serotypes Identified in Spices................................................................................................ 24

3.2 Filth Adulterants Found in Spices................................................................................................................................ 28

4. Prevalence and Concentration of Salmonella and Filth in Spices.................................................................................. 30

4.1 Salmonella............................................................................................................................................................................ 31

4.1.1 Salmonella Prevalence and Concentration in Spice: From Farm to Table Overview ................ 31

4.1.2 Primary Production......................................................................................................................................... 37

4.1.3 Distribution and Storage................................................................................................................................ 37

4.1.4 Secondary Processing and Food Manufacturing.................................................................................... 52

4.1.5 Retail/End User................................................................................................................................................. 57

4.1.6 Frequency of Food Recalls in the United States Associated with Salmonella–

Contaminated Spices .............................................................................................................................................. 57

4.1.7 International Reports of Food Safety Hazards Associated with Salmonella–

Contaminated Spices - RASFF.............................................................................................................................. 58

4.2 Filth........................................................................................................................................................................................ 58

4.2.1. Filth Adulteration Prevalence of Spice: From Farm to Table Overview ....................................... 59

4.2.2. Primary Production........................................................................................................................................ 59

4.2.3. Distribution and Storage............................................................................................................................... 59

4.2.4. Secondary Processing and Multi-Component Food Manufacturing............................................... 61

4.2.5. Retail/End User................................................................................................................................................ 62

4.3 Prevalence of Both Salmonella and Filth Adulteration of Spices ...................................................................... 62

5. Characterization of Contaminants ........................................................................................................................................... 64

5.1 Salmonella............................................................................................................................................................................ 64

5.1.1 General Characteristics of Salmonella....................................................................................................... 64

5.1.2 Antimicrobial Properties of Some Spices................................................................................................. 65

5.1.3 Survivability in Spices..................................................................................................................................... 65

5.1.4 Potential for Growth in Moistened Spices and Spice-Containing Foods........................................ 67

5.1.5 Characteristics of the Non-Typhoidal Salmonellosis ........................................................................... 69

5.2 Filth........................................................................................................................................................................................ 72

6. Overview of Spice Farm-to-Table Continuum and Potential Sources of Pathogen and Filth 

Contamination.............................................................................................................................................................................. 74
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6.1 Primary Production.......................................................................................................................................................... 75

6.2 Distribution and Storage................................................................................................................................................. 78

6.3 Secondary Processing and Multi-Component Food Manufacturing................................................................. 79

6.4 Retail/End User ................................................................................................................................................................. 81

7. Spice Production and Consumption........................................................................................................................................ 82

7.1 U.S. Spice Supply................................................................................................................................................................ 82

7.1.1 U.S. Production.................................................................................................................................................. 82

7.1.2 U.S. Imports ........................................................................................................................................................ 85

7.2 Spice Consumption in the United States.................................................................................................................... 88

7.2.1 Consumer Population ..................................................................................................................................... 88

7.2.2 Consumption Mass and Frequency ............................................................................................................ 88

8. Current Mitigation and Control Options ................................................................................................................................ 91

8.1 U.S. Regulatory Standards and Programs ................................................................................................................. 91

8.1.1 Federal Food, Drug, and Cosmetic Act....................................................................................................... 91

8.1.2 Public Health Service Act............................................................................................................................... 91

8.1.3 U.S. Regulatory Mechanisms......................................................................................................................... 91

8.2 Industry Programs..........................................................................................................................................................103

8.2.1 Pathogen Reduction ......................................................................................................................................103

8.2.2 Industry Guidance from Trade Organizations on Practices Impacting Food Safety of 

Spices.........................................................................................................................................................................121

8.2.3 Recalls ................................................................................................................................................................124

8.3 Codex Alimentarius and FAO/WHO..........................................................................................................................124

9. General Conclusions and Potential Future Mitigation and Control Options............................................................126

9.1 General Conclusions.......................................................................................................................................................126

9.2 Potential Future Mitigation and Control Options................................................................................................. 128

9.2.1 Primary Production.......................................................................................................................................128

9.2.2 Distribution and Storage..............................................................................................................................129

9.2.3 Primary and Secondary Processing .........................................................................................................131

9.2.4 Retail/End user...............................................................................................................................................132

9.2.5 General...............................................................................................................................................................134

10. Data Gaps and Research Needs ............................................................................................................................................136

10.1 Data Gaps.........................................................................................................................................................................136

10.1.1 Foodborne Outbreaks ................................................................................................................................136

10.1.2 Prevalence and Concentration of Pathogens and Filth in Spices.................................................136

10.1.3 Characteristics of Contaminants.............................................................................................................137

10.2.4 Mitigation and Control Options...............................................................................................................137

10.2.5 Consumption.................................................................................................................................................137

10.2 Research Needs .............................................................................................................................................................138

10.2.1 Foodborne Outbreaks ................................................................................................................................138

10.2.2 Prevalence and Concentration of Pathogens and Filth in Spices.................................................138

10.2.3 Characteristics of Contaminants.............................................................................................................139

10.2.4 Mitigation and Control Options...............................................................................................................139

10.2.5 Consumption.................................................................................................................................................140

10.2.6 General ............................................................................................................................................................141

11. References ...................................................................................................................................................................................142

Appendix A: Spice List....................................................................................................................................................................172

Appendix B: Worldwide Spice Production ..............................................................................................................................184

Appendix C: FDA 2010 Study of Concentrations and Distribution of Salmonella in Shipments of 

Capiscum and Sesame Seed Offered for Entry to the United States. ........................................................................192
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LIST OF TABLES

Table 2.1. Summary of enteric illness outbreaks taking place during 1973-2010 associated with 

consumption of microbial contaminants in dried spices and seasonings or foods containing 

these contaminated ingredients ...................................................................................................................................... 10

Table 3.1. Microbial pathogens detected in spices, 1985-2012: Review of the scientific literature and 

the CDC PulseNet and FDA FACTS databasesa ............................................................................................................ 23

Table 3.2. Salmonella species and serotypes found in spices in the United States, 2001-2010.a ............................ 24

Table 3.3. Spices for which filth Food Defect Action Level(s) has/have been established in the United 

States......................................................................................................................................................................................... 28

Table 3.4. Types of filth adulterants found in spices: Surveillance sampling of spice shipments offered 

for U.S. entry, FY2007-FY2009......................................................................................................................................... 29

Table 4.1. Summary of scientific surveillance studies measuring the prevalence of Salmonella in spices, 

2000-2012............................................................................................................................................................................... 33

Table 4.2. Concentration of Salmonella in spices and spice-containing foods implicated in salmonellosis 

illness outbreaks ................................................................................................................................................................... 36

Table 4.3. Observed prevalence of Salmonella–contaminated shipments of imported spice and other 

imported FDA-regulated food shipments offered for entry to the United States, FY2007-FY2009. ........ 39

Table 4.4. Comparison of observed prevalence of Salmonella-contaminated shipments of some whole 

and ground/cracked imported spice offered for entry to the United States, FY2007-FY2009. ................. 41

Table 4.5. Observed prevalence of Salmonella-contaminated imported spice shipments offered for 

entry to the United States as a function of export country, FY2007-FY2009................................................... 42

Table 4.6. Salmonella serotype frequency and percentage among isolatesa in surveillance samples of 

spice from shipments of imported spice offered for entry to the United States, FY2007-FY2009. .......... 43

Table 4.7. Antimicrobial Resistance of Salmonella enterica subspecies enterica isolates from FDA 

surveillance sampling of spices from shipments of imported spice offered for entry to the United 

States, FY2007-FY2009....................................................................................................................................................... 47

Table 4.8. Screening and enumeration test results for Salmonella in sampled shipments of imported 

capsicum or sesame seed offered for entry to the United States August-December 2010.......................... 49

Table 4.9. Observed prevalence of Salmonella contamination in spice lots from some ASTA member 

companies to which no pathogen reduction treatment had been applied, August 1, 2007-July 31, 

2009........................................................................................................................................................................................... 53

Table 4.10. Observed prevalence of Salmonella contamination of spice lots from some ASTA member 

companies to which a pathogen reduction treatment had been applied, August 1, 2007-July 31, 

2009........................................................................................................................................................................................... 54

Table 4.11. Frequency and prevalence of generic Escherichia coli contamination in spice lots in some 

ASTA member companies to which a pathogen reduction treatment had been applied, August 1, 

2007-July 31, 2009............................................................................................................................................................... 56

Table 4.12. Prevalence of filth adulteration in shipments of imported spice or other FDA-regulated 

foods offered for entry to the United States, FY2007-FY2009 .............................................................................. 60

Table 4.13. Hairs found in shipments of imported spice offered for entry to the United States, FY2007-

FY2009...................................................................................................................................................................................... 61

Table 4.14. Examination of relationship between presence of filth and Salmonella adulteration of 

shipments of imported spice offered for entry, FY2000-FY2009 (except) FY2002....................................... 63

Table 4.15. Examination of relationship between presence of filth and Salmonella adulteration of 

shipments of imported foods offered for entry, FY2000-FY2009 (except) FY2002...................................... 63

Table 5.1. Estimated percentage of salmonellosis cases associated with different health endpoints and 

typical duration of illness................................................................................................................................................... 71

Table 6.1. Evaluation of risks for filth contamination at different stages during the production of spices......... 78

Table 7.1. U.S. production of spices in 2010: Dehydrated onion, dehydrated (and fresh) garlic, 

capsicum, mustard seed, and sesame seed. ................................................................................................................. 82

Table 7.2. Spice imports in 2010 by weight. ............................................................................................................................. 86
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Table 7.3. Spice imports by value, 2000-2010. ........................................................................................................................ 87

Table 7.4. Estimated per capita spice consumption based on food availability, 2010a. ............................................. 90

Table 8.1. Classification of inspections of firms that manufacture, pack or re-pack spices, FY2007-

FY2012...................................................................................................................................................................................... 92

Table 8.2. Classification of domestic inspections of firms that manufacture, pack or re-pack low 

moisture foods, average annual rates FY2007-FY2012........................................................................................... 93

Table 8.3. Sixteen most frequent citations reported on FDA Form 483 issued during domestic spice 

firm inspections, August-December 2011.................................................................................................................... 95

Table 8.4. Import Alerts involving DWPE that are primarily/exclusively associated with spices and 

address issues of pathogen and/or filth adulteration. ............................................................................................. 98

Table 8.5. Number of firms listed on Import Alert 99-19 for DWPE in October 2010 and June 2013.................. 98

Table 8.6. Countries with the largest number of firms listed on Import Alert 99-19 for DWPE of spicesa

due to “presence of Salmonella” ....................................................................................................................................... 99

Table 8.7. Primary entries reported to the FDA Reportable Food Registry September 8, 2009-

September 7, 2012..............................................................................................................................................................101

Table 8.8. Accepted reconditioning proposals for spices, 2007 – 2012 (December)................................................104

Table 8.9. Decimal reductions of microbial populations in spices from heat treatments .......................................108

Table 8.10. Decimal reductions from gamma radiation for microbial populations of various spices.................112

Table 8.11. Decimal reductions of APC counts in spices treated with ethylene oxide..............................................117

Table 8.12. Estimates of the number of Salmonella illnesses resulting from a population consuming raw 

spice from a single 40,000 lb. (18144 kg) Salmonella-contaminated lot as a function of mean lot 

concentration and serving size, assuming the contamination is Poisson-distributed within the 

lot..............................................................................................................................................................................................121

Table A1. Spice list by botanical name......................................................................................................................................172

Table A2. Spice list by common name.......................................................................................................................................175

Table A3. Spice list by part of plant used ................................................................................................................................. 178

Table A4. Common use of spice in foods ..................................................................................................................................181

Table B1. Worldwide Spice Production 2009.........................................................................................................................184

Table B2. Anise, badian, fennel, coriander...............................................................................................................................184

Table B3. Chillies and peppers, dry............................................................................................................................................185

Table B4. Cinnamon (canella)......................................................................................................................................................185

Table B5. Cloves................................................................................................................................................................................186

Table B6. Garlic .................................................................................................................................................................................186

Table B7. Ginger................................................................................................................................................................................187

Table B8. Mustard Seed..................................................................................................................................................................187

Table B9. Nutmeg, mace and cardamoms................................................................................................................................188

Table B10. Onions, dried................................................................................................................................................................188

Table B11. Pepper (Piper spp.)....................................................................................................................................................189

Table B12. Poppy Seed...................................................................................................................................................................189

Table B13. Spices, nes.....................................................................................................................................................................190

Table B14. Sesame Seed................................................................................................................................................................. 190

Table B15. Vanilla.............................................................................................................................................................................191

Table C1. Description of sampled and Salmonella-contaminated shipments offered for U.S. entry....................196

Table C2. Model parameters and descriptors.........................................................................................................................197
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LIST OF FIGURES

Figure 4.1. Complementary cumulative distribution functions (p × (1-CDF(λ)) for models of Salmonella

contamination among shipments of imported capsicum offered for entry to the United States 

compared with observations. ........................................................................................................................................... 51

Figure 4.2. Complementary cumulative distribution functions (p× (1-CDF(λ)) for models of Salmonella

contamination among shipments of imported sesame seeds offered for entry to the United 

States compared with observations. .............................................................................................................................. 52

Figure 5.1. Survival of Salmonella at 25°C and high (97%) RH. ......................................................................................... 66

Figure 5.3. Survival of Salmonella at 25°C and ambient (≤40) RH. ................................................................................... 66

Figure 5.2. Survival of Salmonella at 35°C and high (97%) RH. ......................................................................................... 66

Figure 5.4. Survival of Salmonella at 35°C and ambient (≤40) RH. ................................................................................... 66

Figure 5.5. Appearance of ground black pepper at different water activities (aw). ..................................................... 69

Figure 5.6. WHO/FAO dose-response model for Salmonella. .............................................................................................. 70

Figure 5.7. Age dependence of hospitalization and fatality rates for foodborne salmonellosis in the 

United States, 2010............................................................................................................................................................... 72

Figure 6.1. Typical stages in spice farm-to-finished product continuum for spices including transport 

and processing options and control points.................................................................................................................. 74

Figure 6.2. Possible pathways for spice from spice manufacturer to consumer. ......................................................... 75

Figure 7.1. Relative contributions of domestic and imported dehydrated onion to the total annual U.S. 

supply, 1970 to 2010. .......................................................................................................................................................... 83

Figure 7.2. Relative contributions of domestic and imported garlic to the total annual U.S. supply, 1960 

to 2010...................................................................................................................................................................................... 83

Figure 7.3. Relative contributions of domestic and imported capsicum (including paprika) to the total 

annual U.S. supply, 1966 to 2010. ................................................................................................................................... 84

Figure 7.4. Relative contributions of domestic and imported mustard seed to the total annual U.S. 

supply, 1966 to 2010. .......................................................................................................................................................... 85

Figure 7.5. Annual per capita spice consumption in the U.S excluding dehydrated onion and garlic, 

1966-2010............................................................................................................................................................................... 89
Abbreviations and Acronyms |

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ABBREVIATIONS AND ACRONYMS

Acronym Definition

APC aerobic plate count

APHIS Animal and Plant Health Inspection Service

ARS Agricultural Research Service

ASTA American Spice Trade Association

aw water activity

CC controlled condensation

CDC Centers for Disease Control

CDPH California Department of Public Health

CF coliforms

CFR Code of Federal Regulations

CFSAN Center for Food Safety and Applied Nutrition

CFU colony forming units

CGMPs Current Good Manufacturing Practices

CI confidence interval

CO2 carbon dioxide

COA certificate of analysis

Codex Codex Alimentarius

CORE Coordinated Outbreak Response and Evaluation Network

DALs Food Defect Action Levels

DWPE Detention Without Physical Examination

EB Enterobacteriaceae

EC Escherichia coli

EFSA European Food Safety Authority

EIC Export Inspection Council of India

EO ethylene oxide

EPA U.S. Environmental Protection Agency

ERS Economic Research Service

ERU Emergency Response Unit

FACTS “Field Accomplishments and Compliance Tracking System,” an FDA database that 

includes sampling data

FAO Food and Agriculture Organization

FAS Foreign Agricultural Service

FC fecal coliform

FCID Food Commodity Intake Database

FD&C Act Federal Food, Drug, and Cosmetic Act

FDA U.S. Food and Drug Administration

FDB Food and Drug Branch

FDOSS Foodborne Disease Outbreak Surveillance System

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
Abbreviations and Acronyms |

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Acronym Definition

FSIS Food Safety Inspection Service

FSMA FDA Food Safety Modernization Act

GACP Good Agricultural and Collection Practices

GAPs Good Agricultural Practices

GC/FID gas chromatography with flame ionization detection

GC/MS gas chromatography with mass spectrometry detection

GC/O gas chromatography with olfactometry

GFN Global Foodborne Infection Network

GMA Grocery Manufacturers Association

GMPs Good Manufacturing Practices

GRAS Generally Recognized as Safe

H2O water

HACCP Hazard Analysis and Critical Control Points

IBD Inflammatory Bowel Disease

ICMSF International Commission on Microbiological Specification for Foods

ISO International Organization for Standardization

JIFSAN Joint Institute for Food Safety and Applied Nutrition

kGy kilo gray

MPN most probable number

N2 Nitrogen

NACMCF National Advisory Committee on Microbiological Criteria for Foods

NAI no action indicated

NCBI National Center for Biotechnology Information

NCDEX National Commodity and Derivatives Exchange

NEC Not Elsewhere Classified

NGS Next Generation Sequencing

NHANES National Health and Nutrition Examination Surveys

NIH National Institute of Health

OAI official action indicated

PHF Potentially Hazardous Food

PSCA Primary Salmonella Control Area

FSPCA Food Safety Preventive Controls Alliance

RASFF Rapid Alert System for Food and Feed

RFR Reportable Food Registry

RH Relative Humidity

RR Relative Risk

SRA Sequence Read Archive

SSA Seasoning and Spice Association

UNCTAD United Nations Conference on Trade and Development

U.S.C. United States Code

USDA United States Department of Agriculture

USP U.S. Pharmacopeia
Abbreviations and Acronyms |

FDA Draft Risk Profile | x 

Acronym Definition

VAI voluntary action indicated

WHO World Health Organization

WTO World Trade Organization

WWEIA What We Eat in America

YM yeast and mold
FDA Draft Risk Profile | 1 

EXECUTIVE SUMMARY

Overview

In light of new evidence calling into question the effectiveness of current control measures to reduce or 

prevent illness from consumption of spices in the United States, the United States Food and Drug 

Administration (FDA) developed a risk profile on pathogens and filth in spices. The objectives of the risk 

profile were to (1) describe the nature and extent of the public health risk posed by consumption of spices in 

the United States by identifying the most commonly occurring microbial hazards and filth in spice (2) 

describe and evaluate current mitigation and control options designed to reduce the public health risk posed 

by consumption of contaminated spices in the United States (3) identify potential additional mitigation and 

control options and (4) identify critical data gaps and research needs. The draft risk profile for pathogens and 

filth in spices provides information for FDA to use in the development of plans to reduce or prevent illness 

from spices contaminated by microbial pathogens and/or filth. 

Scope

For the purpose of this risk profile, the term “spice” means “any [dried] aromatic vegetable substances in the 

whole, broken, or ground form, except for those substances which have been traditionally regarded as foods, 

whose significant function in food is seasoning rather than nutritional, and from which no portion of any 

volatile oil or other flavoring principle has been removed” and includes additional dried plants listed as 

spices by the Environmental Protection Agency, the American Spice Trade Association, and the Seasoning and 

Spice Association, such as dehydrated onion and garlic, as well as other dehydrated vegetables used as 

seasoning. 

The specific microbial hazards and filth elements in spices considered in this risk profile include pathogens 

and filth adulterants detected in spices, implicated in outbreaks, reported as the reason for recalls, and 

reported in submissions to the Reportable Food Registry. This report primarily focuses on Salmonella, among 

the pathogens detected in spices, because it is the only spice-associated pathogen linked with human illness, 

food recalls, or Reportable Food Registry reports in the United States. 

Research Methods

Research for the report included a comprehensive review of the refereed scientific literature and available 

government/agency reports, and analyses of relevant FDA and CDC data. Data and information from 

stakeholders were formally requested in a Federal Register Notice developed by FDA. Submissions to the 

docket provided critical information on industry guidance and spice sampling and testing by the spice 

industry. Site visits to spice farms and spice processing and packing facilities, facilitated by spice industry 

trade organizations and the government of India, provided the Risk Profile Team with first-hand knowledge 

of current practices. In order to fill some critical data gaps, FDA field assignments and laboratory research 

were also undertaken. 

Types of Pathogens and Filth Adulteration Found in Spices

Microbial pathogens that have been found in spices include Salmonella, Bacillus spp. (including Bacillus 

cereus), Clostridium perfringens, Cronobacter spp., Shigella, and Staphylococcus aureus. Filth adulterants found 

in spices include insects (live and dead whole insects and insect parts), excrement (animal, bird, and insect), 

hair (human, rodent, bat, cow, sheep, dog, cat and others), and other materials (decomposed parts, bird barbs, 

bird barbules, bird feathers, stones, twigs, staples, wood slivers, plastic, synthetic fibers, and rubber bands). 

Foodborne Illness Outbreaks from Microbial Contaminants in Spices

During the period 1973-2010, fourteen reported illness outbreaks were attributed to consumption of 

pathogen-contaminated spice. Countries reporting outbreaks included Canada, Denmark, France, Germany, 

New Zealand, Norway, Serbia, United Kingdom, and the United States. Together, these outbreaks resulted in 

1946 reported human illnesses, 128 hospitalizations and two deaths. Infants and children were the primary 

population segments impacted by five of the spice-associated outbreaks. Salmonella enterica subspecies 
Executive Summary |

FDA Draft Risk Profile | 2 

enterica was identified as the causative agent in ten outbreaks accounting for 87% of reported illnesses. 

Bacillus spp. was identified as the causative agent in four outbreaks, accounting for 13% of reported illnesses. 

Consumption of ready-to-eat foods prepared with spices applied after the final food manufacturing pathogen 

reduction step accounted for 70% of the illnesses. Pathogen growth in spiced food is suspected to have played 

a role in some outbreaks, but it was not likely a contributing factor in three of the larger Salmonella

outbreaks, which involved low-moisture foods. Root causes of spice contamination included contributions 

from both early and late stages of the farm-to-table continuum.

Prevalence and Concentration of Salmonella and Filth in Spices

Limited data were available from the refereed scientific literature on the prevalence of pathogens in spices at 

most points in the farm-to-table continuum. The majority of data available were from shipments of imported 

spice offered for entry to the United States (FDA sampling data), lots of spice in spice industry facilities (spice 

industry sampling data), and retail settings outside the United States (data collected primarily by public 

health government agencies or academic researchers). Most spices consumed in the United States are 

imported. Analysis of FDA sampling and testing data for shipments of imported spice offered for entry to the 

United States during the three year period FY2007-FY2009 revealed an average shipment prevalence for 

Salmonella of 6.6% (750 g sample size; 95% CI 5.7-7.6%). The average prevalence of Salmonella in sampled 

spice shipments during this period was 1.9 times (95% CI 1.6-2.3%) the average prevalence determined for 

shipments of all other FDA-regulated foods sampled during that time (where screening tests examined 375-

1500 g). When only considering shipments of other imported FDA-regulated foods that were sampled with 

the same FDA Category II food sampling protocol as that used for spices, it was found that the Salmonella

shipment prevalence for spices was 4.4 times (95% CI 3.4-5.8%) that of other FDA-regulated imported foods

during FY2007-FY2009. 

A wide diversity of spice types and forms was found to contain Salmonella among shipments of imported 

spice offered for entry to the United States during FY2007-FY2009; differences in prevalence rates were 

observed for some spice types/forms. More than 80 different Salmonella serotypes were isolated from spices 

in contaminated shipments during the three-year period; 6.8% of isolates exhibited antimicrobial-resistant 

properties. Some shipments reported to have been subjected to a pathogen reduction treatment before being 

offered for United States (U.S.) entry were found contaminated. Contaminated shipments identified during 

FY2007-FY2009 were exported by many different countries; some differences in Salmonella shipment 

prevalence were identified. 

FDA undertook a short-term targeted study during Aug-Dec 2010 to collect enumeration data for 

contaminated shipments of imported capsicum and sesame seed. The mean Salmonella concentration

estimates varied widely among contaminated shipments, with ranges of 6 x 10-4 to 0.09 MPN/g-spice (6 MPN 

per 10,000 g to 9 MPN per 100 g) for shipments of imported capsicum and 6 x10-4 to 0.04 MPN/g-spice (6 

MPN per 10,000 g to 4 MPN per 100 g) for shipments of imported sesame seeds offered for entry to the 

United States. A gamma-Poisson model of within- and between-shipment contamination provided the best fit 

to observations among six parametric models considered. Contaminated spice shipments of capsicum or 

sesame seed were typically large in size, constituting millions or tens of millions servings. Approximately onefifth of the contaminated shipments of capsicum or sesame seed was packaged for retail sale (20% for 

capsicum and 22% for sesame seed). No comparable prevalence or enumeration data are available for other 

imported spices or for domestically produced spices.

The American Spice Trade Association (ASTA) provided sampling and testing data collected in spice 

secondary processing/packing facilities of member companies over a two-year period during 2007-2009. 

Analysis and interpretation of these data were complicated by an absence of information characterizing 

sample size examined. The spice industry data provided evidence that the prevalence of Salmonella in spice 

lots that had undergone a pathogen reduction treatment was smaller than that for untreated spice lots. These 

data also provided evidence that the prevalence of Salmonella in these industry sampled treated spice lots 
Executive Summary |

FDA Draft Risk Profile | 3 

was smaller than the average prevalence found for sampled shipments of imported spices offered for import 

to the United States during FY2007-FY2009 (FDA surveillance sampling). 

We were unable to identify any reports characterizing the prevalence or concentration of Salmonella in spices 

at retail (in food/grocery stores, food service, restaurants, or in homes) in the United States. Studies outside 

the United States reported prevalence values ranging from 0% (with non-zero upper limits) to 10% with 

varying confidence intervals. Concentrations of Salmonella reported in retail spice samples outside the United 

States ranged from <0.1 to 0.2 MPN/g-spice (0.086 MPN/g for black pepper and capsicum spice in Japan and 

from <0.1-0.2 MPN/g for sesame seeds and mixtures of seeds in the United Kingdom) for surveillance 

samples. Concentrations of Salmonella determined in traceback investigations of spice-associated foodborne 

outbreaks ranged from <0.03-11 MPN/g-spice. 

Recent prevalence estimates for filth adulteration of spices were only available for shipments of imported 

spice offered for entry to the United States. No data were available for domestically produced spices. Analysis 

of FDA surveillance sampling data for FY2007-FY2009 showed that the average prevalence of filth 

adulteration of shipments of imported spice was 12% (95% CI 10-15%), which was 1.8 times (95% CI 1.4-

2.2%) the value found for the average of all other imported FDA-regulated food shipments examined during 

that period. Prevalence of filth adulteration of imported shipments of ground/cracked and whole spice were 

similar. The prevalence of filth adulteration of imported shipments of imported black pepper was smaller 

than that for several other types/categories of spice shipments. The most common types of filth adulterants 

were insect fragments, whole/equivalent insects, and animal hair. Nearly all of the insects found in spice 

samples were stored product pests, indicating inadequate packing or storage conditions. The presence of 

rodent hair (without a root) in spices generally is generally indicative of contamination by rodent feces. 

Direct evidence of animal fecal and/or insect fecal contamination was found in a small number of the samples. 

The presence of these filth adulterants is indicative of insanitary conditions and failures in the application of 

Current Good Manufacturing Practices (CGMPs). Data on the prevalence of filth adulteration of spice at retail 

in the United States were last gathered in the 1980’s by FDA and were used to set the maximum 

concentrations of natural or unavoidable defects in foods to concentrations achievable by CGMPs. 

Characterization of Contaminants

A variety of animal hosts may introduce Salmonella into a spice production site. Salmonella can survive in the 

natural environment (outside of an animal host) for extended periods and can persist in some food 

production areas for years. Salmonella can also survive for extended periods (exceeding 1 year) in low 

moisture foods including spices. The magnitude of the Salmonella population reduction rate in spice depends 

on the water activity of the spice (or equivalently, the humidity of the spice environment) and temperature, 

when the water activity/humidity is elevated. When Salmonella-contaminated spices are stored in an 

environment that meets spice industry standards for low water activity/humidity, the reduction in 

population of Salmonella in spice with time may be minimal (shown for ground black pepper). FDA research 

has also demonstrated that Salmonella can grow efficiently in wet ground black pepper (no additional 

nutrients needed), such as might occur if spice is improperly processed, packaged or stored. 

Overview of Spice Farm-to-Table Continuum and Potential Sources of Pathogen and Filth Contamination 

A wide diversity of farm sizes and agricultural practices is used in the production of spices around the globe. 

Many spices are produced on very small farms where farm animals are used to plow, crops are harvested by 

hand, and spices are dried in open air. Multi-cropping is also common. Spice from small farms is typically 

aggregated with that of other farms. These collections of spice are later sold to exchanges or to spice

processing/packing companies. Producers may store whole spice for years before selling to a buyer. Larger 

farms, such as those used to produce dehydrated onion and garlic in the United States, may be owned by or 

contracted with a single major/large spice company that dictates/controls growing, harvest, drying, and 

storage practices. Spice companies may also contract with groups of farmers in a single region to educate and 

better control growing, harvest, drying, and storage practices. World Health Organization (WHO), Codex 

Alimentarius (Codex), and industry standards and guidance designed to minimize/prevent introduction of 
Executive Summary |

FDA Draft Risk Profile | 4 

pathogens or filth to the source plant or dried spice, such as those related to irrigation water, restriction of 

animals in the growing area, and farm worker hygiene, can be challenging to implement at many primary 

production sites. 

The distribution of spice from primary producer to consumer can be very complex, involving multiple 

locations, multiple processing and/or packing steps and long periods. Inappropriate packing and storage of 

spice during any one of these steps may lead to the introduction of Salmonella or filth into spice. 

Application of additional mechanical and electromagnetic cleaning processes as well as grinding/cracking, 

blending, and packing typically take place in secondary spice processing facilities. To prevent creation of 

niches, spice processors may use dry sanitation and cleaning processes in process areas handling spice that 

has been subjected to a pathogen reduction treatment. Some level of spice dust is unavoidable so equipment 

and facility design play critical roles in limiting the need for wet cleaning in the spice processing areas and 

preventing cross-contamination of treated spices with untreated spice dust. Replacement of equipment or redesign of facilities can be particularly challenging for small spice firms and use of common equipment for 

multiple types of spice is common.

Pathogen reduction treatments are not uniformly applied to all types of spices or all lots of spice of a given 

type at the secondary processing stage. The efficacy of the most commonly applied pathogen reduction 

treatment methods (steam, irradiation, and ethylene oxide) is dependent on a variety of conditions, which 

can alter reductions by orders of magnitude. No studies have systematically examined efficacy of these 

processes for reductions of Salmonella in spices but data available suggest that each of these methods has the 

potential to achieve substantial decimal reductions in spices under appropriately controlled conditions. 

Similar food safety concerns, described above for secondary spice processing facilities, exist in seasoning and

food manufacturing facilities as well as in wholesalers that pack and re-pack spices. In addition, spice is 

sometimes added to foods after the final food manufacturing pathogen reduction step has been applied, if 

such as step is part of the food preparation process.

In institutional food services, restaurants, and households, application of untreated spice to foods after the 

final lethality (cooking) step and the potential for pathogen growth in foods to which Salmonellacontaminated spice has been added are of primary concern. In addition, the potential for contamination of 

spice by pests in the food preparation and storage environments or cross-contamination of spice from 

surfaces or utensils used to prepare other contaminated foods are also of concern. Preventive controls to 

minimize most of these outcomes include application of the principles described in the state regulations, the 

FDA Food Code, and consumer guidance. At this time, spice sold in retail settings (to households) do not 

generally carry an indication of whether the spice had been treated for reduction of pathogens.

Spice Production and Consumption

Most of the U.S. spice supply is imported with the exception of dehydrated onion. U.S. farms also produce 

large fractions of the U.S. supply of dehydrated garlic, capsicum, and mustard seed. Consumer survey data in 

the Mintel survey reveal that a large majority of U.S. households, estimated to be 86%, use fresh or dried 

herbs, spices and seasonings. Spice use in the United States, as measured by food availability, has been 

increasing by approximately 0.5 lbs./decade since 1966. In 2010, the estimated per capita annual spice 

consumption was 3.64 lbs. (1653 g), excluding dehydrated garlic. Estimates from the FDA/CDC National 

Health and Nutrition Examination Surveys (NHANES) indicate a typical consumption range of 0.3-1.7 g-spice 

per eating occasion for three eating occasions per day. Estimates of the variability and frequency of spice 

consumption are not available. 

Current Mitigation and Control Options

Current U.S. regulatory mechanisms available to mitigate and control adulteration of spice with Salmonella or 

filth include CGMPs, inspections of and environmental sampling in spice manufacturing/packing facilities, 
Executive Summary |

FDA Draft Risk Profile | 5 

product sampling, refusals and reconditioning, import alerts (with or without green lists and country 

agreements), and some provisions of the FDA Food Safety Modernization Act. 

Rates of compliance with CGMPS among spice firms in the United States for the period FY2007-FY2012 was

approximately the same as that found for firms handling other FDA-regulated low moisture foods. Insufficient 

data were available to evaluate compliance with CGMPS in spice facilities outside the United States. FDA 

inspections of 59 domestic firms that manufacture/pack/re-pack spices in 2010 revealed that a significant 

fraction (10%) had Salmonella in the (primarily post-processing) facility environment. Lack of effective pest 

management was the most frequently cited observation in these inspections. No environmental sampling 

data from FDA were available to determine the prevalence of Salmonella in international spice facility 

environments. 

During the period FY2007-FY2010, 906 imported spice shipments (including sesame seeds) were refused 

entry to the United States based on the presence or potential for presence of Salmonella and/or filth. Among 

these shipments, 749 shipments of spice were refused entry because of the presence or potential presence of 

Salmonella and 238 shipments were refused because of the presence or potential presence of filth. During the 

period 2007-2012, CFSAN accepted 50 out of 155 reconditioning proposals for spices, 37of which addressed 

contamination with Salmonella. 

Five U.S. import alerts address adulteration of spice by Salmonella or filth and four of these are specific to 

spice. Import Alert 99-19 lists firms and specific foods for which evidence has indicated the likelihood of 

Salmonella contamination; a majority of firms and foods listed are spices (71% in 2010 and 67% in 2010, 

excluding sesame seeds cited as a seed rather than a spice). 

Import Alert 28-02 for Indian Black Pepper includes an agreement that leverages in-country regulatory 

authority to improve the food safety of shipments of the imported spice offered for entry to the United States. 

This combination of incentives appears to be effective in reducing the prevalence of Salmonella or filth 

contamination in shipments of Indian black pepper offered for entry to the United States. Expansion of this 

type of mechanism to other spices and/or to other countries should lead to further improvements in 

contamination rates. 

The FDA Food Safety Modernization Act provides important new tools to mitigate and control contamination 

and post treatment cross contamination of spices with Salmonella, including authority to mandate recalls and 

increase in the frequency of foreign and domestic inspections (implemented), and prevention standards and 

import safety mandates (proposed rules issued in January 2013 (78 Federal Register 3646) and July 2013 (78 

Federal Register 45730), respectively).

The spice and food trade organizations have developed detailed guidance to prevent and control adulteration 

of spice with pathogens or filth in finished spice or food products. These guidance documents reflect current 

scientific knowledge including the ability of Salmonella to survive in low-moisture foods such as spices, the 

enhanced heat resistance of some Salmonella strains, and lessons learned from past contamination and 

outbreak events. Clean, Safe Spices: Guidance from the American Spice Trade Association, published in 2011, 

highlights the application of Good Agricultural Practices (GAPs) for growing and harvesting spices, supply 

chain approval and re-evaluation programs, Good Manufacturing Practices (GMPs), validated microbial 

reduction processes, ASTA Cleanliness Specifications, post-treatment sampling and testing program, 

environmental sampling and testing program, and the development of Hazard Analysis and Critical Control 

Point (HACCP) plans. The Grocery Manufacturers Association Control of Salmonella in Low-Moisture Foods

guidance and associated journal articles highlight additional preventive controls including stringent control 

of hygienic practices in the Primary Salmonella Control Area (PSCA) and moisture control. The extent to 

which the recommendations in these guidance documents are applied by the spice and food industry is 

unknown. Guidance from Codex and Food and Agriculture Organization (FAO)/WHO provide science-based 

general principles for hygienic production and harvesting, establishment design and hygiene requirements, 
Executive Summary |

FDA Draft Risk Profile | 6 

personnel hygiene, establishment hygienic processing, and end-product specifications that can be applied to 

spice. The spice-specific Code of Hygienic Practice for Spices and Dried Aromatic Plants does not reflect current 

knowledge in hygienic practices and is being revised by the Codex Committee on Food Hygiene (at the time 

this report was written).

General Conclusions and Potential Future Mitigation and Control Options

Failures identified in the farm-to-table food safety system potentially leading to adulteration of consumed 

spice generally arose from poor/inconsistent application of appropriate preventive controls, such as failing to 

limit animal access to the spice source plant during harvest or drying phases, failing to limit insect and rodent 

access to spice during storage, or failing to subject all spice to an effective pathogen reduction treatment (or 

other lethality step). Based on our research, we concluded that knowledge and technology are available to 

significantly reduce the risk of illness from consumption of contaminated spices in the United States. 

We developed a list of potential future mitigations and control options for consideration based on the 

scientific data, information, and analysis in this report. The list includes mitigation and control options that 

FDA, the spice industry, government agencies, food manufacturers/preparers, and the consumer may 

consider to reduce the prevalence and concentration of Salmonella, other pathogens, and filth in spices and to 

reduce the public health burden resulting from consumption of contaminated spices or foods containing 

contaminated spices. Mitigation and control options identified include capacity building, guidance, 

enforcement and regulatory strategies, communication, education, and training. We emphasize capacity 

building through the creation of partnerships with stakeholders to facilitate improvements in spice safety and 

reduce the risk of illness from consumption of pathogen-contaminated spices. These include enhanced 

communication between FDA and the spice industry and within the spice and food manufacturing industry 

itself, combined with training across the spice supply chain to ensure understanding of appropriate 

preventive controls and how to implement them.

Data Gaps and Research Needs

The development of the risk profile revealed many gaps in information and data regarding the adulteration of 

spices by pathogens and filth and the potential for this contamination to impact public health. We identified

these gaps and the research needed to fill them, particularly focusing on research that could improve our 

ability to assess the public health risk posed by consumption of spices in the United States, to better 

characterize system failures that lead to spice contamination, and to explore additional potential future 

mitigations.
FDA Draft Risk Profile | 7 

1. INTRODUCTION

The FDA Draft Risk Profile on Pathogens and Filth in Spices was initiated by the Center for Food Safety and 

Applied Nutrition in response to a large 2008-2009 outbreak of Salmonella illness associated with the 

consumption of microbiologically contaminated ground white pepper in the United States. Subsequently, the 

United States had a larger outbreak of Salmonella illness, this time associated with consumption of products 

containing black and red pepper. This second outbreak, as well as other reports in the literature and within 

FDA served to underscore the importance of researching food safety issues associated with spices.

The Draft Risk Profile on Pathogens and Filth in Spices was primarily developed to provide information for 

the Food and Drug Administration (FDA) risk managers and others to use in regulatory decision-making. The 

information may also be useful to stakeholders and interested parties such as spice producers and importers, 

spice and food manufacturers, retail foods establishments, and consumers.

1.1 RISK PROFILE OBJECTIVES AND SCOPE

The Spice Risk Profile has four main objectives:

1. Describe the nature and extent of the public health risk posed by consumption of spices in the United 

States by identifying the most commonly occurring microbial hazards and filth in spice.

2. Describe and evaluate current mitigation and control options designed to reduce the public health 

risk posed by consumption of contaminated spices in the United States.

3. Identify potential additional mitigation or control options designed to reduce the public health risk 

posed by the consumption of contaminated spices in the United States.

4. Identify data gaps and research needs.

For the purpose of this risk profile, the term “spice” means “any [dried] aromatic vegetable substances in the 

whole, broken, or ground form, except for those substances which have been traditionally regarded as foods, 

whose significant function in food is seasoning rather than nutritional, and from which no portion of any 

volatile oil or other flavoring principle has been removed” (Title 21 Code of Federal Regulations (CFR), 

section 101.22) (FDA, 2012p) and includes spices listed at 21 CFR 182.10 and 21 CFR 184 (FDA, 2012f; FDA, 

2012g ) and additional dried plants listed as spices by the Environmental Protection Agency (EPA), the 

American Spice Trade Association (ASTA) (ASTA, 2012) and the Seasoning and Spice Association (SSA) (SSA, 

2012), such as dehydrated onion and garlic, as well as other dehydrated vegetables used as seasoning. 

The specific microbial hazards and filth elements in spices considered in this risk profile include pathogens 

and filth adulterants detected in spices, implicated in outbreaks, reported as the reason for recalls, and 

reported in submissions to the Reportable Food Registry (RFR). Emphasis is placed on the pathogen(s) with 

the strongest evidence for illness related to consumption of contaminated spices (e.g., outbreaks) and for 

which the potential for exposure in the United States has been established (i.e., outbreaks, recalls, 

submissions to the RFR, and surveillance sampling). 

The risk profile also addresses specific questions posed by risk managers, which include the following:

1. What is known about the frequency and concentrations of pathogen and/or filth contamination of 

spices throughout the food supply chain (e.g., on the farm, at primary processing/manufacturing, at 

intermediary processing (where spices are used as ingredients in multi-component products), at 

distribution (including importation), at retail sale/use, and at the consumer’s home)?

2. What is known about differences in production and contamination of imported and domestic spices?

3. What is known about the effectiveness and practicality of currently available and potential future 

mitigations and control options to prevent human illnesses associated with contaminated spices (e.g., 
Introduction| 1

FDA Draft Risk Profile | 8 

practices and/or technologies to reduce or prevent contamination, surveillance, inspection, import 

strategies, or guidance)?

4. What are the highest priority research needs related to prevention or reduction of contamination of 

spices with pathogens or filth? 

Completion of the risk profile involved decisions about cutoff dates for data inclusion. Within the constraints 

of data access, collection, analysis, and review, we provide a review of current data that address the risk 

management objectives and questions posed. For the review of outbreaks and analysis of FDA and industry 

sampling data, the availability of data and the complexity of the analyses involved determined upper year 

cutoffs for these studies. 
FDA Draft Risk Profile | 9 

2. FOODBORNE ILLNESS OUTBREAKS FROM MICROBIAL 

CONTAMINANTS IN SPICES, 1973-2010

We undertook a comprehensive literature search and reviewed the Centers for Disease Control and

Prevention’s Foodborne Disease Outbreak Surveillance System (CDC’s FDOSS) to identify and describe all the 

foodborne illness outbreaks that have been reported and attributed to consumption of pathogencontaminated spices throughout the world during the years 1973 through 2010. The original report of this 

study was published in Food Microbiology (Van Doren et al., 2013b). The risk profile includes additional 

search criteria, added in response to suggestions by external peer reviewers, but no additional outbreaks 

beyond those reported in the original report have been identified.

The specific objectives of this study were to (1) characterize the public health burden arising from 

consumption of spices contaminated with microbial pathogens, (2) identify the types of microorganisms 

implicated in foodborne illness outbreaks caused by consumption of contaminated spice, (3) identify and 

characterize the types of spices and countries of origin implicated in spice-associated illness outbreaks, and 

(4) identify the leading causes of microbial contamination of spices associated with foodborne outbreaks. 

We define a spice-associated outbreak as the occurrence of two or more similar illnesses resulting from 

ingestion of a food containing a common spice(s) as an ingredient. Only outbreaks with laboratory detection 

of the suspected causative agent in the spice/spice blend and either culture-confirmed detection of the 

causative agent in clinical samples or analytical epidemiological evidence providing a statistically significant 

associated between consumption of the food vehicle and being a case in the outbreak were included. These 

inclusion criteria were selected to ensure that the outbreaks identified had compelling evidence that a 

contaminated spice ingredient was the cause of the reported illnesses. The review included outbreaks taking 

place during the years 1973-2010. The period of review began in 1973 because it was the year CDC’s 

Foodborne Disease Outbreak Surveillance System (FDOSS) was initiated and the period ended with 2010 

because it was the most recent year for which data from FDOSS was available when this report was written. 

To identify and learn about foodborne illness outbreaks associated with consumption of spices, we reviewed 

the refereed scientific literature and available government/agency reports using MEDLINE and Google 

Scholar to search the English-language literature using different combinations of the following keywords: 

outbreak, foodborne, spice, seasoning, herb, pathogen, Bacillus, Campylobacter, Clostridium, Cronobacter, 

Escherichia coli, E. coli, O157, O104, Mycobacterium bovis, Mycobacterium tuberculosis, norovirus, Salmonella, 

sakazakii, Shigella, and Staphylococcus aureus. We also queried the CDC’s FDOSS to identify outbreaks 

reported to CDC during 1973-2010 where a spice was reported as the implicated food (CDC, 2012a). We 

reviewed paper citations and references contained in the articles identified in our search and contacted 

public health agencies in France, New Zealand and the United Kingdom to follow up on reports in the 

literature. Through these contacts, we learned of one additional outbreak, which has not been previously 

reported in the literature. For the two most recent illness outbreaks in the United States, additional 

information was gathered from investigations by FDA and CDC. 

2.1 SUMMARY OF OUTBREAKS, 1973-2010

The review identified fourteen spice-associated illness outbreaks occurring between 1973 and 2010 (Table 

2.1). Four of these outbreaks were identified in a previous review of salmonellosis outbreaks associated with 

consumption of spices and fresh herbs (Zweifel and Stephan, 2012). Together, these outbreaks resulted in 

1946 reported human illnesses, 128 hospitalizations (7% of cases) and two deaths (0.1%). Countries 

reporting outbreaks were Canada (1 outbreak), Denmark (1), France (1), Germany (2), New Zealand (1), 

Norway (1), Serbia (1), United Kingdom (3), and the United States (3). 
Foodborne Illness Outbreaks from Microbial Contaminants in Spices, 1973-2010 | 2

FDA Draft Risk Profile | 10

Table 2.1. Summary of enteric illness outbreaks taking place during 1973-2010 associated with consumption of microbial contaminants in 

dried spices and seasonings or foods containing these contaminated ingredients 

Spice Linked to 

Outbreak Date

Country:

Outbreak

(Spice)a 

Pathogenb Total 

Casesc

Hospitalizations 

(Deaths)

Other 

pathogens 

isolated 

during 

investigation

Comments Reference(s)

Black pepper

(Piper nigrum) 

Dec 1973 

– May 

1974

Canada

(India)

Salmonella 

Weltevreden 17 1 

(Not reported) None reported

Microbiological link between spice 

and illness established.

Outbreak identified in Mar 1974 

after laboratory surveillance 

detected increased human cases of 

S. Weltevreden illness; 2 samples of 

black pepper positive for S. 

Weltevreden had been previously 

identified in Aug 1973. One case 

attributed to consumption of white 

pepper; S. Weltevreden isolated 

from opened container of white 

pepper with same trademark as S. 

Weltevreden positive black pepper 

samples.

Laidley et al., 

1974; WHO, 

1974

Black pepper

(Piper nigrum) 

Nov 1981 

- Aug 

1982

Norway

(Brazil)

Salmonella

Oranienburg 126 >25%(at least 1)

S. Senftenberg, 

S. Lexington,

S. Abaetuba 

from samples 

of implicated 

black pepper.

S. Sendai,

S. Glostrup 

from other 

samples of 

black pepper 

from Brazil.

Microbiological link between spice 

and illness established.

The Brazilian black pepper was 

first shipped to the Federal 

Republic of Germany; only a 

fraction of the original shipment 

was later shipped to Norway. It is 

not known whether the pepper was 

processed or repackaged in 

Germany before shipment to 

Norway.

Enumeration of Salmonella in 12 

samples of black pepper found 

concentrations in the range 0.1 to 

>2.4 MPN/g.

Gustavsen and 

Breen, 1984
Foodborne Illness Outbreaks from Microbial Contaminants in Spices, 1973-2010 | 2

FDA Draft Risk Profile | 11

Spice Linked to 

Outbreak Date

Country:

Outbreak

(Spice)a 

Pathogenb Total 

Casesc

Hospitalizations 

(Deaths)

Other 

pathogens 

isolated 

during 

investigation

Comments Reference(s)

Paprika

(Capsicum 

annum)

(on paprikapowdered potato 

chips)

Apr - Sep 

1993

Germany

(South 

America)

Salmonella

Prevailing 

serotypes: 

Saintpaul, 

Rubislaw, and 

Javiana

~1000 d

Not reported 

(Not reported)

Multiple 

Salmonella

serotypes

Microbiological link between spice 

and illness established.

Spice mix applied after chip 

temperature dropped to 60°C.

Enumeration of Salmonella in 

paprika and paprika-containing 

spice mixes found concentrations 

in the range 0.04-11 MPN/g.

Lehmacher et 

al., 1995

Turmeric

(Curcuma longa)

(on lamb seekh 

kebab)

1995e

United 

Kingdom

(not known)

Bacillus 

subtilis

& Bacillus 

pumilus

2 0 

(0) None reported

Microbiological link between spice 

and illness established.

Outbreak attributed to 

consumption of lamb seekh kebab 

in a restaurant; B. subtilis and B. 

pumilus were detected in the 

turmeric powder used to make the 

lamb seekh kebab.

Little et al., 

2003; Little, 

2012; Health 

Protection 

Agency, 2011

Black pepper

(Piper nigrum) Aug 1996

United 

Kingdom

(not known)

Salmonella

Enteritidis 

PT4

8 1 

(0) None reported

Microbiological link between spice 

and illness established.

S. Enteritidis detected in ground 

black pepper used in meal 

preparation in a restaurant.

Little et al., 

2003; Little, 

2012; Health 

Protection 

Agency, 2011

Pepper

(type not 

specified)

1997 New Zealand

(Malaysia)

Bacillus 

subtilis 2 

None reported

(None 

reported)

None reported

Microbiological link between spice 

and illness established.

Outbreak attributed to 

consumption of peppered steak; B. 

subtilis detected in cooked and 

uncooked steak, pepper mix, and 

peppercorns (>104 CFU/g).

Cameron, 

1998
Foodborne Illness Outbreaks from Microbial Contaminants in Spices, 1973-2010 | 2

FDA Draft Risk Profile | 12

Spice Linked to 

Outbreak Date

Country:

Outbreak

(Spice)a 

Pathogenb Total 

Casesc

Hospitalizations 

(Deaths)

Other 

pathogens 

isolated 

during 

investigation

Comments Reference(s)

Curry Powder

(blend of spices) Aug 2002

United 

Kingdom

(India)

Salmonella

Braenderup 20 1 

(0) None reported

Microbiological link between spice 

and illness established.

S. Braenderup detected in curry 

powder added as garnish to an egg 

dish in a restaurant; dish was kept 

at room temperature before 

serving; S. Braenderup found in 

samples from both opened and 

unopened packages of curry 

powder.

Little, 2012; 

Health 

Protection 

Agency, 2011

Anise seed

(Pimpinella 

anisum) 

(in tea 

containing anise 

seed, fennel 

seed, and 

caraway)

Oct 2002 

-Jul 2003

Germany

(Turkey)

Salmonella

Agona 42 21 of 39

(0)

Other 

unspecified 

Salmonella

serotypes

Microbiological link between spice 

and illness established.

Identification of implicated vehicle 

aided by knowledge during 

hypothesis generation that S. Agona 

had been isolated from anise seed 

during routine food safety 

monitoring in 2002.

All cases of illness in infants <13 

months. 

Enumeration of Salmonella in 

samples of anise seed-containing 

tea found a concentration of 0.036 

MPN/g.

Koch et al., 

2005; Rabsch 

et al., 2005
Foodborne Illness Outbreaks from Microbial Contaminants in Spices, 1973-2010 | 2

FDA Draft Risk Profile | 13

Spice Linked to 

Outbreak Date

Country:

Outbreak

(Spice)a 

Pathogenb Total 

Casesc

Hospitalizations 

(Deaths)

Other 

pathogens 

isolated 

during 

investigation

Comments Reference(s)

Seasoning mix & 

broccoli powder

(coating a snack 

puff)

Jan 2007 

– Dec 

2007

United States

(China for 

dried 

broccoli 

powder; 

sources of 

other 

ingredients 

in seasoning 

mix not 

reported)

Salmonella 

Wandsworth 69 6 of 56(0)

S. 

Typhimurium,

S. Kentucky, 

Cronobacter

sakazakii from 

unopened 

snack puff 

bags; 

S. 

Typhimurium, 

S. Haifa from 

finished 

product in the 

manufacturing 

facility; S. 

Mbandaka from 

parsley powder 

used in the puff 

snack 

seasoning mix.

Microbiological link between spice 

and illness established.

Seasoning mix applied after final 

pathogen reduction step.

Isolating S. Typhimurium from 

seasoning mix led to identification 

of a linked S. Typhimurium 

outbreak.

Sotir et al., 

2009

Seasoning mix & 

broccoli powder

(coating a snack 

puff) continued

Jun 2007 

– Sep 

2007

United States

(China for 

dried 

broccoli 

powder; 

sources of 

other 

ingredients 

in seasoning 

mix not 

reported)

Salmonella 

Typhimurium 18 2 of 18

(0)

S. Wandsworth 

plus “Other 

pathogens” 

listed above for 

related S. 

Wandsworth 

outbreak.

Microbiological link between spice 

and illness established.

Outbreak identified after sample of 

snack food seasoning mix taken 

during S. Wandsworth outbreak 

investigation was positive for S. 

Typhimurium.

Sotir et al., 

2009

Spice Blend

(in couscous 

dish)

2007

France

(Not 

reported)

Bacillus 

cereus

146 0 

(0) Unknown

Analytical epidemiological evidence 

and laboratory detection of B. 

cereus in the spice blend used in the 

couscous dish.

Outbreak in school/kindergarten.

EFSA, 2013; 

EFSA, 2009a; 

Delmas, 2013
Foodborne Illness Outbreaks from Microbial Contaminants in Spices, 1973-2010 | 2

FDA Draft Risk Profile | 14

Spice Linked to 

Outbreak Date

Country:

Outbreak

(Spice)a 

Pathogenb Total 

Casesc

Hospitalizations 

(Deaths)

Other 

pathogens 

isolated 

during 

investigation

Comments Reference(s)

Fennel seed

(Foeniculum 

vulgare) 

(in “baby” tea 

containing 

fennel seed, 

anise seed, and 

caraway)

Mar 

2007- Sep 

2008

Serbia

(Not 

reported)

Salmonella

Senftenberg 14 4 of 14

(Not reported) None reported

Microbiological link between spice 

and illness established.

Parents of case-patients reported 

pouring boiling water over (dry) 

baby tea mixture during 

preparation but did not heat tea 

infusion to boiling.

71% of cases of illness in infants 

<12 months.

Ilic et al., 2010

White pepper

(Piper nigrum) 

Dec 2008 

- Apr 

2009

United States

(Vietnam)

Salmonella

Rissen 87

8 of 60 ; 14 

additional 

patients were 

hospitalized 

before illness

(1)

None reported

Microbiological link between spice 

and illness established.

Environmental samples from spice 

processing facility tested positive 

for the outbreak strain. Multiple 

violations of CGMP noted during 

inspection of spice processing 

facility.

Identification of implicated vehicle 

aided by knowledge that the 

outbreak strain had been isolated 

in 2006 from an FDA import 

sample of black pepper.

CDPH/FDB/

ERU, 2010; 

FDA, 2009a; 

Higa, 2011; 

Hajmeer and 

Myers, 2011; 

Higa, 2012

Black pepper 

(Piper nigrum) 

and red pepper 

(Capsicum spp.)

(on Italian-style 

salami)

Jul 2009 – 

Apr 2010

United States

(black 

pepperVietnam; red 

pepper - 

India & 

China)

Salmonella

Montevideo 272f 52 of 203

(0) S. Senftenberg

Microbiological link between spice 

and illness established.

Black pepper and red pepper 

applied to salami products after the 

final pathogen reduction step.

Isolating S. Senftenberg from 

implicated product led to 

identification of a linked S. 

Senftenberg outbreak.

CDC, 2010; 

Gieraltowski 

et al., 2012; 

DuVernoy, 

2012
Foodborne Illness Outbreaks from Microbial Contaminants in Spices, 1973-2010 | 2

FDA Draft Risk Profile | 15

Spice Linked to 

Outbreak Date

Country:

Outbreak

(Spice)a 

Pathogenb Total 

Casesc

Hospitalizations 

(Deaths)

Other 

pathogens 

isolated 

during 

investigation

Comments Reference(s)

Black pepper 

(Piper nigrum) 

and red pepper 

(Capsicum spp.)

(on Italian-style 

salami) 

continued

Jul 2009 – 

Apr 2010

United States

(black 

pepperVietnam; red 

pepper - 

India & 

China)

Salmonella 

Senftenberg 11 Not reported(Not reported) S. Montevideo

Microbiological link between spice 

and illness established.

Outbreak identified during S.

Montevideo outbreak investigation 

after sample of unopened retail 

package of salami was positive for 

S. Senftenberg.

CDC, 2010; 

DuVernoy, 

2012

White pepper

(Piper nigrum)

(in stew)

2010 Denmark

(Unknown)

Bacillus 

cereus

112 0 

(0) Unknown

Microbiological link between spice 

and illness established.

Contaminated white pepper in 

stew. Canteen/workplace catering 

setting. Storage time/temperature 

abuse suspected as contributing.

EFSA, 2013; 

EFSA, 2011a

a Country where outbreak occurred following by country of origin of the spice in parentheses.

b Salmonella serotypes listed are serotypes of Salmonella enterica subspecies enterica. 

c Number of cases of illness listed are the number of documented cases of illness. Several sources indicate that this number significantly underestimates the actual number of illnesses 

associated with the outbreak (Scallan et al, 2011; Mead et al., 1999; Voetsch et al., 2004; Chalker and Blaser, 1988). See text for further details. 

d Number of human cases of illness associated with rare serotypes of Salmonella found in paprika or paprika-powdered potato chips during the outbreak. Approximately 42% of illnesses 

were associated with the three prevailing S. serotypes

e Duration of outbreak not known (Little, 2012; Health Protection Agency, 2011)

f Number of cases of illness listed are number of epidemiologically linked cases of illness (CDC, 2010). A SNP-based evolutionary analysis of Montevideo isolates suggests that a portion of the 

epidemiologically linked cases of illness may not be associated with this outbreak (see text, den Bakker et al., 2011).
Foodborne Illness Outbreaks from Microbial Contaminants in Spices, 1973-2010 | 2

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Ten of the fourteen (71%) spice-associated outbreaks and 87% of the illnesses were caused by serotypes of 

Salmonella enterica subspecies enterica. Four outbreaks were caused by Bacillus spp., accounting for 13% of 

the illnesses. Four outbreaks were associated with two or more different organisms (multiple serotypes of 

Salmonella or multiple species of Bacillus). Salmonella serotypes associated with human illnesses in these 

outbreaks included Agona (1 outbreak), Braenderup (1), Enteritidis (1), Javiana (1), Montevideo (1),

Oranienburg (1), Rissen (1), Rubislaw (1), Saintpaul (1), Senftenberg (2), Typhimurium (1), Wandsworth (1), 

and Weltevreden (1) (Table 2.1). Bacillus species identified as causative agents in spice-associated outbreaks 

included B. cereus (2 outbreaks), B. subtilis (2) and B. pumilus (1). The evidence for the spice-associated B. 

subtilis and B. pumilus illness outbreaks reported in Table 2.1 included both epidemiological and 

microbiological data (Little, 2012). B. subtilis and B. pumilus are seldom reported as foodborne pathogens but 

these organisms may produce a mild toxin after growing to high numbers in a food (Logan, 2011).

Spices implicated in the outbreaks were black pepper (Piper nigrum; 4 outbreaks), red pepper (Capsicum

spp.; 2 outbreaks), white pepper (Piper nigrum; 2 outbreaks), unspecified pepper (1 outbreak), curry powder 

(a blend of spices; 1 outbreak), anise seed (Pimpinella anisum; 1 outbreak), fennel seed (Foeniculum vulgare; 

1 outbreak), turmeric (Curcuma longa; 1 outbreak), a spice blend (1 outbreak) and a seasoning blend 

containing contaminated broccoli powder (1 outbreak); some outbreaks were associated with multiple spices 

or food vehicles (Table 2.1). Seventy-one percent (10/14) of the outbreaks were associated with spices 

classified as fruits or seeds of the source plant. The countries/regions of origin of the implicated spices were 

identified in nine outbreaks and included Brazil (1 outbreak), China (2), India (3), Malaysia (1), South 

America (1), Turkey (1), and Vietnam (2) (Table 2.1). In every case where it could be determined (9/14 

outbreaks), the spices implicated in the outbreaks were imported. This observation is not unexpected 

because many of the countries in which outbreaks were identified are not major spice producing countries 

(FAO, 2013b). In at least two of the outbreaks, post-import cross-contamination is suspected to have 

contributed to the outbreak (Salmonella Rissen in white pepper [Piper nigrum] and Salmonella Montevideo in 

black pepper [Piper nigrum] and red pepper (Capsicum spp.); see discussion in Section 2.2).

2.2 OUTBREAKS IN THE UNITED STATES

Three foodborne illness outbreaks attributed to consumption of pathogen-contaminated spices were 

reported in the United States during the study period. All three outbreaks took place within a 40 month 

period (Jan 2007-April 2010) and accounted for 457 laboratory-confirmed illnesses, 68 hospitalizations, and 

one death (Table 2.1). Age data were available for 404 of the 457 confirmed cases. The age breakdown for 

these three outbreaks was: <1 year, 5%; 1 to 4 years, 17%; 5 to 9 years, 14%; 20 to 49 years, 32%; and >50 

years, 32%. The distribution of ages affected in these three U.S. outbreaks demonstrates that nearly all ages in 

the population have been affected by these outbreaks.

In the earliest spice-associated outbreak identified in the United States, 69 cases of Salmonella Wandsworth 

illness were confirmed from 23 states between January 2007 and December 2007; 96% of ill persons were 

children < 6 years old (Sotir et al., 2009). Public health investigations performed by state and federal 

regulatory authorities implicated a seasoning mix consisting of broccoli powder, parsley powder, and other 

spices used to coat a snack puff after the final food manufacturing pathogen reduction step (Sotir et al., 2009). 

The only ingredient in the seasoning mix to test positive for Salmonella Wandsworth was the broccoli 

powder, collected at two U.S. snack food manufacturing facilities and imported from China. It is not known 

whether the broccoli powder had undergone a pathogen reduction treatment before its application to the 

snack food (Sotir et al., 2009). None of the environmental samples collected in the two snack food 

manufacturing facilities tested positive for Salmonella (Sotir et al., 2009). Product testing also identified 

Salmonella Typhimurium from the seasoning mix and Salmonella Mbandaka from parsley powder (Sotir et al., 

2009). A cluster of 11 human cases of Salmonella Typhimurium illness epidemiologically linked to the snack 

puffs was subsequently identified; no confirmed human cases of Salmonella Mbandaka illness were reported 

(Sotir et al., 2009).
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In the second spice- associated outbreak in the United States, 87 cases of Salmonella Rissen illness that 

occurred between December 2008 and April 2009 were reported from 5 states (CDPH/FDB/ERU, 2010; Higa, 

2011). Human cases of illness resulted from food consumption at restaurants and hospitals and included 

individuals from age 5 months to 94 years (Higa, 2011). Epidemiologic investigations, traceback 

investigations, and product testing implicated white pepper (Piper nigrum) ground and packed by a single 

company in California (CDPH/FDB/ERU, 2010; Higa, 2011; Hajmeer and Myers, 2011). 

Samples of whole and ground white pepper were collected from the California spice processing and packing 

facility and analyzed during the investigation. One unopened bag of imported whole white peppercorns was 

found to contain the Salmonella Rissen outbreak strain, suggesting contamination of the spice took place 

before import (CDPH/FDB/ERU, 2010). The whole white peppercorns implicated in this outbreak originated 

from Vietnam and had been sold as “steam washed” (CDPH/FDB/ERU, 2010; Myers and Higa, 2011; Hajmeer 

and Myers, 2011). While steam treatments are often applied to spices to reduce/eliminate microbial 

pathogens (ASTA, 2011), “steam washing” is primarily used to clean dirt from spices and may not provide an 

effective pathogen reduction step (Myers and Higa, 2011; Hajmeer and Myers, 2011). No other pathogen 

reduction treatment had been applied to the spice (Myers and Higa, 2011) but the suspected imported whole 

white pepper lot was accompanied by a Certificate of Analysis (COA) that indicted that the lot had tested 

negative for Salmonella before import (CDPH/FDB/ERU, 2010). The sensitivity of the screening test used for 

the COA is not known so it is possible that the lot could have contained a low concentration of Salmonella or a 

highly clustered distribution of Salmonella undetected by the screening test (ICMSF, 2002; Bassett et al., 

2010). 

Environmental sampling data collected in the implicated spice processing and packing facility in California 

found widespread contamination of the spice processing facility, with ~40% (46/116) of swab samples taken 

throughout the facility testing positive for Salmonella (CDPH/FDB/ERU, 2010). All of the Salmonella isolates 

for which a strain was determined (19/46) matched the Salmonella Rissen outbreak strain (CDPH/FDB/ERU, 

2010). Contamination of the grinding room was particularly extensive, with 94% (34/36) of swabs collected 

in the grinding room testing positive for Salmonella Rissen and 100% (14/14) of the isolates examined for 

strain, matching the outbreak strain (Hajmeer and Myers, 2011; FDA, 2009). Inspections (CDPH/FDB/ERU, 

2010; FDA, 2009; Hajmeer and Myers, 2011) of the facility revealed multiple violations of the Current Good 

Manufacturing Practices (CGMP) regulation for foods at 21 CFR 110 (FDA, 2012i; U.S.C., 2007). FDA issued a 

Warning Letter to the firm that stated in part, “The finding of Salmonella in multiple processing locations 

within your facility indicates that this pathogenic organism may have become established in a niche 

environment in your facility” (FDA, 2009). With such gross contamination of the spice processing/packing 

facility, it is possible that cross-contamination from the facility environment to the spice also played a role in 

this outbreak. 

During the third spice- associated outbreak in the United States, epidemiological investigations identified 272 

laboratory-confirmed cases of Salmonella Montevideo illness from 44 states and the District of Columbia 

during the period July 2009 to April 2010 (CDC, 2010; Gieraltowski et al., 2012); ill persons ranged in age 

from <1 to 93 years (CDC, 2010; Gieraltowski et al., 2012). A next generation sequencing (NGS) analysis of 

human isolates collected during the time of the outbreak suggested that the total number of cases of illness 

associated with this outbreak may have been significantly smaller (den Bakker et al., 2011). However, the 

NGS analysis only included 20 putative outbreak isolates and relied on comparison with NGS data from 

known outbreak isolates analyzed on a different experimental platform (Lienau et al., 2011) which may have 

impacted the study conclusions. 

Epidemiologic and traceback investigations of the Salmonella Montevideo outbreak implicated consumption 

of ready-to-eat salami products (including pepper-coated salami) manufactured by a single company in 

Rhode Island (Gieraltowski et al., 2012). Traceback and product testing determined that black pepper (Piper 

nigrum) from Vietnam and red pepper (Capsicum spp.) from India and China used in the salami products 

were contaminated with Salmonella Montevideo (CDC, 2010; Gieraltowski et al., 2012; DuVernoy, 2012). A 
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private laboratory also isolated Salmonella Senftenberg from an unopened retail sample of the implicated 

product (Gieraltowski et al., 2012). PulseNet subsequently identified 11 human cases of Salmonella

Senftenberg with the same pulsed-field gel electrophoresis pattern (PFGE), and two of the patients reported

purchasing the implicated product (Gieraltowski et al., 2012). 

Evidence collected during the outbreak investigation revealed that some of the black pepper used in the 

manufacture of the salami products was reported to have been treated with steam (Gieraltowski et al., 2012). 

Descriptions of the treatments included “steam washed” and “steam sterilized” (DuVernoy, 2012). Some of 

the red pepper lots implicated in the investigation were reported to have been treated with ethylene oxide, 

some before and some after import into the United States (DuVernoy, 2012). It is not known if the steam or 

ethylene oxide treatments had been validated as an effective reduction step for Salmonella. Some of the 

treated imported black pepper shipments were accompanied by Certificates of Analysis (COAs) reporting 

negative tests for Salmonella (DuVernoy, 2012). However, review of the COAs revealed that at least some of 

the tests were conducted on a smaller sample size than FDA typically uses to examine spices at import (i.e., 

examining one 25 g sample as compared with 30 x 25 g [two-375 g composite samples]) (Andrews and 

Hammack, 2003). Therefore, it is possible that some of the treated imported black pepper contained low 

concentrations of Salmonella or highly localized contamination (ICMSF, 2002; Bassett et al., 2010) unreached 

by steam. As in the Salmonella Wandsworth outbreak associated with snack puffs, investigation of the food 

manufacturing process revealed that spices were applied to the salami products after the final (meat 

production/fermentation and drying) pathogen reduction step (CDC, 2010; Gieraltowski et al., 2012). Growth 

of Salmonella in the salami products is not suspected as contributing to this outbreak because salami is a lowmoisture, shelf-stable food.

While it was not possible to definitively determine where in the supply chain the spices were contaminated, 

the weight of evidence suggests that contamination of the black and red pepper with Salmonella Montevideo 

took place after the spice shipments were imported into the United States, that is, from cross-contamination. 

Experimental evidence supporting this hypothesis includes the NGS study that demonstrated that clinical, 

product, and environmental isolates associated with the outbreak were most closely related with one 

Salmonella Montevideo isolate collected from the east coast of the United States and were distinct from 

Montevideo strains from other parts of the world (Lienau et al., 2011; Allard et al., 2012). Other evidence 

supporting post-import contamination includes the facts that the spice associated with the outbreak was 

imported from three different countries that are geographically distinct (CDC, 2010; Gieraltowski et al., 2012) 

and that “a common source in the distribution path from production to the Company A facility [salami 

manufacturing facilities] was not identified between the black and red pepper” (Gieraltowski et al., 2012). 

While “unopened” boxes of spice in the salami manufacturer were found to contain the outbreak strain 

(Gieraltowski et al., 2012), the spice in these boxes came from U.S. suppliers who had stored, repacked, and in 

some cases, processed (e.g., ground/cracked) the spice before shipment to the salami manufacturing facility 

(DuVernoy, 2012).

2.3 SELECTED NON-U.S. OUTBREAKS

The largest spice-associated outbreak was identified in Germany in 1993 (Lehmacher et al., 1995; Table 2.1) 

in which an estimated 1000 cases of Salmonella illness occurred between April and September 1993. The 

majority of illnesses were in children ≤14 years old, including 14 infants <1 year old. A large number of 

Salmonella serotypes were associated with this outbreak; Salmonella Saintpaul, Javiana, and Rubislaw 

accounted for 42% of the human illnesses and many other Salmonella serotypes were isolated from patients 

or implicated foods (Lehmacher et al. 1995). 

Traceback investigations and product testing identified paprika (Capsicum annum), used in seasoning for 

potato chips, as the contaminated food vehicle (Lehmacher et al., 1995). Some, if not all, of the paprika was 

imported from South America. It was not known where or when the paprika was contaminated or whether a 

pathogen reduction treatment had been applied to the paprika. Enumeration experiments revealed that the 
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FDA Draft Risk Profile | 19

concentrations of Salmonella in samples of spice and food implicated in the outbreak were small − 2.5 MPN/g 

(25 MPN per 10 g; paprika), 0.04-11 MPN/g (4 MPN per 100 g to 11 MPN per g; paprika-containing spice 

mixes) and 0.05-0.45 MPN/g (5 MPN per 100 g to 45 MPN per 100 g paprika-powdered potato chips) − and 

that Salmonella can survive in the dry environments of paprika and paprika-powdered potato chips for at 

least 8 and 12 months, respectively (Lehmacher et al., 1995). As noted for other outbreaks, the spice mix was 

applied after the final food manufacturing (potato chip) pathogen reduction step (Lehmacher et al., 1995). 

Four outbreaks of Bacillus spp. illness attributed to consumption of foods containing contaminated spice took 

place in Denmark (EFSA, 2011a; EFSA, 2013), France (EFSA, 2009a; EFSA, 2013), New Zealand (Cameron, 

1998), and the United Kingdom (Little et al., 2003; Little, 2012; Health Protection Agency, 2011), accounting 

for 262 illnesses. Three of these outbreaks took place in settings where food services provide meals for large 

numbers of people (a canteen/workplace, a restaurant, and a school/kindergarten). Growth of the pathogen 

in the food was suspected as contributing to at least one of the outbreaks (EFSA, 2011a). 

Two outbreaks were attributed to consumption of tea infusions prepared from Salmonella-contaminated 

spices and served primarily to infants who were ≤13 months of age (Koch et al., 2005; Rabsch et al., 2005; Ilic 

et al., 2010). Taken together, 52 (93%) of 56 of the individuals who became ill in these two outbreaks were 

infants (Koch et al., 2005; Ilic et al., 2010). In both investigations, contamination of the multicomponent tea 

was traced to a single contaminated spice ingredient: aniseed (Pimpinella anisum) in the Salmonella Agona 

outbreak in Germany (Koch et al., 2005; Rabsch et al., 2005) and fennel seed (Foeniculum vulgare) in the 

Salmonella Senftenberg outbreak in Serbia (Ilic et al., 2010). Epidemiological investigations revealed that in 

some cases, boiling water was not used (Koch et al., 2005) or was probably not used (Ilic et al., 2010) to 

prepare the tea infusions. Subsequent growth of surviving Salmonella cells in the cooled tea infusion may 

have also contributed to the number of cases of illness observed (Koch et al., 2005). The outbreak 

investigations did not reveal where in the supply chain tea contamination took place but both identified 

weaknesses in supplier control, i.e., the use of unregistered producers (fennel seed; Ilic et al., 2010) and the 

reported use of manure as fertilizer in seed production (anise seed, reported by the spice importer; Koch et 

al., 2005).

2.4 PUBLIC HEALTH BURDEN

Although an estimated 1946 human illnesses were identified in the fourteen outbreaks reported above, the 

actual health burden is likely much larger due to underreporting and challenges in foodborne disease 

surveillance and outbreak response. In the United States, the CDC estimates that 1.0 million people in the 

United States become ill from Salmonella-contaminated food consumed each year (Scallan et al., 2011; CDC, 

2011). This estimated value includes a correction for underreporting derived from data obtained from 

several surveillance/reporting systems (Scallan et al., 2011). Applying the CDC underreporting multiplier for 

Salmonella (29.3; Scallan et al., 2011), the public health burden of the three spice-associated outbreaks in the 

United States is roughly estimated at ~13,400 human illnesses. 

Many countries do not have the ability to track foodborne illness and for those countries that do track 

foodborne illness, the reporting structure/information may be insufficient to attribute outbreaks to spices. 

For example, until recently, European Union member country reports of outbreaks attributed to spices were 

reported together with outbreaks attributed to fresh herbs (see for example EFSA, 2009a) and the additional 

information reported did not always allow distinction between fresh and dry. In the United States, reporting 

to PulseNet is limited to selected pathogens, which makes detection of geographically dispersed outbreaks of 

other pathogens, such as Bacillus spp., more difficult. Even when a spice is suspected as being the 

contamination source, it cannot or is not always confirmed. For example, our research identified seven 

additional outbreaks attributed to consumption of contaminated spice (4 Salmonella illness outbreaks, 2 

Bacillus cereus illness outbreaks, 1 Clostridium perfringens outbreak) (Millet and Staff, 1999; Little et al., 2003; 

Little, 2012; Health Protection Agency, 2011; EFSA, 2013), but which did not meet our inclusion criteria 
Foodborne Illness Outbreaks from Microbial Contaminants in Spices, 1973-2010 | 2

FDA Draft Risk Profile | 20

(lacking microbiological or epidemiological evidence specified in Section 2: Materials and Methods). As a 

result, the number of world-wide outbreaks associated with consumption of pathogen-contaminated spice is 

likely underreported. 

Ingredient-related outbreaks are especially challenging to investigate because of the many possible foods that 

could be involved and the potentially complex supply chains associated with each ingredient. In addition, 

consumers of contaminated food may not be aware of all ingredients in the food, especially minor ingredients 

such spices. As a result, it is possible that more spice-associated outbreaks occurred within the United States 

or in other countries that reported one or more spice- associated outbreaks. According to the CDC, only 43% 

of reported foodborne disease outbreaks in the United States in 2009-10 had a food reported (CDC, 2013a). 

The long shelf-life of spices and the ability of pathogens to persist in spice for long periods (demonstrated for 

Salmonella) also create challenges for outbreak identification because illnesses from consumption of 

contaminated spice may be separated by time and space. 

2.5 RELATED OUTBREAKS – SPICE INGREDIENTS USED IN NON-SPICE 

CAPACITIES

At least five outbreaks associated with spice ingredients that are used in non-spice capacities took place 

during the study period. Three Salmonella outbreaks associated with tahini (Unicomb et al., 2005) and one 

Salmonella outbreak linked to helva (Andersson et al., 2001; Fisher et al., 2001; Little, 2001; Brockmann, 

2001; Guérin et al., 2001) were identified during the literature review. Both of these products are made 

predominantly of sesame seeds (Sesamum spp.). Together these outbreaks were responsible for at least 128 

illnesses in six countries (Unicomb et al., 2005; Andersson et al., 2001; Fisher et al., 2001; Little, 2001; 

Brockmann 2001; Guérin et al., 2001). Some spice seeds, such as fennel (Foeniculum vulgare) and mustard 

(Brassica spp.), are also used to produce sprouts for human consumption. Numerous sprout-associated 

outbreaks have occurred, and many of these outbreaks have been traced to bacterial contamination of the 

seed (EFSA, 2011b) amplified during the sprout production process. One B. cereus illness outbreak associated 

with sprout consumption took place in the United States in 1973 and was traced to contamination of the seed 

mixture, which included soy, cress and mustard (Portnoy et al., 1976). The large-scale 2011 outbreak of 

Shiga-toxin producing Escherichia coli serotype O104:H4 in Germany and France, while not in the temporal 

scope of this review, was also attributed to sprout consumption and traced to contaminated fenugreek seeds 

(Trigonella foenum-graecum), although the bacterium was never isolated from the seeds (EFSA, 2011c). 

These outbreaks highlight the fact that some spices have multiple applications in food production and can 

carry a risk of foodborne illness in these other applications. Application of mitigation and control strategies to 

the production, storage and handling of spices could also reduce the risk of illness from these foods.

2.6 GENERAL OBSERVATIONS REGARDING FOODBORNE ILLNESS OUTBREAKS 

ATTRIBUTED TO MICROBIAL CONTAMINANTS IN SPICES

Our review identified fourteen foodborne illness outbreaks attributed to consumption of pathogencontaminated spices between 1973 and 2010. These outbreaks demonstrate that consumption of pathogencontaminated spices can result in human illnesses and that the illnesses that arise can be severe enough to 

necessitate hospitalization and, occasionally, result in death. The review also demonstrates that outbreaks 

attributed to consumption of contaminated spice can involve large numbers of illnesses. Individuals of all 

ages can be affected, including infants and young children, who comprised the majority of cases of illness in 

five outbreaks and were the apparent target consumer of some of the contaminated foods consumed 

(Lehmacher et al., 1995; Koch et al., 2005; Ilic et al., 2010; Sotir et al., 2009; EFSA, 2009a). Within our review, 

Salmonella enterica subspecies enterica and Bacillus spp. were the most common bacterial pathogens linked 

to spice-associated outbreaks. A single spice vehicle can be contaminated with multiple Salmonella serotypes 

or Bacillus species, resulting in multi-serotype/species outbreaks. As evidenced by the 1993 paprika 
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FDA Draft Risk Profile | 21

(Capsicum annum)-associated outbreak (Lehmacher et al., 1995) and documented by other studies (Keller et 

al., 2013; Podolak et al., 2010 and references therein) Salmonella can survive in dried spices and other low 

moisture foods for prolonged periods. Enumeration data collected during three outbreak investigations found 

low concentrations of contamination, indicating that low concentrations of contamination in spices can cause 

human illness (Gustavsen and Breen, 1984; Lehmacher et al., 1995; Koch et al., 2005). The Salmonella

Wandsworth outbreak (Sotir et al., 2009) illustrated that dried vegetable powders used in seasoning blends 

may carry the risk of illness if contaminated. 

Consumption of ready-to-eat foods prepared with spices applied after the final food manufacturing pathogen 

reduction step accounted for at least 70% of the illnesses (CDC, 2010; Sotir et al., 2009; Lehmacher et al., 

1995). In three out of four outbreaks for which spice process treatment information was recorded, it was 

found that no pathogen reduction treatment had been applied to the spice (Rabsch et al., 2005; Sotir et al., 

2009; Myers and Higa, 2011). Pathogen growth in spiced food was suspected to have played a role in some 

outbreaks but it was probably not a contributing factor in three of the larger Salmonella illness outbreaks, 

which involved low-moisture foods (CDC, 2010; Sotir et al., 2009; Lehmacher et al., 1995) that do not support 

microbial growth when maintained at a low water activity. 

The root cause of spice contamination was not determined in most of the outbreaks. In four outbreaks, the 

outbreak strain was isolated from unopened packages of the spice ingredient in the food manufacturing 

facility, which supports the hypothesis that contamination of the spice took place at an early stage in the 

farm-to-table continuum (e.g., during production, early processing, or packing/storage before import) 

(Laidley et al., 1974; Gustavsen and Breen, 1984; CDC, 2010). In two outbreaks, evidence supported possible 

contributions from cross-contamination in later stages of the farm-to-table continuum (e.g., post-import spice 

processing or food manufacturing environments) (Hajmeer and Myers, 2011; Lienau et al., 2011; Allard et al., 

2012). Most investigations did not report whether the spice had been subjected to a pathogen reduction 

treatment before receipt by the spice/food manufacturer/retail user and did not enumerate the pathogen in 

the spice ingredient and food. Gathering this information in future outbreak investigations, could help 

investigators determine which of the possible routes of contamination were involved. 
FDA Draft Risk Profile | 22 

3. TYPES OF PATHOGEN AND FILTH CONTAMINATION FOUND IN 

SPICES

3.1 MICROBIAL PATHOGENS FOUND IN SPICES

3.1.1 TYPES OF MICROBIAL PATHOGENS FOUND IN SPICES

In order to determine the types of microbial pathogens found in spices, we reviewed the refereed scientific 

literature and available government/agency reports using Web of Science, Google Scholar, and PubMed to 

search the English-language literature using different combinations of the following keywords: 

microbiological, microbial, quality, survey, outbreak, foodborne, spice, seasoning, herb, pathogen, Bacillus, 

bovis, Campylobacter, Clostridium, Cronobacter, Escherichia coli, E. coli, O157, 0104, Mycobacterium bovis, 

Mycobacterium tuberculosis, norovirus, Salmonella, sakazakii, Shigella, and Staphylococcus aureus. We 

reviewed paper citations and references contained in the articles identified in our search. The literature 

review examined publications and reports published between January 1, 1985 and July 1, 2012.

We also reviewed the CDC PulseNet database for information about the types of spices in which Salmonella

has been detected and evidence that other pathogens had been detected in spices.1 The review for pepper and 

pepper-type spices (entries including the words “pepper”, “chili”, or “cayenne” and, for the capsicums, clearly 

indicated as a dry product) included information on isolates uploaded to PulseNet during the period Sept 

2001-February 2010 while the review for non-pepper spices included information on isolates uploaded 

between January 2001 and June 2010. Bacteria isolated from food products tested as part of routine food 

safety surveillance and compliance programs as well as foodborne outbreak investigations in the United 

States are normally submitted to PulseNet. Finally, we also reviewed the FDA “Field Accomlishments and 

Compliance Tracking System” (FACTS)2 database for the years 2006-2010, to identify spices not captured in 

the PulseNet review. 

A diversity of microorganisms has been detected in spices. Table 3.1 lists the microbial pathogens detected in 

spices as reported in the scientific literature, the CDC PulseNet database or the FDA FACTS database during 

the review periods described above. A few studies examined selected spices for Escherichia coli O157:H7 

(Singh et al., 2007; Beki 2008; Kahraman and Ozmen, 2009); none was found. Investigations of the 2011 

Shiga-toxin producing Escherichia coli O104 illness outbreak in Europe that was attributed to contaminated 

fenugreek seeds (used in sprout production) were unsuccessful in detecting the outbreak strain in seeds from 

the same source (EFSA, 2011c). Investigations of the Clostridium botulinum outbreak in Japan in 1984 

involving consumption of fried lotus rhizome solid mustard did not isolate the organism from any of the 11 

kinds of mustard samples examined (Otofuji et al., 1987). The report of Listeria monocytogenes identified in 

bay leaves (Vij et al., 2006) was later clarified as a contaminant in fresh bay leaves rather than dried bay 

leaves (Hogan, 2011). 

 

1 PulseNet is a national network of public health and food regulatory agency laboratories in the United States coordinated 

by the CDC. The network consists of state health departments, local health departments, and federal agencies (CDC, 

USDA/FSIS, FDA). PulseNet participants perform standardized molecular subtyping (or “fingerprinting”) of foodborne 

disease-causing bacteria by pulsed-field gel electrophoresis (PFGE). PFGE can be used to distinguish strains of organisms 

such as Salmonella. DNA “fingerprints,” or patterns, are submitted electronically to a dynamic database at the CDC. The 

PFGE data are stored in the CDC PulseNet database.

2 FACTS is an FDA database that includes results of experimental food or environmental sampling tests performed by 

FDA.
Types of Pathogen and Filth Contamination Found in Spices | 3

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Table 3.1. Microbial pathogens detected in spices, 1985-2012: Review of the scientific literature and 

the CDC PulseNet and FDA FACTS databasesa

Microbial Pathogens Spiceb Reference

Salmonella spp.

ajowan, alfalfa seeds, allspice, anise seed, 

asafetida, basil, bay, black pepper, capsicum 

(hot and sweet), cardamom, cayenne, celery 

seed, cinnamon, coriander, cumin, curry leaf, 

fennel, fenugreek leaves and seeds, fingerroot, 

garlic, ginger, nigella, London rocket, mace, 

mint, mustard seed, nutmeg, oregano, parsley, 

sage, thyme, sumac, sesame seeds, turmeric, 

white pepper, spice mixes/seasonings (e.g., 

curry, five spice, garam masala)

Arias et al., 1997; Banerjee and Sarkar, 2003; 

CDC-PulseNetc; DOH/Victoria/AU, 2010; FSAI, 

2004; Gustavsen and Breen, 1984; FDAFACTSd; Hampikyan et al., 2009; Hara-Kudo et 

al,. 2006; Higa, 2011; Kaul and Taneja, 1989; 

Kneifel and Berger 1994; Koch et al. 2005; 

Moreira et al. 2009; Sagoo et al. 2009; Satchell 

et al. 1989; Singh et al. 2007; Shamsuddeen, 

2009; Stewart et al. 2001; Vij et al. 2006

Bacillus spp. 

(including B. cereus) 

ajowan, alligator pepper, allspice, asafetida, 

basil, bay leaf, black pepper, capsicum (hot 

and sweet), caraway, cardamom, celery seed, 

chervil, chives, cinnamon, cumin, cloves, 

coriander, cumin, dill, fennel seeds, fenugreek, 

fennel, garlic, ginger, nutmeg, mace, 

marjoram, mustard seed, nutmeg, onion, 

oregano, unspecified pepper, poppy seed, 

rosemary, saffron, thyme, turmeric, white 

pepper, spice mixes/seasonings 

Antai, 1988; DOH/Victoria/AU, 2010; 

Banerjee and Sarkar, 2003; Brown and Jiang, 

2008; Cosano et al., 2009; FSAI, 2004; Garcia 

et al., 2001; Hampikyan et al., 2009; Kahraman 

and Ozmen, 2009; Kneifel and Berger, 1994; 

Kovács-Domján 1988; Little et al., 2003; 

Moreira et al., 2009; Pafumi, 1986; Sagoo et 

al., 2009; Witkowska et al., 2011

Clostridium 

perfringens

ajowan, anise seed, bay leaf, black cumin, 

black pepper, capsicum (hot and sweet), 

caraway, chives, cinnamon, clove, coriander, 

cumin, ginger, fenugreek, garlic, ginger, mace, 

mustard seed, nutmeg, onion, oregano, 

parsley, saffron, white pepper 

Aguilera et al., 2005; Banerjee and Sarkar, 

2003; Cosano et al., 2009; Pafumi, 1986; 

Rodriguez-Romo, 1998; Sagoo et al., 2009; 

Shamsuddeen, 2009

Cronobacter spp. anise seed, rosemary

Ahene et al., 2011; Baumgartner et al., 2009; 

Iverson and Forsythe (2004); Jaradat et al., 

2009; Turcovský et al., 2011

Shigella ajowan, bay leaf Banerjee and Sarkar, 2003

Staphylococcus 

aureus

asafoetida, black pepper, capsicum, 

cardamom, cinnamon, garlic, ginger, 

white pepper. 

Banerjee and Sarkar, 2003; Hampikyan et al.,

2009; Moreira et al., 2009; Kahraman and 

Ozmen, 2009; Shamsuddeen, 2009

a Literature reviewed period: January 1, 1985 through July 1, 2012. The CDC PulseNet database was reviewed between Sept. 2001 and 

February 2010 for pepper and pepper-type spices and reviewed between January 2001 and June 2010 for non-pepper spices uploaded to 

the CDC PulseNet database, supplemented by the FDA Salmonella isolate database reviewed during the period 2006-2010 for spices not 

captured in the CDC PulseNet database review for the period 2006-2010.

b Different forms of the same spice or spice mixture are generally not distinguished, e.g., dried coriander leaves and seeds, or masala 

spice mix for chicken and masala mix for beef. Capsicum may include both hot and sweet varieties such as cayenne, paprika, chili powder, 

and other dried whole or ground spices made from capsicum peppers. A single common name was selected for a spice in this table, which 

may differ from the name in the original reference, e.g., ajowan instead of bishop’s weed or omum.

c Salmonella isolates from (a) pepper and pepper-type spices (entries including the words “pepper”, “chili”, or “cayenne” and, for the 

capsicums, clearly indicated as a dry product) uploaded to the CDC PulseNet database between Sept. 2001 and February 2010 and (b) all 

other spices uploaded to the CDC PulseNet database between January 2001 and June 2010. 

d Salmonella isolates from spices sampled by FDA during 2006-2010, reported in the FDA FACTS database. 

As discussed in Chapter 2, only Salmonella and Bacillus spp. have been definitively linked to human illness 

outbreaks resulting from consumption of contaminated spices. Furthermore, Salmonella contamination of 

spices has been the leading cause for spice-associated recalls in the United States (1970-2003: Vij et al., 2006; 

2008-2009: Ma, 2013) and the leading hazard reported for spices and seasonings in the Reportable Food 

Registry in first three annual reports (Sept. 8, 2009 - Sept 7, 2012) (FDA, 2013a; FDA, 2012a; FDA, 2012b). 

Therefore, as dictated by the scope of the risk profile, the remainder of the risk profile focuses on Salmonella

contamination of spices and also addresses contamination by commonly occurring types of filth.
Types of Pathogen and Filth Contamination Found in Spices | 3

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3.1.2 SALMONELLA SEROTYPES IDENTIFIED IN SPICES

In order to probe the diversity of serotypes found in spices, we focused on Salmonella isolates from spices 

collected in the United States. Data was gathered from the CDC PulseNet database and the FDA FACTS 

database. Two separate analyses of the CDC PulseNet database were performed to identify bacterial 

pathogens isolated from pepper and non-pepper spices. The first analysis, completed in March 2010, 

evaluated Salmonella isolated from black pepper, white pepper, and/or capsicum, limiting the latter to dried 

chili or cayenne pepper. The second analysis was completed in July 2010, and reviewed bacterial pathogens 

isolated from all other spices. For this analysis, products that were labeled as a “spice” in the CDC PulseNet 

database were included in the spice analysis with the following exceptions: herbs also labeled “fresh”, black 

pepper, white pepper, chili/cayenne pepper capsicum, and products outside of the scope of the risk profile 

(e.g., tahini). Items not labeled as “spice” but which met the risk profile definition of “spice” were included in 

the analysis (e.g., paprika and sesame seeds) with the following exceptions: herbs labeled “fresh” or not 

labeled as dry, ground, powdered or otherwise indicated as low moisture. Additional serotypes were 

identified from the FDA FACTS database, examining years 2006-2010, including both surveillance and 

compliance product sampling. Data in the CDC PulseNet and FDA FACTS databases are collected from reports 

from a number of labs so they may contain errors unknown to the authors. All FDA data submitted to these 

databases, regardless of the lab in which the data was collected, were first reviewed by a supervisor for 

accuracy of analysis.

Table 3.2 lists the serotypes and the spices in which they were found. A wide diversity of Salmonella

serotypes were isolated from domestic or imported spices in the United States or in spice shipments offered 

for entry to the United States between 2001 and 2010. The serotype of some Salmonella isolates from spices 

was not determined, was pending or was not reported from these databases; these isolates were not included 

in Table 3.2. 

Table 3.2. Salmonella species and serotypes found in spices in the United States, 2001-2010.a

Serotypeb Spicec 

Abaetetuba basil, black pepper, capsicum, curry leaf

Aberdeen black pepper, coriander, curry powder, ginger

Adabraka coriander

Agona anise, black pepper, capsicum, cumin, curry powder, garam masala, mint, nutmeg, 

oregano, sesame seed

Alachua cumin

Altona capsicum

Amersfoort sesame seed

Amsterdam sesame seed

Anatum capsicum, coriander, cumin, fenugreek, sesame seed, spice mix

Augustenborg turmeric

Bahrenfeld cumin, London rocket 

Ball black pepper, sage

Bangkok curry, turmeric

Bardo black pepper

Bareilly capsicum, coriander, cumin, curry powder, fennel, ginger, garam masala, sesame seed, 

turmeric, spice/seasoning mix

Barranquilla capsicum, pepper

Bergen curry powder, sesame seed, spice mix 

Bere coriander, masala 

Bispebjerg oregano, sage

Blockley basil

Bonn sesame seed

Bovismorbificans capsicum
Types of Pathogen and Filth Contamination Found in Spices | 3

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Serotypeb Spicec 

Braenderup black pepper, turmeric 

Brandenburg black pepper, thyme

Brazzaville capsicum

Bredeney capsicum

Brindisi sage

Brooklyn sage

Canada black pepper

Caracas basil, cumin

Carmel coriander

Carrau oregano, sesame seed, paprika

Cerro capsicum, sesame seed, turmeric

Champaign capsicum, chili powder, fenugreek

Chandans masala mix, oregano

Chingola spice and seasonings

Claibornei coriander

Colindale cumin

Corvallis cumin

Cubana celery, coriander, cumin, sesame seed, garam masala

Derby black pepper, capsicum, five spice, sage

Djibouti coriander

Dublin curry

Eastbourne turmeric

Elokate black pepper

Enteritidis black pepper, capsicum, fenugreek, oregano, spice/seasoning mix

Everleigh sesame seed

Freetown capsicum, cumin, spice/seasoning mix

Fresno sesame seed

Gamaba cumin

Gaminara anise seed, capsicum, coriander, sesame seed

Give capsicum, oregano, sesame seed, turmeric

Glostrup Sage, sesame seed

Gozo capsicum

Grumpensis capsicum

Haifa basil

Havana anise seed, capsicum, coriander, masala, sesame seed 

Heidelberg black pepper, sesame seed

Hermannswerder sage

Hindmarsh capsicum

Hvittingfoss basil, black pepper, capsicum, coriander, fenugreek leaf, turmeric, sesame seed, white 

pepper

Idikan sesame seed, white pepper

Infantis capsicum, spice/seasoning mix

Inpraw turmeric powder

Istanbul capsicum

Javiana allspice, black pepper, cumin, sage, white pepper

Johannesburg ginger

Kentucky capsicum, cumin, mint, fennel, sesame seed, thyme

Kingabwa capsicum

Kottbus black pepper, white pepper

Kumasi black pepper

Lexington ginger

Liverpool oregano
Types of Pathogen and Filth Contamination Found in Spices | 3

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Serotypeb Spicec 

Livingstone cumin

Llandoff sesame seed

London coriander, fenugreek

Luke garam masala

Madelia oregano, white pepper

Magwa cumin

Martonos capsicum

Mbandaka black pepper, capsicum, cumin, curry powder, garlic, fennel seed, parsley, sesame 

seed, turmeric, spice/seasoning mix

Mgulani black pepper, capsicum, coriander, turmeric, spice/seasoning mix

Miami sage

Mikawasima laurel leaf

Milwaukee capsicum

Minnesota basil, sesame seed

Molade capsicum

Montevideo arnica, black pepper, capsicum, coriander, cumin, mint, oregano, nutmeg, sesame 

seed, thyme, spice/seasoning mix

Muenchen capsicum, cumin, thyme

Muenster spice/seasoning mix

Nchanga cumin

Newport allspice, black pepper, capsicum, cardamom, coriander, cumin, curry powder, nutmeg, 

oregano, sesame seed, turmeric, spice/seasoning mix 

Nordrhein capsicum

Nottingham capsicum, oregano

Onarimon cumin

Onderstepoort cumin, rosemary

Oranienburg capsicum, coriander, oregano, sage

Orion anise seed, curry powder

Oslo black pepper

Othmarschen sage

Panama capsicum

Paratyphi B turmeric, sage, spice mix

Paratyphi B var. L(+) tartrate + black pepper, capsicum, coriander, mint, turmeric, spice mix

Pomona turmeric

Poona black pepper, capsicum, celery, coriander, turmeric, sesame seed, spice/seasoning 

mix

Potsdam cumin, sesame seed

Reading cumin 

Richmond capsicum, coriander, fenugreek, masala, rosemaryd, sesame seed, spice/seasoning mix

Rissen black pepper, capsicum, white pepper

Rubislaw black pepper, caraway seed, sesame seed, white pepper, spice/seasoning mix 

Saintpaul coriander, cumin, ginger, mustard, sesame seed, spice/seasoning mix

Salford cumin, sage

Sandiego black pepper, capsicum, cardamom, coriander, cumin

Saugus capsicum

Schleissheim sesame seeds, thyme, turmeric

Schwarzengrund capsicum, sesame seed, turmeric, spice/seasoning mix

Senftenberg black pepper, capsicum, celery seed, coriander, cumin, curry powder, garam masala

nutmeg, sesame seed, thyme 

Simi sage

Singapore capsicum

Stanley black pepper, capsicum, cumin, white pepper
Types of Pathogen and Filth Contamination Found in Spices | 3

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Serotypeb Spicec 

Stormont curry powder

Sundsvall capsicum, chili powder

Tallahassee masala

Teddington annatto seed

Telaviv cumin, laurel leaf, mint, sage

Telelkebir cumin

Telhashomer fenugreek leaf, spice/seasoning mix 

Tennessee capsicum, celery, sesame seed, spice/seasoning mix

Thompson capsicum, curry powder, spice/seasoning mix

Treforest capsicum

Tucson capsicum

Typhimurium basil, black pepper, capsicum, coriander, curry powder, dill weed, fenugreek, five 

spice, ginger, masala, mint, oregano, rosemary, saffron, sage, sesame seed

Umbilo five spice, garam masala

Urbana black pepper

Vejle black pepper

Virchow basil, black pepper, turmeric, coriander, spice/seasoning mix

Wandsworthd broccoli powderd

Warragul sage

Weltevreden anise, basil, bay, black pepper, capsicum, coriander, cumin, curry powder, mace, 

masala, nigella, onion, sesame seed, turmeric, white pepper, spice/seasoning mix 

Westhampton capsicum

Westminster cumin, sesame seed

Wichita spice/seasoning mix

I 3,15,34:d:- sesame seed

II 40:z4,z24:- oregano

II 40:z4,z24:z39 anise seed, oregano

II 48:d:z6 cinnamon

IIIa 48:z4,z24:- sesame seed

IIIb 60:r:e,n,x,z15 capsicum, cumin

IV 43:z4,z23:- fingerroot

VI 6,14:a:1,5 spice mix

a Salmonella isolates from (a) black pepper, white pepper, and chili/cayenne pepper capsicums uploaded to the CDC PulseNet database 

between Sept. 2001 and February 2010 (b) all other spices uploaded to the CDC PulseNet database between January 2001 and June 2010 

and (c) additional isolates from spices sampled by FDA during 2006-2010 in the FDA FACTS database. Data in the CDC PulseNet and FDA

FACTS databases are collected from reports from a number of labs so they may contain errors unknown to the authors.

b Salmonella enterica subspecies enterica (I) unless noted otherwise

c Different forms of the same spice or spice mixture are generally not distinguished, e.g., dried coriander leaves and seeds, or masala spice 

mix for chicken and masala mix for beef. Capsicum may include both hot and sweet varieties such as cayenne, paprika, chili powder, and 

other dried whole or ground spices made from capsicum peppers. A single common name was selected for a spice, which may differ from 

the name in the original reference, e.g., ajowan instead of bishop’s weed or omum.

d Broccoli powder was the contaminated ingredient in the seasoning mix implicated in the S. Wandsworth outbreak (Sotir et al., 2009; 

see also Chapter 2 and Table 2.1).

Investigations of the microbiological quality of spices produced and examined outside of the United States 

have reported some of the same serotypes reported in Table 3.2 but also have identified additional serotypes 

isolated from spices. For example, Sagoo et al. (2009) identified four additional serotypes associated with 

spices (Aequatoria, Edinburg, Friedenau, and Hato) and isolated 13 of the serotypes listed in Table 3.2. These 

studies demonstrate that a wide variety of spices can become contaminated with a wide variety of Salmonella

serotypes. We were unable to identify any data to support the hypothesis that spice contamination is limited 

to a subset of Salmonella serotypes. Frequency data for individual serotypes (e.g., numbers of isolates 

reported) derived from the CDC PulseNet or FDA FACTS databases are not reported because these data 

cannot be easily interpreted, e.g., serotypes associated with a large outbreak are likely to have multiple 

entries arising from sampling during the outbreak investigation and therefore provide no information on 
Types of Pathogen and Filth Contamination Found in Spices | 3

FDA Draft Risk Profile | 28

relative prevalence in the spice supply (percentage of the contaminated spice supply containing a particular 

serotype). Salmonella prevalence in spices (percentage of the spice supply contaminated with Salmonella), 

including relative prevalence by serotype and antimicrobial resistance, was estimated for shipments of 

imported spice offered for entry to the United States during FY2007-FY2009 and is discussed in Chapter 4. 

3.2 FILTH ADULTERANTS FOUND IN SPICES

A finding of filth adulteration of spice can arise from the presence of avoidable defects in spice or excessive 

concentrations of natural or unavoidable defects in spice. Avoidable defects in spice are extraneous materials, 

defined by FDA as “any foreign matter in a product associated with objectionable conditions or practices in 

production, storage, or distribution” and includes “objectionable matter contributed by insects, rodents, and 

birds; decomposed material; and miscellaneous matter such as sand, soil, glass, rust, or other foreign 

substances” (FDA, 2012g). Spice adulterated with avoidable filth can result in a food being deemed 

“adulterated” under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) , which 

prohibits “any poisonous or deleterious substance that may render it injurious to health,” or section 

402(a)(4) of the FD&C Act, which prohibits foods “prepared, packed or held under insanitary conditions 

whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to 

health.” The concentration of avoidable filth elements that constitute filth adulteration depends on the nature 

of the adulterant and is determined on a case-by-case basis. 

FDA regulations at 21 CFR 110.110 (FDA, 2012h) address how FDA establishes maximum concentrations of 

natural or unavoidable defects in foods for human use that present no health hazard. FDA established Food 

Defect Action Levels (DALs) which define the maximum “levels” (concentrations) of specific elements of filth 

in specific foods (FDA, 2013g). FDA based DALs on an extensive survey of retail foods including spices in the 

1980s and set values to reflect significant deviation from the best practices of industry and agriculture at that 

time. The spices for which a DAL has been established are given in Table 3.3. Not all spices have DALs nor 

have DALs been established for all possible adulterants in a spice. If no DAL has been established for a filth

Table 3.3. Spices for which filth Food Defect Action Level(s) has/have been established in the United 

States

Spice Ground Whole

Allspice x x

Bay (Laurel) Leaves x

Capsicum x x

Paprika x

Cinnamon or Cassia x x

Cloves x

Condimental seeds x

Cumin seed x

Curry Powder x

Fennel seed x

Ginger x

Hops x

Mace x

Marjoram x x

Nutmeg x x

Oregano x x

Pepper (black or white) x x

Sage x x

Sesame seeds x

Spices, leafy x

Thyme x x
Types of Pathogen and Filth Contamination Found in Spices | 3

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element in a spice then FDA will review the analytical results of filth in that shipment on a case-by-case basis 

taking into account the types of filth elements found, concentration of the filth element in the sample, and the

risk to public health to determine whether it violates the FD&C Act. Spice with excessive concentrations of 

natural or unavoidable defects violate section 402(a)(3) of the FD&C Act, “consisting in whole or in part of 

any filthy, putrid, or decomposed substance or is otherwise unfit for food” (FDA, 2012h).

In order to determine the types of filth adulterants found in spices, we reviewed FDA sampling data (reported 

in the FDA FACTS database) for shipments of imported spice offered for entry to the United States during the 

three year period FY2007-FY2009. Table 3.4 lists the various filth adulterants that were isolated from spices 

as part of FDA surveillance sampling of spice shipments offered for U.S. entry, FY2007- FY2009. Almost all of 

the insects that were found in these shipments were stored product pests, which indicate that the spice was 

prepared, packed, or held under insanitary conditions whereby it became contaminated. Among the insects 

isolated from the spices is Monomorium pharaonsis (L.), Pharaoh ant, a known carrier of L. monocytogenes

(Olsen et al., 2001). The presence of rodent hair or hair fragments without a hair root is generally indicative 

of fecal contamination of spice (Vazquez, 1977) because when grooming, rodents ingest hair and hair 

fragments, which are excreted in their feces. Other adulterants may result from improper cleaning of the 

spices (e.g. staples, sticks, stones) or improper storage (e.g. bird feathers or barbs, animal or insect excreta). 

Table 3.4. Types of filth adulterants found in spices: Surveillance sampling of spice shipments offered 

for U.S. entry, FY2007-FY2009.

Insect

Scientific Name

Insect

Common Name Hair Other

Acarus siro L. grain mite Human hair Animal

Ahasverus advena (Waltl) foreign grain beetle Bat Animal Fecal Material

Ahasverus rectus (LeConte) Cat Animal Hair

Araecerus fasciculatus (De Geer) coffee bean weevil Cow Insect Excreta

Cadra cautella almond moth Dog Bird Barbs

Cheyletus eruditus (Schrank) Mammalian Bird Barbules

Cryptolestes ferrugineus (Stephens) rusty grain beetle mouse/rat Bird Excreta

Cryptolestes pusillus (Schonherr) flat grain beetle other Bird Feathers

Dienerella costulata (Reitter) Rabbit Rancid

Enicmus consimilis Mannerheim Rat Moldy

Eurytoma tylodermatis Ashmead Rodent Dirt

Hippodamia convergens (Guerin) convergent lady beetle non-striated Fiber, Synthetic

Laccifer lacca (Kern) Sheep Paper

Lasioderma serricorne (F.) cigarette beetle Striated Plastic

Lophocateres pusillus (Klug) Siamese grain beetle Rubber Band

Monomorium pharaonis (L.) Pharaoh ant Seed

Oryzaephilus mercator (Fauvel) merchant grain beetle Staple

Oryzaephilus surinamensis (L.) Saw-toothed grain 

beetle Stick

Plodia interpunctella (Hubner) Indian meal moth Stone

Rhyzopertha dominica (F.) lesser grain borer Twig

Sitophilus granarius (L.) granary weevil Wood Sliver

Stegobium paniceum (L.) drugstore beetle

Tribolium castaneum (Herbst) red flour beetle

Typhaea stercorea (L.) hairy fungus beetle
FDA Draft Risk Profile | 30 

4. PREVALENCE AND CONCENTRATION OF SALMONELLA AND 

FILTH IN SPICES

We reviewed the scientific literature and available government/agency reports for surveillance studies that 

reported measurements of prevalence and/or concentration of Salmonella and filth in spices at any point 

along the farm-to-table continuum. We also researched Salmonella concentrations found in spice samples 

associated with foodborne outbreaks as well as antimicrobial resistance found in Salmonella strains that have 

been isolated from spices. Our literature review primarily used PubMed, Google, and Google Scholar to search 

the English-language literature using different combinations of the following keywords: Salmonella, filth, 

prevalence, level, enumeration, spice, herb, microbiological, quality, bacteriological, quality, evaluation, 

safety, profile, antimicrobial, activity, resistance, property, properties, drug, resistant, resistance. We also 

reviewed citations and references contained in the articles identified in our internet searches on this topic 

and other references collected during our work on this report (e.g., foodborne outbreaks, Chapter 2). 

In addition to the literature search, we analyzed FDA surveillance sampling data for Salmonella and filth in 

imported spice shipments offered for import over a three year period, FY2007-FY2009. Full details of the 

sampling protocols and inclusion criteria are provided in Van Doren et al. (2013a). FDA undertook a targeted 

sampling assignment to gather information on typical concentrations of Salmonella. Under this assignment, 

FDA analyzed samples of capsicum and sesame seeds from shipments offered for import to the United States 

during a five month period in 2010 for Salmonella. Full details of the study design, Salmonella prevalence and 

concentration results, and data analysis are provided in Van Doren et al. (2013c). The 2010 study also 

examined shipments for the presence of filth and these results are compared with the FY2007-FY2009 study 

results in Section 4.2.3. Finally, we analyzed FDA surveillance data over a ten year period (FY2000-FY2009) 

to explore the potential correlation between presence of Salmonella and filth in imported spice shipments. 

Details of the U.S. study are provided in Section 4.3. 

FDA requested scientific data and information from the spice industry and other stakeholders through a

Federal Register Notice announcing the risk profile project, identifying data gaps, and requesting comments 

and scientific data and information to help fill the data gaps (FDA, 2010e). In response to this request, the 

American Spice Trade Association submitted spice sampling data collected in ASTA member spice processing 

facilities over a two year period by some of its members (ASTA, 2010; Ruckert, 2010). These data are 

discussed in Section 4.1.4.

The discussion that follows summarizes data available from studies around the world on the prevalence and 

concentration of Salmonella and/or filth in spices. Comparison of prevalence values in different studies is

complicated by the fact that each study may have examined a different amount of spice, which generally leads 

to a different limit of detection. For this reason, we report the mass examined whenever reporting prevalence 

values, e.g., 6.6 % (750 g; 95% CI 5.7-7.6%). Where possible, we report the 95% confidence intervals (95% 

CI) for the prevalence values as shown in the previous example. Different studies may have employed 

different methods of analysis, which can lead to differences in test sensitivities or selectivities. We assume 

that methods employed in the reported peer-reviewed and government studies have been validated and that 

results among studies are comparable. Interpretation of differences in prevalence or concentration values 

across studies should consider context (because the spice examined in each study is different), which we 

provide in our discussion.
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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4.1 SALMONELLA 

4.1.1 SALMONELLA PREVALENCE AND CONCENTRATION IN SPICE: FROM FARM TO 

TABLE OVERVIEW

Limited data are available from the scientific literature on the prevalence of pathogens in spices at different 

points in the farm-to-table continuum. Information provided by studies published during the period 2000-

2012 is summarized in Table 4.1. All of the values listed in Table 4.1 are from surveillance studies and most 

samples were collected from retail establishments. It is likely that a majority of spices examined in Australia, 

Belgium, Czech Republic, Federal Republic of Yugoslavia, Germany, Hungary, Ireland, Japan, the Netherlands, 

Slovakia, Slovenia, and the United Kingdom in these studies were imported because these countries are not 

major producers of the spices examined. All spices examined in the U.S. study described in Table 4.1 were 

imported. Nineteen studies examined samples exclusively from retail; the observed Salmonella-prevalence in 

spices in these studies ranged from 0 to 10% (3-135 g; 95% CI 0-40%). Two studies examined samples of 

spices exclusively from spice processing/packing facilities; these reported Salmonella prevalence values 

ranging from 0 to 1% (25-135 g; 95% CI 0 – 10%). Two studies examined spices exclusively from the point of 

import, finding prevalence values of 0.5-6.6% (25-750 g; 95% CI cannot be calculated for one study). Two 

studies examined “non-irradiated spices”, which we presume to mean spice that had not been subjected to a 

pathogen reduction treatment, and reported prevalence values ranging from 3 to 10% (25 g; 95% CI 0.3-

30%). 

A majority of the studies summarized in Table 4.1 reported observed Salmonella prevalence values in the 

range of zero to one percent, regardless of setting, and many of the reported prevalence values reported are 

statistically smaller than the value determined in the U.S. study (Fisher exact test, p < 0.05). Because the 

screening test protocols used in all of the non-U.S. studies examined a smaller mass of spice than that used in 

the U.S. study, it is likely that at least some of the observed differences between the smaller Salmonella

prevalence values reported in tests conducted outside the United States versus tests conducted in the United 

States arise from different limits of detection. The smaller prevalence values reported in the different 

countries and settings may also reflect real differences in prevalence either arising from a difference in the 

microbiological quality of the spices examined or differences resulting from the application of one or more 

processes intended to reduce the microbial load. Pathogen reduction treatments such as ethylene oxide, 

steam treatment or irradiation are commonly applied to spices to reduce the risk of microbial contamination 

(ASTA, 2011; see Section 8.2.1 a discussion of pathogen reduction treatments). Some insight into this latter 

hypothesis is provided in Section 4.1.3, where the prevalence of Salmonella contamination in spice shipments 

offered for import to the United States are compared on the basis of applied processes, and in Section 4.1.4, 

where the prevalence of Salmonella in spice lots examined post-pathogen reduction treatment is compared 

with the value for spice lots pre-treatment. Salmonella prevalence in retail spice samples in the United States 

is unknown. 

Neither FDA nor the spice industry collects enumeration data on a regular basis because the regulatory 

standard is absence of Salmonella. Table 4.2 summarizes Salmonella concentrations measured in spices and 

products associated with salmonellosis outbreaks attributed to contaminated spices or determined in 

surveillance studies. While the outbreaks associated with alfalfa seeds were attributed to consumption of 

alfalfa sprouts, the enumeration data are included in this table because the concentrations were determined 

in the dry seeds and alfalfa seeds can be consumed as spices. 

Salmonella concentrations ranging from 0.0007 to 11 MPN/g-spice (7 MPN per 10,000 g to 11 MPN per g) 

have been reported as shown in Table 4.2. Most of the Salmonella concentrations determined for spices in 

surveillance and outbreak investigations in other countries reported in Table 4.2 are in the same range as the 

values for capsicums and sesame seeds determined in the 2010 U.S. surveillance study (Van Doren, et al., 
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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2013c) but the largest values, reported for samples of spice gathered during the paprika- and black pepperattributed outbreaks listed in Table 4.2 (Lehmacher et al., 1995; Gustavsen and Breen, 1984), are at least one 

order of magnitude larger than the largest values observed in surveillance studies. It should be noted that the 

concentrations of Salmonella in spice samples analyzed in surveillance and outbreak investigations may not 

necessarily reflect actual concentrations in food at the time of consumption.

Surveillance data on the prevalence and concentrations of Salmonella in shipments of imported capsicum or 

sesame seed shipments were gathered by FDA in 2010. These data were used to develop a descriptive model 

of contamination prevalence and concentrations between-and within- imported shipments of capsicum or 

sesame seed offered for entry to the United States and are discussed in Section 4.1.3. The study found 

shipment mean concentrations of Salmonella in contaminated capsicum or sesame seed shipments vary 

widely between shipments and that many contaminated shipments contain low concentrations of 

contaminating organisms (Van Doren et al., 2013c). 

The Salmonella concentrations reported in spices, Table 4.2, are small but not atypical of concentrations 

reported in other foods associated with foodborne salmonellosis (WHO/FAO, 2002). However, in contrast 

with many other types of foods, spices are consumed in very small amounts during a single eating occasion 

(Section 7.2.2) so the Salmonella dose expected from consumption of spice during a single eating occasion is 

expected to be smaller than that for other foods with similar concentrations of contamination but consumed 

in larger quantities. 
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Table 4.1. Summary of scientific surveillance studies measuring the prevalence of Salmonella in spices, 2000-2012

Countrya

Sample 

Collection 

Point

Sample 

Size (g)b N Prevalence (%) 95% CIc Spices sampledd Spices containing Salmonellae Reference

Australia Retail 125f 217 0 0-1 

caraway, chili, cloves, coriander, 

cumin, fennel, fenugreek, ginger, 

mustard, nutmeg, sumac, turmeric, 

Chinese five spice mix, garam masala, 

other spice mixes

none DOH/Victoria/AU, 

2010

Australia Import 25 not 

reported 0.5; 4.9g peppercorn; paprika peppercorn; paprika DOH/Victoria/AU, 2010; FSANZ, 2001

Belgium Processing plant 25 22 0 0-10 not reported none EFSA, 2006a

Brazil Retail 25 233 5.6 3.0-9.4

bay, basil, black pepper, cinnamon, 

clove, cumin, dehydrated green onion, 

oregano, parsley

black pepper, cumin Moreira, et al. 2009

Czech 

Republic

Retail/

Production 

Plants

25 74 3 0.3-9 non-irradiated spice not reported EFSA, 2006a

Egypt Retail 25 297h 0 0-1 

geranium, basil, marjoram, 

peppermint, spearmint, jews mallow, 

dill, celery, parsley, cumin, caraway, 

anise, fennel, coriander, dill, black 

pepper, chamomile, karkade, saffron

 none Abou Donia, 2008

Estonia Retail 25 20 0 0-10 not reported none EFSA, 2006a

Federal 

Republic of 

Yugoslaviai

Retail 25 101 0 0-3 

bay, basil, black pepper, capsicum, 

caraway, cinnamon, clove, coriander, 

curry, dill, ginger, mustard, nutmeg, 

oregano, rosemary, sesame, thyme, 

white pepper

none Stankovic et al., 2006

Germany Retail 25 16 10 2-40 sesame seed sesame seed Brockmann et al., 

2004

Hungary not reported 25 198 1 0.1-4 not reported not reported EFSA, 2010a

Hungary not reported 25 267 0.4 0.009-2 not reported not reported EFSA, 2009b
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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Countrya

Sample 

Collection 

Point

Sample 

Size (g)b N Prevalence (%) 95% CIc Spices sampledd Spices containing Salmonellae Reference

India Retail 25 154 1 0.2-5 

allspice, aniseed, asafetida, bay 

(tejpat), bishop’s weed, black cumin, 

black pepper, caraway, cardamom, 

celery seed (ajmud), chili, cinnamon, 

clove, coriander, cumin, fenugreek, 

garlic, ginger, mustard, poppy, 

turmeric

ginger, poppy seed Banerjee and Sakar, 

2003

Ireland Primarily PreRetailj 125f 25 0 0-10

capsicum, curcuma (including 

turmeric), ginger, nutmeg, other spices 

and herbs

none

FSAI, 2005

Ireland Primarily Retail 25 647 0.93 0.3-2

capsicum, curcuma (including 

turmeric), ginger, nutmeg, piper spp. 

(e.g., black and white pepper), other 

spices and herbs

chili pepper and chili 

powder, curry, sesame 

seeds, turmericj

Japan Retail 25 259 0.8 0.09-3 

allspice, ajowan, anise, artemisia, 

capsicum, basil, bay leaves, black 

pepper, capsicum, caraway, celery, 

Chinese five spice, cinnamon, clove, 

coriander, cumin, curry powder, curry 

leaf, dill weed, fennel, fenugreek, 

garlic, garam masala, mandarin, 

mustard, nutmeg, oregano, paprika, 

parsley, sage, star anise, turmeric, 

white pepper, other dried peppers, 

other spice mixtures

black pepper, red 

pepper

Hara-Kudo et al., 

2006

Mexico Retail 3 304 0l 0-1 bay, cumin, garlic, pepper, oregano none Garcia et al., 2001

Netherlands Retail 25 1857 3.4 2.6-4.3 not reported not reported EFSA, 2010b; EFSA, 

2011d

Slovakia not reported 25 27 10 4-30 non-irradiated spice not reported EFSA, 2007a

Slovenia Retail 25 40 0 0-7 none EFSA, 2006a; EFSA, 

2006b

Slovenia Retail 25 30 0 0-9 none EFSA, 2007a; EFSA, 

2007b

Slovenia Retail 25 44 0 0-7 Noted as convenience sample none EFSA, 2011e; EFSA, 

2012

Turkey Retail 25 75 0 0-4 allspice, black pepper, cinnamon, 

cumin, red pepper none Beki and Ulukanli, 2008
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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Countrya

Sample 

Collection 

Point

Sample 

Size (g)b N Prevalence (%) 95% CIc Spices sampledd Spices containing Salmonellae Reference

Turkey Spice Producers 

and Retail 25 170 0 0-2 black pepper, capsicum, cumin, peppermint, thyme none Kahraman and Ozmen, 2009

Turkey Retail 25 420 2.9 1.5-4.9 allspice, black pepper, capsicum, 

coriander, cumin, ginger, white pepper

allspice, black pepper, 

coriander, cumin, 

ginger, red pepper

Hampikyan et al., 

2009

Turkey Retail 25 65 0 0-5 basil, mint, thyme none Ulukanli and 

Karadag, 2010

United 

Kingdom Retail 25 1031m 1 0.74-2.3 alfalfa, poppy, sesame alfalfa, sesame seed Willis et al., 2009; Willis et al., 2013

United 

Kingdom Retail 135f 2833 1.1 0.74-1.5

aniseed, allspice, basil, bay, black 

pepper, capsicum, cinnamon, coltsfoot, 

coriander, cumin, dill, fennel, 

fenugreek, garam masala, ginger, 

lemongrass, mace, mustard, nutmeg, 

oregano, parsley, saffron, sage, 

tarragon, thyme, turmeric, white 

pepper, other piper spp. (e.g., green, 

red, mixed), other spices and spice 

mixesn

allspice, black pepper, 

cayenne, chili, 

cinnamon, coriander, 

cumin, curry, fennel, 

fenugreek, garam 

masala, mint, okra, 

sage, turmericm

Sagoo, et al., 2009, 

Little, 2012 United 

Kingdom 

Manufacturing 

and Packing 135f 132 1 0.2-5 

United 

Kingdom Retail 25 386 0.3 0.1-1 spice mixes (not specified) spice mix (not specified) Little et al., 2003

United States U.S. Import 750p 2844 6.6 5.7-7.6 Wide variety of spices and spice mixes 

(see Table 4.3)

Wide variety of spices 

and spice mixes 

including basil, black 

pepper, capsicum, 

cinnamon, coriander, 

cumin, curry powder, 

fennel, fenugreek, 

mustard, oregano, 

sesame seed, turmeric, 

white pepper

Table 4.3

Multiple 

Countries Spice Producer 25 79 0 0-4 saffron none Cosano et al., 2009

a Country were sample was collected.

b Total mass examined by Salmonella screening test. c 95% exact confidence limit (Clopper and Pearson, 1934).
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d Spices sampled list combines different forms of the same kind of spice under one name (e.g., ground and whole caraway seeds are listed as caraway) and combines related species under one 

name (e.g., cayenne, chili, paprika, and “red pepper” are listed as capsicum). See reference for more detailed list.

e Spices containing Salmonella list reports spice name as noted in the reference. f Studies tested five sub-samples per spice sample; total mass examined is listed (i.e., five times sub-sample mass). 

g Spice-specific prevalence values for peppercorns (0.5%) and paprika (4.9%). h Does not include tea samples.

i Currently the State Union of Serbia and Montenegro.

j Majority of samples from importers/distributors, producers/blenders, packers/wholesalers or food manufactures/preparers (establishments using large amount of spice). 

k Four of six samples testing positive for Salmonella were from retail; one turmeric sample was collected from import/production/wholesaler and the curry powder sample was collected 

from an establishment that uses large amounts of spices for food production.

l Samples examined for the presence of Salmonella Typhi. 

m Only includes seed samples (sesame, poppy, and alfalfa).

n Sagoo et al. (2009) reported spice types from all sample collection points together.

p Protocol involved two screening tests, each 375-g composite sample derived from 15 25-g sub-samples (total of 30 sub-samples).

Table 4.2. Concentration of Salmonella in spices and spice-containing foods implicated in salmonellosis illness outbreaks

Spice/Food Type of Samplea Concentration

(MPN/g) Nb Reference

Black Pepper Outbreak 0.1 - >2.4 12 Gustavsen and Breen, 1984

Paprika Outbreak 2.5 1 Lehmacher et al., 1995

Paprika-containing spice mixtures Outbreakc 0.04-11 9 Lehmacher et al., 1995

Aniseed-containing tea Outbreak 0.036 4 Koch et al., 2005

Paprika Flavored Potato Chips Outbreak 0.04-0.45 5 Lehmacher et al., 1995

Tahini, hummus, and sesame seed -helva Outbreak <0.03-0.46 10 Unicomb et al., 2005

Alfalfa seeds Outbreak-Sprout 0.0007-0.016d 30 Inami et al., 2001

Alfalfa seeds Outbreak-Sprout < 1e NA Stewart et al., 2001

Black Pepper and Red Pepper Surveillance (retail) 0.086f 2 Hara-Kudo et al., 2006

Sesame seeds and mixtures of seedsg Surveillance (retail) <0.1-0.2 6 Willis et al., 2009; Willis, 2013

Alfalfa seeds Surveillanceh 0.0036 30 Inami et al., 2001

Capsicum Surveillance (Import into U.S) 0.002-0.23 18 Table 4.8; Van Doren et al., 2013c

Sesame seed Surveillance (Import into U.S) 0.002-0.23 23 Table 4.8; Van Doren et al., 2013c a Samples collected as part of salmonellosis illness outbreak investigations or surveillance. Unless otherwise noted, the outbreak was associated with consumption of the spice or lowmoisture food containing the spice. 

b Number of total samples tested. NA indicates the number of samples examined was not reported.

c Enumeration measurements took place approximately 1 year after the salmonellosis outbreak; samples were produced during the outbreak time period.

d Values reported are for the dry seed. Values in table were derived from data reported by Inami et al. (2001) using the excel spreadsheet provided in the FDA Bacteriological Analytical 

Manual (Blodgett, 2010). 

e Values reported are for the seed but seeds were soaked in water for three hours before beginning the enumeration procedure (Stewart et al., 2001), which may have led to some bacterial 

growth.

f Value was derived from the observations reported by Hara-Kudo et al. (2006) (positive screening test and negative MPN tubes) as described in Van Doren et al. (2013c).

g Mixtures of seeds contained sesame, pumpkin, sunflower, linseed, and hemp (Willis, 2013). Identity of seeds sampled from Willis (2013); enumeration values from Willis et al. (2009). 

h Location of surveillance sampling in the seed supply chain was not reported.
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4.1.2 PRIMARY PRODUCTION

We were unable to identify any studies examining Salmonella contamination in/on spice producing plants 

pre-harvest. As a result we can provide no information on the prevalence of Salmonella in/on spice producing 

plants at this point of production. 

Cosano et al. (2009) examined 79 25-g samples of saffron spice collected directly from producers from a 

variety of countries and found no Salmonella, placing a 95% CI on the observed prevalence in these samples 

of 0-4% (25 g, Table 4.1). Kahraman and Ozmen (2009) examined 25-g spice samples from producers and 

retailers in Turkey (distribution of samples from the different points in the spice food chain was not 

specified) and found no Salmonella. It is not possible to evaluate the limit on prevalence specific for primary 

production from the reported data from Kahraman and Ozmen (2009) but the combined sample set yielded a 

95% CI of 0-2%, Table 4.1. The Food Safety Authority of Ireland (FSAI, 2005) reported finding one 25-g 

sample of turmeric collected from “import or production or packing premises or wholesaler” positive for 

Salmonella (reported in the “primarily retail” sample set listed in Table 4.1). None of the batch samples 

examined from “primarily pre-retail” settings, which included a majority of samples from “import or 

production or packing premises or wholesaler” tested positive for Salmonella (FSAI, 2005). As noted above, 

the sample size examined in these studies was only 25 g, which limited detection to larger concentrations of 

Salmonella in the spice samples. 

4.1.3 DISTRIBUTION AND STORAGE

As described in Chapter 6, the supply chain for spices can be complex and span long times. Distribution and 

storage steps can take place at multiple points in the supply chain. Surveillance data on the prevalence and 

concentration of Salmonella in spices during distribution and storage is limited to evaluations of these 

quantities at the point of import. We were not able to identify any surveillance studies of Salmonella

prevalence or concentrations in spices located in storage facilities or at other points of the distribution chain. 

Prevalence data reported between 2000 and 2012 is available from Australia and the United States, Table 4.1. 

In Australia, the prevalence of Salmonella in peppercorns (type not specified) collected at the point of import, 

was determined to be 0.5% (25 g) while that for paprika was 4.9% (25 g) (DOH/Victoria/AU, 2010). Without 

knowledge of the total number of samples examined, it is not possible to determine whether the observed 

differences in prevalence for these two types of spice are significant or whether the observed prevalence 

values determined in Australia are statistically different from those in the United States. As noted in Table 4.1 

the study by the Food Safety Authority of Ireland (FSAI, 2005) included batch and single samples from 

“import or production or packing premises or wholesaler” as well as from other points in the spice supply 

chain. One 25-g sample of turmeric collected from “import or production or packing premises or wholesaler” 

in Ireland tested positive for Salmonella (FSAI, 2005). Reports of Salmonella-positive spice samples in the 

FDA RFR also provide information on the frequency of Salmonella-positive spice samples found in FDAregistered facilities, which include facilities that distribute, manufacture, process, pack/re-pack, and store 

spices. Data from the first three years of the RFR are described in Section 4.1.2. Food recalls associated with 

Salmonella-positive spice may result from samples collected during distribution or storage and these are 

described in Section 4.1.6. 

4.1.3.1 SALMONELLA IN SHIPMENTS OF IMPORTED SPICE OFFERED FOR ENTRY TO THE UNITED 

STATES

Data reported in this section were derived from two studies of FDA surveillance sampling data unless 

otherwise noted: (1) review of results of the annual sampling program for the three years FY2007-FY2009 

and (2) review of sampling results from a targeted sampling assignment in 2010 (August-December) that 

focused on enumeration of Salmonella in shipments of imported capsicum and sesame seed offered for entry 
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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to the United States. Full reports of both studies were originally published in Food Microbiology (Van Doren et 

al., 2013a; Van Doren et al., 2013c). The data from these studies are compared with an earlier study of 

Salmonella prevalence in spice shipments offered for import to the United States (Satchell et al., 1989) and 

other relevant data.

Observed prevalence of Salmonella in shipments of imported spice offered for entry to the United States, 

FY2007-FY2009

Salmonella prevalence in imported spice shipments offered for entry to the United States during FY2007-

FY2009 was 6.6% (750 g; 95% CI 5.7-7.6%), Table 4.3. This value does not differ statistically from the value 

determined by FDA for examination of a set of 31 imported spice shipments offered for entry to the United 

States during the period March 1987-January 1988, 6% (750 g; 95% CI 0.8-20%) (Satchell et al., 1989). These 

two studies are the only published studies to examine the prevalence of Salmonella contamination of spices in 

the United States.

During FY2007-FY2009, sampled imported spice shipments offered for entry to the United States were 1.9 

times more likely to be found contaminated than sampled shipments of all other FDA-regulated foods offered 

for U.S. entry combined (relative risk3 (RR), 95% CI 1.6-2.3; Fisher exact test for difference, p<0.001). 

Interpretation of this value is complicated by the fact that a number of different sampling protocols were 

used for imported shipments of FDA-regulated foods other than spices and these differences could lead to 

test sensitivity differences. Comparing only data for shipments that were sampled with the same FDA 

Category II food sampling protocol used for spices (Andrews and Hammack, 2003), we found an even larger 

RR for contamination of imported spice shipments as compared with shipments of other imported FDAregulated foods: RR = 4.4 (95% CI 3.4-5.8; Fisher exact test for difference, p<0.001). The larger prevalence of 

Salmonella in imported shipments of spices as compared with other imported FDA-regulated foods can be 

surprising to some because the low water activity of spices does not support Salmonella growth, whereas the 

high water activity of some other imported FDA-regulated foods will support growth when other conditions 

for growth are met (e.g., nutrients and pH) (FDA, 2012d). Further, many spices have inhibitory compounds 

that provide antibacterial activity against Salmonella (Arora and Kaur, 1999; Hammer et al., 1999; Ceylan and 

Fung, 2004; Indu et al., 2006; Du et al., 2009a and 2009b; Tajkarimi et al., 2010; Hussien et al., 2011; 

discussed in Section 5.1.2). These compounds can limit growth and survival of Salmonella in (wet/inoculated)

spices and foods containing spices or their essential oils under some conditions (Arora and Kaur, 1999; 

Hammer et al., 1999; Ceylan and Fung, 2004; Indu et al., 2006; Du et al., 2009a and 2009b; Tajkarimi et al., 

2010; Hussien et al., 2011). Clearly, other factors, including the ability of Salmonella to survive in a variety of 

low moisture foods including some, if not all, spices (Podolak et al., 2010; Lehmacher et al., 1995; Keller et al., 

2013), are more important in determining the prevalence of Salmonella in imported spice shipments offered 

for entry to the United States.

Impact of spice properties on observed prevalence of Salmonella in shipments of imported spice offered 

for entry to the United States, FY2007-FY2009

Spices are derived from a variety of plant parts, which may result in differences in exposure to pathogencontaining wildlife, insects, and soil during growth, harvest or primary processing. In order to determine 

whether these differences influence the proportion of imported spice shipments contaminated with 

Salmonella, we grouped spice screening test results by plant part, Table 4.3. Spices derived from plant fruits, 

such as black pepper, white pepper, and capsicums, or plant seeds, such as cumin, mustard and sesame, were 

grouped together in the fruit/seed category. Spices derived from plant roots included dried roots, such as 

turmeric and ginger, as well as dehydrated onion and garlic. Examples of spices included in the leaf category 

are oregano, basil, and varieties of mint. Examples of spices included in the bark/flower category include 

cinnamon/cassia, cloves, and saffron. Data for shipments in which the plant part was ambiguous were 

excluded from this part of the analysis, e.g., shipments described as “coriander” but lacking information as to 

whether it was the seed or leaf. 

 

3 Relative risk is the ratio of prevalence values.
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Table 4.3. Observed prevalence of Salmonella–contaminated shipments of imported spice and other 

imported FDA-regulated food shipments offered for entry to the United States, FY2007-FY2009. 

Spice/Food

# 

Positive N

Salmonella Shipment 

Prevalence (%)

95% Confidence 

Intervala

All Imported Spicesb 187 2844 6.6 5.7-7.6

All other Imported FDA-regulated Foodsb 600 17508 3.4 3.2-3.7

Categories of Spicesc

Fruit/Seedd 92 1465 6.3 5.1-8.0

Rootd 15 202 7.4 4.2-12

Leafd 18 160 11 6.8-17

Bark/Flowerd 1 66 2 0-10

Spices subjected to different processes

Spices subjected to a Pathogen Reduction 

Treatmente 4 137 3 0.8-7

Spices Not Treated/Not Known if treatede 183 2707 6.8 5.8-7.8

Spice Blendf 43 790 5.4 4.0-7.3

Spice Not-Blendf 141 1999 7.1 6.0-8.3

Ground/cracked Spice 131 1658 7.9 6.6-9.3

Whole Spice 51 884 5.8 4.3-7.5

Specific Spicesg

Capsicumh 35 492 7.1 5.0-9.8

Cinnamon/Clove/Nutmeg 1 73 1 0-7

Coriander 16 110 15 8.5-23

Cumin 11 138 8.0 4.0-14

Curry Powder 17 195 8.7 5.2-14

Fennel/Fenugreek/Mustard 3 112 2.7 1-8

Oregano/Basil 10 82 12 6.0-21

Pepper, Black 13 291 4.5 2.4-7.5

Pepper, White 1 87 1 0-6

Sesame Seed 20 177 11 7.0-17

Turmeric 8 118 7 3-10

Spices/Spices and Seasonings, NECi 32 685 4.7 3.2-6.5

All Other spices 20 284 7.0 4.4-11

a 95% exact confidence limit (Clopper and Pearson, 1934). b All shipments of imported FDA-regulated spices or other imported foods that were sampled during the study period. Salmonella

screening tests for spices examined 750 g of spices; screening tests for all other FDA-regulated foods examined 375, 750, or 1500 g of 

food, depending on the FDA food category (Andrews and Hammack, 2003).

c Categorizations derived from product code (FDA, 2012j) and description. When description was insufficient to categorize, the sample 

was not included. 

d Categorization of spice shipment based on the part of the plant from which it is derived. 

e Spice shipment classified as “commercially sterile”, “heat treated” or “irradiated” and those in which the product description identified 

treatment (e.g., “treated with steam” or “treated with ethylene oxide”) are categorized as “Treated Spices.” All other spices are 

categorized as “Not Treated/Not Known if treated.” 

f The category “Spice Blend” includes shipments of spice mixtures while “Spice Not Blend” includes shipments of a single type of spice.

g Different forms of spices with the same name, such as dried coriander leaves and seeds, are grouped together.

h Capsicum includes paprika as well as hot and other sweet dried capsicum peppers.

i Shipments of spices “not elsewhere classified” (NEC) in the product code (FDA, 2012j) are assigned to “Spices, NEC”, “Spices and 

Seasonings, NEC”, or “Mixed Spices and Seasonings, NEC.” 

Prevalence values among the plant part categories ranged from a mean of 2% (750 g; 95% CI 0-10%) for 

spices derived from the bark/flower of the plant to 11% (750 g; 95% CI 6.8-17%) for spices derived from 

plant leaves and differences among some of the categories are significant (chi-square test statistic for 

multiple proportions (8.8) > chi-square critical value (7.8) at the 95% confidence level). Application of the 

Marascuilo procedure establishes that a (statistically) larger proportion of imported shipments of spices in 

both leaf and fruit/seed spice categories offered for entry to the United States are contaminated with 
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Salmonella than imported shipments of bark/flower spices. Because 95% of the bark/flower samples 

examined were either cinnamon/cassia or clove, the difference could arise from reduced test sensitivity for 

these spices (Section 2.2), the antibacterial activity of these spices against Salmonella (Arora and Kaur, 1999; 

Ceylan and Fung, 2004; Du et al., 2009a; Tajkarimi et al., 2010; Hussien et al., 2011), or differences in 

growing/processing conditions, including Salmonella exposure. Reduced test sensitivity and antibacterial 

activity against Salmonella (Hammer et al., 1999; Burt, 2004; Du et al., 2009b; Tajkarimi et al., 2010) were not 

sufficient to significantly limit the prevalence of Salmonella in imported shipments of oregano and allspice in 

the U.S. study; the shipment prevalence of Salmonella for these two spices was 12% (750 g; 95% CI 5.8-22%). 

Salmonella frequency and prevalence in shipments of specific types of imported spices was also evaluated, 

Table 4.3. Values are presented for spices for which there were at least 65 shipments examined during the 

three-year period. In this section of Table 4.3, different spices with the same common name, such as 

coriander seed and leaf, were grouped together. “Capsicum” includes paprika as well as hot and other sweet 

dried capsicum peppers. In a few cases, we grouped results for different spices together in order to be able to 

include these data in Table 4.3 and meet the minimum number of shipments. We included the “spices/spices 

and seasonings, NEC (not elsewhere classified)” category because “NEC” products codes are commonly 

assigned to imported spice shipments and this category includes less common spices and spice mixtures. 

Observed prevalence values ranged from 1%, for shipments of white pepper (750 g; 95% CI 0-6%) or the sum 

of shipments of cinnamon/cassia, clove and nutmeg (750 g; 95% CI 0-7%), to 14% (750 g; 95% CI 8.3- 22%) 

for coriander. Application of the chi square test for multiple proportions indicates that the prevalence values 

for the different types of spices are not all the same (test statistic (50.8) > chi-square critical value (21.03) at 

the 95% confidence level). However, there are not enough data for each type/category of spice to identify 

which differences are significant; the Marascuilo procedure did not identify any pairs of spice types that were 

statistically different. Additional research is needed to distinguish prevalence values among the spice types 

but these data demonstrate that Salmonella shipment contamination is common among a wide range of spice 

types. 

The spice-specific prevalence values in Table 4.3 can be compared with values determined for these spices in 

other countries. Moreira et al. (2009) found major brands of retail black pepper collected in Botucatu, San 

Paolo, Brazil between January 2004 and April 2006 to have a statistically larger prevalence (18%, 25 g; 95% 

CI 1-30%, p <0.001) than that found in imported black pepper shipments in this report, even though the 

Brazilian screening test protocol was less sensitive (examined 25 g as compared with 750 g). While Brazil is a 

major global producer of black pepper, only 3 (1%) of the black pepper shipments examined in the U.S. study 

were imported from Brazil. Willis et al. (2009) found a smaller Salmonella prevalence for sesame seeds at 

retail in the United Kingdom (1.7%; 25 g; 95% CI 0.9-2.9%) than that found in the U.S. study (p<0.001). In this 

U.K. study, the mass of spice examined in the screening test was smaller than that used in the U.S. study (25 g 

as compared with 750 g; Willis et al., 2009; Van Doren et al., 2013a; Table 4.1), which could have led to the 

smaller observed prevalence value. 

Impact of processing on observed prevalence of Salmonella in shipments of imported spice offered for 

entry to the United States, FY2007-FY2009

The frequency and prevalence of Salmonella in shipments of spices that had undergone different processes, 

including pathogen reduction treatments, blending, or grinding, are compared to those for spices that had not 

undergone the process in Table 4.3. Spice shipments which were classified as “commercially sterile”, “heat 

treated”, or “irradiated” or for which the industry supplied product description specified that a pathogen 

reduction process treatment had been applied to the spice (for example, “steam treated” or “treated with 

ethylene oxide”) were grouped together in Table 4.3 as “Spices subjected to a Pathogen Reduction 

Treatment.” A more detailed analysis of these data was precluded because some of these classifications do 

not differentiate among treatment types and the total number of shipments in this group was small. All other 

shipments were grouped in “Spices Not Treated/Not known if treated.” We do not know whether the small 

number of spice shipments in this category is a true reflection of the proportion of imported spice shipments 

that have been subjected to such treatments because importers are not required to provide process 
Prevalence and Concentration of Salmonella and Filth in Spices | 4

FDA Draft Risk Profile | 41

treatment information unless the spice shipment has been irradiated and even in this case, the FDA product 

code builder (FDA, 2012j) allows importers to choose other ways of defining their product. Therefore, it is 

possible that the “Spices Not Treated/Not known if treated” group includes spice shipments that had 

undergone a pathogen reduction treatment before U.S. entry. 

The observed Salmonella prevalence for spice shipments subjected to a pathogen reduction treatment before

U.S. entry was approximately one-half that for shipments of spices that were not treated or for which no 

treatment information was provided but the difference is not statistically significant (Fisher Exact Test). The

confounding of treated and untreated spice shipments in the “Not treated/Not known” category could be 

responsible for the similarity of these prevalence values. What is more important is the fact that shipments of 

“treated” spices were found to contain Salmonella. Effective pathogen reduction treatments should not leave 

any viable Salmonella bacteria in the spice. Sagoo et al. (2009) also reported finding “treated” spice samples 

at retail in the United Kingdom with unsatisfactory microbiological quality but did not note whether 

Salmonella was found. Salmonella contamination of “treated” shipments could reflect insufficient pathogen 

reduction treatment and/or post-treatment contamination. No information was available on whether the 

treatment processes applied to the spices had been validated and as is discussed in detail in Section 8.2.1, 

different treatment processes and treatment conditions can result in very different net reductions in 

microbial populations.

The Salmonella prevalence for shipments of blended spices (mixtures) was statistically similar to that for 

non-blended spice shipments. Similarly, shipments of ground/cracked spice were not found to have 

statistically different prevalence values than shipments containing whole spice. While no differences were 

apparent when comparing the average prevalence for these different categories of spice shipments across all 

types of spices, significant differences did exist for some types of spices. For example, larger prevalence 

values were found for shipments of imported ground/cracked capsicum and coriander shipments as 

compared with their whole counterparts, Table 4.4, with relative risks of contamination of 11 (750 g; 95% CI, 

2-220) and >10 (750 g; 95% CI , 2-∞) respectively. In contrast, differences in shipment prevalence were not 

observed for ground/cracked cumin or black pepper as compared with their whole counterparts, Table 4.4. In 

the United Kingdom, Sagoo et al. (2009) found that a larger proportion of spice flakes had unsatisfactory 

microbiological quality than those in their whole form, but did not specify whether this difference was 

primarily related to Salmonella presence/absence. There are a number of hypotheses that can explain the 

differences in observed prevalence for ground/cracked versus whole forms of capsicum or coriander 

observed (e.g., introduction of Salmonella during the grinding/cracking process or more efficient detection of 

Salmonella in these ground spices due to dispersion of originally highly localized contamination); additional 

research is needed to distinguish among them. 

Table 4.4. Comparison of observed prevalence of Salmonella-contaminated shipments of some whole 

and ground/cracked imported spice offered for entry to the United States, FY2007-FY2009. 

Whole Spicea Ground/Cracked Spicea

Spice # Positive N 

Salmonella

Shipment 

Prevalence (%)

# 

Positive N 

Salmonella

Shipment 

Prevalence (%)

Relative Risk 

(RR) 

[95% CI]b 

Capsicums 1 122 0.8 33 366 9.0 11 [2-220]

Coriander 0 43 0.0 16 68 24 >10 [2- ∞] 

Cumin 5 59 8 6 79 8 0.9 [0.2-3]

Pepper, Black 7 156 4 6 135 4 1.0 [0.3-3] a Categorizations derived from product code (FDA, 2012j) and description. When description was insufficient to categorize, the sample 

was not included. 

b Relative risk of shipment contamination for ground/cracked spice as compared with whole spice ; 95% exact confidence limit (Clopper 

and Pearson, 1934).
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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Impact of source country on observed prevalence of Salmonella in shipments of imported spice offered 

for entry to the United States, FY2007-FY2009

In order to examine whether the “country of origin” impacts the observed prevalence of Salmonella

contamination of imported spice shipments offered for entry to the United States, values were determined for 

spice shipments imported from different countries without regard to spice type. In most cases, the exporting 

country is the country where the spice was grown, dried and, if applicable, processed but in some cases, the 

export country of record is not the country where the spice was grown. 

Shipments from 79 different countries were examined during the study period; contaminated shipments 

came from 37 different countries. Contamination of spice shipments is not limited to only a few source 

countries. Salmonella shipment frequency and prevalence values by country are provided in Table 4.5; only 

countries for which at least 65 imported shipments were examined are included. Country-specific prevalence 

values range from 0.9% (750 g; 95% CI 0-5%) for spice shipments imported from Canada to 14% (750 g; 

95% CI 8.6-21%) for shipments imported from Mexico. Application of the chi-square test for multiple

proportions determined that the Salmonella prevalence values among this set of countries are not all 

statistically similar (Van Doren et al., 2013a). More research is needed to understand the differences in 

prevalence of Salmonella in spice imported from some countries.

Table 4.5. Observed prevalence of Salmonella-contaminated imported spice shipments offered for 

entry to the United States as a function of export country, FY2007-FY2009 

Exporting Country # Positive N 

Salmonella

Shipment 

Prevalence (%)

95% Confidence Intervala

Canada 1 110 0.9 0-5

China 9 245 4 2-7

India 92 1057 8.7 7.1-11

Indonesia 2 82 2 0-9

Mexico 19 136 14 8.6-21

Pakistan 6 205 3 1-6

Thailand 6 111 5 2-10

Vietnam 7 149 5 2-9

All other countriesb 45 749 6.0 4.4-8.0

a 95% exact confidence limit (Clopper and Pearson, 1934).

a Totals 71 other countries for which fewer than 65 imported shipments were examined per country during FY2007-FY2009. 

Willis et al. (2009) found the Salmonella prevalence for retail samples of seeds sold in the United Kingdom 

was smaller for seeds imported from the European Union member countries than for seeds imported from 

non-European Union member countries. Making the same comparison, we find that spice shipments from 

European Union member countries did not have a statistically smaller Salmonella prevalence value than 

shipments from non-European Union member countries (p>0.05), but we note that the total number of 

shipments from these European Union member countries was small (79).

Salmonella serotype diversity isolated from spices in shipments of imported spice offered for entry to the 

United States, FY2007-FY2009

Salmonella serotypes were identified (or partially identified) for isolates from most of the contaminated spice 

shipments (180/187). Multiple serotypes were identified in 12% (22) of the contaminated shipments 

yielding a total of 204 unique isolates. Nearly all of the isolates characterized were determined to be 

Salmonella enterica subspecies enterica. Six isolates were characterized as Salmonella enterica subspecies II, 

IIIa or IIIb, Table 4.6. The serotype Salmonella Rissen was not among the serotypes identified from Salmonella

isolates examined in this surveillance study despite its association with a large scale outbreak attributed to 

contaminated imported white pepper that took place during the study period (CDPH/FDB/ERU, 2010). It was 

isolated from investigative samples associated with the outbreak. 
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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The data in Table 4.6 establish that shipments of imported spices can be contaminated by a wide diversity of 

Salmonella serotypes. The most frequently observed serotype during the three year study was Salmonella

Weltevreden, which constituted only 6.3% of all isolates characterized. Other studies have also reported a 

wide diversity of serotypes found in spices (Lehmacher et al., 1995; Sagoo et al., 2009; Willis et al., 2009). The 

observation that a single sample of spice can be contaminated with multiple Salmonella serotypes is also not 

unusual. In one paprika sample, Lehmacher et al. (1995) isolated eleven different serotypes. 

Table 4.6. Salmonella serotype frequency and percentage among isolatesa in surveillance samples of 

spice from shipments of imported spice offered for entry to the United States, FY2007-FY2009.

Serotype # unique 

Isolatesb

% of unique 

Isolatesb Spice

Weltevreden 13 6.3

anise, bay, capsicum, coriander, curry powder, 

onion, sesame seed, spices and seasonings NEC, 

white pepper

Newport 12 5.9 capsicum, cumin, curry powder, oregano, sesame 

seed, spices NEC

Mbandaka 11 5.4 capsicum, cumin, curry powder, garlic, sesame 

seed, spices and seasonings NEC

Agona 10 4.9 anise, black pepper, capsicum, cumin, curry 

powder, oregano

Bareilly 8 4 capsicum, coriander, cumin, curry powder, fennel, 

ginger

Montevideo 6 3 allspice, capsicum, coriander, mint, spices NEC

Senftenberg 6 3 curry powder, sesame seed, spices and seasonings 

NEC

Typhimurium 6 3 basil, black pepper, coriander, curry powder, five 

spice mix,

Anatum 5 2 capsicum, cumin, sesame, spices NEC

Aberdeen 4 2 ginger, coriander, curry powder

Cubana 4 2 celery, spices and seasonings NEC

Give 4 2 capsicum, oregano, sesame seed

Hvittingfoss 4 2 basil, coriander, spices NEC, turmeric

Mgulani 4 2 capsicum, spices and seasonings NEC

Paratyphi B var. L(+) tartrate + 4 4 capsicum, coriander, mint, spices and seasonings 

NEC

Rubislaw 4 2 black pepper, spices NEC

Tennessee 4 2 capsicum, sesame seed, spices and seasonings NEC

Virchow 4 2 basil, spices and seasonings NEC, turmeric

Derby 3 1 black pepper, five spice mix, sage

Enteritidis 3 1 black pepper, spices and seasonings NEC

Poona 3 1 celery, coriander, turmeric

Sandiego 3 1 cardamom, coriander, cumin

3,10:b:- 2 1 capsicum, sesame seed

Bere 2 1 coriander, spices and seasonings NEC

Bergen 2 1 curry powder, spices and seasonings NEC

Cerro 2 1 sesame seed, turmeric

Havana 2 1 sesame seed, spices and seasonings NEC

Javiana 2 1 allspice, black pepper

Kentucky 2 1 cumin, sesame seed

London 2 1 coriander, fenugreek

Saintpaul 2 1 cumin, mustard

Schwarzengrund 2 1 capsicum, turmeric

II 40:z4,z24:z39 2 1 anise, oregano

IIIb 2 1 mint, spices NEC

Barranquilla 1 0.5 capsicum

Brindisi 1 0.5 sage

39:z10:z6 1 0.5 cumin
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Serotype # unique 

Isolatesb

% of unique 

Isolatesb Spice

43:z4,z23:- 1 0.5 spices NEC

47: z4, z23: - 1 0.5 curry powder

48:d:z6 1 0.5 cinnamon/cassia

6, 14 : a : 1, 5 1 0.5 spices NEC

6,7,14:e,n,z15 1 0.5 capsicum

Abaetetuba 1 0.5 basil

Adabraka 1 0.5 coriander

Altona 1 0.5 capsicum

Ball 1 0.5 black pepper

Bangkok 1 0.5 spices and seasonings NEC

Bonn 1 0.5 sesame seed

Braenderup 1 0.5 black pepper

Brazzaville 1 0.5 capsicum

Bredeney 1 0.5 capsicum

Canada 1 0.5 black pepper

Carmel 1 0.5 coriander

Carrau 1 0.5 oregano

Dublin 1 0.5 curry powder

Eastbourne 1 0.5 turmeric

Elokate 1 0.5 black pepper

Freetown 1 0.5 spices NEC

Gamaba 1 0.5 cumin

Gaminara 1 0.5 coriander

Glostrup 1 0.5 sesame seed

Hermannswerder 1 0.5 sage

Idikan 1 0.5 sesame seed

Lexington 1 0.5 ginger

Llandoff 1 0.5 sesame seed

Martonos 1 0.5 capsicum

Minnesota 1 0.5 basil

Molade 1 0.5 capsicum

Muenchen 1 0.5 capsicum

Muenster 1 0.5 spices and seasonings NEC

Nordrhein 1 0.5 capsicum

Nottingham 1 0.5 oregano

Oranienburg 1 0.5 oregano

Orion 1 0.5 curry powder

Othmarschen 1 0.5 spices NEC

Paratyphi B 1 0.5 turmeric

Potsdam 1 0.5 sesame seed

Richmond 1 0.5 spices and seasonings NEC

Simi 1 0.5 sage

Stanley 1 0.5 capsicum

Sundsvall 1 0.5 capsicum

Telelkebir 1 0.5 cumin

Telhashomer 1 0.5 fenugreek

Umbilo 1 0.5 five spice mix

Vejle 1 0.5 black pepper

Westminster 1 0.5 sesame seed

Wichita 1 0.5 spices and seasonings NEC

IIIa 48:z4,z24:- 1 0.5 sesame seed

IIIa 1 0.5 capsicum a Salmonella enterica subspecies enterica unless otherwise note; partial serotypes included. Where appropriate, serotype names reported

have been combined in this frequency table e.g., “Sieburg” is listed with Cerro, as compared with the table presented in Van Doren et al., 

2013a.

b For each spice shipment sampled, the number of unique isolates identified is the number of different serotypes identified. Therefore, the 

number (percent) of isolates is the number (percent) of contaminated spice shipments found with that serotype.
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Similar serotype diversity has been observed among Salmonella isolates from all FDA-regulated imported 

foods (Zhao et al., 2003; Zhao et al., 2006). Further, the most common serotypes found in spice shipments 

offered for entry to the United States do not appear to differ substantially from those reported for all types of 

FDA-regulated imported food shipments offered for entry and sampled by FDA (Zhao et al. 2003, Zhao et al. 

2006). For example, Weltevreden and Newport were the two most common serotypes isolated from imported 

spice shipments offered for entry to the United States during FY2007-FY2009 (U.S. study) and were among 

the top four serotypes isolated in 2000 and 2001 from examined imported shipments of FDA-regulated foods 

offered for U.S. entry (Zhao et al., 2003; Zhao, et al. 2006). These data support the hypothesis that the 

serotypes most frequently isolated from imported spices are not specific to or preferentially found in spices. 

A more detailed comparison of serotype prevalence values for spices and other imported FDA-regulated 

foods is not possible because of the significant differences in sample design between the FDA FY2007-FY2009 

study (Van Doren et al., 2013a) and the studies of Zhao and coworkers (Zhao et al., 2003; Zhao et al., 2006; 

Zhao, 2008), where data for spices and targeted samples, such as samples collected as part of an outbreak 

investigation, were included in the summary statistics. Inclusion of targeted samples in the analysis of 

serotype prevalence will generally bias values to serotypes associated with the triggering event because 

multiple samples of the same food source are sampled. 

We can also compare the Salmonella serotypes isolated from spices offered for import to the United States 

with those isolated from food samples in other countries. Among the 42 serotypes isolated from food samples 

collected during 2007-2009 in Asia (a major source of spices for the United States) and reported to the World 

Health Organization (WHO) Global Foodborne Infections Network (WHO/GFN, 2012), half were also isolated 

from spices in the U.S. study (Table 4.6). 

The serotype diversity observed for isolates from spices offered for import to the United States and imported 

FDA-regulated foods in general, differs in character with that generally observed for isolates from animal 

meats for which a small number of predominant serotypes is common (USDA/FSIS, 2012; FDA, 2012a; FDA, 

2012c; Sasaki et al., 2012; Guo et al., 2011; Yang et al., 2010; Kudaka et al., 2006; Cui et al., 2005). The much 

wider diversity of Salmonella serotypes found in spices may be a reflection of a much wider diversity of 

contamination sources, such as soil, water, rodents, birds, and insects, as compared with that for animalderived meat products.

Antimicrobial resistance of Salmonella isolated from spices in shipments of imported spice offered for 

entry to the United States, FY2007-FY2009 

Fourteen (6.8%) of the Salmonella isolates from imported spice shipments offered for entry to the United 

States during the three-year study period FY2007-FY2009 were found to exhibit antimicrobial resistance, 

Table 4.7. Approximately half (8/14) of the isolates with antimicrobial resistance were found to be resistant 

to three or more antimicrobials. Two isolates (Salmonella serotypes Agona and Newport) were resistant to 

seven antimicrobials. Perhaps most importantly, approximately one-quarter of the resistant strains (4/14) 

were resistant to first-line antimicrobial agents used to treat salmonellosis in some populations (Guerrant et 

al., 2001; Thielman and Guerrant, 2004): trimethoprim/sulfamethoxazole (2) and ceftriaxone (2). None of the 

isolates was resistant to ciprofloxacin, another first-line antimicrobial for salmonellosis (Guerrant et al., 

2001), although many were resistant to nalidixic acid (8/14), which has been found to be an indicator of low 

level resistance to fluoroquinolones (Rodriguez-Avial et al., 2005; Threlfall et al., 2006) and may be a first 

step towards the development of resistance to ciprofloxacin (Van Looveren et al., 2001). Other common 

antimicrobial resistances exhibited among the resistant isolates were to sulfisoxazole (10/14), tetracycline 

(9/14), chloramphenicol (6/14), streptomycin (5/14), kanamycin (4/14) and ampicillin (3/14). No 

resistance was observed among the isolates to amikacin, amoxicillin/clavulanic acid, or cefoxitin. The 

isolation of highly resistant Salmonella strains from spices has been reported by others (Zhao et al., 2006, 

Zhao, 2008; Brockmann et al., 2004) including Salmonella Typhimurium DT 104, which was involved in the 

2001 salmonellosis outbreak associated with sesame seed-helva consumption (Fisher et al., 2001; 

Brockmann, 2001; Little, 2001; Guérin, 2001) and is characteristically resistant to ampicillin, 
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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chloramphenicol, streptomycin, sulfonamide and tetracycline (ACSSuT). This phenotype was observed in one 

isolate each of serotype Typhimurium and Agona in the U.S. study, Table 4.7. 

The prevalence of antimicrobial resistant Salmonella strains in imported spices contaminated with Salmonella

does not appear to be larger than that found for strains isolated from imported FDA-regulated foods in 

general (Zhao et al., 2003; Zhao et al., 2006; Zhao, 2008) and is smaller than that reported for retail meats in 

the United States (USDA/FSIS, 2012), Japan (chickens; Sasaki et al., 2012) or in China (Yang et al. 2010). As 

with the serotype diversity, the smaller antimicrobial resistance profile for spices as compared with retail 

meats is consistent with a much wider diversity of contamination sources.
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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Table 4.7. Antimicrobial Resistance of Salmonella enterica subspecies enterica isolates from FDA surveillance sampling of spices from 

shipments of imported spice offered for entry to the United States, FY2007-FY2009.

Serotype

Amikacin

Amoxicillin/ 

Clavulanic Acid

Ampicillin

Cefoxitin

Ceftriaxone

Chloramphenicol

Ciprofloxacin

Gentamicin

Kanamycin

Nalidixic Acid

Sulfisoxazole

Tetracycline

Trimethoprim/ 

Sulfamethoxazole

Streptomycin

Export Country Spice

43:z4,z23:- s s s s s s s s s s R s s s Thailand spices NEC

Agona s s R s R R s s R s R R s R Mexico oregano

Bareilly s s s s s s s s s s R s s s Trinidad and 

Tobago curry powder

Bredeney s s s s s s s s R R R R s R Syrian Arab 

Republic capsicum

Derby s s s s s R s s s R s R s s China (Mainland) five spice mix

Give s s s s I s s s s R s s s s India capsicum

Havana s s s s s R s s s s s s s s India spices and 

seasonings NEC

Muenster s s s s s R s s s R R R s R Pakistan curry mix

Newport s s R s s s s R R s R R R R Mexico oregano

Siegburg s s s s s s s s s R s s s s India turmeric

Typhimurium s I R s s R s s s R R R s R Egypt basil

Typhimurium s s s s s s s s s s R R s s Pakistan curry mix

Virchow s s s s s s s s s R R R R s India turmeric

Virchow s s s s s R s s R R R R s s Egypt basil a Resistant (R), Intermediate (I), Susceptible (s), Not Tested (-).
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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Salmonella concentration in shipments of imported capsicum and sesame seed offered for entry to the 

United States, Aug-Dec 2010. 

In order to determine the typical concentrations of Salmonella in spice shipments offered for entry to the 

United States, FDA undertook a special sampling assignment targeting two spices: capsicum and sesame seed. 

The short term assignment was designed to sample shipments randomly and thereby provide a snapshot of 

the shipment distribution with respect to Salmonella presence and concentration. A full report on this study 

has been published (Van Doren et al., 2013c). A total of 299 capsicum and 233 sesame seed shipments were 

sampled. Results and discussion relevant to this section of the risk profile are presented below. Full details of 

the sampling plan and methods used in the study as well as characteristics of the shipments sampled are 

provided in Appendix C. 

Screening and MPN test results are presented in Table 4.8. Between-shipment distributions of Salmonella

mean concentrations in contaminated shipments examined varied widely among sampled shipments with 

estimated mean shipment concentrations among contaminated shipments ranging from 6 x 10-4 to 0.09 

MPN/g (6 MPN per 10,000 g to 9 MPN per 100 g) for capsicum shipments and 6 x 10-4 to 0.04 MPN/g (6 MPN 

per 10,000 g to 4 MPN per 100 g) for sesame seed shipments. Within-shipment contamination observed was 

not inconsistent with a Poisson distribution. Our experiments were not capable of discerning the withinshipment contamination distribution among spice-serving sized samples. 

Observations from this 2010 FDA study were used to develop a model of between- and within-shipment 

Salmonella contamination of imported capsicum or sesame seed shipments offered for entry to the United 

States. Six parametric models were examined; four of these are illustrated in Figures 4.1 and 4.2. The best-fit 

models of contamination for both shipments of imported capsicum and imported sesame seed were gammaPoisson distributions (nominal shipment contamination prevalence of 100%), as determined by AIC, i.e., 

between-shipment mean concentrations of contamination were described by a gamma distribution while 

within-shipment distribution was described by a Poisson distribution. The assumption of Poisson-distributed 

within-shipment contamination was explicitly examined in the study for both types of spices and it was found 

that the data were not inconsistent with the assumption (Van Doren et al., 2013c).

The observations and models developed in the 2010 FDA study predict that most contaminated shipments of 

capsicum or sesame seeds contain relatively small mean concentrations of Salmonella. As a consequence, 

sampling plan design, particularly selections of an appropriate sample size and validated method of analysis, 

are critical to ensure efficient surveillance. For the best-fit parametric model descriptions of Salmonella

contamination found in this study, we estimate that approximately 25-50% of contaminated capsicum or 

sesame seed shipments examined would be detected by FDA’s standard 750 g or 1500 g testing protocols. In 

contrast, sampling protocols examining only 25 g of sample would be much less efficient, detecting 

approximately 5-10% of contaminated shipments examined. These results and others are shown in Appendix 

C, Table C3.
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Table 4.8. Screening and enumeration test results for Salmonella in sampled shipments of imported capsicum or sesame seed offered for 

entry to the United States August-December 2010

Spice # Shipments

Mean Composite Concentration (MPN/g) [95% CI] (MPN Pattern)a Mean Shipment 

Concentration 

(MPN/g)a [95% CI] Composite 1 Composite 2 Composite 3 Composite 4

Capsicum

3

0.002

[0.00027-0.015]

(1/0,0,0,0)

(0/NA) (0/NA) (0/NA) 0.0006

[0.00008-0.0043]

1

0.0097

[0.0026-0.036]

(1/2,0,0,0)

(0/NA) (0/NA) (0/NA) 0.0020

[0.0006-0.0062]

1

0.002

[0.00027-0.015]

(1/0,0,0,0)

0.002

[0.00027-0.015]

(1/0,0,0,0)

(0/NA) (0/NA) 0.0011

[0.0003-0.0046]

1 (1/POS) (1/POS) (1/POS) (0/NA) 0.0054

[0.0021-0.0135]

1

0.002

[0.00027-0.015]

(1/0,0,0,0)

0.0048

[0.0011-0.021]

(1/1,0,0,0)

0.0080

[0.0023-0.028]

(1/1,1,0,0)

(0/NA) 0.0035

[0.0015-0.0081]

1

0.0048

[0.0011-0.021]

(1/1,0,0,0)

0.0048

[0.0011-0.021]

(1/1,0,0,0)

0.0097

[0.0026-0.036]

(1/2,0,0,0)

(0/NA) 0.0045

[0.0020-0.0097]

1

0.002

[0.00027-0.015]

(1/0,0,0,0)

0.002

[0.00027-0.015]

(1/0,0,0,0)

0.002

[0.00027-0.015]

(1/0,0,0,0)

0.0097

[0.0026-0.036]

(1/2,0,0,0)

0.0033

[0.0014-0.0076]

1

0.023

[0.0057-0.093]

(1/3,0,0,0)

0.092

[0.022-0.38]

(1/3,2,0,0)

0.23

[0.057-0.94]

(1/3,3,0,0)

0.23

[0.057-0.94]

(1/3,3,0,0)

0.092

[0.045-0.19]

Sesame 

Seed

2 (1/POS) (0/NA) (0/NA) (0/NA) 0.0014

[0.0003-0.0056]

7

0.002

[0.00027-0.015]

(1/0,0,0,0)

(0/NA) (0/NA) (0/NA) 0.0006

[0.00008-0.0043]

1

0.0048

[0.0011-0.021]

(1/1,0,0,0)

(0/NA) (0/NA) (0/NA) 0.0013

[0.0003-0.0051]

1 (1/NA) (1/NA) (0/NA) (0/NA) 0.0018

[0.0004-0.0076]

1 (1/NEG) (1/POS) (0/NA) (0/NA) 0.0019

[0.0006-0.0061]
Prevalence and Concentration of Salmonella and Filth in Spices | 4

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Spice # Shipments

Mean Composite Concentration (MPN/g) [95% CI] (MPN Pattern)a Mean Shipment 

Concentration 

(MPN/g)a [95% CI] Composite 1 Composite 2 Composite 3 Composite 4

2

0.002

[0.00027-0.015]

(1/0,0,0,0)

0.002

[0.00027-0.015]

(1/0,0,0,0)

(0/NA) (0/NA) 0.0011

[0.0003-0.0046]

1 (1/NA) (1/NA) (1/NA) (0/NA) 0.0037

[0.0011-0.0126]

2 (1/POS) (1/POS) (1/POS) (0/NA) 0.0054

[0.0021-0.0135]

1 

0.0043

[0.001-0.018]

(1/0,1,0,0)b

Revisedc: (1/POS)

0.032

[0.013-0.078]

(1/2,0,2,2)b

Revisedc: (1/POS)

0.038

[0.0096-0.15]

(1/3,0,1,0)b

Revisedc: (1/POS)

(0/NA) 0.0104

[0.0059-0.019]

1 (1/POS) (1/POS) (1/POS) (1/POS) > 0.006

1

0.0048

[0.0011-0.021]

(1/1,0,0,0)

0.0097

[0.0026-0.036]

(1/2,0,0,0)

0.0097

[0.0026-0.036]

(1/2,0,0,0)

0.015

[0.0046-0.048]

(1/2,1,0,0)

0.0091

[0.0048-0.017]

1

0.0097

[0.0026-0.036]

(1/2,0,0,0)

0.0097

[0.0026-0.036]

(1/2,0,0,0)

0.015

[0.0046-0.048]

(1/2,1,0,0)

0.023

[0.0057-0.093]

(1/3,0,0,0)

0.013

[0.0069-0.024]

1

0.023

[0.0057-0.093]

(1/3,0,0,0)

0.042

[0.0098-0.18]

(1/3,1,0,0)

0.042

[0.0098-0.18]

(1/3,1,0,0)

0.093

[0.022-0.39]

(1/3,2,0,0)

0.042

[0.020-0.088]

1

0.023

[0.0057-0.093]

(1/3,0,0,0)

0.023

[0.0057-0.093]

(1/3,0,0,0)

0.023

[0.0057-0.093]

(1/3,0,0,0)

0.23

[0.057-0.94]

(1/3,3,0,0)

0.036

[0.017-0.074]

a Screening and enumeration test results as reported and described in Van Doren et al., (2013c). 95% confidence limits on mean concentration are provided in brackets (Blodgett, 2010). 

MPN pattern for composite samples, given in parentheses, includes 1/ for the positive screening test followed by the number of tubes at each dilution that tested positive, ordered from 

highest to lowest sample mass used (375g/100g,10g,1g,0.1g); 1/POS for composites in which one or more tubes in the dilution assay tested positive for Salmonella; 1/NEG for composites 

in which none of the dilution assay tubes tested positive; 1/NA or 0/NA for composites in which no follow-up dilution assay was performed. Estimates for the mean Salmonella

concentration in the shipment was determined from the full set of test results for that shipment. See Van Doren et al. (2013c) for details. 

b Rarity index for dilution assay results is small (<0.05), indicating the pattern is unusual/unexpected. 

c We use the binary dilution assay result (POS/NEG) (noted as “Revised”) when developing models of shipment contamination. See Van Doren et al. (2013c) for additional detail
Prevalence and Concentration of Salmonella and Filth in Spices | 4

FDA Draft Risk Profile | 51

Figure 4.1. Complementary cumulative distribution functions (p × (1-CDF(λ)) for models of Salmonella

contamination among shipments of imported capsicum offered for entry to the United States 

compared with observations. The series of solid black steps illustrates the observed between-shipment 

distribution; dashed series of steps describe the 95% confidence limits for observed values (Kaplan-Meier 

estimates; Kaplan and Meier, 1958). Smooth curves illustrate model estimates: gamma-Poisson (blue), 

lognormal-Poisson (orange), log-logistic-Poisson (green), and Weibull-Poisson (red). 

-3.5 -3.0 -2.5 -2.0 -1.5 -1.0

0.00 0.01 0.02 0.03 0.04 0.05

Salmonel la level, log10(MPN/g)

Probability
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Figure 4.2. Complementary cumulative distribution functions (p× (1-CDF(λ)) for models of Salmonella

contamination among shipments of imported sesame seeds offered for entry to the United States 

compared with observations. The series of solid black steps illustrates the observed between-shipment 

distribution; dashed series of steps describe the 95% confidence limits for observed values (Kaplan-Meier 

estimates; Kaplan and Meier, 1958). Smooth curves illustrate model estimates: gamma-Poisson (blue), 

lognormal-Poisson (orange), log-logistic-Poisson (green), and Weibull-Poisson (red). 

4.1.4 SECONDARY PROCESSING AND FOOD MANUFACTURING

As described in Chapter 6, spices may undergo a number of processes such as removal of debris, 

cracking/grinding, blending, pathogen reduction treatment, and/or re-packing at secondary spice processing 

facilities and may be added to foods in food manufacturing facilities. Once added to foods, the spice may be 

subjected to a pathogen reduction treatment, such as cooking. Because spices are shelf-stable, they are 

commonly warehoused. 

Information about the prevalence of Salmonella in spice lots in ASTA member spice processing facilities was 

provided by data submitted by ASTA in response to the Federal Register Notice and is discussed below in 

Section 4.1.4.1. Sagoo et al. (2009) found a Salmonella prevalence of 1% (135 g; 95% CI 0.2-5%) for a wide 

variety of spices collected from spice “production” facilities (secondary spice processing facilities) in the 

United Kingdom, Table 4.1. Two of the Salmonella-positive spice samples in the study reported by the Food 

Safety Authority of Ireland (FSAI, 2005) were from (1) an “import or production or packing premises or 

wholesaler” and (2) an “establishment[s] using large amounts of herbs/spices for food preparation.” A study 

-3.5 -3.0 -2.5 -2.0 -1.5 -1.0

0.00 0.02 0.04 0.06 0.08 0.10 0.12

Sal monel l a level, log10(MPN/g)

Probability
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examining spices in processing plant facilities in Belgium found no samples contaminated with Salmonella

(25 g; 95% CI 0-10%; EFSA, 2006a), Table 4.1. The FDA RFR also provides data on the frequency of 

Salmonella-positive spice samples found in FDA-registered facilities, which include facilities that distribute, 

process, pack/re-pack, and store spices. Data from the first three years of the RFR are described below. 

Spice/food recalls associated with Salmonella-positive samples may arise from samples collected from preretail sites or retail/end user sites. Information about spice-associated U.S. recalls is provided in Section 4.1.6.

4.1.4.1 SALMONELLA PREVALENCE IN SPICE SAMPLES COLLECTED IN SPICE INDUSTRY

MANUFACTURING FACILITIES (ASTA MEMBERS)

ASTA submitted a large set of microbiological testing data on spice lots (ASTA, 2010; Ruckert, 2010) in 

response to the Federal Register Notice requesting scientific data and information to support development of 

the risk profile on pathogens and filth in spices (FDA, 2010e). According to the submission, “The ASTA 

members that provided the information handled more than 50% of the spices distributed during the 

reporting period (August 1, 2007-July 31, 2009)” (Ruckert, 2010), i.e., domestic and imported spices sold in 

the United States (Van Doren, 2011). Unfortunately, it is not possible to determine from the information 

provided, the fraction of spice distributed that are represented by this data set. However, this data set does 

provide some information on the relative prevalence of Salmonella and generic Escherichia coli in spice lots 

that had not undergone a pathogen reduction treatment as compared with those that had undergone such a 

treatment, information that is not easily determined from FDA surveillance data.

Methods of analysis and sample mass tested in the Salmonella screening tests varied somewhat among the 

different contributing ASTA members, according to the ASTA submission (Ruckert, 2010). Specifically, the 

submission indicates that at least one composite sample was tested for Salmonella for each result, that “a 

number of participants followed the Bacteriological Analytical Manual FDA Category II or Category III testing 

procedures for Salmonella,” and that the mass of that composite sample “ranged between 25 to 375 grams.” 

(Ruckert, 2010). No other method/sample-mass information was provided. Because the sensitivity of the test 

depends strongly on the mass of spice analyzed and can also depend on the sample compositing scheme 

(Bassett et al., 2010), the absence of this information complicates interpretation of the Salmonella lot 

prevalence values derived from these data and quantitative comparisons within this data set and with other 

data sets. 

Table 4.9 summarizes the data ASTA provided on the prevalence of Salmonella in spice lots that had not been 

subjected to a pathogen reduction treatment and includes an average prevalence value for all spice lots tested 

and individual prevalence values for types of spice for which at least 55 lots were tested. We decided to use 

this slightly smaller cutoff for inclusion to allow more comparisons between pre/no treatment and posttreatment spice from this data set. Confidence limits are provided for all values. 

Table 4.9. Observed prevalence of Salmonella contamination in spice lots from some ASTA member 

companies to which no pathogen reduction treatment had been applied, August 1, 2007-July 31, 2009

Spice # Positivea N Salmonella Lot 

Prevalence (%)a

95% Confidence 

Intervalb 

All Spices 228 12178 1.87 1.64-2.13

Specific Spices

Cassia 0 877 0 0.0-0.3

Cloves 0 60 0 0-5

Cumin Seed 50 191 26 20-33

Parsley 0 1032 0 0.0-0.3

Paprika 155 9731 1.59 1.35-1.86

Pepper, Black 19 55 35 22-49

All other spices 4 232 2 0.5-4 a Screening tests examined a total of 25-375 g spice.

b 95% exact confidence limit (Clopper and Pearson, 1934).
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The average Salmonella prevalence value for all spice lots examined (1.87%; 25-375 g; 95% CI 1.64-2.13%) is 

strongly influenced by the prevalence among paprika lots because 80% of the lots tested were paprika. 

Assuming that the distribution of testing procedures were approximately the same for the different types of 

spice, these data suggest that lots of untreated black pepper and cumin seed are more likely to be 

contaminated with Salmonella than lots of other types of spice and that lots of untreated cassia, parsley, and 

possibly also cloves, are unlikely to be contaminated, at least from the sources and suppliers used by the 

members of ASTA who contributed to this data set. 

Table 4.10 provides information on the prevalence of Salmonella in spice lots that had been subjected to a 

pathogen reduction treatment, including values for specific types of spice for which at least 65 lots were 

tested. 

Table 4.10. Observed prevalence of Salmonella contamination of spice lots from some ASTA member

companies to which a pathogen reduction treatment had been applied, August 1, 2007-July 31, 2009

Spicea N # Positiveb Salmonella Lot 

Prevalence (%)b 95% Confidence Intervalc 

All Spices 3 18421 0.02 0.0-0.5

Specific Spices

Anise 0 155 0.00 0-2

Basil 0 1383 0.00 0.0-0.2

Bay 0 123 0.00 0-2

Cassia/Cinnamon 0 460 0.00 0.0-0.6

Celery 0 310 0.00 0.0-1.0

Cloves 0 488 0.00 0.0-0.6

Coriander 0 488 0.00 0.0-0.6

Cumin 0 795 0.00 0.0-0.4

Dill 0 170 0.00 0-2

Fennel 0 533 0.00 0.0-0.6

Ginger 0 91 0.00 0.00-0.03

Marjoram 0 354 0.00 0.0-0.8

Nutmeg 0 256 0.00 0-1

Oregano 0 1192 0.00 0.0-0.3

Paprika 0 903 0.00 0.0-0.3

Parsley 0 95 0.00 0-3

Pepper, Black 1 5456 0.02 0.0-0.1

Pepper, White 0 971 0.00 0.0-0.3

Pepper, Red 1 2363 0.04 0.0-0.2

Rosemary 0 312 0.00 0-1

Sage 0 597 0.00 0.0-0.5

Savory 0 141 0.00 0-2

Thyme 0 436 0.00 0.0-0.6

Turmeric 0 136 0.00 0-2

All other spices 1 213 0.5 0.01-3 a Spice categories include all lots described by this name, e.g., “Pepper, Red” includes lots described as “Pepper, Red” and “Pepper, Red – 

High Heat” and “Dill” includes lots described as “Dill”, “Dill Seed”, or “Dill Weed.”

b Screening tests examined a total of 25-375 g spice.

c 95% exact confidence limit (Clopper and Pearson, 1934).

Only three lots of treated spices tested positive post treatment during the two-year period: one lot 

each of black pepper, red pepper, and tarragon leaves. Of these lots, two had been treated with steam (one lot 

treated in the United States and the other lot treated in the source country) and one had been treated with 

ethylene oxide outside the spice source country (non-source/”other” country). There are not enough 

Salmonella-positive results to compare prevalence values by either treatment type or location. 
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The overall prevalence of Salmonella in the ASTA-member pathogen reduction treated spice lots sampled is 

statistically smaller than the value for imported spice shipments sampled at the point of entry to the United 

States during FY2007-FY2009. The difference is so large that it cannot be fully explained by a difference in 

sample size examined in the screening tests (25-375 g versus 750 g). Assuming that the methods of analysis 

used by ASTA members were validated and are comparable with the data from FDA and that the distribution 

of contamination within lots was not dramatically different than that found in the shipments examined by 

FDA, a plausible explanation for the difference observed is a difference in the sampled lots/shipments that 

had undergone a pathogen reduction treatment. 

ASTA members also tested spice lots for generic Escherichia coli post treatment during this time period, Table 

4.11. As with Salmonella sampling and testing data, contributing members used a number of different 

methods of analysis for Escherichia coli. “Typically,” two methods with similar detection limits were 

employed (AOAC method 991.14 (< 10 CFU/g; as reported by Ruckert, 2010)4 and AOAC method 966.24 (< 3 

MPN/g; as reported by Ruckert, 2010). We presume both methods examined 50 g of sample (AOAC method 

966.23, referenced in methods 991.13 and 966.24). Method descriptions are available from AOAC 

International (2005a, 2005b, 2005c). The three lots that tested positive for Salmonella post-treatment were 

not tested for the presence of Escherichia coli. 

The data on the prevalence of generic Escherichia coli post-treatment in Table 4.11 provide insights into the 

effectiveness of bacterial reduction treatments and post-treatment preventive controls. The predominance of 

black pepper lots in the data set (representing 30% of all lots sampled and 78% of lots testing positive) 

strongly influences the summary statistics and confounds other factors such as spice form (ground/whole) or 

the type of pathogen reduction treatment applied. The observations of positive Escherichia coli tests on spice 

lots after pathogen reduction treatment indicate that either the treatments were not totally effective or posttreatment preventive controls were ineffective in preventing contamination or growth of remaining 

Escherichia coli in the spice. Further research is needed to determine the cause(s) for these observations and 

whether the cause could have implications for contamination of spice lots with other pathogens.

The sampling results in Table 4.11 also indicate that lots of ground black pepper sampled had a statistically 

larger prevalence of Escherichia coli when compared with raw/whole black pepper. This differs from the 

result found for Salmonella prevalence among sampled shipments of black pepper offered for entry to the 

United States (Table 4.4). These same data are reflected in the summary data for all raw/whole spices and 

ground spices in Table 4.11. Additional data are needed to determine the reason for the difference.

 

4 Ruckert (2010) reported AOAC method 991.1 but it is likely the method was 999.14, which is the PetrifilmTM Escherichia 

coli /Coliform Count PlateTM method.
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Table 4.11. Frequency and prevalence of generic Escherichia coli contamination in spice lots in some 

ASTA member companies to which a pathogen reduction treatment had been applied, August 1, 2007-

July 31, 2009

Spice N # Positivea 

Escherichia coli

Lot Prevalence 

(%)a

95% Confidence 

Intervalb 

All Spicesb 25604 213 0.83 0.72-0.95

Spices subjected to different processes

Raw/Whole spicesc 11119 30 0.27 0.18-0.39

Ground Spicesc 9291 170 1.83 1.57-2.12

Whole Black Pepperc 3742 18 0.48 0.28-0.76

Ground Black Pepperc 3966 138 3.48 2.93-4.10

Spice treated with Ethylene Oxide 11601 4 0.03 0.01-0.09

Spice treated with Steam 12086 208 1.72 1.50-1.97

Spice treated with Irradiation 345 0 0.0 0.0-0.9

Spice treated with PPO 303 1 0.3 0.01-2

Spice treated with unspecified pathogen 

reduction processd 1270 0 0.0 0.0-0.0.2

a We presume both methods examined 50 g of sample (AOAC method 966.23, referenced in methods 991.13 and 966.24).

b 95% exact confidence limit (Clopper and Pearson, 1934). b Test data for one lot was excluded because of ambiguity as to whether the lot had undergone a pathogen reduction treatment before 

testing.

c Test data on lots for which raw/whole/ground status could not be determined were excluded in this analysis.

d Test data on lots for which a unique pathogen reduction process was not specified were grouped into this category.

4.1.4.2 FREQUENCY OF REPORTABLE FOOD REGISTRY ENTRIES ASSOCIATED WITH SALMONELLA 

–CONTAMINATED SPICES AND SEASONINGS. 

The Reportable Food Registry was established by Section 1005 of the Food and Drug Administration 

Amendments Act of 2007 (Pub. L. 110-85), which amended the FD&C Act by creating a new section 417 of the 

FD&C Act, Reportable Food Registry [21 U.S.C. 350f.] (U.S.C. 2007)

The FDA Reportable Food Registry tracks patterns of adulteration of food in the United States by requiring 

industry (responsible parties) (FDA, 2010b) to submit reportable food (FDA, 2010c) reports when “there is 

reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health 

consequences or death to humans or animals” (FDA, 2010c) and accepting voluntary reports from federal, 

state and local public health officials. More details about the program are provided in Section 8.1.3.4. 

Within the “Spices and Seasonings” category, described in the RFR Commodity Definitions document (FDA, 

2012e), Salmonella contamination led all other hazards reported in the first three years of the program. This 

category includes spices identified at 21 CFR 182.10 (FDA 2013f), and also lists examples of products such as 

whole and ground spices, rooibos, sesame seeds, poppy seeds, caraway, anise, fenugreek seeds, meat coatings 

and rubs, seafood seasonings, dried herbs, and dried ginger (FDA, 2012e.)

The number of primary entries, or the initial reports submitted by industry (responsible party) (FDA, 2010b) 

about a reportable food (FDA, 2010c) to FDA, reported for Salmonella in “Spices and Seasonings” was 16, 23, 

and 5 for years 1 (September 8-2009-September 7, 2010), 2 (September 8, 2010 – September 7, 2011), and 3 

(September 8, 2011 – September 7, 2012), respectively. The frequency of primary entries for Salmonella in 

“Spices and Seasonings” was the largest among all 28 food categories in Year 1, second largest in Year 2 and 

tied for fourth largest (with two other RFR food commodities) in Year 3. However, it is difficult to interpret 

frequency values and relative rankings without knowledge of the total number of products/lots tested of each 

food commodity type.
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4.1.5 RETAIL/END USER 

We were unable to identify any reports characterizing Salmonella prevalence or concentration in spices at 

retail (food service, grocery store, restaurants, or in the home) in the United States. Information from the FDA 

targeted sampling assignment in 2010 established that shipments of imported spice offered for entry to the 

United States and packaged for retail may be contaminated and may comprise a significant percentage of the 

contaminated shipments (~ 20% for imported capsicum and sesame seed shipments sampled during the 

Aug-Dec 2010 study period; Van Doren et al., 2013c). Surveillance studies at retail have been conducted in a 

number of different countries, Tables 4.1 and 4.2. Observed prevalence values ranged from 0% (with nonzero upper limits) to 10% with varying confidence limits listed in Table 4.1. Salmonella has been found in a 

wide variety of spices and spice blends at retail (listed in Table 4.1). As mentioned previously, most of the 

studies examined small samples of spice, which limit the ability of the screening test to detect Salmonella at 

low concentrations. 

Determinations of Salmonella concentrations in spices found at retail are listed in Table 4.2, with most arising 

from outbreak investigations. The largest concentration of Salmonella reported in a spice/spice blend was 11 

MPN/g (Lehmacher et al., 1995), sampled from the food manufacturer’s spice supply for the food implicated 

in the salmonellosis outbreak. A surveillance study from retail samples of black pepper and red pepper 

(capsicum) in Japan found mean concentrations of Salmonella of 0.086 MPN/g (86 MPN per 1000 g; HaraKudo et al., 2006; see Table 4.2 for details of calculation). Another surveillance study in the United Kingdom 

reported a range of Salmonella concentrations in sesame seeds and mixtures of seeds of <0.1-0.2 MPN/g 

(<10-20 MPN per 100 g; Willis et al., 2009). 

4.1.6 FREQUENCY OF FOOD RECALLS IN THE UNITED STATES ASSOCIATED WITH 

SALMONELLA–CONTAMINATED SPICES

Recalls of food products can provide insights into the prevalence of contamination in foods at retail but can 

also involve spice/spiced-foods collected at other stages of the farm-to-table continuum, e.g., during spice 

processing or food manufacturing. In the United States, recalls are typically initiated when analysis has 

identified that a food does not meet regulatory requirements, e.g., the product is contaminated or is 

mislabeled, or when a spice/food has been linked to human illness, such as an outbreak. Class I recalls involve 

“a situation in which there is a reasonable probability that the use of or exposure to a violative product will 

cause serious adverse health consequences or death” whereas Class 2 recalls involve “a situation in which use 

of or exposure to a violative product may cause temporary or medically reversible adverse health 

consequences or where the probability of serious adverse health consequences is remote” (FDA, 2013c). FDA 

further distinguishes recall events as either primary or secondary. Primary recall events are recalls initiated 

by the firm in which the triggering violation was found or that caused the violation whereas secondary recalls 

arise from firms that are recipients of the violative products for use as an ingredient in a final product. 

From 1969-2003, FDA identified 20 primary recalls of spices, all of which were because of Salmonella

contamination (Vij et al., 2006). The one other recall noted in the report, associated with Listeria

monocytogenes in bay leaves, was later determined to be a recall for fresh bay leaves, rather than dried bay 

leaves (Hogan, 2011). Most of the recalls (15/20) took place in the final four years of the study, 2001-2003. 

The large increase in recalls associated with Salmonella-contaminated spices in the latter four years of the 

study was attributed primarily to an increase in surveillance of Florida spice companies following a 

contamination finding in 2001 (Vij et al., 2006). None of the recalls were linked to outbreaks, despite the fact 

that some of the spice recalled had been marketed for some period of time (1-18 months; Vij et al., 2006).
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More recently, FDA has reviewed primary recall events associated with contaminated spices during the two 

year period January 1, 2008-December 31, 2009 (that were classified by FDA by March 23, 2010). Eight 

primary recall events involving one hundred and sixteen different products were initiated because of the 

presence/potential presence of Salmonella (Ma, 2013). The eight spice-associated recalls represented 2% of 

all Class I and II primary recall events and 26% of the Class I and II primary recall events associated with 

Salmonella contamination during that time period (Ma, 2013). Products recalled in one spice-associated event 

were also implicated in or related to the Salmonella Rissen outbreak (described in Chapter 2) attributed to 

consumption of contaminated white pepper (Ma, 2013). 

Root causes for the spice recalls were determined by a panel of seven FDA scientists from an analysis of the 

data and information provided by industry and FDA. Lack of supplier control was identified as a contributing 

factor in each of the eight primary recall events associated with Salmonella contamination of spices. In 

addition, insufficient/inadequate sanitation controls, environmental monitoring and training were also 

identified as root causes for the recalls associated with the white pepper outbreak (Ma, 2013). 

The scope of spice recalls is not easily captured by the number of events or products recalled. For example, 

the single recall event in the United States involving ready-to-eat salami products related to the Salmonella

Montevideo/Senftenberg outbreak associated with contaminated black and red pepper resulted in 234,686 

pounds of salami products being recovered from the marketplace (USDA/FSIS, 2010). In the Salmonella

Wandsworth and Typhimurium outbreak associated with a contaminated broccoli powder ingredient in a 

snack puff food, recalls focused on trying to capture some of the ~1.3 million bags of the snack food that had 

been distributed in the United States and Canada (Hogan, 2010).

4.1.7 INTERNATIONAL REPORTS OF FOOD SAFETY HAZARDS ASSOCIATED WITH 

SALMONELLA–CONTAMINATED SPICES - RASFF

The European Commission Rapid Alert System for Food and Feed (RASFF) notifies member states of the 

“existence of a serious direct or indirect risk to human health deriving from food or feed, this information is 

immediately notified to the Commission under the RASFF” (EC/DG SANCO, 2012a). During the years 2001-

2011, 44.8% of RASFF notifications on selected biological hazards (including Salmonella, Escherichia coli, 

Bacillus spp., Campylobacter spp., Listeria monocytogenes, Shigella spp., Staphylococcus aureus, Clostridium 

botulinum, Hepatitis A, norovirus, and Caliciviruses) in food of non-animal origin were from the category

“Herbs and Spices.” Eighty percent of the “Herbs and Spices” RASFF notifications during this time period 

were associated with Salmonella (Altieri and Robinson, 2013; EC/DG SANCO, 2012b). Products in the “Herbs 

and Spices” category may include dry or fresh products. 

4.2 FILTH

Methods of analysis used to determine filth adulteration of spice vary with filth element and spice type and 

form (e.g., ground or whole). All methods of analysis used by FDA are described in the Macroanalytical 

Procedures Handbook (FDA, 1998a). To determine whether the concentration of filth is less than the DAL (for 

natural or unavoidable defects in foods), FDA typically examines six spice subsamples taken from different 

portions of the spice shipment/lot. For example, the DALs for ground black pepper include specifications for 

insect fragment parts (≥475 insect fragments per 50-g spice) and rodent hairs (≥2 rodent hairs per 50-g 

spice). To determine whether a shipment of ground black pepper is adulterated with filth, FDA collects six 50-

g samples and examines each subsample for insect fragment and rodent hairs. The shipment would be 

adulterated if the average concentration of either of the filth elements was not smaller than the DAL.
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4.2.1. FILTH ADULTERATION PREVALENCE OF SPICE: FROM FARM TO TABLE OVERVIEW 

Little experimental data have been reported on the prevalence or concentration of filth in spices throughout 

the farm-to-table continuum. FDA regularly samples imported foods including spices, for filth and these data 

were analyzed to provide a measure of the extent of filth contamination of imported spices at the point of 

import. 

4.2.2. PRIMARY PRODUCTION 

We were unable to identify any reports characterizing filth contamination in/on spice source plants preharvest, filth adulteration of spices, or concentrations of filth elements in spices at primary production sites. 

Because spices are derived from parts of plants and are often dried in open air environments, the presence of 

twigs, dirt and field insect parts are not unexpected (ASTA, 2011). These types of filth are termed “natural or 

unavoidable defects” by FDA and are acceptable when found in spices at concentrations below the DALs. 

4.2.3. DISTRIBUTION AND STORAGE

Surveillance data on the prevalence of filth adulteration of spices during distribution and storage is limited to 

evaluations of these quantities at the point of import; we were not able to identify any surveillance studies of 

the prevalence of filth adulteration of spice located in storage facilities or at other points of the distribution 

chain. However, inspections of spice processing/packing facilities and food manufacturing facilities provide 

some information about the potential for adulteration of spice/food in the storage areas of the facilities. 

Inspections are discussed in Section 8.1.3.1. 

4.2.3.1 FILTH ADULTERATION OF SHIPMENTS OF IMPORTED SPICE OFFERED FOR ENTRY TO THE 

UNITED STATES

Data reported in this section are derived from two studies of FDA sampling data (1) review of results from 

the annual sampling program for the years FY2007-FY2009 and (2) review of sampling results from a 

targeted sampling assignment in 2010 (August-December) that focused on examining imported shipments of 

capsicum and sesame seed offered for entry to the United States for potential filth adulteration. 

Selection of shipments of imported spice/other food for examination under FDA’s annual field work plan is 

based on a number of factors including the inherent risk of the product, general surveillance activities 

described in the FDA work plan, FDA work performance goals and/or congressional work performance goals. 

All data examined in the FY2007-FY2009 study presented below were drawn from “surveillance sampling 

activities”, as described above, as opposed to compliance activities. 

All shipments of imported capsicum or sesame seed were eligible for sampling for the 2010 targeted study. A 

total of 299 shipments of capsicums and 233 shipments of sesame seeds were sampled at the point of import 

into the United States between August and December 2010. The shipments sampled constituted 

approximately 10 or 20 percent of all shipments of imported capsicum or imported sesame seed shipments, 

respectively, offered for entry to the United States.
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Observed filth adulteration in shipments of imported spice offered for entry to the United States

Summary results for prevalence of filth adulteration (defined in Section 3.2) in imported shipments of spices 

offered for entry to the United States during FY2007-FY2009 are presented in Table 4.12. The overall 

prevalence for filth adulteration of imported spice shipments during that time period was 12% (95% CI 10-

15%). This value is 1.8 times (RR 95% CI 1.4-2.2) the value found for all other shipments of imported FDAregulated foods sampled during this time period. 

Table 4.12. Prevalence of filth adulteration in shipments of imported spice or other FDA-regulated 

foods offered for entry to the United States, FY2007-FY2009 

Spice/Food # Positive N Filth Shipment 

Prevalence (%)

95% Confidence 

Intervala

All Imported Spicesb 82 665 12 9.9-15

All other Imported FDA-regulated Foodsb 585 8350 7.00 6.47-7.57

Spices Subject to different processesc

Ground/cracked Spice 28 257 11 7.4-15

Whole Spice 24 165 15 9.5-21

Specific Spices

Capsicumd 21 115 18 12-27

Pepper, Black 1 54 2 0-10

Sesame Seed 7 71 10 4-19

Spices/Spices and Seasonings, NECe 28 181 15 10-22

All other spices 25 244 10 6.7-15 a 95% exact confidence limit (Clopper and Pearson, 1934). b All shipments of imported FDA-regulated spices or other imported foods that were sampled during the study period. c Categorizations derived from product code and description. When description was insufficient to categorize, the sample was not 

included. Note that analytical methods used to determine filth in ground/cracked spices differs from those used to determine filth in 

whole spices. See text for details. 

d Capsicum includes paprika as well as hot and other sweet dried capsicum peppers.

e Shipments of spices “not elsewhere classified” (NEC) in the product code are assigned to “Spices, NEC”, “Spices and Seasonings, NEC”, or 

“Mixed Spices and Seasonings, NEC.”

Our data indicate that the prevalence rates for imported shipments of ground/cracked spice do not differ 

statistically from that of whole spice (p>0.05). When comparing filth adulteration prevalence values for 

shipments of different types of spice, we find that the prevalence for shipments of imported black pepper was 

smaller than that for shipments of imported capsicum, “spices/spices and seasonings, NEC”, or the category 

“all other spices” (Marascuilo procedure) among those sampled during FY2007-FY2009. Results from the 

2010 sampling assignment targeting imported shipments of sesame seeds and capsicums found essentially 

the same filth adulteration prevalence for capsicum (18% 95% CI 14-24%) but a much smaller filth 

adulteration prevalence for shipments of sesame seed (0.5%, 95% CI 0.0-2.5%) than was observed for the 

period FY2007-FY2009. More data are needed to determine whether the smaller prevalence value reflects a 

sustained reduction in the prevalence of filth in imported sesame seed shipments. 

The types of filth adulteration found in sampled shipments of imported spices offered for import during the 

three year study period are presented in Table 3.4. The most prevalent types of filth elements were insect 

fragments, whole/equivalent insects, and animal hair. As mentioned in Chapter 3, almost all of the insects 

found in these spice samples are stored product pests with some test portions analyzed containing four or 

more species of pests in a single test portion. The presence of the specific insects found indicates poor 

handling, storage, or cleaning of the spices. One of the species found, Monomorium pharaonis (Pharaoh ant), 
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has been identified as a vector of food borne pathogens (Olsen et al., 2001). Another, Acarus siro (grain mite), 

has been associated with allergic reactions in people handling products containing this mite (Olsen, 1998b). 

A review of the FDA sampling database for imported spice shipments offered for U.S. entry FY2007-FY2009 

showed that hair was detected in 253 (38% of sampled) shipments of imported spice (Table 4.13), although 

not all of these shipments were determined to be adulterated by filth. Of the hair found, 38% was identified to 

be from rodents. As discussed in Chapter 3, the presence of rodent hair without a hair root in spices generally 

is an indication that the spice had been contaminated with rodent feces. All hairs found in food are indicative 

of insanitary conditions and therefore failures in the application of Good Agricultural Practices (GAPs) and

Table 4.13. Hairs found in shipments of imported spice offered for entry to the United States, FY2007-

FY2009

FY 07-09 Hair Summary # Test Portions # Shipments 

Human hair 47 35

Bat 1 1

Cat 32 19

Cow 1 1

Dog 1 1

Mammalian 23 11

Mouse/Rat 244 85

Other 19 10

Rabbit 3 3

Rat 1 1

Rodent 15 11

Non-striated 13 7

Sheep 1 1

Striated 37 18

Unknown 129 49

All Hairs 567 253

Current Good Manufacturing Practices (CGMPs). For example, human hair in spice could arise when workers 

handling the spice fail to use hair nets while cat/dog hair could arise if the spice processing/packing/storing 

facility employs these animals for rodent control. In addition, direct evidence of animal fecal and/or insect 

fecal contamination was found in a small number of the samples.

Foreign substances found in spices ranged from twigs and sticks to staples, stones, and various fibers (Table 

3.4). Most of these materials can be classified as hard and/or sharp objects; e.g. sticks, stones, staples; which 

are physical hazards in foods (Olsen, 1998a) and are classified as action Category 1 analytes (indicators of a 

potential food safety hazard) according to the 1999 revised filth strategy, and violate section 402(a)(1) of the 

FD&C Act. Others, such as fibers or rubber bands, are action category 2 (detectable and objectionable to the 

consumer), potentially violating section 402(a)(4) of the FD&C Act.

4.2.4. SECONDARY PROCESSING AND MULTI-COMPONENT FOOD MANUFACTURING

We were unable to identify any reports characterizing the prevalence or concentrations of filth adulteration 

in spice found in processing, packing or food manufacturing facilities. Spice manufacturers regularly apply 

physical cleaning techniques to remove filth elements from raw spice during secondary processing. However, 

inspections of spice processing/packing facilities and food manufacturing facilities provide information about 
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the facility environment and the potential for adulteration of the spice/food within that environment. 

Inspections are discussed in Section 8.1.3.1. Review of FDA inspection data for a group of 59 domestic spice 

firms inspected as part of a special assignment to support this risk profile revealed that the presence of pests 

was among the most common findings reported. 

4.2.5. RETAIL/END USER

We were unable to identify any reports characterizing the prevalence or concentrations of filth in spice at 

retail other than the surveys FDA conducted in the 1980s (Gecan et al., 1983; Gecan et al., 1986) which were 

used to set the DALs for the spices listed in Table 3.3. FDA generally set DALs to values that would reflect 

significant deviation from the best practices of industry and agriculture at that time. 

4.3 PREVALENCE OF BOTH SALMONELLA AND FILTH ADULTERATION OF SPICES

In 1960, Kenton Harris wrote in Food and Drug Technical Bulletin No. 1:

“Often the line of demarcation between a harmful and a filthy food is exceedingly narrow. 

Many of the sources of filth in food products are potential sources of disease organisms. It is 

well known that rodents are vectors of several diseases transmissible to man, including 

typhus, plague, infectious jaundice, and Salmonella infection. Flies and roaches may harbor 

pathogenic bacteria and transmit infection to foods. Rodents, flies, and other insects closely 

associated with filth and insanitary conditions are capable of mechanically transferring 

pathogenic and spoilage organisms from such filth directly to food products. Therefore, 

certain forms of filth contamination of food carry implications of danger to health although 

the demonstration of specific agents of disease may be difficult or impossible” 

By 2001, the body of scientific evidence demonstrating a relationship between some types of filth and specific 

agents of disease had grown significantly, as described in detail in FDA’s 2001 review of the scientific 

literature (Olsen et al., 2001). Insects, rodents and other animals possessing the following five attributes: 

“synanthropy, endophily, communicative behavior, attraction to filth and to human food, and harborage of 

pathogens in the natural (wild) populations” are recognized as having the potential to spread pathogens to 

human food (Olsen et al., 2001 and references therein). As a consequence, it is possible that the presence of 

filth and pathogens in spices could be correlated, at least at some points along the farm-to-table continuum.

In 1989 FDA performed a limited study comparing the microflora recovered from samples of spice and fecal 

pellets found in spice from shipments of spice offered for entry to the United States and reported no 

correlation (Satchell et al., 1989). Interpretation of these data with regard to the correlation between filth and 

spice contamination with pathogens is limited because the results were based on a very small data set. In the 

1989 study, 1-4 fecal pellets from each of nine shipments were examined for microflora and compared with 

microbiological test results on two 375 g samples from each shipment. Escherichia coli (generic) was found in 

two pellets but neither Salmonella nor Escherichia coli was found in spice samples from the nine shipments 

(Satchell et al., 1989).

In order to address whether adulteration of spice by filth and Salmonella are correlated at the point of entry 

to the United States, we analyzed FDA sampling data for shipments of imported spices and food offered for 

entry during the years FY2000-FY2009 (except FY2002 for which there were incomplete data). A total of 883 

shipments of imported spice were examined for both Salmonella and filth during this time period. Results of 

FDA tests are presented in Table 4.14. Evaluation of the Fisher exact p-value indicates that the correlation 

between Salmonella and filth contamination of imported spices at the point of import is not significant 

(p>0.05) for the sampled shipments examined. In contrast, correlation between Salmonella and filth 
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contamination in other imported FDA-regulated food shipments examined for both contaminants during this 

same time period (4557 shipments) was found to be highly significant (p<0.001), as shown in Table 4.15. 

Table 4.14. Examination of relationship between presence of filth and Salmonella adulteration of 

shipments of imported spice offered for entry, FY2000-FY2009 (except) FY2002

Filth

# Positive for 

Salmonella

# Negative for 

Salmonella

Fisher Exact 

p-Valuea

# Positive for 

Filth 13 100 na

# Negative for 

Filth 59 711 na

Fisher Exact 

p-Valuea na na 0.195

a Fisher exact p-value (SAS, 2012). “na” indicates measure is not applicable for the cell.

Table 4.15. Examination of relationship between presence of filth and Salmonella adulteration of 

shipments of imported foods offered for entry, FY2000-FY2009 (except) FY2002

Filth

# Positive for 

Salmonella

# Negative for 

Salmonella

Fisher Exact 

p-Valuea

# Positive for 

Filth 25 234 na

# Negative for 

Filth 151 4147 na

Fisher Exact 

p-Valuea na na <0.001

a Fisher exact p-value (SAS, 2012). “na” indicates measure is not applicable for the cell.

The absence of a correlation for shipments of imported spices offered for entry to the United States may 

result from a lack of statistical power (data for a small number of shipments are compared) or may signify 

that spices or the spice supply chain practices before import are characteristically different (on average) with 

regard to contamination with Salmonella and filth from those of other imported FDA-regulated products 

(among those sampled). It is common for spice producers and/or processors to physically clean raw spices to 

remove visible filth; this often takes place at primary production, while additional cleaning can take place 

during secondary processing (see Chapter 6). Pathogen reduction treatments are also commonly applied to 

some spices. Such treatments are performed in the secondary processing phase of the spice farm-to-table 

continuum, which may take place before or after import. The combination of these practices may remove any 

correlation between the presence of Salmonella and filth in shipments of imported spice at the point of entry 

to the United States, if any existed initially. More research is needed to understand how the prevalence of filth 

and Salmonella adulteration of spices changes along the supply chain from farm to the consumer table.
FDA Draft Risk Profile | 64 

5. CHARACTERIZATION OF CONTAMINANTS

The goal of this section is to highlight the characteristics of Salmonella and filth adulteration that impact their 

potential risk to public health when found in spices. The sections below are not meant to reproduce or 

comprehensively review the vast literature on Salmonella or filth but rather provide general/representative 

references for key statements. 

Data on the survival of Salmonella in spices and the potential for growth of Salmonella in wet spices were very 

limited. In order to begin to address this data gap, FDA scientists undertook a series of experiments to 

evaluate these properties in ground black pepper. A full description of the experiments and results can be 

found in Keller et al. (2013). In sections 5.1.2 and 5.1.3, we present key results and conclusions and compare 

our results with related reports in the literature. 

5.1 SALMONELLA

5.1.1 GENERAL CHARACTERISTICS OF SALMONELLA

There are two species of Salmonella: S. enterica and S. bongori (WHO, 2007). Salmonella enterica is further 

divided into six subspecies, each with many serovars: enterica (I), salamae (II), arizonae (IIIa), diarizonae

(IIIb), houtenae (IV), and indica (VI) (WHO, 2007). As shown in Table 3.2, all of the Salmonella strains isolated 

from spices in the United States have been Salmonella enterica and have included strains from five of the six S. 

enterica subspecies.

While the primary habitat for Salmonella is considered to be the intestinal tract of vertebrates such as birds, 

animals, rodents, reptiles, and humans (FDA, 2012d) most variants can survive for extended periods in nonhost environments. For example, it has been shown that Salmonella can survive in soil (Garcia et al., 2010; 

Bech et al., 2010), water (Ceballos et al., 2003; Skariyachan et al., 2012; Micallef et al., 2012), plants (Franz 

and van Bruggen, 2008; Barak et al., 2011; Gu et al., 2013), manure and soil amended with manure (Ongeng et 

al., 2011; Bech et al., 2010; Semenov et al., 2009; Islam et al., 2004; Garcia et al., 2010), on 

equipment/surfaces (Mattick et al., 2003; Castelijn et al., 2013), and in low moisture foods (Podolak et al., 

2010; Ristori et al., 2007; Beuchat and Scouten, 2002; Komitopoulou and Penaloza, 2009; Lehmacher et al., 

1995; Uesugi et al., 2006; Keller et al., 2013; FDA, 2012d). Indeed, a key characteristic of Salmonella related to 

spice contamination is its ability to resist dry, desiccation conditions for extended periods (Beuchat and 

Scouten, 2002; Hiramatsu et al., 2005; Du et al. 2010; Beuchat and Mann, 2010; Podolak et al., 2010; Kimber 

et al., 2012; Blessington et al., 2012). 

Salmonella has been found in and on insects, which can transport the bacteria from one location to another 

(Crumrine et al., 1971; Holt et al., 2007; Wang et al., 2011; Hoelzer et al., 2011; Pava-Ripoll et al., 2012). 

Beyond survival, most variants of Salmonella can grow in a variety of non-host environments, given sufficient 

water, nutrients, and other appropriate environmental conditions (Combase Consortium, 2012; Harris et al., 

2003; Brandl, 2006; Danyluk et al., 2008; Franz and van Bruggen, 2008; Du et al., 2009a; Beuchat and Mann, 

2010; Keller et al., 2013). This adaptability enables Salmonella to cycle between animal host and 

environment, thereby extending the lifetime of the bacteria/bacterial colony and “ensuring its passage to the 

next host” (Winfield and Groisman, 2003; Foster and Spector, 1995; Podolak et al., 2010).

A direct consequence of Salmonella’s ability to survive in non-host environments is that it is widely dispersed 

in nature and that when Salmonella-contaminated material (animate or inanimate) comes in contact with the 
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spice source plant or spice before human consumption it may be a potential source of viable bacterial 

contamination. 

5.1.2 ANTIMICROBIAL PROPERTIES OF SOME SPICES

Essential oils of some spices possess antimicrobial properties which can inhibit the growth of bacteria 

including Salmonella, Bacillus cereus, Staphylococcus aureus, and Escherichia coli under some conditions (AlDelaimy and Ali, 1970; Farbood et al., 1976; Shelef et al., 1980; Shelef, 1983; Shelef, et al., 1984; Aktug and 

Karapinar, 1986; Karapinar and Aktug, 1987; Zaika, 1988; Billing and Sherman, 1998; Smith-Palmer et al., 

1998; Arora and Kaur, 1999; Hammer et al., 1999; Dorman and Deans, 2000; Ceylan and Fung, 2004; Burt, 

2004; Du et al., 2009a; Du et al., 2009b; Tajkarimi et al., 2010; Weerakkody et al., 2011). For example, AlDelaimy and Ali (1970) reported that 1% v/v garlic extract inhibited growth of Escherichia coli and 

Salmonella Typhi while Smith-Palmer et al. (1998) reported that essential oils of bay, cinnamon, clove and 

thyme inhibited growth of Salmonella Enteritidis at a concentration of 0.075%.

Many studies have demonstrated that the strength of the inhibitory effect depends on the essential oil, its 

concentration, and the pathogen (including strain), among other factors (Al-Delaimy and Ali, 1970; Farbood

et al., 1976; Shelef et al., 1980; Shelef, 1983; Shelef et al., 1984; Aktug and Karapinar, 1986; Karapinar and 

Aktug, 1987; Zaika, 1988; Billing and Sherman, 1998; Smith-Palmer et al., 1998; Arora and Kaur, 1999; 

Hammer et al., 1999; Dorman and Deans, 2000; Ceylan and Fung, 2004; Burt, 2004; Tajkarimi et al., 2010; 

Weerakkody et al., 2011). For example, Shelef et al. (1980) reported that Salmonella Typhimurium needed 10 

times more sage for inhibition in broth than B. cereus. Karapinar and Aktug (1987) reported that eugenol, 

which is the key antimicrobial compound in cloves, had a smaller minimum inhibitory concentration for 

Salmonella Typhimurium than thymol or anethole, essential oils in thyme and anise seed, respectively. 

Spices containing essential oils with strong inhibitory effects towards Salmonella may limit the growth of the 

pathogen in some foods if the concentration of the spice/essential oil is sufficient and other conditions are 

appropriate. What is not known is the extent to which the presence of antimicrobial essential oils in some 

spices impact survivability of Salmonella in low moisture foods in general or the spice itself. The relatively 

large Salmonella prevalence found by FDA for shipments of oregano and allspice offered for import to the 

United States during FY2007-FY2009 demonstrates that the antimicrobial activity against Salmonella is not 

sufficient to eliminate Salmonella contamination from shipments of these types of spices (as discussed in 

Section 4.1.3.1). 

5.1.3 SURVIVABILITY IN SPICES

It is well established that salmonellae survive long periods in low moisture foods and dry environments 

(Beuchat and Scouten, 2002; Hiramatsu et al., 2005; Du et al. 2010; Beuchat and Mann, 2010; Podolak et al., 

2010; Kimber et al., 2012; Blessington et al., 2012). Lehmacher et al. (1995), analyzing samples of paprika, 

demonstrated that Salmonella can survive for at least 8 months in samples of that spice but the specific 

conditions under which the spice was stored and how these impacted survival were not recorded. FDA 

undertook a series of experiments to characterize how survival of Salmonella in a spice depends on storage 

conditions (Keller et al., 2013). Samples of ground black pepper were inoculated with a cocktail of Salmonella

strains, held at 35 or 25°

C, and stored under either high relative humidity (RH, 97%) or under low RH 

(typically ≤ 40%). Results for these experiments are presented in Figures 5.1-5.4. 
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Figure 5.1. Survival of Salmonella at 25°C and 

high (97%) RH. Mean and standard deviation of 

Salmonella population (▲); black pepper water 

aw, (∆). Error bars represent the standard 

deviation calculated from three replicate samples; 

absence of detection was assigned a value of zero. 

Limit of detection (LOD) for the analysis was 1.69 

log CFU. 

Figure 5.3. Survival of Salmonella at 25°C and 

ambient (≤40) RH. Mean and standard deviation 

of Salmonella population (▲); black pepper water 

aw, (∆). Error bars represent the standard 

deviation calculated from three replicate samples; 

absence of detection was assigned a value of zero. 

LOD for the analysis was 1.69 log CFU.

Figure 5.2. Survival of Salmonella at 35°C and 

high (97%) RH. Mean and standard deviation of 

Salmonella population (▲); black pepper water 

aw, (∆). Error bars represent the standard 

deviation calculated from three replicate samples; 

absence of detection was assigned a value of zero. 

LOD for the analysis was 1.69 log CFU.

Figure 5.4. Survival of Salmonella at 35°C and 

ambient (≤40) RH. Mean and standard deviation 

of Salmonella population (▲); black pepper water 

aw, (∆). Error bars represent the standard 

deviation calculated from three replicate samples; 

absence of detection was assigned a value of zero. 

LOD for the analysis was 1.69 log CFU.

Under high humidity conditions, a rapid decline in the population of Salmonella was observed (Figures 5.1 

and 5.2) and was faster at 35oC than at 25oC. At 35oC, the surviving Salmonella population fell below detection 

limits (1.69 log CFU/g) after 60 days, while at 25oC, Salmonella decreased below this point after 100 days of 

0.00

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storage. In contrast, at low RH, population reduction rates were much smaller, with Salmonella survival 

exceeding 280 days at 35oC and 365 days at 25oC (the length of the experiments), as illustrated in Figures 5.3 

and 5.4. Figures 5.1-5.4 also illustrate how the humidity of the environment affects the water activity (aw) of 

the exposed black pepper and suggests that the Salmonella population reduction rate is related to the water 

activity of the black pepper. Beuchat and Scouten (2002), investigating Salmonella population reduction rates 

in alfalfa seeds, also found that Salmonella population reduction rates decreased with decreasing water 

activity or temperature. Ristori et al. (2007), examining Salmonella Rubislaw in black pepper, also found 

Salmonella population reduction rates increased with storage temperature but did not find statistically 

different population reduction rates for aw in the range 0.663-0.937. The absence of a significant aw

dependence for the population reduction rate in their experiments may be related to the short time scale of 

the experiment (15 days) and the limited aw range examined (Ristori et al., 2007). Similarly slow population 

reduction rates have been found for Salmonella on almonds, pistachios, or walnut kernels held at 23-24°C, 

after initial drying following addition of a wet inoculum (Kimber et al., 2012; Blessington et al., 2012). 

Although the humidity of the storage environment may vary from location to location and in some locations, 

may not be well controlled, it may not often reach the high levels examined in the FDA study that resulted in 

reduced survival of Salmonella. Storage conditions meeting spice industry standards (ASTA, 2011; ESA, 2011) 

will result in spice with relatively low water activity, a condition that can result in long-term survival of 

Salmonella, if present. 

The mechanism by which Salmonella is able to survive desiccation so efficiently is an active area of research. 

Some studies have pointed to that Salmonella morphological changes such as the formation of filamentous 

cells and multicellular morphology (rdar) during desiccation are critical for its survival (White et al., 2008; 

Mattick et al., 2000), while other studies have identified that the o-antigen capsule determined by 

extracellular polysaccharides is critical for Salmonella persistence in dry environments (Garmi et al., 2008; 

Gibson et al., 2006; Finn et al., 2012). Transcription analysis at genomic level suggests the involvement of 

fatty acids metabolism and osmotic compatible solutes in Salmonella desiccation stress response (Li et al., 

2012). The relative importance of these and other factors in facilitating the survival of Salmonella in low 

moisture foods has yet to be determined.

Resistance to heat, irradiation, and disinfectants.

Salmonellae are desiccated/dehydrated when in low moisture foods such as spices and desiccation/ 

dehydration of some strains of Salmonella has been shown to increase the organism’s tolerance to heat, UV 

irradiation, and disinfectants (Doyle and Mazzotta, 2000; Hiramatsu et al., 2005; Podolak et al., 2010; Gruzdev 

et al., 2011; Keller et al., 2012; Harris et al., 2012) as compared with the non-desiccated organism. For 

example, Gruzdev et al. (2011) found that application of 100oC for 1 hour to desiccated Salmonella enterica

serovar Typhimurium was insufficient to eliminate all viable bacteria in the sample. Other studies have 

shown that heat and irradiation tolerance are related to water activity of the food/sample (Barrile and Cone, 

1970; Goepfert et al., 1970; Jeong et al., 2012). The extent of tolerance can also be dependent on serotype and 

food matrix (Gruzdev et al., 2011; Nascimento et al., 2012) and decimal reductions during thermal pathogen 

reduction treatments can exhibit non-linear behavior where the rate of decline decreases with increasing 

time (Beuchat and Mann, 2012; Abd et al., 2012; Blessington et al., 2012). Gruzdev et al. (2011) found that 

rehydration of previously desiccated Salmonella may not fully restore susceptibility to heat. These 

observations indicate that application of pathogen reduction and disinfection methods developed for foods 

other than spices may not be as effective as anticipated when applied to spices.

5.1.4 POTENTIAL FOR GROWTH IN MOISTENED SPICES AND SPICE-CONTAINING FOODS

The threshold water activity for growth of Salmonella is reported to be 0.94 (ICMSF, 1996) which is much 

higher than the water activity recommended for storage of spices by the spice industry (≤0.75, ASTA, 2011; 

0.65, ESA, 2011). Therefore, Salmonella will not grow in spice when maintained at recommended water 
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activities. However, we wanted to determine whether Salmonella could grow in spice when water is added, 

i.e., are there sufficient nutrients in spice to support growth when wet that could potentially lead to increased 

concentrations of Salmonella in spice or create Salmonella niches in the spice supply chain environment that 

could facilitate cross-contamination? Whole black pepper could be exposed to moisture during the drying 

process, if not protected from rain, or during storage, if the packing material is not waterproof. Ground black 

pepper, either in the production line or in the spice /food manufacturing environment, could become wet 

during processing/packing as a result of wet cleaning or poor facility design/maintenance. Ground black 

pepper could also become wet during storage if the material in which it is packaged or stored is not 

waterproof and the environment in which it is stored is not designed and maintained properly (e.g., holes in 

the roof, condensation, or high humidity). In addition, ground black pepper could become wet during food 

preparation in a home or restaurant, e.g., when exposed to steam or humid air. To minimize the occurrence of 

these possibilities, Codex Alimentarius (Codex) has developed guidance for spice production, processing and 

use (Codex Alimentarius, 1995), the U.S. has developed the Current Good Manufacturing Practices (FDA, 

2012a) and the spice and food industries have developed guidance for processing and food manufacturing 

facilities handling low moisture foods (ASTA, 2011; ESA, 2011; GMA, 2009). 

FDA scientists designed experiments to determine whether Salmonella can grow in moist/wet black pepper 

at temperatures typical of spice processing, storage and use (excluding cooking) and if so, whether growth 

rates are comparable to those in optimized media (Keller et al., 2013). The water activity threshold for 

growth in ground black pepper at 35oC was determined to be 0.979 ± 0.003 (Keller et al., 2013) which is 

higher than the threshold (0.94) reported for Salmonella in other food products (ICMSF, 1996). The difference 

between the threshold for Salmonella growth in ground black pepper and the threshold reported in other 

foods may be related to the presence of antimicrobial compounds in ground black pepper but also could be 

related to other differences in the black pepper growth environment as compared with an optimized growth 

environment. 

Salmonella generation times in ground black pepper under permissive water activity conditions were short, 

similar to maximum growth rates recorded in optimal growth media (ICMSF, 1996). Therefore, growth of 

Salmonella could represent a substantial risk to the food industry should the pepper become wet, that is, 

when industry standards for spice water activity are exceeded. These experiments demonstrated that ground 

black pepper at water activities near the threshold for growth of Salmonella may not be noticeably wet, as 

shown in Figure 5.5. Small, local areas of high water activity may be able to develop if condensate or other 

small drops of water are allowed to contaminate stored black pepper or black pepper dust that may 

accumulate in the spice processing/packaging or food manufacturing environments. These local areas may 

also develop from the condensation of moisture from insect respiration (Williams et al., 2004). Such small 

localized areas may not be obvious during storage and manufacture but could result in a significant risk of 

Salmonella growth in contaminated black pepper products or in the creation of environmental niches. 

However, generation and lag times increased when the water activity of the ground black pepper was 

lowered below the optimal value (Keller et al., 2013). This means that in the case of an accidental addition of 

water to ground black pepper, growth may be limited if the time for evaporation is shorter than the lag time 

for growth initiation.

Spice-containing foods can exceed the threshold water activity value for growth and provide nutrients and an 

environment that support growth (Combase Consortium, 2012). However, not all moist foods will support 

growth due to intrinsic characteristics of the food such as pH and salt content. For example, Fedoruk (2011) 

estimated the risk of salmonellosis from consumption of dairy-based snack food dips made from 

contaminated spice and found that the acidity of the food limited growth.
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Figure 5.5. Appearance of ground black pepper at different water activities (aw).

5.1.5 CHARACTERISTICS OF THE NON-TYPHOIDAL SALMONELLOSIS

Salmonella Dose-Response 

While there is no dose-response model specifically derived from outbreak investigations or challenge studies 

of Salmonella in spices or low moisture foods, the WHO/FAO developed a dose-response model for 

Salmonella in 2002 based on 20 outbreaks associated with food (WHO/FAO, 2002). Figure 5.6 illustrates the 

WHO/FAO beta-Poisson model and the insert shows predictions for low dose, illustrating a nearly linear 

dose-response relationship predicted for doses up to ~20 CFU. Low dose exposures are expected from 

consumption of contaminated spices based on the concentrations of Salmonella reported in spices (Section 

4.1.1 and Table 4.2) and the typical serving size for spice per eating occasion (Section 7.2.2). 

This beta-Poisson model predicts that a dose of approximately 4 CFU (95% CI 3-5 CFU) would infect 1% of 

the exposed population (ID1) while a dose of approximately 63 CFU (95% CI 44-90 CFU) would infect 10% of 

the exposed population (ID10). Although data used to develop the dose-response model did not include 

spices, the ID1 predicted by the WHO model is consistent with the rough estimate made by Lehmacher et al. 

(1995) of 4-45 MPN, based on data from the 1995 salmonellosis outbreak attributed to consumption of 

contaminated paprika in paprika-powdered potato chips. Low doses of Salmonella from consumption of 

contaminated spices would be anticipated from the concentration of Salmonella found in contaminated spices 

(Table 4.2) and the typical amounts of spice consumed in a single eating occasion (Section 7.2.2).
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Figure 5.6. WHO/FAO dose-response model for Salmonella. Solid line is expected value; dashed lines 

bracket 95% confidence limits, derived from WHO/FAO, 2002. Inserted graph is an expansion of the main 

graph in the dose range 0-60 CFU.

Teunis et al. (2010), analyzing an expanded data set from that used by WHO/FAO and using more complex 

modeling strategies that included a two-level dose-response model, predicts the ID1 for illness to be 0.395 

CFU (95% CI: 0.01-89.7 CFU). The study examined whether the dose-response relationship differed by 

serotype or susceptibility (defined as less than 12 years of age or older than 65 years of age) and reported no 

statistically significant differences in models for different serotypes or susceptibility categories among those 

considered.5 

Bollaerts et al. (2008), also using a two-level dose-response model, re-examined the dataset used by WHO 

and found differences in dose-response models for different Salmonella serotype-food matrix combinations. 

Spices were not among the foods in the data set but an outbreak involving one low moisture food (cheddar 

cheese) was included. The models developed by Bollaerts et al. (2008) were not able to separate the effects of 

serotype and food matrix. The dose-response models of Bollaerts et al. (2008) predict larger probabilities of 

illness for susceptible populations (>60 years of age) for certain ranges of dose. For the serotype-food 

matrices with the steepest dose-response relationships, susceptible individuals are predicted to have a 

greater probability of illness at low dose than non-susceptible individuals. For the serotype-food matrices 

with less steep dose-response relationships, differences in susceptible and non-susceptible populations are 

 

5 Teunis et al. (2010) used his model to estimate the number of people exposed in the outbreak attributed to consumption 

of contaminated paprika-powdered potato chips. However, the estimated attack rate taken from Lehmacher et al. (1995) 

quoted in Teunis et al. (2010) was incorrect.
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predicted for high doses (Bollaerts et al., 2008). For all other doses, susceptible and non-susceptible 

populations have similar responses.

None of the three dose-response models address the severity of illness or health outcome and whether these 

differ with age. 

Primary Disease and Sequelae

The onset of symptoms of salmonellosis, a gastrointestinal disease, typically occurs 12-72 hours after 

infection and typically lasts 4-7 days, although times outside the general ranges have been reported (see for 

example, that, 2003 (reporting on Guthrie, 1992)). Symptoms often include diarrhea, fever and abdominal 

pain (CDC, 2013b). Antibiotic resistant strains of Salmonella can cause complications in patients (Lynch and 

Tauxe, 2009). Death may occur when the infection spreads beyond the intestines to other parts of the body. 

Infants, elderly, and immuno-compromised individuals are most likely to have severe symptoms (CDC, 

2013b). In addition to these factors, some data suggest that the severity of illness may also depend on 

serotype (Jones et al., 2008). Overall estimates of hospitalization and mortality rates among infected 

individuals are 2% and 0.03% , respectively, based primarily on 2000-2008 public health data (value includes 

correction for underreporting; Scallan et al., 2011) and are shown in Table 5.1. 

Table 5.1. Estimated percentage of salmonellosis cases associated with different health endpoints and 

typical duration of illness.

Health Endpoint Fraction of Casesa Typical Duration

Gastroenteritis: unconfirmed 0.966 4-7 days

Gastroenteritis: culture-confirmed 0.034 11 daysc

Gastroenteritis: Hospitalization 0.019 16 daysc

Mortality in general population 0.0003 n/a

Reactive Arthritis b 0.5-≥7 yearsd

a Data from Scallan et al. (2011b) unless otherwise noted.Hospitalization and mortality fractions include the correction for 

underreporting. Sum of unconfirmed and culture-confirmed cases of gastroenteritis percentages is 1. Percentages for individuals who 

were hospitalized, died, or later acquired reactive arthritis are relative to the full set of salmonellosis cases. 

b Value not well established. See text for details. c Data from Kemmeren et al. (2006) based on data collected in the Netherlands; duration of culture-confirmed illness equated with illness 

associated with a visit to a medical doctor. 

d Data from Curry et al. (2010) for reactive arthritis regardless of etiology. See text for details.

A breakdown of hospitalization and mortality rates by age from CDC’s FoodNet Surveillance Report for 2011 

(CDC, 2012b) is illustrated in Figure 5.7. These data suggest that hospitalization rates generally increase with 

age, with largest rates for individuals who are ≥80 years of age. However, infants (<1 year of age) have an 

increased risk of hospitalization relative to older children. Fatality rates also increased with age for older 

adults beginning at ages >40 years old (CDC, 2012b).

Reactive arthritis can develop several weeks after initial illness (Locht et al., 1993; Dworkin et al., 2001; 

Hannu et al., 2002; Townes et al., 2008) in some cases, however the incidence rate is not well established 

(Townes, 2010; Townes et al., 2008; Kemmeren et al., 2006). Curry et al. (2010), examining reactive arthritis 

cases among U.S. military personnel, found that reactive arthritis symptoms can last for years; 35.5% of cases 

(Reiter’s disease or post-dysenteric arthropathy) still had symptoms after two years and ~30% had 

symptoms after seven years. 

Inflammatory bowel disease (IBD) has been associated with salmonellosis (see for example, Helms et al., 

2006; Gradel et al., 2009; Kemmeren et al., 2006) but there is disagreement in the literature as to whether a 

person’s relative risk for IBD is increased following infection with Salmonella (Jess et al., 2011; Mann and 

Saeed, 2012).
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Figure 5.7. Age dependence of hospitalization and fatality rates for foodborne salmonellosis in the 

United States, 2010. Hospitalization rate (%) ( white bars) and Fatality Rate (%) ( black bars) as a 

function of age of the individual with Salmonella-caused illness. Data from FoodNet 2011 Surveillance Report 

(CDC, 2012b), based on 8273 total laboratory-confirmed salmonellosis infections. 

5.2 FILTH 

Filth can be broadly broken down into three categories, each of which has different health and regulatory 

impacts (Olsen et al., 2001). In the first category are adulterants that can be direct food safety hazards. This 

group would include hard and sharp objects that can cause physical injury to the consumer. This group also 

contains those insects that exhibit attributes for a contributing factor (synanthropy, endophily, 

communicative behavior, attraction to excrement and to human food, and ability to harbor pathogens in wild 

populations; Olsen et al., 2001), for the spread of food-borne pathogens when there is no effective control in 

place to eliminate or neutralize the hazard. For example house flies, Musca domestica, are attracted to filth 

and human food and readily move between them. They also travel between the outside and inside of homes 

and processing facilities and have a close association with people. Most importantly, they are vectors for 

human diseases and the disease organism can be found in the wild populations of the insect. Pava-Ripoll et al. 

(2012) found Salmonella spp. (6% of the flies tested), Cronobacter spp. (14%) and Listeria monocytogenes

(3%) in wild populations of M. domestica. 

Rats and mice are attracted to excrement, to other pathogen reservoirs, and to human food. Wild populations 

harbor food-borne pathogens, especially disease causing strains of Escherichia coli, Salmonella, and Listeria. 

These diseases can be transmitted from rodent to rodent. Rodents have been implicated in at least nine 

documented outbreaks of salmonellosis in humans (Olsen et al., 2001). Rodents can also be vectors for 

plague, murine typhus, and Weil’s disease (Vazquez, 1977). Evidence of their presence in foods, e.g., rodent

hairs and feces, is indicative of insanitary conditions, suggesting failures in the application of GAPs or CGMPs. 
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The second category includes those filth elements that are alive and/or are clearly detectable and 

objectionable to the consumer. This category would include live infestation of insects/mites in the food or 

adulteration with foreign matter associated with objectionable conditions or practices in production, storage, 

or distribution that are clearly visible to the consumer. 

The third category includes those filth elements that are natural or unavoidable filth and would include hair 

fragments, whole insects or insect fragments, mold filaments, etc. The same filth element could be classified in 

all three categories based on its size, life stage, life status (alive/dead), and whether the product has been 

subject to a microbial kill step (Olsen et al., 2001). FDA has analyzed spices that were adulterated by all three 

categories of filth elements at the same time.
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6. OVERVIEW OF SPICE FARM-TO-TABLE CONTINUUM AND 

POTENTIAL SOURCES OF PATHOGEN AND FILTH CONTAMINATION

An overview of the farm-to-finished product storage continuum for spices created by ASTA is shown in Figure 

6.1. This comprehensive figure illustrates the basic processes involved in primary production and secondary 

processing of spices. Not all spice products pass through each of the processes, e.g., some spices are not 

subjected to a pathogen reduction treatment, some spices are not ground, and some spices are not 

transported by ship because they are grown domestically. ASTA has included in the figure some of the key 

preventive practices that may be used during these phases to support the food safety of spices such as Good 

Agricultural Practices (GAPs), Good Manufacturing Practices (GMPs), moisture control (of dried product), 

process validation, warehouse sanitation, container inspection, and a Hazard Analysis Critical Control Point 

system. The diagram also notes product cleanliness specifications such as the DALs and the ASTA Cleanliness 

Specifications.

Figure 6.1. Typical stages in spice farm-to-finished product continuum for spices including transport 

and processing options and control points. Figure developed by ASTA for “Clean, Safe Spices: Guidance 

from the American Spice Trade Association” ( Figure 1) published in 2011 by ASTA. Reprinted with 

permission.
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The supply chain from finished spice product-to-consumer can be relatively simple or very complicated, as 

illustrated by Figure 6.2. Spice manufacturers may sell/transfer their spice products wholesale to a seasoning 

manufacturer, food manufacturer, food wholesaler, institutional food service, or restaurant, each of which 

will further handle and possibly also process the spice. Spice manufacturers may also package their own spice 

for retail sale, selling directly to grocers, or retail food establishments where consumers may purchase them. 

Figure 6.2. Possible pathways for spice from spice manufacturer to consumer. 

6.1 PRIMARY PRODUCTION 

Spices are a large, diverse group of plants, some of which have been domesticated, cultivated, and used since 

the times of the pharaohs to enhance the flavor of foods or as drugs. It is impossible to describe in this report 

the wide variety of agricultural practices involved for each of the spices. Instead, we provide a brief overview 

of spices, typical growing practices, and potential sources of pathogen or filth contamination during primary 

production.

Spice and lifecycle diversity

Any part of a particular plant can be used as a spice. Table A3 in Appendix A provides a list of over 80 

different plants that are used as spices and the part of the plant used or sold in commerce. For this report, 

they have been grouped into broad categories of bark, flowers, fruit/seeds, leaf, or roots. These terms are not 

used in their narrow botanical definitions but in the colloquial use of the term. For example, the flower group 
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contains whole dried flowers such as calendula (Calendula officinalis) or just part of the flower such as the 

stamen of saffron Crocus sativus (saffron); or the dried flower bud such as cloves, Syzygium aromaticum. 

Similarly, the root group includes rhizomes such as ginger (Zingiber officinale); bulbs such as onion (Allium 

cepa) or garlic (Allium sativum); or true roots such as horseradish (Armoracia lapathifolia). The part of the 

plant used has a great impact on how it is harvested, dried, processed, and the kinds of pests that may affect 

it.

Likewise, the life cycle of the plant has a great influence on its processing as well. Some plants are annuals, 

coriander (Coriandrum sativum); others are perennials, nutmeg/mace (Myristica fragrans), while others are 

long lived annuals or perennials that are grown as annuals, chili peppers (Capsicum annuum, C. frutescens).

The growth pattern of the plant influences the ease of harvest and exposure to potential pathogens. Some 

spices grow on vines, e.g., black pepper (Piper nigrum), others are leafy shrubs, e.g., oregano (Lippia spp.), 

while others are the fruits of a tall tree, e.g., nutmeg or mace (Myristica fragrans).

In some cases, the species of the plant that sold in commerce may not be known. For example, spices sold as 

“oregano” may be any of over 200 species of herbs, shrubs, or small trees of the family Verbenaceae, genus, 

Lippia. “Oregano” may also be of the family Labiatae, Origanum vulgare but the same species may also be 

named “marjoram.” FDA regulations at 21 CFR 182.10 (FDA, 2012f) provide a list of “Spices and other natural 

seasonings and flavorings” by common and botanical name that are considered to be “Generally Recognized 

as Safe” (GRAS) substances. To add to the confusion regarding precise identification of source plant materials, 

there have been significant taxonomic changes since the last revision of 21 CFR 182.10 (FDA, 2012f). 

Growing practices

As discussed in more detail in Chapter 7, many types of spices grow in tropical or semi-tropical environments. 

A few are temperate crops (garlic, onion, mustard, horseradish). The size of the farm and the agricultural 

techniques used to grow spices varies with the particular spice and growing region. For example, many spice 

farms in India are comprised of an acre or less and large farms typically contain less than 100 acres. In 

contrast, in the United States spice-producing farms are typically larger, where small farms are typically 

comprised of tens of acres and large farms are typically comprised of hundreds of acres. Of course, only a few 

types of spices can be easily grown on farms in the United States (see Chapter 7 for a discussion of spice 

production).

Spices can be grown in monoculture (chili peppers, garlic), intercropped with other species (black pepper 

grown with nutmeg/mace, rubber, cocoa, etc.), wild-crafted (collected in the wild) or semi-wild-crafted 

(oregano/marjoram). Many spices are produced on very small farms where farm animals are used to plow, 

irrigation water is taken from nearby surface water sources, fertilization is achieved with manure/soilamended manure, and crops are harvested by hand. Spice source plants on these farms are on mats, cement 

slabs, or on raised platforms in the sun, but may in some cases be left to dry directly on the ground. 

For some spices (e.g., capsicum in India or dehydrated garlic in the United States) a larger spice company may 

contract with growers and supply them with seed, fertilizers, pesticides, and technical expertise on 

agricultural and food safety growing and harvesting practices. Spice farms in the United States producing 

dehydrated onion and garlic are generally owned by or contracted with a single spice company that 

dictates/controls growing and harvest practices and may even provide their own proprietary seed. Use of 

automated equipment to plant, grow and harvest the spice source plant crops, and temperature/moisture 

controlled ovens to dehydrate source plants is more common on large farms.

Spices are typically cleaned to remove foreign matter and extraneous materials at the primary production site 

but may also undergo additional cleaning at one or more points along the supply chain. The cleaning process 

can range from hand sorting to remove sticks, stones, or other extraneous materials to the use of simple 

winnowing, brushing, or sieving machines to remove the extraneous materials. The technology for cleaning 
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spices typically involves simple milling and sieving. Metal detectors are commonly employed during primary 

processing to remove extraneous metallic material that may have inadvertently been added to the spice 

during harvest or processing (e.g., a staple).

Potential sources of pathogens or filth in spices during production

A variety of animals including birds, animals, rodents, reptiles, insects, and humans may introduce Salmonella

or filth into the spice production environment. Once present in the environment, Salmonella may remain 

viable for long periods and may possibly even grow in the soil, irrigation water, manure or soil-amended 

manure (Chapter 5 and references therein). Spice source plants may become contaminated with Salmonella

or other pathogens when contaminated animals or environmental materials come in contact with them. 

During the traceback investigation for one spice-related outbreak, the importing company declared that 

manure fertilizer used during production was the likely contamination source (Koch et al., 2005; Chapter 2). 

In addition to fertilizer source, irrigation water quality, application method (overhead, flooding, or drip), and 

timing, as well as animal access to the crop are likely to be critical parameters in determining whether the 

spice source plant or (dry) spice could become contaminated. In a review of risk factors for microbial 

contamination of fruits and vegetables, Park et al. (2012) identified contaminated irrigation water and soil as 

among the most critical and the prevention and control of contamination in irrigation water and soil as the

most effective targets for pre-harvest risk management. 

The drying phase for spices is another critical point where filth and pathogen contamination may occur, 

particularly for spices that are dried in the open environment on mats or directly on the ground for extended

periods (1-7 days). During drying, the spice may be exposed to possible rodent, bird, flies, and field pests. 

If the spices are not dried quickly enough or adequately, mold growth may take place. Some strategies for 

drying spice source plant material can reduce the risk of contamination during this phase, for example, use of 

raised platforms with simple tarp roofs will reduce the risk of contamination of spices by bird feces as 

compared with drying on mats on the ground without a roof.

Cross-contamination from equipment to spice source plants or spices may take place if equipment used to 

plant, harvest. dry or store the spice source plants becomes contaminated and is not adequately cleaned. 

Human transfer of pathogens or filth is possible when harvest or other aspects of the production process are 

primarily manual and personal hygiene is insufficient. 

Filth is not a major issue during the pre-cultivation step because the spice has not developed. As the plants 

get older and the economically important parts start to develop, the risk of contamination by filth such as 

insects and animals increases (Table 6.1). Cross-contamination from equipment or field workers can also be 

an issue during primary production. Contamination of the spice of interest with other parts of the dried 

source plant may occur if appropriate cleaning/harvesting methods are not applied. The ranking in Table 6.1 

was derived by FDA from site visits, knowledge of source plants and pests, and data on filth adulteration of 

spice.

The extent to which the identified potential sources of contamination contribute to contamination of spice 

depends on the specific production practices employed. 
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Table 6.1. Evaluation of risks for filth contamination at different stages during the production of 

spices

Production steps Filth1

Pre-cultivation -

Field Cultivation +

Harvest ++

Intermediate storage +++

Transportation (+)

Processing (cleaning/cutting/drying/packaging) +

Final product (package/stored)3 - to ++ 1 Explanation of symbols: - usually no risk, (+) no to low risk, + low to medium risk, ++high risk, +++ very high risk. 

3. The risk depends on the packaging of the spice and how it is stored.

6.2 DISTRIBUTION AND STORAGE

The distribution system can be very complex and as a result, storage may occur at many different points. 

Some crops are harvested, processed, and sold relatively quickly because their quality starts to decrease 

immediately upon picking (for example, capsicum). Other crops, if left whole, have a long shelf life. For 

example, whole black pepper can be held in storage for 5-7 years before it is sold. FDA personnel learned 

during their visits to India that because black pepper is a readily sold cash crop, small farmers may keep the 

whole (dried) spice on site for years, to serve as an emergency fund for unexpected events. 

Producers may sell to a local buyer or directly to a spice processor/packer. In India, black pepper is often sold 

to a local buyer, sometimes in lots as small as one kilogram. The buyer consolidates small lots from tens to 

hundreds of farms to create a 50-100 kilogram lot, which is then sold to a regional buyer. The regional buyer 

collects spice into a much larger lot to sell on the NCDEX (National Commodity and Derivatives Exchange Ltd., 

Mumbai; 1 metric tonne needed) or directly to a spice processor/packer. Larger farms may produce sufficient 

volumes of spice to avoid some of the aggregation steps (that may increase the risk for contamination of the 

spice) and the ensuing delay to market associated with it. Some spice manufacturers who contract groups of 

farmers for production of spices may coordinate and control aggregation of spices from contractors.

Spice processing may take place before and/or after export. For example, the Spices Board of India has 

created “spice parks” where producers can bring their spices to undergo filth and pathogen reduction 

treatments as well as microbiological testing to ensure compliance with U.S. standards (Spices Board India, 

2013; see discussion of the Indian EIC certificate program in Chapter 8 for more details on processing of black 

pepper). 

Individual shipments of imported spice offered for import to the United States often contain large amounts of 

spice, e.g., thousands or tens of thousands of kilograms (Table C1; Van Doren et al., 2013c). After arrival, the 

lot may be processed, and/or re-packaged and distributed multiple times before being used in food 

preparation. 

Potential sources of pathogens or filth in spices during distribution and storage

At each stage of the often complex and lengthy spice distribution process, spice is stored for some period. 

This characteristic of the spice farm-to-table continuum makes proper packaging and storage a critical issue 

for preventing contamination. When improperly packaged or stored, the spice may become contaminated 

through contact with animals or contaminated soil, water, or equipment, or may become wet, which can 

facilitate the growth of pathogens such as Salmonella and/or mold. Re-use of storage bags/boxes may 

enhance the potential for contamination of spice, particularly if the bag is in direct contact with the spice. 
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FDA observed problems with storage conditions during some of its site visits and inspections. Some facilities 

had gaps in walls or around doors, open unscreened windows, holes in walls, ceilings, or roofs. These facility 

features provide opportunities for insects, rodents, birds, and water to enter the facility. FDA analysis of filth

adulteration of spices in shipments of imported spice offered for entry to the United States during the threeyear period FY2007-FY2009 found that most of the insect adulterants were stored product pests, indicative of 

poor handling, storage, and cleaning of the spices. 

Transportation can also be a source of contamination if trucks and cargo holds of ships are not maintained, 

cleaned or sanitized, and spice packaging allows the spice itself to come in contact with contaminated 

surfaces. Adulteration has been documented for other commodities in transit. 

The extent to which the identified potential sources of contamination contribute to contamination of spice 

depends on the specific distribution and storage practices employed. 

6.3 SECONDARY PROCESSING AND MULTI-COMPONENT FOOD 

MANUFACTURING

As with the other stages of the spice supply, the practices involved in processing, packing and food 

manufacture can vary tremendously. Spice secondary processing typically includes additional cleaning steps 

to remove element of filth, application of a pathogen reduction treatment, and for some spices, grinding, 

cracking and/or blending procedures. Processing practices can vary tremendously among facilities and firms. 

For example, some spice processors/packers may pack finished spice product manually while other use a 

completely automated system. Smaller firms tend to use less automation and may use common pieces of 

equipment or lines for different spices or processing activities. Combinations of practices in a single firm has 

also been observed.

Based on conversations with ASTA, we know that a majority of spices in U.S. commerce are used by food 

manufacturers as ingredients in the production of multi-component foods. These secondary manufacturers 

range in size from very small firms to multi-national corporations. Some spice is also sold to foodservices and 

restaurants (or restaurant chains) as well as to retail outlets for consumers, as shown in Figure 6.2.

Manufacturing processes for multi-component foods can be as complicated as the myriad of foods currently 

available on the U.S. market. However, three basic scenarios illustrate the spectrum of possibilities with 

regard to the application of a pathogen reduction step: (1) a manufacturing process that does not include any 

pathogen reduction step (e.g., some dry spice blends); (2) a manufacturing process that includes a pathogen 

reduction step after the spice ingredient has been added to the food (e.g., canning of low acid foods); (3) a 

manufacturing process that includes a pathogen reduction step before addition of the spice ingredient(s) to 

the food (e.g., spice coatings on deli meats/cheeses, snack food coatings, garnish). In the case of (1) and (2), 

manufacturers typically use spice that has been already subjected to a pathogen reduction step (e.g., by the 

spice processor). 

Potential sources of pathogens or filth in spices during secondary processing and multi-component food 

manufacturing

In a recent review published in the Journal of Food Protection, Podolak et al. (2010) identified five factors 

contributing to contamination by Salmonella in low-moisture food manufacturing: (1) contamination 

associated with poor sanitation practices; (2) contamination associated with poor facility and equipment 

design and maintenance; (3) contamination associated with lack of GMPs; (4) contamination associated with 

poor ingredient control and handling; and (5) contamination associated with poor pest control. The review 

provided many examples from foodborne outbreaks attributed to these types of system failures.
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Cleaning and sanitation is particularly challenging in facilities processing low moisture foods because the 

presence of water, used to clean equipment, floors and walls, may facilitate growth of Salmonella or other 

pathogens, once present in the facility environment, which could lead to sustained opportunities for crosscontamination through the creation of Salmonella niches. For this reason, spice processors and food 

manufactures of low moisture foods generally apply dry cleaning and sanitation methods, particular in the 

“Primary Salmonella Control Area (PSCA),” the post-pathogen reduction treatment area in the facility (Chen et 

al., 2009b; GMA, 2009). In some instances, wet cleaning is used, e.g., after grinding dehydrated garlic and 

preparing to grind cinnamon with the same grinder. If the equipment cannot be disassembled, it is cleaned in 

place. FDA personnel observed excess water on floors and near spice grinding/mixing equipment during site 

visits to both domestic and foreign spice processors. The potential for Salmonella to actively grow under 

these specific conditions and create niches in the processing environment from which cross-contamination 

may occur cannot be ruled out without further study. 

Dry cleaning and sanitation methods for food contact surfaces may not remove all spice particles or eliminate 

all Salmonella. As a result, use of common equipment for processing different spices or foods, such as a 

common grinder or common transfer line, can lead to cross-contamination of previously uncontaminated 

spice with contaminated spice. During a visit to one facility, FDA personnel observed that the same piping 

was used to transfer raw and pathogen reduction treated spice to the finished product area and the 

processing worker was unaware that the system allowed for cross-contamination of treated spice with 

untreated spice.

For spices, grinding/crushing/cracking of whole spices creates a lot of spice dust that, if not contained, may 

lead to cross-contamination in a processing facility. For example, widespread spice and Salmonella

contamination of the grinding room was found and cross-contamination was suspected as a contributing 

cause of the 2009 Salmonella Rissen outbreak associated with ground white pepper. Salmonella was also 

found in the environment of 10% of domestic spice manufacturing/packing/re-packing facilities inspected in 

2010 (Aug-Dec). When air, personnel and material flow is not adequately controlled, “raw” spice that may be 

contaminated with Salmonella may contaminate spice in the PSCA (after it has undergone a pathogen 

reduction treatment) (see examples in Podolak et al., 2010 and GMA, 2009). 

As noted above, FDA has learned that some spice does not undergo a pathogen reduction treatment during 

the secondary processing phase. If contaminated spice does not undergo such a treatment or kill step before 

consumption, consumers may become ill. In many cases, spice processors sell untreated spice to a food 

manufacturer who will apply a lethality step to the spice before allowing it to reach the consumer. Ineffective 

or inefficient pathogen reduction treatments may allow some Salmonella to survive. Pathogen reduction 

treatments that have not been validated or for which the process parameters are not monitored and verified, 

have the potential for insufficient treatment. 

Spice processors as well as seasoning and food manufacturers that purchase spice that has not been 

produced, transported, distributed, or stored using appropriate preventive controls may have a higher risk of 

purchasing contaminated spice. 

FDA inspections of domestic spice facilities found that pests were the most often cited CGMP violation. 

Surprisingly, most of the facilities inspected for which information was available, did have established pest 

control programs. Pests can transfer Salmonella or other pathogens from one location to the spice. 

Poor facility design and lack of control of movement of people and material in areas where finished product is 

located can enhance opportunities for contamination of the environment or cross-contamination to the 

product (see for example, Podolak et al., 2010 and Beuchat et al., 2013). 

The extent to which the identified potential sources of contamination contribute to contamination of spice 

depends on the specific spice processing and/or multi-component food manufacturing practices employed.
Overview of Spice Farm-to-Table Continuum and Potential Sources of Contamination | 6

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6.4 RETAIL/END USER

Retailers (institutional foodservices, restaurants, and retail food stores) may source their spices from a 

diversity of company types including importers, warehouses, re-packers, secondary processers 

(grinders/blenders) and wholesalers. Depending on the retail facility type, spice may be stored in a large 

warehouse, small storage room or directly in the kitchen area and/or customer access areas. Consumers 

purchasing spice for home use may obtain their spice products in small pre-packaged retail containers or 

from bulk bins via direct purchase from retail stores, markets, internet venders, etc., or from home gardening 

(limited by climate). Storage in consumers’ homes can be in the kitchen, pantry or elsewhere, in the original 

retail packaging or transferred into other containers (e.g., spice rack specific containers). When adding spice 

to foods, it is not uncommon for food preparers to shake the spice out of its container directly into the food or 

cooking pot rather than using a utensil to do so. 

Potential sources of pathogens or filth in spices in the retail or home environment

The greatest concern for spice at the retail/home setting is the potential for growth of Salmonella in foods to 

which contaminated spice has been added when food is not maintained at an appropriate temperature. It is 

suspected that growth contributed to the illness rates observed in several of the spice-related outbreaks, such 

as the outbreaks associated with spice-containing tea (Chapter 2). It is not known whether the practice of 

shaking a spice container over a pot during cooking can add sufficient moisture to the container to allow 

growth of Salmonella. Keller et al. (2013) found that initiation of Salmonella growth in contaminated ground 

black pepper at permissive water activities and room temperature generally includes a long lag-time. In such 

a case, evaporation of added moisture may reduce the water activity of the spice below the threshold for 

growth before growth begins. (Keller et al., 2013). 

Cross-contamination may also take place, if the spice is allowed to come in contact with contaminated 

surfaces in the food preparation area such as the surfaces of common utensils used for spices and other foods. 

Contamination of spice by insects or rodent feces/hairs may take place if the spice is kept in open containers 

for extended periods and insects and rodents can enter the facility. These pests, if allowed access to the spice, 

can introduce pathogens into the spice.

The extent to which the identified potential sources of contamination contribute to contamination of spice 

depends on the specific distribution and storage practices employed. 
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7. SPICE PRODUCTION AND CONSUMPTION

7.1 U.S. SPICE SUPPLY 

7.1.1 U.S. PRODUCTION 

Only five spices are produced in the United States in large quantities: dehydrated onion, dehydrated garlic, 

capsicum, mustard seed, and sesame seed (USDA/ERS, 2012a-c; ASGA, 2012). Dry weight production values 

are available from the USDA Economic Research Service and are shown for 2010 in Table 7.1. The value for 

garlic in Table 7.1 includes production for both the dehydrated and fresh markets (converted to dry weight); 

separate values are not available (USDA/ERS, 2012b). As of 2010, imports of four out of five of these spices 

exceeded U.S. production (USDA/ERS, 2012a-c). 

Table 7.1. U.S. production of spices in 2010: Dehydrated onion, dehydrated (and fresh) garlic, 

capsicum, mustard seed, and sesame seed.

Spice U.S. Production 

(million lbs., dry weight)

Dehydrated Oniona 104.3

Dehydrated and Fresh Garlicb 138.4

Capsicumc 93.0

Mustard Seedc 41.9

Sesame Seedd >22 a Dehydrated weight, estimated by dividing fresh weight by factor of 9. Data and conversion factor from USDA/ERS (2012a)

b Dehydrated weight for combined dehydrated and fresh garlic supply, estimated by dividing fresh weight by factor of 2.7 Data and 

conversion factor from USDA/ERS (2012b).

c Data from USDA/ERS (2012c).

d Data from ASGA (2012) which reported “over 11,000 tons.”

Domestic production of dehydrated onions is much larger than import, and has been for at least the past 30 

years, Figure 7.1. As of 2010, 90% of the total U.S. supply was produced domestically (USDA/ERS, 2012a). 

Production far exceeds U.S. needs for the food supply; approximately half of U.S. production is exported 

(USDA/ERS, 2012a). Although small in a relative sense, dehydrated onion imports have grown over the last 

decade in both absolute and relative terms (USDA/ERS, 2012a). 

Domestic production of garlic (dehydrated and fresh) accounted for all of the U.S. supply until 1969 and then 

~85% of the U.S. supply until 1997, Figure 7.2. After 1997, the relative contribution of domestically produced 

garlic began to decrease annually, until 2006. Comparing absolute production and import values for the

period after 1997, one finds that the observed change arose from an acceleration of garlic imports and a 

relatively stagnant, then decreasing, domestic production (USDA/ERS, 2012b). Since 2006, imports have 

surpassed domestic production, but only slightly. A change in U.S. import restrictions issued in 2011 may 

expand garlic imports even further by allowing importation from the European Union and several other 

countries (39 countries in all) (USDA/APHIS, 2011). 
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Figure 7.1. Relative contributions of domestic and imported dehydrated onion to the total annual U.S. 

supply, 1970 to 2010. Total annual supply values used to calculate relative contributions only include new 

crop and imports; beginning stocks and loss of domestic product during processing were excluded. Data 

derived from USDA/ERS 2012a.

Figure 7.2. Relative contributions of domestic and imported garlic to the total annual U.S. supply, 

1960 to 2010. Data includes California production only (the major producing state) and combines 

dehydrated and fresh garlic. Data derived from USDA/ERS (2012b).

The relative contributions of domestic production and importation of capsicum to the total U.S. spice supply 

have varied over the years, Figure 7.3, while the total supply has increased more than 750%, from 41.5 

million pounds in 1966 to 320.8 million pounds in 2010 (peak supply was 382.9 million pounds in 2006; 

USDA/ERS, 2012c). The increase in the relative contribution of domestic capsicum production to the supply 

from 1966 to 1980, Figure 7.3, is a reflection of increased domestic production; imports were approximately 

constant during that period (USDA/ERS, 2012c). After 1980, both domestic and importation supplies 
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increased through 1992 but after 1992, domestic production generally decreased while imports continued to 

increase in volume (USDA/ERS, 2012c). The contribution of imported capsicum to the total supply has 

exceeded domestic production since 1998. In 2010, domestic production of capsicums constituted 20% of the 

total capsicum supply (USDA/ERS, 2012c). 

Figure 7.3. Relative contributions of domestic and imported capsicum (including paprika) to the total 

annual U.S. supply, 1966 to 2010. Data includes California production and New Mexico production 

(beginning 1976). Data derived from USDA/ERS (2012c). 

The U.S. supply of mustard seed is also primarily derived from imports, Figure 7.4. From 1966 to 2010, 

imports have contributed more than 60% of the total U.S. supply (except for 2002, when U.S. production was 

exceptionally large; USDA/ERS 2012c). In 2010, 20% of the mustard seed supply was produced domestically 

(USDA/ERS, 2012c).

Production of domestic sesame seeds has recently increased from approximately 5 million pounds per year to 

over 22 million pounds in 2009 and 2010 (ASGA, 2012). As a proportion of the supply, the domestic 

production in 2010 represents at least 21% of the total supply (USDA/ERS 2012c; ASGA, 2012). Part of this 

growth in production can be attributed to the development of non-dehiscent varieties, which allow drying in 

the field and mechanical harvest techniques to be used (ASGA, 2012). 

Several other types of spice source plants can grow effectively in the United States, e.g., basil, oregano and 

thyme, and are even wild harvested (see for example, Oregon’s Wild Harvest, 2012) but production of the 

(dried) spices is small.
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Figure 7.4. Relative contributions of domestic and imported mustard seed to the total annual U.S. 

supply, 1966 to 2010. Domestic mustard seed production weights used to calculate relative contribution is 

determined from the previous year’s production minus product used as seed. Data derived from USDA/ERS 

(2012c).

7.1.2 U.S. IMPORTS

The United States is the single largest export market for spices (International Trade Center UNCTAD/WTO, 

2006), importing more than 1.1 billion pounds of spices in 2009 (USDA/ERS 2010, 2011a). Import data for 

individual spices are provided by the USDA Economic Research Service (USDA/ERS, 2010) and data for 2009 

is provided in Table 7.2. The relative contributions to total imports are calculated for each spice with the 

caveat that garlic has been excluded (because the relative proportions of imports intended for the dehydrated 

market is not available). While five spices (capsicum, mustard seed, black and white pepper (tabulated 

together), and ginger root) accounted for one half of the 2009 imports by weight, a much larger number of 

spices and spice blends account for the other half. Indeed, the USDA Economic Research Service found in its 

2007 report that “the share of traditional spices, such as peppers, cinnamon, and vanilla declined [between 

1998 and 2007] as the U.S. palate increasingly sought diverse tastes and increased its demand for such 

products as nutmeg, saffron, fennel and turmeric” (Brooks et al., 2009).

Spices are primarily produced in developing countries (International Trade Centre UNCTAD/WTO, 2006). 

However, data from the USDA Foreign Agricultural Service (FAS) on U.S. imports of spices show that spice 

imports to the United States came from over 140 countries (USDA/FAS, 2011). Table 7.3, derived from FAS 

tables, identifies the top 20 countries for 2010 U.S. spice import, based on value; dehydrated onion and garlic 

are not included in these figures. The table also provides a comparison of imports from the same countries 

one decade earlier. Comparing 2010 with 2000, we see that total spice imports increased by nearly 60% by 

value over this time period, with imports valued at more than 1 billion dollars in 2010. The relative 

contribution to spice imports from different countries has also changed with time. 
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Table 7.2. Spice imports in 2010 by weight.

Spice 2010 Import Weighta (million 

pounds)

2010 Percent of Total Spice Importsb

(%)

Capsicumc 227.8 18.7

Mustard Seed 169.3 13.9

Pepper, Black and White 155.4 12.8

Ginger Root 97.4 8.0

Sesame Seed 81.6 6.7

Cassia and Cinnamon 54.3 4.5

Cumin Seed 22.7 1.9

Dehydrated Oniond 17.8 1.5

Coriander Seed 10.6 0.9

Poppy Seed 10.2 0.8

Fennel Seed 8.6 0.7

Turmeric 7.8 0.6

Caraway Seed 6.2 0.5

Sage 5.0 0.4

Anise Seed 4.7 0.4

Celery Seed 4.7 0.4

Vanilla Beans 3.9 0.3

Nutmeg 3.9 0.3

Pimento (Allspice) 2.8 0.2

Cloves 2.8 0.2

Mace 0.7 0.1

Dehydrated and Fresh Garlic 159.6e –e

Other Spices 317.7 26.1

Total Spice Imports (excluding dehydrated 

garlic) 1215.9 100.0 a Data fromUSDA/ERS (2012c), unless noted otherwise 

b Total spice weight used to calculate percent values excludes garlic. 

c Capsicum includes dried capsicum and paprika. 

d Dry weight equivalent. Data from USDA/ERS (2012a). 

e Dry weight equivalent. Data from USDA/ERS (2011b).
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Table 7.3. Spice imports by value, 2000-2010.

Country 2000 Import Value1

(million $)

2010 Import Value1

(million $)

2010 Percent of All 

Imports

Change in Percentage 

of All Imports, 2000-

2010

India 101.9 161.8 16.1 -0.1

Indonesia 132.4 146.2 14.6 -6.5

China 26.9 109 10.9 6.6

Canada 30.2 70.9 7.1 2.3

Mexico 42 64.3 6.4 -0.3

Vietnam 18.6 64.3 6.4 3.4

Peru 1.5 49.5 4.9 4.7

Spain 17.7 42 4.2 1.4

Brazil 40.7 39.9 4 -2.5

Madagascar 30.6 28.3 2.8 -2.0

Guatemala 20 23.7 2.4 -0.8

Turkey 18.4 20.4 2 -0.9

Egypt 7.3 19.2 1.9 0.7

Germany 3.9 15.6 1.6 0.9

Sri Lanka 7.4 15.4 1.5 0.3

Israel 10.4 12.6 1.3 -0.4

France 5.9 10.4 1 0.1

Colombia 0.5 10.3 1 1.0

Syria 7.5 8.1 0.8 -0.4

Pakistan 1.8 7.2 0.7 0.4

Other Countries 102.4 83.3 8.3 -8.0

World Total 627.9 1002.4 100 - 1 Data from USDA/FAS (2011).

China’s share increased by 6.6 percentage points from 2000 to 2010 while that of Indonesia decreased by 

nearly that amount. Smaller gains in import share during this period were observed for Peru, Vietnam, and 

Canada, in decreasing order of gain. In 2010, India, Indonesia and China together provided nearly 42% of 

imported spices (excluding dehydrated onion and garlic). Ten countries supplied 77% of spice imports by 

value in 2010 (excluding dehydrated onion and garlic). It is also noteworthy that some countries, for example, 

Germany, that are not major spice producers, are major exporters of spice to the United States. These 

countries import spice from developing countries and may process, blend, or re-package it before exporting it 

to the United States. In 2007, crushed black pepper imports from Germany were valued at $8 million (Brooks 

et al., 2009).

The relative contributions from each country to U.S. supplies of individual spices have been reviewed by the 

USDA Economic Research Service for 1980-1994 (Buzzanell et al., 1995) and 1998-2007 (Brooks et al., 2009). 

In 2007, capsicums were primarily imported from China, Mexico, Peru and India whereas black pepper was 

imported from Brazil, Vietnam and India (Brooks, et al., 2009). Mustard seed is primarily imported from 

Canada (Buzzanell et al., 1995) while ginger is primarily imported from China (Brooks et al., 2009). More than 

70% of vanilla imports in 2007 were from Madagascar with smaller contributions from Uganda, Indonesia, 

India and Papua New Guinea. Cumin seeds are imported from a number of countries including India, Syria, 

Turkey, China and Pakistan while cinnamon is imported from Indonesia, Sri Lanka, Vietnam, Brazil and China. 

The country-spice import matrix for the United States continues to evolve. Appendix B lists the main spiceproducing countries and their absolute and relative contributions to world-wide production for 2010. Review 

of the tables included in Appendix B (from FAO 2013a-b) demonstrate the wide diversity of production 

countries and illustrates the potential for future growth and evolution of the U.S. import market. 
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7.2 SPICE CONSUMPTION IN THE UNITED STATES

7.2.1 CONSUMER POPULATION

A large fraction of the U.S. population consumes spices. Based on a retail study of household use in July 2009, 

an estimated 86% of households in the United States use fresh or dried herbs, spices, or seasoning blends 

(Mintel International Group, 2009). A similarly large fraction, 78%, of households report using herbs, spices 

and seasoning blends beyond salt and pepper (Mintel International Group, 2009). Small differences in 

household use by gender, age, ethnicity/race, and household income are reported. Among the survey 

participants (aged 18-65+ years), a slightly larger percentage of women (84%), people in the age range 25-34 

(82%), Hispanic households, and households with annual incomes in the range $100K-149K (84%) report 

using herbs, spices and seasoning blends other than salt and pepper (Mintel International Group, 2009). 

These estimates do not include the additional percentage of the population that may only consume spices in 

foods prepared or seasoned outside the home, e.g., by food manufacturers, food services, restaurants or other

prepared food suppliers. Indeed, a majority of the spice supply is sold wholesale and most is ultimately 

incorporated into prepared foods (Buzzanell et al., 1995). 

7.2.2 CONSUMPTION MASS AND FREQUENCY

An estimate of annual per capita spice consumption in the United States is provided by the USDA Economic 

Research Service. This estimate is based on annual food availability data and the U.S. population. From 1966 

to 2010, per capita consumption of spices other than dehydrated onion and garlic, increased nearly 300%, 

with an average rate of increase of 0.5 lbs./decade (USDA/ERS, 2012c), Figure 7.5. Per capita consumption of 

garlic, dry and fresh, has also increased dramatically with a rate of increase of ~0.3 lbs./decade (dry weight 

equivalent rate), between 1970 and 2010 (USDA/ERS, 2012b). In contrast, per capita consumption of 

dehydrated onion, as estimated from the total net supply, has been approximately constant since 1970 

(USDA/ERS, 2012a). In 2010, annual per capita consumption of spices excluding dehydrated onion and garlic 

was approximately 3.47 lbs. (1575 g) and including dehydrated onion was approximately 3.64 lbs. (1653 g; 

USDA/ERS, 2012c). Assuming spices are consumed in three meals per day, the per capita spice consumption 

is estimated to be 1.4 g per eating occasion. 
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Figure 7.5. Annual per capita spice consumption in the U.S excluding dehydrated onion and garlic, 

1966-2010. Data from USDA/ERS (2012c). 

The FDA/CDC National Health and Nutrition Examination Surveys (NHANES), employing the U.S. EPA Food 

Commodity Intake Database (FCID), which includes commodity-specific intake data derived from the What 

We Eat in America (WWEIA) survey, provide estimates of daily spice intake for spice consumers in the United 

States. For 2003-2006, average daily consumption was approximately 1 g for spices other than capsicum and 

5 g for spices including capsicum (DiNovi and Edwards, 2013; EPA, 2012a). These estimates include 

consumption of fresh herbs and chili peppers and are derived from standard recipes for foods consumed and 

reported to WWEIA. Based on these estimates, the mean spice consumption per eating occasion is 0.3-1.7 g 

for 3 eating occasions per day (DiNovi and Edwards, 2013; EPA, 2012a). The inclusion of fresh herbs and chili 

peppers (in capsicums) positively biases this estimate while the use of standard recipes, which do not 

necessarily include minor spice ingredients, increases its uncertainty. 

Daily or eating occasion consumption estimates for certain individual spices are available from the NHANES 

database while others can be derived from food availability data. The NHANES database indicates that the 

highest mean eating occasion consumption estimates for individual spices are for sesame seeds and dried 

basil, at approximately 150 mg/eating occasion (DiNovi and Edwards, 2013; EPA, 2012a). Capsicum 

consumption is larger, ~1.4 g/eating occasion, but this value includes dry and fresh. Table 7.4 provides 

estimates for daily consumption of a wide range of spices based on food availability data. Except for 

dehydrated onion and the combined estimate for dehydrate and fresh garlic, where net supply estimates are 

available, the consumption estimates in Table 7.4 provide upper limits to the per capita daily consumption of 

each spice because the values are derived from gross supply data. Further, the per capita estimates assume all 

spices in the supply are consumed each year and that everyone in the population is a consumer. These 
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assumptions increase the uncertainty in these values as measures of true consumption. Finally, the food 

availability-based daily consumption estimates for spices that are infrequently consumed or consumed by 

only a small segment of the population, will provide particularly poor estimates of actual consumption. 

Table 7.4. Estimated per capita spice consumption based on food availability, 2010a. 

Spice lbs./yr. g/day

Capsicumb 1.0 1.3

Other spices 1.0 1.3

Dehydrated and Fresh Garlicc 0.9 1.1

Mustard 0.7 0.8

Black and white pepper 0.5 0.6

Sesame seed 0.3 0.4

Ginger 0.3 0.4

Dehydrated Onion 0.2 0.2

Cassia 0.2 0.2

Cumin 0.07 0.09

Coriander 0.03 0.04

Poppy 0.03 0.04

Fennel 0.03 0.03

Turmeric 0.03 0.03

Caraway 0.02 0.02

Sage 0.02 0.02

Anise Seed 0.02 0.02

Vanilla Beans 0.01 0.02

Celery 0.02 0.02

Cloves 0.01 0.01

Allspice 0.01 0.01

Mace 0.002 0.003 a Based on gross supply (USDA/ERS, 2012c) except for dehydrated onion and garlic, where net supply data was available (USDA/ERS, 

2012a-b). See text for discussion.

b Includes paprika

c Dehydrated weight for combined dehydrated and fresh garlic supply, estimated by dividing fresh weight by factor of 2.7 Data and 

conversion factor from USDA/ERS (2012b).

Estimates of the variability and frequency of spice consumption for all spices, for individual spices, and for 

different segments of the population are not available. We know that some dishes or foods contain amounts 

of spice larger than the per eating occasion means listed above, e.g., black pepper encrusted foods such as 

salami, and when consuming these foods, exposure may be larger if the food is contaminated with Salmonella. 

Despite the absence of data variability, based on experience we do not expect consumption of any particular 

spice during a single eating occasion to exceed more than a few grams. The most important data gap with 

regard to consumption of spices is a measure of the fraction of spices that are cooked sufficiently to provide 

an effective kill step for microbial pathogens such as Salmonella. 
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8. CURRENT MITIGATION AND CONTROL OPTIONS 

8.1 U.S. REGULATORY STANDARDS AND PROGRAMS

In this section we briefly review major regulatory standards and discuss regulatory programs that address 

the food safety of spices with respect to adulteration by pathogens or filth.

8.1.1 FEDERAL FOOD, DRUG, AND COSMETIC ACT

FDA can take action against a food if it is adulterated, misbranded, or otherwise not in compliance with all 

applicable federal laws. Four main sections in the Federal Food, Drug, and Cosmetic Act (FD&C Act) address 

spice adulteration:

For spices adulterated with any poisonous or deleterious substance: section 402(a)(1) of the FD&C Act – “A food 

shall be deemed adulterated if it bears or contains any poisonous or deleterious substance which may render 

it injurious to health.” This means that a spice containing Salmonella or another human pathogen violates the 

FD&C Act.

For spices adulterated with filth: section 402(a)(3) of the FD&C Act – “A food shall be deemed adulterated if it 

consists in whole or in part of any filthy, putrid, or decomposed substance or is otherwise unfit for food.” The 

Defect Action Levels describe the maximum concentrations of natural or unavoidable defects in foods that 

present no health hazards for humans. If the Defect Action Levels (DALs) 21 CFR 110.110 (FDA, 2012h) are 

exceeded, FDA would consider that spice to be adulterated. 

For spices manufactured under insanitary conditions: section 402(a)(4) of the FD&C Act – “A food shall be 

deemed adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have 

become contaminated with filth, or whereby it may have been rendered injurious to health.” 

For spices offered for import into the United States: section 801(a)(3) of the FD&C Act authorizes FDA to detain 

a regulated product that appears to be adulterated or misbranded. 

8.1.2 PUBLIC HEALTH SERVICE ACT

The Public Health Service Act (42 U.S.C., Chapter 6A, Subchapter II, Part G, Section 264; FDA, 2013p) allows 

the Surgeon General, with approval of the Secretary of Health and Human Services, “to make and enforce such 

regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of 

communicable diseases from foreign countries into the States or possessions, or from one State or possession 

into any other State or possession.”

8.1.3 U.S. REGULATORY MECHANISMS

8.1.3.1 CURRENT GOOD MANUFACTURING PRACTICES (CGMPS), INSPECTIONS AND 

ENVIRONMENTAL SAMPLING

FDA provides regulatory oversight of food through its field staff. Current Good Manufacturing Practices 

(CGMP) regulations for manufacturing, packing or holding human food describe general food safety principles 

and specific aspects of production that impact the safety of a product. These regulations currently can be 
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found at 21 CFR 110 (FDA, 2012i); proposed changes to these regulations can be found in proposed 21 CFR 

117 (78 Federal Register 3646, January 16, 2013) (FDA, 2013s). 

FDA performs both foreign and domestic inspections of food (including spice) manufacturing, packing, and 

storage facilities each year. Some inspections include environmental sampling. While most of the spice supply 

is imported, domestic firms handling imported spice may process (e.g., treat, grind, crack, and/or blend), pack 

and/or re-pack the spice before the product is made available to the consumer/customer. 

Domestic inspections differ from foreign inspections in a number of ways, including the fact that domestic 

inspections can be unannounced, whereas foreign inspections need to be planned and coordinated well in 

advance. Additionally, domestic inspections may include environmental and/or product sampling, whereas, 

except in very limited circumstances (i.e., outbreak investigations), FDA inspectors do not currently take 

environmental or product samples during foreign inspections. 

Effectiveness of CGMPs, Inspections and Environmental Sampling in preventing contamination of spice 

with pathogens or filth. FDA evaluates compliance of food facilities with CGMPS through inspections, which 

may include environmental sampling. Data from FDA inspection reports on firms that manufacture, pack or 

re-pack spices for the years FY2007-FY2012 are shown in Table 8.1. Each inspection is assigned one of three 

classifications: Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).

In addition, FDA evaluates all the evidence collected during inspections and determines whether additional 

actions are warranted, e.g., issuing a warning letter, recall, or regulatory meeting. 

Table 8.1 provides the average annual percentage of FDA domestic or foreign inspections of firms that 

manufacture, pack, or re-pack spices that were classified as OAI or VAI. In addition, FDA evaluates all the 

evidence collected during inspections and determines whether additional actions are warranted, e.g., issuing 

a warning letter, recall, or regulatory meeting. 

During FY2007-FY2012, FDA inspected 2649 domestic firms that manufacture, pack, or re-pack spices, with 

the annual total inspections for this group of firms in the range of 321-555. Between FY2007-FY2010, there 

were too few foreign inspections of firms that manufacture, pack, or re-pack spices to provide a meaningful 

rate for these classifications. However, during FY2011-FY2012, 70-73 foreign inspections of firms that 

manufacture, pack, or re-pack spices were performed annually and rates for OAI and VAI classifications are 

provided.

Table 8.1. Classification of inspections of firms that manufacture, pack or re-pack spices, FY2007-

FY2012

Domestic Firms Foreign Firmsa 

Fiscal 

Year

OAI Classification

Percentage (%)

VAI Classification 

Percentage (%)

OAI Classification 

Percentage (%)

VAI Classifications 

Percentage (%)

2007 0.3 33 NA NA

2008 0 31 NA NA

2009 1 38 NA NA

2010 1 35 NA NA

2011 3 34 0 49

2012 0.7 26 6 60 a No statistics are calculated for years in which fewer than 30 inspections were performed.

As illustrated in Table 8.1, only a small percentage of domestic or foreign inspections of firms that 

manufacture, pack, or re-pack spices during the years FY2007-FY2012 identified significant objectionable 

conditions or practices. A substantial percentage of inspections were classified as VAI, with a significantly 

larger proportion of foreign inspections in FY2012 resulting in this decision as compared with domestic

inspections during that year. Because the observations that lead to a VAI classification do not necessarily 

pertain to an immediate food safety issue, interpretation of the VAI classification rates is difficult.
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Comparison of the inspection statistics for firms that manufacture, pack, or re-pack spices with those for 

other food sectors provides a relative measure of compliance with CGMPs. Table 8.2 provides statistics for 

domestic inspections of firms that manufacture, pack, or re-pack spices as well as firms that manufacture, 

pack, or re-pack other low moisture foods. Annual numbers of domestic inspections for the firms in the food 

sectors listed in Table 8.2 ranged from 78-758 during this time period. Also provided in Table 8.2 are the 

average statistics for inspections of all other FDA regulated foods sectors, which numbered annually in the 

range ~17,000 – 24,000 for FY2007-FY2012. The rate of OAI and VAI classifications for inspections of 

domestic firms manufacturing, packing or re-packing spices is not statistically different (p>0.05) from rates 

for firms manufacturing, packing or re-packing other low moisture foods, such as cereals, chocolate, 

coffee/tea, nuts/edible seeds, milled whole grain, or the average rate for firms handling other categories of 

foods.

Table 8.2. Classification of domestic inspections of firms that manufacture, pack or re-pack low 

moisture foods, average annual rates FY2007-FY2012 

Average Annual Percentage of 

FY2007-FY2012 Domestic Inspections

Product Group

OAI Classifications

Percentage of firms

mean % (SD)

VAI Classifications

Percentage of firms

mean % (SD)

Spices 1.0 (1.0) 33 (4)

Cereal prepared/Breakfast food 0.1 (0.3) 32 (5)

Chocolate/Cocoa Powder 0.5 (0.4) 34 (2)

Coffee, Tea 0.7 (0.4) 33 (5)

Nuts/Edible Seeds 1.3 (1.0) 38 (6)

Whole grain, milled 1.4 (1.5) 29 (5)

All Other FDA-regulated Food Categories 1.9 (1.1) 38 (3)

In order to learn more about spice manufacturing, packing and re-packing environments, a special 

assignment was issued by FDA in 2010 for inspections of 59 domestic firms of varying sizes that manufacture, 

pack and/or re-pack spices. Each inspection included environmental sampling and the collection of additional 

information. Inspectors were instructed to restrict environmental sampling to non-food contact surfaces in 

order to gauge the potential for cross-contamination in the facility. Sampling was focused in processing and 

packing areas positioned after the pathogen reduction step in the product flow, if such a step took place in 

the firm, which has been referred to by the food industry as the “Primary Salmonella Control Area (PSCA)” 

(Chen et al., 2009b; GMA, 2009). Inspectors were instructed to sample areas where cross contamination 

between the floor or other surfaces and food contact surfaces and equipment may take place as well as

locations/pathway where pre-treatment products (e.g. spice dust) may be transported to the post-treatment 

areas inadvertently. Inspectors were also asked to sample and identify areas where moisture was observed or 

was likely to occur in the processing area. 

Ten percent of spice firms inspected (6/59) were found to have Salmonella-positive environmental samples. 

Among the six firms with Salmonella-positive environmental samples, two were very small (<$100,000 

annual sales), three were medium size ($1,000,000 –$9,999,999 annual sales), and one was very large 

(>$50,000,000 annual sales). Most of the firms (5/6) processed spices and many also packed/re-packed 

spices; one firm was engaged in only packing/re-packing spices. 

Multiple Salmonella-positive environmental samples were found in two of the firms, with 7% (14/193) and 

23 % (24/103) of environmental samples collected in these firms testing positive, respectively. Salmonellapositive swab samples obtained in the six spice firms were recovered from three different zones: zone 2 

(non-product contact surfaces in close proximity to product such as the exterior of spice grinding equipment, 

floors or walls), zone 3 (non-product contact surfaces in the spice processing/handling areas of the facility 
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that are not in close proximity to food contact surfaces such as forklifts, drains, or walls) and zone 4 (nonproduct contact surfaces far from the spice processing/handling areas of the facility such as locker rooms, 

bathrooms, hallways, and stairways). Most samples, including most positive samples, were collected from 

areas classified by inspectors as Zone 2. Common locations for Salmonella-positive samples were in the 

grinding and packing/re-packing areas, where cross-contamination from the environment to the product 

could occur.

Two of the firms in which Salmonella was found in the environment had undergone FDA environmental 

sampling in past inspections and one of them had had Salmonella-positive environmental samples during the 

past inspection. Some of the samples that tested positive in the firm with a past history of Salmonella-positive 

environmental samples contained the same Salmonella strain (identical PFGE) as that found two years earlier. 

This observation raises the possibility that the Salmonella strain was never eradicated from the environment 

after the first inspection or that a common/frequent source of contamination is responsible for recontamination of the facility. These data demonstrate that serotyping Salmonella isolates found in the 

environment (or product) provides additional information about the contamination that may be useful in 

investigating possible contamination sources. Product samples were not taken as a part of this study so a 

relationship between the observation of positive environmental samples and the likelihood of contamination 

of finished product could not be determined.

Data on CGMP practices, applications of pathogen- and pest-reduction processes, and product testing were 

collected for many of the firms. The most commonly reported CGMP citations listed on the FDA Form 483’s 

issued to the firms in these inspections are listed in Table 8.3. Citation frequencies ranged from 2 to 12 firms 

among the 59 inspected. 

Grouping citations into major CGMP categories, these inspections identified a number of areas of concern: (1) 

cleaning (e.g., accumulation of food particles on equipment or within the facility, equipment not easily 

cleanable, insufficient cleaning; 21 firms, 23% of all FDA Form 483 citations), (2) pests (17 firms, 19% of 

citations), (3) employee hygiene issues (e.g., using bare hands on spices, lack of hand washing, failure to 

provide hand washing facilities at each necessary location; 16 firms, 17% of citations) and (4) issues with the 

facility design or state of repair (e.g., holes in the ceiling, cracks in floors, no bathroom doors, product debris 

in unreachable areas; 19 firms, 15% of citations). Even though pests were often identified in CGMP citations, a 

majority of firms reported having a regular pest-prevention/reduction program (28/29 inspected firms for 

which this information was available). 

FDA Form 483 citations for moisture (e.g., leaking water from ceiling, dripping water from air conditioning

vent, standing water) were issued to 6 firms. One inspector observed whole dried capsicums being sprayed 

with water and was told the practice was used to reduce the likelihood of cracking/breaking during 

packaging. 

Information on the frequency that spices handled by each firms underwent a pathogen reduction treatment 

was also gathered. Of the 26 firms for which this information was gathered, 23 firms reported some (10/23) 

or all (13/23) of the spice handled by the firm treated. In most cases (15/23 firms), spice was treated before

reaching the facility. 

Information on environmental sampling and Salmonella product sampling and testing programs within firms 

was recorded in 25 of the inspections. Among these, a larger percentage of large spice firms (>$10 million 

annual sales) reported having environmental sampling programs (73% (11/15)) and/or product sampling 

programs (87% (13/15)) than smaller spice firms (<$10 million annual sales) where 10% (1/10) of firms 

reported having environmental sampling program and 30% (3/10) of firms reporting having product 

sampling programs. 
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Table 8.3. Sixteen most frequent citations reported on FDA Form 483 issued during domestic spice 

firm inspections, August-December 2011

Rank Citationa 21 CFR 

Reference Short Description Long Description

1 1560 110.35c Lack of effective 

pest exclusion

Effective measures are not being taken to [exclude pests from 

the processing areas] [protect against the contamination of 

food on the premises by pests]. 

2 1306 110.20(b)(7) Screening Failure to provide adequate screening or other protection 

against pests. 

3 1422 110.20B4 Floors, walls and 

ceilings

The plant is not constructed in such a manner as to allow 

[floors] [walls] [ceilings] to be [adequately cleaned and kept 

clean] [kept in good repair]. 

4 1553 110.35a Buildings/good 

repair

Failure to maintain [buildings] [fixtures] [physical facilities] 

in repair sufficient to prevent food from becoming 

adulterated. 

5 3652 110.37e1 Suitable locations Failure to provide [hand washing] [hand sanitizing] facilities 

at each location in the plant where needed. 

6 1554 110.35a

Cleaning and 

sanitizing 

operations

Failure to conduct cleaning and sanitizing operations for 

utensils and equipment in a manner that protects against 

contamination of [food] [food-contact surfaces] [foodpackaging materials]. 

7 1695 110.80b2 Manufacturing 

conditions

Failure to [manufacture] [package] [store] foods under 

conditions and controls necessary to minimize [the potential 

for growth of microorganisms] [contamination]. 

8 2392 110.80b1

Maintenance of 

equip., utensils, and 

finished food 

packaging

Failure to maintain [equipment] [utensils] [finished food 

containers] in an acceptable condition through appropriate 

cleaning and sanitizing. 

9 1125 110.40a Materials and 

workmanship

The [design] [materials] [workmanship] of [equipment] 

[utensils] does not allow proper [cleaning] [maintenance]. 

10 1293 110.20b2

Contamination 

with 

microorganisms, 

chemicals, filth, etc.

Proper precautions to protect [food] [food-contact surfaces] 

[food-packaging materials] from contamination with 

[microorganisms] [chemicals] [filth] [extraneous material] 

cannot be taken because of deficiencies in plant [size] 

[construction] [design]. 

11 1406 110.10b6 Effective use of hair 

restraint

Failure to wear [hair nets] [head bands] [caps] [beard covers] 

[appropriate hair restraints] in an effective manner. 

12 1427 110.20b5 Safety lighting and 

glass

Failure to provide safety-type [light bulbs] [lighting fixtures] 

[skylights] [glass] suspended over exposed food. 

13 1552 110.35a Buildings/sanitary Failure to maintain buildings, fixtures, or other physical 

facilities in a sanitary condition. 

14 1701 110.80b7 Equipment, 

containers, utensils

Failure to [construct] [handle] [maintain] equipment, 

containers and utensils used to [convey] [hold] [store] food in 

a manner that protects against contamination. 

15 2386 110.80a1 Storage Failure to store raw materials in a manner that [protects 

against contamination] [minimizes deterioration]. 

16 2394 110.80b6

Contamination by 

raw materials, 

refuse, other 

ingredients

Failure to take effective measures to protect finished food 

from contamination by [raw materials] [refuse] [other 

ingredients].

a The citation number is an FDA number for the specific observation described in the corresponding long description. Several different 

observations may be associated with the same section of the CFR, so the CFR reference is not sufficient to identify the observation. 

In summary, when measured by FDA inspection classifications, ≤ 3% of domestic firms that manufacture, 

pack, or re-pack spices were found to be out of compliance with FDA regulations regarding food safety and 

sanitation during the years FY2007-FY2012. The annual percentage of domestic firms that manufacture, pack, 

or re-pack spices that were inspected and found to be out of compliance during the years FY2007-FY2012 
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was not statistically different from the annual percentages for inspections of firms that manufacture, pack, or 

re-pack other low moisture foods. More data are needed to evaluate the rate of compliance among foreign 

firms.

Information gathered in 2010 from 59 inspections of domestic firms that manufacture, pack, or re-pack spices 

provide additional information about the potential for contamination within firms and preventive control 

programs and practices used by firms. Salmonella was found in the environment of ten percent of firms 

inspected including in the PSCA and most contamination sites were in locations where cross-contamination 

to spice product is most likely to occur (Zone 2). Among the 26 firms for which this information was available, 

88% reported that some (38%) or all (50%) of the spice handled by the firm had been or would be subjected 

to a pathogen reduction treatment before leaving the firm. Regular environmental and product sampling 

programs were common in large firms (≥73%) but not as common in small firms (≤30%). 

8.1.3.2 PRODUCT SAMPLING, REFUSALS, AND RECONDITIONING

Product sampling is a mechanism used within the FDA Import Foods - General Compliance Program, which 

covers imported food entries, and within the FDA Domestic Food Safety - Compliance Program, covering food 

products in domestic commerce. Spices may be sampled as part of either of these programs. Because spices 

are primarily produced outside the United States, the majority of sampling activities related to spices target 

imported shipments of spice offered for entry to the United States. In addition to general surveillance 

activities, FDA can issue field assignments to request targeted activities for a particular food. Field 

assignments are often used to gather data regarding a specific problem or product that are not addressed 

directly in a routine compliance program. Additionally, spices may be sampled at different points along the 

food chain, e.g., as part of a foodborne illness outbreak investigation.

The FDA regulatory programs help prevent contaminated spices from reaching the U.S. consumer by (1) 

directly identifying contaminated spice shipments/lots and either having them removed from the food supply 

or reconditioned to meet food safety requirements, (2) placing importers with shipments found 

contaminated on import alert and (3) indirectly encouraging the spice industry to prevent/remove 

contamination and eliminate/mitigate practices that would lead to contamination to avoid FDA enforcement 

actions for shipments found violative.

When a food is found to be adulterated with pathogens or filth, it is refused admission. When a product is 

initially refused admission, the importer can (1) export the product; (2) destroy the product; or (3) request 

permission from FDA to recondition the product to bring the product into compliance. If the importer 

requests reconditioning, the reconditioning proposal is approved by FDA and the reconditioning is successful 

in remedying the violation, FDA will release the product into U.S. commerce.

Effectiveness of product sampling, refusals and reconditioning in preventing contaminated spice from 

entering the U.S. food supply. Refusal of or reconditioning contaminated shipments identified by the FDA 

product sampling program prevents the contaminated spice from entering the U.S. supply or eliminates the 

contamination from the spice. During the period FY2007-FY2010, 906 imported spice shipments (including 

sesame seeds) were refused entry on the basis of the presence or potential for presence of Salmonella and/or 

filth. Among these shipments, 749 shipments of spice were refused entry because of the presence or potential 

presence of Salmonella and 238 shipments were refused because of the presence or potential presence of 

filth. Data on reconditioned imported shipments is provided in section 8.2.1.1.

While only a small fraction of shipments of imported spice offered for entry to United States are examined by 

FDA for the presence of Salmonella (~1%) or filth (~0.05%), when a shipment is found violative, the importer 

can be placed on import alert. Once on import alert, all subsequent shipments of the same spice from that 

importer would be subject to “detention without physical examination.” FDA’s decision to remove a product 

from detention without physical examination is based on evidence establishing that the conditions that gave 

rise to the appearance of a violation have been resolved. FDA’s decision to remove the product from the 
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Import Alert is based on evidence that provides confidence that future entries will be in compliance with the 

FD&C Act. In this way, the product sampling program can identify and prevent importers of contaminated 

spice from impacting the food safety of spice in the United States. Import Alerts related to shipments of spice 

contaminated with Salmonella or filth are discussed in the next section (8.2.1.3).

The indirect deterrent effect of regulatory sampling is difficult to measure but comparisons of compliance 

rates among surveillance samples provide insights into the extent of contamination of spices with Salmonella

and/or filth; these were discussed in Sections 4.1.3 and 4.2.3.

Finally, FDA has examined the efficacy of its sampling protocol for spices (Andrews and Hammack, 2003) in 

detecting shipments of imported spice contaminated with Salmonella. Based on models developed from 

Salmonella prevalence and enumeration data collected for shipments of imported capsicum and sesame seed, 

the sampling protocols employed by FDA to test samples of spice for the presence of Salmonella are predicted

to be efficient in detecting the more highly contaminated spice shipments, which contain the majority of the 

Salmonella in the imported supply (Appendix C, Table C3; Van Doren et al., 2013c). Additional research is 

needed to determine the applicability of these predictions to other types of imported spice.

8.1.3.3 IMPORT ALERTS, GREEN LISTS AND COUNTRY AGREEMENTS

Import Alerts. An Import Alert is a communication tool developed by FDA to disseminate import information 

(problems, violations, trends, etc.) for inspectional and compliance operating instructions to FDA field 

personnel, Centers (such as the Center for Food Safety and Applied Nutrition) and the Office of Regulatory 

Affairs headquarter units. FDA’s use of Import Alerts results in effective and uniform import coverage 

nationwide, as well as significantly improving the uniformity of enforcement in import problem areas. The 

subject of an Import Alert may be a specific hazard, commodity, geographical area, firm, or any combination 

thereof.

Historically, FDA has decided that issuance of an Import Alert is appropriate when (1) there is evidence of the 

importation of violative products; (2) there is evidence of the importation of products that may appear 

violative; or (3) when other information indicates that future entries of an imported product may appear 

violative. For example, when an imported product is found to be adulterated or misbranded, FDA can use that 

information as evidence that future shipments from that manufacturer appear to violate the FD&C Act. FDA 

can subject future entries to “Detention Without Physical Examination” (DWPE), and list the manufacturer 

and product on an import alert. If there is no existing import alert to address the violation, FDA can create a 

new import alert.

Products subject to DWPE will be detained without examination when they are offered for entry to the United 

States. Firms have the opportunity to submit evidence to overcome the appearance of the violation. If they are 

successful, the product will be allowed entry. If they are unable to overcome the appearance of the violation, 

the product will be refused admission.

For spices, the most common causes for DWPE are filth and pathogens. Table 8.4 lists the import alerts 

involving DWPE that are primarily/exclusively associated with spices and address issues of pathogen and/or 

filth adulteration (FDA, 2013h). 

Import Alert 99-19 (Detention Without Physical Examination of Food Products Due to the Presence of 

Salmonella; FDA, 2013i) lists firms and the specific foods for which evidence has indicated the likelihood of 

Salmonella contamination. Firms importing shipments of imported spices other than black pepper from India 

and white and black pepper from Brazil (which are covered by Import Alerts 28-02 and 28-04, respectively) 

may be listed on this import alert. As can be seen from Table 8.5, a majority of the firms on Import Alert 99-19 

are cited for the likelihood Salmonella contamination of spices and/or sesame seeds, even though the import 

alert is not limited to spices and sesame seeds. The names and numbers of firms on the import alert have 
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changed through time but the proportion of firms cited for the likelihood of Salmonella contamination of 

spices remains large. 

Table 8.4. Import Alerts involving DWPE that are primarily/exclusively associated with spices and 

address issues of pathogen and/or filth adulteration.

Number Years Activea Problem Type Actionb

99-19 1994-present Salmonella Firm DWPE particular foods from each 

firm

28-02 1987-present

Salmonella, filth, mold, 

foreign matter Country/World Wide DWPE of Indian Pepper

28-04 1989-present Salmonella Country/World Wide DWPE of Black and White Pepper 

from Brazil

24-11 1988-present excessive mold Country/World Wide DWPE Dried Peppers from Mexico

28-03 1977-present Filth (mammalian and 

other excreta, insect filth) Firm

DWPE Sesame seeds from Mexico 

and surveillance of sesame seeds 

from other countries a First year in range is date when the Import Alert was initiated. For the “Firm” type Import Alerts, this data corresponds to the date when 

the import alert was initiated. The date when each food/firm was put on the Import Alert is listed in the Import Alert.

b DWPE means “detention without physical examination.”

Table 8.5. Number of firms listed on Import Alert 99-19 for DWPE in October 2010 and June 2013

a Data taken from Import Alert 99-19 as of October 2010 (FDA, 2013i).

b Included in the count may be multiple listings of the same parent company because the company used several FEI numbers, listed 

different addresses or spelled its name differently. 

c Data taken from Import Alert 99-19 as of June 2013 (FDA, 2013i).

The firms listed on Import Alert 99-19 are from many different countries. Table 8.6 lists the countries with 

the largest number of firms identified for DWPE of one or more types of spices (sum of firms with industry 28 

and/or product code 23K02) as of July 1, 2011 and June 26, 2013. The largest number of firms on Import 

Alert 99-19 cited for the likelihood of Salmonella contamination of spices are from India and the “top ten” list

of countries in Table 8.6 is nearly the same in 2013 as it was in 2011 (nine out of the ten countries listed are 

the same). The numbers of firms listed for each country is in part a reflection of the numbers of shipments 

offered for import and sampled. Based on the FDA FY2007-FY2009 study comparing Salmonella prevalence in 

shipments of imported spice offered for import to the United States by export country, the prevalence of 

Salmonella in shipments is not strongly dependent on export country (Van Doren et al., 2013a; discussed in 

Section 4.2.3 and Table 4.5).

Green Lists and Country Agreements. If certain conditions are met, FDA may allow exemptions to DWPE for 

some firms. For example, for Import Alert 28-02, imports of Indian black pepper that are accompanied by an 

official Indian Export Inspection Council certificate will not be subject to DWPE when the Indian EIC 

certificate indicates that the spice shipment has been sampled and tested for compliance with U.S. 

requirements for Salmonella, filth, mold and foreign matter (see Import Alert 28-02 for a detailed list of 

information the certificates must include; FDA, 2013j) Another example is Import Alert 24-11 where firms 

that provided information to overcome the appearance of a continued violation for foods, particularly mold, 

can apply for exemption from DWPE (FDA, 2013k). Regardless of importer status, FDA may monitor or 

sample any shipment of regulated product offered for import to the United States. 

Number of Firms on 

Import Alert 99-19 # Firms (2010)a,b # Firms (2013)b,c

Total firms with one or more products identified for DWPE 733 882

Firms with spices cited as industry code 28 520 (71%) 595 (67%)

Firms with spices cited as industry code 23K-02 110 (15%) 83 (9%)
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Table 8.6. Countries with the largest number of firms listed on Import Alert 99-19 for DWPE of spicesa

due to “presence of Salmonella” 

a Spices identified as industry code 28 or product code 23K02 (sesame seeds)

b Data taken from Import Alert 99-19 as of 7/1/2011 (FDA (2013i).

c Included in the count may be multiple listings of the same parent company because the company used several FEI numbers, listed 

different addresses or spelled its name differently. 

d Data taken from Import Alert 99-19 as of 6/26/2013 (FDA, 2013i). 

Effectiveness of Import Alerts and Country Agreements in preventing contaminated spice from entering the 

U.S. food supply. Shipments subject to DWPE at entry to the United States must be accompanied by evidence 

that the shipment meets U.S. requirements before the product is allowed to enter U.S. commerce. Typical 

evidence for compliance with the Salmonella and filth requirements includes results from third party 

microbiological or filth tests and/or certification that the shipment has been subjected to an effective 

microbial reduction treatment. In this regard, import alerts are expected to be highly effective in reducing the 

risk of contamination in the particular products from the particular firms/countries identified. 

FDA periodically examines the effectiveness of exemption programs for imports by sampling spice in 

shipments from exempted firms. An audit of the exemption program for Import Alert 28-02, took place in 

2010. For a period of one month, FDA examined all 55 Indian black pepper shipments offered for entry to the 

United States during that time period. Most of the shipments were accompanied by an Indian EIC certificate 

(51/55), although some of the certificates were out of date or had other discrepancies. 

Using FDA sampling and testing protocols (750 g for Salmonella; Andrews and Hammack, 2003; Andrews et 

al., 2011; 6 x 50 g spice for ground black pepper and ~ 4kg (8 x 500 g) for whole black pepper; FDA, 1998a), 

the 55 shipments were tested for the presence of Salmonella and filth adulteration. None of the samples from 

the 51 shipments accompanied by an EIC certificate were found to contain Salmonella or to be adulterated by 

filth. Of the four shipments that were not accompanied with a certificate, two were adulterated by Salmonella, 

none were adulterated by filth, and two were not actually Indian black pepper, but rather were imported to 

India from Vietnam. 

This audit provides evidence that the exemption program for Import Alert 28-02, which requires assurance of 

food safety be provided by a certificate from the government of the country of origin, does provide some 

assurance that the black pepper shipment will comply with U.S. regulations for Salmonella and filth in spices. 

Specifically, the absence of Salmonella or filth in all of the shipments with EIC certificates indicates that the 

prevalence of Salmonella or filth in these shipments is in the range of 0.0-5.7% (750 g; 95% C.L.). More data 

are needed to determine whether the exemption program provides added food safety value, i.e., shipments 

accompanied by an EIC certificate have a smaller likelihood of being contaminated with Salmonella or filth 

than other shipments of black pepper from India. Collecting these data would be difficult because it appears 

that most of the shipments of black pepper from India offered for entry to the United States are accompanied 

by an Indian EIC certificate (51/55 in this study).

2011 2013

Country # Firmsb,c Country # Firmsc,d

India 172 India 187

Mexico 36 Mexico 37

Turkey 34 Turkey 37

Syrian Arab Republic 33 Syrian Arab Republic 34

Vietnam 30 Vietnam 29

Egypt 26 Egypt 29

China 25 China 26

Indonesia 15 Indonesia 18

Thailand 15 Thailand 18

Pakistan 14 Lebanon 16
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8.1.3.4 REPORTABLE FOOD REGISTRY

The Food and Drug Administration Amendments Act of 2007 required FDA to establish an electronic portal 

by which instances of reportable food may be submitted; this is the Reportable Food Registry (FDA, 2013d). 

Under section 417(a)(2) of the FD&C Act, a reportable food is “an article of food... for which there is a 

reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health 

consequences or death to humans or animals.” FDA interprets the definition of a reportable food to include 

those foods that would meet the definition of a Class I recall situation, for example, spice contaminated with 

Salmonella. 

Reportable foods must be reported by industry (responsible party) (FDA, 2010b) while federal, state, and 

local public health officials have the option to submit voluntary reports. Public health officials with 

knowledge of a reportable food can inform a food facility that it may be required to submit a food report.

The congressionally-identified purpose of the Reportable Food Registry is to provide a reliable mechanism to 

track patterns of adulteration in food in order to support efforts by FDA to target limited inspection resources 

to protect public health.

Effectiveness of the Reportable Food Registry in preventing contaminated spice from entering the U.S. food 

supply. Data on primary entries (initial reports) submitted during the first three years of the Reportable Food 

Registry program are listed in Table 8.7. Reports for all FDA-regulated foods except dietary supplements and 

infant formula (for which FDA has other mandatory reporting systems) are included in the RFR. The FDAregulated food commodities covered by the RFR have been separated into 28 types. “Spices and Seasonings” 

is the food commodity type that includes spices. 

Most of the primary entries associated with “Spices and Seasonings” reported contamination with Salmonella. 

No other pathogens were associated with “Spices and Seasonings” primary entries. Other hazards reported 

for “Spices and Seasonings” during this time period included undeclared allergens (4), presence of a foreign 

object (1) and presence of lead (1). 

As seen in Table 8.7, the number of primary entries reported for “Spices and Seasonings” during the first two 

years of the program were larger than that for most of the other food commodity types for all hazards and for 

Salmonella in particular. However, the absolute and relative (e.g., rank) number of primary entries for “Spices 

and Seasonings” were much smaller in Year 3 of the program. As mentioned previously, the absence of 

information about the total number of tests performed or lots examined, makes it difficult to interpret the 

meaning of these data, including changes from year to year. However the publication of the reports and 

summary statistics has been effective in alerting the industry to reported problems. 

Each primary entry may be followed by many related “subsequent reports” (defined as a report by either a 

supplier (upstream) or a recipient (downstream) of a food/feed (including ingredients) for which a primary 

report has been submitted; FDA, 2013d). The number of subsequent reports depends on whether the primary 

report is on a widely used ingredient or a finished food distributed to many different locations. For example, a 

food manufacturer may test a spice for Salmonella and find that it is contaminated. Subsequent reports will 

then be expected from the supplier of the spice and downstream recipients of spice from the implicated lot, if 

applicable. In this way, the Reportable Food Registry, with the help of industry, is able to identify and remove 

contaminated spice from the food supply.

Data from the RFR on spices and other commodities has increased the speed with which FDA and its state and 

local partners investigate reports and take appropriate follow-up action, including removing reportable foods 

from commerce when necessary (FDA, 2013d). The data has also improved FDA’s understanding of how

products including spices are distributed through commodity supply chains, increasing FDA’s ability to trace 
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reportable foods upstream and downstream (FDA, 2013d). Data from the RFR has also supplied information 

to help FDA target inspections, plan work, and identify and prioritize risks (FDA, 2013d). 

Table 8.7. Primary entries reported to the FDA Reportable Food Registry September 8, 2009-

September 7, 2012

Reportable Food Registry Food Commodity Hazard Year 1a Year 2a Year 3a

All FDA-regulated Food Categories all 229 225 224

“Spices and Seasonings” all 17 25 8

Rank out of total number of primary entries for “Spices and 

Seasonings” among all 28 RFR food commodity typesb all 3rd-4th 2nd 10th

All FDA-regulated RFR Food Categories Salmonella 86 86 63

“Spices and Seasonings” Salmonella 16 23 5

Rank of number of primary entries for “Spices and 

Seasonings” among all 28 RFR food commodity types Salmonella 1st 2nd 4th (tied)

a Year 1 included September 8, 2009-September 7, 2010; Year 2 included September 8, 2010-September 7, 2011; Year 3 included 

September 8, 2011-September 7, 2012.

b Dietary supplements and infant formula are excluded.

c Tied with two other RFR food commodities.

8.1.3.5 GOOD AGRICULTURAL PRACTICES

Good agricultural practices (GAPs) are a collection of science-based principles of on-farm production and 

post-production processes that, when used, result in safer food. GAPs criteria are developed and applied 

based, in part, on the type of agricultural production system in use. Although many GAPs principles (such as 

worker health and hygiene) are applicable to any agricultural system, GAPs guidance in the United States has 

been developed mainly for the fresh produce industry (FDA, 1998b; USDA/ARS, 2013). The FDA Guide to 

Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (FDA, 1998b) has 

relevance for spice crops grown in systems similar to fresh produce crops (e.g., capsicums) as does the 

Produce GAPs Harmonized Food Safety Standards (USDA/ARS, 2013). 

While FDA and USDA/ARS currently have no GAPs guidance for small-scale, multi/inter-cropping and/or 

‘managed wild-craft’ agricultural systems, which are internationally used to grow spice crops, FDA has 

worked with WHO to create guidance for rural workers who grow fresh fruits and vegetables (WHO, 2012). 

The Five keys to growing safer fruits and vegetables: promoting health by decreasing microbial contamination

manual was designed “to be easy to use, adopt and adapt so that community and health educators can tailor 

the training materials to meet local needs” (WHO, 2012). The target audience for this guidance is “rural 

workers, including small farmers who grow fresh fruits and vegetables for themselves, their families and for 

sale in local markets” but could also be used by small-scale spice producers (WHO, 2012). 

Effectiveness of Good Agricultural Practices in preventing contamination of spices with Salmonella and/or 

filth during primary production. WHO, FDA, and USDA guidance documents were developed based on the 

best available science, and as a result, it is expected that application of the principles and recommendations 

outlined in these guidance documents should reduce the risk of contamination of fresh produce (including 

capsicums) with microbial pathogens and filth. We are unaware of any systematic studies that have measured 

changes in the prevalence of microbial or filth contamination in capsicums or other spice source plants as a 

result of applications of these principles or any surveys that measure the extent to which these practices have 

been adapted by the food industry in general or the spice industry in particular. However, FDA commissioned 

a study to examine the cost-effectiveness of practices intended to prevent tomato-related foodborne illness, 

which quantified the predicted relative impact specific growing and harvest practices have on the risk of 

Salmonella contamination (Robert et al., 2009). In support of the proposed produce rule (FDA, 2013e), FDA 

also completed a quantitative assessment of the impact of Enterohemorrhagic Escherichia coli (EHEC) 

contamination of irrigation water on the risk of illness from consumption of leafy greens (FDA, 2013e). 
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8.1.3.6 RETAIL ESTABLISHMENT AND CONSUMER GUIDANCE 

The FDA Food Code is a model code developed and regularly updated by FDA that “assists food control 

jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis 

for regulating the retail and food service segment of the industry. Local, state, tribal, and federal regulators 

use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with 

national food regulatory policy” (FDA, 2013m)

Nearly all of the U.S. states have adopted the FDA Food Code as the basis for their food safety regulatory 

oversight of retail food and institutional facilities (FDA, 2013b). The FDA Food Code uses the term “Potentially 

Hazardous Food” (PHF) to define foods that should have time/temperature controls for safety to limit 

pathogen growth or toxin formation. The definition of PHF takes into consideration pH, water activity (aw), 

pH and aw interaction, heat treatment, and packaging. Several decision trees and tables are included in the 

annex to the FDA Food Code to aid in determining if a food is considered a PHF. According to the FDA Food 

Code algorithms (FDA, 2013n), spices would not be classified as a PHF because the typical aw is too small. 

The U.S. Government provides consumers general safe food handling information such as the current multimedia Advertising Council campaign Safe Food Families that provides messages on cleaning utensils and 

surfaces, preventing cross-contamination, safe cooking and proper chilling of food. Education campaigns also 

provide product/pathogen-specific advice for high profile, recurring hazards (e.g., egg safety, or food safety 

for pregnant women). The information and learning materials are disseminated through the media, Enewsletters to health educators, school-based programs, and FDA Consumer Updates, food safety agency 

websites, agency displays at regional food shows and health fairs, and health care provider offices. 

FoodSafety.gov is a “Gateway to Federal Food Safety Information” website that provides information on 

outbreaks and recalls, as well as feature articles delivering messages to consumers. Guidance for consumers 

regarding the safe handling of low-moisture foods, such as spices has not been addressed. 

Effectiveness of retail establishment and consumer guidance in preventing contamination of spices with 

Salmonella and/or filth in retail establishments, including consumer homes, and in preventing consumption 

of contaminated spice. While neither the FDA Food Code nor consumer guidance developed by FDA currently 

provide specific guidance on preventive practices for spices, these documents provide general information on 

practices that are designed to reduce the likelihood of contamination of food with pathogens (such as 

Salmonella) and filth and practices that limit growth and survival of pathogens in foods. FDA evaluated trends 

in food safety practices in retail food establishments (institutional foodservice, restaurants, and retail food 

stores) during the period 1998-2008, evaluating compliance with 42 different foodborne illness risk factors 

(FDA, 2010d). All but one (nursing homes) of the facility types investigated, showed a statistical improvement 

in applying food safety practices that reduce the prevalence of risk factors for foodborne illness (e.g., 

maintaining food at 5oC or below except during preparation, cooking, cooling or when time is used as a public 

health control).

All major education campaigns for consumers are developed through the use of formative evaluation with the 

target audiences, and each program is evaluated with the end users. Because consumers receive food safety 

information through a variety of outlets, it is difficult to evaluate the impact of a particular educational 

campaign on the population as a whole.

8.1.3.7 FDA FOOD SAFETY MODERNIZATION ACT

The FDA Food Safety Modernization Act (FSMA) was signed into law January 4, 2011 (FDA, 2011a). FSMA

addresses five areas of food safety (1) preventive controls (2) inspection and compliance (3) imported food 

safety (4) response and (5) enhanced partnerships. Some of the provisions of FSMA have been implemented 

while other regulations and guidance documents required by FSMA were either under development by FDA 

or under review by appropriate authorities when this report was written. Below we briefly describe the 

FSMA provisions that have been implemented and which are expected to significantly impact the food safety 
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of the U.S. spice supply. The information provided below was gathered from the FDA FSMA information 

website available to the public (2013o), unless otherwise noted.

FDA is increasing the frequency of domestic and foreign inspections pursuant to section 201 of FSMA. FDA 

also has the authority to detain food if, during an inspection, examination, or investigation, FDA “has reason 

to believe” that the product is “adulterated or misbranded” (section 207 of FSMA). FDA also has the authority 

to deny entry of products to the United States from foreign food facilities that refuse access to FDA inspectors 

or third party inspectors authorized by the agency (section 306 of FSMA).

 

In general, before an imported food can enter the United States, a prior notice must be submitted to FDA (21 

CFR 1.279; FDA, 2013r). Implementation of section 304 of FSMA adds the requirement that the notice provide 

the name of “any country to which the article has been refused entry.” This requirement should help FDA 

stop refused shipments from being allowed entry to the United States by a different U.S. port. 

FDA now has the authority to mandate food recalls for all FDA-regulated foods (section 206 of FSMA). Prior to 

FSMA, FDA only had the authority to mandate recalls of infant formula. This authority allows FDA to require 

recalls of foods to protect the public health in cases when industry does not voluntarily do so.

FDA has developed an International Food Safety Capacity-Building Plan (FDA, 2013q) to “expand technical, 

scientific and regulatory food safety capacity of foreign governments and their respective food industries” 

(section 305 of FSMA) (FDA, 2013q). Building capacity is an important part of FSMA (Section 305). As one 

part of its capacity building efforts, FDA has begun to set up new and expand established international posts 

in a range of countries and regions including China, India and Latin American. 

Important new rules to implement Sections 103 and 301 of FSMA related to spice safety (proposed rule 

“Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human 

Food” (78 Federal Register 3646; January 16, 2013) (FDA, 2013s) and “Foreign Supplier Verification 

Programs for Importers of Food for Humans and Animals” (78 Federal Register 45730; July 29, 2013) (FDA, 

2013t) are discussed under future efforts since they were not finalized at the time this report issued.

Effectiveness of the FDA Food Safety Modernization Act in improving spice food safety. Data addressing the 

effectiveness of each of the provisions of FSMA described above was not available at the time this report was 

written because of the brief period since implementation. 

8.2 INDUSTRY PROGRAMS 

8.2.1 PATHOGEN REDUCTION

8.2.1.1 INTRODUCTION

While post-harvest treatments such as physical cleaning and garbling (inspecting and removing refuse) of 

raw spices may reduce filth and possibly sources of pathogenic bacteria, they are not sufficient to eliminate or 

reduce microbial populations associated with the spices. The most common spice processing treatments that 

impact the viability of microorganisms, including human pathogens such as Salmonella, can generally be 

grouped into three categories: 1) steam treatment, 2) gamma radiation, and 3) fumigation with ethylene 

oxide (EO). These treatments are also commonly used for other materials such as pharmaceuticals and 

biologics as described by the U.S. Pharmacopeia (USP, 2011). 

Other treatment options have been studied and are described in the scientific literature; however, they are 

not currently used or are only minimally used on a commercial basis for spice treatment. These include dry 

heat, microwave radiation, high pressure processing, supercritical carbon dioxide (CO2), ozone, pulsed light, 
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and an alternative steam treatment “controlled condensation.” These technologies are explained in more 

detail in Section 8.2.1.8 which describes alternative pathogen reduction treatments.

As mentioned in Section 8.1.3.2, imported spice shipments initially refused for import on the basis of 

microbial hazards may be accepted for entry after reconditioning. Between January 2007 and December 

2012, CFSAN accepted 50 out of 155 reconditioning proposals for spices (Table 8.8). Thirty-seven proposals 

(74%) addressed contamination with Salmonella (amaranth [1], anise seed [1], basil [1], black pepper [4], 

celery seed [1], chili pepper powder/flakes [5], coriander powder [1], cumin powder [1], dill seeds [1], ginger 

[1], onion granulated [1], parsley powder [1], sage leaves [1], sesame seeds [16], turmeric [1]). Ten proposals 

(22%) were for contamination with filth (chili/paprika powder/flakes/whole [7], cumin [1], ginger [1], and 

sesame seeds [1]). One sesame seed proposal (2%) addressed contamination with both filth and Salmonella. 

Table 8.8. Accepted reconditioning proposals for spices, 2007 – 2012 (December)

Product CFSAN 

Review Year Country of Origin Adulteration Type of Reconditioning

Amaranth 2012 India Salmonella Controlled condensation steam 

treatment

Anise Seeds 2012 Turkey Salmonella Irradiation

Basil 2011 Egypt Salmonella Irradiation

Black Pepper 2008 Mexico Salmonella Irradiation

Black Pepper 2010 Vietnam Salmonella Irradiation

Black Pepper 2011 Indonesia Salmonella Ethylene Oxide

Black Pepper 2011 Indonesia Salmonella Propylene Oxide

Celery Seeds 2011 India Salmonella Ethylene Oxide and Steam

Chili pepper flakes 2008 Mexico Filth Cold treatment

Chili pepper flakes 2012 Mexico Salmonella Irradiation

Chili pepper, whole dried 

(Ancho) 2012 Mexico Filth/Mold Separate/sort/treat and visible inspection

Chili pepper, whole dried 

(Ghost) 2011 India Filth Separate/sort/treat and visible inspection

Chili pepper, whole dried 

(Habanero) 2012 Mexico Filth Separate/sort/treat and visible inspection

Chili pepper, whole dried 

(Puya) 2012 Mexico Filth Separate/sort/treat and visible inspection

Chili pepper, whole dried 2011 China Filth/Mold Steam/sort, visual inspection

Chili powder 2011 India Salmonella Irradiation

Chili powder 2011 India Salmonella Irradiation

Chili powder 2011 Mexico Salmonella Irradiation

Chili powder 2009 Mexico Filth Blend and sort

Chili powder 2012 Mexico Salmonella Irradiation

Coriander powder 2012 India Salmonella Irradiation

Cumin powder 2011 India Salmonella Irradiation

Cumin Seeds 2008 Turkey Filth Aspirate and sort

Dill Seeds 2012 India Salmonella Ethylene Oxide

Fennel 2012 India Filth Steam; clean (separate/sift) and 

mill

Ginger, dried split 2011 Nigeria Salmonella Controlled condensation steam 

treatment

Ginger, whole dried 2008 China Filth/Mold Propylene oxide (mold); tumble; 

aspirate
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Product CFSAN 

Review Year Country of Origin Adulteration Type of Reconditioning

Onion, granulated 2011 Egypt Salmonella Irradiation

Paprika peppers, dried 

whole mild 2012 China Filth/Mold Separate/Sort and visible inspection

Parsley powder 2010 Hungary Salmonella Irradiation

Paprika peppers, dried 

whole mild 2012 Peru Filth/Mold/Mites

Separate/Sort and visible 

inspection and fumigation

Sage Leaves 2011 Germany Salmonella Propylene Oxide

Sesame Seeds 2009 Mexico Salmonella, 

Filth

Irradiation (Salmonella); Scalp 

and sift, hull, dry (filth)

Sesame Seeds 2010 India Salmonella Irradiation

Sesame Seeds 2010 India Salmonella Ethylene Oxide

Sesame Seeds 2010 India Salmonella Ethylene Oxide

Sesame Seeds 2010 India Salmonella Ethylene Oxide

Sesame Seeds 2007 Venezuela Salmonella Ethylene Oxide

Sesame Seeds 2010 India Salmonella Irradiation

Sesame Seeds 2011 Guatemala Salmonella Irradiation

Sesame Seeds 2011 India Salmonella Irradiation

Sesame Seeds 2011 India Salmonella Irradiation

Sesame Seeds 2012 India Salmonella Irradiation

Sesame Seeds, hulled 2011 India Salmonella Irradiation

Sesame Seeds, hulled 2011 India Salmonella Controlled condensation steam 

treatment

Sesame Seeds, hulled 2011 India Salmonella Irradiation

Sesame Seeds, hulled 2011 Guatemala Salmonella Irradiation

Sesame Seeds, hulled 2011 India Filth Cold treatment

Sesame Seeds, hulled 2012 India Salmonella Controlled condensation steam 

treatment

Turmeric 2011 India Salmonella Ethylene Oxide

Indigenous Spice Microflora. The microflora of different spices is highly variable in size and scope. Not only 

will the population of microorganisms differ among various spices, it will also differ within a spice category 

based on cultivation, handling, storage and processing conditions. Spices are derived from botanic sources 

typically cultivated outside and exposed to environmental contamination such as dust, water, insects, 

animals, and human contact. Additionally, spices are subject to various handling, storage and processing 

techniques that expose them to other possible contamination sources. Because they are agricultural 

commodities, it should not be surprising that spices have a large and varied microflora including occasional 

contamination with pertinent human pathogens.

The presence and survival of Salmonella in various spices is well established (Chapters 4 and 5). While 

numerous researchers have reported the presence of Salmonella in spices, few have provided enumeration 

data. Based on available data (Table 4.2) and analysis (Section 4.1.3; Figures 4.1 and 4.2; Van Doren et al., 

2013c), the bioburden of Salmonella in adulterated spices is thought to be low, typically averaging less than 1 

MPN/g but documented as being as large as 11 MPN/g (Lehmacher et al., 1995) in samples associated with a 

spice-attributed salmonellosis outbreak. 
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8.2.1.2 COMMONLY USED TREATMENTS

To evaluate the efficacy of processes designed to inactivate pathogens, a review of scientific refereed 

literature related specifically to treatment of spices was conducted. Information below in text and related 

tables reflect this analysis. Data on changes in microbial populations before and after treatment were 

obtained from graphs, tables and text in the refereed papers. Because of the widespread utilization of steam, 

gamma radiation and EO treatments, direct comparisons of results from these processes were made for the 

microbial populations reported. Seventy-four publications related to spice treatments were obtained as 

refereed journal articles or book chapters after a review of literature, including 11 related to steam 

treatment, 42 to gamma radiation, 14 to EO, and 35 related to other treatments such as microwave heating, 

dry heat, hydrostatic high pressure, pulsed light, pulsed electric field, high pressure CO2, x-rays and electron 

beam. (The sum of individual treatments is greater than the total reviewed because many papers conducted 

direct comparisons of more than one treatment.) A number of these refereed papers did not contain original 

treatment data because they were review articles or addressed other spice issues such as toxicology or 

quality effects. The number of publications with original microbiological data that were used to construct the 

tables were five for steam, five for EO, and 19 for gamma radiation. The reviewed refereed papers and book 

chapters were published between 1942 and 2010.

Data from an individual refereed paper was selected for analysis when the numerical size of a microbial 

population was clearly presented in tabular or graphical form for spice samples taken before and after 

treatment. The decimal reduction for a specific spice and treatment combination was calculated from these 

data pairs. Because some “after” treatment results were reported as “zero”, it was assumed the microbial 

population was below the limit of detection for the enumeration method used. In those cases, the decimal 

reduction was assumed to be “greater than” (>) the beginning population. This assumption was modified only 

if the paper indicated that the lower limit of detection was greater than 1 CFU/g. Most data pairs reported 

were for total aerobic plate counts (APC) while those for yeasts and molds, coliforms, Escherichia coli and 

Enterobacteriaceae were also included. The more valuable decimal reduction data were obtained from APCs 

because they are generally several logs higher than other measurable populations before treatment. Having a 

larger initial population increased chances of obtaining a measurable population after treatment therefore 

yielding a discrete decimal reduction. 

It was noteworthy that none of the reviewed studies involved experiments on spices inoculated with a 

pathogen or pathogen surrogate. While reductions in the overall microbial populations (APCs) observed in 

these studies may provide a relative comparison of the efficacy of different treatment types, results do not 

predict expected Salmonella reductions. Specific treatment validation studies using Salmonella or appropriate 

surrogates are needed and highly recommended. 

8.2.1.3 STEAM TREATMENT

Steam treatment of foods is a well-known traditional technology used to address both quality and safety 

issues. It is well characterized and has been the subject of considerable scientific study for many decades. 

According to Pflug and Holcomb (2001), there are three general factors affecting the thermal resistance of 

microorganisms to heat: 1) microbial inherent resistance, 2) environmental influences during cell growth 

and/or sporulation, and 3) environmental influences during the heating cycle. Microbial thermal resistance is 

traditionally measured in terms of D- and z-values where D, standing for Decimal Reduction Time, is the time 

at a specific temperature needed to reduce the target population by one log (90%) and z-value, representing 

the reciprocal of the slope of the line in a Thermal Death Time curve is the change interval in temperature 

needed for the line to pass through to increase/decrease the D-value by one log. Environmental influences 

during cell growth and spore formation of vegetative cells and spores impact the cell physiological state, 

which has an impact on the thermal resistance. These influences include issues such as incubation 

temperature, nutrient medium composition, and cell age. Environmental influences during the heat cycle may 
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include, among others, medium pH, ionic strength, substrate composition, and the presence of antimicrobial 

compounds that might impact cell survival.

Perhaps the best known and studied steam process for foods is retorting whereby canned foods are rendered 

commercially sterile using pressurized, saturated steam. As an example, cans of low acid foods are packed 

into a steam chamber and subjected to steam at 121°C and pressure of 15 psig for a set time period. Microbial 

death (lethality) occurs based on numerous factors including, among others, the time and temperature of 

treatment and thermal resistance characteristics (D and z values) of the target organism. 

In steam treatment of spices, lethality arises from the time and temperature of exposure of the spice 

microflora to steam. Treatments that provide thorough exposure of spice particles to steam for an 

appropriate time should successfully eliminate vegetative bacterial pathogens (e.g., Salmonella). Steam 

system designs vary greatly in their abilities to fully expose spice particles to steam, and may or may not 

include pressure and saturated steam. Traditional steam treatments expose spice to steam that consists of 

vaporized water and usually a very small portion of liquid water (saturated steam) at a pressure (or vacuum) 

to control its temperature. Steam treatments employing a vacuum-steam-vacuum process create an 

environment that removes the gases from within the chamber and allows for the steam to penetrate 

throughout the product. The steam temperature, because it is saturated steam, will be dependent on the 

vacuum held within the processing chamber. A final vacuum step is used for these processes to remove any 

water that may have condensed onto the spice. Steam treatments that include supplemental electrical or 

indirect heat employ saturated steam condensation and heat conduction to both heat the spice to remove any 

microbial contamination and control the moisture level of the spice so that it does not change during the 

process. These dual heating systems may not include a drying step, but could include a cooling step to cool 

the spice back to pre-processing conditions. Both vacuum-steam-vacuum and dual heating processes aim to 

reduce the undesirable effects of excessive wetting of spice that may take place during traditional steam 

treatment.

Two basic methods used for steam treatments include batch and continuous processing. In batch processing, 

packages of spices are palletized, loaded into a treatment chamber followed by steam injection into the 

chamber with or without pressure. Due to variations in bulk density among spices (as well as other factors 

such as packing permeability and stacking configuration), there is no set of conditions for steam treatments 

that would be effective for all spices; therefore, processors should determine treatment time that will ensure 

steam penetration throughout the package for an adequate time period to reduce the number of vegetative 

pathogens.

Continuous steam processing involves equipment designed to continually move spice through a system 

where steam is injected. System designs differ in the way in which the unpackaged product is exposed to 

steam and conveyed through the system. Some may use rotational devices to provide tumbling action for 

enhanced exposure of spice particles to the steam and to convey the spice through the steam chamber. Others 

may layer spices on a conveyor belt without enhanced mixing action of the spice particles as they traverse the 

steam chamber. Other systems may use different conveyance systems. In a properly designed and operated 

system, all particles will be directly exposed to steam for an appropriate time period. Continuous systems 

that agitate spice particles within the steam chamber theoretically need less exposure time than the batch 

method, which relies on passive steam penetration. A continuous system that has less mixing action (e.g., 

conveyor belt) would need longer exposure time to ensure complete coverage as compared to continuous 

systems that use mixing action.

Applicability and Practicality of steam treatments. Steam treatments can effectively reduce microbial 

populations in dried spices but may impact spice quality. Advantages are that the technology is well 

established and effective when properly applied, and equipment is readily available. Disadvantages are that 

some systems are not designed to provide the most effective reduction in microbial populations, and 

physicochemical quality parameters related to color and flavor may be negatively impacted by steam.
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Effectiveness of steam treatment in reducing Salmonella in spices. Refereed publications that address spices 

inoculated with Salmonella populations are limited to presence/absence data after steam treatment and do 

not discuss enumeration. However, data on thermal inactivation of Salmonella in low moisture foods are 

available. In a review by Doyle and Mazzotta (2000), the thermal resistance of salmonellae in chocolate, a low 

moisture food, was shown to be much higher than for higher moisture foods. For example, D-values at 71°C 

ranged between 210 and 1,200 min for S. Anatum in chocolates with various moisture contents between 0 

and 4% whereas S. Typhimurium in roast beef had a D-value of 0.095 min at 70°C. As discussed in Section 

5.1.3, many refereed publications have established that salmonellae in low moisture foods have significantly 

higher D- and z-values compared to other foods with higher moisture levels (Podolak et al., 2010; Hiramatsu 

et al., 2005; Gruzdev et al., 2011; Keller et al., 2012; Harris et al., 2012), It has also been shown that reductions 

are not always linear and that significant tailing may occur (Beuchat and Mann, 2010; Abd et al., 2012; 

Blessington et al., 2012).

Reductions of different microbial populations in spices (aerobic plate counts, yeast/mold counts, total 

coliforms, fecal coliforms, Escherichia coli, and Enterobacteriaceae) by steam treatments were reviewed in 

four refereed publications (Table 8.9). 

Table 8.9. Decimal reductions of microbial populations in spices from heat treatments

STEAM

Spice

Trmt 

Timea

(min)

Trmt 

Tempa

(°C) 

Pressure 

(psig) 

Type 

of 

Countb

Process 

Typec

Decimal 

Reduction Adapted from:

Paprika 0.1 160 15 APC C 2 Almela et al.,2002

Paprika 0.1 160 30 APC C > 4.8 Almela et al., 2002

Paprika 0.1 160 15 CF C > 3.5 Almela et al., 2002

Paprika 0.1 160 30 CF C > 3.5 Almela et al., 2002

Paprika 0.1 160 15 EB C > 3.9 Almela et al., 2002

Paprika 0.1 160 30 EB C > 3.9 Almela et al., 2002

Pepper, black ground 20 115 10 APC B 4.8 Yesair and 

Williams (1942)

Pepper, black ground 15 121 15 APC B 7.9 Yesair and 

Williams (1942)

Pepper, black ground 5 108 5 APC B 4.3 Yesair and 

Williams (1942)

Pepper, black ground 16 ~100 0 APC B 2.6 Waje et al., 2008

Pepper, black ground 16 ~100 0 CF B 4.2 Waje et al., 2008

Pepper, black ground 16 ~100 0 YM B 2.3 Waje et al., 2008

Pepper, black whole 3 130 0 

assumed APC U 0.8 Sádecká, 2010

Pepper, red ground 16 ~100 0 APC B 1.3 Rico et al., 2010

Pepper, red ground 16 ~100 0 YM B 2.7 Rico et al., 2010
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DRY HEAT

Spice

Trmt 

Timea

(min)

Trmt 

Tempa

(°C) 

Pressur

e (psig) 

Type 

of 

Count1

Process 

Type2

Decimal 

Reduction Adapted from:

Anise seed 15 70 0 APC B 1.9 Farag Zaied et al., 1996

Anise seed 15 70 0 YM B 2.5 Farag Zaied et al., 1996

Coriander 15 70 0 APC B 2 Farag Zaied et al., 1996

Coriander 15 70 0 YM B 2.3 Farag Zaied et al., 1996

Fennel seed 15 70 0 APC B 3 Farag Zaied et al., 1996

Fennel seed 15 70 0 YM B 3 Farag Zaied et al., 1996

Paprika 0.1 152 0 APC C 1.6 Almela et al., 2002

Paprika 0.1 152 30 APC C 1.8 Almela et al., 2002

Paprika 0.1 152 0 CF C 1.3 Almela et al., 2002

Paprika 0.1 152 30 CF C 2.4 Almela et al., 2002

Paprika 0.1 152 0 EB C 3.8 Almela et al., 2002

Paprika 0.1 152 30 EB C > 3.9 Almela et al., 2002

Pepper, black whole 15 70 0 APC B 3 Farag Zaied et al., 1996

Pepper, black whole 15 70 0 YM B 3.1 Farag Zaied et al., 1996

Turmeric 15 70 0 APC B 2.9 Farag Zaied et al., 1996

Turmeric 15 70 0 YM B 2.7 Farag Zaied et al., 1996

MICROWAVE

Spice

Trmt 

Timea

(min)

Trmt 

Tempa

(°C)

Pressure 

(psig) 

Type of 

Count1

Process 

Type2

Decimal 

Reduction Adapted from:

Oregano 15 100 0 APC C 1.2 Legnani et al., 2001

Oregano 15 100 0 EC C 0.2 Legnani et al., 2001

Oregano 15 100 0 FC C 3.8 Legnani et al., 2001

Pepper, black ground 0.67 160 0 APC B 1.3 Emam el al., 1995

Pepper, black ground 1.25 240 0 APC B 3.5 Emam el al., 1995

Pepper, black whole 15 100 0 APC C 0.1 Legnani et al., 2001

Pepper, black whole 15 100 0 EC C 0.2 Legnani et al., 2001

Pepper, black whole 15 100 0 FC C 2.5 Legnani et al., 2001

Pepper, red chili 15 100 0 APC C 1.3 Legnani et al, 2001

Pepper, red chili 15 100 0 EC C 0.7 Legnani et al., 2001

Pepper, red chili 15 100 0 FC C 3.6 Legnani et al., 2001

Rosemary 15 100 0 APC C 1.6 Legnani et al., 2001

Rosemary 15 100 0 EC C 0.2 Legnani et al., 2001

Rosemary 15 100 0 FC C 3 Legnani et al., 2001

Sage 15 100 0 APC C 1.5 Legnani et al., 2001

Sage 15 100 0 EC C 0.8 Legnani et al., 2001

Sage 15 100 0 FC C 3.7 Legnani et al., 2001 a Trtmt = treatment.

b APC = total aerobic plate count, CF = coliforms, EB = Enterobacteriaceae, EC = Escherichia coli, FC = fecal coliforms, YM = yeasts and 

molds.

c B = batch, C = continuous, U = unknown

APC population reductions ranged from 1.3 log for a 16 min continuous process at 100°C at atmospheric 

pressure to 7.9 log for an autoclave process in saturated steam at 121°C for 15 min. Data in Table 8.9 indicate 

that steam treatment produces a relatively higher reduction of spice microflora than dry heat or microwave 

treatment; however, this comparison is limited by the small number of steam-treated spices in the studies 

(black pepper, red pepper and paprika), the small number of studies published in scientific literature with 

usable data, especially for dry heat and microwave treatments, and the different study conditions and thermal 

processes used in the studies. For example, some studies used steam chambers with pressure while others 
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used only flowing steam without pressure. Another noteworthy issue is that all studies reviewed for this 

document used the native microflora of test spices rather than inoculating with specific microorganisms of 

concern or a surrogate. 

Therefore, none of the published studies specifically address Salmonella. Despite this difficulty in making 

direct comparisons among the studies, conclusions can be drawn:

• Some steam treatments effectively reduce microbial populations on dried spices, and based on APC 

decimal reductions achieved appears to be more effective than dry heat or microwave treatment;

• Steam systems that use saturated steam and pressure under specific time/temperature constraints 

reduce microbial populations more than those that do not. Those not utilizing pressure reduced APCs 

between <1 and 4 logs depending upon time/temperature and exposure conditions while APC 

reductions in steam systems that used pressures ranged from 2 logs in a continuous system to almost 

8 logs in a batch system with 15 psig pressure. Microbial reductions from dry heat and microwave 

treatments ranged from 1.3 to 3.9 logs and 0.1 to 3.7 logs, respectively.

Early tests conducted by Yesair and Williams (1942) established that ground black pepper could be 

autoclaved at various temperature/pressure combinations to yield low total counts of microorganisms. They 

reported minimal change to pepper sensory quality. Treatment conditions ranged from 5 min at 108°C (5 psig 

pressure) to 15 min at 121°C (15 psig pressure) yielding 4.3 and 7.9 decimal reductions in APC, respectively. 

Pepper quality was determined using subjective sensory methods and did not incorporate chemical analyses. 

Sádecká (2010) reported that heat treatment of black pepper for 3 min with dry steam at 130°C produced “a 

remarkable decrease in the overall aroma of heat sterilized black pepper” which is counter to the report from 

Yesair and Williams (1942). The Sádecká study used gas chromatographic instrumentation (GC/FID, GC/MS) 

including a combined instrumentation/sensory technique (GC olfactometry, or GC/O) to establish changes in 

volatile compounds in the pepper, whereas Yesair and Williams conducted qualitative human sensory 

evaluation without instrumentation.

A unique continuous process designed and tested by Almela et al. (2002) used dry nitrogen with and without 

various amounts of steam at a constant temperature of 160°C and pressure of 1 or 2 kg/cm2 (15 or 30 psig) 

for 6 seconds. Treatment combinations that used steam combined with dry nitrogen was more effective at 

reducing microbial populations than the use of dry nitrogen alone (Almela et al., 2002).

Rico et al. (2010) determined that atmospheric steam treatment (16 min, 100°C) of dried whole red peppers 

in a commercial tumbling chamber before re-drying and grinding into powder produced a reduction in APC of 

less than 2 logs with greater negative impact on physicochemical properties compared to gamma radiation or 

control pepper. This laboratory also studied these same treatments on black pepper with similar results 

(Waje et al., 2008). APC, coliform and yeast/mold counts were reduced 2.6 log, 4.2 log, and 2.3 log, 

respectively, with significant loss of color and flavor of the black pepper due to steam treatment. 

An alternative steam treatment that relies on “controlled condensation” is discussed below in 8.2.1.8. This 

type of treatment was designed to reduce the impact on sensory quality of spices while also 

reducing/eliminating salmonellae that might be present in the spice. It appears that this type of steam 

treatment may produce an acceptable reduction in Salmonella while having a reduced impact on the spice 

sensory qualities as compared to more rigorous steam treatments.

8.2.1.4 GAMMA RADIATION TREATMENT

Radiation is an efficient method to eliminate pathogens from foods. Cobalt-60 and cesium-137 are commonly 

used sources of gamma rays to which pre-packaged foods are exposed for specific time periods to provide a 

dose that effectively reduces microbial populations. Dosage of gamma rays decreases with wave penetration 

into a food such that food particles closer to the source receive a higher dose. For this reason, gamma 

irradiators usually increase penetration efficiency with use of a system whereby food packages are not static 
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but are moved past the gamma ray source during the exposure time to ensure thorough coverage of the 

package. Suggested minimum doses for a variety of spices are found in the ASTM Standard Guide for 

Irradiation of Dried Spices, Herbs, and Vegetable Seasonings to Control Pathogens and Other Microorganisms 

(ASTM International, 2010) and range from a low of 3 to 8 kilogray (kGy) for caraway, cinnamon, paprika, red 

pepper and turmeric to a high of 7 to 15 kGy for onion powder. Ranges for minimum doses are necessary to 

address lot-to-lot variability in initial microbial populations. 

Under section 201(s) of the FD&C Act, sources of irradiation used on food are included in the definition of

food additives. Food additives are subject to premarket review and approval by FDA. FDA reviews the 

evidence to determine whether a food additive is safe for its intended use in food. FDA regulations permit the 

irradiation of spices up to a 30 kGy maximum absorbed dose (21 CFR 179.26(b)(5) (FDA, 2012k). As with all 

permitted food additives, the dose used on spices should be no greater than that needed to achieve the 

desired technical effect. Three sources of radiation may legally be used; gamma sources (which include the 

isotopes cobalt-60 and cesium-137), electron beam sources with a maximum energy of 10 MeV, and X-ray 

sources with a maximum energy of 7.5 MeV. Although electron beam and x-ray sources are allowed for food 

treatment under 21 CFR 179 (FDA, 2012l), these technologies have to date not been described in proposals 

submitted for FDA review on reconditioning of violative spices. Published information on the effectiveness for 

these technologies is covered at the end of this section under Alternative Pathogen Reduction Treatments.

FDA regulations also specify the types of packaging materials allowed for irradiation treatment of foods (21 

CFR 179.45) (FDA, 2012m). Package labeling to indicate the spice has been irradiated is required under 21 

CFR 179.26(c) (FDA, 2012n); however, the labeling requirement does not apply to a food that contains 

ingredients irradiated before being incorporated into the food.

Applicability and Practicality of gamma radiation treatments. Gamma radiation is described in literature 

as a cost effective method of microbial inactivation that provides minimal impact on physicochemical 

characteristics of spices compared to either steam or EO. In a review by Kiss and Farkas (1988), numerous 

citations were given for research that demonstrates “no substantial changes” in the volatile oil content of 

most spices treated up to 15 kGy. Steam treatment adds moisture to spices that may have detrimental quality 

effects while EO may cause chemical changes that impact quality (Kiss and Farkas, 1988) and toxicity (e.g., EO 

residues). The major disadvantage with gamma radiation is consumer resistance to the use of this technology 

on foods. 

Effectiveness of gamma radiation treatment in reducing Salmonella in spices. Effects of gamma radiation on 

various strains of Salmonella in foods have been reported in literature. Although little published information 

exists for the irradiation kinetics of Salmonella inoculated into spices, D-values (kGy dose that reduces a 

population by 1 log) exist for a variety of products. Salmonella D-value results for a few low moisture 

products that might be considered representative for spices are 1.0 kGy (alfalfa seeds; Thayer et al., 2003), 

0.7 to 1.1 kGy (broccoli seeds; Rajkowski et al,. 2003), 0.9 kGy (bone meal; calculated from Ley et al., 1963) 

and 1.5 kGy (desiccated coconut; calculated from Ley et al., 1963). Notably, reported D-values are lower for 

Salmonella inoculated onto produce and meats before irradiation, ranging from about 0.2 to 0.7 kGy. 

Among the refereed publications reviewed, 19 contained original treatment data related to gamma radiation 

of at least 25 spices at various dosage levels ranging between 2 and 20 kGy (Table 8.10). When viewed as a 

function of dosage level across all spices, observed APC decimal reductions fall within the following ranges:

• 1.6 to 5.8 decimal reduction for doses between 2 and 5 kGy (n=52)

• 2.2 to >6.9 decimal reduction for doses between 6 and 10 kGy (n=49)

• 3.5 to >6.9 decimal reduction for doses between 11 and 20 kGy (n=8)

The differences in spice results at any particular dosage level likely reflect treatment and biological variability 

within the experimental conditions for a particular study. Differences within a spice category and specific 

dosage level suggest that other elements of the studies impact results. Issues such as accurate dosimetry and 
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dose mapping, the type of enumeration method and medium, the type of spice, and diversity of microbial 

species in the spice could impact final population counts after treatment. 

Table 8.10. Decimal reductions from gamma radiation for microbial populations of various spices

Spicea kGy 

dose

Decimal 

Reduction

D-value 

(kGy/decimal 

reduction)

Type of 

Countb Adapted from:

Allspice 5 3.0 1.7 APC Kiss and Farkas, 1988

Allspice 8 4.9 1.6 APC Vajdi and Pereira, 1973

Anise seed 4 2.1 1.9 APC Grecz et al., 1986

Anise seed 5 2.8 1.8 APC Farag Zaied et al., 1996

Anise seed 5 3.5 1.4 APC Kiss and Farkas, 1988

Anise seed 7 3.9 1.8 APC Grecz et al., 1986

Anise seed 10 5.2 1.9 APC Farag Zaied et al., 1996

Anise seed 5 2.8 1.8 YM Farag Zaied et al., 1996

Anise seed 10 >c 2.9 > 3.4 YM Farag Zaied et al., 1996

Cardamom 2 1.6 1.3 APC Grecz et al., 1986

Cardamom 5 1.6 3.1 APC Sharma et al., 1984

Cardamom 10 > 2.6 > 3.8 APC Sharma et al., 1984

Celery seed 8 3.7 2.2 APC Vajdi and Pereira, 1973

Chili 5 2.4 2.1 APC Munasiri et al., 1987

Chili 5 4.5 1.1 APC Singh et al., 1988

Chili 5 4.0 1.3 APC Alam et al., 1992

Chili 10 5.1 2.0 APC Munasiri et al., 1987

Chili 10 6.3 1.6 APC Alam et al., 1992

Cinnamon 5 1.2 4.2 APC Sharma et al., 1984

Clove 5 1.4 3.6 APC Sharma et al., 1984

Coriander 5 1.6 3.1 APC Farag Zaied et al., 1996

Coriander 5 1.8 2.8 APC Munasiri et al., 1987

Coriander 5 1.6 3.1 APC Alam et al., 1992

Coriander 5 4.0 1.3 APC Kiss and Farkas, 1988

Coriander 10 > 4.1 > 2.4 APC Farag Zaied et al., 1996

Coriander 10 > 4.2 > 2.4 APC Munasiri et al., 1987

Coriander 10 4.1 2.4 APC Alam et al., 1992

Coriander 5 > 2.8 > 1.8 YM Farag Zaied et al., 1996

Coriander 10 > 2.8 > 3.6 YM Farag Zaied et al., 1996

Cumin 2 3.0 0.7 APC Grecz et al., 1986

Cumin 5 2.6 1.9 APC Alam et al., 1992

Cumin 5 4.1 1.2 APC Kiss and Farkas, 1988

Cumin 10 > 4.0 > 2.5 APC Alam et al., 1992

Curry 4 2.3 1.7 APC Grecz et al., 1986

Curry 10 > 5.0 > 2.0 APC Munasiri et al., 1987

Fennel seed 5 2.7 1.9 APC Farag Zaied et al., 1996

Fennel seed 10 4 2.5 APC Farag Zaied et al., 1996

Fennel seed 5 3.3 1.5 YM Farag Zaied et al., 1996

Fennel seed 10 > 3.3 > 3.0 YM Farag Zaied et al., 1996

Garlic 4 3.0 1.3 APC Vajdi and Pereira, 1973

Ginger 5 2.5 2.0 APC Farag et al., 1995

Ginger 10 3.0 3.3 APC Farag et al., 1995
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Spicea kGy 

dose

Decimal 

Reduction

D-value 

(kGy/decimal 

reduction)

Type of 

Countb Adapted from:

Marjoram 5 1.7 2.9 APC Farag et al., 1995

Marjoram 5 4.6 1.1 APC Kiss and Farkas, 1988

Marjoram 10 2.1 4.8 APC Farag et al., 1995

Nutmeg 5 1.8 2.8 APC Sharma et al., 1984

Nutmeg 10 > 3.1 > 3.2 APC Sharma et al., 1984

Onion powder 4 2.5 1.6 APC Kiss and Farkas, 1988

Onion powder 4 1.8 2.2 APC Silberstein et al., 1979

Onion powder 4 2.1 1.9 APC Silberstein et al., 1979

Onion powder 5 2.9 1.7 APC Kiss and Farkas, 1988

Onion powder 8 2.3 3.5 APC Silberstein et al., 1979

Onion powder 8 3.5 2.3 APC Silberstein et al., 1979

Onion powder 9 1.1 8.2 APC Silberstein et al., 1979

Onion powder 9 2.2 4.1 APC Silberstein et al., 1979

Onion powder 9 2.0 4.5 APC Silberstein et al., 1979

Onion powder 10 3.3 3.0 APC Kiss and Farkas, 1988

Onion powder 10 3.1 3.2 APC Silberstein et al., 1979

Onion powder 10 4.5 2.2 APC Silberstein et al., 1979

Onion powder 13 4.8 2.7 APC Silberstein et al., 1979

Onion powder 13 4.6 2.8 APC Silberstein et al., 1979

Onion powder 15 5.5 2.7 APC Silberstein et al., 1979

Onion powder 15 4.8 3.1 APC Silberstein et al., 1979

Onion powder 15 5.5 2.7 APC Silberstein et al., 1979

Onion powder 15 4.8 3.1 APC Silberstein et al., 1979

Oregano 5 5.0 1.0 APC Legnani et al., 2001

Oregano 6 3.2 1.9 APC Vajdi and Pereira, 1973

Oregano 10 5.4 1.9 APC Legnani et al., 2001

Paprika 5 2.0 2.5 APC Kiss and Farkas, 1988

Paprika, added oil 6.5 2.2 3.0 APC Franco et al., 1986

Paprika, fine grind 6.5 2.8 2.3 APC Franco et al., 1986

Paprika, granulated 6.5 2.7 2.4 APC Franco et al., 1986

Paprika 8 4.3 1.9 APC Vajdi and Pereira, 1973

Paprika 9 2.6 3.5 APC Kiss and Farkas, 1987

Paprika 11 3.5 3.1 APC Kiss and Farkas, 1988

Pepper, black ground 4 2.8 1.4 APC Soedarman et al., 1984

Pepper, black ground 4 3.0 1.3 APC Singh et al., 1988

Pepper, black 5 5.8 0.9 APC Legnani et al., 2001

Pepper, black 5 3.2 1.6 APC Kiss and Farkas, 1988

Pepper, black ground 5 2.3 2.2 APC Farkas and Andrássy, 1984

Pepper, black ground 5 2.3 2.2 APC Farkas and Andrássy, 1984

Pepper, black ground 5 3.8 1.3 APC Farkas and Andrássy, 1984

Pepper, black ground 5 3.8 1.3 APC Farkas and Andrássy, 1984

Pepper, black ground 5 4.1 1.2 APC Sharma et al., 1984

Pepper, black ground 5 2.7 1.9 APC Grecz et al., 1986

Pepper, black ground 5 3.3 1.5 APC Munasiri et al., 1987

Pepper, black ground 5 1.1 4.5 APC Emam et al., 1995

Pepper, black whole 5 2.1 2.4 APC Farag Zaied et al., 1996

Pepper, black whole 5 > 6.0 > 0.8 APC Sádecká, 2010

Pepper, black ground 6 4.1 1.5 APC Soedarman et al., 1984

Pepper, black ground 7.5 5.0 1.5 APC Singh et al., 1988

Pepper, black ground 8 5.9 1.4 APC Soedarman et al., 1984

Pepper, black ground 9 5.0 1.8 APC Grecz et al., 1986

Pepper, black ground 10 > 6.2 > 1.6 APC Soedarman et al., 1984

Pepper, black ground 10 > 5.7 > 1.8 APC Sharma et al., 1984

Pepper, black ground 10 > 5.5 > 1.8 APC Munasiri et al., 1987

Pepper, black ground 10 3.3 3.0 APC Emam et al., 1995
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Spicea kGy 

dose

Decimal 

Reduction

D-value 

(kGy/decimal 

reduction)

Type of 

Countb Adapted from:

Pepper, black 10 6.8 1.5 APC Legnani et al., 2001

Pepper, black 10 > 6.9 > 1.4 APC Shigemura et al., 1991

Pepper, black powder 10 3.9 2.6 APC Waje et al., 2008

Pepper, black whole 10 4.7 2.1 APC Farag Zaied et al., 1996

Pepper, black ground 12 5.0 2.4 APC Vajdi and Pereira, 1973

Pepper, black 17 > 6.9 > 2.5 APC Shigemura et al., 1991

Pepper, black 20 > 6.9 > 2.9 APC Shigemura et al., 1991

Pepper, black whole 5 2.4 2.1 YM Farag Zaied et al., 1996

Pepper, black 10 > 3.7 > 2.7 YM Shigemura et al., 1991

Pepper, black powder 10 2.8 3.6 YM Waje et al., 2008

Pepper, black whole 10 > 3.4 > 2.9 YM Farag Zaied et al., 1996

Pepper, black 17 > 3.7 > 4.6 YM Shigemura et al., 1991

Pepper, black 20 > 3.7 > 5.4 YM Shigemura et al., 1991

Pepper, black ground 4 2.3 1.7 EB Soedarman et al., 1984

Pepper, black ground 8 > 4.2 > 1.9 EB Soedarman et al., 1984

Pepper, black whole 5 > 0.9 > 5.6 COL Farag Zaied et al., 1996

Pepper, black powder 10 4.6 2.2 COL Waje et al., 2008

Pepper, black whole 10 > 0.9 > 11.1 COL Farag Zaied et al., 1996

Pepper, red chili 5 5.7 0.9 APC Legnani et al., 2001

Pepper, hot (red) 5 4.5 1.1 APC Farag et al., 1995

Pepper, hot (red) 10 4.8 2.1 APC Farag et al., 1995

Pepper, red chili 10 6.0 1.7 APC Legnani et al., 2001

Pepper, red powder 10 5.1 2.0 APC Rico et al., 2010

Pepper, red powder 10 2.3 4.3 YM Rico et al., 2010

Pepper, white 5 3.0 1.7 APC Kiss and Farkas, 1988

Pepper, white 10 > 6.8 > 1.5 APC Shigemura et al., 1991

Pepper, white 17 > 6.8 > 2.5 APC Shigemura et al., 1991

Pepper, white 20 > 6.8 > 2.9 APC Shigemura et al., 1991

Rosemary 5 3.9 1.3 APC Legnani et al., 2001

Rosemary 10 4.1 2.4 APC Legnani et al., 2001

Sage 5 5.4 0.9 APC Legnani et al., 2001

Sage 10 4.9 2.0 APC Legnani et al., 2001

Thyme 4 1.8 2.2 APC Grecz et al., 1986

Thyme 7 3.5 2.0 APC Grecz et al., 1986

Turmeric 5 3.1 1.6 APC Farag Zaied et al., 1996

Turmeric 5 3.7 1.4 APC Munasiri et al., 1987

Turmeric 5 4.0 1.3 APC Singh et al., 1988

Turmeric 5 3.5 1.4 APC Alam et al., 1992

Turmeric 7.5 5.5 1.4 APC Singh et al., 1988

Turmeric 10 > 3.2 > 3.1 APC Farag Zaied et al., 1996

Turmeric 10 > 5.0 > 2.0 APC Munasiri et al., 1987

Turmeric 10 > 6.5 > 1.5 APC Alam et al., 1992

Turmeric 5 > 2.8 > 1.8 YM Farag Zaied et al., 1996

Turmeric 10 > 2.8 > 3.6 YM Farag Zaied et al., 1996 a Spice descriptors taken from references. 

b APC = total aerobic plate count, COL = coliforms, EB = Enterobacteriaceae, YM = yeasts and molds

c ">" symbol used when microbial count after treatment is below the detectable limit. Number represents the population before 

treatment based on the enumeration method.

Decimal reductions in Table 8.10 were calculated by subtracting the log of the microbial population after 

treatment from that of the population before treatment. When the final microbial population after treatment 

was below detectable limits, the decimal reduction was calculated based upon the type of enumeration 

method used and the initial population, and was expressed with a “greater than” symbol. When initial 

populations were small, such as typically seen for yeast/mold, coliforms or Enterobacteriaceae, and the 

population after treatment was not detectable; it is difficult to draw inferences about the actual decimal 
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reduction. In theory, the actual decimal reduction for “greater than” results could have been significantly 

higher than what was reported. In some instances, large initial APC counts were reduced to concentrations 

below detection after treatments. For example, black and white pepper with initial counts of log 6.8 APCs had 

non-detectable populations after treatment at 17 or 20 kGy (Shigemura et al., 1991). With the assumption 

that the method of detection allowed an enumeration estimate of 1 colony per gram, the decimal reduction

was reported in Table 8.10 as “>6.8.” 

The average D-value for APCs across all spices for which discrete post-process enumerations were available 

is 2.2 ± 1.0 kGy (n=102). D-values are commonly generated for a specific species or strain of organism rather 

than a general group count such as APCs or YM counts, as was done here. With that noted, D-values for 

irradiation data may provide a useful relative comparison with other treatments but should be interpreted 

with care. Research on irradiation treatment using Salmonella or a suitable surrogate is needed.

Numerous individual refereed publications refer to a range of kGy doses roughly between 3 and 10 for 

reduction of overall microbial populations to concentrations deemed “acceptable.” One publication states that 

a dose of 20 kGy will reduce microbial populations to less than 10 CFU/g and render a spice “sterile.” In a 

review article on gamma radiation, Sjöberg et al. (1991) reported kGy doses that resulted in a 3 decimal 

reduction for 35 spices. These ranged from a low of 3 kGy to a high of 10 kGy with an average of around 6 kGy 

to achieve a 3 decimal reduction in APCs. As mentioned earlier, ASTM International (2010) provides ranges of 

minimum doses to achieve “acceptable levels” (acceptable concentrations) of microorganisms in 19 spices 

with dosage levels ranging between 3 and 15 kGy. 

There exists considerable variability in dose responses reported in Table 8.10. For example, decimal 

reductions for ground black pepper at 5 and 10 kGy range between 1.1 to 4.1 log and 3.3 to >6.9 log, 

respectively. This large degree of variability within a single dose suggests additional factors influence the 

efficacy of gamma radiation. Based on the understanding that significant variability exists in published 

refereed data, additional research would likely be necessary in order to ensure achievement of a desired 

decimal reduction related to Salmonella in specific spices. 

8.2.1.5 ETHYLENE OXIDE TREATMENT

Ethylene oxide (EO or EtO) is a colorless gas that chemically reacts with components of vegetative cells and 

spores thereby resulting in cell death. Alkylation of nucleic acids in cells treated by EO has been 

demonstrated (Parisi and Young, 1991) and is thought to contribute to cell inactivation. EO is commonly used 

as an alternative to heat treatments and has provided a method for sterilization of heat sensitive materials 

such as plastic-based medical devices, drugs, and treatment of spices or other foods. Use of EO as an 

antimicrobial treatment is more complex than for steam and irradiation due to the large number of variables 

that should be controlled for the treatment to be effective. According to USP, variables include temperature, 

exposure time, humidity, vacuum/positive pressure and gas concentration (USP, 2011). Gilbert et al. (1964) 

demonstrated that desiccation of various organisms increased their resistance to EO treatment and resulted 

in non-linear inactivation curves. Other variables are the permeability of packaging in which spices are 

packed and the loading designs of individual pallets and the treatment chamber itself. Variations in package 

material permeability, spice bulk density and chamber/pallet loading patterns will impact the ability of the 

gas to penetrate the most inaccessible points within the packs thereby affecting the treatment time. In some 

cases, such as with foil lined film, packaging material will essentially block penetration of EO rendering the 

technology ineffective. Additionally, inert balance gases, such as CO2 or N2, and a series of chamber air washes 

at the end of a cycle are needed to address concerns about EO flammability and mutagenic properties of toxic 

EO residues. While toxic residues of EO in treated materials remains a concern, an assessment of cancer risk 

(Fowles et al., 2001) from EO residues in spices concludes that “risks are practically negligible” based on 

current understanding of exposure from concentrations of EO found in spices. Factors described here 

demonstrate the complexity of conducting validation studies for EO treatment chambers and conditions. 

Despite these limitations, EO is a well-established technology that is commonly used for sterilization of 

medical devices and pharmacological products resulting in reductions of at least 6 log (USP, 2011). On the 
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other hand, due to concerns about toxicity and safety, EO is banned for fumigation of foods in the European 

Union and Australia.

Leistritz (1997) provides an overview of steps used in EO processing. Packaged spices are placed into a 

chamber, which is then sealed. This is followed by a vacuum step and heating of the chamber to the process 

temperature. Humidity is introduced into the chamber followed by the EO / inert gas mixture. After holding 

for a specified time period, usually several hours to ensure gas penetration into the package interior, gas is 

removed from the chamber, which is then flushed with air several times. After the chamber returns to 

atmosphere pressure, product is removed. 

Applicability and Practicality of ethylene oxide treatments. The use of EO as a treatment method for spices 

is well established although the effectiveness at reducing Salmonella may be less than for irradiation or steam 

treatments. Research opportunities exist to demonstrate clearly the expected decimal reductions of 

Salmonella in spices from EO. Due to the larger number of variables to be controlled with this technology, as 

compared to steam or irradiation, validation studies would be more complex, but it should be possible to 

design scientific studies that will specify variables such as gas concentration, exposure time/temp, humidity, 

and product type and density to achieve successful results.

Under the U.S. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (EPA, 2012b) the Environmental 

Protection Agency (EPA) regulates substances intended for preventing, destroying, repelling, or mitigating 

any pest. Ethylene oxide is used to reduce pests and microbiological contamination. In 2008, the EPA 

reregistered ethylene oxide as a legal pesticide that may be used on spices. Spices may be decontaminated 

using ethylene oxide consistent with EPA’s regulation under 40 CFR 180.151 (EPA, 2012c). Application of 

ethylene oxide treatment to spices in prohibited in some countries. 

Effectiveness of ethylene oxide treatment in reducing Salmonella in spices. Five refereed studies on EO 

treatment of spices were reviewed. Decimal reductions of spice APCs found in refereed scientific journals 

range from 1.3 log to >6 log with an average of about 3.0 log. Several data points were available for paprika 

and ground black pepper with only one data point each for allspice, celery seed, cinnamon, garlic and 

oregano. A comparison of results among the studies is difficult due to substantial differences in gas 

concentrations, exposure time, temperature and moisture. As stated above, EO treatment involves control of 

several variables. One data point in Table 8.11 was determined from pre- and post-treatment APC counts 

provided by a company to FDA after a reconditioning treatment accepted by FDA in 2010 was applied.

Farkas and Andrássy (1984) demonstrated that EO fumigation was more effective at water activities of 0.75 

and 0.50 than at 0.25, which supports results by Gilbert et al. (1964), mentioned above. 

Michael and Stumbo (1970) studied the effect of EO on lyophilized Salmonella Senftenberg (alone and in egg 

solids) and Escherichia coli. Treatment conditions included 40°C, 700 mg/L gas concentration, and relative 

humidity between 11 and 73%. D-values (min) for lyophilized cells alone were 2.2 at 11% RH, 3.4 at 23% RH, 

4.0 at 33% RH, 5.0 at 53% RH and 5.9 at 73% RH indicating that fumigation was more effective at lower 

relative humidity which is counter to results of Farkas and Andrássy (1984) and Gilbert el al. (1964). The 

reasons for differences in results in these studies is unknown. When cells were lyophilized in an egg solids 

mixture, the D-value at 11% RH increased from 2.2 to 4.5 min thereby indicating that the food matrix can 

influence cell survival.
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Table 8.11. Decimal reductions of APC counts in spices treated with ethylene oxide

Spice Time 

(Hr)

Temp 

(°C) Gas Conditions Aw or % Moisture

Decimal 

Reduction Adapted from:

Allspice, 

ground 12 57

10% EO + 90% CO2

(w/w)/4.5 m3

150 mL H2O/160 

cu. ft. 4.6

Vajdi and Pereira, 

1973a

Celery seed, 

ground 16 57

10% EO + 90% CO2

(w/w)/ 4.5 m3

150 mL H2O/160 

cu. ft. 4.7

Vajdi and Pereira, 

1973

Cinnamon, 

ground 5 80 15cc/11.4 L NRb 2.9 Yesair et al., 1942

Garlic, ground 5 57

10% EO + 90% CO2

(w/w)/ 4.5 m3

150 mL H2O/160 

cu. ft. 3.5

Vajdi and Pereira, 

1973

Oregano, 

ground 16 57

10% EO + 90% CO2

(w/w)/ 4.5 m3

150 mL H2O/160 

cu. ft. > 3.5

Vajdi and Pereira, 

1973

Paprika, 

ground 16 57

10% EO + 90% CO2

(w/w)/ 4.5 m3

150 mL H2O/160 

cu. ft. > 6

Vajdi and Pereira, 

1973

Paprika, 

ground 3 54 470 mg/L 23% RH 1.7

Reconditioning 

treatment

Paprika, 

ground NR NR NR NR 2.2

Kiss and Farkas, 

1988

Paprika, 

granulated 48 25 750 g/m3 c 11.12% mois. 1.5 Franco et al., 1986

Paprika, added 

oil 48 25 750 g/m3 6.64% mois. 1.3 Franco et al., 1986

Paprika, fine 

grind 48 25 750 g/m3 7.05% mois. 1.8 Franco et al., 1986

Pepper, black 

ground 16 57

10% EO + 90% CO2

(w/w)/ 4.5 m3

150 mL H2O/160 

cu. ft. 3.4

Vajdi and Pereira, 

1973

Pepper, black 

ground 5 80 15cc/11.4 L NR 3 Yesair et al., 1942

Pepper, black 

ground 6 22 600 g/m3 0.25 Aw; 8.5% 2.1

Farkas and 

Andrássy, 1984

Pepper, black 

ground 6 22 600 g/m3 0.50 Aw; 11.0% 3.8

Farkas and 

Andrássy, 1984

Pepper, black 

ground 6 22 600 g/m3 0.75 Aw; 15.0% 3.8

Farkas and 

Andrássy, 1984 a Study by Vajdi and Pereira 1973 described gas and moisture conditions based on chamber geometry of 160 cubic feet.

b NR = Not Reported, likely ambient

c g/m3 is equivalent to mg/L

8.2.1.6 COMPARISON OF TREATMENT EFFECTIVENESS

Several publications compare gamma radiation to steam and/or EO. Recent studies on red and black peppers 

suggest gamma radiation of 5 or 10 kGy produces a larger reduction in microbial populations than selected 

steam treatments with a reduced impact on physicochemical quality (Waje et al., 2008; Rico et al., 2010, 

Sádecká, 2010); however, the type of steam treatment used in these studies is less effective at reducing 

microbial populations when compared to the more aggressive steam treatments of other studies (Yesair et al., 

1942; Almela et al., 2002). In another comparison of gamma radiation with saturated steam, Kispéter et al.

(2003) concluded that ionizing radiation was more appropriate than steam treatment of paprika due to 

changes in quality parameters associated with steam.

In a comparison of EO and gamma radiation, Vajdi and Pereira (1973) concluded that irradiation was more 

effective at reducing spice microflora with insignificant changes in volatile oil composition or color of paprika 

compared to EO. Franco et al. (1986) also found that irradiation was more effective than EO at reducing 

paprika microflora. Narayanan et al. (2000) concluded that gamma radiation is a superior technology to 

steam, microwave or EO. They indicated that EO was least desirable due to its flammability and toxic nature. 
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While all three major treatment types will reduce microbial populations to some degree, an evaluation of data 

and expert opinion published in the scientific literature suggests that gamma radiation is the most efficient 

method of pathogen elimination while causing the fewest changes in physicochemical quality parameters of 

spices. The major disadvantage for gamma radiation is lack of public acceptance whereas steam and EO have 

disadvantages related to changes in spice quality, e.g., color, flavor, and aroma, while EO has additional 

disadvantages related to toxicity, complexity of treatment operations, and is prohibited from being applied to 

spices in some countries. The data in tables 8.9, 8.10, and 8.11 demonstrate that large reductions in microbial 

populations can be achieved by these treatments under certain circumstances. Data are needed to 

characterize achievable reductions of Salmonella, or an appropriate surrogate, in spices and the conditions 

necessary to achieve such reductions. 

8.2.1.7 TREATMENT VALIDATIONS

The lack of data specifically related to the impact of treatment options on Salmonella in spices indicates there 

is a critical need for comprehensive validation research related to the effects of various treatments on 

Salmonella, and on selection of appropriate surrogates for spice matrices. There is also a need to establish an 

acceptable performance standard for treatments to destroy pathogens to achieve an appropriate level of 

protection. Information about methods to validate processes have been published (Scott, 2005; Codex, 2008; 

NACMCF, 2010; USP, 2011) thereby providing guidance on how to plan and conduct a validation to ensure 

that a process will inactivate Salmonella in spices and meet a relevant food safety objective. Companies that 

treat spices with an antimicrobial process should validate that the process is effective at eliminating the 

pertinent pathogen(s). 

Generally speaking, steps involved in ensuring that a process will provide a desired kill step include 

establishing that the equipment and process control instruments will operate within identified parameters, 

and determining the processing conditions necessary to achieve elimination of the identified hazard to an 

appropriate level or protection. Determination of these conditions may involve reviewing scientific or 

technical literature, reviewing previous validation studies, reviewing government documents, mathematical 

modeling, or operational data and surveys. Alternatively, experiments may be designed and conducted to 

produce relevant reproducible data on process conditions necessary to eliminate the food hazard. 

Experiments should be repeated to provide a statistically sound view of variability. Finally in the validation 

process, companies should document successful completion of the steps taken in the protocol.

In those instances when a pathogen cannot safely be used during a validation challenge study, the pathogen 

should be replaced with a surrogate. Surrogates should be non-pathogenic and have inactivation 

characteristics and kinetics that can be used to predict behavior of the target pathogen exposed to the 

inactivation technology. Other desirable characteristics of surrogates include having stable and consistent 

growth characteristics, easy preparation and enumeration, being genetically stable, and lack of spoilage 

characteristics if used on equipment in a production area. (FDA, 2000)

Of critical importance in the validation is determination of the amount of kill needed to achieve the desired 

objective. For example, the juice HACCP regulation (21 CFR 120) (FDA, 2012o) requires that juices receive a 

process capable of producing a 5-decimal reduction of the pertinent pathogen. USP standard sterilization 

treatments (USP, 2011) are to achieve at least a 10-6/unit microbial survivor probability (i.e., greater than a 1 

in 1 million chance that a viable cell survives treatment per unit of product). Such a numerical standard is not 

established for spices although Schaffner et al. (2013) provides some discussion about which issues to 

consider when setting standards for low moisture foods. 

A typical USP-like validation protocol would be implemented in different stages including 1) an installation 

qualification stage to ensure that equipment is properly designed, installed and calibrated; 2) an operational 

qualification stage to ensure that the equipment functions properly; 3) a confirmatory stage that includes test 

treatments of materials using appropriate measurements to ensure treatment uniformity that is adequate to 
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produce the pathogen reduction desired ; and 4) a final stage whereby all supporting information and data 

used to execute the validation is properly documented.

An additional resource for information on process validations is the report, “Parameters for Determining 

Inoculated Pack/Challenge Study Protocols” published by the National Advisory Committee on 

Microbiological Criteria for Foods (NACMCF, 2010). Although this report largely addresses growth inhibition 

challenge studies, portions related to inactivation studies are pertinent to development of studies on 

treatment of spices. The report provides information on factors related to the product, target organisms, 

inoculum concentrations and preparation, inoculation method, sampling considerations, sampling intervals, 

and interpretation of test results. Additionally, the report recommends that “challenge studies must be 

designed and evaluated by an expert food microbiologist” thereby emphasizing the need for companies to 

engage experts in the validation process. Other validation information is available from additional sources 

(GHTF, 2004; Hardin, 2012; Taormina, 2012; FDA, 2011b; Codex, 2008).

8.2.1.8 ALTERNATIVE PATHOGEN REDUCTION TREATMENTS

Research on a variety of alternative processing methods applied to the treatment of spices has been 

published. A steam method in which condensation and evaporation are controlled to prevent harmful effects 

on spice quality while reducing concentrations of salmonellae has been developed and is currently available 

commercially. Other processes, such as electron beam and x-ray radiation, high hydrostatic pressure with 

heat, ozonation, and high pressure CO2 with heat, appear to produce significant reductions in microbial 

populations. 

Controlled condensation (CC) steam processes are commercially available whereby condensation and 

evaporation are controlled to allow thermal inactivation of microorganisms while reducing negative 

physicochemical quality changes usually associated with pressurized or atmospheric pressure steam 

treatment (Koco Inc., 2008; Perren, 2008). Experiments on almonds inoculated with Enterococcus faecium 

NRRL B 2354 as a surrogate for Salmonella Enteritidis PT30 showed decimal reductions of 2.5, 3.6, 5.0 and 

6.1 after CC treatment for 1, 2, 5 and 10 min, respectively. This technology may be appropriate for use on 

spices, but should be properly validated.

Zhao and Cranston (1995) investigated the effect of ozonized air (6.7 mg/L ozone) on various 

microorganisms in ground black pepper or water containing whole black pepper. Reductions in Escherichia 

coli, Salmonella, of 3 to 4 logs were produced in ground pepper while similar reductions in APCs were seen 

for whole peppercorns. Researchers concluded that this technology would be best used for treatment of 

whole peppercorns in ozonized water. Treatment of ground black pepper could result in unacceptable 

changes in volatile oils depending upon the moisture content of the pepper. Emer et al. (2008) reported that 

an ozone concentration of 0.1 ppm for 360 min could reduce Escherichia coli in whole and ground black 

pepper approximately 7 log without a negative impact on product quality.

Butz et al. (1994) showed that a three cycle high pressure processing (HPP) treatment at 70 ̊C for 30 min at 

80 MPa followed by 30 min at 350 MPa successfully inactivated the microflora of spice mixtures. It was 

necessary to raise the water activity to 0.91 to achieve microbial inactivation possibly making the process less 

desirable for spices. Skapska et al. (2003) demonstrated the application of combined dry heat and high 

hydrostatic pressure to eliminate vegetative cells from black pepper with minimal impact on volatiles. A 

minimum treatment of 1000 MPa under argon for 30 min at 60 ̊C reduced the mesophilic population of the 

native microflora less than one log. The same treatment at 140 ̊C reduced the mesophilic population 3.4 logs. 

Finally, Neetoo and Chen (2011) determined that a two phase treatment using dry heat followed by 600 MPa 

for 2 min produced a 5 decimal reduction of Salmonella spp. and Escherichia coli O157:H7 inoculated onto 

alfalfa seeds, a commodity similar in characteristics to some spices.

Dry heat and microwave heat treatments were addressed by a variety of researchers (Emam et al., 1995; 

Faraq Zaied et al., 1996; Legnani et al., 2001; and Almela et al., 2002). In general, dry heat and microwave 
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techniques were less effective than steam at reducing microbial populations with reductions ranging from 1.3 

to >3.9 log and from 0.1 to 3.8 log, respectively as compared to steam which ranged from 0.8 to 7.9 decimal 

reductions (Table 8.9). Neetoo and Chen (2011) reported that dry heat of 65°C for 10 days or 70°C for 24 hr. 

reduced Salmonella on alfalfa seeds, a low moisture product similar to spices such as celery seeds by 

approximately 5 log. Such extreme treatments may not be viable for spices due to changes in volatile oil 

concentration and quality. A review article by Narayanan et al. (2000) suggests that microwave treatments 

will reduce microbial populations by a factor of 10 to 103. Results in Table 8.9 generally fall within that range 

further indicating that microwave treatment may not provide an adequate reduction of pathogens.

Supercritical CO2 is a method of using pressurized liquid CO2 as a processing method for foods and has been 

demonstrated to reduce Salmonella populations in a variety of foods achieving decimal reductions of <1 to >8 

(Garcia-Gonzalez et al., 2007). This process method is also currently used to extract volatile oil constituents 

from spices yielding liquid spice extracts. The usefulness of supercritical CO2 as an antimicrobial process for 

raw paprika was investigated by Calvo and Torres (2010) who reported that mild process conditions that 

would not affect extractable volatiles or color (25-30% moisture, 85-90°C, 60-100 bar pressure) “were 

sufficient to achieve the disinfection and total count reduction required by the most exigent clients.” Data 

appeared to suggest that the heat used during this treatment was a major contributor to the microbial 

reductions observed. Further studies would be needed to determine the effect of pressurized CO2 on 

Salmonella in spices. 

Pulsed UV light was studied for microbial inactivation in wheat flour and black pepper. Although a 7-log 

inactivation of Saccharomyces cerevisiae occurred on glass beads and quartz plate, pulsed UV light treatment 

under the conditions of study produced less than 1 decimal reduction for wheat flour or black pepper (Fine 

and Gervais, 2004). Further refinements will be needed before this technology would be useful for 

inactivation of microorganisms in food powders. The effect of another pulsed technology, pulsed electric field, 

on microflora of spices was investigated by Keith et al. (1997) and found to produce no more than a 1 decimal 

reduction in APCs of dried onion, dill and basil powders.

Electron beam and x-ray radiation treatments of foods have been studied since the 1940s. Proctor et al.

(1950) reported on the impact of supervoltage cathode rays on the native microflora of several spices and dry 

food ingredients. APCs were reduced between 3 and >6 logs after treatment. Van Calenberg et al. (1998) 

found that reductions in microflora of spices were similar for electron beam and x-ray radiation and appeared 

to be >4 log for APCs in white pepper, 3 to 4 log in paprika, and 2 to 3 log in nutmeg at doses of 7.5 kGy. 

Hayashi et al. (1998) showed that “soft electrons” (electrons with an energy of 300 keV or lower; defined by 

study authors) would reduce the total microbial load in black pepper, white pepper, turmeric, coriander and 

basil to below detectable concentrations (<10 CFU/g). Nieto-Sandoval et al. (2000) reported minimum 

electron beam irradiation D-values of 2.12 kGy for APCs, 2.66 kGy for Enterobacteriaceae, 3.15 kGy for 

coliforms, 3.84 kGy for sulfide-reducing clostridia, and 3.36 kGy for yeasts/molds. The D-value represents the 

kGy dosage level needed to produce a 1-decimal reduction. They further reported no impact on the red color 

of paprika after treatment.

8.2.1.9 APPLICATION OF PATHOGEN REDUCTION TREATMENTS

ASTA “recommends the use of validated microbial reduction techniques” (ASTA, 2011) and many spice 

processing and packing/re-packing facilities apply such treatments to their spices. However, it is not known 

what fraction of the total U.S. supply is treated other than it is not 100%. Treatment may take place in the 

source country, another country or in the country of import, e.g., in the United States information shared by 

spice producers and manufacturers during our site visits and information gathered during FDA inspections 

(see Section 8.1.3.1.) indicate that practices differ among spice manufacturers/packers/re-packers and 

among spices treated. Some spice manufacturers/packers/re-packers subject all or nearly all of the spice they 

handle to a pathogen reduction treatment (either before acquisition or during their processing) while others 

subject the spice to a pathogen reduction treatment only when the customer requests it. Some types of spices 

are more commonly treated with pathogen reduction treatments, e.g., black pepper, than others, e.g., 
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dehydrated onion and garlic. Many spices will be subjected to one or more treatments capable of killing 

pathogenic bacteria such as Salmonella during food preparation (canning or cooking). However, some spices 

receive no antimicrobial treatment before consumption. 

More data are needed to determine treatment conditions to ensure elimination of vegetative pathogens in 

spices. The data on concentrations of Salmonella in imported capsicum or sesame seed shipments offered for 

entry to the United States (Van Doren, 2013c) and those found in samples of spices associated with foodborne 

outbreaks (Table 4.2) provide some guidance. Table 8.12 provides estimates of the number of Salmonella

illnesses resulting from a population consuming raw spice from a single 40,000 lb. (18144 kg) Salmonellacontaminated shipment/lot as a function of mean shipment/lot concentration and serving size, assuming the 

contamination is Poisson-distributed within the lot. The FDA study examining within- and between-shipment 

distribution of Salmonella in imported shipments of capsicum or sesame seeds provides some support for this 

assumption (Van Doren et al., 2013c).

Table 8.12. Estimates of the number of Salmonella illnesses resulting from a population consuming 

raw spice from a single 40,000 lb. (18144 kg) Salmonella-contaminated lot as a function of mean lot 

concentration and serving size, assuming the contamination is Poisson-distributed within the lot

Lot S. Mean 

Concentration 

(MPN/g)

Serving 

Size (g)

Estimated Number of Illnesses 

if all spice eaten rawa 

Decimal reduction 

to reduce illnesses 

to <1

1 1 45,133 5

0.1 1 4,556 4

0.01 1 456 3

0.001 1 46 2

1 0.15 45,541 5

0.1 0.15 4,561 4

0.01 0.15 456 3

0.001 0.15 46 2 aBased on the WHO/FAO Salmonella dose-response model (WHO/FAO, 2002).

8.2.2 INDUSTRY GUIDANCE FROM TRADE ORGANIZATIONS ON PRACTICES IMPACTING 

FOOD SAFETY OF SPICES 

Spice and food trade associations have developed and published guidelines on the production, handling and 

packing of spices and low moisture foods that address food safety issues including mitigation and control 

programs and practices that prevent/reduce the risk of contamination of spice with pathogens and filth. 

These include:

• American Spice Trade Association (ASTA)

o Clean, Safe Spices: Guidance from the American Spice Trade Association, 2011

o HACCP Guide for Spices and Seasonings, February , 2006

o Clean Spices: A Guidebook for Shippers of Products to the U.S. Spice Trade, May, 2008

• American Dehydrated Onion and Garlic Association, Official Standard and Methods, 14th edition, April 

2005.

• International Organization of Spice Trade Associations, General Guidelines for Good Agricultural 

Practices Spices, April 2008

• Grocery Manufacturing Association, Control of Salmonella in Low-Moisture Foods, Feb. 2009

In addition to the guidance documents identified above, the Grocery Manufacturer Association (GMA) 

published a series of reports of their research and best practices for controlling Salmonella in low moisture 

foods:
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• Control of Salmonella in Low-Moisture Foods I: Minimizing Entry of Salmonella into Processing 

Facility (Scott et al., 2009)

• Control of Salmonella in Low-Moisture Foods II: Hygiene Practices to Minimize Salmonella

Contamination and Growth (Chen et al., 2009a)

• Control of Salmonella in Low-Moisture Foods III: Process Validation and Environmental Monitoring 

(Chen et al., 2009b)

• Sources and risk factors for contamination, survival, persistence, and heat resistance of Salmonella in 

Low-moisture foods (Podolak et al., 2010).

The Clean, Safe Spices: Guidance from the American Spice Trade Association (ASTA, 2011) document was 

developed to “assist the spice industry in developing programs that minimize the risk for contamination 

during growing, harvesting, drying transport, processing, and post-processing storage, helping industry firms 

to provide clean, safe spices to their industrial, food service and consumers customers” (ASTA, 2011). This 

spice industry guidance provides five major recommendations:

1. Minimize the risk for introduction of filth throughout the supply chain.

2. Prevent environmental contamination, cross-contamination, and post-processing contamination 

during processing and storage.

3. Use validated microbial reduction techniques.

4. Perform post-treatment testing to verify a safe product.

5. Test to verify a clean and wholesome manufacturing environment.

The guidance identifies the specific programs and practices that should be established in order to implement 

the recommendations including

• Good Agricultural Practices for growing and harvesting spices

• Supply chain approval and re-evaluation programs 

• Good Manufacturing Practices (FDA CGMPs and Codex General Principles of Food Hygiene)

• Hazard Analysis Critical Control Point (HACCP) Plans.

• Validated microbial reduction process

• ASTA Cleanliness Specifications

• Post-treatment product sample and testing program 

• Environmental sample and test program

The guidance describes key elements of each program (e.g., evaluation of each potential supplier’s 

implementation and use of preventive controls such as GAPs, GMPs, and HACCP plans as part of a supplier 

approval program). Figure 6.1, copied with permission from this guidance document, illustrates 

recommended preventive controls to be applied at each stage of the farm to finished product continuum. 

ASTA Cleanliness Specifications, described in the guidance document, identify limits for macroscopic 

extraneous matter for spices similar to FDA DALs. The concentrations in these specifications are in some 

cases smaller than the FDA DALs and provide limits for some spices for which specific FDA DALs were not 

established. 

Clean Spices: A Guidebook for Shippers of Products to the U.S. Spice Trade (ASTA, 2008) provides descriptions 

of U.S. regulations regarding importation of spice (including relevant food safety regulations), an overview of 

CGMPs and HACCP, FDA DALs and ASTA Cleanliness Specifications, warehouse/storage sanitation practices, 

and cleaning practices to remove extraneous material. This guide describes specific equipment that can used 

to remove extraneous material from spice and a chart to link spice, filth element, and equipment.
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HACCP Guide for Spices and Seasonings (ASTA, 2006) identifies pre-requisite programs, HACCP principles, 

HACCP plan implementation and documentation as it applies to spices and seasonings. It describes hazards 

including microbial and physical, and provides examples and suggestions of how to conduct a hazard analysis. 

GMA 2009 guidance Control of Salmonella in Low-Moisture Foods and related reports (Scott, et al., 2009; Chen 

et al., 2009a; Chen et al., 2009b) identify seven control elements to minimize the risk of Salmonella

contamination of low moisture foods in the manufacturing environment:

1. Prevent ingress of spread of Salmonella in the processing facility.

2. Enhance the stringency of hygiene practices and controls in the PSCA. 

3. Apply hygienic design principles to building and equipment design.

4. Prevent or minimize growth of Salmonella within the facility.

5. Establish a raw materials/ingredients control program.

6. Validate control measures to inactivate Salmonella. 

7. Establish procedures for verification of Salmonella controls and corrective actions.

These documents also describe common industry practices associated with implementation of each element. 

The PSCA in a facility handling low moisture foods such as spices is defined as “the area where handling of 

ingredient and product requires the highest level of hygiene control. In a facility where products receive a 

pathogen inactivation treatment, the PSCA is the area subsequent to the terminal pathogen reduction 

(lethality) step. In a facility where no inactivation step is employed, the entire process area may become the 

PSCA” (GMA, 2009; Chen et al., 2009a). 

General Guidelines for Good Agricultural Practices Spices (IOSTA, 2008) addresses preventive controls to limit 

the introduction mycotoxins, heavy metals, pesticide residues, allergens, undeclared colors, and processing 

aides from spices.

The International Organization for Standardization (ISO) has issued over 50 standards for sampling and 

testing of spices. These recommendations are concerned with quality standards rather than food safety 

standards. 

Effectiveness of industry guidance from trade organizations in preventing contamination of spices with 

Salmonella and/or filth and in preventing contaminated spice from entering the spice supply. The guidance 

documents represent the spice and food manufacturing industries’ best practices. The guidance has evolved 

as data have demonstrated the ability of Salmonella to survive in low moisture foods and research has 

revealed causes for contamination not previously recognized, particularly for low-moisture foods. As a result, 

it is expected that application of the principles and recommendations outlined in these documents would 

reduce the risk of contamination of spices with microbial pathogens and filth. We are not aware of any 

surveys that have measured compliance with guidance recommendations or changes in contamination 

prevalence in spice production sites. As discussed in Section 8.1.3.4 and illustrated in Table 8.7, the number of 

RFR primary entries for “Spices and Seasonings” in Year 3 of the program, was smaller than that found the 

previous two years. It is noteworthy that the ASTA guidance Clean, Safe Spices: Guidance from the American 

Spice Trade Association was issued during Year 3. Unfortunately, absence of information about the total 

number of tests performed or lots examined in each year, makes it difficult to interpret the significance of the 

observed changes. 

As seen in Table 8.7, the number of primary entries reported for “Spices and Seasonings” during the first two 

years of the program were larger than that for most of the other food commodity types for all hazards and for 

Salmonella in particular. However, the absolute and relative (e.g., rank) number of primary entries for “Spices 

and Seasonings” were much smaller in Year 3 of the program. As mentioned previously, the absence of 

information about the total number of tests performed or lots examined, makes it difficult to interpret the 
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meaning of these data, including changes from year to year. However the publication of the reports and 

summary statistics has been effective in alerting the industry to reported problems. 

8.2.3 RECALLS

Until FSMA was enacted in 2011, recalls of spices or spice-containing foods were conducted on a firm's own

initiative or by FDA request. FDA did not have the authority to mandate a recall. Classification of recalls and 

discussion of recent recalls were described in Section 4.1.6. 

Effectiveness of recalls in preventing contaminated spice from entering or remaining in the U.S. food supply.

Recalls remove contaminated product or potentially contaminated product from the commercial market. As 

such, they directly impact public health by avoiding illnesses that would otherwise have been realized, if the 

contaminated food had been consumed. Estimates of (potential) illnesses prevented for each spice-associated 

recall event is hampered by lack of information about the serving size for each of the products recalled. 

Development and reporting such a metric would allow comparison of “illnesses prevented’ from recalls to 

other mitigation strategies.

8.3 CODEX ALIMENTARIUS AND FAO/WHO

Codex Alimentarius (Codex), as a joint effort of the WHO and the Food and Agriculture Organization (FAO), 

serves to assemble experts from its member nations who set global standards for the safety and quality of 

foods. A number of guidance documents provided by Codex (Codex Alimentarius, 2013) address practices 

important to ensure spice food safety including 

• General Principles of Food Hygiene (CAC/RCP 1-1969) (CAC, 2003)

• Code of Hygienic Practice for Spices and Dried Aromatic Plants (CAC/RCP 42-1995) (CAC, 1995)

• Guide for the Microbiological Quality of Spices and Herbs Used in Processed Meat and Poultry 

Products (CAC/GL 14-1991) (CAC, 1991)

• Code of Hygienic Practice for Fresh Fruits and Vegetables (CAC/RCP 53-2003) (CAC, 2010)

These documents provide broad requirements for hygienic production and harvesting, establishment design 

and hygiene, personnel hygiene, establishment hygienic processing, and end-product specifications. The 

spice-specific code is currently being revised by the Codex Committee on Food Hygiene (USDA, 2012). WHO

has established WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants and 

created Five keys to growing safer fruits and vegetables: promoting health by decreasing microbial 

contamination which may be applicable to spice production (WHO, 2003; WHO, 2012). The latter document, 

which was discussed briefly in Section 8.1.3.5, targets rural workers and adapts the strategy of “Five keys to 

safer food manual” by providing graphics as well as text to communicate better with the intended audience. 

FAO of the United Nations has also developed general GAP principles for all commodities that address soil, 

water, crop selection and rotation, and crop protection from pests (FAO, 2013a). 

 

A “Microbiological Sampling Plan Analysis Tool” is now available from the Joint FAO/WHO Expert Meetings 

on Microbiological Risk Assessment (JEMRA, 2013) and the Codex Committee on Food Hygiene is developing 

detailed examples for the revised Principles and Guidelines for the Establishment and Application of 

Microbiological Criteria for Foods to aid in its implementation. 

Effectiveness of Codex and FAO/WHO guidance in preventing contamination of spices with Salmonella

and/or filth and in preventing contaminated spice from entering the spice supply. These general guidance 

documents provide guidance for the spice and food industries based on sound scientific evidence and most 

have been revised to reflect current knowledge in food safety. As a result, it is expected that application of the 

principles and recommendations outlined in these guidance documents should reduce the risk of 

contamination of spices with microbial pathogens and filth. The Code of Hygienic Practices for Spices and Dried 
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Aromatic Plants is not based on currently available data and information but is being revised. We are unaware 

of any systematic studies that have measured changes in the prevalence of microbial or filth contamination in 

spices as a result of applications of these guidance documents or any surveys that measure the extent to 

which these practices have been adapted by the food industry in general or the spice industry in particular.
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9. GENERAL CONCLUSIONS AND POTENTIAL FUTURE MITIGATION 

AND CONTROL OPTIONS

9.1 GENERAL CONCLUSIONS

A wide diversity of pathogens have been found in spices including Salmonella, Bacillus spp. (including B. 

cereus), Clostridium perfringens, Cronobacter spp., Shigella, and Staphylococcus aureus. Human illness 

outbreaks attributed to consumption of pathogen-contaminated spice have most commonly been associated 

with Salmonella or Bacillus spp. contamination. Ten of fourteen (71%) spice-associated outbreaks identified 

worldwide during the period 1973-2010 and 87% of the documented human illnesses in the outbreaks 

attributed to consumption of contaminated spices were caused by serotypes of Salmonella. Salmonella was 

the only pathogen associated with reported spice-associated outbreaks, food recalls, and Reportable Food 

Registry reports in the United States, for the review periods covered in this report. The absence of spiceassociated Bacillus spp. outbreaks or food recalls reported in the United States is somewhat surprising, 

particularly in light of reports of Bacillus spp. outbreaks associated with consumption of contaminated spice 

in the European Union during the 1973-2010 review period covered in this report, and additional Bacillus

spp. outbreaks (4) reported in the European Union in 2011 (EFSA, 2013). The apparent differences in the 

types of outbreaks attributed to contaminated spice and most commonly reported in the United States and 

the European Union or other regions/countries may arise in part from differences in awareness, surveillance 

(including test methodology), regulations, clinical diagnoses of suspected foodborne illnesses, and reporting 

requirement for different kinds of illnesses. Differences in diet, food preparation, and food storage practices 

may also contribute to the observed differences in types of reported outbreaks.

Evidence described in this report demonstrates the potential for introduction of Salmonella into/on spice 

during primary production, distribution and storage, secondary processing and food manufacturing, and at 

retail. Salmonella can survive in the natural environment (outside of an animal host) for extended periods and 

may persist in production environments for years. During primary production, contact between the spice 

source plant during growth, harvest, or drying and Salmonella-contaminated materials in the environment, 

including soil, water, insects, animals, or animal feces, has the potential to contaminate the spice. Once in/on

the spice, Salmonella can continue to survive for long periods. 

Most spices consumed in the United States are imported. The overall prevalence of Salmonella-contaminated 

shipments of imported spice offered for entry to the United States was 6.6% (750 g sample size; 95% CI 5.7-

7.6%) for FY2007-FY2009. This value is 1.9 times (95% CI 1.6-2.3) the prevalence found for other shipments 

of FDA-regulated foods examined during the same period. Salmonella was found in shipments of many 

different types of spices, in a variety of forms (whole, cracked, ground or blended) and from many different 

countries. As a result, we conclude that the presence of Salmonella is a general problem in the spice supply 

chain rather than a problem of a specific type/form of spice or source country. A few differences in 

prevalence rates with spice type, form, or country were significant and these should be explored further to 

better understand the increased/decreased contamination rate.

Salmonella concentrations ranging from 0.0007 to 11 MPN/g-spice (7 MPN per 10,000 g to 11 MPN per g) 

have been reported. Observations and models developed from an FDA 2010 study of shipments of imported 

capsicum (299 shipments) or sesame seed (233 shipments) offered for entry to the United States predict 

wide variability in the mean concentration of contamination among contaminated shipments of these types of 

spices and that many contaminated shipments contain very low concentrations of Salmonella. Estimated 

prevalence values based on sampling results are likely to be underestimates. Sampling plan design, 

particularly selections of an appropriate sample size and validated method of analysis, are critical to ensure 

efficient surveillance.
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Salmonella has also been found in the environment of spice/food facilities, including spice/food facilities

associated with two of the three spice-associated outbreaks identified in the United States. Crosscontamination from the spice/food manufacturing environment to the spice product was suspected to have 

been a contributing factor in both of these outbreaks. An FDA surveillance study involving environmental 

sampling in 59 spice manufacturers/packing/re-packing facilities in the United States during 2010 found 

10% of the facilities contained Salmonella in the environment. In that study, Salmonella was found on nonproduct contact surfaces in close proximity to product such as the exterior of spice grinding equipment, floors 

or walls. The relatively large prevalence of Salmonella-positive facility environments observed in the survey 

indicates that Salmonella presence in spice manufacturers/packing/re-packing facilities is not uncommon. 

Experiments have shown that Salmonella can grow quickly in some spices when moistened/wet (in the 

absence of other nutrients) which means that environmental niches may be created in facilities where 

Salmonella is present in the environment and moisture is not controlled (e.g., where wet cleaning is used). 

Site visits and conversations with the spice industry revealed that not all spices sold by spice manufacturers 

have been treated with a pathogen reduction step. Food manufacturers and food preparers who purchase 

spice may subsequently apply a pathogen reduction step that would limit the potential for the spice, if initially 

contaminated, to cause illness. However, investigations of spice-associated outbreaks revealed that in at least 

three of the outbreaks, the consumed spice had not undergone a pathogen reduction treatment before 

reaching the consumer. Addition of spices to foods after cooking is not uncommon in the United States (e.g., 

addition of capsicum or Italian seasoning to a pizza and black pepper to salads, steaks, and other foods). Once 

present in a moist food, pathogens from spice ingredients may grow if appropriate time/temperature 

conditions are not maintained. Growth of the pathogen in the food was suspected to have contributed to the 

numbers of illnesses in some of the outbreaks. 

Many of the spice-associated outbreaks during 1973-2010 were associated with consumption of lowmoisture foods, including outbreaks leading to large numbers of illnesses. Large numbers of Salmonella

illnesses can occur from consumption of spices when the exposed population is large, even when the 

concentration of Salmonella in the spice is small. This was the case for the1993 outbreak associated with 

consumption of contaminated paprika-powdered potato chips. A single contaminated shipment/lot of spice 

can contain millions to tens of millions of servings. 

A diversity of filth adulteration has been found in spices offered for import to the United States that includes 

insects, excrement, hair, and other materials. Filth shipment prevalence during FY2007-FY2009 was 12% 

(95% CI 10-15%) which was 1.8 times (RR 95% CI 1.4-2.2) the value found for all other imported shipments 

of FDA-regulated foods sampled during this time period. Filth was found in shipments of many different types 

of spices, in a variety of forms (whole, cracked, ground or blended) and from many different countries. As a 

result, we conclude that the presence of filth is a general problem in the spice supply chain rather than a 

problem of a specific type/form of spice or source country. However, shipments of imported black pepper 

during FY2007-FY2009 and sesame seeds during FY2010 had significantly smaller violation rates than many 

other types of spice. The most prevalent types of filth were storage product insects/insect parts and animal 

hair (especially rodent). These types of filth are indicative of insanitary conditions and failures in the 

application of CGMPS. 

Current mitigation and control options to prevent or control adulteration of spice by pathogens and filth 

include GAPs, CGMPS, inspections of and environmental sampling in spice manufacturing/packing facilities, 

product sampling, refusals and reconditioning, import alerts (with or without green lists and country 

agreements), recalls, application of pathogen reduction treatments, and guidance from FDA, other U.S. federal 

agencies, international agencies and industry trade organizations. Many of the current enforcement and 

regulatory strategies are effective but, with modification, could have greater impact on compliance. One 

example is Import Alert 28-02 for Indian Black Pepper, which includes an agreement that leverages incountry regulatory authority to improve the food safety of shipments of the imported spice offered for entry 
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to the United States. This combination of incentives appears to be effective in reducing the prevalence of 

Salmonella or filth contamination in shipments of Indian black pepper offered for entry to the United States. 

Expansion of this type of mechanism to other spices and/or to other countries should lead to further 

improvements. The FDA Food Safety Modernization Act provides important new tools to mitigate and control 

contamination and post treatment cross contamination of spices with Salmonella, including authority to 

mandate recalls and increase in the frequency of foreign and domestic inspections. Prevention standards and 

import safety mandates required by FSMA are included in the potential future mitigation and control options, 

because they were still in development when this report was written.

Failures identified in the farm-to-table food safety system potentially leading to adulteration of consumed 

spice generally arose from poor/inconsistent application of appropriate preventive controls, such as failing to 

limit animal access to the source plant during harvest and drying phases, failing to limit insect and rodent 

access to spice during storage, and failing to subject all spice to an effective pathogen reduction treatment (or 

other lethality step). On the basis of our research, we concluded that the knowledge and technology is 

available to significantly reduce the risk of illness from consumption of contaminated spices in the United 

States. Capacity building through the creation of partnerships with stakeholders can facilitate improvements 

in spice safety and reduce the risk of illness from consumption of pathogen-contaminated spices. Specifically, 

enhanced communication between FDA and the spice industry and within the spice and food manufacturing 

industry itself, combined with training across the spice supply chain are needed to ensure understanding of 

appropriate preventive controls and how to implement and maintain them. 

9.2 POTENTIAL FUTURE MITIGATION AND CONTROL OPTIONS

We developed the following list of potential future mitigations and control options for consideration based on 

a review and analysis of the scientific data and information available about the prevalence, concentration and

public health risk of pathogen (primarily Salmonella) and filth adulteration of spices and our assessment of 

the efficacy of current mitigation and control options. The list includes mitigation and control options that 

FDA, the spice industry, government agencies, food manufacturers/preparers, and the consumers may 

consider to reduce the prevalence and concentration of Salmonella, other pathogens, and filth in spices and to 

reduce the public health burden resulting from consumption of contaminated spices or foods containing 

contaminated spices. Mitigation and control options identified include capacity building, guidance, 

enforcement and regulatory strategies, communication, education, and training. Research needed to explore 

additional potential mitigations is described in Chapter 10. For each mitigation and control option, we briefly 

describe the observation/data that motivated it, provide a brief description of the option, identify expected 

benefits/effectiveness, and provide additional comments about implementation (practicality), as needed. 

Mitigation and control options are organized by the stage in the farm-to-table continuum in which it would be 

implemented or the part of the continuum that would be most highly impacted. More data are needed to rank 

the relative importance of the different kinds of system failures identified in the report and the potential 

impact of the proposed mitigation and control options.

9.2.1 PRIMARY PRODUCTION

Update and produce industry and government guidance documents to reflect current knowledge and 

practices and improve utility of these documents by creating flexible communication platforms. 

Poor/inconsistent application of industry and government guidance was identified as one of the contributing 

factors leading to spice contamination with pathogens and filth. Some of the guidance documents for spice 

production, storage, distribution, processing, and use described in Chapter 8 do not describe the most up-todate science-based principles for preventing/limiting contamination during on-farm production and postproduction processes of spices (e.g., the Codex Code of Hygienic Practices for Spices and Dried Aromatic 
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Herbs.) The proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for 

Human Consumption” (78 Federal Register 3504, January 16, 2013) (FDA, 2013e), which would implement 

section 105 of FSMA, provides information on mitigation in connection with pre-harvest commodities. It may 

be applicable to certain types of spice source plant production and could be relevant to updated guidance 

documents. Each guidance document should be reviewed and updated, as necessary. To improve the utility of 

these documents, tools should be developed to allow individuals/organizations to create customized 

extracts/compilations of the guidance(s) to review, share, discuss, and educate with particular groups. For 

example, one could create a single extract that collects all the sections of Codex documents that are relevant 

to the primary production of spices from the numerous relevant Codex food hygiene guidance documents. 

Some of this work is underway (e.g., development of a proposed revision of the Codex Code of Hygienic 

Practices for Spices and Dried Aromatic Herbs; FDA, 2012f). Alternatively, an alliance of stakeholders could 

work together to harmonize standards for the industry, as has been done in the produce industry (United 

Fresh, 2013). Creation of flexible and comprehensive resources, such as the examples described above, would 

require resources to complete, but may improve adoption by clarifying recommendations. 

Enhance education and training for spice primary producers. Poor/inconsistent application of industry 

and government guidance was identified as one of the causes of spice contamination with pathogens and filth. 

While a number of guidance documents have been developed and have been reviewed in Chapter 8, some 

may not be accessible to all primary producers for a variety of reasons, e.g., not available, culturally 

insensitive, too general, wrong language, or uses the written word. New/revised versions of these documents 

could be developed to address limitations, perhaps building off of the novel GAPs tools developed by WHO 

(2013b) and the National GAPs Program at Cornell University (2013). Further improvements in application of 

guidance may be realized if practical examples are provided, either as part of the guidance or in another 

document/media format. For example, possible strategies for implementing guidance for primary production 

could address issues specific to different spices, growing practices/environments, and different available 

resources. Best practices for training and education resulting from these efforts should be shared as they 

could be used to enhance the efficacy of other training/education initiates. Development of these new 

educational tools will require resources and would likely benefit from a collaboration that includes primary 

spice producers, secondary spice processors, experts in GAPs, and experts in communication. Members of the 

spice industry have invested much time and effort to understand local regulations, practices, and traditions in 

different spice producing regions and this information should inform education and training development. 

Collaborative initiatives in place that might consider taking part in this work include the industry-academiagovernment Preventive Controls Alliance (FDA, 2013f) or the Joint Institute for Food Safety and Nutrition 

(JIFSAN)-country specific food safety training partnership (JIFSAN, 2013). The development of a Collaborative 

Training Centre for Food Safety and Supply Chain Management in Spices and Botanical Ingredients in India is 

already in progress. The partners in this initiative are the Confederation of India Industry Food Agriculture 

Centre of Excellence (CII-FACE), Spices Board India, and JIFSAN (Food Agriculture Centre of Excellence, 

2013.) FDA participated in the initial “train the trainer” programs by training individuals from the CII-FACE, 

Spices Board India, Indian government officials, and industry representatives who will support the new 

initiative.

9.2.2 DISTRIBUTION AND STORAGE

FDA work with governments of spice producing countries to enhance food safety oversight by developing 

and formalizing programs such as the Indian EIC certificate program. FDA audits of the Indian EIC 

certificate program suggest that the program is effective in reducing the incidence of contamination in 

imported Indian black pepper, although some discrepancies in its application were found, as described in 

Chapter 8. Therefore, it is anticipated that reductions in the prevalence of pathogens and filth in imported 

spice shipments offered for import to the United States may be realized by expanding (and improving) the 

current program to include other spices imported from India and developing similar programs with other 

countries that are major sources of spice in the United States. The relatively large Salmonella-shipment 
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prevalence for shipments of Indian spices other than black pepper found in the FDA study of FY2007-FY2009 

import surveillance data, argues for expansion of the program. The current program provides market 

advantage to black pepper industry participants because shipments to the United States are no longer subject 

to DWPE at the border. In the future, the preventive controls, foreign supplier verification program, and 

voluntary qualified imported program provisions of FSMA (sections 103, 301, and 302 of FSMA) would 

provide additional incentives and may impact the nature and structure of food safety oversight programs 

developed. The imported food certification provision of FSMA (section 303 of FSMA) provides FDA with the 

authority to require a certificate of compliance for imported foods. 

Strengthen the capacity of regulatory systems in spice source countries. Many major spice source 

countries are developing nations with developing food safety systems. Improvements in countries’ food 

safety systems can significantly improve the quality of spices consumed in the country as well as exports. One 

strategy employed by India is the creation of “spice parks” where producers and aggregators may bring spice 

to be cleaned, treated and tested. Capacity-building was one of the major recommendations made by the 

Institute of Medicine of the National Academies in its report “Ensuring Safe Foods and Medical Products 

through stronger regulatory systems abroad,” (IOM, 2012) and is an area of emphasis in FSMA. FDA has 

developed a comprehensive International Food Safety Capacity-Building Plan (FDA, 2013q; discussed in 

Section 8.1.3.7) to engage both government and industry leaders in food source countries to improve the 

quality of food produced and exported. As one part of these capacity building efforts, FDA has begun to set up 

new and expand established international posts in a range of countries and regions including China, India and 

Latin America. 

Improve storage practices for spices. The prevalence of stored product pests in spices observed in 

shipments of imported spices offered for entry to the United States during FY2007-FY2009 indicates that 

insanitary storage conditions are not uncommon. Efficient improvement of storage practices would involve a 

systematic review of the practices employed and prevalence of stored-product pests in spices across the 

farm-to-table continuum (or other indicators of poor storage practices) to identify the stages and type of 

practices that contribute the most to the presence of stored-product pests in spices (see research Chapter 

10). 

FDA to improve Import Alert communication. Nearly three quarters (71%) of the firms listed on the 

generalized Import Alert 99-19 for Salmonella contamination of imported foods were cited for violations in 

one or more spices. One option is to consider creating a commodity specific import alert for Salmonella

and/or filth in spices to enable industry to more easily identify firms on detention and to facilitate tracking 

and trending analyses. This will communicate to all stakeholders that these specific contaminants may be 

found in spices. It is not known whether this option would significantly reduce the prevalence of Salmonella

or filth in imported shipments of spice because shipments from importers on either the current or proposed 

import alert would be subject to DWPE. Improvements might be realized if this modification more clearly 

communicated to the food industry the magnitude of the problem and thereby triggered new efforts to 

prevent contamination of spice. In addition, FSMA includes import food safety mandates that may lead to 

reductions in the prevalence of pathogen contamination or filth adulteration in shipments of imported spice 

in the future, e.g., the preventive controls rule for human food (section 103 of FSMA), the foreign supplier 

verification program (section 301 of FSMA), the prior notice provision (section 304 of FSMA, final rule 

issued), and possibly also the imported food certification provision (section 303 of FSMA). Final rules and 

their implementation may determine the extent to which these mechanisms reduce the prevalence of 

pathogen or filth adulteration in shipments of imported spices.
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9.2.3 PRIMARY AND SECONDARY PROCESSING 

FDA, industry and academic experts work together to develop regulations, and potentially guidance, for 

the spice industry (manufacturers, processors including treatment facilities, packers and holders of 

spice) on developing food safety plans that include preventive controls. Poor/inconsistent application of 

appropriate preventive controls was identified as one of the contributing factors leading to contamination of 

spice with Salmonella or filth. Section 103 of FSMA “Hazard analysis and risk-based preventive controls” 

requires food facilities to evaluate hazards that could affect food safety, identify and implement preventive 

controls to prevent hazards, monitor controls and maintain monitoring records, and conduct verification 

activities. FDA issued the proposed rule “Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Human Food” (78 Federal Register 3646, January 16, 2013) that would, when 

finalized, implement section 103 of FSMA. The proposed rule proposes to require facilities to conduct a 

hazard analysis, identify hazards reasonably likely to occur, and establish preventive controls for such 

hazards. There are also proposed requirements for a food safety plan, monitoring and corrective actions for 

preventive controls, validation of preventive controls, and records. In addition the proposed rule “Foreign 

Supplier Verification Programs for Importers of Food for Humans and Animals” (78 Federal Register 45730, 

July 29, 2013) (FDA, 2013t) proposes to require that importers verify that the foods they import are 

produced using processes and procedures that ensure the same level of safety as food produced in the United 

States. 

Guidance could also be developed to support the FSMA rulemakings. Guidance may be specific for spices or 

included in preventive controls guidance for low-moisture foods and should address environmental sampling. 

Such guidance would improve awareness of hazards and effective preventive controls. Guidance would be 

science-based and built off of science-based industry guidance and best practices. Implementation of the 

guidance by the spice industry may be improved if the guidance is accompanied by outreach following its 

initial publication. For example, ASTA has been actively engaging the spice industry in webinars about their

guidance and presented a webinar on environmental sampling to interested parties in April 2013 (ASTA, 

2013).

Enhance education and training for primary and secondary spice processors. Poor/inconsistent 

application of appropriate preventive controls was identified as one of the contributing factors leading to 

contamination of spice with Salmonella or filth. This option is analogous to that described for primary 

producers in 9.2.1. A number of guidance documents and reports have been developed by the spice and food 

industries on preventive controls for primary and secondary processing of spices and low moisture foods 

(see Section 8.2.2). However, observations and conversations between some spice processors and members 

of the risk profile development team engaged in educational or inspectional visits revealed lack of awareness 

or understanding of some provisions in industry spice processing guidance documents. Education and 

training efforts could include development and application of new strategies to make the information in the 

documents accessible to all primary and secondary spice processors. Development of practical tools or 

examples for implementing the guidance for spice processors may also expand implementation of preventive

controls. For example, providing floor plans for hygienic design for operations of differing sizes and available 

resources, ideas on how to adapt facilities and equipment to improve food safety (e.g., sanitary equipment 

design), and identification of the best approaches for appropriate cleaning and sanitation of spice processing 

facilities and equipment may be helpful. Already in progress is the development of a Collaborative Training 

Centre for Food Safety and Supply Chain Management in Spices and Botanical Ingredients in India, described in 

9.2.1 (Food Agriculture Centre of Excellence, 2013).

FDA develops guidance for industry on the criteria recommended for validation of spice pathogen 

reduction treatment processes. A significant percentage of reconditioning proposals are rejected by FDA 

each year and it is suspected that some pathogen reduction treatments applied to spices may not be efficient 

in reducing the microbial population (evidence that spice shipments/lots that had been subjected to a 

pathogen reduction treatment were contaminated, although this could have arisen from post-process 
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contamination). FDA, possibly in collaboration with appropriate professional societies, could establish best 

practices and develop guidance for testing and verifying the process and protocols used to treat spices to 

reduce microbial loads. Such guidance would clarify FDA expectations for validation studies and is also likely 

to help industry improve their treatment processes to deliver consistent effective pathogen reduction 

treatments and thereby reduce the incidence of contamination across the entire U.S. spice supply. 

Implementation of the guidance by the spice/processing industry may be improved if the guidance is 

accompanied by outreach following its initial publication. 

Increase (or mandate) application of validated pathogen reduction treatments for reduction of 

Salmonella to all spices intended for human consumption in the United States at an appropriate point 

before or after packaging. Our research revealed that some raw spice reaches the consumer. The spice and 

food manufacturing industries could develop new strategies to increase the application of validated pathogen 

reduction treatments to spice. As mentioned previously, the proposed rule “Current Good Manufacturing 

Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” (78 Federal Register 

3646; January 16, 2013) (FDA, 2013s) proposes to require validation of food safety preventive controls as 

part of verification. Such a requirement in a final rule would increase the application of validated pathogen 

reduction treatment of spices for reduction of Salmonella. Because research discussed in this document has 

revealed that pathogen reduction treatments have not been applied to all spices reaching the consumer, 

success of such initiatives would likely decrease consumer exposure to potential life threatening microbial 

diseases.

FDA and spice industry increase inspections of foreign and domestic spice warehouses, spice processing, 

and spice pathogen reduction treatment facilities that include environmental sampling and assess 

compliance with CGMPS. Our review of spice facility inspections demonstrated that review of hazard 

analysis and preventive controls during inspections can identify potential problems before contamination 

occurs. In addition, appropriate and regular environmental sampling within a facility provides an additional 

assessment of the facility environment, one that is not necessarily captured by an observational inspection 

alone. In the event of a Salmonella-positive environmental sample, additional sampling in the facility can help 

to characterize the spatial extent and possibly the source of contamination. Serotyping Salmonella-positive 

environmental samples can determine whether the organism has been found previously in the facility. This 

information can also help with identifying and eliminating the contamination source. Such an initiative could 

also involve training for inspectors on hazards and preventive controls for spices (or low moisture foods) and 

how to conduct preventive control inspections. Such training would improve awareness of hazards and 

preventive controls among inspectors. FDA is currently implementing an increase in frequency of foreign and 

domestic food facility inspections, as required by FSMA. As mentioned above, ASTA presented a webinar on 

environmental sampling in April 2013, which may encourage adoption and improved application of this food 

safety tool. The proposed rule “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food 

Safety Audits and to Issue Certifications” (78 Federal Register 45781, July 29, 2013) (FDA, 2013u), which, 

when finalized would implement section 307 of FSMA, would increase the capacity for regulatory and 

consultative audits of spice warehouses, processing and pathogen reduction facilities, once implemented. 

9.2.4 RETAIL/END USER 

FDA work with CDC and states to develop methods to facilitate collection of spice consumption and 

purchase information from individual cases and restaurant sub-clusters during outbreak investigations. 

Attribution of foodborne illnesses to foods, particularly minor ingredients such as spices, is difficult and is 

often not accomplished during routine outbreak investigations. This information would improve our ability to 

characterize the public health risk associated with consumption of spices. New tools/methods could be 

developed for use by state and local partners that will promote rapid collection of key information for 

traceback investigations. These tools should consider the potential role of ingredients such as spices in food 
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contamination and could include improved patient/food preparer questionnaires/interviews that would 

include question(s) about use and consumption of spices and seasonings in the outbreak investigation. The 

team should also explore methods of using adjunct data sources (e.g., shopper loyalty cards or photo menu 

cards of dishes consumed at restaurants) to aid investigations. These new strategies will enhance the flow of 

product information to public health and regulatory agencies during traceback investigations, thereby 

expediting identification of any common food source. Development and implementation of new tools and 

methods for outbreak investigations could be facilitated through collaboration between the FDA Coordinated 

Outbreak Response and Evaluation Network (CORE) and the CDC outbreak and response team.

Increase efforts and improve strategies to identify the root cause of ingredient contamination including 

whether growth in the food or environment contributed to the outbreak. As revealed by the analysis of 

spice-associated outbreaks presented in this report, root cause of contamination was rarely identified in 

spice-associated outbreaks. This information is critical for reducing the burden of illness associated with 

consumption of contaminated spices because it identifies failure(s) in the food safety system. Once failures 

have been identified, they can be addressed, thereby improving/strengthening the food safety system. As 

illustrated by the extensive research efforts that went into trying to reveal the location/root cause of 

contamination in the Salmonella Montevideo outbreak attributed to consumption of black or red peppercoated salami products, finding the root cause can be extremely difficult, particularly for such a complex 

supply chain as is typical for spices. Increased efforts could include increased sampling of products and 

environment at different points in the traceback diagram with serotype determined and NGS analyses or 

other appropriate subtyping analysis performed. FDA’s CORE would likely lead the development of new 

strategies to better obtain root cause information. 

Public health agency scientists involved in outbreak investigations enumerate pathogens in samples of 

food and ingredients in the food-chain that have been identified as having strains identical to the 

outbreak strain. Enumeration of pathogens such as Salmonella is rarely pursued during outbreak 

investigations but this information can provide data to indicate the relative role of CGMP and supply-chain 

failures in the outbreak (e.g., a high concentration of Salmonella in a spice could be indicative of conditions 

that supported growth of the microorganism). Enumeration of the implicated food in an outbreak will also 

provide a measure of the actual “dose” consumed, which can be used to estimate the size of the exposed 

population or to explore the impact of food/patient properties on the probability for illness. This information 

is critical for application of quantitative risk assessment efforts and can be used to characterize the public 

health burden associated with pathogen contaminated spice as well as the impact of different mitigation and 

control options on that burden. Enumeration data gathered during outbreak events could be added to the 

data resources available for FDA’s risk ranking tool iRisk, which is a publicly available rapid risk assessment 

and risk ranking tool developed by FDA.

Develop new strategies to identify related illnesses attributed to spices or other low-moisture/long 

shelf-life foods. Retail packages of spices and other low moisture or shelf-stable products have the potential 

of being used by a large number of consumers over very long periods (years). As a result related illnesses may 

be spread out in time and space. Serotype/PFGE data are very helpful in identifying related illnesses, 

particularly when clustered in time. When serotypes are rare, related illnesses may be able to be linked 

across time and space. However, when common serotypes are involved, sequencing information, such as 

afforded by Next Generation Sequencing, are likely needed to link these illnesses across time and space. 

NIH/NCBI's Sequence Read Archive (SRA) is currently being developed to collect these data (NCBI, 2013). 

The data deposited in the SRA will be available for public download without geographic and/or political 

restrictions. The SRA is part of the international partnership of archives (INDSC) at NIH/NCBI, the European 

Bioinformatics Institute, and the DNA Database of Japan. Data submitted to any of these 3 sites will be shared 

among them. These new tools will enable researchers to identify more outbreaks, which would lead to a 

better characterization of the public health risk associated with consumption of spices. The data collected 

may also provide information such as the regional origin of the pathogen causing illness, which can 

significantly aid in the determining of root cause/system failures. 
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FDA, spice industry, and foreign governments work together to develop guidance, and potentially 

regulations, to improve traceability during outbreaks of illness from spices. The complexity of the spice 

supply chain complicated the development of an accurate traceback diagram in the Salmonella Montevideo 

outbreak in the United States associated with black or red-pepper coated salami products. Improved 

traceability would help in identifying and eliminating contaminated spice from the supply and has the 

potential to identify the cause of contamination, which could prevent future contamination events. Improved 

traceability would also decrease the time needed for the traceback investigation and as a result, could reduce 

the numbers of illnesses by more quickly identifying and removing/remediating all potential contaminated 

spice lots in the supply. Once developed, such guidance may be more effectively implemented if a companion 

training program is developed and implemented. In implementing section 204(a) of FSMA, FDA established 

product tracing pilots, which were conducted by IFT. One of these product tracing pilots included an 

exploration of scenarios involving processed foods containing spice ingredients and this pilot project has 

been completed. IFT’s report about the product tracing pilots (McEntire and Bhatt, 2012), which provides 

recommendations on strategies that FDA can use to improve product tracing, was made available for public 

comment by FDA (FDA, 2013v). FDA intends to use the findings from this report and other recent tracingrelated efforts to help inform the development of the rulemaking on tracing mandated in Section 204 of 

FSMA. That rulemaking will establish additional recordkeeping requirements for facilities that manufacture, 

process, pack or hold foods that FDA designates as high-risk. If FDA designates spices as high-risk, then the 

requirements established by the rulemaking will improve the traceability of spices. 

Report recalls arising from contamination based on serving size of the product recalled in addition to 

the amount recalled. It is currently very complicated, if not impossible, to determine the number of servings 

of a product that has been recalled when the product is an ingredient in many different foods. 

Characterization of recalls on the basis of standard serving size would help to better define the public health 

impact of each recall event and would enable FDA and others to characterize each recall on the basis of 

potential foodborne illnesses prevented. 

9.2.5 GENERAL

Increase surveillance of pathogens other than Salmonella in spices and in human cases of foodborne 

illness. The absence of evidence for spice-associated illnesses, food recalls, or RFR primary entries linked to 

pathogens other than Salmonella in the United States may arise from lack of surveillance. First efforts should 

focus on Bacillus spp., which was the second most common pathogen associated with spice-associated 

outbreaks reported during the period 1973-2010. Additional pathogen targets could include Clostridium 

perfringens, which was identified in one of the possible spice-associated outbreaks discussed in Section 2.4 

and pathogenic Escherichia coli, which has been shown to be able to survive for long periods in low moisture 

foods (Kimber et al., 2012; Blessington et al., 2012). 

 

Educate and train regulatory partners, and reach out to countries and food trade organizations to 

communicate common spice hazards and available preventive controls. Initial efforts could involve 

developing a variety of communication strategies to effectively share the present risk profile with regulatory 

partners and stakeholders. Scientific publications and public presentations, including webinars, are one 

forum open to all stakeholders and FDA has used these forums to communicate results ahead of publication

of this report. Additional efforts could include the creation of partnerships with regulatory partners and 

stakeholders to craft communication tools to improve awareness of common spice hazards and application of 

available preventive controls. Collaborative initiatives in place that might consider taking part in this work 

include the industry-academia-government Preventive Controls Alliance or the JIFSAN-country specific food 

safety training partnerships. 
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Improve understanding and application of appropriate sample designs and analytical protocols for 

spice (and environmental) sampling for pathogens. In light of the small concentrations of Salmonella

reported in spices, it is critical that public health agencies and the spice and food industries use effective 

product sampling plans (including sample size) when screening spice (or the environment) for Salmonella. 

Guidance for sample designs is available in the published scientific literature (e.g., ICMSF, 2002) and also 

online (JEMRA, 2013). The Codex Committee on Food Hygiene is developing detailed examples for the revised 

Principles and Guidelines for the Establishment and Application of Microbiological Criteria for Foods to aid in its 

implementation. Guidance on analytical protocols for detection of Salmonella in spices is provided in the FDA

Bacteriological Analytical Manual (Andrews et al., 2011). These new tools build on the extensive scientific 

literature on product sampling. All resources noted here are free and publicly available. Education and 

training on sampling plan design and laboratory methods of detection, isolation and confirmation of 

Salmonella would enhance capacity, improve data quality and most importantly, would ultimately improve 

detection efficiencies when appropriate plans and methods are used. 

FDA alert/communicate with the spice industry as a whole when observations suggest that the 

application of current preventive controls for pathogens and filth in spices may not be adequate. 

Observations that might warrant communication could include an increasing or significantly larger 

prevalence of pathogens or filth in all spices or a particular type of spice as compared with other FDAregulated foods, an increase or unusually large number of inspections with poor CGMP compliance, or a new 

or unusual system failure identified as part of an investigation. The form of the communication could vary 

depending on the urgency and scope of the problem. For example, FDA could issue a constituent update, 

industry letter, publication, or give a webinar or presentation at a public or scientific meeting. Such 

communications would heighten awareness across the industry to potential problems and would provide the 

industry with an opportunity to develop systemic reforms to reduce/eliminate contamination in spices to 

minimize the public health impact. FDA has already used some of these mechanisms to share key results of 

this report ahead of publication.

FDA alert/communicate with spice producing countries when observations suggest that the application 

of current preventive controls for pathogens and filth in spices may not be adequate. Observations that 

might warrant communication might include an unusually large number of spice firms on Import Alert, or a 

sudden increase in the prevalence of Salmonella-positive spice shipments from that country. Such 

communications would alert countries to potential systemic or new problems in the spice supply chain that 

threaten public health in the United States and possibly also the source country. 

Overhaul FDA product codes to allow for better identification of products and more precise tracking 

and trending of products by FDA. Current product codes complicate tracking and trending. Revisions could 

include providing unique identifiers for low moisture foods such as spices, foods that had undergone a 

pathogen reduction step, and foods packaged for retail. Such revisions would help FDA to more precisely 

characterize and compare contamination findings across the spice/food spectrum, such as prevalence in 

imported shipments offered for import, and would improve the ability to identify emerging food safety 

problems with spices or other FDA-regulated products and improve FDA’s ability to target the types of 

shipments that pose the greatest public health risk for sampling. 

 
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10. DATA GAPS AND RESEARCH NEEDS 

The development of the risk profile revealed many gaps in information and data regarding adulteration of 

spices by pathogens and filth and the potential for this contamination to impact public health. Below we 

identify these gaps and the research needed to fill them, particularly focusing on research that will improve 

our ability to assess the public health risk posed by consumption of spices in the United States, to better 

characterize system failures that lead to spice contamination, and to explore additional potential future 

mitigations.

10.1 DATA GAPS

10.1.1 FOODBORNE OUTBREAKS

• What stage of the farm-to-table continuum did the spice contamination take place? Where 

specifically did contamination take place?

• What were the root cause(s)/failure(s) that allowed the spice to be contaminated?

• Were there additional failures in the food safety system that allowed the initial contamination to 

reach the consumer? 

• Did cross-contamination contribute to the outbreak or was it the major cause?

• Did growth of the pathogen in the spice/food contribute to the public health burden (increased 

numbers of illnesses)?

• What was the concentration of contamination in the spice implicated in causing illness? (was it 

significantly larger than that found in surveillance?)

• What percentage of foodborne outbreaks attributed to complex foods or for which the food could not 

be determined were caused by contaminated spice?

10.1.2 PREVALENCE AND CONCENTRATION OF PATHOGENS AND FILTH IN SPICES 

• What is the prevalence, concentration and distribution of Salmonella or other pathogens in spices 

(domestic and imported) at different stages of the farm-to-table continuum? Where is the most 

common point of entry? Are there large differences among spices (including whether it is whole or 

ground?) 

• What is the prevalence of filth in spices (domestic and imported), particularly storage pests, at 

different stages of the farm-to-table continuum? Which is the most common point of entry and what 

is the most common cause of contamination? Has the prevalence of filth in spices at retail in the 

United States changed since last measured in the 1980’s? If so, why?

• How does the prevalence of Salmonella in imported shipments of raw spice offered for import to the 

United States compare with that for shipments of spice that have undergone a pathogen reduction 

treatment? Is this dependent of the type of spice? How do these measures compare for spice at 

retail? How does contamination prevalence in raw domestic spice differ from domestic spice at 

retail?

• In which stages of the farm-to-table continuum do the presence of filth and Salmonella in spice 

correlate (if any)? 
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10.1.3 CHARACTERISTICS OF CONTAMINANTS

• Are the survival of Salmonella in (dry) spice and the growth of Salmonella in wet spice strongly 

dependent on spice type?

• What are the survival and growth characteristics of other pathogens in spice? 

• How does survival of Salmonella differ at low concentrations of contamination; are the antimicrobial 

compounds sufficient in concentration/number to kill the little Salmonella present?

10.2.4 MITIGATION AND CONTROL OPTIONS 

10.2.4.1 CGMPS AND ENVIRONMENTAL SAMPLING 

• What is the risk for spice contamination when Salmonella or other pathogens are found in the facility 

environment? (What is the relationship between prevalence of Salmonella in the environment and 

prevalence of Salmonella or other pathogens in the product? What are typical transfer rates from 

equipment or surfaces in spice processing/packing facilities to spice?)

• What is the prevalence of Salmonella or other pathogens in foreign spice processing/packing facility 

environments?

• What percentages of spice processing/packing firms follow the guidelines for spices and low 

moisture foods? Which practices are least often adopted and why? Which CGMP recommendations 

are most predictive of adulteration of the spice product?

• What percentage of spice processing/packing firms perform regular environmental sampling? Does 

this sampling include testing the environment for Salmonella? Other pathogens?

• What are the economic and social/consumer costs/concerns associated with requiring filth 

reduction treatments for all spices and seasonings?

10.2.4.2 PATHOGEN REDUCTION

• What is the efficacy of commonly applied pathogen reduction treatments on the population of 

Salmonella in spice? 

• What are the economic and social/consumer costs/concerns associated with requiring pathogen 

reduction treatments for all spices and seasonings?

• What percentage of spice in the U.S. supply subjected to a pathogen reduction treatment before 

reaching the consumer? How does this percentage vary by spice type, size of spice/food firm, and 

stage in the farm-to-table continuum?

10.2.4.2 SAMPLING

• How would the efficacy of a three-class attribute system for filth in spices differ from the current 

system?

10.2.4.3 IMPORT ALERTS

• What is the effectiveness of firm-type import alerts? Does this differ from country-wide commodity 

specific import alerts?

10.2.5 CONSUMPTION

• What is the distribution of consumption patterns for spice in the U.S. population? How does this 

depend on the type of spice or consuming population?
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• What is the relative frequency of consuming uncooked spice among the various U.S. populations? Are 

there spices that are more frequently consumed raw or added to foods near the end of cooking? Are 

there cuisines or specific foods in which raw/lightly cooked spice is generally included?

10.2 RESEARCH NEEDS

10.2.1 FOODBORNE OUTBREAKS

Research novel methods/strategies to efficiently identify the contaminated ingredient in foodborne 

illness outbreaks. Such methods would improve foodborne illness attribution.

Research novel methods/strategies to efficiently identify the root cause in a foodborne outbreak 

involving spices. Such methods would identify failures in the spice food safety system, which would enable 

the spice industry to improve these systems.

Research novel methods/strategies to efficiently traceback spice ingredients to their original source. 

Traceback for spices can be very complicated because of the multiple sources, suppliers, processors, packers, 

food manufacturers and retail establishments that may be involved. Novel strategies are needed to more 

quickly understand the complex web of relationships.

10.2.2 PREVALENCE AND CONCENTRATION OF PATHOGENS AND FILTH IN SPICES 

Determine the distribution and concentration of Salmonella in spices at critical points in the farm-totable continuum. Much data are needed to determine the relative importance of contamination at different 

stages of the spice supply chain, including studies of spices at production, before undergoing a pathogen 

reduction treatment, and at U.S. retail. Interpretation of analyzed data would be enhanced if the data collected 

would distinguish pathogen reduction treated spices and spices that had not undergone a pathogen reduction 

treatment as well as spice type.

Determine the prevalence and concentration of pathogens other than Salmonella in spices at critical 

points in the farm-to-table continuum. A wide diversity of pathogens have been identified in spices outside 

the United States including Bacillus spp. which have been reported to have caused human illness from 

consumption of contaminated spice. Research should include pathogens detected in spices as well as 

pathogenic Escherichia coli strains (e.g., O104) which have been identified in sprouts of seeds commonly used 

as spices. Surveillance data are especially needed at the point of import, in spice/food processing facilities, 

and at retail in the United States. 

Determine the prevalence of different kinds of filth at critical points in the farm-to-table continuum. The 

prevalence of stored product pests in spices observed in shipments of imported spices offered for entry to the 

United States during FY2007-FY2009 indicates that insanitary storage conditions are not uncommon. A 

systematic review of the practices employed and prevalence of stored-product pests in spices across the 

farm-to-table continuum (or other indicators or poor storage practices) would be able to identify the stages 

and type of practices that contribute the most to the presence of stored-product pests in spices. Similarly, 

prevalence data on other types of filth along the farm-to-table continuum may reveal additional weaknesses 

in the food safety system. 

Determine the prevalence of filth at retail in the United States. These data would reveal whether spice 

contamination with filth has improved since the establishment of DALs. 
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Determine the relationship between prevalence and concentration of Salmonella in the spice processing 

environment and Salmonella in spices. These data would better characterize the potential role of crosscontamination from the spice-processing environment to the spice in facilities where Salmonella is present, 

and could include quantitative measures of transfer (e.g., coefficients). 

Determine the percentage of firms that receive pathogen reduction treated spice or that treat spice to 

eliminate pathogens and the percentage of firms that perform regular environmental sampling for

Salmonella. These data would provide information about extent of application of these preventive controls in 

the spice industry.

10.2.3 CHARACTERISTICS OF CONTAMINANTS

Determine how survival of Salmonella in dry spice and growth of Salmonella in wet/moist spice varies 

with spice type. This research extends the research initiated by FDA on black pepper and would provide a 

more comprehensive understanding of survival and potential for growth in spices.

Determine whether Salmonella survival in spice is strongly dependent on the initial 

numbers/concentration introduced. Contamination concentrations detected in “naturally” contaminated 

samples are small compared with the concentrations used in survival and growth studies. Data are needed to 

determine whether at low concentrations of contamination, other factors, such antimicrobial compounds 

present in the spice, lead to different survival rates. 

Determine survival and potential for growth of other pathogens in spices. Research should include 

pathogens detected in spices as well as pathogenic Escherichia coli strains (e.g., O104) which have been 

identified in sprouts of seeds commonly used as spices.

10.2.4 MITIGATION AND CONTROL OPTIONS

Identify and characterize appropriate surrogate microorganisms that can produce similar inactivation 

results as Salmonella for specific technologies in specific spices. Optimal surrogates should be 

nonpathogenic, have inactivation kinetics that can predict reductions in Salmonella populations, be stable and 

exhibit consistent growth characteristics, easy to prepare in high-density populations, easy to enumerate and 

differentiate from other microflora, and have injury susceptibility similar to Salmonella. 

Measure the relative efficacy of Salmonella reduction processes commonly used on spices and validate 

mitigation treatments. The study should include evaluation of the impact of spice form 

(whole/cracked/ground), equipment design, and critical parameters on the efficacy of Salmonella reduction 

using a variety of treatment processes commonly used on spices. This effort should also address surrogate 

selection, inoculum preparation, and detection/enumeration of desiccation-stressed salmonellae in spices. 

Data from such a study would provide critical information to FDA and the spice industry. 

 

Develop new and improved methods of dry cleaning and sanitation that are effective in reducing the 

prevalence and concentration of Salmonella (and other microbial pathogens). The research should 

include efficacy and validation studies.

Determine the economic and social/consumer costs/concerns associated with requiring pathogen 

reduction treatments for all spices and seasonings. The research should include a survey that assesses

consumer acceptance of spices treated with the most commonly applied pathogen reduction treatment 

technologies and study to determine the economic impact of a mandate.
Data Gaps and Research Needs | 10

FDA Draft Risk Profile | 140

Determine the economic and social/consumer costs/concerns associated with requiring all spices 

receive treatment to remove filth. This research would be needed before a new regulation could be 

developed. The research should include a survey to assess consumer tolerance of natural and unavoidable 

defects in food. 

Develop a rapid accurate method to measure mold in spices. Analysis for mold, especially in ground spices, 

is time consuming and complex. Development of a rapid method for detection of mold in spices would allow 

more samples to be analyzed more accurately and would lead to a better characterization of the prevalence of 

mold in spices across the supply chain. 

Develop a rapid method for screening and/or quantifying filth in spices. Current methods are labor 

intensive and time consuming, thereby limit the annual capacity for filth sampling by FDA, the spice and food 

industries. Development of a rapid analytical method would increase capacity for filth analysis. 

Optimize methods for detection and enumeration of Salmonella (and other pathogens) in spices. 

Detection of pathogens such as Salmonella in spices is challenging for a number of reasons including the 

desiccated state of bacteria and the presence of antimicrobial compounds in some spices. Contamination

concentration is needed to determine probability of illness, efficacy of pathogen reduction treatments, 

magnitude of growth, and other factors that can help determine root cause in outbreak/contamination 

investigations yet is rarely collected. Current methods are slow and labor intensive. Rapid reliable analytical 

methods for both detection and enumeration would improve capacity for government agencies and the 

spice/food industry to collect these data.

Determine the impact of a three-class attribute system for the evaluation of filth in foods on the quality 

and food safety of foods. Such a system would eliminate marginally compliant foods from the food supply 

and thereby improve the quality and food safety of foods. A three-class system increases the ability to detect 

food lots that have widespread but low concentrations of filth. 

Determine metrics and develop plans to assess the efficacy of mitigation and control options including 

guidance. Better measures of the public health impact of different mitigation and control options will lead to 

a better characterization of the relative reduction in public health risk afforded by different types of options 

and will ultimately lead to the development of more effective options. 

10.2.5 CONSUMPTION

Determine the fraction and type of spices consumed that had never received a pathogen reduction step 

(including cooking). These data should distinguish among spice type, cuisine, type of use, and food 

preparation setting (e.g., food manufacturers, institution, restaurant, or home). This information will help to 

characterize the public health risk posed by contaminated spices and help to identify the most likely 

populations to consume contaminated spices. Further characterization could be realized if the fraction and 

type of spices consumed as “partially cooked” spice (spice added to foods near the end of cooking where the 

heat treatment may be inefficient) could be estimated. 

Determine the distribution and variability of spice consumption servings among general and susceptible 

U.S. populations. This information cannot be accurately determined with NHANES data. Such data are needed 

to quantitative characterize the public health risk associated with spice consumption and would be most 

useful if it included additional data about high consumers and susceptible populations. 

Conduct research to determine the fraction and type of spices eaten raw. Research should assess the 

fraction of spices consumed in the United States that never undergo a pathogen reduction treatment 

(including cooking), preferably by type of spice. 
Data Gaps and Research Needs | 10

FDA Draft Risk Profile | 141

10.2.6 GENERAL

Develop a quantitative risk assessment to estimate the risk of illness from consumption of spices and 

determine the relative effectiveness of potential control options to minimize the risk of illness from 

consumption of spices. The risk assessment would have to address differences among spices or groups of 

spices. Comparison of the impact of different potential mitigation and control options on predicted risk of 

illness estimates (e.g., risk of illness per spice serving or annual per capita risk of illness) will provide 

information for all stakeholders to make appropriate risk management decisions. However, much of the data 

that would be needed for a fully quantitative model is lacking. FAO is currently engaged in evaluating the risk 

posed by consumption of spices (FDA, 2012f).
FDA Draft Risk Profile | 142 

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Spice List | Appendix A

FDA Draft Risk Profile | 172

APPENDIX A: SPICE LIST 

Over 100 different plants are commonly used as spices. The list of plants in this appendix was compiled from 

21 CFR 182.10 (FDA, 2012f), EPA, and on-line lists of spices maintained by the American Spice Trade 

Association and the Seasoning and Spice Association. Spices are listed by botanical name (Table A1) and by 

common name (Table A2). Each is also categorized by the plant part used (Table A3). Typical spice use in 

foods is characterized in Table A4. Not all plants used as spices are listed in these tables.

Table A1. Spice list by botanical name

Botanical Name Common Name Plant Part Used Sourcea

Allium cepa Onionb root ASTA, SSA

Allium sativum Garlicc root ASTA, SSA

Allium schoenoprasum Chives leaf 21CFR182.10

Alpinia galanga Greater Galangal root SSA

Alpinia galanga Greater Galangal seed fruit/seed SSA

Alpinia officinarum Galanga (Galangal) root 21CFR182.10

Amomum melegueta Grains Of Paradise fruit/seed 21CFR182.10

Anethum graveolens Dillc leaf ASTA, SSA

Anethum graveolens Dillc seed fruit/seed ASTA, SSA

Anethum sowa Dilld leaf ASTA

Anethum sowa Dilld seed fruit/seed ASTA

Angelica archangelica Angelica leaf 21CFR182.10

Angelica archangelica Angelica Root root 21CFR182.10

Angelica archangelica Angelica Seed seed 21CFR182.10

Angelica spp. Angelica leaf 21CFR182.10

Angelica spp. Angelica Root root 21CFR182.10

Angelica spp. Angelica Seed seed 21CFR182.10

Anthemis nobilis Camomile (Chamomile), English Or 

Roman

flower 21CFR182.10

Anthriscus cerefolium Chervil leaf 21CFR182.10

Apium graveolens Celery Seed fruit/seed 21CFR182.10

Armoracia lapathifolia Horseradish root 21CFR182.10

Artemisia dracunculus Tarragon leaf 21CFR182.10

Bixa orellana Anattoc fruit/seed ASTA

Brassica hirta Mustard, White Or Yellow fruit/seed 21CFR182.10

Brassica juncea Mustard, Brown fruit/seed 21CFR182.10

Brassica nigra Mustard, Black Or Brown fruit/seed 21CFR182.10

Calendula officinalis Calendula flower 21CFR182.10

Calendula officinalis Marigold, Pot flower 21CFR182.10

Calendula officinalis Pot Marigold flower 21CFR182.10

Capparis spinosa Capers flower 21CFR182.10

Capsicum annuum Capsicum fruit/seed 21CFR182.10

Capsicum annuum Cayenne Pepper fruit/seed 21CFR182.10

Capsicum annuum Paprika fruit/seed 21CFR182.10

Capsicum annuum Pepper, Cayenne fruit/seed 21CFR182.10

Capsicum annuum Pepper, Red fruit/seed 21CFR182.10

Capsicum frutescens Capsicum fruit/seed 21CFR182.10

Capsicum frutescens Cayenne Pepper fruit/seed 21CFR182.10

Capsicum frutescens Pepper, Cayenne fruit/seed 21CFR182.10

Capsicum frutescens Pepper, Red fruit/seed 21CFR182.10

Carum carvi Caraway fruit/seed 21CFR182.10

Cinnamomum burmanni Cassia, Padang Or Batavia bark 21CFR182.10

Cinnamomum cassia Cassia, Chinese bark 21CFR182.10
Spice List | Appendix A

FDA Draft Risk Profile | 173

Botanical Name Common Name Plant Part Used Sourcea

Cinnamomum cassia Cinnamon, Chinese bark 21CFR182.10

Cinnamomum loureirii Cassia, Saigon bark 21CFR182.10

Cinnamomum loureirii Cinnamon, Saigon bark 21CFR182.10

Cinnamomum zeylanicum Cinnamon, Ceylon bark 21CFR182.10

Citrus hystrix Kaffir Limed leaf SSA

Citrus hystrix Kaffir Limed fruit/seed SSA

Coriandrum sativum Coriander fruit/seed 21CFR182.10

Coriandrum sativum Coriander leaf 21CFR182.10

Crocus sativus Saffron flower 21CFR182.10

Cuminum cyminum Cumin (Cummin) fruit/seed 21CFR182.10

Curcuma longa Turmeric root 21CFR182.10

Curcuma zedoaria Zedoary root 21CFR182.10

Cymbopogon citratus Lemon Grassc leaf SSA

Elettaria cardamomum Cardamom (Cardamon) fruit/seed 21CFR182.10

Foeniculum vulgare Fennel, Common fruit/seed 21CFR182.10

Foeniculum vulgare var. duice Fennel, Sweet (Finocchio, Florence 

Fennel)

fruit/seed 21CFR182.10

Galipea officinalis Angostura (Cusparia Bark) bark 21CFR182.10

Hibiscus abelmoschus Ambrette Seed fruit/seed 21CFR182.10

Hyssopus officinalis Hyssop leaf 21CFR182.10

Illicium verum Anise, Star fruit/seed 21CFR182.10

Illicium verum Star Anise fruit/seed 21CFR182.10

Juniperus communis Juniperc fruit/seed ASTA, SSA

Laurus nobilis Bay leaf 21CFR182.10

Lavandula officinalis Lavender flower 21CFR182.10

Lippia spp. Oregano Oreganum, Mexican 

Oregano, Mexican Sage, Origan)

leaf 21CFR182.10

Majorana hortensis Marjoram, Sweet leaf 21CFR182.10

Majorana onites Marjoram, Pot leaf 21CFR182.10

Majorana onites Pot Marjoram leaf 21CFR182.10

Marrubium vulgare Horehound (Hoarhound) leaf 21CFR182.10

Matricaria chamomilla Camomile (Chamomile), German 

Or Hungarian

flower 21CFR182.10

Medicago sativa Alfalfa Herb And Seed leaf 21CFR182.10

Medicago sativa Alfalfa Herb And Seed seed 21CFR182.10

Melissa officinalis Balm (Lemon Balm) leaf 21CFR182.10

Mentha piperita Peppermint leaf 21CFR182.10

Mentha spicata Spearmint leaf 21CFR182.10

Myristica fragrans Mace fruit/seed 21CFR182.10

Myristica fragrans Nutmeg fruit/seed 21CFR182.10

Nigella sativa Caraway, Black (Black Cumin) fruit/seed 21CFR182.10

Nigella sativa Cumin, Black (Black Caraway) fruit/seed 21CFR182.10

Ocimum basilicum Basil, Sweet leaf 21CFR182.10

Ocimum minimum Basil, Bush leaf 21CFR182.10

Origanum vulgare Oreganoc leaf ASTA, SSA

Papayer somniferum Poppy Seed fruit/seed 21CFR182.10

Pelargonium spp. Geranium leaf 21CFR182.10

Petroselinum crispum Parsley leaf 21CFR182.10

Pimenta officinalis Allspice fruit/seed 21CFR182.10

Pimpinella anisum Anise fruit/seed 21CFR182.10

Piper nigrum Pepper, Black fruit/seed 21CFR182.10

Piper nigrum Pepper, White fruit/seed 21CFR182.10

Rosmarinus officinalis Rosemary leaf 21CFR182.10

Salvia officinalis Sage leaf 21CFR182.10

Salvia sclarea Clary (Clary Sage) leaf 21CFR182.10
Spice List | Appendix A

FDA Draft Risk Profile | 174

Botanical Name Common Name Plant Part Used Sourcea

Salvia triloba Sage, Greek leaf 21CFR182.10

Sambucus canadensis Elder Flowers flower 21CFR182.10

Satureia hortensis (Satureja). Savory, Summer leaf 21CFR182.10

Satureia montana (Satureja). Savory, Winter leaf 21CFR182.10

Schinus terebinthifolia Pink Pepperc fruit/seed ASTA, SSA

Sesamum indicum Sesame fruit/seed 21CFR182.10

Syzygium aromaticum Clovesc flower ASTA, SSA

Thymus serpyllume Thyme, Wild Or Creeping leaf 21CFR182.10

Thymus vulgarise Thyme leaf 21CFR182.10

Tilia spp. Linden Flowers flower 21CFR182.10

Trifolium spp. Clover leaf 21CFR182.10

Trigonella foenum-graecum Fenugreek fruit/seed 21CFR182.10

Vanilla planifolia Vanilla fruit/seed 21CFR182.10

Vanilla tahitensis Vanilla fruit/seed 21CFR182.10

Zanthoxylum piperitum Sichuan Pepperb fruit/seed SSA

Zingiber officinale Ginger root 21CFR182.10 a Plants listed as spices in commerce as cited by 21CFR182.10 (FDA, 2012f), ASTA (2012), or SSA (2012).

b Common name is from Herbs of Commerce (McGuffin et al., 2000). 

c Common name is from Herbs of Commerce (McGuffin et al., 2000) as per 21 CFR101.4(h) (FDA, 2012q) 

d Common name from source(s) noted.

e ASTA (2012) includes the species Thymus satureioides (thyme) on their list of spices. There is no history of use as a food in either GRIN, 

World Spice Plants, or Mansfeld’s World Database of Agricultural and Horticultural Crops. It is a valid scientific name in the Missouri 

Botanical Garden Tropicos database as Thymus saturejoides Coss.
Spice List | Appendix A

FDA Draft Risk Profile | 175

Table A2. Spice list by common name

Common name Botanical name Plant Part 

Used Sourcea

Alfalfa Medicago sativa leaf 21CFR182.10

Alfalfa Medicago sativa seed 21CFR182.10

Allspice Pimenta officinalis fruit/seed 21CFR182.10

Ambrette Seed Hibiscus abelmoschus fruit/seed 21CFR182.10

Anattoc Bixa orellana fruit/seed ASTA

Angelica Angelica archangelica leaf 21CFR182.10

Angelica Angelica spp. leaf 21CFR182.10

Angelica Angelica archangelica root 21CFR182.10

Angelica Angelica spp. root 21CFR182.10

Angelica Angelica archangelica seed 21CFR182.10

Angelica Angelica spp. seed 21CFR182.10

Angostura (Cusparia Bark) Galipea officinalis bark 21CFR182.10

Anise Pimpinella anisum fruit/seed 21CFR182.10

Anise, Star Illicium verum fruit/seed 21CFR182.10

Balm (Lemon Balm) Melissa officinalis leaf 21CFR182.10

Basil, Bush Ocimum minimum leaf 21CFR182.10

Basil, Sweet Ocimum basilicum leaf 21CFR182.10

Bay Laurus nobilis leaf 21CFR182.10

Calendula Calendula officinalis flower 21CFR182.10

Camomile (Chamomile), English Or 

Roman Anthemis nobilis flower 21CFR182.10

Camomile (Chamomile), German Or 

Hungarian Matricaria chamomilla flower 21CFR182.10

Capers Capparis spinosa flower 21CFR182.10

Capsicum Capsicum annuum fruit/seed 21CFR182.10

Capsicum Capsicum frutescens fruit/seed 21CFR182.10

Caraway Carum carvi fruit/seed 21CFR182.10

Caraway, Black (Black Cumin) Nigella sativa fruit/seed 21CFR182.10

Cardamom (Cardamon) Elettaria cardamomum fruit/seed 21CFR182.10

Cassia, Chinese Cinnamomum cassia bark 21CFR182.10

Cassia, Padang Or Batavia Cinnamomum burmanni bark 21CFR182.10

Cassia, Saigon Cinnamomum loureirii bark 21CFR182.10

Cayenne Pepper Capsicum annuum fruit/seed 21CFR182.10

Cayenne Pepper Capsicum frutescens fruit/seed 21CFR182.10

Celery Seed Apium graveolens fruit/seed 21CFR182.10

Chervil Anthriscus cerefolium leaf 21CFR182.10

Chives Allium schoenoprasum leaf 21CFR182.10

Cinnamon, Ceylon Cinnamomum zeylanicum bark 21CFR182.10

Cinnamon, Chinese Cinnamomum cassia bark 21CFR182.10

Cinnamon, Saigon Cinnamomum loureirii bark 21CFR182.10

Clary (Clary Sage) Salvia sclarea leaf 21CFR182.10

Clover Trifolium spp. leaf 21CFR182.10

Clovesc Syzygium aromaticum flower ASTA, SSA

Coriander Coriandrum sativum leaf 21CFR182.10

Coriander Coriandrum sativum fruit/seed 21CFR182.10

Cumin (Cummin) Cuminum cyminum fruit/seed 21CFR182.10

Cumin, Black (Black Caraway) Nigella sativa fruit/seed 21CFR182.10

Dillc Anethum graveolens leaf ASTA, SSA

Dillc Anethum graveolens fruit/seed ASTA, SSA

Dilld Anethum sowa leaf ASTA, SSA

Dilld Anethum sowa fruit/seed ASTA, SSA

Elder Flowers Sambucus canadensis flower 21CFR182.10

Fennel, Common Foeniculum vulgare fruit/seed 21CFR182.10

Fennel, Sweet (Finocchio, Florence 

Fennel) Foeniculum vulgare var. duice fruit/seed 21CFR182.10
Spice List | Appendix A

FDA Draft Risk Profile | 176

Common name Botanical name Plant Part 

Used Sourcea

Fenugreek Trigonella foenum-graecum fruit/seed 21CFR182.10

Greater Galangalc Alpinia galanga root SSA

Greater Galangalc seed Alpinia galanga fruit/seed SSA

Galanga (Galangal) Alpinia officinarum root 21CFR182.10

Garlicc Allium sativum root ASTA, SSA

Geranium Pelargonium spp. leaf 21CFR182.10

Ginger Zingiber officinale root 21CFR182.10

Grains Of Paradise Amomum melegueta fruit/seed 21CFR182.10

Horehound (Hoarhound) Marrubium vulgare leaf 21CFR182.10

Horseradish Armoracia lapathifolia root 21CFR182.10

Hyssop Hyssopus officinalis leaf 21CFR182.10

Juniperc Juniperus communis fruit/seed ASTA, SSA

Kaffir Limed Citrus hystrix leaf SSA

Kaffir Limed Citrus hystrix fruit/seed SSA

Lavender Lavandula officinalis flower 21CFR182.10

Lemon Grassc Cymbopogon citratus leaf SSA

Linden Flowers Tilia spp. flower 21CFR182.10

Mace Myristica fragrans fruit/seed 21CFR182.10

Marigold, Pot Calendula officinalis flower 21CFR182.10

Marjoram, Pot Majorana onites leaf 21CFR182.10

Marjoram, Sweet Majorana hortensis leaf 21CFR182.10

Mustard, Black Or Brown Brassica nigra fruit/seed 21CFR182.10

Mustard, Brown Brassica juncea fruit/seed 21CFR182.10

Mustard, White Or Yellow Brassica hirta fruit/seed 21CFR182.10

Nutmeg Myristica fragrans fruit/seed 21CFR182.10

Onionb Allium cepa root ASTA, SSA

Oreganoc Origanum vulgare leaf ASTA, SSA

Oregano Oreganum, Mexican Oregano, 

Mexican Sage, Origan) Lippia spp. leaf 21CFR182.10

Paprika Capsicum annuum fruit/seed 21CFR182.10

Parsley Petroselinum crispum leaf 21CFR182.10

Pepper, Black Piper nigrum fruit/seed 21CFR182.10

Pepper, Cayenne Capsicum annuum fruit/seed 21CFR182.10

Pepper, Cayenne Capsicum frutescens fruit/seed 21CFR182.10

Pepper, Red Capsicum annuum fruit/seed 21CFR182.10

Pepper, Red Capsicum frutescens fruit/seed 21CFR182.10

Pepper, White Piper nigrum fruit/seed 21CFR182.10

Peppermint Mentha piperita leaf 21CFR182.10

Pink Pepperc Schinus terebinthifolia fruit/seed ASTA, SSA

Poppy Seed Papayer somniferum fruit/seed 21CFR182.10

Pot Marigold Calendula officinalis flower 21CFR182.10

Pot Marjoram Majorana onites leaf 21CFR182.10

Rosemary Rosmarinus officinalis leaf 21CFR182.10

Saffron Crocus sativus flower 21CFR182.10

Sage Salvia officinalis leaf 21CFR182.10

Sage, Greek Salvia triloba leaf 21CFR182.10

Savory, Summer Satureia hortensis (Satureja). leaf 21CFR182.10

Savory, Winter Satureia montana (Satureja). leaf 21CFR182.10

Sesame Sesamum indicum fruit/seed 21CFR182.10

Sichuan Pepperb Zanthoxylum piperitum fruit/seed SSA

Spearmint Mentha spicata leaf 21CFR182.10

Star Anise Illicium verum fruit/seed 21CFR182.10

Tarragon Artemisia dracunculus leaf 21CFR182.10

Thyme Thymus vulgaris leaf 21CFR182.10

Thyme, Wild Or Creeping Thymus serpyllum leaf 21CFR182.10

Turmeric Curcuma longa root 21CFR182.10
Spice List | Appendix A

FDA Draft Risk Profile | 177

Common name Botanical name Plant Part 

Used Sourcea

Vanilla Vanilla planifolia fruit/seed 21CFR182.10

Vanilla Vanilla tahitensis fruit/seed 21CFR182.10

Zedoary Curcuma zedoaria root 21CFR182.10 a Plants listed as spices in commerce as cited by 21CFR182.10 (FDA, 2012f), ASTA (2012), or SSA (2012).

b Common name is from Herbs of Commerce (McGuffin et al., 2000). 

c Common name is from Herbs of Commerce (McGuffin et al., 2000) as per 21 CFR101.4(h) (FDA, 2012q) 

d Common name from source(s) noted.

e ASTA (2012) includes the species Thymus satureioides (thyme) on their list of spices. There is no history of use as a food in either GRIN, 

World Spice Plants, or Mansfeld’s World Database of Agricultural and Horticultural Crops. It is a valid scientific name in the Missouri 

Botanical Garden Tropicos database as Thymus saturejoides Coss.
Spice List | Appendix A

FDA Draft Risk Profile | 178

Table A3. Spice list by part of plant used

Plant Part 

Used Botanical Name Common name Sourcea

bark Cinnamomum burmanni Cassia, Padang Or Batavia 21CFR182.10

bark Cinnamomum cassia Cassia, Chinese 21CFR182.10

bark Cinnamomum cassia Cinnamon, Chinese 21CFR182.10

bark Cinnamomum loureirii Cassia, Saigon 21CFR182.10

bark Cinnamomum loureirii Cinnamon, Saigon 21CFR182.10

bark Cinnamomum zeylanicum Cinnamon, Ceylon 21CFR182.10

bark Galipea officinalis Angostura (Cusparia Bark) 21CFR182.10

flower Anthemis nobilis Camomile (Chamomile), English Or Roman 21CFR182.10

flower Calendula officinalis Calendula 21CFR182.10

flower Calendula officinalis Marigold, Pot 21CFR182.10

flower Calendula officinalis Pot Marigold 21CFR182.10

flower Capparis spinosa Capers 21CFR182.10

flower Crocus sativus Saffron 21CFR182.10

flower Lavandula officinalis Lavender 21CFR182.10

flower Matricaria chamomilla Camomile (Chamomile), German Or 

Hungarian

21CFR182.10

flower Sambucus canadensis Elder Flowers 21CFR182.10

flower Syzygium aromaticum Clovesc ASTA, SSA

flower Tilia spp. Linden Flowers 21CFR182.10

fruit/seed Alpinia galanga Greater Galangalc seed SSA

fruit/seed Amomum melegueta Grains Of Paradise 21CFR182.10

fruit/seed Anethum graveolens Dill seedc ASTA, SSA

fruit/seed Anethum sowa Dill seedd ASTA

fruit/seed Angelica archangelica Angelica Seed 21CFR182.10

fruit/seed Angelica spp. Angelica Seed 21CFR182.10

fruit/seed Apium graveolens Celery Seed 21CFR182.10

fruit/seed Bixa orellana Anattoc ASTA

fruit/seed Brassica hirta Mustard, White Or Yellow 21CFR182.10

fruit/seed Brassica juncea Mustard, Brown 21CFR182.10

fruit/seed Brassica nigra Mustard, Black Or Brown 21CFR182.10

fruit/seed Capsicum annuum Capsicum 21CFR182.10

fruit/seed Capsicum annuum Cayenne Pepper 21CFR182.10

fruit/seed Capsicum annuum Paprika 21CFR182.10

fruit/seed Capsicum annuum Pepper, Cayenne 21CFR182.10

fruit/seed Capsicum annuum Pepper, Red 21CFR182.10

fruit/seed Capsicum frutescens Capsicum 21CFR182.10

fruit/seed Capsicum frutescens Cayenne Pepper 21CFR182.10

fruit/seed Capsicum frutescens Pepper, Cayenne 21CFR182.10

fruit/seed Capsicum frutescens Pepper, Red 21CFR182.10

fruit/seed Carum carvi Caraway 21CFR182.10

fruit/seed Citrus hystrix Kaffir Limed SSA

fruit/seed Coriandrum sativum Coriander 21CFR182.10

fruit/seed Cuminum cyminum Cumin (Cummin) 21CFR182.10

fruit/seed Elettaria cardamomum Cardamom (Cardamon) 21CFR182.10

fruit/seed Foeniculum vulgare Fennel, Common 21CFR182.10

fruit/seed Foeniculum vulgare var. duice Fennel, Sweet (Finocchio, Florence Fennel) 21CFR182.10

fruit/seed Hibiscus abelmoschus Ambrette Seed 21CFR182.10

fruit/seed Illicium verum Anise, Star 21CFR182.10

fruit/seed Illicium verum Star Anise 21CFR182.10

fruit/seed Juniperus communis Juniperc ASTA, SSA

fruit/seed Medicago sativa Alfalfa Herb And Seed 21CFR182.10

fruit/seed Myristica fragrans Mace 21CFR182.10

fruit/seed Myristica fragrans Nutmeg 21CFR182.10
Spice List | Appendix A

FDA Draft Risk Profile | 179

Plant Part 

Used Botanical Name Common name Sourcea

fruit/seed Nigella sativa Caraway, Black (Black Cumin) 21CFR182.10

fruit/seed Nigella sativa Cumin, Black (Black Caraway) 21CFR182.10

fruit/seed Papayer somniferum Poppy Seed 21CFR182.10

fruit/seed Pimpinella anisum Anise 21CFR182.10

fruit/seed Pimenta officinalis Allspice 21CFR182.10

fruit/seed Piper nigrum Pepper, Black 21CFR182.10

fruit/seed Piper nigrum Pepper, White 21CFR182.10

fruit/seed Schinus terebinthifolia Pink Pepperc ASTA, SSA

fruit/seed Sesamum indicum Sesame 21CFR182.10

fruit/seed Trigonella foenum-graecum Fenugreek 21CFR182.10

fruit/seed Vanilla planifolia Vanilla 21CFR182.10

fruit/seed Vanilla tahitensis Vanilla 21CFR182.10

fruit/seed Zanthoxylum piperitum Sichuan Pepperb SSA

leaf Allium schoenoprasum Chives 21CFR182.10

leaf Anethum graveolens Dillc ASTA, SSA

leaf Anethum sowa Dilld seed ASTA

leaf Angelica archangelica Angelica 21CFR182.10

leaf Angelica spp. Angelica 21CFR182.10

leaf Anthriscus cerefolium Chervil 21CFR182.10

leaf Artemisia dracunculus Tarragon 21CFR182.10

leaf Citrus hystrix Kaffir Limed SSA

leaf Coriandrum sativum Coriander 21CFR182.10

leaf Cymbopogon citratus Lemon Grassc SSA

leaf Hyssopus officinalis Hyssop 21CFR182.10

leaf Laurus nobilis Bay 21CFR182.10

leaf Lippia spp. Oregano Oreganum, Mexican Oregano, 

Mexican Sage, Origan)

21CFR182.10

leaf Majorana hortensis Marjoram, Sweet 21CFR182.10

leaf Majorana onites Marjoram, Pot 21CFR182.10

leaf Majorana onites Pot Marjoram 21CFR182.10

leaf Marrubium vulgare Horehound (Hoarhound) 21CFR182.10

leaf Medicago sativa Alfalfa Herb And Seed 21CFR182.10

leaf Melissa officinalis Balm (Lemon Balm) 21CFR182.10

leaf Mentha piperita Peppermint 21CFR182.10

leaf Mentha spicata Spearmint 21CFR182.10

leaf Ocimum basilicum Basil, Sweet 21CFR182.10

leaf Ocimum minimum Basil, Bush 21CFR182.10

leaf Origanum vulgare Oreganoc ASTA, SSA

leaf Pelargonium spp. Geranium 21CFR182.10

leaf Petroselinum crispum Parsley 21CFR182.10

leaf Rosmarinus officinalis Rosemary 21CFR182.10

leaf Salvia officinalis Sage 21CFR182.10

leaf Salvia sclarea Clary (Clary Sage) 21CFR182.10

leaf Salvia triloba Sage, Greek 21CFR182.10

leaf Satureia hortensis (Satureja). Savory, Summer 21CFR182.10

leaf Satureia montana (Satureja). Savory, Winter 21CFR182.10

leaf Thymus serpyllum Thyme, Wild Or Creeping 21CFR182.10

leaf Thymus vulgaris Thyme 21CFR182.10

leaf Trifolium spp. Clover 21CFR182.10

root Allium cepa Onionb ASTA, SSA

root Allium sativum Garlicc ASTA, SSA

root Alpinia galanga Greater Galangalc SSA

root Alpinia officinarum Galanga (Galangal) 21CFR182.10

root Angelica archangelica Angelica Root 21CFR182.10
Spice List | Appendix A

FDA Draft Risk Profile | 180

Plant Part 

Used Botanical Name Common name Sourcea

root Angelica spp. Angelica Root 21CFR182.10

root Armoracia lapathifolia Horseradish 21CFR182.10

root Curcuma longa Turmeric 21CFR182.10

root Curcuma zedoaria Zedoary 21CFR182.10

root Zingiber officinale Ginger 21CFR182.10 a Plants listed as spices in commerce as cited by 21CFR182.10 (FDA, 2012f), ASTA (2012), or SSA (2012).

b Common name is from Herbs of Commerce (McGuffin et al., 2000). 

c Common name is from Herbs of Commerce (McGuffin et al., 2000) as per 21 CFR101.4(h) (FDA, 2012q) 

d Common name from source(s) noted.

e ASTA (2012) includes the species Thymus satureioides (thyme) on their list of spices. There is no history of use as a food in either GRIN, 

World Spice Plants, or Mansfeld’s World Database of Agricultural and Horticultural Crops. It is a valid scientific name in the Missouri 

Botanical Garden Tropicos database as Thymus saturejoides Coss.
Spice List | Appendix A

FDA Draft Risk Profile | 181

Table A4. Common use of spice in foods 

Common use of spice in foods is characterized as raw, cooked or both. Spice use was assigned “raw” when dry 

spice is typically added to food without a microbial kill step. The term “cooked” was assigned when the 

cooking step is expected to provide an effective microbial kill step. The term “both” was assigned when both 

raw and cooked uses were identified or when the cooking step is not expected to always be sufficient to 

provide an effective kill step. Assignment of spice use is based on recipes and information on spice use 

available on the internet. More research is needed to distinguish use by cuisine or culture. 

Common name Botanical name Plant Part 

Used

How used 

raw/cooked

Alfalfa Medicago sativa leaf raw

Alfalfa Medicago sativa fruit/seed both

Allspice Pimenta officinalis fruit cooked

Ambrette Seed Hibiscus abelmoschus fruit/seed both

Anattoc Bixa orellana fruit/seed both

Angelica Angelica archangelica leaf both

Angelica Angelica spp. leaf both

Angelica Angelica archangelica root cooked

Angelica Angelica spp. root cooked

Angelica Angelica archangelica seed cooked

Angelica Angelica spp. seed cooked

Angostura (Cusparia Bark) Galipea officinalis bark cooked

Anise Pimpinella anisum fruit/seed both

Anise, Star; Star Anise Illicium verum fruit/seed cooked

Balm (Lemon Balm) Melissa officinalis leaf both

Basil, Bush Ocimum minimum leaf both

Basil, Sweet Ocimum basilicum leaf both

Bay Laurus nobilis leaf cooked

Calendula Calendula officinalis flower cooked

Camomile (Chamomile), English Or Roman Anthemis nobilis flower both

Camomile (Chamomile), German Or Hungarian Matricaria chamomilla flower both

Capers Capparis spinosa flower both

Capsicum Capsicum annuum fruit/seed both

Capsicum Capsicum frutescens fruit/seed both

Caraway Carum carvi fruit/seed both

Caraway, Black (Black Cumin) Nigella sativa fruit/seed both

Cardamom (Cardamon) Elettaria cardamomum fruit/seed both

Cassia, Chinese Cinnamomum cassia bark both

Cassia, Padang Or Batavia Cinnamomum burmanni bark both

Cassia, Saigon Cinnamomum loureirii bark both

Cayenne Pepper Capsicum annuum fruit/seed both

Cayenne Pepper Capsicum frutescens fruit/seed both

Celery Seed Apium graveolens fruit/seed both

Chervil Anthriscus cerefolium leaf both

Chives Allium schoenoprasum leaf both

Cinnamon, Ceylon Cinnamomum zeylanicum bark both

Cinnamon, Chinese Cinnamomum cassia bark both

Cinnamon, Saigon Cinnamomum loureirii bark both

Clary (Clary Sage) Salvia sclarea leaf cooked

Clover Trifolium spp. leaf both

Clovesc Syzygium aromaticum flower both

Coriander Coriandrum sativum leaf both

Coriander Coriandrum sativum fruit/seed both

Cumin (Cummin) Cuminum cyminum fruit/seed both

Cumin, Black (Black Caraway); Caraway, black 

(black cumin)

Nigella sativa fruit/seed both

Dill Anethum graveolens leaf both

Elder Flowers Sambucus canadensis flower cooked
Spice List | Appendix A

FDA Draft Risk Profile | 182

Common name Botanical name Plant Part 

Used

How used 

raw/cooked

Fennel, Common Foeniculum vulgare fruit/seed cooked

Fennel, Sweet (Finocchio, Florence Fennel) Foeniculum vulgare var. 

duice

fruit/seed cooked

Fenugreek Trigonella foenumgraecumfruit/seed both

Greater Galangalc Alpinia galanga root both

Galanga (Galangal) Alpinia officinarum root both

Garlicc Allium sativum root both

Geranium Pelargonium spp. leaf raw

Ginger Zingiber officinale root both

Grains Of Paradise Amomum melegueta fruit/seed both

Horehound (Hoarhound) Marrubium vulgare leaf both

Horseradish Armoracia lapathifolia root raw

Hyssop Hyssopus officinalis leaf both

Juniperc Juniperus communis fruit/seed cooked

Kaffir Limed Citrus hystrix leaf cooked

Kaffir Limed Citrus hystrix fruit/seed both

Lavender Lavandula officinalis flower both

Lemon Grassc Cymbopogon citratus leaf both

Linden Flowers Tilia spp. flower both

Mace Myristica fragrans fruit/seed both

Marigold, Pot; Pot Marigold Calendula officinalis flower cooked

Marjoram, Pot; Pot Marjoram Majorana onites leaf both

Marjoram, Sweet Majorana hortensis leaf both

Mustard, Black Or Brown Brassica nigra fruit/seed both

Mustard, Brown Brassica juncea fruit/seed both

Mustard, White Or Yellow Brassica hirta fruit/seed both

Nutmeg Myristica fragrans fruit/seed both

Onionb Allium cepa root both

Oreganoc Origanum vulgare leaf both

Oregano Oreganum, Mexican Oregano, Mexican 

Sage, Origan)

Lippia spp. leaf both

Paprika Capsicum annuum fruit/seed both

Parsley Petroselinum crispum leaf both

Pepper, Black Piper nigrum fruit/seed both

Pepper, Cayenne Capsicum annuum fruit/seed both

Pepper, Cayenne Capsicum frutescens fruit/seed both

Pepper, Red Capsicum annuum fruit/seed both

Pepper, Red Capsicum frutescens fruit/seed both

Pepper, White Piper nigrum fruit/seed both

Peppermint Mentha piperita leaf both

Pink Pepperc Schinus terebinthifolia fruit/seed both

Poppy Seed Papayer somniferum fruit/seed both

Rosemary Rosmarinus officinalis leaf both

Saffron Crocus sativus flower cooked

Sage Salvia officinalis leaf both

Sage, Greek Salvia triloba leaf both

Savory, Summer Satureia hortensis 

(Satureja).

leaf cooked

Savory, Winter Satureia montana 

(Satureja).

leaf cooked

Sesame Sesamum indicum fruit/seed both

Sichuan Pepperb Zanthoxylum piperitum fruit/seed both

Spearmint Mentha spicata leaf both

Tarragon Artemisia dracunculus leaf both

Thyme Thymus vulgaris leaf both
Spice List | Appendix A

FDA Draft Risk Profile | 183

Common name Botanical name Plant Part 

Used

How used 

raw/cooked

Thyme, Wild Or Creeping Thymus serpyllum leaf both

Turmeric Curcuma longa root cooked

Vanilla Vanilla planifolia fruit/seed cooked

Vanilla Vanilla tahitensis fruit/seed cooked

Zedoary Curcuma zedoaria root cooked a Plants listed as spices in commerce as cited by 21CFR182.10 (FDA, 2012f), ASTA (2012), or SSA (2012).

b Common name is from Herbs of Commerce (McGuffin et al., 2000). 

c Common name is from Herbs of Commerce (McGuffin et al., 2000) as per 21 CFR101.4(h) (FDA, 2012q) 

d Common name from source(s) noted.

e ASTA (2012) includes the species Thymus satureioides (thyme) on their list of spices. There is no history of use as a food in either GRIN, 

World Spice Plants, or Mansfeld’s World Database of Agricultural and Horticultural Crops. It is a valid scientific name in the Missouri 

Botanical Garden Tropicos database as Thymus saturejoides Coss.
FDA Draft Risk Profile | 184 

APPENDIX B: WORLDWIDE SPICE PRODUCTION

The worldwide spice production data for 2009 included in this appendix was obtained from the FAO 

FAOSTAT Production website (FAO, 2013b). The top 20 producers are listed for each spice and the spice 

descriptions, country production, percent of worldwide production and data source listed were obtained 

from this FAO source. 

Table B1. Worldwide Spice Production 2009

Spice Worldwide Production

(Metric Tonnes)

Anise, badian, fennel, coriander 499,626

Chilies and peppers, dry 3,137,545

Cinnamon (canella) 155,400

Cloves 104,881

Garlic 22,282,060

Ginger 1,615,974

Mustard seed 683,918

Nutmeg, mace and cardamoms 77,641

Onions, dry 73,231,830

Pepper (Piper spp.) 451,220

Poppy seed 98,835

Sesame seed 3,976,968

Spices, nesa 1,588,807

Vanilla 9,815 a nes: not elsewhere specified

Table B2. Anise, badian, fennel, coriander 

Include: anise (Pimpinella anisum); badian or star anise (Illicium verum); caraway (Carum carvi); coriander 

(Coriandrum sativum); cumin (Cuminum cyminum); fennel (Foeniculum vulgare); juniper berries (Juniperus 

communis). Seeds and berries from the various plants listed. They are normally used as spices, but also have 

industrial (e.g. in distilleries) and medicinal applications.

Country Metric Tonnes % of Worldwide Production Data Sourcea

India 176,615 35.35 Im

Mexico 50,000 10.01 F

China 42,000 8.41 F

Bulgaria 33,957 6.80 Im

Iran (Islamic Republic of) 31,431 6.29 Im

Syrian Arab Republic 30,829 6.17

Morocco 23,000 4.60 F

Egypt 22,000 4.40 F

Russian Federation 11,200 2.24

Tunisia 9,800 1.96 F

Turkey 9,472 1.90

Afghanistan 8,904 1.78 Im

Peru 7,194 1.44 F

Canada 7,068 1.41 F

Romania 7,063 1.41

Viet Nam 5,080 1.02 Im

Ukraine 4,509 0.90 Im

Australia 2,940 0.59

Hungary 2,906 0.58 Im

Occupied Palestinian Territory 2,706 0.54 F a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate.
Worldwide Spice Production | Appendix B

FDA Draft Risk Profile | 185

Table B3. Chillies and peppers, dry

Red and cayenne pepper, paprika, chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper 

(Pimenta officinalis). Uncrushed or unground fresh pimentos are considered to be vegetables.

Country Metric Tonnes % of Worldwide Production Data Sourcea

India 1,300,000 43.155 F

China 260,000 8.29 F

Pakistan 186,700 5.95

Thailand 170,125 5.42

Peru 140,216 4.47 Im

Ethiopia 118,514 3.78 Im

Myanmar 116,000 3.70 F

Viet Nam 112,937 3.60 Im

Bangladesh 109,337 3.48

Ghana 93,641 2.98 F

Mexico 50,988 1.63 Im

Nigeria 50,000 1.59 F

Egypt 45,600 1.45 F

Romania 35,251 1.12 Im

Democratic Republic of the Congo 32,000 1.02 F

Benin 25,867 0.82

Bosnia and Herzegovina 20,429 0.65 Im

Côte d'Ivoire 20,000 0.64 F

Hungary 19,982 0.64

Morocco 18,265 0.58 Im a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate/

Table B4. Cinnamon (canella)

Ceylon cinnamon (Cinnamomum zeylanicum); Chinese, common cinnamon, cassia (C. cassia). The inner bark 

of young branches of certain trees of the Laurus family. Includes cinnamon- tree flowers, cinnamon fruit and 

cinnamon waste (chips), whether whole, crushed or ground.

Country Metric Tonnes % of worldwide Production Data Sourcea

Indonesia 67,209 43.25 Im

China 58,000 37.32 F

Sri Lanka 14,600 9.40

Viet Nam 13,965 8.99 Im

Madagascar 1,253 0.81 Im

Timor-Leste 133 0.09 Im

Sao Tome and Principe 70 0.05 F

Seychelles 63 0.04

Dominica 52 0.03 Im

Grenada 37 0.02 F

Comoros 18 0.01 Im a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate.
Worldwide Spice Production | Appendix B

FDA Draft Risk Profile | 186

Table B5. Cloves

Eugenia caryophyllata; Caryophyllus aromaticus. The whole fruit of the clove tree, including the flowers 

picked before maturity and dried in the sun, and the stems of the clove flowers.

Country Metric Tonnes % of Worldwide Production Data Sourcea

Indonesia 81,000 77.23 F

Madagascar 7,594 7.24 Im

United Republic of Tanzania 7,518 7.17 Im

Sri Lanka 3,790 3.61

Comoros 2,658 2.53 Im

Kenya 1,159 1.11 Im

China 900 0.86 F

Malaysia 249 0.24 Im

Grenada 13 0.01 F a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate.

Table B6. Garlic

Allium sativum. Numbers reflect fresh garlic production.

Country Metric Tonnes % of Worldwide Production Data Sourcea

China 17,967,857 80.64

India 1,070,000 4.80 F

Republic of Korea 380,000 1.71 F

Russian Federation 227,270 1.02

Myanmar 200,000 0.90 F

Ethiopia 179,658 0.81 *

United States of America 178,760 0.80

Egypt 174,659 0.78

Bangladesh 154,831 0.69

Spain 154,000 0.69

Ukraine 150,100 0.67

Argentina 120,391 0.54 Im

Turkey 105,363 0.47

Democratic People's Republic of Korea 101,347 0.45 Im

Brazil 86,752 0.39

Thailand 71,433 0.32

Pakistan 67,204 0.30

Iran (Islamic Republic of) 64,002 0.29

Romania 63,245 0.28

Algeria 59,932 0.27 a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate
Worldwide Spice Production | Appendix B

FDA Draft Risk Profile | 187

Table B7. Ginger

Zingiber officinale. Rhizome of a perennial herb. It also is used for making beverages. Includes fresh, 

provisionally preserved or dried, whereas ginger preserved in sugar or syrup is excluded.

Country Metric Tonnes % of Worldwide Production Data Sourcea

India 380,100 23.52

China 331,393 20.51 F

Indonesia 192,500 11.91 F

Nepal 174,268 10.78 Im

Thailand 170,125 10.53

Nigeria 152,106 9.41 Im

Bangladesh 72,608 4.49

Japan 52,000 3.22 F

Philippines 27,415 1.70

Cameroon 12,000 0.74 F

Malaysia 11,200 0.69

Sri Lanka 10,780 0.67

Côte d'Ivoire 7,680 0.48 Im

Ethiopia 6,834 0.42 Im

Bhutan 3,766 0.23

Fiji 3,041 0.19

Republic of Korea 3,000 0.19 F

Costa Rica 1,105 0.07

United States of America 816 0.05 F

Mauritius 616 0.04 a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate.

Table B8. Mustard Seed

White mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra). In addition 

to the oil extracted from them, white mustard seeds, may be processed into flour for food use. Black mustard 

seeds also yield oil and are processed into flour that is used mainly in pharmaceutical products.

Country Metric Tonnes % of Worldwide Production Data Sourcea

Canada 208,300 30.46

Nepal 135,494 19.81

Myanmar 70,000 10.24 F

Czech Republic 38,651 5.65

United States of America 22,391 3.27

Ukraine 118,200 17.28

Russian Federation 23,690 3.46

China 18,000 2.63 F

Romania 10,633 1.55

France 9,500 1.39

Hungary 9,568 1.40

Germany 7,411 1.08 Im

Slovakia 3,785 0.55

Ethiopia 2,924 0.43 Im

Bhutan 1,741 0.25

Bulgaria 1,222 0.18 Im

Sri Lanka 300 0.04

Kazakhstan 900 0.13 *

Denmark 30 0.00 Im

Mexico 16 0.00 a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate.
Worldwide Spice Production | Appendix B

FDA Draft Risk Profile | 188

Table B9. Nutmeg, mace and cardamoms

Nutmeg, mace (Myristica fragrans); cluster cardamon (Elettaria cardamomum); other cardamons 

(Aframomum angustifolium; A. hambury; Amomun aromaticum; A. cardamomum); Malaguetta pepper, grains 

of paradise (Aframomum melegueta). Nutmeg is the inner brown kernel of the fruit of the nutmeg tree. Mace 

is the net-like membrane between the outer shell and the kernel. Cardamon seeds are enclosed in the capsule 

produced by perennial herbs of the Zingiberaceae family.

Country Metric Tonnes % of Worldwide Production Data Sourcea

Guatemala 23794 30.65% Im

India 17000 21.90% F

Nepal 9774 12.59% Im

Bhutan 9082 11.70% Im

Indonesia 8600 11.08% F

Lao People's Democratic Republic 3982 5.13% Im

Grenada 2395 3.08% Im

United Republic of Tanzania 795 1.02% Im

Malaysia 711 0.92% Im

Sri Lanka 480 0.62%

Honduras 285 0.37% Im

Trinidad and Tobago 192 0.25% Im

Saint Vincent and the Grenadines 172 0.22% Im

Malawi 133 0.17% F

Ethiopia 100 0.13% F

Kenya 60 0.08% Im

Togo 35 0.05% F

Saint Lucia 30 0.04% F

Madagascar 16 0.02% Im

Dominica 5 0.01% F a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate.

Table B10. Onions, dried

Allium cepa. Includes onions at a mature stage, but not dehydrated onions.

Country Metric Tonnes % of Worldwide Production Data Sourcea

China 21,046,969 28.74% F

India 13,900,000 18.98% F

United States of America 3,400,560 4.64%

Turkey 1,849,580 2.53%

Egypt 1,800,000 2.46% F

Pakistan 1,704,100 2.33%

Russian Federation 1,601,550 2.19%

Iran (Islamic Republic of) 1,512,150 2.06%

Brazil 1,511,850 2.06%

Netherlands 1,269,000 1.73%

Spain 1,263,400 1.73%

Republic of Korea 1,200,000 1.64% F

Mexico 1,195,820 1.63%

Japan 1,154,000 1.58%

Myanmar 1,050,000 1.43% F

Algeria 980,160 1.34%

Indonesia 952,638 1.30%

Ukraine 875,600 1.20%

Uzbekistan 795,000 1.09% *

Bangladesh 735,140 1.00%

a FAO official data unless noted otherwise. F: FAO estimate; *: unofficial figure.
Worldwide Spice Production | Appendix B

FDA Draft Risk Profile | 189

Table B11. Pepper (Piper spp.)

Black, white pepper (Piper nigrum); long pepper (P. longum). Perennial climbing vines. Includes whole, 

crushed or ground berries. Black pepper is produced from partially ripe berries, while white pepper is from 

fully ripe berries, which have had the outer hull removed.

Country Metric Tonnes % of Worldwide Production Data Sourcea

Vietnam 137,280 30.42% *

Indonesia 80,000 17.73% F

Brazil 65,398 14.49%

India 47,400 10.50%

China 28,218 6.25% F

Sri Lanka 25,300 5.61%

Malaysia 23,210 5.14%

Thailand 6,730 1.49%

Mexico 5,805 1.29% Im

Madagascar 3,949 0.88% Im

Ghana 3,584 0.79% F

Philippines 3,208 0.71% Im

Cambodia 2,704 0.60% Im

Ecuador 2,626 0.58% Im

Rwanda 2,408 0.53% Im

Niger 2,000 0.44% F

Uganda 1,901 0.42% Im

Zimbabwe 1,883 0.42% Im

Bolivia (Plurinational State of) 1,263 0.28%

Costa Rica 1,040 0.23% a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate; *: unofficial figure.

Table B12. Poppy Seed

Papaver somniferum. The source of opium, poppy seeds are also used in baking and confectionery.

a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate. 

Country Metric Tonnes % Of Worldwide Production Data Sourcea

Turkey 34,194 34.60%

Czech Republic 32,692 33.08%

Spain 7,000 7.08% F

France 6,500 6.58% F

Hungary 3,458 3.50%

Croatia 3,349 3.39%

Germany 3,294 3.33% Im

Occupied Palestinian Territory 2,200 2.23% F

Romania 1,956 1.98% Im

Austria 1,504 1.52%

Serbia 859 0.87% Im

Slovakia 832 0.84%

Netherlands 493 0.50% Im

The former Yugoslav Republic of 

Macedonia 504 0.51%
Worldwide Spice Production | Appendix B

FDA Draft Risk Profile | 190

Table B13. Spices, nes

Including inter alia: bay leaves (Laurus nobilis); dill seed (Anethum graveolens); fenugreek seed (Trigonella 

foenum-graecum); saffron (Crocus sativus); thyme (Thymus vulgaris); turmeric (Curcuma longa). Other spices 

that are not identified separately because of their minor relevance at the international level. Because of their 

limited local importance, some countries report spices under this heading that are classified individually by 

FAO. This heading also includes curry powder and other mixtures of different spices.

Country Metric Tonnes % of Worldwide Production Data Sourcea

India 1,100,000 69.23% F

Bangladesh 140,113 8.82%

Turkey 87,028 5.48% Im

China 85,987 5.41% F

Pakistan 45,473 2.86% Im

Colombia 19,760 1.24% Im

Nepal 17,404 1.10% Im

Iran (Islamic Republic of) 13,226 0.83% Im

Burkina Faso 6,705 0.42% F

Niger 5,100 0.32% F

Nigeria 4,959 0.31% F

Sri Lanka 4,817 0.30% Im

Indonesia 4,481 0.28% Im

Bhutan 4,158 0.26% Im

Occupied Palestinian Territory 4,070 0.26% Im

Thailand 3,283 0.21% Im

Zambia 3,257 0.20% Im

Spain 3,195 0.20% Im

Georgia 3,100 0.20% *

Morocco 3,000 0.19% F a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate; *: unofficial figure.

Table B14. Sesame Seed

Sesamum indicum. Valued for its oil, but also as a food, either raw or roasted, as well as in bakery products 

and o

Country Metric Tonnes % of Worldwide Production Data Sourcea

Myanmar 867,520 21.81%

India 657,000 16.52%

China 622,905 15.66%

Sudan 318,000 8.00%

Ethiopia 260,534 6.55% *

Uganda 178,000 4.48%

Nigeria 110,000 2.77% *

Niger 75,632 1.90%

Paraguay 65,000 1.63%

Somalia 64,445 1.62% Im

Burkina Faso 56,252 1.41%

Central African Republic 50,008 1.26%

United Republic of Tanzania 48,000 1.21% *

Thailand 46,039 1.16%

Egypt 41,000 1.03% *

Chad 35,000 0.88% *

Pakistan 33,400 0.84%

Bangladesh 32,306 0.81%

Afghanistan 32,000 0.80% *

Cambodia 31,000 0.78% F

ther food preparations.

a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate; *: unofficial figure.
Worldwide Spice Production | Appendix B

FDA Draft Risk Profile | 191

Table B15. Vanilla

Vanilla planifolia; V. pompona. The fruit (or bean) of a climbing plant of the orchid family. Includes whole, 

crushed or ground.

Country Metric Tonnes % of Worldwide Production Data Sourcea

Indonesia 4,362 44.44% Im

Madagascar 2,830 28.83% Im

China 1,382 14.08% Im

Mexico 524 5.34%

Tonga 263 2.68% Im

Turkey 215 2.19% Im

French Polynesia 74 0.75%

Comoros 65 0.66% Im

Uganda 48 0.49% Im

Malawi 15 0.15% Im

Kenya 12 0.12% Im

Réunion 12 0.12% *

Guadeloupe 8 0.08% F

Zimbabwe 5 0.05% Im a FAO official data unless noted otherwise. Im: FAO data based on imputation methodology; F: FAO estimate; *: unofficial figure.
FDA Draft Risk Profile | 192 

APPENDIX C: FDA 2010 STUDY OF CONCENTRATIONS AND 

DISTRIBUTION OF SALMONELLA IN SHIPMENTS OF CAPISCUM AND 

SESAME SEED OFFERED FOR ENTRY TO THE UNITED STATES. 

The 2010 FDA study “Prevalence, level and distribution of Salmonella in shipments of imported capsicum and 

sesame seed spice offered for entry to the United States: Observations and modeling results” was originally 

published in Food Microbiology (Van Doren et al., 2013c). Below we provide information from the study most 

relevant to the results discussed in the present risk profile document.

Material and Methods

Sample Collection

All imports of dried capsicum and sesame seeds were eligible for sampling during the study period. A total of 

299 shipments of capsicums and 233 shipments of sesame seeds were sampled at the point of import into the 

United States between August and December 2010. The shipments sampled constituted approximately 10 or 

20 percent of all shipments of imported capsicum or imported sesame seed shipments, respectively, offered 

for entry to the United States. Sixty subsamples, each comprised of approximately 160 grams, were collected 

randomly from each shipment. Typically, each sub-sample was collected from a different container or sack of 

spice in the shipment selected at random. Samples were sent to U.S. Food and Drug Administration (FDA) 

laboratories for analysis. 

Sample Preparation, Salmonella Screening, Isolation and Confirmation

Composite samples were prepared by dividing the 60 subsamples into four groups of fifteen. Twenty-five 

gram analytical units of product from each of the fifteen subsamples were combined to form a 375 g 

composite sample (Andrews and Hammack, 2003). Each composite sample was screened for the presence of 

Salmonella using one of the following methods: AOAC’s Official Methods of Analysis (OMA): 2004.03, 2001.07, 

2001.08, or 2001.09, which are available from AOAC International (2007a, 2007b, 2007c, 2007d). All 

methods are validated and have similar performance criteria.

Salmonella was isolated from each of the composite samples testing positive using the procedures described 

in Chapter 5 of the FDA Bacteriological Analytical Manual (BAM) (Andrews et al., 2011; Jacobson, and 

Hammack, 2003). Presumptive-positive Salmonella isolates were confirmed with OMA methods 978.24 or 

991.13 (available from AOAC International (2005d, 2005e). Salmonella isolates recovered from the spices 

were serotyped (Ewing, 1986). 

Salmonella Enumeration

A dilution assay was undertaken for composite samples of spice that were found to contain Salmonella by the 

screening test. The serial dilution protocol involved a three tube analysis on each of four different dilutions of 

spice. Spice sampled for the dilution assay analysis were drawn from a composite (thoroughly mixed) sample 

created from equal proportions of the same set of 15 subsamples used in the corresponding Salmonellapositive screening test. Separate composite spice product portions of 100, 10, 1, and 0.1 g were each 

rehydrated at a 1:9 ratio with a tryptic soy broth pre-enrichment medium by swirling or soaking as instructed 

in the BAM method (Andrews et al., 2011; Jacobson, and Hammack, 2003). This procedure was repeated 

three times (for three tubes) for each of the four different dilutions (100, 10, 1, and 0.1 g). The enrichment 

tubes were kept at room temperature for 60 ± 5 min, pH adjusted to 6.8 ± 0.2, if necessary, and then 

incubated for 24 ± 2 h at 35 ± 2oC. Once incubation was complete, the BAM Salmonella culture method was 

followed (Andrews et al., 2011; Jacobson, and Hammack, 2003). The relative likelihood of each reported 

dilution assay pattern for a thoroughly mixed sample was evaluated on the basis of the rarity index (Blodgett, 

2010a; Jarvis et al. 2010).
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Most Probable Number (MPN) values and 95% confidence intervals for each of the four composite samples 

were determined from the five results, screening test plus the four dilutions using the excel spreadsheet 

provided in the BAM (Blodgett, 2010b), where the screening test was treated as another “dilution” for the 

MPN analysis. For a few shipments, the procedure described above was not followed. For samples in one 

shipment of capsicum and six shipments of sesame seeds, the dilution assay result patterns were not reported 

by the field labs but rather the presence/absence of Salmonella was reported for the enumeration experiment 

as a whole. In these cases, we interpret the experiments as providing a second screening test with total spice 

mass of 333.3 g. For samples from two other shipments of sesame seeds with confirmed positive Salmonella

samples, enumeration experiments were not performed. MPN estimates and confidence intervals for the 

mean Salmonella concentration in a shipment were calculated taking into account the full set of screening test 

and dilution assay results.

The assumption of Poisson-distributed contamination within shipments, which was used to estimate the 

shipment mean concentration of contamination and is part of some of the parametric models developed, was 

examined. We evaluated for each of the 4 composite sample results, a rarity index (Blodgett, 2010a). 

Specifically we evaluated the probability to obtain the pattern of results observed for one composite sample 

given the estimated mean shipment concentration divided by the probability to observe the most probable 

pattern of results in the composite sample given the estimated mean shipment concentration. This statistic 

has the advantage of being quantifiable for all of the outcomes obtained in this study including missing 

dilution assay results and binary dilution assay result outcomes. The second advantage is that this rarity 

index evaluates in one statistic the adequacy of the assumption of within shipment Poisson distribution and 

within dilution assay Poisson distribution. There is no a priori expectation that contamination concentrations 

in different composites from the same shipment should be the same/similar because the spice contained in 

different composites are from different locations in the shipment. If the local concentration in a given 

composite is far higher or lower than the value estimate at the shipment level, the probability to observe the 

given pattern will be low with regards to the most probable one, leading to a low rarity index. We use the 

recommendations of Jarvis et al (2010) for thresholds of probability: the pattern of results is likely to occur if 

its rarity index is ≥0.05; is expected to occur only rarely if the rarity index falls within the range 0.01< rarity 

index < 0.05; and is expected to occur extremely rarely if the rarity index is ≤ 0.01

Probabilistic Models

Probabilistic models of imported spice shipment contamination were examined for their ability to describe 

the Salmonella sampling data. Features included in the models were selected for their ability to describe 

between- and within-shipment distributions of Salmonella in spices. Each model was fit to the capsicum and 

sesame seed data separately, and evaluated for its quality of fit. Mathematical descriptions of the models, 

development of the likelihood functions, and derivation of the maximum likelihood solutions, where 

applicable, are presented in the Supplementary Material. All information gathered in this study, including 

positive and negative test results of screening and enumeration experiments, was used in determining model 

parameter estimates. Maximum likelihood estimates of model parameters were determined from the 

analytical solutions or determined numerically using the R general-purpose optimization function “optim” (R 

Development Core Team, 2008). Standard errors for model parameters were derived from the Hessian matrix 

while confidence intervals for model predications were estimated using a parametric bootstrap procedure. 

Models are compared for quality of fit on the basis of the Akaike information criterion (AIC). Deviations of 

model predictions from observations are compared in a number of ways. Model between-shipment 

contamination distributions are compared with observations graphically. Model predicted prevalence for the 

sampling plan used in the present study is compared with the observed one. Observed data on the 

distribution of contamination within each shipment are compared with results predicted under a Poisson 

distribution assumption (see Section 2.2). Finally, model fits, as quantified by the AIC, are compared with that 

of an empirical model. 
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Model 1

Model 1 assumes (1) imported spice shipments offered for U.S. entry can be divided into two populations: 

uncontaminated shipments (zero probability of one or more bacterium in the shipment, designated 

“Population I”) and contaminated shipments (non-zero probability of one or more bacterium in the shipment, 

designated “Population II”) (2) contamination within Population II shipments is characterized by a Poisson 

distribution and (3) all contaminated spice shipments (Population II) have the same mean concentration of 

Salmonella. The explicit inclusion of a Salmonella-free population in this model and the additional models that 

follow is similar to the zero-inflated distributions used by others to describe microbial distributions in foods 

(see for example, Gonzales-Barron et al., 2010; Bassett et al., 2010; Jongenburger et al., 2012). Model 1 is 

characterized by two parameters, p and , which are the probability of being in Population II and the mean 

concentration of Salmonella in Population II shipments, respectively. 

Model 2

Model 2 assumes (1) imported spice shipments at U.S. entry can be divided into two populations, i.e., 

uncontaminated shipments (Population I) and contaminated shipments (Population II) as defined in Model 1 

(2) contamination within Population II shipments is concentrated in isolated contamination clusters or “hotspots” (probability of at least one bacterium in each hot spot is non-zero while the probability outside the hot 

spot is zero) (3) all hot spots have the same mean concentration of Salmonella and (4) the contamination 

within each hot spot is described by a Poisson distribution. This model is characterized by three parameters, 

p, h and , which are the probability of being in Population II, the probability that a sample taken from a

shipment in Population II is from a hot spot, and the mean concentration of Salmonella in each hot spot, 

respectively. 

Models 3a-3d

Models 3a-3d assume (1) imported spice shipments offered for U.S. entry can be divided into two 

populations, i.e., uncontaminated shipments (Population I) and contaminated shipments (Population II) as 

defined in Model 1 (2) contamination within Population II shipments is characterized by a Poisson 

distribution and (3) different shipments may have different mean concentrations, where the distribution of 

mean concentrations is defined by a gamma distribution (3a), lognormal distribution (3b), log-logistic 

distribution (3c), or Weibull distribution (3d).

Models 3a, 3c, and 3d are characterized by three parameters, p, α, and . p is the probability of being in 

Population II. In Models 3a, 3c, and 3d, is the shape parameter and is the scale parameter. In Model 3b, 

is the mean of the natural logarithm of Salmonella concentration and is the standard deviation of the natural 

logarithm of Salmonella concentration. 

Empirical Model

Empirical models were developed for Salmonella contamination of imported capsicum and sesame seed 

shipments offered for entry to the United States. These models assume (1) imported spice shipments offered 

for U.S. entry can be divided into two populations, i.e., uncontaminated shipments (Population I) and 

contaminated shipments (Population II) as defined in Model 1 (2) contamination within Population II 

shipments is characterized by a Poisson distribution and (3) different shipments may have different mean 

concentrations, where the distribution of mean concentrations is defined empirically from the withinshipment contamination concentration estimated from the observations. The fraction of uncontaminated 

shipments in each model is given by the fraction of shipments for which all four screening tests (4 composites 

of 375 g) tested negative, i.e., the observed prevalence. The distribution of mean concentrations among 

contaminated shipments is drawn from the discrete set of 10 (capsicum) or 23 (sesame seed) contaminated 

shipment estimated mean concentrations. Thus, the empirical models are saturated models. The empirical 

model for capsicum shipments includes 11 parameters and the empirical model for sesame seed shipments 

contains 24 parameters.
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Efficacy of Salmonella Sampling Plans in Reducing Risk 

Four sampling plans were evaluated for their ability to (1) identify Salmonella contaminated spice shipments 

offered for U.S. entry and (2) reduce Salmonella contamination in the imported spice supply, assuming 

identified shipments are reconditioned. Each sampling plan was applied to both the Model 1 and the best 

model identified among Models 3a-3d. In these analyses, we assumed the screening test has perfect 

sensitivity and specificity. 
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Description of Sampled Shipments and Model Results

Table C1. Description of sampled and Salmonella-contaminated shipments offered for U.S. entry

Descriptor

Capsicuma Sesame Seeda

Sampled

(299 Shipments)

Contaminated

(10 Shipments)

Sampled

(233 Shipments)

Contaminated

(23 Shipments)

Total Mass and Value for All Shipmentsb -

$6.1 × 106

7.5 × 104 kg

$1.6 × 105

-

$5.3 × 106

3.5 × 105 kg

$7.1 × 105

Mean Shipment Sizeb: Mass - 7.5 × 103 kg - 1.5 × 104 kg

Median Shipment Sizeb: Mass - 4.8 × 103 kg - 1.8 × 104 kg

Shipment Size Rangeb: Mass - 125 -2.5 × 104 kg - 24 - 3.8 × 104 kg

Percentage of Shipments Retailc ≥15 20 ≥11 22

Percentage of Shipments Ground/Crackedd 46 80 NA NA

Fraction (Percentage) of Shipments Known 

to have Undergone a Pathogen Reduction 

Treatmente 

≥14/299

(≥4.7%)

0/7

(≤30%)

≥6/233

(≥3%)

0/14

(≤40%)

Fraction (Percentage) Fraction of Shipments 

with COANeg. for Salmonellaf - 2/7(≥20%) - 4/14(≥17%)

Percentage of Imported Shipments Sampled ~10 - ~20 -

Observed Prevalence [95% CI] of 

Salmonella-Contaminated Imported Spice 

Shipmentsg

3.3%

[1.6-6.1%] NA 9.9%[6.3-14%] NA

a Dash indicates the data were not available; NA indicates the descriptor is not applicable. b Mass and value determined from FDA sample collection report. 

c Retail defined as shipments packaged in bags/boxes containing ≤5 lbs (2.3 kg).

d Percentages of ground/cracked and whole capsicum were determined by FDA product code and description. Information was available to assess form for 297 of the imported shipments

e As determined by FDA product code and description for all imported shipments plus documents examined at import for contaminated shipments. Pathogen reduction treatment indications 

included “commercially sterile”, “heat treated”, “irradiated”, and “steam” or “eto” treated. The numbers of shipments identified is likely an underestimate because industry is not required 

to supply this information except for the case of irradiated spice and FDA officials are not required to record this information in their collection report. 

f COA means Certificate of Analysis. Documents provided at import for contaminated shipments were reviewed for COAs; information was available for 7 of the contaminated capsicum 

shipments and 14 of the contaminated sesame seed shipments.

g 95% CI, exact confidence limits for the observed/apparent prevalence determined with the sampling protocol employed in this study (Clopper and Pearson, 1934). Observed/apparent 

prevalence is a lower limit on the true prevalence.
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Table C2. Model parameters and descriptors

Spice

Modela: Prevalenceb

[S]>0 (SE)

Mean S. 

Concentration 

in 

Contaminated 

Shipments

Hot Spot Prevalence

(SE)c

Hot Spot Mean 

Concentration

(SE)c

AIC

Model #: # populations, BetweenWithin Distribution (%) (MPN/g) (%) (MPN/g) (unitless)

Capsicum 1: 2 Populations, Poisson 3.4 (1.0) 3.64 × 10-3 241.4

2: 2 Populations, Hot Spot 3.5 (1.1) 7.2 (1.9) 5.79 (1.54) x 10-2 217.9

Sesame Seedd 1: 2 Populations, Poisson 9.9 (2.0) 3.53 × 10-3 405.7

2: 2 Populations, Hot Spot 10.3 (2.1) 5.9 (1.1) 7.75 (1.43) x 10-2 351.7

Between-Shipment Distribution parameters

α (SE)e β (SE)e 

Capsicum

3a: 1 Population/gamma- Poissonf 100 3.20 × 10-4 0.00833 (0.0031) 0.0384 (0.0315) 174.7

3b: 2 Populations/lognormal- Poisson 7.3 (7.1) 5.74 × 10-3 -8.150 (3.067)g 2.445 (1.399)h 175.1

3c: 2 Populations/log-logistic- Poisson 3.3 (1.0) 6.54 × 10-3 1.406 (0.465) 0.00231 (0.00062) 180.0

3d: 2 Populations/Weibull- Poisson 3.3 (1.0) 7.93 × 10-3 0.603 (0.153) 0.0053 (0.0028) 184.4

Sesame Seedd 

3a: 1 Population/gamma- Poissonf 100 6.17 × 10-4 0.02977 (0.0076) 0.02073 (0.0105) 286.6

3b: 2 Populations/lognormal- Poisson 24.5 (19.3) 4.77 × 10-3 -8.543 (2.487)g 2.529 (1.078)h 288.0

3c: 2 Populations/log-logistic- Poisson 9.9 (2.0) 7.83 × 10-3 1.319 (0.285) 0.00226 (0.00042) 301.9

3d: 2 Populations/Weibull- Poisson 9.9 (2.0) 5.77 × 10-3 0.730 (0.136) 0.00474 (0.00136) 305.9

Capsicum Saturated Empirical 3.3 (1.3-5.4) 1.13 × 10-2 167.8

Sesame Seedd Saturated Empirical 9.9 (6.0-14) 5.93 × 10-3 289.2

a Following each model number is an abbreviated description of the model assumptions including the between-shipment distribution of Salmonella contamination (number of different 

populations) and the within-shipment distribution of Salmonella (Poisson or Hot Spot). See text for detailed description.

b Percentage of Salmonella-contaminated shipments (as defined in the text) followed by standard error in parentheses. 

c SE means standard error.

d Models for contamination of sesame seed shipments use the revised data. See Table 2 and text for details.

e Distribution parameters shape ( ) or scale ( ) followed by standard error for that parameter in parentheses, unless otherwise noted.

f The optimized zero-inflated gamma-Poisson model was degenerate with the two-parameter gamma-Poisson model, where shipment prevalence for Salmonella is 100%. See text for details.

g Mean of the of the natural logarithm of concentration followed by standard error for that parameter in parentheses.

h Standard deviation of the natural logarithm of concentration distribution followed by standard error for that parameter in parentheses.
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Table C3. Predicted Impact of Testing Shipments of Imported Capsicum or Sesame Seed Offered for entry to the United States for the presence 

of Salmonella as a function of the mass of spice examined for contamination distributions in the incoming supply described by Model 1 and 

Model 3a (the best-fit parametric model).

Spice - Model 

Effectiveness Measure

Shipment 

Sizea

Prevalence 

(95% CI) Salmonella Screening Method

(kg) (%) 25 g

COAb

375 g

FDA IIIc

750 g

FDA IId

1500 g

FDA Ie

Capsicum - Model 1

Supply characteristics All sizes 3.4 (1.4-5.4)

Expected value for percentage (95% CI) of 

shipments detected (among all shipments)

All sizes 0.3 (0.1-0.5) 2.5 (1.0-4.1) 3.1 (1.3-5.1) 3.3 (1.3-5.4)

Expected value for percentage (95% CI) of 

contaminated shipments detected

All sizes 8.7 (6.5-11) 75 (63-83) 93 (87-97) 99.6 (98-99.9)

Expected value for percentage (95% CI) of 

Salmonella in supply captured in detected 

shipments

All sizes 8.7 (6.5-11) 75 (63-83) 93 (87-97) 99.6 (98-99.9)

Expected value for log10 reduction (95% CI) of 

Salmonella in spice supply if detected 

shipments are reconditionedf

All sizes 0.04 (0.03-0.05) 0.6 (0.4-0.8) 1.2 (0.9-1.5) 2.4 (1.7-3.0)

Capsicum - Model 3agamma-Poisson (Best Fit Model)

Supply characteristics

125

7.5 x 103

1.5 x 104 

Infinite

6.8 (3.3-12)

9.9 (4.7-18)

10.8 (5.2-19)

100

Expected value for percentage (95% CI) of 

shipments detected (among all shipments) All sizes 0.6 (0.1-1.1) 2.2 (0.9-3.6) 2.8 (1.2-4.5) 3.0 (1.7-5.4)

Expected value for percentage (95% CI) of 

contaminated shipments detected

125

7.5 x 103

1.5 x 104

8.2 (1.8-15)

5.6 (1.1-11)

5.2 (1.0-10)

33 (16-41)

23 (10-29)

21 (9.2-27)

41 (24-48)

28 (15-34)

26 (14-32)

49 (33-55)

34 (21-39)

31 (19-36)

Expected value for percentage (95% CI) of 

Salmonella in supply captured in detected 

shipments

All sizes 49 (10-76) 94 (64-98) 97 (78-99) 98 (88-99.5)

Expected value for log10 reduction (95% CI) of 

Salmonella in spice supply if detected 

shipments are reconditionedf

All sizes 0.3 (0.05-0.6) 1.2 (0.4-1.7) 1.5 (0.7-2.0) 1.8 (0.9-2.3)
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Spice - Model 

Effectiveness Measure

Shipment 

Sizea

Prevalence 

(95% CI) Salmonella Screening Method

(kg) (%) 25 g

COAb

375 g

FDA IIIc

750 g

FDA IId

1500 g

FDA Ie

Capsicum- Empirical

Supply characteristics All sizes 3.3 (1.3-5.4)

Expected value for percentage (95% CI) of 

shipments detected (among all shipments) All sizes 0.5 (0.06-1.2) 1.9 (0.6-3.1) 2.4 (0.8-3.8) 2.9 (1.0-4.3)

Expected value for percentage (95% CI) of 

contaminated shipments detected

All sizes 14 (4.1-40) 56 (42-81) 72 (54-89) 85 (78-99)

Expected value for percentage (95% CI) of 

Salmonella in supply captured in detected 

shipments

All sizes 14 (4.1-40) 56 (42-81) 72 (54-89) 85 (78-99)

Expected value for log10 reduction (95% CI) of 

Salmonella in spice supply if detected 

shipments are reconditionedf

All sizes 0.07 (0.02-0.2) 0.4 (0.2-0.7) 0.6 (0.3-1.0) 0.8 (0.7-2.0)

Sesame Seed - Model 1

Supply characteristics All sizes 9.9 (6.5-13.8)

Expected value for percentage (95% CI) of 

shipments detected (among all shipments) All sizes 0.8 (0.5-1.2) 7.3 (4.5-10.3) 9.2 (5.8-13.0) 9.9 (6.4-13.7)

Expected value for percentage (95% CI) of 

contaminated shipments detected All sizes 8.4 (7.0-9.9) 73 (66-79) 93 (89-96) 99.5 (98.8-99.8)

Expected value for percentage (95% CI) of 

Salmonella in supply captured in detected 

shipments

All sizes 8.4 (7.0-9.9) 73 (66-79) 93 (89-96) 99.5 (98.8-99.8)

Expected value for log10 reduction (95% CI) of 

Salmonella in spice supply if detected 

shipments are reconditionedf

All sizes 0.04 (0.03-0.05) 0.6 (0.5-0.7) 1.2 (1.0-1.4) 2.3 (1.9-2.7)
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Spice - Model 

Effectiveness Measure

Shipment 

Sizea

Prevalence 

(95% CI) Salmonella Screening Method

(kg) (%) 25 g

COAb

375 g

FDA IIIc

750 g

FDA IId

1500 g

FDA Ie

Sesame Seed - Model 3a -

gamma-Poisson (Best Fit Model)

Supply characteristics

24

1.5 x 104

3.8 x 104

Infinite

17(11-24)

31(20-45)

33(21-47)

100

Expected value for percentage (95% CI) of 

shipments detected (among all shipments) All sizes 1.2 (0.6-2.0) 6.3 (3.8-8.7) 8.0 (5.0-11) 9.8 (6.0-14)

Expected value for percentage (95% CI) of 

contaminated shipments detected

24

1.5 x 104

3.8 x 104

7.3 (3.6-12)

3.9 (1.8-6.8)

3.7 (1.7-6.4)

37 (28-44)

20 (14-25)

19 (13-23)

47 (38-53)

26 (19-30)

24 (18-28)

58 (50-29)

31 (25-35)

30 (34-33)

Expected value for percentage (95% CI) of 

Salmonella in supply captured in detected 

shipments

All sizes 35 (16-55) 89 (75-95) 94 (86-97) 97 (92-99)

Expected value for log10 reduction (95% CI) of 

Salmonella in spice supply if detected 

shipments are reconditionedf

All sizes 0.2 (0.08-0.3) 1.0 (0.6-1.3) 1.2 (0.9-1.5) 1.5 (1.1-2.0)

Sesame Seed - Empirical

Supply characteristics All sizes 9.9 (4.7-12)

Expected value for percentage (95% CI) of 

shipments detected (among all shipments) All sizes 1.2 (0.4-2.1) 5.4 (2.8-7.6) 6.9 (3.6-9.1) 8.3 (4.3-11)

Expected value for percentage (95% CI) of 

contaminated shipments detected All sizes 12 (6.6-24) 54 (48-75) 70 (64-86) 84 (81-95)

Expected value for percentage (95% CI) of 

Salmonella in supply captured in detected 

shipments

All sizes 12 (6.6-24) 54 (48-75) 70 (64-86) 84 (81-95)

Expected value for log10 reduction (95% CI) of 

Salmonella in spice supply if detected 

shipments are reconditionedf

All sizes 0.6 (0.03-0.1) 0.3 (0.3-0.6) 0.5 (0.4-0.9) 0.8 (0.7-1.3)

a Shipment sizes selected are the smallest, mean and largest contaminated shipment sizes observed in this study for each particular spice type. b Sample mass examined for Salmonella screening tests reported on industry Certificates of Analyses accompanying some of the spice shipments examined in this study. c Typical sample mass used for FDA Category III foods which are foods that would normally be subjected to a process lethal to Salmonella between the time of sampling and consumption 

(Andrews and Hammack, 2003).

d Typical sample mass used for FDA Category II foods which are foods that would not normally be subjected to a process lethal to Salmonella between the time of sampling and 
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consumption (Andrews and Hammack, 2003). 

e Typical sample mass used for FDA Category I foods which are foods that would not normally be subjected to a process lethal to Salmonella between the time of sampling and consumption 

and are intended for consumption by the aged, the infirm, or infants (Andrews and Hammack, 2003).

f Assumes reconditioning eliminates all Salmonella from the shipment.