1 

Center for Food Safety and Applied Nutrition

Food and Drug Administration

U.S. Department of Health and Human Services

Qualitative Risk Assessment: 

Risk of Activity/Food Combinations for Activities (Outside the 

Farm Definition) Conducted in a Facility Co-Located on a 

Farm

August 2015
2 

Contributors 

Team Leader: Jenny Scott, FDA 

Team Members: Draft

• Linda Kahl, FDA 

• Donald Kraemer, FDA (retired) 

• Julie Lovas, FDA 

• Sharon Edelson-Mammel, FDA

• Michael Mahovic, FDA

• John Misock, FDA 

Team Members: Final

• Eileen Abt, FDA 

• Linda Kahl, FDA 

• Julie Lovas, FDA

Acknowledgements

The following individuals and groups are acknowledged for their contributions to this project:

CFSAN food safety and processing experts, (in addition to the team members), for their input and 

advice for the draft risk assessment on activity/food combinations likely to be conducted by farm 

mixed-type facilities:

• Samir Assar

• Cecilia (Maria) Crowley

• Dennis Gaalswyk

• James Gorny (formerly at CFSAN, now at Produce Marketing Association) 

• Daria Kleinmeier

Yinqing Ma (FDA), for organizing and managing references 

Sherri Dennis (FDA), for advice on the approach to a risk assessment 

Lori Papadakis (FDA), for professional formatting and editing of the report 

Richard Galloway (Galloway & Associates LLC), for information regarding the production of 

soybeans 

Pamela Miles (Virginia Department of Agriculture and Consumer Services, Food Safety & Security 

Program), for information regarding on-farm manufacturing, processing, packing, and holding 

activities of food not grown, raised or consumed on the farm that conducts the manufacturing, 

processing, packing, and holding activity 
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Executive Summary

The Food and Drug Administration (FDA) has conducted a qualitative risk assessment (RA) related 

to manufacturing, processing, packing, and holding activities for human food when such activities 

are conducted on farms. The purpose of the RA is to provide a science-based risk analysis of those 

activity/food combinations that would be considered low risk. FDA conducted this RA to satisfy 

requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk 

analysis and to consider the results of that analysis in determining whether to exempt small or very 

small businesses that are engaged only in specific types of on-farm manufacturing, processing, 

packing, or holding activities involving specific foods that FDA determines to be low risk from the 

requirements of sections 418 and 421 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or 

whether to modify such requirements for such facilities. 

The RA identified the following as low-risk activity/food combinations: 

• Boiling gums, latexes, and resins; 

• Chopping/coring/cutting/peeling/pitting/shredding/slicing acid fruits and vegetables with 

pH<4.2 (e.g., cutting lemons, limes), baked goods (e.g., slicing bread), dried fruit and 

vegetable products (e.g., pitting dried plums), dried herbs and other spices (e.g., chopping 

intact dried basil, intact dried mint), game meat jerky, gums/ latexes/ resins, other grain 

products (e.g., shredding dried cereal), peanuts and tree nuts, and peanut and tree nut 

products (e.g., chopping roasted peanuts) 

• Coating dried fruit and vegetable products (e.g., coating raisins with chocolate), other fruit 

and vegetable products except for non-dried, non-intact fruits and vegetables (e.g., coating 

dried plum pieces, dried pitted cherries, and dried pitted apricots with chocolate are low-risk 

activity/food combinations but coating apples on a stick with caramel is not a low-risk 

activity food combination), other grain products (e.g., adding caramel to popcorn or adding 

seasonings to popcorn provided that the seasonings have been treated to significantly 

minimize pathogens), peanuts and tree nuts (e.g., adding seasonings provided that the 

seasonings have been treated to significantly minimize pathogens), and peanut and tree nut 

products (e.g., adding seasonings provided that the seasonings have been treated to 

significantly minimize pathogens);

• Dehydration/drying (that includes additional manufacturing or is performed on processed 

foods) of other fruit and vegetable products with pH<4.2 (e.g., cut fruit and vegetables with 

pH<4.2), and other herb and spice products (e.g., chopped fresh herbs, including tea); 

• Extracting (including by pressing, by distilling, by solvent extraction) dried herbs and other 

spices (e.g., dried mint), fresh herbs (e.g., mint), fruits and vegetables (e.g., olives, 

avocados), grains (e.g., oilseeds), and other herb and spice products (e.g., chopped, fresh 

mint);

• Freezing acid fruits and vegetables with pH<4.2 and other fruit and vegetable products with 

pH <4.2 (e.g., cut fruits and vegetables); 

• Grinding/milling/cracking/crushing baked goods (e.g., crackers), cocoa beans (roasted), 

coffee beans (roasted), dried fruit and vegetable products (e.g., raisins, dried legumes), dried 

herbs and other spices (e.g., intact dried basil), grains (e.g., oats, rice, rye, wheat), other fruit 

and vegetable products that are processed foods (e.g., dried, pitted dates), other grain 

products that are processed foods (e.g., dried cereal), other herb and spice products (e.g., 

chopped dried herbs), peanuts and tree nuts, and peanut and tree nut products (e.g., roasted 

peanuts); 
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• Labeling baked goods that do not contain food allergens (e.g., crackers that do not contain 

wheat, milk, egg, or nuts), candy that does not contain food allergens (e.g., maple candy and 

maple cream), cocoa beans (roasted), cocoa products that do not contain food allergens, 

coffee beans (roasted), game meat jerky, gums/ latexes/ resins that are processed foods, 

honey (pasteurized), jams/ jellies/ preserves, milled grain products that do not contain food 

allergens (e.g. corn meal) or that are single ingredient foods (e.g., wheat flour, wheat bran), 

molasses and treacle, oils, other fruit and vegetable products that do not contain food 

allergens (e.g., snack chips made from potatoes or plantains), other grain products that do not 

contain food allergens (e.g., popcorn), other herb and spice products (e.g., chopped or 

ground dried herbs), peanut and tree nut products that are single ingredient, are in forms in 

which the consumer can reasonably be expected to recognize the allergen(s) without label 

declaration, or both (e.g., roasted or seasoned whole nuts, single-ingredient peanut or tree nut 

flours), processed seeds (e.g., roasted pumpkin or roasted sunflower seeds), soft drinks and 

carbonated water, sugar/syrups, trail mix and granola (other than those containing milk 

chocolate and provided that peanuts and/or tree nuts are in forms in which the consumer can 

reasonably be expected to recognize the allergen(s) without label declaration), vinegar, any 

other processed food that does not require time/temperature control for safety and that does 

not contain food allergens (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) 

in powdered, granular, or other solid form); 

• Making baked goods from milled grain products (e.g., breads and cookies); 

• Making candy (including boiling, evaporation, mixing) from peanuts and tree nuts (e.g., nut 

brittles), sugar/syrups (e.g., taffy, toffee), and saps (e.g., maple candy, maple cream); 

• Making cocoa products (including grinding, mixing, conching, tempering) from roasted 

cocoa beans;

• Making dried pasta from grains; 

• Making jams, jellies and preserves (including cutting/mashing, boiling, mixing, canning) 

from acid fruits and vegetables with a pH < 4.6 (e.g., rhubarb, strawberries) ; 

• Making molasses and treacle (including extracting, boiling, concentrating, evaporating) from 

sugar beets, sugarcane; 

• Making oat flakes from grains; 

• Making popcorn from grains; 

• Making snack chips from fruits and vegetables (e.g., plantains, potatoes); 

• Making soft drinks and carbonated water (including flavoring, carbonating) from sugar, 

syrups, water; 

• Making syrups and sugars (including extracting, boiling, concentrating, evaporating, 

crystalizing) from fruits and vegetables (e.g., dates), grains (e.g., rice, sorghum), other grain 

products (e.g., malted grains such as barley), sap (e.g., agave, birch, maple, palm), sugar 

beets, and sugarcane;

• Making trail mix or granola from cocoa products (e.g., chocolate), dried fruit and vegetable 

products (e.g., raisins), other fruit and vegetable products (e.g., chopped dried fruits), other 

grain products (e.g., oat flakes), peanut and tree nut products, and seeds (processed) 

(provided that peanut and tree nut products, and seeds (processed) have been treated to 

significantly minimize pathogens);

• Making vinegar (including fermenting) from fruits and vegetables, other fruit and vegetable 

products (e.g., fruit wines, apple cider), and other grain products (e.g., malt); 

• Mixing/blending baked goods (e.g., cookie types), candy (e.g., varieties of taffy), cocoa 

beans (roasted), coffee beans (roasted), dried fruit and vegetable products (e.g., raisins, dried 
5 

currants and dried blueberries), dried herbs and other spices (e.g., dried intact basil and dried 

intact oregano), honey (pasteurized), milled grain products (e.g., flour, bran, corn meal), 

other fruit and vegetable products (e.g., dried, sliced apples and dried sliced peaches); other 

grain products (e.g., different types of dried pasta), other herb and spice products (e.g., 

chopped or ground dried herbs, dried herb- or spice-infused honey, dried herb- or spiceinfused oils and/or vinegars), peanut and tree nut products, sugar/syrups, vinegar, any other 

processed food that does not require time/temperature control for safety (e.g., vitamins, 

minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid 

form); 

• Packaging (including modified atmosphere or vacuum packaging) baked goods, candy, 

cocoa beans (roasted), cocoa products, coffee beans (roasted), game meat jerky, gums/ 

latexes/ resins that are processed foods, honey (pasteurized), jams/ jellies/ preserves, milled 

grain products (e.g., flour, bran, corn meal), molasses and treacle, oils, other fruit and 

vegetable products (e.g., pitted, dried fruits; sliced, dried apples; snack chips), other grain 

products (e.g., popcorn), other herb and spice products (e.g., chopped or ground dried herbs), 

peanut and tree nut products, processed seeds, soft drinks and carbonated water, 

sugar/syrups, trail mix and granola, vinegar, any other processed food that does not require 

time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., 

bone meal) in powdered, granular, or other solid form);

• Packing/re-packing baked goods, candy, cocoa beans (roasted), cocoa products, coffee beans 

(roasted), game meat jerky, gums/ latexes/ resins that are processed foods, honey 

(pasteurized), jams/ jellies/ preserves, milled grain products (e.g., flour, bran, corn meal), 

molasses and treacle, oils, other fruit and vegetable products (e.g., flours made from 

legumes, pitted, dried fruits; sliced, dried apples; snack chips), other grain products (e.g., 

popcorn), other herb and spice products (e.g., chopped or ground dried herbs and herbal 

extracts), peanut and tree nut products, processed seeds, soft drinks and carbonated water, 

sugar/syrups, trail mix and granola, vinegar, any other processed food that does not require 

time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., 

bone meal) in powdered, granular, or other solid form);

• Pasteurizing honey; 

• Roasting/toasting baked goods (e.g., toasting bread for croutons); 

• Salting other grain products (e.g., soy nuts), peanut and tree nut products, processed seeds; 

• Sifting milled grain products (e.g., flour, bran, corn meal), other fruit and vegetable products 

(e.g., chickpea flour), peanut and tree nut products (e.g., peanut flour, almond flour); 

• Storing/holding (cold, ambient or controlled atmosphere) baked goods, candy, cocoa beans 

(roasted), cocoa products, coffee beans (roasted), game meat jerky, gums/ latexes/ resins that 

are processed foods, honey (pasteurized), jam/ jellies/ preserves, milled grain products (e.g., 

flour, bran, corn, meal), molasses and treacle, oils, other fruit and vegetable products (e.g., 

pitted dried fruits, sliced dried apples, snack chips), other grain products (e.g., popcorn), 

other herb and spice products, peanut and tree nut products, processed seeds, soft drinks and 

carbonated water, sugar/syrups, trail mix and granola, vinegar, any other processed food that 

does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary 

ingredients (e.g., bone meal) in powdered, granular, or other solid form).

 

 
6 

Table of Contents

Contributors .......................................................................................................................................... 2

Acknowledgements .............................................................................................................................. 2

Executive Summary .............................................................................................................................. 3

Table of Contents.................................................................................................................................. 6

List of Tables ........................................................................................................................................ 8

I. Background and Purpose ................................................................................................................... 9

A. Statutory and Regulatory Framework of the FDA Food Safety Modernization Act 

(FSMA) ..................................................................................................................................... 9

B. Approach to the Qualitative Risk Assessment ........................................................................... 10

C. Food Types That Are Out of Scope of the Qualitative Risk Assessment .................................. 11

D. Specific Questions to be Addressed in the RA .......................................................................... 12

E. Definitions of Low-Risk Activity and Low-Risk Activity/Food Combination ......................... 12

F. Data Limitations ......................................................................................................................... 13

II. Scope (Activity/food Combinations within the Scope of the RA) ................................................ 14

III. Hazard Identification .................................................................................................................... 23

IV. Hazard Characterization ............................................................................................................... 36

A. Biological Hazards .................................................................................................................... 36

B. Chemical Hazards – Non-Allergic-type Reactions .................................................................... 40

C. Chemical Hazards – Allergic-type Reactions ............................................................................ 41

D. Physical Hazards ........................................................................................................................ 42

V. Exposure Assessment .................................................................................................................... 43

A. Approach ................................................................................................................................... 43

B. Factors That Impact the Frequency and Levels of Contamination of the Food - Biological 

Hazards .................................................................................................................................... 44

1. Impact of water activity on growth of foodborne pathogens ................................................. 44

2. Impact of pH on growth of foodborne pathogens .................................................................. 45

3. Impact of temperature on growth of foodborne pathogens .................................................... 45

4. The impact of other factors on growth of foodborne pathogens ............................................ 46

5. Interaction of factors that impact the growth of foodborne pathogens .................................. 47

6. Inherent Controls for the Biological Hazards Relevant to This Risk Assessment ................. 47

7. Interventions to Control the Biological Hazards Relevant to This Risk Assessment ............ 48

8. Activities That Can Introduce, or Increase the Potential for, Biological Hazards Relevant to 

This Risk Assessment ................................................................................................................. 52

C. Factors That Impact the Frequency and Levels of Contamination of the Food – Chemical 

(including Radiological) and Physical hazards ....................................................................... 54

D. Frequency of Consumption and Amount of Food Consumed ................................................... 55

VI. Risk Characterization ................................................................................................................... 56

A. Approach ................................................................................................................................... 56

B. Qualitative Risk Characterization of Biological Hazards .......................................................... 56

C. Qualitative Risk Characterization of Chemical (including Radiological) and Physical 

Hazards .................................................................................................................................... 59

D. Characterizing Interventions with Respect to the Definition of Low-Risk Activity ................. 60

E. Characterizing Activity/Food Combinations ............................................................................. 61

VII. Conclusions ................................................................................................................................. 89

A. Answers to the Questions to be Addressed in This Risk Assessment ....................................... 89

B. Summary .................................................................................................................................... 97
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VIII. References .................................................................................................................................. 98

Appendix 1. Definitions Relevant to Activities of Farms and Farm Mixed-Type Facilities ........... 109

Appendix 2: Chronology of Technical and Scientific Reviews of the Qualitative Risk Assessment

 .......................................................................................................................................................... 111
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List of Tables

Table 1: Manufacturing, Processing, Packing, and Holding Activity/Food Combinations That 

May Be Conducted by Farm Mixed-type Facilities on Foods for Human Consumption, 

Excluding Those Always Within the Farm Definition ........................................................ 15

Table 2. Surveillance Information, Outbreak-Associated Foodborne Illness, 2009-2010 (CDC, 

2013) .................................................................................................................................... 24

Table 3. Primary RFR Reports for Human Food in Year 1 (FDA, 2011a) ........................................ 26

Table 4. Primary RFR Reports for Human Food in Year 2 (FDA, 2012b) ........................................ 26

Table 5. Primary RFR Reports for Human Food in Year 3 (FDA, 2013) .......................................... 26

Table 6. Primary RFR Reports for Human Food in Year 4 (FDA, 2014) .......................................... 27

Table 7. Potential Biological and Chemical Hazards That Are Reasonably Likely to Be 

Associated with the Food Categories Manufactured, Processed, Packed, or Held on a 

Farm Mixed-Type Facility ................................................................................................... 28

Table 8. Numbers of Illness and Numbers and Rates of Hospitalization and Death for 

Representative Foodborne Pathogens Identified in the Hazard Identification (Scallan et 

al., 2011) ............................................................................................................................... 36

Table 9. Inherent Controls for Biological Hazards ............................................................................. 47

Table 10. Examples of Interventions to Control Representative Biological Hazards ........................ 49

Table 11. Examples of Activities that Can Introduce, or Increase the Potential for, Biological 

Hazards ................................................................................................................................. 52

Table 12. Examples of Interventions and Activities that Can Affect Chemical Hazards .................. 55

Table 13. Ranking of Numbers of Illness for Representative Foodborne Pathogens Identified in 

the Hazard Identification (Scallan et al., 2011) .................................................................... 57

Table 14. Ranking of Rates of Hospitalization for Representative Foodborne Pathogens 

Identified in the Hazard Identification (Scallan et al., 2011) ............................................... 57

Table 15. Ranking of Rates of Death for Representative Foodborne Pathogens Identified in the 

Hazard Identification (Scallan et al., 2011) ......................................................................... 57

Table 16. Qualitative Risk Characterization of Representative Biological Hazards That Are 

Reasonably Likely to Be Associated With Foods Manufactured, Processed, Packed, or 

Held on a Farm Mixed-Type Facility* ................................................................................. 58

Table 17. Qualitative Risk Characterization of Chemical (including Radiological) and Physical 

Hazards That Are Reasonably Likely to Be Associated with Foods Manufactured, 

Processed, Packed, or Held on a Farm Mixed-Type Facility ............................................... 60

Table 18. Is an Activity/Food Combination Low Risk? ..................................................................... 62

Table 19. Why Certain Activity/Food Combinations Are Not Low Risk .......................................... 80

Chronology of Technical and Scientific Reviews of the Qualitative Risk Assessment ................... 111
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I. Background and Purpose

A. Statutory and Regulatory Framework of the FDA Food Safety Modernization Act 

(FSMA) 

On January 4, 2011, the FDA Food Safety Modernization Act (FSMA) (Public Law 111–353) was 

signed into law. Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, 

amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a new section 418 with the 

same name. Among other things, Section 418 requires facilities to evaluate the hazards that could 

affect food manufactured, processed, packed, or held by the facility, identify and implement 

preventive controls, monitor the performance of those controls, and maintain records of the 

monitoring. Section 418 is applicable to food facilities that are required to register under section 

415 of the FD&C Act (Registration of Food Facilities). The registration requirement in section 415 

of the FD&C Act does not apply to farms. However, it does apply to “farm mixed-type facilities,” 

which are establishments that are farms, but that also conduct activities outside the “farm” definition

that require the establishment to be registered. 

Section 103(c) of FSMA directs the Secretary of HHS to conduct a science-based risk analysis to 

cover “(i) specific types of on-farm packing or holding of food that is not grown, raised, or 

consumed on such farm or another farm under the same ownership, as such packing, and holding 

relates to specific foods; and (ii) specific on-farm manufacturing and processing activities as such 

activities relate to specific foods that are not consumed on that farm or on another farm under 

common ownership.” We previously issued for public comment a document entitled “Draft 

Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the 

Farm Definition) Conducted in a Facility Co-Located on a Farm” (Draft RA) (78 FR 3824, January 

16, 2013; Docket No. FDA-2012-N-1258). The activities listed in the Draft RA were those on-farm 

activities that were outside the farm definition as it existed at the time FSMA became law. 

Therefore at that time all such activities triggered the registration requirements of section 415 of the 

FD&C Act and, thus, would make an establishment subject to the new requirements of section 418 

of the FD&C Act and the mandatory inspection frequencies in section 421 of the FD&C Act. FDA 

has since revised the farm definition to include some of the listed activities within the farm 

definition, thereby narrowing the scope of the activity/food combinations that need to be considered 

in this risk assessment. (See Appendix 1 for the revised definition of “farm,” harvesting, holding, 

packing, and manufacturing/processing.) 

Section 103(c) of FSMA also requires that the Secretary of HHS consider the results of the sciencebased risk analysis and exempt certain facilities from the requirements in section 418 of the FD&C 

Act, and the mandatory inspection frequency in section 421 of the FD&C Act, or modify the 

requirements, as the Secretary determines appropriate, if such facilities are engaged only in specific 

types of on-farm manufacturing, processing, packing, or holding activities that the Secretary 

determines to be low risk involving specific foods the Secretary determines to be low risk. The 

exemptions or modifications would apply only to small businesses and very small businesses (as 

would be defined in the regulation implementing section 418). 

The purpose of this document is to satisfy these requirements of FSMA 103(c) for a science-based 

risk analysis covering certain manufacturing, processing, packing, and holding activities conducted 

on farms. Risk managers at FDA will consider the results of the risk analysis presented in this RA 
10 

in determining, in part, whether to establish any exemptions from, or modifications to, requirements 

that would otherwise apply to small or very small farm mixed-type facilities. 

Since issuing the Draft RA, we have considered the following information with respect to its impact 

on the Draft RA:

• Revisions that FDA proposed to definitions that affect the regulatory status of activities that 

take place on farm in rulemaking entitled “Current Good Manufacturing Practice and Hazard 

Analysis and Risk-Based Preventive Controls for Human Food,” (proposed human 

preventive controls rule; Docket No. FDA-2011-N-0920):

o Proposed rule, 78 FR 3646, January 16, 2013; 

o Supplemental notice of proposed rulemaking (79 FR 58524, September 29, 2014). 

• Comments submitted to Docket FDA-2012-N-1258 on the Draft RA; 

• Comments submitted to Docket FDA-2011-N-0920 on the proposed rule relevant to 

activities conducted on foods on farms; and

• A Food Processing Sector Study on domestic establishments co-located on farms, 

(Capogrossi et al., 2015), updated from the Food Processing Sector Study available in 2011 

(Muth et al., 2011). 

We revised the Draft RA as appropriate after considering all of this information. A summary of key 

changes in this final risk assessment compared to the draft risk assessment is available (FDA, 2015). 

B. Approach to the Qualitative Risk Assessment 

We focused on activity/food combinations that we identified as being conducted on farms (and, 

thus, might be conducted by farm mixed-type facilities), but we did not consider activity/food 

combinations that would be solely within the farm definition (such as growing, harvesting and 

packing fruits and vegetables on farm) and, thus, are not relevant to the requirements of section 103 

of FSMA. 

We focused on considering the risk of activity/food combinations rather than separately considering 

the risk of specific food categories because doing so would better enable us to focus on whether a 

specific manufacturing, processing, packing, or holding activity conducted on food by a farm 

mixed-type facility warranted an exemption from, or modified requirements for, the provisions of 

section 418 of the FD&C Act. 

The decision before FDA was in part to determine the need for preventive controls required by 

section 418 of the FD&C Act for small and very small farm mixed-type facilities. Therefore, in this 

RA we assessed whether the types of controls that would be required by section 418 of the FD&C 

Act are needed to ensure the safety of the food manufactured, processed, packed, or held by small or 

very small farm mixed-type facilities in light of the regulatory framework that would apply to such 

facilities that would become exempt from, or subject to modified requirements for, the requirements 

for hazard analysis and risk-based preventive controls that would be established under section 418 

of the FD&C Act. Examples of the types of controls that facilities may implement under section 

418 include process controls (where a process is used to significantly minimize or prevent a hazard), 

sanitation controls, and food allergen controls. The regulatory framework that would apply to small 

or very small farm mixed-type facilities includes FDA’s long-standing current good manufacturing 

practice (CGMP) requirements for manufacturing, packing, or holding human food and the 

adulteration provisions of section 402 of the FD&C Act. Any classification of an activity/food 
11 

combination as “low risk” should not be interpreted to suggest that facilities engaged in these 

activities do not have an obligation to ensure the safety of the food they manufacture, process, pack, 

or hold; such facilities must comply with applicable requirements of the FD&C Act and its 

implementing regulations, including CGMP requirements. 

C. Food Types That Are Out of Scope of the Qualitative Risk Assessment 

The following foods are not within the scope of this RA: 

• Baked goods that require time/temperature control for safety (e.g., cream-filled pastries)

• Eggs;

• Game meat and game meat products that require time/temperature control for safety; 

• Honey infused with fresh herbs1

; 

• Low-acid2

 cut fruits and vegetables; 

• Milk and milk products (e.g., butter, cheese, cream, and ice cream mixes); and

• Oils infused with fruits and vegetables with pH>4.6 or with fresh herbs (e.g., fresh garlic in 

oil)3. 

All of these food types require one or more preventive controls (e.g., heat treatment, 

time/temperature control for safety) to significantly minimize or prevent a hazard that is reasonably 

likely to cause serious adverse health consequences or death. (For additional discussion regarding 

foods that require time/temperature control for safety, see FDA’s Model Food Code (FDA, 2013a).) 

Additionally, we considered that when a food requires refrigeration to control pathogens (Institute of 

Food Technologists, 2001b; FDA, 2013d; FDA, 2013b; FDA, 2013e; FDA, 2013c), temperature 

control is necessary at all steps, and therefore no activity involving such food would be low risk. 

Thus, activities involving baked goods that require time/temperature control for safety, eggs, game 

meat and game meat products that require time/temperature control for safety, honey infused with 

fresh herbs, low-acid cut produce, milk and a number of milk products, and oils infused with fruits 

and vegetables with pH>4.6 or with fresh herbs could not be considered low-risk activity/food 

combinations, and we eliminated these foods and on-farm activities that applied solely to them (e.g., 

churning, curing, eviscerating) from further consideration. 

In addition, based on the statutory framework of FSMA, activities solely related to the production of 

seafood, juice, dietary supplements, and alcoholic beverages are outside the scope of this RA and 

activities related to low-acid canned foods are within the scope of the RA only with respect to 

chemical (including radiological) and physical hazards. 

 

1 Fresh herbs have a moisture content that could allow sporeforming pathogens such as C. botulinum to grow in an 

anaerobic environment; honey could create such an environment. 

2 Low-acid foods have a pH greater than 4.6; acid foods are those that have a natural pH of 4.6 or below. This pH has 

long been used to separate foods that may support growth of C. botulinum from those that do not. However, other 

pathogens are capable of growing at pH values of 4.6 or below, e.g., E. coli O157:H7 (Conner and Kotrola, 1995) and 

Salmonella (Chung and Goepfert, 1970; Jung and Beuchat, 2000) have been shown to grow at pH 4.0 in laboratory 

media under certain conditions. The minimum pH at which growth of pathogens occurs is higher in foods than the 4.0 

minimum in laboratory media; the Food Code considers foods with a pH<4.2 to not require time/temperature control for 

safety (non-TCS food) (Food Code 2013d). 3 Fruits and vegetables with pH>4.6, including fresh herbs, in oil provide conditions (e.g., aw and anaerobic conditions) 

that present a risk of toxin production by C. botulinum (Nummer et al., 2011; Solomon et al. 1991).
12 

D. Specific Questions to be Addressed in the RA

Question 1: What are the foods that would be manufactured, processed, packed, or held by a farm 

mixed-type facility?

Question 2: What are the activities that might be conducted by farm mixed-type facilities on those 

foods? 

Question 3: What are the known or reasonably foreseeable hazards4 associated with the foods 

manufactured, processed, packed, or held by a farm mixed-type facility? 

Question 4: For the purpose of determining whether an activity/food combination is low risk, which 

hazards should be considered to have a reasonable probability of causing serious adverse health 

consequences or death? 

Question 5: For the purpose of determining whether an activity/food combination is low risk, what 

foods have inherent controls that significantly minimize or prevent in these foods a hazard that is a 

known or reasonably foreseeable biological hazard and that is reasonably likely to cause serious 

adverse health consequences or death?

Question 6: What interventions significantly minimize or prevent in these foods a hazard that is a 

known or reasonably foreseeable hazard and that is reasonably likely to cause serious adverse health 

consequences or death? 

Question 7: Which of these activities are reasonably likely to introduce, or increase the potential 

for occurrence of, hazards that are reasonably likely to cause serious adverse health consequences or 

death and what are these hazards?

Question 8: Which of these activities are interventions to significantly minimize or prevent hazards 

that are reasonably likely to cause serious adverse health consequences or death from consumption 

of these foods? 

Question 9. Which activity/food combinations are low risk? 

E. Definitions of Low-Risk Activity and Low-Risk Activity/Food Combination 

For the purpose of the analysis required by section 103(c)(1)(C) of FSMA, we are defining “lowrisk activity” and “low-risk activity/food combinations” as follows. 

• We are defining “low-risk activity” to mean an activity that:

1. Is performed on, or during production of, a food that has inherent controls for 

foodborne pathogens, provided that the food does not require preventive controls to 

significantly minimize or prevent other types of hazards (e.g., a chemical hazard such 

as mycotoxins); or 

2. Satisfies both of the following criteria:

 

4 A known or reasonably foreseeable hazard is a biological, chemical (including radiological), or physical hazard that is 

known to be, or has the potential to be, associated with the facility or the food.
13 

a) Is not reasonably likely to introduce (or increase the potential for) a hazard 

for which there is a reasonable probability that use of, or exposure to, the food 

will cause serious adverse health consequences or death to humans (a 

SAHCODH hazard); and

b) Does not significantly minimize or prevent a SAHCODH hazard. 

• We are defining “low-risk activity/food combination” to mean a low-risk activity that applies 

to a specific food. 

For the purpose of this analysis, we: 

• Refer to the above three parts of the definition of “low-risk activity” as:

o #1 (inherent controls); 

o #2a (activity not likely to introduce, or increase the potential for, a SAHCODH

hazard; and 

o #2b (activity does not significantly minimize or prevent a SAHCODH hazard).

• Use the term “inherent controls” to mean that in making the food the hazard is controlled, 

and it is highly unlikely that the food will be made in a way that the hazard is not adequately 

addressed. 

• Use the phrase “reasonably likely to cause serious adverse health consequences or death” to 

mean that there is a reasonable probability that use of, or exposure to, a food containing a 

hazard will cause serious adverse health consequences or death to humans. It is important to 

note that our conclusions in this document with respect to whether there is a reasonable 

probability that use of, or exposure to, a food containing a hazard will cause serious adverse 

health consequences or death to humans are limited to the purposes of this document. In this 

document, we are considering such hazards and foods in general terms, on a forward-looking 

basis, and not in reference to a particular food contamination incident or foodborne-illness 

outbreak. Determinations of whether there is such a reasonable probability in specific 

situations may be different from the conclusions made for the limited purposes of this 

document. 

Importantly, under the definition of low-risk activity food combination, to be low risk the 

activity/food combination must either:

• Satisfy part #1; or 

• Satisfy both part #2a and part #2b. 

F. Data Limitations 

There are many limitations to the data used in this analysis. 

• Although the final RA considers the additional information, submitted to Docket Nos. FDA2012-N-1258 and FDA- 2011-N-0920, about activities conducted on farms, we continue to 

have limited data on the types of activity/food combinations specifically associated with 

small and very small farm mixed-type facilities, especially for foreign facilities.

• We lack data on the frequency and levels of contamination of the food and occurrences of 

serious adverse health consequences or death from hazards associated with manufacturing, 

processing, packing or holding activities conducted on foods by small and very small farm 
14 

mixed-type facilities. Thus, we relied in large part on our existing understanding of hazards 

(such as pathogens associated with food types) and processes in order to characterize risk. 

• The CDC data on biological and chemical hazards associated with foodborne illness is not 

limited to foods that are in the scope of this RA, nor are the data limited to reports of serious 

adverse health consequences or death.

• CDC illness data have limitations in that most cases of foodborne illness are sporadic and go 

unreported; many outbreaks go undetected; and the vehicle for a foodborne illness outbreak 

is often not identified. 

• Data on serious adverse health consequences or death from physical and chemical (including 

radiological) hazards associated with manufacturing, processing, packing or holding of food 

are limited, and there are no data of this kind associated specifically with manufacturing, 

processing, packing or holding activities conducted on foods by small and very small farm 

mixed-type facilities.

• We lack data to conduct a dose-response assessment, including for specific susceptible

populations, for hazard characterization for all pathogens in all foods, in particular for foods 

that may be manufactured, processed, packed, or held by small and very small farm mixedtype facilities, and especially for foreign facilities. 

• We lack data on the amount of food consumed per serving and the number of servings 

consumed annually for the food categories produced by small or very small farm mixed-type 

facilities within the scope of the RA, which is a limitation in conducting an exposure 

assessment. 

The lack of evidence associating occurrences of serious adverse health consequences or death with 

biological, chemical (including radiological) and physical hazards associated with manufacturing, 

processing, packing or holding activities conducted on foods by small and very small farm mixedtype facilities, along with the other data limitations noted above, are significant limitations of this 

RA.

II. Scope (Activity/food Combinations within the Scope of the RA) 

The scope of the RA is limited to an assessment of the risk of serious adverse health consequences 

or death from hazards associated with manufacturing, processing, packing or holding activities 

conducted on foods by small and very small farm mixed-type facilities, including both domestic and 

foreign facilities, to determine which activity/food combinations conducted by such facilities are 

low risk. 

The activity/food combinations considered within the scope of this RA are those that we identified 

as likely to be conducted by farm mixed-type facilities by: 

• Soliciting input from food safety and processing experts and economists within the Center 

for Food Safety and Applied Nutrition (FDA Memorandum, 2012d; FDA Memorandum, 

2002); 

• Requesting information from outside experts (FDA Memorandum, 2011a; FDA 

Memorandum, 2012b); 

• Conducting an Internet search on state requirements for on-farm marketing (farm-direct 

sales), farm stands and farmers’ markets (Washington State Department of Agriculture, 

2010; University of California Small Farm Program, 2005; Best, 2009; Oregon Department 

of Agriculture, 2009; Connecticut Department of Agriculture, 2009; Connecticut 
15 

Department of Agriculture, 2008; Connecticut Department of Agriculture, 2011; Leff, 2009; 

Massachusetts Department of Public Health, 2005; New York Department of Agriculture & 

Markets Agricultural Districts, 2010); and

• Considering information from a “Food Processing Sector Study” on co-location of farms 

with food processing facilities (“Food Processing Sector Study”). A 2011 version of this 

study was available for the purpose of the draft RA (Muth et al., 2011). For the final RA, 

we considered an updated Food Processing Sector Study (Capogrossi et al., 2015). 

We do not have specific data on activity/food combinations likely to be conducted by foreign farm 

mixed-type facilities, which may include activity/food combinations not considered here. 

FDA requested and received comments on other activity/food combinations that should be 

considered (Docket No. FDA-2012-N-1258, 78 FR 3824; and Docket FDA-2011-N-0920, 78 FR 

3646). We updated the Draft RA to reflect these additional activity/food combinations. 

If an expert or a reference identified an activity/food combination that is outside the scope of this 

RA (i.e., for activities conducted on alcoholic beverages, baked goods that require time/temperature 

control for safety, dietary supplements, eggs, game meat and game meat products that require 

time/temperature control for safety, honey infused with fresh herbs, juice, low-acid cut fruits and 

vegetables, milk and milk products, oils infused with fruits and vegetables with pH>4.6 or with 

fresh herbs, or seafood ), we did not include that activity/food combination in the list. We also did 

not include activity/food combinations (e.g., manufacturing pet food) that are solely related to food 

for animals or activity/food combinations (e.g., applying pesticides prior to harvest, 

drying/dehydrating grapes to produce raisins) that are always within the farm definition. 

Table 1 lists the resulting activity/food combinations that we identified as likely to be conducted by 

farm mixed-type facilities. Table 1: 

• Does not include activity/food combinations that are always within the farm definition (e.g., 

growing fruits and vegetables, drying/dehydrating raw agricultural commodities (RACs) 

without additional manufacturing/processing, such as drying grapes to make raisins). 

• Includes activities that encompass multiple steps (e.g., making jams, jellies and preserves 

may involve steps such as cutting, mashing, boiling, mixing, and canning) and groups these 

steps to better identify the end product. As such, activities that are encompassed within the 

making of a particular product are not listed as separate activities within the table. (For 

example, because making syrup includes boiling sap, boiling sap is not listed as a separate 

activity.) 

• Breaks the broad categories of foods into smaller groups. These smaller groups are denoted 

by footnotes in the table (on first mention), and are described within their broader food 

categories at the end of the table. 

Table 1: Manufacturing, Processing, Packing, and Holding Activity/Food Combinations That 

May Be Conducted by Farm Mixed-type Facilities on Foods for Human Consumption, 

Excluding Those Always Within the Farm Definition

Activity Food 

Acidification/Pickling/Fermenting Fruits and vegetables
16 

Activity Food 

Boiling Fruits and vegetables; gums, latexes, and 

resins; peanuts

Canning/bottling/jarring (packaging that includes

additional manufacturing/processing)

Fruits and vegetables

Chopping/Coring/Cutting/Peeling/

Pitting/Shredding/Slicing

Baked goods (e.g., to make bread crumbs); 

dried fruit and vegetable products that are 

processed foods; dried herbs and other 

spices that are processed foodsa

; fresh 

herbs; fruits and vegetables; game meat 

jerky; gums, latexes, and resins; other 

grain products that are processed foods 

(e.g., making cereal crumbs); peanuts and 

tree nuts; peanut and tree nut products that 

are processed foods

Coating (other than coating fruits and vegetables with 

wax/oil/resin)

Dried fruit and vegetable products that are 

processed foods; fruits and vegetables

(e.g., adding caramel to apples, coating 

strawberries and raisins with chocolate);

other fruit and vegetable products that are 

processed foodsa (e.g., coating dried plum 

pieces, dried pitted cherries, and dried 

pitted apricots with chocolate, coating 

apples on a stick with caramel); other grain 

products that are processed foods (e.g., 

popcorn); peanuts and tree nuts; and 

peanut and tree nut products that are 

processed foodsa (e.g., adding seasoning1)

Cooking Fruits and vegetables

Dehydration/ Drying (that includes additional 

manufacturing/processing or is performed on 

processed foods)

Other fruit and vegetable products that are 

processed foods (e.g., cut acid fruits and 

vegetables); other herb and spice products 

that are processed foodsa 

Extracting (including by pressing, by distilling, by 

solvent extraction) 

Dried herbs and other spices that are 

processed foods; fresh herbs; fruits and 

vegetables (e.g., olives, avocados); grainsb; 

other herb and spice products that are 

processed foods 

Freezing Fruits and vegetables; other fruit and 

vegetable products that are processed 

foods
17 

Activity Food 

Grinding/Milling/Cracking/Crushing Baked goods (e.g., crackers); cocoa beans

(roasted); coffee beans (roasted); dried 

fruit and vegetable products that are 

processed foods; dried herbs and other 

spices that are processed foods; grains; 

other fruit and vegetable products that are 

processed foods (e.g., dried, pitted dates); 

other grain products that are processed 

foods; other herb and spice products that 

are processed foods; peanuts and tree nuts; 

peanut and tree nut products that are 

processed foods 

Labeling Baked goodsb; candyc; cocoa beans

(roasted); cocoa products; coffee beans 

(roasted); game meat jerky; gums, latexes, 

and resins that are processed foods; honey 

(pasteurized); jams, jellies, and preserves; 

milled grain productsb; molasses and 

treacle; oils; other fruit and vegetable

products that are processed foodsa; other 

grain products that are processed foodsb

; 

other herb and spice products that are 

processed foods; peanut and tree nut

products that are processed foods; seeds 

for direct consumption that are processed 

foodsa; soft drinks and carbonated water; 

sugar; syrups; trail mix and granolac; 

vinegar; any other processed food that 

does not require time/temperature control 

for safety (e.g., vitamins, minerals, and 

dietary ingredients (e.g., bone meal) in 

powdered, granular, or other solid form).

Making baked goods (including mixing, baking) Milled grain products 

Making candy (including boiling, evaporation, 

mixing)

Peanuts and tree nuts (e.g., nut brittles); 

sugar; syrups; saps (e.g., maple candy)

Making cocoa products (including grinding, mixing, 

conching, tempering)

Cocoa beans (roasted)

Making dried pasta Grains

Making jams/jellies/preserves from acid fruits and 

vegetables (including cutting/mashing, boiling, 

mixing, canning)

Fruits and vegetables (e.g., rhubarb, 

strawberries) 

Making jams/jellies/preserves from low-acid fruits and 

vegetables (including cutting/mashing, boiling, 

mixing, canning)

Fruits and vegetables

Making molasses and treacle (including extracting, 

boiling, concentrating, evaporating)

Sugar beets, sugarcane
18 

Activity Food 

Making oat flakes Grains

Making popcorn Grains

Making snack chips Fruits and vegetables

Making soft drinks and carbonated water (including 

flavoring, carbonating)

Sugar; syrups; water

Making syrups and sugars (including extracting, 

boiling, concentrating, evaporating) 

Fruits and vegetables (e.g., dates); grains 

(e.g., rice, sorghum); other grain products 

that are processed foods (e.g., malted 

grains such as barley); sap (e.g., agave, 

birch, maple, palm); sugar beets; sugarcane 

Making trail mix or granola Cocoa products (e.g., chocolate); dried 

fruit and vegetable products that are 

processed foodsa

; other fruit and vegetable 

products that are processed foods; other 

grain products that are processed foods; 

peanuts and tree nuts; peanut and tree nut 

products that are processed foods; seeds 

for direct consumption; seeds for direct 

consumption that are processed foods 

Making vinegar (including fermenting) Fruits and vegetables; other fruit and 

vegetable products that are processed 

foods (e.g., apple cider, fruit wines); other 

grain products that are processed foods 

(e.g., malt)

Malting Grains

Mixing/Blending Baked goods; candy (e.g., hard candy, 

fudge, maple candy, maple cream, nut 

brittles, taffy, and toffee); cocoa beans 

(roasted); coffee beans (roasted); dried 

fruit and vegetable products that are 

processed foods (e.g., different types of 

raisins); dried herbs and other spices that 

are processed foods; honey (pasteurized);

milled grain products; other fruit and 

vegetable products that are processed 

foods; other grain products that are 

processed foods; other herb and spice 

products that are processed foods; peanut

and tree nut products that are processed 

foods; sugar; syrups; vinegar; any other 

processed food that does not require 

time/temperature control for safety (e.g., 

vitamins, minerals, and dietary ingredients 

(e.g., bone meal) in powdered, granular, or 

other solid form)
19 

Activity Food 

Packaging (including modified atmosphere or vacuum

packaging)5

Baked goods; candy; cocoa beans (roasted) 

and cocoa products; coffee beans (roasted);

game meat jerky; gums, latexes, and resins 

that are processed foods; honey 

(pasteurized); jams, jellies and preserves; 

milled grain products; molasses and 

treacle; oils; other fruit and vegetable 

products that are processed foods; other 

grain products that are processed foods; 

other herb and spice products that are 

processed foods; peanut and tree nut

products that are processed foods; seeds 

for direct consumption that are processed 

foods; soft drinks and carbonated water; 

sugar; syrups; trail mix and granola; 

vinegar; any other processed food that 

does not require time/temperature control 

for safety (e.g., vitamins, minerals, and 

dietary ingredients (e.g., bone meal) in 

powdered, granular, or other solid form).

Packing/Re-Packing, including activities incidental to 

packing/re-packing (e.g., activities performed for the 

safe or effective packing of that food) 

Baked goods; candy; cocoa beans (roasted) 

and cocoa products; coffee beans (roasted); 

game meat jerky; gums, latexes, and resins 

that are processed foods; honey 

(pasteurized); jams, jellies and preserves; 

milled grain products; molasses and 

treacle; oils; other fruit and vegetable 

products that are processed foods; other 

grain products that are processed foods; 

other herb and spice products that are 

processed foods; peanut and tree nut

products that are processed foods; seeds 

for direct consumption that are processed 

foods; soft drinks and carbonated water; 

sugar; syrups; trail mix and granola; 

vinegar; any other processed food that 

does not require time/temperature control 

for safety (e.g., vitamins, minerals, and 

dietary ingredients (e.g., bone meal) in 

powdered, granular, or other solid form).

Pasteurizing Honey

 

5 Modified atmosphere and vacuum packaging can create an environment conducive to growth of C. botulinum in TCS 

foods; however, such foods are out of scope of this risk assessment.
20 

Activity Food 

Roasting/toasting Baked goods (e.g., toasting bread for 

croutons); cocoa beans; coffee beans; 

grains (e.g., soybeans) peanuts and tree 

nuts; seeds for direct consumption; 

Salting Peanut and tree nut products that are 

processed foods; seeds for direct 

consumption that are processed foods 

Sifting Milled grain products; other fruit and 

vegetable products that are processed 

foods (e.g., chickpea flour); peanut and 

tree nut products that are processed foods 

(e.g., peanut flour, almond flour) 

Storing/Holding (Cold, ambient or controlled 

atmosphere), including activities incidental to holding 

(e.g., activities performed for the safe or effective 

storage of that food and activities performed as a 

practical necessity for the distribution of that food) 

Baked goods; candy; cocoa beans (roasted) 

and cocoa products; coffee beans (roasted); 

game meat jerky; gums, latexes, and resins 

that are processed foods; honey 

(pasteurized); jams, jellies and preserves; 

milled grain products; molasses and 

treacle; oils; other fruit and vegetable 

products that are processed foods; other 

grain products that are processed foods; 

other herb and spice products that are 

processed foods; peanut and tree nut

products that are processed foods; seeds 

for direct consumption that are processed 

foods; soft drinks and carbonated water; 

sugar; syrups; trail mix and granola; 

vinegar; any other processed food that 

does not require time/temperature control 

for safety (e.g., vitamins, minerals, and 

dietary ingredients (e.g., bone meal) in 

powdered, granular, or other solid form).

Sulfiting Fruits and vegetables

a Fruits and Vegetables and their Products 

Examples of dried fruit and vegetable products that are processed foods include raisins, unpitted dried plums, and 

dried legumes. This category includes only dried fruit and vegetable products that have been made without additional 

manufacturing/processing other than: (1) drying that creates a distinct commodity, (2) packaging, and/or (3) labeling. 

The drying, packaging, and labeling of these products is within the farm definition and these activity/food combinations 

are out of scope of the risk assessment. 

Examples of other fruit and vegetable products that are processed foods include those that have undergone one or 

more of the following processes: acidification, boiling, canning, coating with things other than wax/oil/resin, cooking, 

cutting, chopping, grinding, peeling, shredding, slicing, or trimming. Examples include caramel apples, flours made 

from legumes (such as chickpea flour), pickles, and snack chips made from potatoes or plantains. This category does 

not include dried fruit and vegetable products that have been made without additional manufacturing/processing other 

than: (1) drying/dehydrating that creates a distinct commodity, (2) packaging, and/or (3) labeling (e.g., raisins). 

Examples of dried fruit and vegetable products made with additional manufacturing/processing include dried apple 

slices; pitted, dried plums, cherries, and apricots; and sulfited raisins. 
21 

Examples of peanut and tree nut products that are processed foods include roasted peanuts and tree nuts, seasoned 

peanuts and tree nuts, and peanut and tree nut flours. 

Examples of seeds for direct consumption that are processed foods include roasted pumpkin seeds, roasted sunflower 

seeds, and roasted flax seeds. (By contrast, the raw (unroasted) seeds are examples of seeds for direct consumption.) 

For purposes of this risk assessment, we treat seeds for direct consumption as within the fruit and vegetable category 

when used for direct consumption, and within the grains category when used as a grain.

Examples of dried herbs and other spices that are processed foods include intact dried basil, intact dried bay leaves, 

and intact dried mint. This category includes only dried herbs and other spices that have been made without additional 

manufacturing/processing other than: (1) drying/dehydrating that creates a distinct commodity, (2) packaging, and/or (3) 

labeling. The drying, packaging, and labeling of these products is within the farm definition and these activity/food 

combinations are out of scope of the risk assessment. 

Examples of other herb and spice products that are processed foods include chopped fresh herbs, chopped or ground 

dried herbs (including tea), herbal extracts (e.g., essential oils, extracts containing >20% ethanol, extracts containing 

>35% glycerin), dried herb- or spice-infused honey, and dried herb- or spice-infused oils and/or vinegars. This category 

excludes those dried herbs and other spices made without additional manufacturing/processing other than: (1)

drying/dehydrating that creates a distinct commodity, (2) packaging, and/or (3) labeling.

b Grain and Grain Products 

Examples of food grains include barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, 

buckwheat and oilseeds for oil extraction (e.g., cotton seed, flax seed, rapeseed, soybean, and sunflower seed). 

Examples of milled grain products include flour, bran, and corn meal. 

Examples of baked goods include breads, brownies, cakes, cookies, and crackers.

Examples of other grain products that are processed foods include dried cereal, dried pasta, malt, oat flakes, popcorn, 

and soy nuts.

c Other Processed Foods 

Other processed foods include candy; honey (pasteurized); jams, jellies, and preserves; oils (e.g., olive, avocado); soft 

drinks and carbonated water; trail mix and granola; vinegar 

Examples of trail mix and granola include combinations of dried fruit, dried cut fruit, peanuts, tree nuts, seeds for 

direct consumption, seeds for direct consumption that are processed foods, other grains that are processed foods (e.g., 

oat flakes), and/or other ingredients such as chocolate. 

Examples of candy include hard candy, fudge, maple candy, maple cream, nut brittles, taffy, and toffee. 

1 (By “seasoning” we mean addition of herbs, spices, sugar, honey, soy sauce, pepper sauce or other ingredients to 

enhance flavor.) 

FDA believes that Table 1includes most of the activity/food combinations (except for those always 

within the farm definition) that are conducted by farm mixed-type facilities on foods that are within 

the scope of the RA. However, based on the study on co-location of farms with food processing 

facilities, we acknowledge that Table 1may not include all such activity/food combinations. For 

example, the Food Processing Sector Study classifies 96 small and very small facilities co-located 

on farms that produce “Food Preparations, Not Elsewhere Classified” (Capogrossi et al., 2015). The 

SIC code (Standard Industrial Classification code from Dun & Bradstreet) for this category lists 

more than a dozen foods for which we are unable to determine the specific foods produced by the 

small and very small facilities co-located on farms. Thus, Table 1may not include activity/food 

combinations for these facilities. 

In addition, Table 1does not include certain activity/food combinations identified in the study on 

co-location of farms with food processing facilities as being conducted at an establishment colocated on a farm because the raw materials or other ingredients, the specific steps involved, or the 

actual product made on-farm are unknown, e.g., making flavored syrups, concentrates, fruit juices (1 
22 

establishment), refining and blending fats and oils (3 establishments), making frozen specialties not 

elsewhere classified (e.g., meals and pizzas, 2 establishments) (Capogrossi et al., 2015). 

The list of activity/food combinations likely to be conducted at farm mixed-type facilities contains 

the food categories that are within the scope of the RA (see the second column in Table 1). We 

grouped these food categories6 as follows: 

• Baked goods (other than those requiring time/temperature control for safety)

• Candy

• Cocoa beans 

• Cocoa products (e.g., chocolate, cocoa powder and cocoa butter)

• Coffee beans 

• Dried fruit and vegetable products that are processed foods (e.g., raisins, unpitted dried 

plums) 

• Dried herbs and other spices that are processed foods (e.g., intact dried basil, intact dried bay 

leaves, intact dried mint) 

• Fresh herbs7

• Fruits and vegetables (as described immediately below). Note that, for the purpose of this 

analysis, we separately consider several foods (i.e., coffee beans, cocoa beans, fresh herbs, 

peanuts, sugarcane, sugar beets, tree nuts, seeds for direct consumption) that are within the 

category of fruits and vegetables to appropriately address specific hazards associated with 

these foods and/or processing activities conducted on these foods 

• Game meat jerky

• Grains as described immediately below (e.g., corn, wheat, barley, rye, grain sorghum, oats, 

rice, wild rice, oilseeds [e.g., soybeans]). (Note that, for the purposes of this analysis, some 

oilseeds may also be considered to be in the category of fruits and vegetables when 

consumed directly, e.g., sunflower seeds.) 

• Gums, latexes, and resins 

• Honey 

• Jams, jellies, and preserves

• Milled grain products (flour, bran, corn meal) 

• Molasses and treacle

• Oils

• Other fruit and vegetable products that are processed foods (other than low-acid cut fruits 

and vegetables) (e.g., dried apple slices; pitted, dried fruits, flours made from legumes) 

• Other grain products that are processed foods (dried cereal, dried pasta, malt, oat flakes, 

popcorn, and soy nuts) 

• Other herb and spice products that are processed foods (e.g., chopped fresh herbs, chopped 

or ground dried herbs, and herbal extracts) 

• Peanuts and tree nuts (e.g., almonds, walnuts) 

 

6 Note that the food categories include some foods that may be produced within the farm definition, (e.g., fresh herbs, 

dried fruit and vegetable products that are processed foods, gums/resins/latexes, honey) because of the activities farm 

mixed-type facilities perform on these foods that may be low-risk activity/food combinations. The food categories also 

include some non-TCS foods (e.g., game meat jerky) made from foods that are out of scope (e.g., game meat), because 

of the activities (e.g., cutting and packaging) that farm mixed-type facilities perform on the non-TCS foods. 7

 For the purpose of this risk assessment we include tea (Camellia sinensis) as an herb. 
23 

• Peanut and tree nut products that are processed foods (e.g., roasted peanuts and tree nuts, 

seasoned peanuts and tree nuts, and peanut and tree nuts flours) 

• Sap (for making syrup, e.g., agave, birch, maple, palm) and the syrups made from them

• Seeds for direct consumption 

• Seeds for direct consumption that are processed foods (e.g., roasted pumpkin seeds, roasted 

sunflower seeds, roasted flax seeds)

• Soft drinks and carbonated water 

• Sugarcane, sugar beets and sugar 

• Trail mix and granola

• Vinegar

• Any other processed food that does not require time/temperature control for safety (e.g., 

vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other 

solid form) 

For the purpose of this document, a fruit is the edible reproductive body of a seed plant or tree nut 

(such as apple, orange and almond) such that fruit means the harvestable or harvested part of a plant 

developed from a flower. For the purpose of this document, a vegetable is the edible part of an 

herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as white 

button or shiitake) grown for an edible part such that vegetable means the harvestable or harvested 

part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, 

leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as basil or 

cilantro). Examples of fruits and vegetables are apples, apricots, avocados, bananas, berries, 

broccoli, cabbage, cantaloupe, carrots, cauliflower, celery, cherries, citrus, cucumbers, garlic, 

grapes, green beans, herbs (such as basil, chives, cilantro, mint, oregano, and parsley), honeydew, 

kiwifruit, lettuce, mangos, mushrooms, onions, papaya, peaches, pears, peas, peppers, pineapple, 

plums, radish, scallions, snow peas, spinach, sprouts, squash, tomatoes, and watermelon. 

For the purposes of this document, “grains” means the small, hard fruits or seeds of arable crops, or 

the crops bearing these fruits or seeds, that are primarily grown and processed for use as meal, flour, 

baked goods, cereals and oils rather than for direct consumption as small, hard fruits or seeds 

(including cereal grains, pseudo cereals, oilseeds and other plants used in the same fashion). 

Examples of food grains include barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, 

amaranth, quinoa, buckwheat and oilseeds for oil extraction (e.g., cotton seed, flax seed, rapeseed, 

soybean, and sunflower seed). 

III. Hazard Identification 

The purpose of the Hazard Identification step of a food safety risk assessment is to identify the 

hazards of concern. The scope of this RA requires consideration of the broad range of biological, 

chemical (including food allergens, drug residues, unapproved food and color additives, and 

radiological hazards) and physical hazards that are relevant to a farm mixed-type facility under 

section 418 of the FD&C Act. Whether or not a hazard can cause adverse health effects in an 

individual depends on the host, the agent and the environment. For our purposes, we are interested 

in identifying (based on sources such as illness data, the scientific literature, and the Reportable 

Food Registry), the hazards that are reasonably likely to cause adverse effects. To identify the 

hazards of concern, we initially considered surveillance information, available from CDC, on 

biological and chemical hazards associated with outbreaks of foodborne illness, even though this 

surveillance information covers a broader range of foods than those that are in the scope of this RA 
24 

and is not limited to reports of serious adverse health consequences (i.e., serious illness or death). 

For example, the CDC surveillance information includes reports of foodborne illness: 

• From consumption of eggs, milk products, and seafood, which are outside the scope of this 

RA; 

• Associated with pathogens (such as norovirus) that have low rates of hospitalization or 

death (see the discussion of norovirus in the Hazard Characterization section of this RA); 

• Associated with pathogens (such as Toxoplasma gondii) that are primarily germane to foods 

that are outside the scope of this RA; 

• Associated with biological hazards likely to have been introduced at retail or foodservice 

operations rather than through manufacturing, processing, packing or holding food prior to 

retail or foodservice operations. 

The vast majority of hazards identified in the CDC outbreak surveillance information that are 

reasonably likely to cause serious adverse health consequences or death from foods, including foods 

that are manufactured, processed, packed, or held on a farm mixed-type facility, are biological 

hazards - i.e., foodborne pathogens and their toxins (CDC, 2013; Muth et al., 2011) (see Table 2). 

During the period 2009-2010, chemical hazards (such as natural toxins (e.g., mycotoxins)) 

accounted for only approximately one percent of mean annual illnesses associated with outbreaks 

(CDC, 2013), and more than two-thirds of these chemical-related outbreaks were due to seafood 

toxins (e.g., scombrotoxin/histamine, ciguatoxin) that are outside the scope of this RA (because 

seafood is outside the scope of this RA). 

Table 2. Surveillance Information, Outbreak-Associated Foodborne Illness, 2009-2010 (CDC, 

2013) 

Hazard Total

Outbreaks 

(No.) 

Total

Outbreaks 

(Percent)

Total

Illnesses 

(No.) 

Total

Illnesses 

(Percent)

Comments

Biological: 

Bacterial 

pathogens 

480 47 13,127 45 Examples of bacterial 

foodborne pathogens 

include L. 

monocytogenes, E. coli

O157:H7, Salmonella

spp., and C. botulinum. 

Biological: 

Viral 

pathogens 

497 49 9,825 33 Examples of viral 

foodborne pathogens 

include norovirus and 

hepatitis A virus. 

Biological: 

Parasites

2 0 13 0 E.g., Cryptosporidium

Chemical 

(excluding 

food 

allergens)

43 4 209 1 E.g., natural toxins such 

as mycotoxins. 

Viral pathogens account for an estimated 5.5 million foodborne illnesses each year, with norovirus 

responsible for most foodborne illnesses on an annual basis (58 percent) (Scallan et al., 2011). 
25 

Among the bacterial pathogens causing foodborne illnesses, the three most common are Salmonella

spp. (11 percent), Clostridium perfringens (10 percent) and Campylobacter spp. (9 percent) (Scallan 

et al., 2011). Other bacterial pathogens causing relatively large numbers of illness include Bacillus 

cereus, E. coli O157:H7, non-O157 Shiga-toxin producing E. coli, Shigella spp., Staphylococcus 

aureus, and Yersinia enterocolitica (Scallan et al., 2011). 

For the purpose of this RA, we selected several pathogens we consider representative of the food 

types identified as being manufactured, processed, packed, or held by farm mixed-type facilities. 

We are not considering several of the foodborne pathogens commonly associated with foodborne 

illness because they are not representative of pathogens associated with the foods that are within the 

scope of the RA. The foodborne pathogens we are not considering further are C. perfringens

(because it is largely associated with temperature abuse of prepared foods (FDA, 2012a)); 

Campylobacter spp. and Yersinia enterocolitica (because they are largely associated with animal 

products that are out of scope of this RA (FDA, 2012a)); and Shigella (because it is largely 

transmitted through fecally contaminated water and unsanitary handling by food handlers (FDA, 

2012a) and because other biological hazards being considered (e.g., norovirus and hepatitis A virus) 

can be considered representative of this type of biological hazard).

The CDC surveillance information does not include reports of illness or injury due to consumption 

of food products contaminated with physical hazards. The CDC surveillance information also does 

not include reports of illness or injury due to consumption of food products contaminated with the 

subset of chemical hazards that are food allergen hazards. For the purpose of this RA, we consider 

food allergen hazards to be the major food allergens as defined in section 201(qq) of the FD&C 

Act.8

 To supplement the CDC surveillance information with information about the frequency of 

consumption of food contaminated with physical hazards or food allergen hazards, we considered 

information about primary reports to the RFR regarding human food available from the Reportable 

Food Registry Annual Reports. 

Table 3, Table 4, Table 5, and Table 6 provide information obtained from 4 years, Year 1 

(September 8, 2009 through September 7, 2010); Year 2 (September 8, 2010-September 7, 2011), 

Year 3 (September 8, 2011-September 7, 2012), and Year 4 (September 8, 2012-September 7, 

2013), respectively (FDA, 2011a; 2012b; 2013; 2014). To provide context relevant to the CDC 

surveillance information, these tables include summary information about all primary reports 

associated with multiple biological hazards in human food, even though the RFR Annual Reports 

separately report information regarding specific biological pathogens (e.g., L. monocytogenes, 

Salmonella). As with the CDC surveillance information, the information in Table 3, Table 4, Table 

5, and Table 6 includes information about foods (e.g., eggs, milk products, and seafood) that are 

outside the scope of this RA. In contrast to the CDC surveillance information, the information in 

Table 3, Table 4, Table 5, and Table 6 is limited to reports of hazards that are reasonably likely to

cause serious adverse health consequences or death. 

 

8 Section 403(w) of the FD&C Act establishes the circumstances under which food is considered misbranded if it is, or it 

contains an ingredient that bears or contains, a major food allergen. Section 201(qq) defines the term “major food 

allergen” to mean any of the following: milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, 

lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans, or a food ingredient that 

contains protein derived from one of these foods, with certain exceptions.
26 

Table 3. Primary RFR Reports for Human Food in Year 1 (FDA, 2011a) 

Hazard Number of Primary RFR 

Reports for Human Food

Percent of Primary RFR 

Reports for Human 

Food*

Biological (including E. coli

O157:H7, L. monocytogenes, 

Salmonella) 

112 56

Undeclared food allergens 69 34

Undeclared sulfites 11 5.5

Physical 0 0

Total 192 95.5

 *Total number of primary RFR reports for human food for year 1= 201. Percent does not total 100 because the table 

does not include RFR reports such as uneviscerated fish and “other.” 

Table 4. Primary RFR Reports for Human Food in Year 2 (FDA, 2012b) 

Hazard Number of Primary RFR 

Reports for Human Food

Percent of Primary RFR 

Reports for Human 

Food*

Biological (including E. coli

O157:H7, L. monocytogenes, 

Salmonella) 

119 58

Undeclared food allergens 75 36

Undeclared sulfites 3 1

Physical 2 1

Total 199 96

 *Total number of primary RFR reports for human food for year 2= 206. Percent does not total 100 because the table 

does not include RFR reports such as uneviscerated fish and “other.”

Table 5. Primary RFR Reports for Human Food in Year 3 (FDA, 2013) 

Hazard Number of Primary RFR 

Reports for Human Food 

Percent of Primary RFR 

Reports for Human 

Food*

Biological (including E. coli

O157:H7, L. monocytogenes, 

Salmonella) 

110 54

Undeclared food allergens 85 41

Undeclared sulfites 1 0.5

Physical 0 0

Total 196 95.5
27 

 *Total number of primary RFR reports for human food for year 3= 205. Percent does not total 100 because the table 

does not include RFR reports such as uneviscerated fish and “other.”

Table 6. Primary RFR Reports for Human Food in Year 4 (FDA, 2014) 

Hazard Number of Primary RFR 

Reports for Human Food

Percent of Primary RFR 

Reports for Human 

Food*

Biological (including E. coli

O157:H7, L. monocytogenes, 

Salmonella) 

79 46

Undeclared food allergens 88 51

Undeclared sulfites 2 1.2

Physical 0 0

Total 169 98.2

 *Total number of primary RFR reports for human food for year 4= 172. Percent does not total 100 because the table 

does not include RFR reports such as uneviscerated fish and “other.”

The information from the RFR Annual Reports for Years 1, 2, 3, and 4 regarding reports of food 

allergen hazards in human food is consistent with FDA’s analysis of Class I and Class II recalls 

during the periods 1999 through 2003 (FDA Memorandum, 2004) and 2008 through 2009 (FDA 

Memorandum, 2012a). A Class I recall situation is one 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 (21 CFR 7.3(m)(1)). A Class II recall situation is one 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 (21 CFR 7.3(m)(2)). 

Undeclared food allergens accounted for 34 percent of Class I and Class II recalls analyzed by FDA 

during the period 1999 through 2003 and for 42.9 percent of Class I and Class II recalls analyzed by 

FDA during the period 2008 through 2009. Of 174 recalls for undeclared food allergens in 2008-

2009, 120 (69%) involved food recalls classified as Class I (reasonable probability of serious 

adverse health consequences or death). Undeclared sulfites accounted for 8.4 percent of Class I and 

Class II recalls analyzed by FDA during the period 2008 through 2009; 82 percent of the 34 recalls 

for sulfites were classified as Class I. (The analysis of recalls from 1999-2003 did not break out 

recalls that were due to undeclared sulfites.) 

Physical hazards infrequently are the cause of Class I and Class II recalls, which is consistent with 

the information from the RFR Annual Reports from Years 1, 2, 3, and 4 regarding reports of 

physical hazards in human food. Foreign objects, which include physical hazards, accounted for 

only 3 percent of Class I and Class II recalls analyzed by FDA during the period 1999 through 2003 

and 3.2 % of those during 2008-2009 (FDA Memorandum, 2004; FDA Memorandum, 2012a). 

None of the recalls for physical hazards in 2008-2009 were Class I (FDA Memorandum, 2012a). 

Table 7 provides information about the association of biological and chemical hazards (including 

food allergen hazards) that are the subject of reports of illness or injury to CDC or FDA’s RFR with 

the food categories that we identified in section II.A of this document as likely to be manufactured, 

processed, packed, or held on a farm mixed-type facility. With regard to biological hazards in Table 

7, viruses were included if the contamination from the virus may occur in production (e.g., the use 
28 

of contaminated water during growing and harvesting of fruits and vegetables); viral contamination 

that may result from handling by infected food handlers during processing (and that would be 

ordinarily controlled through applicable CGMP controls) is not included. Our task in this RA is in 

part to determine whether the additional controls that would be required by section 418 of the 

FD&C Act are needed to ensure the safety of the product in light of the existing regulatory 

framework.

Table 7 does not include physical hazards, which could be a contaminant in virtually any food 

category.

Table 7 is not intended to be exhaustive; extensive information on the association of biological and 

chemical hazards with specific food categories is available in textbooks and other scientific 

literature that are widely available. We provide information about the severity of each of the 

hazards identified in Table 7 in the Hazard Characterization section of this document. 

Table 7. Potential Biological and Chemical Hazards That Are Reasonably Likely to Be 

Associated with the Food Categories Manufactured, Processed, Packed, or Held on a Farm 

Mixed-Type Facility

Food Category Associated Biological 

Hazards 

Associated 

Chemical 

Hazards 

Comments

Baked goods (e.g. breads, 

cookies, crackers) 

Bacterial pathogens 

(e.g., Salmonella spp., 

and sporeforming 

bacteria such as B. 

cereus) 

Food allergens, 

Gluten 

(associated with 

celiac disease),

Mycotoxins (e.g., 

aflatoxin and 

deoxynivalenol)

International Commission on 

Microbiological Specifications 

for Foods, 2005a; Taylor and 

Hefle, 2001; FDA, 2011b 

Candy (e.g., hard candy, 

fudge, maple candy, 

maple cream, nut brittles, 

taffy, toffee) 

Bacterial pathogens 

(e.g., Salmonella) 

Food allergens Salmonellosis has been 

associated with contaminated 

candy, but not the ones specified 

here (International Commission 

on Microbiological Specifications 

for Foods, 2005b). The boiling 

required to make these products 

provides inherent control against 

biological hazards. Fudge, taffy 

and toffee usually contain the 

allergen milk (e.g., from butter). 

In addition, fudge may contain 

food allergens such as tree nuts, 

and brittles contain peanuts or 

tree nuts.

Cocoa beans Bacterial pathogens 

(e.g. Salmonella) 

Mycotoxins (e.g., 

aflatoxins) 

Cocoa beans are susceptible to 

contamination with Salmonella 

(International Commission on 

Microbiological Specifications 

for Foods, 2005b). 
29 

Food Category Associated Biological 

Hazards 

Associated 

Chemical 

Hazards 

Comments

Cocoa products (e.g., 

chocolate, cocoa powder 

and cocoa butter)

Bacterial pathogens 

(e.g. Salmonella) 

Food allergens Cocoa beans are susceptible to 

contamination with Salmonella

and several outbreaks of 

salmonellosis have been 

attributed to cocoa powder and 

chocolate (International 

Commission on Microbiological 

Specifications for Foods, 2005b; 

Scott et al., 2009).

Milk chocolate contains the 

allergen milk.

Coffee beans Bacterial pathogens 

(e.g., Salmonella) 

Mycotoxins (e.g. 

Ochratoxin A) 

International Commission on 

Microbiological Specifications 

for Foods, 2005c; Bayman and 

Baker, 2006.

Dried fruit and vegetable 

products that are 

processed foods (e.g., 

raisins, unpitted dried 

plums) 

Bacterial pathogens 

(e.g., E. coli O157:H7, 

L. monocytogenes, 

Salmonella, and C. 

botulinum), 

Viruses (e.g., norovirus 

and hepatitis A virus)

Parasites (e.g., 

Cryptosporidium)

Sulfites

Pesticide residues

Institute of Food Technologists, 

2001a; Timbo et al., 2004; FDA, 

2010 

Dried herbs and other 

spices that are processed 

foods (e.g., intact dried 

basil, intact dried bay 

leaves, intact dried mint) 

Bacterial pathogens 

(e.g., Salmonella, 

E.coli O157:H7 C. 

botulinum, and B. 

cereus) 

Mycotoxins 

Pesticide residues

FAO/WHO 2014

Fresh herbs Bacterial pathogens 

(e.g., Salmonella, 

E.coli O157:H7, and C. 

botulinum, B. cereus), 

Parasites (e.g., 

Cryptosporidium)

Pesticide residues

FAO/WHO 2008; Pesticide 

Residues Committee 2010 

Fruits and vegetables Bacterial pathogens 

(e.g., E. coli O157:H7, 

L. monocytogenes, 

Salmonella, and C. 

botulinum), 

Viruses (e.g., norovirus 

and hepatitis A virus)

Parasites (e.g., 

Cryptosporidium) 

Pesticide residues Institute of Food Technologists, 

2001a; Timbo et al., 2004; FDA, 

2010 
30 

Food Category Associated Biological 

Hazards 

Associated 

Chemical 

Hazards 

Comments

Game meat jerky Bacterial pathogens 

(e.g., Salmonella, 

E.coli O157:H7) 

Antibiotic 

residues

Animal drugs or antibiotics may 

be administered to live animals 

for therapeutic reasons. Failure to 

observe label withdrawal periods 

before slaughter may result in

illegal drug residues in meat

(FDA, 1982).

Grains including barley, 

dent- or flint-corn, 

sorghum, oats, rice, rye, 

wheat, amaranth, quinoa, 

buckwheat and oilseeds 

(e.g., cotton seed, 

soybeans, rapeseed) 

Bacterial pathogens 

(e.g., Salmonella spp., 

and sporeforming 

bacteria such as B. 

cereus) 

Food allergens, 

Gluten 

(associated with 

celiac disease)

Mycotoxins (e.g., 

aflatoxin and 

deoxynivalenol) 

International Commission on 

Microbiological Specifications 

for Foods, 2005a; Taylor and 

Hefle, 2001; FDA, 2011b; (for oil 

seeds: Andrews et al., 1979); 

International Commission on 

Microbiological Specifications 

for Foods, 2005c) 

Gums, latexes and resins Bacterial pathogens 

(e.g., Salmonella spp., 

and sporeforming 

bacteria such as B. 

cereus) 

N/A Gums, latexes, and resins are 

RACs harvested from plants 

(often by tapping a tree or bush to 

obtain an exudate) (Coppen, 

1995). As such, they are expected 

to occasionally be contaminated 

with bacterial pathogens. FAO 

includes microbiological 

specifications for Salmonella for 

a number of gums, e.g. gum 

Arabic, Tragacanth gum, in its 

"Combined Compendium of Food 

Additive Specifications." 

Although some gums, latexes and 

resins may be boiled on farm, this 

boiling is not viewed as a 

preventive control that 

significantly minimizes or 

prevents a hazard because 

controls to prevent 

recontamination are lacking. The 

hazards associated with these 

ingredients are addressed in 

further manufacturing.
31 

Food Category Associated Biological 

Hazards 

Associated 

Chemical 

Hazards 

Comments

Honey N/A* N/A Honey has not been associated 

with illnesses from foodborne 

pathogens (other than infant 

botulism from C. botulinum

spores (FDA, 2012a), which can 

only be addressed by not feeding 

honey to infants). Although 

pathogenic sporeforming bacteria 

may be present, the water activity 

of honey is such that they cannot 

grow and thus the production of 

toxin from C. botulinum is not a 

concern (International 

Commission on Microbiological 

Specifications for Foods, 2005e). 

We have taken action against 

imported honey containing 

residues of the antibiotic 

chloramphenicol but we are not 

aware of adverse reactions from 

such products.

Jams, jellies, preserves Bacterial pathogens 

(e.g., E. coli O157:H7, 

L. monocytogenes, 

Salmonella, and C. 

botulinum). 

Pesticides The hazards are those associated 

with the raw materials (fruits and 

vegetables). However, shelfstable jams, jellies and preserves 

made from acid fruits and 

vegetables have inherent controls 

against biological hazards due to 

a combination of the boiling 

required to produce them, the low 

pH, and the reduced water 

activity (International 

Commission on Microbiological 

Specifications for Foods, 2011). 

This is not the case when made 

with low-acid fruits or 

vegetables, as spores of C. 

botulinum can survive and must 

be controlled.

Milled grains (e.g., flour, 

bran, corn meal)

Bacterial pathogens 

(e.g., Salmonella spp., 

and sporeforming 

bacteria such as B. 

cereus) 

Food allergens, 

Gluten 

(associated with 

celiac disease)

Mycotoxins (e.g., 

aflatoxin and 

deoxynivalenol) 

International Commission on 

Microbiological Specifications 

for Foods, 2005a; Taylor and 

Hefle, 2001; FDA, 2011b 
32 

Food Category Associated Biological 

Hazards 

Associated 

Chemical 

Hazards 

Comments

Molasses and treacle N/A N/A Molasses and treacle are byproducts of the refining of 

sugarcane or sugar beets into 

sugar. No significant foodborne 

pathogens are associated with the 

sugar made from sugarcane and 

sugar beets (International 

Commission on Microbiological 

Specifications for Foods, 2005e). 

Oils N/A N/A The process of extracting and 

refining oil from oilseeds 

effectively removes bacterial 

pathogens and aflatoxin from the 

products consumed by humans 

and acts as an inherent control 

(International Commission on 

Microbiological Specifications 

for Foods, 2005c).

Other fruit and vegetable 

products that are 

processed foods (e.g., 

dried apple slices; pitted, 

dried plums; caramel 

apples; flours made from 

legumes; snack chips)

Bacterial pathogens 

(e.g., Salmonella, L. 

monocytogenes, and 

pathogenic 

sporeformers (e.g., B. 

cereus, C. botulinum) 

Sulfites

Pesticide residues

Survival of pathogenic bacteria 

on dried fruits is usually poor; 

long storage periods further 

minimize risk from bacterial 

pathogens (International 

Commission on Microbiological 

Specifications for Foods, 2011a). 

Snack chips (such as potato 

chips) are cooked and have a low 

water activity such that the 

production process provides 

inherent control. Mycotoxins can 

occur in dried figs. For dried 

vegetables, blanching and 

effective packaging and storage 

to maintain dry conditions 

controls bacterial pathogens 

(International Commission on 

Microbiological Specifications 

for Foods, 2011a).
33 

Food Category Associated Biological 

Hazards 

Associated 

Chemical 

Hazards 

Comments

Other grain products that 

are processed foods (e.g., 

malt, oat flakes, popcorn, 

soy nuts, dried pasta) 

Bacterial pathogens 

(e.g., Salmonella spp. 

and sporeforming 

bacteria such as B. 

cereus) 

Food allergens, 

Gluten 

(associated with 

celiac disease), 

Mycotoxins (e.g., 

aflatoxin and 

deoxynivalenol) 

Heat treatment of cereals reduces 

the microbial load, including 

bacterial pathogens (International 

Commission on Microbiological 

Specifications for Foods, 2005a, 

2011b). Preparing popcorn for 

consumption involves heating 

kernels in hot oil. 

Granum and Lund, 1997; 

International Commission on 

Microbiological Specifications 

for Foods, 2005a; Taylor and 

Hefle, 2001; FDA, 2011b

Other herb and spice 

products that are 

processed foods (e.g., 

chopped fresh herbs, 

chopped or ground dried 

herbs, and herbal 

extracts)

Bacterial pathogens 

(e.g., Salmonella, 

E.coli O157:H7, C.

botulinum, and B. 

cereus) 

Mycotoxins (e.g. 

aflatoxins), 

sulfites, 

Pesticide residues

Timbo et al., 2004; FAO/WHO 

2008; FAO/WHO 2014; Pesticide 

Residues Committee 2010 

Peanuts and tree nuts Bacterial pathogens 

(e.g., Salmonella and E. 

coli O157:H7) 

Food allergens,

Mycotoxins (e.g., 

aflatoxin)

International Commission on 

Microbiological Specifications 

for Foods, 2005c; 

Dorner, 2008; Molyneux et al., 

2007; Taylor and Hefle, 2001; 

Whitaker, 2010; WHO/ IARC, 

2012; Wu et al., 2013. 

Outbreaks of salmonellosis have 

been attributed to almonds (CDC, 

2004; Isaacs et al., 2005) and a 

recent outbreak of foodborne 

illness caused by E. coli O157:H7 

was attributed to hazelnuts (CDC, 

2011b). 
34 

Food Category Associated Biological 

Hazards 

Associated 

Chemical 

Hazards 

Comments

Peanut and tree nut 

products that are 

processed foods (e.g., 

roasted peanuts and tree 

nuts, seasoned peanuts 

and tree nuts, and peanut 

and tree nuts flours) 

Bacterial pathogens 

(e.g., Salmonella and E. 

coli O157:H7) 

Food allergens,

Mycotoxins (e.g., 

aflatoxin)

Taylor and Hefle, 2001; 

International Commission on 

Microbiological Specifications 

for Foods, 2005c; Dorner, 2008; 

WHO/IARC, 2012; Wu et al., 

2013; Molyneux et al., 2007; 

Whitaker, 2010 

Outbreaks of salmonellosis have 

been attributed to peanutcontaining products and almonds 

(CDC, 2004; CDC, 2011a; CDC, 

2009; Cavallaro et al., 2011; 

Isaacs et al., 2005) 

Sap (for making syrup, 

e.g., agave, birch, maple, 

palm) and the syrups 

made from them 

N/A N/A Syrup has not been associated 

with illnesses from foodborne 

pathogens. Sap must be 

extensively boiled (evaporated) to 

produce syrup. This boiling, 

combined with the reduced water 

activity of 0.83-0.86, acts as an 

inherent control for foodborne 

pathogens (International 

Commission on Microbiological 

Specifications for Foods, 2005e). 

Seeds for direct 

consumption 

Bacterial pathogens

(e.g., Salmonella) 

Pesticide residues Andrews et al., 1979; FDA, 2010; 

FDA memorandum, 2015 

Seeds for direct 

consumption that are 

processed foods (e.g., 

roasted pumpkin seeds, 

roasted sunflower seeds, 

roasted flax seeds)

Bacterial pathogens 

(e.g., Salmonella) 

Pesticide residues Andrews et al., 1979; FDA, 2010; 

FDA memorandum, 2015 

Soft drinks and 

carbonated water

Foodborne pathogens 

that could be present in 

water not subject to 

EPA’s National 

Primary Drinking 

Water Requirements in 

40 CFR 141

N/A International Commission on 

Microbiological Specifications 

for Foods, 2005d 
35 

Food Category Associated Biological 

Hazards 

Associated 

Chemical 

Hazards 

Comments

Sugar beets, sugarcane, 

and sugar 

Bacterial pathogens 

(e.g., Salmonella) 

N/A As with many RACs, sugarcane 

and sugar beets may be 

susceptible to contamination with 

enteric pathogens. However, no 

significant foodborne pathogens 

are associated with the sugar 

made from sugarcane and sugar 

beets (International Commission 

on Microbiological Specifications 

for Foods, 2005e). 

Trail mix and granola Bacterial pathogens 

(e.g., Salmonella and E. 

coli O157:H7) 

Food Allergen

Mycotoxins (e.g., 

aflatoxins) 

Sulfites

Pesticide residues

The hazards are those associated 

with the individual ingredients. 

The processes used in making the 

individual ingredients may 

address the hazards. Heat 

treatment of cereals used to 

produce granola reduces the 

microbial load (International 

Commission on Microbiological 

Specifications for Foods, 2005a)

Vinegar N/A Food allergens 

(e.g., malt vinegar 

made from malted 

wheat)

Fermentation (e.g., of alcohol, 

wine, malt, cider) results in high 

acetic acid content (8-11%); 

vinegar is usually not sensitive to 

spoilage (ICMSF 2005f)

Any other processed food 

that does not require 

time/temperature control 

for safety (e.g., vitamins, 

minerals, and dietary 

ingredients (e.g., bone 

meal) in powdered, 

granular, or other solid 

form)

Bacterial pathogens 

(e.g., Salmonella) and 

sporeforming bacteria 

such as B. cereus) 

Food allergens The hazards associated with these 

foods are variable and depend on 

the starting components. Many 

of these foods are likely to be 

associated with hazards that 

require preventive controls. 

*N/A = Not Applicable

We did not identify drug residues or decomposition products as known or reasonably foreseeable 

potential chemical hazards in any of the foods within the scope of this RA. Drug residues and 

decomposition products would have a greater probability of being in foods of animal origin. 

Sulfites, which are a chemical hazard when not declared on a food label, are a food ingredient added 

as a substance that is generally recognized as safe (GRAS) under specified conditions of use (21 

CFR 182.3798; Sodium sulfite); that regulation excludes the use of sodium sulfite in certain foods. 

The uses of sulfites that are GRAS are not subject to the premarket review and approval 

requirements that apply to food additives. 
36 

We did not identify any specific unapproved food or color additives as a known or reasonably 

foreseeable chemical hazard in any of the foods within the scope of this RA. A hypothetical 

discussion of the potential association of all possible food and color additives associated with each 

of the food categories that are within the scope of this RA is beyond the scope of this RA. 

IV. Hazard Characterization 

The Hazard Characterization step describes the nature, severity, and duration of adverse effects that 

may result from ingestion of the hazard applicable to a food category. These will depend on the 

host, the agent and the environment, and there is generally a range of adverse effects (i.e., there is a 

high degree of variability) that occurs in a population ingesting a contaminated food. 

A. Biological Hazards 

In the Hazard Identification section of this RA, we identified six bacterial foodborne pathogens (i.e., 

B. cereus, C. botulinum, E. coli O157, L. monocytogenes, Salmonella, and S. aureus), two viral 

foodborne pathogens (i.e., norovirus and hepatitis A virus), and one parasite (i.e., Cryptosporidium) 

as representative of the biological (microbial) hazards of concern for food categories that are likely 

to be manufactured, processed, packed, or held on a farm mixed-type facility and within the scope 

of this RA. Adverse effects associated with biological hazards occur as a result of consumption of a 

contaminated food during a single eating occasion. A common measure of the frequency of a 

hazard is the number of reported illnesses. Two common measures of the severity of illness are the 

rates of hospitalization and death. Table 8 presents information about the number of illnesses and 

the number and rate of hospitalizations and deaths associated with these foodborne pathogens. 

Whereas information about the number of hospitalizations and deaths demonstrates the frequency of 

serious foodborne illness associated with these foodborne pathogens, the rates of hospitalization and 

death present a more accurate reflection of the severity of the foodborne illnesses. For example, 

although Table 8 demonstrates a large number of illnesses, hospitalizations and deaths from 

norovirus, it also demonstrates that norovirus has the lowest hospitalization rate and has one of the 

lowest death rates of the selected pathogens. Thus, the relatively large numbers of hospitalizations 

and deaths associated with norovirus reflect the frequency, rather than the severity, of the illness. 

Table 8. Numbers of Illness and Numbers and Rates of Hospitalization and Death for 

Representative Foodborne Pathogens Identified in the Hazard Identification (Scallan et al., 

2011) 

Pathogen 

Mean 

Number of 

Annual 

Episodes of 

Foodborne 

Illness*

Mean Number 

of Annual 

Hospitalizations

Hospitalization 

Rate (%)**

Mean 

Number of 

Annual 

Deaths** 

Death Rate 

(%)**

B. cereus 63,400 20 0.4 0 0

C. botulinum 55 42 82.6 9 17.3

Cryptosporidium 57,616 210 25 4 0.3

E. coli O157 63,153 2,138 46.2 20 0.5

Hepatitis A 

Virus

1,566 99 31.5 7 2.4
37 

Pathogen 

Mean 

Number of 

Annual 

Episodes of 

Foodborne 

Illness*

Mean Number 

of Annual 

Hospitalizations

Hospitalization 

Rate (%)**

Mean 

Number of 

Annual 

Deaths** 

Death Rate 

(%)**

L. 

monocytogenes

1,591 1,455 94 255 15.9

Norovirus 5,461,731 14,663 0.03 149 <0.1

Salmonella (nontyphoidal)1,027,561 19,336 27.2 378 0.5

S. aureus 241,148 1,064 6.4 6 <0.1

* Based on laboratory surveillance adjusted for underreporting and under-diagnosis. For additional information, see the 

2011 report by Scallan et al., 2011. 

** Based on unadjusted laboratory-confirmed illnesses. For additional information about this calculation, see the report 

by Scallan et al., 2011. 

In the paragraphs that follow, we briefly characterize the nature, severity and duration of the adverse 

effects associated with the representative biological (microbial) hazards of concern for the food 

categories that are likely to be manufactured, processed, packed, or held on a farm mixed-type 

facility and within the scope of this RA. 

Bacillus cereus is a sporeforming aerobic bacterium that causes two types of illness, a diarrheal 

illness due to an enterotoxin produced in the intestine when large numbers of toxigenic B. cereus are 

ingested and an emetic (vomiting) illness due to an emetic toxin produced in food (FDA, 2012a). 

Symptoms of the diarrheal type of foodborne illness include watery diarrhea, abdominal cramps, 

and pain within 6-15 hours after consumption of contaminated food and mimic those of C. 

perfringens foodborne illness. Nausea may accompany diarrhea, but vomiting rarely accompanies 

the diarrheal type of illness. Symptoms of the diarrheal type of foodborne illness generally persist 

for no more than 24 hours. Symptoms of the emetic type of foodborne illness include nausea and 

vomiting within 0.5 to 6 h after consumption of contaminated foods and mimic those caused by S. 

aureus foodborne intoxication. Occasionally, abdominal cramps and/or diarrhea may also occur. 

Symptoms of the emetic type of foodborne illness generally persist for no more than 24 hours. Both 

types of illness are associated with relatively large numbers of B. cereus in a food (greater than a 

million organisms per gram of food). On rare occasions, B. cereus has caused severe systemic 

infections, septic meningitis, and death (FDA, 2012a; Granum, 2007). 

Clostridium botulinum is a sporeforming anaerobic bacterium that causes botulism, a rare but 

serious paralytic illness caused by a nerve toxin that is produced by the bacterium (CDC, 2010). 

Symptoms of botulism include double vision, blurred vision, drooping eyelids, slurred speech, 

difficulty swallowing, dry mouth, and muscle weakness, which, if untreated, may progress to 

paralysis of the respiratory muscles, arms, legs, and trunk. Death due to respiratory failure can 

occur. A patient with severe botulism may require a breathing machine as well as intensive medical 

and nursing care for several months, and some patients die from infections or other problems related 

to remaining paralyzed for weeks or months. Patients who survive an episode of botulism 

intoxication may have fatigue and shortness of breath for years and long-term therapy may be 

needed to aid recovery.
38 

Cryptosporidium is a protozoan parasite that causes an intestinal disease (cryptosporidiosis) that is 

self-limiting in most healthy individuals (i.e., symptoms resolve without medical intervention) 

(FDA, 2012a; Ortega, 2007). The principal symptom of cryptosporidiosis in most people is profuse 

watery diarrhea (FDA, 2012a; Ortega, 2007). Symptoms generally persist for 2-4 days, although in 

some outbreaks at day care centers diarrhea has lasted 1 to 4 weeks. Individuals who have a 

deficient immune system, especially AIDS patients, develop severe, watery, cholera-like diarrhea 

that can persist for years, contributing to death (FDA, 2012a; Ortega, 2007). Invasion of the 

pulmonary system may also be fatal (FDA, 2012a). Hospitalization rates are high for those ill 

enough to see a doctor and be tested (Scallan et al., 2011); 24 percent of hospitalizations for 

cryptosporidiosis involve immunocompromised patients, and the average length of hospitalization is 

6.5 days (Collier et al., 2012). 

Escherichia coli O157:H7 is a bacterium that causes an intestinal illness (FDA, 2012a). The 

infectious dose is low (fewer than 100 cells) (Meng et al., 2007). Symptoms include severe 

cramping (abdominal pain) and diarrhea, which often becomes bloody (hemorrhagic colitis) after 1 

to 2 days (Meng et al., 2007). Occasionally vomiting occurs. The illness is usually self-limiting and 

lasts for an average of 8 days. Some hemorrhagic colitis victims, particularly the very young (up to 

15 percent in children under 10), develop hemolytic uremic syndrome (HUS), characterized by renal 

failure and hemolytic anemia (Meng et al., 2007). The disease can lead to permanent loss of kidney 

function and death (the case fatality rate is approximately 1 percent) (FDA, 2012a; Meng et al., 

2007). 

Infection with hepatitis A virus (HAV) may or may not result in clinical disease (FDA, 2012a), or it 

can take 15-50 days for symptoms to manifest themselves (Fiore, 2004). Symptoms of HAV 

infection include fever, malaise, nausea, vomiting, diarrhea, anorexia, and abdominal discomfort, 

followed in several days by jaundice (FDA, 2012a; Fiore, 2004). Many persons (particularly 

children) infected with HAV do not experience clinical disease or, if they do experience clinical 

disease, do not experience jaundice (FDA, 2012a; Fiore, 2004). When disease does occur, symptoms 

are usually mild and recovery is complete in 1-2 weeks. Occasionally, the symptoms are severe and 

convalescence can take several months. Patients who experience severe symptoms suffer from 

feeling chronically tired during convalescence, and their inability to work can cause financial loss. 

The illness can be fatal (estimated to be as high as 2.4 percent based on laboratory-confirmed cases 

of those who are sick enough to see a doctor and be tested) (Scallan et al., 2011). Deaths usually 

occur in the elderly and in persons with underlying chronic liver disease (Fiore, 2004). The 

infectious dose is unknown but has been assumed to be 10-100 virus particles. Persons who are 

exposed to HAV generally develop immunity to the virus, and vaccination against the virus has 

increased. Consequently, in the United States the percentage of adults with immunity increases with 

age (i.e., 10 percent of adults aged 18-19 years show signs of immunity whereas 65 percent of adults 

over 50 years show signs of immunity) (FDA, 2012a). 

Listeria monocytogenes is a bacterium that can cause a mild non-invasive intestinal illness (called 

listerial gastroenteritis) or a severe, sometimes life-threatening, illness (called invasive listeriosis). 

Most healthy persons who are infected with L. monocytogenes either show no symptoms or 

experience the mild illness listerial gastroenteritis (FDA, 2012a). Symptoms of listerial 

gastroenteritis include diarrhea, fever and fatigue (Painter and Slutsker, 2007). Persons at higher risk 

for severe, invasive listeriosis include the elderly, individuals who have a deficient immune system, 

pregnant women, and fetuses and neonates who are infected after the mother is exposed to L. 

monocytogenes during pregnancy (Painter and Slutsker, 2007; FDA, 2012a). Symptoms and 
39 

manifestations of invasive listeriosis include septicemia, meningitis, encephalitis, or intrauterine or 

cervical infections in pregnant women, which may result in spontaneous abortion or stillbirth (FDA, 

2012a; Painter and Slutsker, 2007). Serious, invasive listeriosis is usually preceded by influenzalike symptoms (including persistent fever) or gastrointestinal symptoms such as nausea, vomiting, 

and diarrhea (Food and Agriculture Organization and World Health Organization, 2004b; Goulet et 

al., 2012). The infective dose of L. monocytogenes is unknown but is believed to vary with the strain 

and susceptibility of the victim (FDA, 2012a). In 2003, FDA and the Food Safety and Inspection 

Service (FSIS) of the U.S. Department of Agriculture, in consultation with CDC, released a 

quantitative assessment (the FDA/FSIS Lm RA) of relative risk associated with consumption of 23 

categories of ready-to-eat (RTE) foods that had a history of contamination with L. monocytogenes, 

or that were implicated epidemiologically with an outbreak or a sporadic case of listeriosis (FDA 

and USDA, 2003b). The FDA/FSIS Lm RA shows that the risk of illness from L. monocytogenes

increases with the number of cells ingested and that there is greater risk of illness from RTE foods 

that support growth of L. monocytogenes than from those that do not (FDA and USDA, 2003a). A 

key finding of an FAO/WHO risk assessment on L. monocytogenes in RTE foods in 2004 was that 

the models developed predict that nearly all cases of listeriosis result from the consumption of high 

numbers of the pathogen (Food and Agriculture Organization and World Health Organization, 

2004b). Refrigerated foods present a greater risk from L. monocytogenes because some refrigerated 

foods that support growth may be held for an extended period of time, thus increasing the risk if L. 

monocytogenes is present in a food. Growth of L. monocytogenes does not occur if the food is 

frozen, but the organism may survive. If a frozen food contaminated with L. monocytogenes is 

thawed and held at temperatures that support growth, e.g., under refrigeration, the risk of illness 

from L. monocytogenes in that food increases. 

Infection with norovirus causes an intestinal illness (FDA, 2012a). Symptoms usually include 

acute-onset vomiting, watery non-bloody diarrhea with abdominal cramps, and nausea. Low-grade 

fever also occasionally occurs, and diarrhea is more common than vomiting in children. 

Dehydration is the most common complication, especially among the young and elderly, and may 

require medical attention. Symptoms usually persist 24 to 72 hours. Recovery is usually complete 

and there is no evidence of any serious long-term sequelae (i.e., chronic conditions resulting from 

the illness) (CDC, 2012).

Salmonella is a bacterium that causes the illness salmonellosis (FDA, 2012a). Symptoms of 

salmonellosis include diarrhea, fever, abdominal cramps, headache, nausea, and vomiting (FDA, 

2012a). Acute symptoms may persist for 1 to 2 days or may be prolonged, depending on host 

factors, ingested dose, and characteristics of the specific bacterial strain (FDA, 2012a). Most 

healthy people recover, but the infection can spread to the bloodstream, and then to other areas of 

the body, leading to severe and fatal illness, which is more likely to occur in children, the elderly, 

and persons with weakened immune systems (FDA, 2012a). The infective dose can be as few as 15-

20 cells, depending on age and health of the victim and strain differences among the members of the 

genus (FDA, 2012a). S. Typhi and S. Paratyphi A, B, and C produce typhoid and typhoid-like fever 

in humans, infecting various organs and leading to lesions. The fatality rate for most forms of 

salmonellosis is less than 1 percent, although it is usually higher for typhoid fever (FDA, 2012a). 

However, a number of strains can cause severe disease, e.g., the fatality rate of S. Dublin is 15 

percent when septicemic in the elderly, and the fatality rate of S. Enteritidis is approximately 3.6 

percent in hospital/nursing home outbreaks, with the elderly being particularly affected (FDA, 

2012a). Reactive arthritis may occur in about 2 percent of culture-confirmed cases (FDA, 2012a). 
40 

Septic arthritis, subsequent to or coincident with septicemia, also occurs and can be difficult to treat 

(FDA, 2012a).

S. aureus is a bacterium that produces an enterotoxin causing an illness called staphylococcal food 

poisoning (FDA, 2012a). Symptoms include nausea, vomiting, retching, abdominal cramping, and 

prostration. In more severe cases, headache, muscle cramping, and transient changes in blood 

pressure and pulse rate may occur. Symptoms generally persist for two days; however, in severe 

cases symptoms may persist for three days or longer. Death from staphylococcal food poisoning is 

very rare, although such cases have occurred among the elderly, infants, and severely debilitated 

persons. 

For additional information on pathogens, including a discussion of the diseases they cause, see 

FDA’s Bad Bug Book (FDA, 2012a). In addition, a number of textbooks on foodborne pathogens 

have been published. 

B. Chemical Hazards – Non-Allergic-type Reactions

The Hazard Identification section of this RA identified mycotoxins (e.g., aflatoxins, ochratoxin A, 

deoxynivalenol) as representative of the chemical hazards associated with food categories (e.g., 

grains, peanuts, tree nuts) that are likely to be manufactured, processed, packed, or held on a farm 

mixed-type facility and within the scope of this RA. The adverse reactions due to mycotoxin 

hazards depend on the type of mycotoxin and the amount to which a person is exposed, and may be 

acute or chronic. The effects of mycotoxins on humans are still not well understood, and much 

information on adverse effects is based on animal models. In the past, a number of outbreaks of 

human illness (including some with severe illnesses and death) associated with high levels of 

mycotoxins have been documented. Currently, in developed countries such as the United States and 

those of the European Union, significant investments in production, storage and drying facilities, 

coupled with the country’s regulatory system, now result in low concentrations of mycotoxins in 

foods (Tran-Dinh 2013; Williams et al., 2004). Acute adverse effects of mycotoxins currently are 

more common in developing countries (Bryden 2007; Pestka and Smolinski, 2005; Williams et al., 

2004). Adverse effects associated with chemical hazards such as mycotoxins tend to be the result of 

chronic exposure rather than manifesting as an acute illness (Bryden 2007; Williams et al., 2004). 

Large doses of aflatoxin can result in acute illness and death, usually through liver cirrhosis; reports 

of serious illness and death usually originate in the zone of risk for mycotoxin production (at 

latitudes between 40 degrees North and South of the equator) and occur infrequently (Williams et 

al., 2004; Wu et al. 2011). Adults usually have a high tolerance for aflatoxin, and some ingested 

aflatoxin is detoxified (Williams et al., 2004). Long-term, cumulative exposure to aflatoxin can 

result in liver cancer (Santini and Ritieni 2013; Shephard, 2008; Williams et al., 2004; WHO/IARC 

2012). Ochratoxin A, which has been identified in barley, wheat, rye, corn, rice and coffee, is

classified as a human carcinogen and has been associated with kidney effects in animals but has not 

been associated with acute illnesses (Bayman and Baker, 2006). In contrast, deoxynivalenol, 

associated with wheat, corn and barley, has been associated with acute gastroenteritis similar to 

staphylococcal food poisoning (vomiting, abdominal pain, diarrhea, headache, dizziness and fever), 

although not in the United States (Pestka and Smolinski, 2005). 

Establishing exposure limits on mycotoxins involves various factors, including scientific 

considerations surrounding hazards, food consumption data, knowledge about the level and 

distribution of mycotoxins in commodities, and analytical methodologies. Over time there have 
41 

been an increased number of limits and regulations established for mycotoxins, given the greater 

availability of data (Van Egmond and Jonker 2004). 

The Hazard Identification section of this RA also identified antibiotic residues as a potential 

chemical hazard associated with game meat jerky. Animal drugs or antibiotics may be administered 

to live animals (i.e., before slaughter) for therapeutic reasons. Failure to observe label withdrawal 

periods before slaughter may result in illegal drug residues in meat (FDA, 1982). Antibiotic 

residues generally are addressed at slaughter. Both raising the animals and slaughtering them are 

outside the scope of this risk assessment. 

C. Chemical Hazards – Allergic-type Reactions 

The Hazard Identification section of this RA identified tree nuts, peanuts, and grains as food 

allergen hazards of concern with respect to food categories that are likely to be manufactured, 

processed, packed, or held on a farm mixed-type facility and within the scope of this RA. Food 

allergies affect two to three percent of adults and four to six percent of children (Sampson, 2004; 

Sampson, 2005; Sicherer and Sampson, 2010). Allergic reactions (immediate hypersensitivity 

reactions) can range from mild to severe and symptoms can involve the gastrointestinal tract (e.g., 

nausea, vomiting, diarrhea), skin (e.g., hives, eczema), or respiratory tract (e.g., asthma) (Taylor and 

Hefle, 2001). The most severe reaction is anaphylactic shock, which usually involves multiple 

systems, including the gastrointestinal tract, skin, respiratory tract and the cardiovascular system 

(Taylor and Hefle, 2001). Severe hypotension and death from cardiovascular and/or respiratory 

collapse can occur within minutes of ingestion of the allergen-containing food (Taylor and Hefle, 

2001). The severity of a food allergic reaction varies depending on factors such as the amount of 

allergen ingested, the type of allergen, and the presence of other underlying medical conditions, but 

as high as one-third of sensitive individuals can experience severe reactions at the minimal eliciting 

dose of an allergen. Allergic reactions from food result in an estimated 125,000 emergency room 

visits in the United States each year (Ross et al., 2008), and as many as 100-150 deaths in the United 

States each year (Simon and Mulla, 2008; Yocum et al., 1999). For children under 18 years of age, 

CDC estimates that there are approximately 9,500 food allergy-related hospitalizations per year 

(Branum and Lukacs, 2009). 

Allergic reactions due to peanuts (and peanut-containing products) and tree nuts (and tree nutcontaining products) often cause severe, life-threatening allergic reactions in allergic individuals 

(Sicherer et al., 1998). Only a few people with food allergies are at risk for severe, life-threatening 

allergic reactions, but numerous deaths involving asthma and/or anaphylactic shock have been 

reported (Taylor and Hefle, 2001). Cereal grains such as wheat are not a frequent cause of allergic 

reactions in adults, but cereal allergy is frequent in children, and wheat is the most frequent cause of 

allergy among the cereal grains (European Food Safety Authority, 2004). Cereals elicit the typical 

immediate symptoms of allergic diseases such as atopic dermatitis (eczema), hives, swelling and 

anaphylaxis (European Food Safety Authority, 2004).

Celiac disease is a delayed hypersensitivity reaction that involves an abnormal immunological 

response by genetically predisposed individuals to gluten in certain grains (e.g., wheat, rye, barley) 

(Taylor and Hefle, 2001). An inflammatory response damages the small intestine and impairs the 

absorption of nutrients (72 FR 2795 at 2796) (Taylor and Hefle, 2001). The symptoms associated 

with celiac disease can be gastrointestinal (e.g., abdominal bloating, cramping and pain, chronic 

diarrhea, vomiting) or can involve other parts of the body (e.g., fatigue, bone or joint pain, skin rash, 

mouth ulcers) (72 FR 2795 at 2796). A large portion of the subpopulation with celiac disease may 
42 

not have any symptoms (72 FR 2795 at 2796). The disease is also associated with a number of 

significant health problems, including iron-deficiency anemia, vitamin deficiencies, growth 

retardation, and infertility, and persons with celiac disease may be at increased risk of developing 

other serious medical conditions including cancers (72 FR 2795 at 2797). A more complete review 

of the health effects of celiac disease can be found in FDA’s Health Hazard Assessment for Gluten 

Exposure in Individuals with Celiac Disease (FDA, 2011b). 

The Scope section of this RA identified sulfiting (i.e., adding sulfur dioxide, potassium 

metabisulfite, sodium metabisulfite, potassium bisulfite, sodium bisulfite or sodium sulfite to fruits 

and vegetables) as a manufacturing or processing activity that may be conducted by a farm mixedtype facility and Table 7 in the Hazard Identification section of this RA identified sulfites as a 

hazard that can be associated with fruits and vegetables (e.g., dried fruits). The adverse response to 

sulfites is not a true allergy, but the response is similar to that of some allergic reactions (i.e., 

asthma, hives, swelling within a short time after ingestion), so we discuss sulfites as a chemical 

hazard leading to allergic-type reactions (Timbo et al., 2004; Yang and Purchase, 1985). Although 

sulfite-induced asthma affects only a small percentage of asthmatics (1-1.5 percent), the reaction to 

sulfites may be quite severe, including death (Taylor and Hefle, 2001). Ingestion of 10 mg or more 

on a single occasion could potentially cause a serious adverse reaction in a susceptible person 

(Timbo et al., 2004).

Table 7 in the Hazard Identification section of this RA identified pesticide residues as a chemical 

hazard that can be associated with fruits and vegetables. Whether a pesticide is safe for a particular 

use, in a particular food, at a particular level, depends on factors such as the amount of the food that 

is consumed and, if the pesticide is ingested by a living animal before slaughter, how the product is 

metabolized in that animal. Pesticide residues that are present in food in the absence of or in excess 

of a tolerance established by the EPA are deemed by the FD&C Act to be unsafe (60 FR 65096 at 

65119, Federal Register of December 18, 1995). Reports from FDA’s pesticide monitoring program 

consistently demonstrate that levels of pesticide residues in the U.S. food supply are 

overwhelmingly in compliance with EPA’s permitted pesticide uses and tolerances (FDA, 2010).

D. Physical Hazards 

The scope of this RA requires consideration of physical hazards that are relevant to a farm mixedtype facility under section 418 of the FD&C Act. Table 7 in the Hazard Identification section of this 

document does not include physical hazards because they could be a contaminant in virtually any 

food category. Injuries associated with physical hazards have been reviewed (Hyman et al., 1993; 

Olsen, 1998). They include laceration of the throat or mouth tissues, breaking or chipping teeth, and 

gastrointestinal perforations. Most ingested foreign objects (80-90 percent) pass through the 

gastrointestinal tract spontaneously, but some require removal by endoscopy or, less frequently, 

surgery (Olsen, 1998). An estimated 1-5 percent of foreign objects ingested by people result in 

minor to serious injury (Hyman et al., 1993; Olsen, 1998). In the first year of the RFR, there were 12 

submissions involving foreign objects in foods, none of which were deemed reasonably likely to 

pose serious adverse health consequences or death, and in the second year there were 18 

submissions, of which 2 were deemed reportable (i.e., two presented the risk of serious adverse 

health consequences or death - one with metal and one with glass) (FDA Memorandum, 2012c). No 

submissions involving foreign objects in foods were deemed to pose a risk of serious adverse health 

consequences or death in years 3 and 4. 
43 

V. Exposure Assessment 

A. Approach 

Exposure assessment for foodborne hazards includes an evaluation of the actual or anticipated 

human exposure to the hazards from consumption of contaminated foods. Factors that have a direct 

effect on consumer exposure to hazards include: 

• Frequency and levels of contamination of the food; and 

• Frequency of consumption of the food and the amount of food consumed. 

For the purposes of this qualitative RA, we used CDC surveillance information on the frequency of 

occurrence of illness (see Table 1 and Table 8) as an overall indicator of exposure to biological 

hazards. We took this approach because the CDC surveillance information provides data on 

illnesses from the nine representative biological hazards relevant to this RA. An alternative 

approach would be to attempt to characterize (e.g., as high, medium, or low) the frequency and 

levels of contamination of each of the food categories addressed by the RA with each of these nine 

biological hazards, as well as to characterize (e.g., as high, medium, or low) the frequency of 

consumption of the food, and the amount of food consumed, for food manufactured, processed, 

packed, or held by farm mixed-type facilities. There are limitations to our approach of using CDC 

surveillance information on illness as an overall indicator of exposure to biological hazards - e.g., 

the illness data are not limited to the food categories addressed by this RA. However, these 

limitations do not outweigh the expediency of using this information in light of the difficulty in 

obtaining meaningful information on frequency and levels of contamination of the food categories 

with the representative biological hazards, as well as data on the frequency of consumption of the 

food, and the amount of food consumed, for food manufactured, processed, packed, or held by farm 

mixed-type facilities.

For the purposes of this qualitative RA, we used the frequency of occurrence, as reflected in reports 

to the RFR (see Table 3) and recall data (FDA Memorandum, 2004; FDA Memorandum, 2012a), as 

an overall indicator of exposure to food allergen hazards, sulfite hazards, and physical hazards. We 

took this approach because most of the available data and information address the presence, but not 

the level, of food allergen hazards, sulfite hazards, and physical hazards. For example, RFR reports 

and recall reports generally would provide some information about the level of sulfites in foods, 

because the level is needed to determine whether a food meets the definition of a reportable food 

and to classify a recall. However, RFR reports and recall reports generally do not provide 

information about the level of food allergen hazards (because sensitive individuals may experience 

allergic reactions at doses as low as a few micrograms) or to physical hazards (because a single 

foreign object may cause injury). As with our approach to exposure to biological hazards, the 

approach of using frequency of occurrence as an overall indicator to exposure to food allergen 

hazards, sulfite hazards, and physical hazards has limitations (e.g., the RFR reports and recall data 

are not limited to the food categories addressed by this RA). In addition, we did not attempt to 

include the frequency of consumption of foods contaminated with food allergen hazards, sulfite 

hazards, or physical hazards, and the amount of food consumed, for food manufactured, processed, 

packed, or held by farm mixed-type facilities in light of the difficulty in obtaining meaningful data 

on the frequency of consumption of the food, and the amount of food consumed, for food 

manufactured, processed, packed, or held by farm mixed-type facilities. However, these limitations 

do not outweigh the expediency of using this information in light of the difficulty in obtaining 

meaningful information on frequency and levels of contamination of the food categories with the 
44 

food allergen hazards, sulfite hazards, and physical hazards, as well as data on the frequency of 

consumption of the food, and the amount of food consumed, for food manufactured, processed, 

packed, or held by farm mixed-type facilities.

For the purpose of this RA, we considered exposure to mycotoxins to be low. We discuss our 

reasons in section V.C of this RA. 

For the purpose of this RA, the factors that are relevant to likelihood that hazards would 

contaminate the food when consumed include: 

• Potential for growth of biological hazards in the food; 

• Inherent controls for biological hazards (e.g., low water activity preventing growth); 

• Interventions (e.g., preventive control measures applied to significantly minimize or prevent 

a hazard that is reasonably likely to cause serious adverse health consequences or death (e.g., 

cooking)); and

• Activities that can introduce hazards into food (e.g., cutting fresh fruits and vegetables).

B. Factors That Impact the Frequency and Levels of Contamination of the Food - 

Biological Hazards 

In some cases, the presence of a foodborne pathogen in food may not present a risk to consumers 

unless they are exposed to high numbers of the organism resulting from its growth in foods (e.g., 

pathogenic sporeformers such as B. cereus) (Granum, 2007). In other cases, the presence of a 

foodborne pathogen in food may present a significant risk to consumers even when they are exposed 

to low numbers of the organism (e.g., Salmonella in a ready-to-eat food) (D'Aoust and Maurer, 

2007). In still other cases, the presence of high numbers of a foodborne pathogen in food may 

present a risk of only mild illness to the general population while the presence of fewer organisms 

presents a risk of serious illness and death to susceptible populations (e.g., L. monocytogenes in 

refrigerated ready-to-eat foods) (Food and Agriculture Organization and World Health 

Organization, 2004a). 

Importantly, the risk of illness from foodborne pathogens that cause illness from consumption of 

only a few cells significantly increases if growth occurs. Thus, if the food containing a foodborne 

pathogen supports growth of that pathogen, and the food may be subject to conditions that allow 

growth, the risk for illness increases. The primary factors impacting the risk of illness from most 

foodborne pathogens in a food, therefore, are intrinsic factors and extrinsic factors that influence 

growth (Jay, 2000; Montville and Matthews, 2007). Intrinsic factors are chemical and physical 

factors that are inherent to the food (e.g., pH and water activity (abbreviated aw). Extrinsic factors 

are those that refer to the environment surrounding the food (e.g., storage temperature). 

Below, we discuss key intrinsic and extrinsic factors that can influence growth of bacterial 

pathogens. We also describe inherent controls for the representative biological hazards relevant to 

this RA, interventions to control these representative biological hazards, and activities that can 

introduce these representative biological hazards into the food categories relevant to this RA. 

1. Impact of water activity on growth of foodborne pathogens 

The aw of a food product is a key intrinsic factor affecting the growth of foodborne pathogens. The 

term “water activity” relates to the amount of unbound water that a microorganism needs to grow. 

As moisture is removed from a food or bound by solutes such as salt or sugar, aw decreases. All 
45 

microorganisms require a certain aw for growth to occur, and when aw is reduced below that point, 

the organism stops growing. For example, Salmonella does not grow below an aw of 0.94 

(International Commission on Microbiological Specifications for Foods, 1996b), S. aureus does not 

grow below an aw of 0.83 (International Commission on Microbiological Specifications for Foods, 

1996c), and C. botulinum does not grow below an aw of 0.935 (International Commission on 

Microbiological Specifications for Foods, 1996a). 

Generally, the aw of most fresh foods is greater than 0.99, which supports the growth of bacterial 

foodborne pathogens (Jay, 2000). Foods such as honey, chocolate, potato chips, crackers and cereal 

have very low water activities (e.g., 0.60 and below) (Scott et al., 2001) and do not support growth 

of bacterial foodborne pathogens. Some foods may be dried to a moisture level at which foodborne 

pathogens will not grow (e.g., pasta and dried fruits and vegetables, including herbs). However, 

many foodborne pathogens will survive for extended periods of time under dry conditions, including 

Salmonella spp. (Scott et al., 2009; D'Aoust and Maurer, 2007) and the spores of sporeforming 

pathogens such as B. cereus. Overall, moist foods with aw of 0.85 and above (e.g., cut fruits and 

vegetables) usually require refrigeration or other processes as an intervention to control growth of 

foodborne pathogens, while foods with lower aw (e.g., flour, jam, honey, dried fruits) do not require 

refrigeration to control growth of pathogens (although in some cases the food might have limited 

shelf life without refrigeration as a result of spoilage due primarily to yeasts and molds). 

Intervention measures that rely on aw to prevent the growth of foodborne pathogens require strict 

control. Lack of such control can result in growth of foodborne pathogens, leading to serious 

adverse health consequences or death.

2. Impact of pH on growth of foodborne pathogens 

The pH of a food product is a key intrinsic factor affecting the growth of foodborne pathogens. 

Most bacterial pathogens grow best at pH values near neutral (i.e., 6.6-7.5) (Jay, 2000). Low pH 

inhibits the growth of bacterial foodborne pathogens and in some cases can kill such pathogens. 

Some foods are naturally acidic (i.e. have a low pH) (e.g., many fruits, including citrus fruits, apples 

and grapes) and do not support growth of bacterial foodborne pathogens. Other foods (e.g., melons) 

have pH values that support growth of bacterial foodborne pathogens. Most vegetables (e.g., 

lettuce, cabbage, beans) have pH values above 5.0 and support growth of bacterial foodborne 

pathogens when the natural protective barriers are cut. Some foods may be fermented by bacteria to 

produce products with a reduced pH (e.g., sauerkraut, pickles, and yogurt). While many strains of 

foodborne pathogens die off under conditions of low pH, other strains, including strains of E. coli

O157:H7 and Salmonella, can survive under conditions of low pH for a long time, even though their 

growth might be inhibited (Conner and Kotrola, 1995; Leyer and Johnson, 1992). Therefore, the 

effectiveness of pH as an intervention measure to kill or prevent the growth of bacterial foodborne 

pathogens is variable. Such intervention measures require strict control throughout manufacturing 

or processing. Lack of such control can result in the survival and growth of foodborne pathogens, 

leading to serious adverse health consequences or death. 

3. Impact of temperature on growth of foodborne pathogens 

Temperature is a key extrinsic parameter affecting growth of foodborne pathogens. As temperature 

decreases, the growth of microorganisms slows; all microorganisms have a temperature below 

which growth cannot occur. Some foodborne pathogens do not grow, or grow very slowly, at 

refrigeration temperatures (e.g., most strains of Salmonella (International Commission on 
46 

Microbiological Specifications for Foods, 1996b) and S. aureus (International Commission on 

Microbiological Specifications for Foods, 1996c)), whereas others (such as L. monocytogenes) do 

grow at refrigeration temperatures (Swaminathan et al., 2007; FDA, 2012a). The risk of illness 

from L. monocytogenes associated with a particular food is dependent on five key factors (Codex 

Alimentarius Commission, 2007; FDA and USDA, 2003b), including the temperature of 

refrigerated/chilled food storage; and the duration of refrigerated/chilled storage. Foodborne 

pathogens cannot grow when a food is frozen (Jay, 2000). Intervention measures that use reduced 

temperatures to minimize growth of foodborne pathogens require strict, ongoing control (often 

referred to as “maintaining the cold chain”). Lack of such control can result in the growth of 

foodborne pathogens, leading to serious adverse health consequences or death. 

The growth of foodborne pathogens can also be controlled by increasing temperature above a 

temperature that permits growth (e.g., holding foods hot). Increasing the temperature high enough 

will kill foodborne pathogens. Intervention measures that use high temperatures to kill foodborne 

pathogens require expert knowledge of the heat resistance of the specific pathogen in the specific 

food product, the delivery of heat to foods to inactivate pathogens, and the parameters that impact 

the heat process. Improper application of such interventions can result in survival and growth of 

foodborne pathogens, leading to serious adverse health consequences or death. 

4. The impact of other factors on growth of foodborne pathogens 

Raw foods from plant and animal origins often have physical barriers that provide very good 

protection against entry and growth of foodborne pathogens. These physical barriers are biological 

structures that act as natural coverings for the foods. Examples of such physical barriers include the 

outer coverings of fruits and vegetables (including the shells of nuts), animal hides, and the cuticle, 

shell and membranes of eggs. Activities that cut or remove these barriers can result in 

contamination of tissues and allow growth of pathogens in the contaminated tissues. Survival and 

growth of foodborne pathogens on produce are significantly enhanced once the protective epidermal 

barrier has been broken e.g., by physical damage, such as punctures or bruising, or in the 

manufacturing or processing of fresh cut produce (Institute of Food Technologists, 2001a). For 

example, an intact fruit such as a melon or a tomato is unlikely to support growth. Once the fruit is 

cut, protective barriers of the food are compromised, allowing microorganisms to access parts of the 

fruit that can support growth. An example is tomatoes used to make salsa. The intact fresh tomato 

does not support growth of pathogens such as Salmonella. However, once the tomato is chopped 

and mixed with other ingredients to produce salsa, the salsa may support growth of pathogens such 

as Salmonella, unless there is an intervention such as adding one or more antimicrobial compounds 

to the salsa during manufacture, heating the salsa during manufacture to a sufficient temperature to 

eliminate the pathogens of concern, or refrigerating the final salsa product in order to control the 

growth of pathogens. Increasing the temperature of foods during manufacture, e.g., the cooking of 

vegetables, could also result in the breakdown of these protective coverings and hence could allow 

the potential contamination of foods with pathogens. 

Preservatives (such as sorbate and benzoate) can minimize growth of foodborne pathogens, and in 

some cases aid in killing them. If preservatives that are used to control pathogens are not added 

properly (e.g., at the correct concentration and at the proper pH of the food), pathogens can survive 

and grow, leading to serious adverse health consequences or death. Thus, intervention measures 

that use preservatives to control foodborne pathogens require specialized expertise to understand the 

conditions under which the preservatives are effective in controlling pathogens. 
47 

5. Interaction of factors that impact the growth of foodborne pathogens 

Factors such as aw, pH, temperature, and preservatives, can interact to affect growth of foodborne 

pathogens (Jay, 2000). For example, as temperature decreases, the minimum aw for growth increases 

(Koutsoumanis et al., 2004). For example a pathogen that would grow at room temperature if the aw

is 0.95 or above may need an aw of 0.97 to grow under refrigeration temperatures. These 

interactions are complex and have been discussed in scientific reviews (The Institute of Food 

Technologists, 2003) and in regulatory references such as FDA’s Food Code (FDA, 2013a). Using 

combinations of factors to control foodborne pathogens requires specialized expertise. Improper 

application of interventions involving the interaction of intrinsic and extrinsic factors can result in 

the growth of foodborne pathogens, leading to serious adverse health consequences or death. 

6. Inherent Controls for the Biological Hazards Relevant to This Risk Assessment 

Table 9 provides information about inherent controls for the biological hazards relevant to this RA. 

The products listed in Table 9 as having inherent controls for biological hazards generally have not 

been associated with illnesses from pathogens. 

Table 9. Inherent Controls for Biological Hazards 

Food Inherent Control Comments

Baked goods (e.g., 

bread and cookies) 

The baking process inactivates 

vegetative pathogens; factors 

such as low aw would prevent 

the growth of sporeforming 

pathogens in non-TCS baked 

goods.

International Commission on 

Microbiological Specifications 

for Foods, 2005a.

Candy (e.g., hard 

candy, fudge, maple 

candy, maple cream,

nut brittles, taffy, 

and toffee

Boiling ingredients to achieve 

the needed texture; low aw

would prevent the growth of 

pathogens if present. 

International Commission on 

Microbiological Specifications 

for Foods, 2005b. 

Carbonated soft 

drinks and 

carbonated water

Combination of low pH, high 

carbon dioxide level and the 

antimicrobial activity of acids 

such as phosphoric acid

International Commission on 

Microbiological Specifications 

for Foods, 2005d. 

Honey (pasteurized) Lack of association of the food 

with microbial pathogens and 

low aw that would prevent their 

growth if present

See Table 7 and International 

Commission on Microbiological 

Specifications for Foods, 2005e. 

Jams, jellies and 

preserves (shelfstable) made from 

acid fruits and 

vegetables 

Combination of the boiling 

required to produce the foods, 

and the low pH (below 4.6) 

and low aw that would prevent 

the growth of pathogens 

(including spores of C. 

botulinum) if present 

International Commission on 

Microbiological Specifications 

for Foods, 2011. 
48 

Food Inherent Control Comments

Molasses and treacle The heat steps needed in the 

process of making molasses

and treacle; low aw would 

prevent the growth of 

pathogens if present

See Table 7 and International 

Commission on Microbiological 

Specifications for Foods, 2005e. 

Oil Lack of association of oils with 

microbial pathogens and 

process of extracting and 

refining oils from grains 

(including oilseeds) and from 

fruits and vegetables such as 

herbs, olives

International Commission on 

Microbiological Specifications 

for Foods, 2005c; Medina et al. 

2007; Palumbo and Harris, 

2011. 

Popcorn Heat treatment required to pop 

the kernels; low aw would 

prevent the growth of 

pathogens if present

Virot, 2015.

Snack chips made 

from fruits and 

vegetables (e.g., 

plantains, potatoes) 

Heat treatment needed to cook 

the chips (e.g., frying 350°-

380°F) to the desired texture; 

low aw would prevent the 

growth of pathogens if present

Bernard, 1985; Onyejegbu and 

Olorunda, 1995. 

Sugar The heat steps needed in the 

process of making sugar; low 

aw would prevent the growth of 

pathogens if present

International Commission on 

Microbiological Specifications 

for Foods, 2005e. 

Syrups (e.g., agave, 

birch, maple, palm) 

Lack of association of the food 

with microbial pathogens and 

low aw that would prevent their 

growth if present; heat 

evaporation process

See Table 7 and International 

Commission on Microbiological 

Specifications for Foods, 2005e. 

Vinegar Fermentation resulting in low 

pH and high acetic acid content

Medina et al. 2007.

7. Interventions to Control the Biological Hazards Relevant to This Risk Assessment 

As discussed in sections V.B.1 through V.B.5 of this document, there are a number of interventions 

that may reduce the risk of the biological hazards relevant to this RA. If an intervention is not 

properly conducted, the applicable hazard is reasonably likely to be present in food. Moreover, 

some interventions may require special expertise to ensure they are conducted properly. For 

example, acidification or “pickling” of vegetables significantly minimizes or prevents the hazard of 

toxin production by C. botulinum. The proper processing of shelf-stable acidified foods such as 

pickles, relishes and salsas requires an understanding of the principles of salt and acid diffusion, 

heat penetration and the microbiology of canned foods, as well as the equipment to accurately 

measure acidity and temperature. The time for acid to penetrate and reduce the pH of low-acid 

components to below 4.6 is critical in the safe preparation of acidified foods, and this depends on a 

number of factors that require stringent controls. If the vegetable is not properly acidified, C. 
49 

botulinum spores can germinate and the organism can grow and produce toxin (44 FR 16204 at 

16204, Federal Register of March 16, 1979) (Townsend et al., 1954; Ito and Chen, 1978; 

Notermans, 1993). 

Table 10 provides examples of interventions to control the representative biological hazards relevant 

to this RA. Some of these interventions are CGMPs already required by current part 110, such as 

disease controls and personal hygiene controls in 21 CFR 110.10 and requirements for the safety 

and sanitary quality of water in 21 CFR 110.37(a). Other interventions would be preventive 

controls that facilities may implement under section 418 of the FD&C Act, such as treatment of 

food to inactivate foodborne pathogens. 

Table 10. Examples of Interventions to Control Representative Biological Hazards

Hazard Examples of Interventions to Control 

Hazards Comments

B. cereus • Inactivating the spores of the 

organism with heat.

• Preventing germination of spores 

and growth of the organism/toxin 

production by: 

o Reducing pH to below 4.9 

(e.g., by acidification or 

through fermenting); 

o Refrigerating or freezing; 

o Adding preservatives; 

o Reducing the aw.

Granum, 2007

FDA, 2012a

When a kill step is applied 

the food must be protected 

from recontamination. 

C. botulinum • Inactivating the spores of the 

organism with heat (e.g., canning 

under pressure).

• Preventing germination of spores 

and growth of the organism/toxin 

production by: 

o Reducing pH to 4.6 or 

below (e.g., by acidification 

or through fermenting); 

o Refrigerating or freezing; 

o Adding preservatives; 

o Reducing the aw.

Johnson, 2007

When a kill step is applied 

the food must be protected 

from recontamination. 

Cryptosporidium • Use of water that is safe and of 

adequate sanitary quality. 

• Disease controls and personal 

hygiene controls to prevent 

contamination by infected food 

handlers. 

• Treatment of food, e.g., with heat, 

to inactivate the organism.

Based on information in 

Ortega, 2007 and FDA, 

2012a. 

When a kill step is applied 

the food must be protected 

from recontamination. 
50 

Hazard Examples of Interventions to Control 

Hazards Comments

E. coli O157:H7 • Killing the organism - e.g., 

through: 

o Heat treatments (e.g., 

baking, boiling, cooking, 

roasting); 

o Reducing the pH in 

combination with specific 

conditions (e.g., type and 

concentration of acid, time 

of exposure, and 

temperature).

• Preventing the growth of the 

organism - e.g., by: 

o Reducing the pH or aw; 

o Refrigerating or freezing; 

o Adding preservatives.

• Sanitation controls.

• Personal hygiene controls to 

prevent contamination by food 

handlers.

When a kill step is applied 

the food must be protected 

from recontamination. The 

organisms can survive for 

extended periods of time 

under some conditions that 

prevent the growth but do 

not kill the organism 

(Conner and Kotrola, 

1995).

Hepatitis A virus • Disease controls and personal 

hygiene controls to prevent 

contamination by infected food 

handlers. 

• Vaccination of food handlers. 

• Treatment of food, e.g., with heat, 

to inactivate the organism.

FDA, 2013a.

When a kill step is applied 

the food must be protected 

from recontamination. 
51 

Hazard Examples of Interventions to Control 

Hazards Comments

L. monocytogenes, • Killing the organism - e.g., through: 

o Heat treatments (e.g., 

baking, boiling, cooking, 

roasting); 

o Reducing the pH in 

combination with specific 

conditions (e.g., type and 

concentration of acid, time 

of exposure, and 

temperature).

• Preventing the growth of the 

organism - e.g., by: 

o Reducing the pH or aw; 

o Refrigerating or freezing; 

o Adding preservatives.

• Sanitation controls.

• Personal hygiene controls to 

prevent contamination by food 

handlers.

When a kill step is applied 

the food must be protected 

from recontamination. The 

organisms can survive for 

extended periods of time 

under some conditions that 

prevent the growth but do 

not kill the organism; 

refrigeration slows, but 

does not prevent, growth in 

all foods (Codex 

Alimentarius 

Commission, 2007). 

Norovirus Disease controls and personal hygiene 

controls to prevent contamination by 

food handlers

Salmonella spp. • Killing the organism - e.g., through: 

o Heat treatments (e.g., 

baking, boiling, cooking, 

and roasting); 

o Reducing the pH in 

combination with specific 

conditions (e.g., type and 

concentration of acid, time 

of exposure, and 

temperature).

• Preventing the growth of the 

organism - e.g., by: 

o Reducing the pH or aw; 

o Refrigerating or freezing; 

o Adding preservatives.

• Sanitation controls.

• Disease controls and personal 

hygiene controls to prevent 

contamination by food handlers.

When a kill step is applied 

the food must be protected 

from recontamination. The 

organisms can survive for 

extended periods of time 

under some conditions that 

prevent the growth but do 

not kill the organism (Leyer 

and Johnson, 1992).
52 

Hazard Examples of Interventions to Control 

Hazards Comments

S. aureus • Killing the organism - e.g., through: 

o Heat treatments (e.g., 

baking, boiling, cooking, 

and roasting); 

o Reducing the pH in 

combination with specific 

conditions (e.g., type and 

concentration of acid, time 

of exposure, and 

temperature).

• Preventing the growth of the 

organism - e.g., by: 

o Reducing the pH or aw; 

o Refrigerating or freezing; 

o Adding preservatives.

• Sanitation controls.

• Personal hygiene controls to 

prevent contamination by food 

handlers.

When a kill step is applied 

the food must be protected 

from recontamination. 

Humans commonly carry 

the organism and the 

organisms can survive for 

extended periods of time 

under some conditions that 

prevent the growth but do 

not kill the organism; toxin 

is heat stable (International 

Commission on 

Microbiological 

Specifications for Foods, 

1996c) 

8. Activities That Can Introduce, or Increase the Potential for, Biological Hazards 

Relevant to This Risk Assessment

Conducting some activities on a food may increase the risk from a biological hazard. These are 

often specific to the food in which the hazard occurs. For example, slicing, peeling or cutting intact 

fruits and vegetables can transfer microorganisms, including pathogens, from the exterior to the 

interior of that fruit or vegetable; in many cases this allows growth, thereby increasing the risk of

illness (FDA, 2008; Institute of Food Technologists, 2001a). Table 11 provides examples of 

activities that can introduce, or increase the potential for, biological hazards. 

Table 11. Examples of Activities that Can Introduce, or Increase the Potential for, Biological 

Hazards

Hazard 

Examples of Activities That Are 

Reasonably Likely to Introduce or 

Increase the Potential for the Hazard 

Comments

B. cereus None identified
53 

Hazard 

Examples of Activities That Are 

Reasonably Likely to Introduce or 

Increase the Potential for the Hazard 

Comments

C. botulinum If a food has a pH and aw that support 

growth of C. botulinum, activities such as 

cooking that create a food that requires 

time/temperature control can increase the 

potential for C. botulinum (which survives 

the heating) to grow if the food is held at 

temperatures that support growth. 

Johnson, 2007.

Cryptosporidium Use of contaminated water in a food that 

does not receive a treatment that will 

remove or inactivate the organism can lead 

to contamination of the food. 

Based on information in 

Ortega, 2007 and FDA, 

2012a. 

E. coli O157:H7 Cutting fruits and vegetables can transfer 

the organism from the low-moisture 

exterior (where it cannot grow) to the 

high-moisture interior and release juices 

from tissues, providing conditions that 

enhance microbial growth.

FDA, 2008. Institute of 

Food Technologists, 2001a. 

Hepatitis A virus Contact with ready-to-eat foods by 

infected food handlers can result in 

contamination.

FDA, 2013a; FDA 2013c.

L. monocytogenes Cutting (or piercing) fruits and vegetables 

can transfer the organism from the lowmoisture exterior (where it cannot grow) 

to the high-moisture interior and can 

release juices from tissues, providing 

conditions that enhance microbial growth. 

Coating fresh fruits such as apples with a 

product such as caramel can result in 

growth of pathogens such as L. 

monocytogenes on the surface of the fruit 

under the caramel layer when a 

contaminated product is stored at room 

temperature for several days (with and 

without sticks).

FDA, 2008. Institute of 

Food Technologists; 2001a; 

Glass, 2015.

Norovirus Contact with ready-to-eat foods by 

infected food handlers can result in 

contamination.

FDA, 2013a; FDA 2013c.

Salmonella spp. Cutting fruits and vegetables can transfer 

the organism from the low-moisture 

exterior (where it cannot grow) to the 

high-moisture interior and release juices 

from tissues, providing conditions that 

enhance microbial growth 

FDA, 2008. Institute of 

Food Technologists, 2001a. 
54 

Hazard 

Examples of Activities That Are 

Reasonably Likely to Introduce or 

Increase the Potential for the Hazard 

Comments

S. aureus Contact with ready-to-eat foods by food 

handlers can result in contamination, 

which can result in growth and toxin 

production if the food is held at 

temperatures that allow growth for 

sufficient time.

FDA, 2013a.

C. Factors That Impact the Frequency and Levels of Contamination of the Food – 

Chemical (including Radiological) and Physical hazards 

The presence and levels of mycotoxins in foods in the United States is low (Williams et al., 2004). 

The presence and levels of mycotoxins in foods is dependent in large part on growing and 

harvesting activities. The type of mold, weather conditions, soil types, insect activity, and 

commodity type, along with timely harvest and rapid and adequate drying before storage are 

important in determining the likelihood of contamination (Williams et al., 2004). Insect activity and 

condensation can result in pockets of moisture that can result in production of mycotoxins (Williams 

et al., 2004). As noted previously, in developed countries significant investments in production, 

storage and drying facilities, coupled with the country’s regulatory system, have resulted in low 

concentrations of mycotoxins in foods (Williams et al., 2004). In developing countries where a 

wide range of commodities may be contaminated, the country exports the least contaminated foods, 

while more contaminated foods may be consumed within the country (Williams et al., 2004). Thus, 

the exposure of the population in the United States to mycotoxins such as aflatoxins is low in both 

domestic and imported foods (Williams et al., 2004; WHO/IARC, 2012).

The prevalence of undeclared food allergen hazards in foods is high (FDA Memorandum, 2004; 

FDA Memorandum, 2012a; FDA, 2011a; FDA, 2012b). The prevalence of undeclared sulfites in 

foods is common but not as high as for undeclared food allergens (FDA Memorandum, 2004; FDA 

Memorandum, 2012a; FDA, 2012b). Interventions to prevent undeclared food allergen hazards 

include preventing cross-contact between an allergen-containing food and one that does not contain 

that allergen, and ensuring that the presence of food allergens is declared on the package label. 

Interventions to prevent sulfite hazards include ensuring that the presence of sulfite is declared on 

the package label.

 The prevalence of physical hazards in foods is low (FDA, 2011a; FDA, 2012b; FDA, 2013f; FDA, 

2014). The potential presence of physical hazards depends on the activities performed on the food, 

including activities that can remove foreign objects (e.g., sorting, use of screens) and those that can 

introduce them (e.g., cutting, bottling). Adherence to Good Manufacturing Practices minimizes the 

potential for physical hazards to be present in foods to which consumers are exposed (Jantschke and 

Elliott, 2006). 

Table 12 provides examples of interventions to control the representative chemical hazards relevant 

to this RA. Some of these interventions are CGMPs already required by current part 110, such as 

storing raw materials at such temperature and relative humidity and in such a manner as to prevent 
55

the food from becoming adulterated within the meaning of the FD&C Act (21 CFR 110.80(a)(5)). 

Other interventions would be preventive controls that facilities may implement under section 418 of 

the FD&C Act, such as ensuring that the presence of food allergens or sulfites is declared on the 

package label. 

Table 12. Examples of Interventions and Activities that Can Affect Chemical Hazards

Hazard

Examples of 

Interventions to 

Control Hazards

Examples of 

Activities That Are 

Reasonably Likely to 

Introduce or Increase 

the Potential for the 

Hazard

Comments

Food allergen 

hazards • Sanitation controls.

• Preventing crosscontact between an 

allergen-containing 

food and one that 

does not contain 

that allergen. 

• Preventing crosscontact between 

foods containing 

different allergens

• Ensuring that the 

presence of food 

allergens is declared 

on the package label

• Improper 

labeling.* 

• Improper cleaning 

between allergencontaining foods 

and foods that do 

not contain that 

allergen. 

Gendel et al. 2013; 

Stone and Stevenson, 

2009.

Mycotoxins • Control moisture 

during storage

• Pest control

• Improper storage 

• Lack of pest 

control

Williams et al., 2004; 

Dorner 2008; Abbas 

and Shier 2010; Pitt et 

al. 2013

Sulfites • Ensuring that the 

presence of sulfites 

is declared on the 

package label

• Improper labeling Timbo et al., 2004

* Improper labeling of a single-ingredient allergenic food (e.g., whole or chopped peanuts, single-ingredient nut flours), 

and foods that are in a form in which a consumer can reasonably be expected to recognize the food as containing 

allergen(s) without a label declaration (e.g., trail mix containing whole peanuts), does not present the same risk as 

labeling a food bearing or containing allergen(s) that is not a single-ingredient food and that has been manufactured or 

processed into a form in which the allergenic food cannot reasonably be expected to be recognized by a consumer 

without a label declaration (e.g., multi-ingredient nut flours)

D. Frequency of Consumption and Amount of Food Consumed 

The amount of food that is consumed (commonly called “dietary exposure”) impacts the risk that 

consumption of a contaminated food will cause foodborne illness. The risk of foodborne illness can 

be addressed on a per serving basis (i.e., the amount of food consumed by an individual on a single 

eating occasion) or on a per annum basis (i.e., the amount of food consumed by a specified 

population over the course of a year). Several of the food categories considered in this RA are eaten 

in relatively large quantities on a frequent basis (e.g., fruits, vegetables, grains and grain products), 

whereas other food categories are eaten in smaller quantities on a less frequent basis (e.g., honey 
56

and maple syrup). We have not attempted to determine the amount of food consumed per serving or 

the number of servings consumed annually for the food categories produced by small or very small 

farm mixed-type facilities within the scope of the RA. However, we do know, based on the study 

on co-location of farms with food processing facilities (Caprogrossi, 2015), that the proportion of 

food sold from establishments co-located on farms for small and very small facilities (i.e., those 

with fewer than 500 employees) is only 2.6 percent of total sales. Thus, on a relative basis, the 

overall consumption by the U.S. population of all foods produced at farm mixed-type facilities is 

low and the consumption of such foods containing hazards would be even lower. 

VI. Risk Characterization 

A. Approach

In this section, we qualitatively characterize the risk from hazards and activity/food combinations 

based on the available information in the Hazard Identification, Hazard Characterization, and 

Exposure Assessment sections of this RA. There is uncertainty associated with each of these 

components of this RA, which leads to uncertainty in the Risk Characterization. The outcome of this 

Risk Characterization of hazards is a determination of whether, for the limited purposes of this RA, 

a hazard presents a reasonable probability of causing serious adverse health consequences or death 

in the absence of preventive controls that would be required under section 418 of the FD&C Act. In 

this RA, we are considering such hazards and foods in general terms, on a forward-looking basis, 

and not in reference to a particular food contamination incident or foodborne illness outbreak. 

Determinations of whether there is such a reasonable probability in specific situations may be 

different from the conclusions made for the limited purposes of this document. The characterization 

of exposure to the hazard, the severity of adverse health consequences resulting from use of, or 

exposure to, a food containing the hazard, and the conclusions with respect to “reasonable 

probability of serious adverse health consequences or death” are made in relative terms. 

B. Qualitative Risk Characterization of Biological Hazards 

To provide a qualitative characterization of risk, we first ordered information from Table 8 related to 

frequency and severity to allow us to group information into “high,” “medium” and “low” 

categories. (See Table 13, Table 14, and Table 15 and the text that follows.) These rankings are 

useful for a relative qualitative characterization of risk.

Table 2 and associated text in the Hazard Identification section of this RA summarize surveillance 

information available from CDC about frequency of outbreaks and illnesses from consumption of 

food contaminated with biological hazards. Table 7 and associated text in the Hazard Identification 

section of this RA identify nine biological hazards (i.e., B. cereus, C. botulinum, Cryptosporidium, 

E. coli O157:H7, hepatitis A virus, L. monocytogenes, norovirus, Salmonella, and S. aureus) as 

representative biological hazards in foods that might be manufactured, processed, packed, or held at 

farm mixed-type facilities. Table 8 and associated text in the Hazard Characterization section of this 

RA present information about the numbers and rates of hospitalization and death for these nine 

representative biological hazards. As discussed in the Hazard Characterization, adverse effects 

associated with biological hazards occur as a result of consumption of a contaminated food during a 

single eating occasion.
57 

Table 13. Ranking of Numbers of Illness for Representative Foodborne Pathogens Identified 

in the Hazard Identification (Scallan et al., 2011) 

Agent Frequency of Illness (Mean Number of 

Annual Episodes)

Norovirus 5,461,731

Salmonella (non-typhoidal) 1,027,561

S. aureus 241,148

B. cereus 63,400

E. coli O157:H7 63,153

Cryptosporidium 57,616

L. monocytogenes 1,591

Hepatitis A virus 1,566

C. botulinum 55

Table 14. Ranking of Rates of Hospitalization for Representative Foodborne Pathogens 

Identified in the Hazard Identification (Scallan et al., 2011) 

Agent Hospitalization Rate (Percent)

L. monocytogenes 94

C. botulinum 82.6

E. coli O157:H7 46.2

Hepatitis A virus 31.5

Salmonella (non-typhoidal) 27.2

Cryptosporidium 25

S. aureus 6.4

B. cereus 0.4

Norovirus 0.03

Table 15. Ranking of Rates of Death for Representative Foodborne Pathogens Identified in the 

Hazard Identification (Scallan et al., 2011) 

Agent Death Rate (Percent)

C. botulinum 17.3

L. monocytogenes 15.9

Hepatitis A virus 2.4

E. coli O157:H7 0.5

Salmonella (non-typhoidal) 0.5

Cryptosporidium 0.3

S. aureus <0.1

Norovirus <0.1

B. cereus 0

Table 16 presents a qualitative risk characterization of representative biological hazards that may be 

associated with foods manufactured, processed, packed, or held on a farm mixed-type facility. 

Table 16 draws from information presented in Table 2, Table 7, and Table 8 of this RA and from 

discussions in the Hazard Identification, Hazard Characterization, and Exposure Assessment 

sections of this RA. 
58 

Table 16 characterizes the mean number of annual episodes of foodborne illness from the 

information presented in Table 8 and Table 13 of this document as follows: 

• Low = No more than 50,000 illnesses; 

• Medium = Between 50,000 and 100,000 illnesses; and 

• High = 100,000 or more illnesses. 

Table 16 characterizes the severity of the biological hazard in terms of rate of hospitalization from 

the information presented in Table 8 and Table 14of this document as follows: 

• Low = Less than 20%; 

• Medium = Between 20% and 50%; and 

• High = 50% or more. 

Table 16 characterizes the severity of the biological hazard in terms of rate of death from the 

information presented in Table 8 and Table 15 of this document as follows: 

• Low = No more than 1%; 

• Medium = Between 1% and 5%; and 

• High = More than 5%. 

In characterizing the risk of the biological hazards relevant to this RA, we: 

• Used CDC surveillance information on the frequency of illness as an overall indicator of 

exposure to these biological hazards (see discussion in section V.A of this document); 

• Considered that all of the representative biological hazards relevant to this RA lead to 

adverse effects as a result of a single eating occasion; 

• Used CDC surveillance information on the rates of hospitalization and death to assess the 

severity of these representative biological hazards. 

o We considered that a biological hazard presents a reasonable probability of serious 

adverse health consequences or death for the purposes of this RA if: 

• Severity was assessed as high or medium by either the rate of hospitalization or 

the rate of death; or

• One of the measures of severity was assessed as low, but the exposure was 

medium or high. 

o We did not consider that a biological hazard presents a reasonable probability of 

serious adverse health consequences or death for the purposes of this RA if both 

measures of severity were low, even if the exposure was high.

Table 16. Qualitative Risk Characterization of Representative Biological Hazards That Are 

Reasonably Likely to Be Associated With Foods Manufactured, Processed, Packed, or Held on 

a Farm Mixed-Type Facility*

Hazard Exposure Severity (Rate of 

Hospitalization)

Severity 

(Rate of 

Death)

Reasonable Probability of 

Causing Serious Adverse Health 

Consequences or Death?**

B. cereus Medium Low Low No
59 

Hazard Exposure Severity (Rate of 

Hospitalization)

Severity 

(Rate of 

Death)

Reasonable Probability of 

Causing Serious Adverse Health 

Consequences or Death?**

C. botulinum Low High High Yes

Cryptosporidium Medium Medium Low Yes

E. coli O157:H7 Medium Medium Low Yes

Hepatitis A virus Low Medium Medium Yes

L. monocytogenes Low High High Yes

Norovirus High Low Low No

Salmonella spp. 

(non-typhoidal)

High Medium Low Yes

S. aureus High Low Low No

* See Table 2, Table 7, and Table 8. 

**For the purposes of this RA.

Based on Table 16, six of the representative biological hazards relevant to this RA present a 

reasonable probability of causing serious adverse health consequences or death for the purposes of 

this RA - i.e., C. botulinum, Cryptosporidium, E. coli O157:H7, hepatitis A virus, L. 

monocytogenes, and Salmonella spp. (non-typhoidal). 

C. Qualitative Risk Characterization of Chemical (including Radiological) and Physical 

Hazards

Table 17 presents a qualitative risk characterization of chemical (including radiological) and 

physical hazards that may be associated with foods manufactured, processed, packed, or held on a 

farm mixed-type facility. Table 17 draws from information presented in Table 2, Table 3, and Table 

7 of this RA and from discussions in the Hazard Identification, Hazard Characterization, and 

Exposure Assessment sections of this RA. 

We lack data on the annual incidence of the chemical (including radiological) and physical hazards 

relevant to this RA. In characterizing the risk of these hazards, we:

• Used reports to the RFR (see Table 3 and recall data (FDA Memorandum, 2004; FDA 

Memorandum, 2012a) as an overall indicator of exposure to food allergen hazards, sulfite 

hazards, and physical hazards. 

• Characterized exposure to mycotoxin hazards as low based on the available information 

(Williams et al., 2004; WHO/IARC, 2012; Pereira et al. 2014). We did not assess the effects 

of long-term exposure to mycotoxin hazards. Data are lacking to assess the frequency with 

which serious adverse health consequences or death occur due to chronic exposure to 

mycotoxin hazards in foods nor are there data to indicate that long-term chronic, high 

exposure to mycotoxin hazards is likely in the U.S. 

• Characterized severity of the hazard as “High” if adverse reactions resulting from a single 

eating occasion are serious and are reasonably likely to include death. 

• Considered that a chemical (including radiological) and physical hazard presents a 

reasonable probability of serious adverse health consequences or death for the purposes of 

this RA if exposure was assessed to be relatively high and was likely to result in serious 

adverse health consequences from a single eating occasion.
60 

Table 17. Qualitative Risk Characterization of Chemical (including Radiological) and Physical 

Hazards That Are Reasonably Likely to Be Associated with Foods Manufactured, Processed, 

Packed, or Held on a Farm Mixed-Type Facility

Hazard Exposure

Single Eating 

Occasion or 

Cumulative 

Exposure?

Severity

Reasonable 

Probability of 

Causing Serious 

Adverse Health 

Consequences or 

Death?** 

Comments

Food 

allergen 

hazards

High Single eating 

occasion

High Yes See Table 3

Sulfites High Single eating 

occasion

High Yes See Table 3

Mycotoxins Low Cumulative 

exposure 

Low No See Table 2

for frequency 

of chemical 

hazards 

relative to 

frequency of 

biological 

hazards 

Foreign 

objects

Low Single eating 

occasion

Low No See Table 3

** For the purposes of this RA

Based on Table 17: 

• Two chemical hazards relevant to this RA present a reasonable probability of causing serious 

adverse health consequences or death for the purposes of this RA - i.e., food allergen hazards 

and sulfite hazards; and 

• None of the physical hazards relevant to this RA present a reasonable probability of causing 

serious adverse health consequences or death for the purposes of this RA. 

D. Characterizing Interventions with Respect to the Definition of Low-Risk Activity 

We characterized the interventions described in Table 10 and Table 12 under part #2b of the 

definition of low-risk activity (see section I.E of this document). Under part #2b, if a hazard is 

ordinarily controlled through applicable CGMP controls (e.g., the requirements in current 21 CFR 

part 110), these CGMP controls should not be considered a preventive control for that food to 

significantly minimize or prevent a hazard for the purposes of this RA. Our task in this RA is in part 

to determine whether the additional controls that would be required by section 418 of the FD&C Act 

are needed to ensure the safety of the product in light of the existing regulatory framework. 

The interventions described for two of the six representative biological hazards determined to 

present a reasonable probability of serious adverse health consequences or death for the purposes of 

this RA (i.e., Cryptosporidium and hepatitis A virus) are largely addressed by the CGMP controls 

already required by current part 110 (disease controls and personal hygiene controls in 21 CFR 
61

110.10, and requirements for the safety and sanitary quality of water in 21 CFR 110.37(a)). 

Although both Cryptosporidium and hepatitis A virus can also be controlled by additional 

preventive controls required under section 418 of the FD&C Act, such preventive controls likely 

would already be applied to significantly minimize or prevent other biological hazards that are more 

likely to occur (such as Salmonella spp.) or have more severe effects (such as E. coli O157:H7). 

Therefore we did not separately consider these hazards in section VI.E of this document 

(immediately below).

E. Characterizing Activity/Food Combinations

Table 18 presents a matrix of activity/food combinations. Activities and foods are taken from Table 

1, and activity/food combinations are evaluated to determine if they are or are not low-risk. Food 

groups are explained by letter footnotes in the table on first mention; number footnotes are used 

when there is a qualification to a low-risk designation.

As discussed in section I.E of this document, there are three parts of the definition of low-risk 

activity/food combination. 

Importantly, under the definition of low-risk activity food combination, to be low risk the 

activity/food combination must either:

• Satisfy part #1 (inherent controls); or

• Satisfy both part #2a (activity not likely to introduce, or increase the potential for, a 

SAHCODH hazard) and part #2b (activity does not significantly minimize or prevent a 

SAHCODH hazard).

For each row in Table 18, we ask whether an activity/food combination would be low risk (as 

defined in section I.E of this document) and provide the rationale for this determination. In 

answering the question whether an activity/food combination is low risk, we:

• Answer the question “Yes” if the activity satisfies the definition of low-risk activity/food 

combination; and

• Answer the question “No” if the activity does not satisfy the definition of low-risk 

activity/food combination.

In addressing the rationale:

For each activity/food combination that has a “Yes” answer, we provide the part of the definition of 

low-risk activity governing the classification of low-risk: 

• #1 (inherent controls); or

• #2 (if the activity satisfies both part #2a and part #2b of the definition of low-risk activity).

For each activity/food combination that has a “No” answer, we provide the part of the definition of 

low-risk activity governing the conclusion that the activity/food combination is NOT low risk: 

• #2a (if the activity introduces, or increases the potential for, a SAHCODH hazard); or

• #2b (if the activity significantly minimizes or prevents a SAHCODH hazard, i.e., if the 

activity would be a preventive control)

For those activity/food combinations that are not low risk, Table 19 explains the specific reasons 

why.
62

Table 18. Is an Activity/Food Combination Low Risk?

Activity Food Low risk 

(Y/N)

Rationale

Acidification/Pickling/Fermenting Fruits &Vegetables No #2b

Boiling Fruits &Vegetables No #2a and 2b

Boiling Gums, latexes, and 

resins

Yes #2

Boiling Peanuts No #2a and 2b

Canning/Bottling/Jarring (packaging 

that includes additional manufacturing/

processing)

Fruits &Vegetables No #2b

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Baked goods (e.g. 

bread)

Yes #2

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Dried F&V 

products (e.g., 

pitting dried plums)

Yes #2

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Dried herbs & other 

spicesb (e.g., intact 

dried basil, intact 

dried mint)

Yes #2

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Fresh herbs No1 #2a

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Fruits &Vegetables 

(low-acid and acid

with pH≥4.2)

No #2a

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Fruits & Vegetables 

(acid, pH<4.2), 

(e.g., lemons, 

limes)

Yes #2

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Game meat jerky Yes #2

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Gums, latexes, and 

resins

Yes #2

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Other grain 

products (e.g., dried 

cereal)

Yes #2

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Peanuts and tree 

nuts

Yes #2

Chopping/Coring/Cutting/Peeling

Pitting/Shredding/Slicing

Peanut and tree nut 

products

Yes #2

Coating (other than coating fruits and 

vegetables with wax/oil/resin)

Dried F&V 

productsa (e.g., 

coating raisins with 

chocolate)

Yes #2
63

Activity Food Low risk 

(Y/N)

Rationale

Coating (other than coating fruits and 

vegetables with wax/oil/resin)

Fruits &Vegetables, 

(e.g., coating intact 

apples with 

caramel)

No #2a

Coating (other than coating fruits and 

vegetables with wax/oil/resin)

Other F&V 

productsa (e.g., 

coating dried plum 

pieces, dried pitted 

cherries, and dried 

pitted apricots with 

chocolate), except 

for other F&V 

products that are 

not dried and not 

intact

Yes #2

Coating (other than coating fruits and 

vegetables with wax/oil/resin)

Other F&V 

products that are 

non-dried and nonintact (e.g., coating 

apples that are on a 

stick with caramel) 

No #2a

Coating (other than coating fruits and 

vegetables with wax/oil/resin)

Other grain 

products (e.g., 

popcorn), such as 

by adding caramel 

or by adding 

seasonings that 

have been treated to 

significantly 

minimize pathogens

Yes #2

Coating (other than coating fruits and 

vegetables with wax/oil/resin)

Other grain 

products (e.g., 

popcorn), such as 

by adding 

seasonings that 

have not been 

treated to 

significantly 

minimize pathogens

No #2a

Coating (other than coating fruits and 

vegetables with wax/oil/resin)

Peanuts and tree 

nuts (e.g., adding 

seasonings that 

have been treated to 

significantly 

minimize 

pathogens)

Yes #2
64 

Activity Food Low risk 

(Y/N)

Rationale

Coating (other than coating fruits and 

vegetables with wax/oil/resin)

Peanuts and tree 

nuts (e.g., adding 

seasonings that 

have not been 

treated to 

significantly 

minimize 

pathogens)

No #2a

Coating (other than coating fruits and 

vegetables with wax/oil/resin)

Peanut and tree nut 

productsd (e.g., 

adding seasonings 

that have been 

treated to 

significantly 

minimize 

pathogens)

Yes #2

Coating (other than coating fruits and 

vegetables with wax/oil/resin)

Peanut and tree nut 

productsd (e.g., 

adding seasonings 

that have not been 

treated to 

significantly 

minimize 

pathogens)

No #2a

Cooking Fruits &Vegetables No #2a and 2b

Dehydration/Drying (that includes 

additional manufacturing/processing or 

is performed on processed foods) 

Other F&V 

products with 

pH<4.2 (e.g., cut 

F&V with pH<4.2)

Yes #2

Dehydration/Drying (that includes 

additional manufacturing/processing or 

is performed on processed foods) 

Other F&V 

products with 

pH≥4.2 (e.g., cut 

acid F&V with 

pH≥4.2)

No #2a

Dehydration/Drying (that includes 

additional manufacturing/processing or 

is performed on processed foods) 

Other herb & spice 

productsc (e.g., 

chopped fresh 

herbs, including 

tea)

Yes #2
65 

Activity Food Low risk 

(Y/N)

Rationale

Extracting (including by pressing, by 

distilling, by solvent extraction)

Dried herbs & other 

spices (e.g., dried 

mint)

Yes #2 (or in 

some cases, 

i.e., by 

distilling 

and by 

solvent 

extraction: 

#1)

Extracting including (by pressing, by 

distilling, by solvent extraction) 

Fresh herbs (e.g., 

mint)

Yes #2 (or in 

some cases 

#1)

Extracting (including by pressing, by 

distilling, by solvent extraction) 

Fruits &Vegetables 

(e.g., olives, 

avocados)

Yes #2 (or in 

some cases 

#1)

Extracting (including by pressing, by 

distilling, by solvent extraction) 

Grains (e.g., 

oilseeds)

Yes #2 (or in 

some cases 

#1) 

Extracting (including by pressing, by 

distilling, solvent extraction)

Other herb & spice 

products (e.g., 

chopped, fresh 

mint)

Yes #2 (or in 

some cases 

#1) 

Freezing Fruits &Vegetables

(acid, pH<4.2)

Yes #2

Freezing Fruits &Vegetables

(low-acid and acid 

pH≥4.2)

No #2a

Freezing Other F&V 

products (acid, pH 

<4.2) (e.g., cut 

rhubarb, cut 

peaches)

Yes #2

Freezing Other F&V 

products (acid, 

pH≥4.2)

No #2a

Grinding/Milling/Cracking/Crushing Baked goods (e.g., 

crackers)

Yes #2

Grinding/Milling/Cracking/Crushing Cocoa beans

(roasted)

Yes #2

Grinding/Milling/Cracking/Crushing Coffee beans

(roasted)

Yes #2

Grinding/Milling/Cracking/Crushing Dried fruit and 

vegetable products 

(e.g., raisins, dried 

legumes)

Yes #2
66 

Activity Food Low risk 

(Y/N)

Rationale

Grinding/Milling/Cracking/Crushing Dried herbs & other 

spices (e.g., intact 

dried basil) 

Yes #2

Grinding/Milling/Cracking/Crushing Grains (e.g., oats, 

rice, rye, wheat)

Yes #2

Grinding/Milling/Cracking/Crushing Other F&V 

products that are 

processed foods 

(e.g., dried, pitted 

dates)

Yes #2

Grinding/Milling/Cracking/Crushing Other grain 

products (e.g., dried 

cereal)

Yes #2

Grinding/Milling/Cracking/Crushing Other herb & spice 

products (e.g., 

chopped dried 

herbs) 

Yes #2

Grinding/Milling/Cracking/Crushing Peanuts and tree 

nuts

Yes #2

Grinding/Milling/Cracking/Crushing Peanut & tree nut 

products (e.g., 

roasted)

Yes #2

Labeling Baked goods that 

contain food 

allergen(s) (e.g., 

those that contain 

wheat, milk, egg, or 

nuts)

No2 #2b

Labeling Baked goods that 

do not contain food 

allergens (e.g., 

crackers that do not 

contain wheat, 

milk, egg, or nuts)

Yes2 #2

Labeling Candy containing 

food allergen(s) 

(e.g., fudge, nut 

brittles, taffy, toffee 

containing milk, 

butter, or chopped 

nuts)

No2 #2b

Labeling Candy that does not 

contain food 

allergens (e.g., 

maple candy and 

maple cream)

Yes2 #2
67 

Activity Food Low risk 

(Y/N)

Rationale

Labeling Cocoa beans

(roasted) and cocoa 

products that do not 

contain food 

allergens

Yes

2 #2

Labeling Cocoa products that 

contain food 

allergen(s) (e.g., 

milk chocolate)

No

2 #2b

Labeling Coffee beans

(roasted)

Yes #2

Labeling Game meat jerky Yes #2

Labeling Gums, latexes, and 

resins that are 

processed foods

Yes #2

Labeling Honey

(pasteurized)

Yes #2

Labeling Jams, jellies, & 

preserves

Yes #2

Labeling Milled grain 

products that do not 

contain food 

allergens (e.g. corn 

meal) or that are 

single ingredient 

foods (e.g., wheat 

flour, wheat bran)

Yes

2 #2

Labeling Milled grain 

products that 

contain food 

allergen(s) and are 

not single 

ingredient foods 

(e.g., flour made 

from wheat and 

other ingredients)

No

2 #2b

Labeling Molasses and 

treacle

Yes #2

Labeling Oils Yes #2

Labeling Other F&V 

products that do not 

contain food 

allergens (e.g., 

snack chips made 

from potatoes or 

plantains)

Yes #2
68 

Activity Food Low risk 

(Y/N)

Rationale

Labeling Other F&V 

products that 

contain food 

allergen(s) (e.g., 

snack chips made 

from potatoes or 

plantains to which 

ingredients 

containing food 

allergens have been 

added)

No

2 #2b

Labeling Other grain 

products

g that 

contain food 

allergen(s) (e.g., dried pasta)

No

2 #2b

Labeling Other grain 

products that do not 

contain food 

allergens (e.g., 

popcorn)

Yes

2 #2

Labeling Other herb & spice 

products (e.g., 

chopped fresh 

herbs, chopped or 

ground dried herbs)

Yes #2

Labeling Peanut & tree nut 

products that are 

single ingredient, 

are in forms in 

which the consumer 

can reasonably be 

expected to 

recognize the 

allergen(s) without 

label declaration, or 

both (e.g., roasted 

or seasoned whole 

nuts, singleingredient peanut or 

tree nut flours)

Yes

2 #2
69 

Activity Food Low risk 

(Y/N)

Rationale

Labeling Peanut & tree nut 

products that 

contain multiple 

ingredients and that 

are in forms in 

which the consumer 

cannot reasonably 

be expected to 

recognize the food 

allergen(s) without 

label declaration 

(e.g., multiingredient peanut or 

tree nut flours)

No

2 #2b

Labeling Seeds(processed)

f

(e.g., roasted 

pumpkin or roasted 

sunflower seeds)

Yes #2

Labeling Soft drinks & 

carbonated water

Yes #2

Labeling Sugar/syrups Yes #2

Labeling Trail mix and 

granola (other than 

those containing 

milk chocolate and 

provided that 

peanuts and/or tree 

nuts are in forms in 

which consumer 

can reasonably be 

expected to 

recognize the 

allergen(s) without 

label declaration)

Yes

2 #2

Labeling Trail mix and 

granola (containing 

milk chocolate, or 

containing peanuts 

and/or tree nuts in 

forms in which 

consumer cannot 

reasonably be 

expected to 

recognize the food 

allergen(s) without 

label declaration)

No

2 #2b
70 

Activity Food Low risk 

(Y/N)

Rationale

Labeling Vinegar Yes #2

Labeling Any other 

processed food that 

does not require 

time/temperature 

control for safety 

and that does not 

contain food 

allergens (e.g., 

vitamins, minerals, 

and dietary 

ingredients (e.g., 

bone meal) in 

powdered, granular, 

or other solid form) 

Yes #2

Labeling Any other 

processed food that 

does not require 

time/temperature 

control for safety 

that contains a food 

allergen(s) (e.g., 

vitamins, minerals, 

and dietary 

ingredients (e.g., 

bone meal) in 

powdered, granular, 

or other solid form) 

No2 #2b

Making baked goods (including mixing, 

baking)

Milled grain 

products

Yes #1

Making candy (including boiling, 

evaporation, mixing) 

Peanuts and tree 

nuts (e.g., nut 

brittles), 

sugars/syrups (e.g., 

taffy, toffee), saps 

(e.g., maple candy, 

maple cream)

Yes #1

Making cocoa products (including 

grinding, mixing, conching, tempering)

Cocoa beans 

(roasted)

Yes #2

Making dried pasta Grains Yes #2

Making jams/jellies/preserves (including 

cutting/mashing, boiling, mixing, 

canning)

Fruits & Vegetables 

(acid, pH < 4.6) 

(e.g., rhubarb, 

strawberries)

Yes #1
71 

Activity Food Low risk 

(Y/N)

Rationale

Making jams/jellies/preserves (including 

cutting/mashing, boiling, mixing, 

canning)

Fruits & Vegetables 

(low acid, pH > 

4.6)

No #2b

Making molasses and treacle (including 

extracting, boiling, concentrating, 

evaporating)

Sugar beets, 

sugarcane

Yes #1

Making oat flakes Grains Yes #2

Making popcorn Grains Yes #1

Making snack chips Fruits & Vegetables 

(e.g., plantains, 

potatoes)

Yes #1

Making soft drinks and carbonated 

water (including flavoring, carbonating)

Sugar, syrups, 

water

Yes #1

Making syrups and sugars (including 

extracting, boiling, concentrating, 

evaporating, crystalizing)

Fruits & Vegetables 

(e.g., dates)

Yes #1

Making syrups and sugars (including 

extracting, boiling, concentrating, 

evaporating, crystalizing)

Grains (e.g., rice, 

sorghum) 

Yes #1

Making syrups and sugars (including 

extracting, boiling, concentrating, 

evaporating, crystalizing)

Other grain 

products(e.g., 

malted grains such 

as barley)

Yes #1

Making syrups and sugars (including 

extracting, boiling, concentrating, 

evaporating, crystalizing)

Sap (e.g., agave, 

birch, maple, palm) 

Yes #1

Making syrups and sugars (including 

extracting, boiling, concentrating, 

evaporating, crystalizing)

Sugar beets, 

sugarcane

Yes #1
72 

Activity Food Low risk 

(Y/N)

Rationale

Making trail mix or granola Cocoa products 

(e.g., chocolate), 

dried F&V products 

(e.g., raisins), other 

F&V products(e.g., 

chopped dried 

fruits), other grain 

products (e.g., oat 

flakes), peanut & 

tree nut products, 

seeds (processed) 

(provided that 

peanut & tree nut 

products and seeds 

(processed) have 

been treated to 

significantly 

minimize 

pathogens)e

Yes #2

Making trail mix or granola Cocoa products 

(e.g., chocolate), 

dried F&V products 

(e.g., raisins), other 

F&V products(e.g., 

chopped dried 

fruits), other grain 

products (e.g., oat 

flakes), peanuts & 

tree nuts, peanut & 

tree nut products, 

seeds, seeds 

(processed) (where 

peanuts, tree nuts, 

or seeds have not 

been treated to 

significantly 

minimize 

pathogens)

No #2a

Making vinegar (including fermenting) Fruits &Vegetables Yes #1

Making vinegar (including fermenting) Other F&V 

products (e.g., fruit 

wines, apple cider) 

Yes #1

Making vinegar (including fermenting) Other grain 

products (e.g., malt)

Yes #1

Malting Grains No3 #2a
73 

Activity Food Low risk 

(Y/N)

Rationale

Mixing/Blending Baked goods (e.g., 

cookie types)

Yes #2

Mixing/Blending Candy (e.g., 

varieties of taffy) 

Yes #2

Mixing/Blending Cocoa beans 

(roasted)

Yes #2

Mixing/Blending Coffee beans 

(roasted)

Yes #2

Mixing/Blending Dried F&V 

products (e.g., 

raisins, dried 

currants and dried 

blueberries)

Yes #2

Mixing/Blending Dried herbs & other 

spices (e.g., intact 

dried basil and 

intact dried 

oregano)

Yes #2

Mixing/Blending Honey 

(pasteurized)

Yes #2

Mixing/Blending Milled grain 

products (e.g., 

flour, bran, corn 

meal)

Yes #2

Mixing/Blending Other F&V 

products (e.g., 

dried, sliced apples 

and dried sliced 

peaches)

Yes #2

Mixing/Blending Other grain 

products (e.g., 

different types of 

dried pasta)

Yes #2

Mixing/Blending Other herb and 

spice products (e.g., 

chopped or ground 

dried herbs, dried 

herb- or spiceinfused honey, and 

dried herb- or 

spice-infused oils 

and/or vinegars)

Yes #2

Mixing/Blending Peanut and tree nut 

products

Yes #2

Mixing/Blending Sugar/Syrups Yes #2
74 

Activity Food Low risk 

(Y/N)

Rationale

Mixing/Blending Vinegar Yes #2

Mixing/Blending Any other

processed food that 

does not require 

time/temperature 

control for safety 

(e.g., vitamins, 

minerals, and 

dietary ingredients 

(e.g., bone meal) in 

powdered, granular, 

or other solid form) 

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Baked goods Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Candy Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Cocoa beans 

(roasted)

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Cocoa products Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Coffee beans 

(roasted)

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Game meat jerky Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Gums, latexes, and 

resins that are 

processed foods

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Honey 

(pasteurized)

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Jams, jellies, and 

preserves

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging) 

Milled grain 

products (e.g., 

flour, bran, corn 

meal) 

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Molasses and 

treacle

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Oils Yes #2

Packaging (including modified 

atmosphere and vacuum packaging) 

Other F&V 

productse (e.g., 

pitted dried fruit, 

sliced dried apples, 

snack chips)

Yes #2
75 

Activity Food Low risk 

(Y/N)

Rationale

Packaging (including modified 

atmosphere and vacuum packaging)

Other grain 

products (e.g., 

popcorn)

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Other herb and 

spice products 

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Peanut and tree nut 

products

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Seeds (processed) Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Soft drinks and 

carbonated water

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Sugar/syrups Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Trail mix and 

granola

Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Vinegar Yes #2

Packaging (including modified 

atmosphere and vacuum packaging)

Any other

processed food that 

does not require 

time/temperature 

control for safety 

(e.g., vitamins, 

minerals, and 

dietary ingredients 

(e.g., bone meal) in 

powdered, granular, 

or other solid form)

Yes #2

Packing/Re-Packing Baked goods Yes #2

Packing/Re-Packing Candy Yes #2

Packing/Re-Packing Cocoa beans 

(roasted) 

Yes #2

Packing/Re-Packing Cocoa products Yes #2

Packing/Re-Packing Coffee beans 

(roasted)

Yes #2

Packing/Re-Packing Game meat jerky Yes #2

Packing/Re-Packing Gums, latexes, and 

resins that are 

processed foods

Yes #2

Packing/Re-Packing Honey 

(pasteurized)

Yes #2

Packing/Re-Packing Jams, jellies, and 

preserves

Yes #2
76 

Activity Food Low risk 

(Y/N)

Rationale

Packing/Re-Packing Milled grain 

products (e.g., 

flour, bran, corn 

meal) 

Yes #2

Packing/Re-Packing Molasses and 

treacle

Yes #2

Packing/Re-Packing Oils Yes #2

Packing/Re-Packing Other F&V 

products (e.g., 

pitted dried fruit, 

sliced dried apples, 

snack chips)

Yes #2

Packing/Re-Packing Other grain 

products (e.g., 

popcorn)

Yes #2

Packing/Re-Packing Other herb and 

spice products (i.e., 

chopped or ground 

dried herbs and 

herbal extracts)

Yes #2

Packing/Re-Packing Peanut and tree nut 

products

Yes #2

Packing/Re-Packing Seeds (processed) Yes #2

Packing/Re-Packing Soft drinks and 

carbonated water

Yes #2

Packing/Re-Packing Sugar/syrups Yes #2

Packing/Re-Packing Trail mix and 

granola

Yes #2

Packing/Re-Packing Vinegar Yes #2

Packing/Re-PackingAny other 

processed food that 

does not require 

time/temperature 

control for safety 

(e.g., vitamins, 

minerals, and

dietary ingredients 

(e.g., bone meal) in 

powdered, granular, 

or other solid form)

Yes #2

Pasteurizing Honey Yes #1

Roasting/toasting Baked goods (e.g., 

toasting bread for 

croutons)

Yes #2

Roasting/toasting Cocoa beans No #2b
77 

Activity Food Low risk 

(Y/N)

Rationale

Roasting/toasting Coffee beans No #2b

Roasting/toasting Grains (e.g., 

Soybeans)

No #2b

Roasting/toasting Peanuts and tree 

nuts

No #2b

Roasting/toasting Seeds (e.g., 

sunflower, 

pumpkin)

No #2b

Salting Other grain 

products (e.g., soy 

nuts)

Yes #2

Salting Peanut and tree nut 

products

Yes #2

Salting Seeds(processed) Yes #2

Sifting Milled grain 

products (e.g., 

flour, bran, corn 

meal)

Yes #2

Sifting Other F&V 

products (e.g., 

chickpea flour)

Yes #2

Sifting Peanut and tree nut 

products (e.g., 

peanut flour, 

almond flour)

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Baked goods Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Candy Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Cocoa beans 

(roasted)

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Cocoa products Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Coffee beans 

(roasted)

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Game meat jerky Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere) 

Gums, latexes, and 

resins that are 

processed foods

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Honey 

(pasteurized)

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Jams, jellies, and 

preserves

Yes #2
78 

Activity Food Low risk 

(Y/N)

Rationale

Storing/Holding (Cold, ambient or 

controlled atmosphere) 

Milled grain 

products (e.g., 

flour, bran, corn 

meal)

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Molasses and 

treacle

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Oils Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere) 

Other F&V 

products(e.g., 

pitted dried fruit, 

sliced dried apples, 

snack chips)

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere) 

Other grain 

products (e.g., 

popcorn)

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Other herb and 

spice products

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Peanut and tree nut 

products

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Seeds (processed) Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Soft drinks and 

carbonated water

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Sugar/syrups Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Trail mix and 

granola

Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere)

Vinegar Yes #2

Storing/Holding (Cold, ambient or 

controlled atmosphere) 

Any other 

processed food that 

does not require 

time/temperature 

control for safety 

(e.g., vitamins, 

minerals, and 

dietary ingredients 

(e.g., bone meal) in 

powdered, granular, 

or other solid form)

Yes #2

Sulfiting Fruits &Vegetables No #2a 

a

Dried F&V products means dried fruit and vegetable products that are processed foods and includes raisins, 

unpitted dried plums, and dried legumes. This category includes only dried fruit and vegetable products that have been 
79 

made without additional manufacturing/processing other than: (1) drying that creates a distinct commodity, (2) 

packaging, and/or (3) labeling. The drying, packaging, and labeling of these products is within the farm definition and 

these activity/food combinations are out of scope of the risk assessment.

b

Dried herbs & other spices means dried herbs and other spices that are processed foods and this includes intact 

dried basil, intact dried bay leaves, and intact dried mint. This category includes only dried herbs and other spices that 

have been made without additional manufacturing/processing other than: (1) drying/dehydrating that creates a distinct 

commodity, (2) packaging, and/or (3) labeling. The drying, packaging, and labeling of these products is within the farm 

definition and these activity/food combinations are out of scope of the risk assessment. 

c Other herb & spice products means other herb and spice products that are processed foods and this includes 

chopped fresh herbs, chopped or ground dried herbs (including tea), herbal extracts (e.g., essential oils, extracts 

containing >20% ethanol, extracts containing >35% glycerin), dried herb- or spice-infused honey, and dried herb- or 

spice-infused oils and/or vinegars. This category excludes those dried herbs and other spices made without additional 

manufacturing/processing other than: (1) drying/dehydrating that creates a distinct commodity, (2) packaging, and/or (3) 

labeling.

d Peanut & tree nut products means peanut and tree nut products that are processed foods and this includes roasted 

peanuts and tree nuts, seasoned peanuts and tree nuts, and peanut and tree nut flours.

e Other F&V products means other fruit and vegetable products that are processed foods and this includes those that 

have undergone one or more of the following processes: acidification, boiling, canning, coating with things other than 

wax/oil/resin, cooking, cutting, chopping, grinding, peeling, shredding, slicing, or trimming. Examples include caramel 

apples, flours made from legumes (such as chickpea flour), pickles, and snack chips made from potatoes or plantains. 

This category does not include dried fruit and vegetable products that have been made without additional 

manufacturing/processing other than: (1) drying/dehydrating that creates a distinct commodity, (2) packaging, and/or (3) 

labeling (e.g., raisins). Examples of dried fruit and vegetable products made with additional manufacturing/processing 

include dried apple slices; pitted, dried plums, cherries and apricots; and sulfited raisins.

f Seeds (processed) means seeds for direct consumption that are processed foods and this includes roasted pumpkin 

seeds, roasted sunflower seeds, and roasted flax seeds. (By contrast, raw (unroasted) seeds are examples of seeds for 

direct consumption.) For purposes of this risk assessment, we treat seeds as within the fruit and vegetable category when 

used for direct consumption, and within the grains category when used as a grain.

g Other grain products means other grain products that are processed foods and this includes malt, oat flakes, 

popcorn, soy nuts, and dried pasta.

1

Drying chopped herbs is low risk and chopping as part of the process of making dried chopped herbs is considered low 

risk.

2

Labeling of foods bearing or containing an allergen (i.e., eggs, fish, milk, peanuts, shellfish, soy beans, tree nuts, wheat) 

is low risk only if the food is a single-ingredient food, the food is in a form in which a consumer can reasonably be 

expected to recognize the food as containing the allergen(s) without a label declaration, or both. For example, milk 

chocolate is not a single ingredient food and is in a form in which a consumer cannot reasonably be expected to 

recognize the food as containing milk without a label declaration, so labeling foods containing milk chocolate is not low 

risk. Fudge, nut brittles, taffy, and toffee containing food allergens (e.g. milk, peanuts, tree nuts), are not singleingredient foods and are in a form in which a consumer cannot reasonably be expected to recognize the food as 

containing the specific allergen without a label declaration, so labeling these foods is not low risk. 

3 Malting when conducted in conjunction with making sugar, syrups, or vinegar is considered low risk, since the heat 

process used to make sugar and syrups and the low pH of vinegar mitigate the risk from microbial pathogens. 
80 

Table 19. Why Certain Activity/Food Combinations Are Not Low Risk 

Activity Food 

Activity Introduces, 

or Increases the 

Potential for, a 

SAHCODH Hazard 

(#2a)

Activity Significantly 

Minimizes or Prevents a 

SAHCODH Hazard (i.e., it 

would be a preventive 

control) (#2b)

Acidification/

Pickling/

Fermenting 

Fruits and 

vegetables • Requires careful controls 

to significantly minimize 

or prevent a hazard from 

C. botulinum.

• Activity needs to 

significantly minimize 

biological hazards such 

as E. coli O157 and 

Salmonella that may be 

present on the fruit or 

vegetable.

Boiling Fruits and 

vegetables

For some foods 

increases the potential 

for a hazard, e.g., 

growth of pathogenic 

sporeformers such as 

C. botulinum that 

survive the heating. 

(The activity would 

create a food that 

requires 

time/temperature 

control to prevent the 

growth of pathogens 

that survive cooking, 

e.g., C. botulinum.)

Activity needs to 

significantly minimize 

biological hazards such as E. 

coli O157 and Salmonella

that may be present on the 

fruit or vegetable.

Boiling Peanuts Increases the aw and 

thus the potential for a 

hazard, e.g., growth of 

pathogenic 

sporeformers such as 

C. botulinum that 

survive the heating. 

(The activity would 

create a food that 

requires 

time/temperature 

control to prevent the 

growth of pathogens 

that survive cooking, 

e.g., C. botulinum.)

Activity needs to 

significantly minimize 

biological hazards such as E. 

coli O157 and Salmonella

that may be present on the 

peanuts. 
81 

Activity Food 

Activity Introduces, 

or Increases the 

Potential for, a 

SAHCODH Hazard 

(#2a)

Activity Significantly 

Minimizes or Prevents a 

SAHCODH Hazard (i.e., it 

would be a preventive 

control) (#2b)

Canning/Bottling/

Jarring (packaging that 

includes additional 

manufacturing, 

processing) 

Fruits and 

vegetables • Requires careful controls 

to significantly minimize 

or prevent a hazard from 

C. botulinum.

• Activity needs to 

significantly minimize 

biological hazards such 

as E. coli O157 and 

Salmonella that may be 

present on the fruit or 

vegetable.

Chopping/Coring/

Cutting/ Peeling/ 

Pitting/Shredding/

Slicing

Fresh herbs The activity is 

reasonably likely to 

increase the potential 

for biological hazards 

(i.e., microbial 

pathogens) by 

releasing fluids from 

tissues, thereby 

providing conditions 

that enhance microbial 

growth.

Chopping/Coring/

Cutting/ Peeling/ 

Pitting/Shredding/

Slicing

Fruits and 

vegetables (acid, 

pH≥4.2)

The activity is 

reasonably likely to 

(1) introduce 

biological hazards 

(i.e., microbial 

pathogens) to the 

interior of the fruit or 

vegetable where they 

may be able to grow 

and (2) to release 

fluids from tissues, 

providing conditions 

for growth of 

microbial pathogens.
82 

Activity Food 

Activity Introduces, 

or Increases the 

Potential for, a 

SAHCODH Hazard 

(#2a)

Activity Significantly 

Minimizes or Prevents a 

SAHCODH Hazard (i.e., it 

would be a preventive 

control) (#2b)

Coating (other than 

coating fruits and 

vegetables with 

wax/oil/resin)

Fruits 

&Vegetables, (e.g., 

coating intact 

apples with 

caramel)

The activity is 

reasonably likely to 

introduce, or create 

the potential for, a 

hazard by providing 

an environment in 

which biological 

hazards such as L. 

monocytogenes that 

may be present on the 

exterior of the fruit or 

vegetable can 

multiply9.

Coating (other than 

coating fruits and 

vegetables with 

wax/oil/resin)

Other F&V 

products that are 

non-dried and nonintact (e.g., coating 

apples that are on a 

stick with caramel)

The activity is 

reasonably likely to 

introduce, or create 

the potential for, a 

hazard by providing 

an environment in 

which biological 

hazards such as L. 

monocytogenes that 

may be present on the 

exterior of the fruit or 

vegetable can 

multiply10.

Coating (other than 

coating fruits and 

vegetables with 

wax/oil/resin)

Other grain 

products (e.g., 

popcorn), such as 

by adding 

seasonings that 

have not been 

treated to 

significantly 

minimize 

pathogens

The activity is 

reasonably likely to 

introduce biological 

hazards (pathogens).

 

9 Studies have shown that L. monocytogenes can grow by 1 log in 7 days in caramel apples without sticks, possibly due 

to fluid from the apple creating increased aw and pH at the apple-caramel interface (Glass, 2015). Such coatings appear 

to create a food that requires time/temperature control for safety. 

10 Studies have shown that L. monocytogenes can grow by 3 logs within 3 days in caramel apples with sticks held at 

25°C, possibly due to fluid from the apple creating increased aw and pH at the apple-caramel interface (Glass, 2015). 

Such coatings appear to create a food that requires time/temperature control for safety. 
83 

Activity Food 

Activity Introduces, 

or Increases the 

Potential for, a 

SAHCODH Hazard 

(#2a)

Activity Significantly 

Minimizes or Prevents a 

SAHCODH Hazard (i.e., it 

would be a preventive 

control) (#2b)

Coating (other than 

coating fruits and 

vegetables with 

wax/oil/resin)

Peanuts and tree 

nuts (e.g., adding 

seasonings that 

have not been 

treated to 

significantly 

minimize 

pathogens)

The activity is 

reasonably likely to 

introduce biological 

hazards (pathogens).

Coating (other than 

coating fruits and 

vegetables with 

wax/oil/resin)

Peanut and tree nut 

products (e.g., 

adding seasonings 

that have not been 

treated to 

significantly 

minimize 

pathogens)

The activity is 

reasonably likely to 

introduce biological 

hazards (pathogens).

Cooking Fruits and 

vegetables

For some foods 

increases the potential 

for a hazard, e.g., 

growth of pathogenic 

sporeformers such as 

C. botulinum that 

survive the heating. 

(The activity would 

create a food that 

requires 

time/temperature 

control to prevent the 

growth of pathogens 

that survive cooking, 

e.g., C. botulinum.)

Activity needs to 

significantly minimize 

biological hazards such as E. 

coli O157 and Salmonella

that may be present on the 

fruit or vegetable.

Dehydration/Drying (that 

includes additional 

manufacturing/processing 

or is performed on 

processed foods)

Other F & V 

products with 

pH≥4.2 (e.g., cut 

acid F&V with 

pH≥4.2)

Microbial pathogens 

may grow prior to 

reduction of the water 

activity to a level that 

prevents growth
84 

Activity Food 

Activity Introduces, 

or Increases the 

Potential for, a 

SAHCODH Hazard 

(#2a)

Activity Significantly 

Minimizes or Prevents a 

SAHCODH Hazard (i.e., it 

would be a preventive 

control) (#2b)

Freezing Fruits and 

vegetables (low 

acid)

The activity is 

reasonably likely to 

create the potential for 

a biological hazard

such as E. coli O157, 

Salmonella, and L. 

monocytogenes that 

may be present on the 

exterior of the fruit or 

vegetable to grow 

when such foods are 

thawed and held at 

temperatures that 

support growth. (The 

activity would create a 

food that requires 

time/temperature 

control to prevent the 

growth of pathogens 

that may be present.)

Freezing Other F&V 

products (acid, pH 

≥4.2)

The activity is 

reasonably likely to 

create the potential for 

a biological hazard

such as E. coli O157, 

Salmonella, and L. 

monocytogenes that 

may be present on the 

exterior of the fruit or 

vegetable to grow 

when such foods are 

thawed and held at 

temperatures that 

support growth. (The 

activity would create a 

food that requires 

time/temperature 

control to prevent the 

growth of pathogens 

that may be present.)
85 

Activity Food 

Activity Introduces, 

or Increases the 

Potential for, a 

SAHCODH Hazard 

(#2a)

Activity Significantly 

Minimizes or Prevents a 

SAHCODH Hazard (i.e., it 

would be a preventive 

control) (#2b)

Labeling Baked goods 

containing food 

allergen(s)

Labeling of baked goods 

containing food allergen(s) 

such as wheat, peanuts, tree 

nuts, milk, and eggs (when 

the food is not a singleingredient food and is in a 

form in which a consumer 

cannot reasonably be 

expected to recognize the 

food as containing the 

specific allergen) prevents the 

hazard of an undeclared food 

allergen.

Labeling Candy containing 

food allergen(s) 

(e.g., fudge, nut 

brittles, taffy, 

toffee) 

Labeling of candy containing 

food allergen(s) such as milk, 

peanuts, or tree nuts (when 

the food is not a singleingredient food and is in a 

form in which a consumer 

cannot reasonably be 

expected to recognize the 

food as containing the 

specific allergen) prevents the 

hazard of an undeclared food

allergen.

Labeling Cocoa products 

that contain food 

allergen(s) (e.g., 

milk chocolate)

Labeling of cocoa products 

containing food allergen(s) 

such as milk (when the food 

is not a single-ingredient food 

and is in a form in which a 

consumer cannot reasonably 

be expected to recognize the 

food as containing the 

specific allergen) prevents the 

hazard of an undeclared food 

allergen.
86 

Activity Food 

Activity Introduces, 

or Increases the 

Potential for, a 

SAHCODH Hazard 

(#2a)

Activity Significantly 

Minimizes or Prevents a 

SAHCODH Hazard (i.e., it 

would be a preventive 

control) (#2b)

Labeling Milled grain 

products that 

contain food 

allergen(s) and are 

not single 

ingredient foods 

(e.g., flour made 

from wheat and 

other ingredients) 

Labeling of milled grain 

products containing food 

allergen(s) such as wheat 

(when the food is not a 

single-ingredient food and is 

in a form in which a 

consumer cannot reasonably 

be expected to recognize the 

food as containing the 

specific allergen) prevents the 

hazard of an undeclared food 

allergen.

Labeling Other F&V 

products 

containing food 

allergen(s) (e.g., 

snack chips made 

from potatoes or 

plantains to which 

ingredients 

containing food 

allergens have been 

added) 

Labeling of snack chips 

containing food allergen(s) 

(such as milk or soy in added 

seasonings) (when the food is 

not a single-ingredient food 

and is in a form in which a 

consumer cannot reasonably 

be expected to recognize the 

food as containing the 

specific allergen) prevents the 

hazard of an undeclared food 

allergen.

Labeling Other grain 

products that 

contain food 

allergen(s) (e.g., 

dried pasta)

Labeling of other grain 

products that contain food 

allergens such as wheat 

(when the food is not a 

single-ingredient food and is 

in a form in which a 

consumer cannot reasonably 

be expected to recognize the 

food as containing the 

specific allergen) prevents the 

hazard of an undeclared food 

allergen.
87 

Activity Food 

Activity Introduces, 

or Increases the 

Potential for, a 

SAHCODH Hazard 

(#2a)

Activity Significantly 

Minimizes or Prevents a 

SAHCODH Hazard (i.e., it 

would be a preventive 

control) (#2b)

Labeling Peanut & tree nut 

products that 

contain multiple 

ingredients and that 

are in forms in 

which consumer 

cannot reasonably 

be expected to 

recognize the food 

allergen(s) without 

label declaration 

(e.g., multiingredient peanut 

or tree nut flours)

Labeling of peanut & tree nut 

products that are not singleingredient foods and are in a 

form in which a consumer 

cannot reasonably be 

expected to recognize the 

food as containing the 

specific allergen prevents the 

hazard of an undeclared food 

allergen.

Labeling Trail mix and 

granola 

(containing milk 

chocolate, or 

containing peanuts, 

and/or tree nuts in 

forms in which 

consumer cannot 

reasonably be 

expected to 

recognize the food 

allergen(s) without 

label declaration)

Labeling of trail mix or 

granola containing food 

allergens such as milk (in 

milk chocolate), or 

containing peanuts or tree 

nuts in a form in which a 

consumer cannot reasonably 

be expected to recognize the 

food as containing the 

specific allergen prevents the 

hazard of an undeclared food 

allergen.

Labeling Any other 

processed food that 

does not require 

time/temperature 

control for safety 

that contains food 

allergen(s) (e.g., 

vitamins, minerals, 

and dietary 

ingredients (e.g., 

bone meal) in 

powdered, 

granular, or other 

solid form) 

Labeling of allergencontaining foods (when the 

food is not a single-ingredient 

food and is in a form in 

which a consumer cannot 

reasonably be expected to 

recognize the food as 

containing the specific 

allergen) prevents the hazard 

of an undeclared food 

allergen. 

Making baked goods 

(including mixing, 

baking)

Milled grain 

products 

Activity needs to 

significantly minimize 

biological hazards such as E. 

coli O157 and Salmonella

that may be present on the 

milled grain products.
88 

Activity Food 

Activity Introduces, 

or Increases the 

Potential for, a 

SAHCODH Hazard 

(#2a)

Activity Significantly 

Minimizes or Prevents a 

SAHCODH Hazard (i.e., it 

would be a preventive 

control) (#2b)

Making jams/jellies/

preserves (including 

cutting/mashing, boiling, 

mixing, canning)

Fruits and 

vegetables (low

acid, pH > 4.6) 

Requires careful controls to 

significantly minimize or 

prevent a hazard from C. 

botulinum.

Making trail mix or 

granola 

Cocoa products 

(e.g., chocolate), 

dried F&V 

products (e.g., 

raisins), Other 

F&V products 

(e.g., chopped 

dried fruits), 

Peanuts & tree 

nuts, Peanut & tree 

nut products, 

Seeds, Seeds 

(processed) (where 

peanuts, tree nuts, 

or seeds have not 

been treated to 

significantly 

minimize 

pathogens)

The activity is 

reasonably likely to 

introduce biological 

hazards (pathogens).

Malting Grains Increases the potential 

for a hazard, e.g., 

growth of microbial 

pathogens such as 

Salmonella, during the 

germination process.

Roasting/toasting Cocoa beans Activity needs to 

significantly minimize 

biological hazards such as E. 

coli O157 and Salmonella

that may be present on the 

cocoa beans. 

Roasting/toasting Coffee beans Activity needs to 

significantly minimize 

biological hazards such as E. 

coli O157 and Salmonella

that may be present on the 

coffee beans. 

Roasting/toasting Grains (e.g., soy 

beans) 

Activity needs to 

significantly minimize 

biological hazards such as 

Salmonella that may be 

present on the grains.
89 

Activity Food 

Activity Introduces, 

or Increases the 

Potential for, a 

SAHCODH Hazard 

(#2a)

Activity Significantly 

Minimizes or Prevents a 

SAHCODH Hazard (i.e., it 

would be a preventive 

control) (#2b)

Roasting/toasting Peanuts and tree 

nuts 

Activity needs to 

significantly minimize 

biological hazards such as E. 

coli O157 and Salmonella

that may be present on the 

peanut and tree nuts. 

Roasting/toasting Seeds (e.g., 

sunflower, 

pumpkin) 

Activity needs to 

significantly minimize 

biological hazards such as E. 

coli O157 and Salmonella

that may be present on the 

seeds.

Sulfiting Fruits and 

vegetables

The activity is 

reasonably likely to 

introduce a chemical 

hazard (i.e., sulfite) 

which, if not properly 

labeled, is reasonably 

likely to cause serious 

adverse health 

consequences or 

death.

VII. Conclusions

A. Answers to the Questions to be Addressed in This Risk Assessment 

Question 1: What are the foods that would be manufactured, processed, packed, or held by a farm 

mixed-type facility?

The RA identified the following food categories that are within the scope of the RA11 and that 

would be manufactured, processed, packed, or held by a farm mixed-type facility:

• Baked goods (other than those requiring time/temperature control for safety)

• Candy

• Cocoa beans 

• Cocoa products (e.g., chocolate, cocoa powder and cocoa butter)

• Coffee beans 

• Dried fruit and vegetable products that are processed foods (e.g., raisins, unpitted dried 

plums, dried legumes) 

 

11 Note that the food categories include some foods that may be produced within the farm definition, (e.g., fresh herbs, 

dried fruit and vegetable products that are processed foods, honey) because of the activities farm mixed-type facilities 

perform on these foods that may be low-risk activity/food combinations.
90 

• Dried herbs and other spices that are processed foods (e.g., intact dried basil, intact dried bay 

leaves, intact dried mint)

• Fresh herbs

• Fruits and vegetables (as described previously). Note that, for the purpose of this analysis, 

we separately consider several foods (i.e., coffee beans, cocoa beans, fresh herbs, peanuts, 

sugarcane, sugar beets, tree nuts, seeds for direct consumption) that are within the category 

of fruits and vegetables to appropriately address specific hazards associated with these foods 

and/or processing activities conducted on these foods 

• Game meat jerky 

• Grains (e.g., corn, wheat, barley, rye, grain sorghum, oats, rice, wild rice, oilseeds [e.g., 

soybeans]). (Note that for the purpose of this analysis some oilseeds may also be considered 

to be in the category of fruits and vegetables when consumed directly, e.g., sunflower seeds). 

• Gums, latexes, and resins 

• Honey 

• Jams, jellies, and preserves

• Milled grain products (flour, bran, corn meal) 

• Molasses and treacle

• Oils

• Other fruit and vegetable products that are processed foods (other than low-acid cut fruits 

and vegetables) (e.g., dried apple slices; pitted, dried fruits) 

• Other grain products that are processed foods (dried cereal, dried pasta, malt, oat flakes, 

popcorn, and soy nuts) 

• Other herb and spice products that are processed foods (e.g., chopped fresh herbs, chopped 

or ground dried herbs (including tea), herbal extracts (e.g., essential oils extracts containing 

>20% ethanol, extracts containing >35% glycerin), dried herb- or spice-infused honey, and 

dried herb- or spice-infused oils and/or vinegars) 

• Peanuts and tree nuts (e.g., almonds, walnuts) 

• Peanut and tree nut products that are processed foods (e.g., roasted peanuts and tree nuts, 

seasoned peanuts and tree nuts, and peanut and tree nuts flours) 

• Sap (for making syrup, e.g., agave, birch, maple, palm) and the syrups made from them

• Seeds for direct consumption 

• Seeds for direct consumption that are processed foods (e.g., roasted pumpkin seeds, roasted 

sunflower seeds, roasted flax seeds)

• Soft drinks and carbonated water 

• Sugarcane, sugar beets and sugar 

• Trail mix and granola

• Vinegar

• Any other processed food that does not require time/temperature control for safety (e.g., 

vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other 

solid form) 

Question 2: What are the activities that might be conducted by farm mixed-type facilities on those 

foods [foods that would be manufactured, processed, packed, or held by a farm mixed-type facility]?

Table 1in section II.A of this document lists the activities that might be conducted by farm mixedtype facilities on those foods. 
91 

Question 3: What are the known or reasonably foreseeable hazards in those foods [that would be 

manufactured, processed, packed, or held by a farm mixed-type facility]? 

The RA identified the following hazards as representative of the hazards of concern for food 

categories that are likely to be manufactured, processed, packed, or held on a farm mixed-type 

facility and within the scope of this RA: 

• Nine biological hazards, including six bacterial foodborne pathogens (i.e., B. cereus, C. 

botulinum, E. coli O157, L. monocytogenes, Salmonella, and S. aureus), two viral foodborne 

pathogens (i.e., norovirus and hepatitis A virus), and one parasite (i.e., Cryptosporidium); 

• Mycotoxins and pesticides; 

• Food allergen hazards and sulfites; and

• Physical hazards

. 

Question 4: For the purpose of determining whether an activity/food combination is low risk, which 

hazards should be considered to have a reasonable probability of causing serious adverse health 

consequences or death? 

For the purpose of determining whether an activity/food combination is low risk, the RA identified 

the following hazards as having a reasonable probability of causing serious adverse health 

consequences or death: 

• The biological hazards C. botulinum, E. coli O157, L. monocytogenes, Salmonella, hepatitis 

A virus, and Cryptosporidium; 

• Food allergen hazards; and 

• Sulfites. 

Question 5: For the purpose of determining whether an activity/food combination is low risk, what 

foods have inherent controls that significantly minimize or prevent in these foods a hazard that is a 

known or reasonably foreseeable biological hazard and that is reasonably likely to cause serious 

adverse health consequences or death?

For the purpose of determining whether an activity/food combination is low risk, the RA identified 

the following foods as having inherent controls that significantly minimize or prevent a known or 

reasonably foreseeable biological hazard in these foods: 

• Baked goods (e.g., breads and cookies) 

• Candy (e.g., hard candy, fudge, maple candy, maple cream, nut brittles, taffy, and toffee); 

• Carbonated soft drinks and carbonated water; 

• Honey (pasteurized); 

• Jams, jellies, and preserves (shelf stable) made from acid fruits and vegetables; 

• Molasses and treacle; 

• Oil from grains (e.g., corn, soybeans, oilseeds) and fruits and vegetables (e.g., olives, 

avocados, herbs); 

• Popcorn; 

• Snack chips made from fruits and vegetables (e.g., plantains, potatoes) 

• Sugar;

• Syrups (e.g., agave, birch, maple, palm); and
92 

• Vinegar. 

Question 6: What interventions significantly minimize or prevent in these foods a hazard that is a 

known or reasonably foreseeable hazard and that is reasonably likely to cause serious adverse health 

consequences or death? 

The RA identified the following examples of interventions to significantly minimize or prevent a 

known or reasonably foreseeable hazard in these foods and that for purposes of this RA, is 

considered reasonably likely to cause serious adverse health consequences or death: 

• For the sporeforming bacterial pathogen C. botulinum: 

o Inactivating the spores of the organism with heat (e.g., canning under pressure); 

o Preventing germination of spores and growth of the organism/toxin production by: 

 Reducing pH to 4.6 or below (e.g., by acidification or through 

fermenting); 

 Refrigerating or freezing; 

 Adding preservatives, or 

 Reducing the aw. 

• For the bacteria E. coli O157:H7, L. monocytogenes, and Salmonella: 

o Killing the organism - e.g., through: 

 Heat treatments (e.g., baking, boiling, cooking, roasting); 

 Reducing the pH in combination with specific conditions (e.g., type and 

concentration of acid, time of exposure and temperature); 

o Preventing the growth of the organism - e.g., by: 

 Reducing the pH or aw; 

 Refrigerating or freezing; 

 Adding preservatives. 

o Applying sanitation controls. 

o Applying disease controls and personal hygiene controls to prevent contamination by 

food handlers. 

• For hepatitis A virus: 

o Preventing contamination by infected food handlers through disease controls and 

personal hygiene controls; 

o Vaccination of food handlers 

o Treatment of food, e.g., heat, to inactivate the virus. 

• For Cryptosporidium: 

o Use of water that is safe and of adequate sanitary quality. 

o Preventing contamination by infected food handlers through disease controls and 

personal hygiene controls. 

o Treatment of food, e.g., with heat, to inactivate the parasite. 

• For food allergen hazards: 

o Preventing cross-contact between an allergen-containing food and one that does not 

contain that allergen; 

o Preventing cross-contact between different allergen-containing foods; 

o Ensuring that the presence of food allergens is declared on the package label. 

• For sulfites: Ensuring that the presence of sulfites is declared on the package label.
93 

Question 7: Which of these activities are reasonably likely to introduce, or increase the potential 

for occurrence of, hazards that are reasonably likely to cause serious adverse health consequences or 

death and what are these hazards? 

The RA identified the following examples of activities that are reasonably likely to introduce, or 

increase the potential for occurrence of, hazards that are reasonably likely to cause serious adverse 

health consequences or death: 

• Boiling some fruits and vegetables and peanuts increases the potential for a hazard, e.g., 

growth of pathogenic sporeformers such as C. botulinum that survive the heating. The 

activity would create a food that requires time/temperature control to prevent the growth of 

pathogens that survive cooking, e.g., C. botulinum. 

• Chopping/coring/cutting/peeling/pitting/shredding/slicing fresh herbs and fruits and 

vegetables (low-acid and acid, pH≥4.2) is reasonably likely to introduce biological hazards 

(i.e., microbial pathogens) to the interior of the fruit or vegetable, or to release fluids from 

tissues, providing conditions that enhance microbial growth. 

• Coating (other than coating fruits and vegetables with wax/oil/resin) fruits and vegetables 

(e.g., coating intact apples with caramel) is reasonably likely to introduce, or create the 

potential for, a hazard by providing an environment in which a biological hazard such as L. 

monocytogenes that may be present on the exterior of the fruit or vegetable can multiply. 

• Coating (other than coating fruits and vegetables with wax/oil/resin) non-dried and nonintact fruits and vegetables (e.g., coating apples that are on a stick with caramel) is 

reasonably likely to introduce, or create the potential for, a hazard by providing an 

environment in which a biological hazard such as L. monocytogenes that may be present on 

the exterior of the fruit or vegetable can multiply. 

• Coating (other than coating fruits and vegetables with wax/oil/resin) other grain products 

(e.g., popcorn), such as by adding seasonings that have not been treated to significantly 

minimize pathogens. Other grain products (e.g., adding seasonings that have not been treated 

to significantly minimize pathogens to popcorn 

• Coating (other than coating fruits and vegetables with wax/oil/resin) peanuts and tree nuts 

(e.g., adding seasonings that have not been treated to significantly minimize pathogens). 

• Coating (other than coating fruits and vegetables with wax/oil/resin) peanut and tree nut 

products (e.g., adding seasonings that have not been treated to significantly minimize 

pathogens). 

• Cooking some fruits and vegetables increases the potential for a hazard, e.g., growth of 

pathogenic sporeformers such as C. botulinum that survive the heating. The activity would 

create a food that requires time/temperature control to prevent the growth of pathogens that 

survive cooking, e.g., C. botulinum. 

• Dehydration/Drying (that includes additional manufacturing/processing or is performed on 

processed foods) of other fruit and vegetable products with pH≥4.2 (e.g., cut acid fruits and 

vegetables with pH≥4.2) is reasonably likely to provide conditions where microbial 

pathogens may grow prior to reduction of the water activity to a level that prevents growth. 

• Freezing intact or cut low-acid fruits and vegetables and intact or cut acid fruits and 

vegetables with pH≥4.2 is reasonably likely to create the potential for a biological hazard 

(such as E. coli O157, Salmonella and L. monocytogenes that may be present on the exterior 

of the fruit or vegetable) to grow when such foods are thawed and held at temperatures that 

support growth. The activity would create a food that requires time/temperature control to 

prevent the growth of pathogens that may be present. 
94 

• Making trail mix or granola from cocoa products (e.g., chocolate), dried F&V products (e.g., 

raisins), other F&V products(e.g., chopped dried fruits), other grain products (e.g., oat 

flakes), peanuts and tree nuts, peanut and tree nut products, seeds, processed seeds (where 

peanuts, tree nuts, or seeds have not been treated to significantly minimize pathogens) is 

reasonably likely to introduce biological hazards (pathogens).

• Malting grains increases the potential for growth of microbial pathogens such as Salmonella 

during the germination process. 

• Sulfiting intact or cut fruits and vegetables is reasonably likely to introduce a chemical 

hazard (i.e., sulfite) which, if not properly labeled, is reasonably likely to cause serious 

adverse health consequences or death. 

Question 8: Which of these activities are interventions to significantly minimize or prevent hazards 

that are reasonably likely to cause serious adverse health consequences or death from consumption 

of these foods? 

The RA identified the following examples of activities that are interventions to significantly

minimize or prevent hazards that are reasonably likely to cause serious adverse health consequences 

or death from consumption of these foods: 

• Acidification/pickling/fermenting fruits and vegetables;

• Boiling fruits and vegetables and peanuts; 

• Canning/bottling/jarring (packaging that includes additional manufacturing/processing, e.g., 

water bath canning, pressure canning) fruits and vegetables; 

• Cooking fruits and vegetables; 

• Labeling food bearing or containing food allergens if the food is not a single-ingredient food 

and is in a form in which a consumer cannot reasonably be expected to recognize the food as 

containing the specific food allergen without a label declaration (e.g., baked goods that 

contain food allergen(s) (e.g., those that contain wheat, milk, egg, or nuts), candy containing 

food allergen(s) (e.g., fudge, nut brittles, taffy, toffee containing milk, butter, or chopped 

nuts), cocoa products that contain food allergen(s) (e.g., milk chocolate), milled grain 

products that contain food allergen(s) and are not single ingredient foods (e.g., flour made 

from wheat and other ingredients), other fruit and vegetable products that contain food 

allergen(s) (e.g., snack chips made from potatoes or plantains to which ingredients 

containing food allergens have been added), other grain products that contain food 

allergen(s) (e.g., dried pasta), peanut and tree nut products that contain multiple ingredients 

and that are in forms in which consumer cannot reasonably be expected to recognize the 

food allergen(s) without label declaration (e.g., multi-ingredient peanut or tree nut flours), 

trail mix and granola (containing milk chocolate, or containing peanuts, and/or tree nuts in 

forms in which consumer cannot reasonably be expected to recognize the food allergen(s) 

without label declaration), and any other processed food that does not require 

time/temperature control for safety that contains a food allergen(s) (e.g., vitamins, minerals, 

and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form)); 

• Making jams/jellies/preserves from low-acid (pH >4.6) fruits and vegetables; 

• Roasting/toasting cocoa beans, coffee beans, grains (e.g., soy beans), peanuts and tree nuts, 

and seeds (e.g., sunflower, pumpkin). 

Question 9: Which activity/food combinations are low risk, i.e., what on-farm activity/food 

combinations are not reasonably likely to introduce hazards that are reasonably likely to cause 
95 

serious adverse health consequences or death or serve as preventive controls (interventions) to 

significantly minimize or prevent a hazard that could cause serious adverse health consequences or 

death?

Based on the information in Table 18, and for the purposes of the analysis required by section 

103(c)(1))(C) of FSMA, the RA identified the following low-risk activity/food combinations. 

• Boiling gums, latexes, and resins; 

• Chopping/coring/cutting/peeling/pitting/shredding/slicing acid fruits and vegetables with 

pH<4.2 (e.g., cutting lemons, limes), baked goods (e.g., slicing bread), dried fruit and 

vegetable products (e.g., pitting dried plums), dried herbs and other spices (e.g., chopping 

intact dried basil, intact dried mint), game meat jerky, gums/ latexes/ resins, other grain 

products (e.g., shredding dried cereal), peanuts and tree nuts, and peanut and tree nut 

products (e.g., chopping roasted peanuts)

• Coating dried fruit and vegetable products (e.g., coating raisins with chocolate), other fruit 

and vegetable products except for non-dried, non-intact fruits and vegetables (e.g., coating 

dried plum pieces, dried pitted cherries, and dried pitted apricots with chocolate are low-risk 

activity/food combinations but coating apples on a stick with caramel is not a low-risk 

activity food combination), other grain products (e.g., adding caramel to popcorn or adding 

seasonings to popcorn provided that the seasonings have been treated to significantly 

minimize pathogens), peanuts and tree nuts (e.g., adding seasonings provided that the 

seasonings have been treated to significantly minimize pathogens), and peanut and tree nut 

products (e.g., adding seasonings provided that the seasonings have been treated to 

significantly minimize pathogens); 

• Dehydration/drying (that includes additional manufacturing or is performed on processed 

foods) of other fruit and vegetable products with pH<4.2 (e.g., cut fruit and vegetables with 

pH<4.2), and other herb and spice products (e.g., chopped fresh herbs, including tea);

• Extracting (including by pressing, by distilling, by solvent extraction) dried herbs and other 

spices (e.g., dried mint), fresh herbs (e.g., mint), fruits and vegetables (e.g., olives, 

avocados), grains (e.g., oilseeds), and other herb and spice products (e.g., chopped, fresh 

mint);

• Freezing acid fruits and vegetables with pH<4.2 and other fruit and vegetable products with 

pH <4.2 (e.g., cut fruits and vegetables); 

• Grinding/milling/cracking/crushing baked goods (e.g., crackers), cocoa beans (roasted), 

coffee beans (roasted), dried fruit and vegetable products (e.g., raisins, dried legumes), dried

herbs and other spices (e.g., intact dried basil), grains (e.g., oats, rice, rye, wheat), other fruit 

and vegetable products that are processed foods (e.g., dried, pitted dates), other grain 

products that are processed foods (e.g., dried cereal), other herb and spice products (e.g., 

chopped dried herbs), peanuts and tree nuts, and peanut and tree nut products (e.g., roasted 

peanuts);

• Labeling baked goods that do not contain food allergens (e.g., crackers that do not contain 

wheat, milk, egg, or nuts), candy that does not contain food allergens (e.g., maple candy and 

maple cream), cocoa beans (roasted), cocoa products that do not contain food allergens, 

coffee beans (roasted), game meat jerky, gums/ latexes/ resins that are processed foods, 

honey (pasteurized), jams/ jellies/ preserves, milled grain products that do not contain food 

allergens (e.g. corn meal) or that are single ingredient foods (e.g., wheat flour, wheat bran), 

molasses and treacle, oils, other fruit and vegetable products that do not contain food 

allergens (e.g., snack chips made from potatoes or plantains), other grain products that do not 
96 

contain food allergens (e.g., popcorn), other herb and spice products (e.g., chopped or 

ground dried herbs), peanut and tree nut products that are single ingredient, are in forms in 

which the consumer can reasonably be expected to recognize the allergen(s) without label 

declaration, or both (e.g., roasted or seasoned whole nuts, single-ingredient peanut or tree nut 

flours), processed seeds (e.g., roasted pumpkin or roasted sunflower seeds), soft drinks and

carbonated water, sugar/syrups, trail mix and granola (other than those containing milk 

chocolate and provided that peanuts and/or tree nuts are in forms in which the consumer can 

reasonably be expected to recognize the allergen(s) without label declaration), vinegar, any 

other processed food that does not require time/temperature control for safety and that does 

not contain food allergens (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) 

in powdered, granular, or other solid form); 

• Making baked goods from milled grain products (e.g., breads and cookies); 

• Making candy (including boiling, evaporation, mixing) from peanuts and tree nuts (e.g., nut 

brittles), sugar/syrups (e.g., taffy, toffee), and saps (e.g., maple candy, maple cream); 

• Making cocoa products (including grinding, mixing, conching, tempering) from roasted 

cocoa beans;

• Making dried pasta from grains; 

• Making jams, jellies and preserves (including cutting/mashing, boiling, mixing, canning) 

from acid fruits and vegetables with a pH < 4.6 (e.g., rhubarb, strawberries) ; 

• Making molasses and treacle (including extracting, boiling, concentrating, evaporating) from 

sugar beets, sugarcane; 

• Making oat flakes from grains; 

• Making popcorn from grains; 

• Making snack chips from fruits and vegetables (e.g., plantains, potatoes); 

• Making soft drinks and carbonated water (including flavoring, carbonating) from sugar, 

syrups, water; 

• Making syrups and sugars (including extracting, boiling, concentrating, evaporating, 

crystalizing) from fruits and vegetables (e.g., dates), grains (e.g., rice, sorghum), other grain 

products (e.g., malted grains such as barley), sap (e.g., agave, birch, maple, palm), sugar 

beets, and sugarcane;

• Making trail mix or granola from cocoa products (e.g., chocolate), dried fruit and vegetable 

products (e.g., raisins), other fruit and vegetable products (e.g., chopped dried fruits), other 

grain products (e.g., oat flakes), peanut and tree nut products, and seeds (processed)

(provided that peanut and tree nut products, and seeds (processed) have been treated to 

significantly minimize pathogens); 

• Making vinegar (including fermenting) from fruits and vegetables, other fruit and vegetable 

products (e.g., fruit wines, apple cider), and other grain products (e.g., malt); 

• Mixing/blending baked goods (e.g., cookie types), candy (e.g., varieties of taffy), cocoa 

beans (roasted), coffee beans (roasted), dried fruit and vegetable products (e.g., raisins, dried 

currants and dried blueberries), dried herbs and other spices (e.g., dried intact basil and dried 

intact oregano), honey (pasteurized), milled grain products (e.g., flour, bran, corn meal), 

other fruit and vegetable products (e.g., dried, sliced apples and dried sliced peaches); other 

grain products (e.g., different types of dried pasta), other herb and spice products (e.g., 

chopped or ground dried herbs, dried herb- or spice-infused honey, dried herb- or spiceinfused oils and/or vinegars), peanut and tree nut products, sugar/syrups, vinegar, any other 

processed food that does not require time/temperature control for safety (e.g., vitamins, 
97 

minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid 

form); 

• Packaging (including modified atmosphere or vacuum packaging) baked goods, candy, 

cocoa beans (roasted), cocoa products, coffee beans (roasted), game meat jerky, gums/ 

latexes/ resins that are processed foods, honey (pasteurized), jams/ jellies/ preserves, milled 

grain products (e.g., flour, bran, corn meal), molasses and treacle, oils, other fruit and 

vegetable products (e.g., pitted, dried fruits; sliced, dried apples; snack chips), other grain 

products (e.g., popcorn), other herb and spice products (e.g., chopped or ground dried herbs), 

peanut and tree nut products, processed seeds, soft drinks and carbonated water, 

sugar/syrups, trail mix and granola, vinegar, any other processed food that does not require 

time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., 

bone meal) in powdered, granular, or other solid form); 

• Packing/re-packing baked goods, candy, cocoa beans (roasted), cocoa products, coffee beans 

(roasted), game meat jerky, gums/ latexes/ resins that are processed foods, honey 

(pasteurized), jams/ jellies/ preserves, milled grain products (e.g., flour, bran, corn meal), 

molasses and treacle, oils, other fruit and vegetable products (e.g., flours made from 

legumes, pitted, dried fruits; sliced, dried apples; snack chips), other grain products (e.g., 

popcorn), other herb and spice products (e.g., chopped or ground dried herbs and herbal 

extracts), peanut and tree nut products, processed seeds, soft drinks and carbonated water, 

sugar/syrups, trail mix and granola, vinegar, any other processed food that does not require 

time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., 

bone meal) in powdered, granular, or other solid form); 

• Pasteurizing honey; 

• Roasting/toasting baked goods (e.g., toasting bread for croutons); 

• Salting other grain products (e.g., soy nuts), peanut and tree nut products, processed seeds; 

• Sifting milled grain products (e.g., flour, bran, corn meal), other fruit and vegetable products 

(e.g., chickpea flour), peanut and tree nut products (e.g., peanut flour, almond flour); 

• Storing/holding (cold, ambient or controlled atmosphere) baked goods, candy, cocoa beans

(roasted), cocoa products, coffee beans (roasted), game meat jerky, gums/ latexes/ resins that 

are processed foods, honey (pasteurized), jam/ jellies/ preserves, milled grain products (e.g., 

flour, bran, corn, meal), molasses and treacle, oils, other fruit and vegetable products (e.g., 

pitted dried fruits, sliced dried apples, snack chips), other grain products (e.g., popcorn), 

other herb and spice products, peanut and tree nut products, processed seeds, soft drinks and 

carbonated water, sugar/syrups, trail mix and granola, vinegar, any other processed food that 

does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary 

ingredients (e.g., bone meal) in powdered, granular, or other solid form). 

 

B. Summary 

This RA assesses the risk of activities conducted on foods by farm mixed-type facilities to 

determine low-risk activity/ food combinations. It advances our ability to describe our current state 

of knowledge about known or reasonably foreseeable hazards for foods and activities on-farm and to 

assess which activities are low risk. It provides a framework for integrating and evaluating the 

scientific knowledge related to public health as applied to on-farm activities and can be used in 

support of regulatory decisions in the implementation of FSMA. 
98 

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Appendix 1. Definitions Relevant to Activities of Farms and Farm Mixed-Type 

Facilities

The following definition of “farm” is an excerpt from FDA’s regulation entitled “Registration of 

Food Facilities” as published in the Title 21 of the Code of Federal Regulations, part 1, subpart H. It 

is formatted according to styles associated with the Code of Regulations including numbering styles 

not otherwise associated with this document. 

Farm means: 

(1) Primary production farm. A primary production farm is an operation under one 

management in one general (but not necessarily contiguous) physical location devoted to the 

growing of crops, the harvesting of crops, the raising of animals (including seafood), or any 

combination of these activities. The term “farm” includes operations that, in addition to 

these activities: 

(i) Pack or hold raw agricultural commodities;

(ii) Pack or hold processed food, provided that all processed food used in such 

activities is either consumed on that farm or another farm under the same management, or is 

processed food identified in paragraph (1)(iii)(B)(1) of this definition; and

(iii) Manufacture/process food, provided that: 

(A) All food used in such activities is consumed on that farm or another farm under 

the same management; or 

(B) Any manufacturing/processing of food that is not consumed on that farm or 

another farm under the same management consists only of: 

(1) Drying/dehydrating raw agricultural commodities to create a distinct commodity 

(such as drying/dehydrating grapes to produce raisins), and packaging and labeling such 

commodities, without additional manufacturing/processing (an example of additional 

manufacturing/processing is slicing); 

(2) Treatment to manipulate the ripening of raw agricultural commodities (such as by 

treating produce with ethylene gas), and packaging and labeling treated raw agricultural 

commodities, without additional manufacturing/processing; and

(3) Packaging and labeling raw agricultural commodities, when these activities do 

not involve additional manufacturing/processing (an example of additional 

manufacturing/processing is irradiation); or 

(2) Secondary activities farm. A secondary activities farm is an operation, not located 

on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, 

and/or holding of raw agricultural commodities, provided that the primary production 

farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities 

harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a 

majority interest in the secondary activities farm. A secondary activities farm may also 

conduct those additional activities allowed on a primary production farm as described in 

paragraph (1)(ii) and (iii) of this definition. 

The following definitions of “harvesting,” “holding,” “manufacturing/processing,” and “packing” 

also are excerpted from FDA’s regulation entitled “Registration of Food Facilities” as published in 

the Title 21 of the Code of Federal Regulations, part 1, subpart H. 

Harvesting applies to farms and farm mixed-type facilities and means activities that are 

traditionally performed on farms for the purpose of removing raw agricultural commodities from the 
110 

place they were grown or raised and preparing them for use as food. Harvesting is limited to 

activities performed on raw agricultural commodities, or on processed foods created by 

drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a 

farm. Harvesting does not include activities that transform a raw agricultural commodity into a

processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. 

Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw 

agricultural commodity from the crop plant and removing or trimming part of the raw agricultural 

commodity (e.g., foliage, husks, roots or stems). Examples of harvesting also include cooling, field 

coring, filtering, gathering, hulling, removing stems and husks from, shelling, sifting, threshing, 

trimming of outer leaves of, and washing raw agricultural commodities grown on a farm. 

Holding means storage of food and also includes activities performed incidental to storage of a food 

(e.g., activities performed for the safe or effective storage of that food, such as fumigating food 

during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating 

does not create a distinct commodity (such as drying/dehydrating hay or alfalfa). Holding also 

includes activities performed as a practical necessity for the distribution of that food (such as 

blending of the same raw agricultural commodity and breaking down pallets)), but does not include 

activities that transform a raw agricultural commodity into a processed food as defined in section 

201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities could include warehouses, 

cold storage facilities, storage silos, grain elevators, and liquid storage tanks. 

Manufacturing/processing means making food from one or more ingredients, or synthesizing, 

preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples 

of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, 

cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity 

(such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, 

formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging 

(including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate 

ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, 

manufacturing/processing does not include activities that are part of harvesting, packing, or holding. 

Packing means placing food into a container other than packaging the food and also includes repacking and activities performed incidental to packing or re-packing a food (e.g., activities 

performed for the safe or effective packing or re-packing of that food (such as sorting, culling, 

grading, and weighing or conveying incidental to packing or re-packing), but does not include 

activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal 

Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg) of the Federal 

Food, Drug, and Cosmetic Act. 
Appendix 2: Chronology of Technical and Scientific Reviews of the 

Qualitative Risk Assessment

FDA solicited the advice and opinions of scientific experts and the public

throughout the conduct of this risk assessment. A summary of the dates, type of 

review activity, and participants is provided below.

Chronology of Technical and Scientific Reviews of the Qualitative Risk Assessment 

Date Activity Participants

2011-2012 Risk Assessment Team assembled FDA

March 2012 Submit draft risk assessment for peer 

review

Independent, 

external peer review 

conducted by 

June 2012 Peer review comments received from 

Versar, Inc. on draft risk assessment 

Independent, 

external peer review 

conducted by 

Versar, Inc.

June 2012 Submit draft risk assessment and draft peer 

review comments to OMB as part of 

rulemaking for FSMA

OMB

June – July 2012 Draft risk assessment revised FDA

August 2012 External Peer Review of the FDA/CFSAN 

Draft Qualitative Risk Assessment. Peer 

Review Report 

FDA

November 2012 Draft risk assessment formatted for posting FDA

January 2013 Notice of Availability of draft risk

assessment for public comment (78 FR 

3824, January 16, 2013)

Public

March 2013 Notice reopening public comment 

period (78 FR 15894)

Public

April 2013 1st extension of public comment period (78 

FR 24693)

Public

August 2013 2nd extension of comment period (78 FR 

48636)

Public

November 2013-

June 2015

Revisions made to draft risk assessment to 

reflect public comments

FDA

June 2015 Submit draft risk assessment to OMB as 

part of rulemaking for FSMA

OMB

August 2015 Revisions to draft risk assessment FDA

September 2015 Notice of Availability of

revised risk assessment 

N/A