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: 

Response to Public Comments

August 2015 
2

Table of Contents

I. A Summary of Key Changes in the Final Risk Assessment Compared to the Draft Risk Assessment .... 3

II. Public Comments and FDA/CFSAN’s Responses ................................................................................... 5

A. Comments on Activity/Food Combinations ........................................................................................ 5

B. Comments on Hazards ......................................................................................................................... 7

C. Comments on Data and Data Sources .................................................................................................. 7

D. Comments on Definitions .................................................................................................................... 9

E. Comments on Organization .................................................................................................................. 9

F. Comments on Opportunity for Public Comment ................................................................................ 10

III. Packing/Holding Activities ................................................................................................................... 11

IV. Manufacturing/Processing Activities .................................................................................................... 13

List of Tables

Table 1. A Summary of Key Changes in the Final Risk Assessment Compared to the Draft Risk 

Assessment ..................................................................................................................................... 3

Table 2. Comments on Activities.................................................................................................................. 5

Table 3. Comments on Hazards .................................................................................................................... 7

Table 4. Comments on Data and Data Sources ............................................................................................. 7

Table 5. Comments on Definitions ............................................................................................................... 9

Table 6. Comments on Organization ............................................................................................................ 9

Table 7. Comments on Opportunity for Public Comment .......................................................................... 10

Table 8. Requested Food or Food Category and Relevant Exemption for On-Farm Low-Risk Packing 

and Holding Activities .................................................................................................................. 11

Table 9. Why Certain Requested Food Categories Are Not Included in the Exemption for On-Farm 

Low-Risk Packing and Holding Activities ................................................................................... 12

Table 10. Requested Activity/Food Combinations and Relevant Exemption for On-Farm Low-Risk 

Manufacturing/Processing Activities ........................................................................................... 13

Table 11. Why Certain Requested Activity/Food Combinations Are Not Included in the Exemption 

for On-Farm Low-Risk Manufacturing/Processing Activities ..................................................... 14
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I. A Summary of Key Changes in the Final Risk Assessment Compared to the Draft 

Risk Assessment 

Table 1. A Summary of Key Changes in the Final Risk Assessment Compared to the Draft Risk 

Assessment

Applicable 

Section of 

the Risk 

Assessment

Applicable 

Table of 

the Risk 

Assessment

Change

I, III, VII N/A Asked questions and discussed hazards with respect to “known or 

reasonably foreseeable hazards” rather than “hazards reasonably likely to 

occur” because of changes in terminology and because the hazards that 

require a preventive control are specific to a food and a facility.

I, II 1, 18, 19 Excluded baked goods that require refrigeration for safety from the scope of 

the risk assessment and limited the exclusion for cut fruits and vegetables to 

those that are low-acid. When considering the risk of activities related to 

acid fruits and vegetables, we considered the risk for growth of pathogens 

when the pH is between 4.2 and 4.6. Excluded game meat products that 

require refrigeration for safety in addition to excluding game meat.

I,II 1, 18, 19 Considered information from an updated Food Processing Sector Study.

II, VI, VII 1, 18, 19 Made changes to reflect the revised farm definition, which increased the 

number of activities within the farm definition thereby narrowing the scope 

of the activity/food combinations that needed to be considered in the final 

risk assessment. (For example, drying/dehydrating raw agricultural 

commodities (RACs) without additional manufacturing/processing, such as 

drying grapes to make raisins, now falls within the farm definition.)

II, VI, VII 1, 18, 19 Added foods and activities as a result of comments submitted on the draft 

RA and on the proposed preventive controls for human food rule.

II, VI, VII 1, 18, 19 Revised the way foods were grouped, e.g., broad categories of foods were 

broken into smaller categories.

II, VI, VII 1, 18, 19 Included activities that encompass multiple steps (e.g., making jams, jellies 

and preserves may involve steps such as cutting, mashing, boiling, mixing, 

and canning) and grouped these steps to better identify the end product. As 

such, activities that are encompassed within the making of a particular 

product are no longer listed as separate activities within the table. (For 

example, because making syrup includes boiling sap, boiling sap is not 

listed as a separate activity.)

III 2, 3, 4, 5, 

and 6 

Updated the foodborne illness surveillance information in Table 2. Updated 

the Reportable Food Registry information in Table 3 (now Tables 3, 4, 5, 

and 6).

III 7 Updated Table 4 (now Table 7) on the potential biological and chemical 

hazards likely to be associated with the food categories manufactured, 

processed, packed, or held on a farm mixed-type facility to include the 

revised food categories.

III, IV 7 Updated information in Table 4 (now Table 7) on mycotoxins and added 

references.
4

Applicable 

Section of 

the Risk 

Assessment

Applicable 

Table of 

the Risk 

Assessment

Change

IV N/A Deleted discussion of radiological hazards in the RA, because the preventive 

controls for human foods rule now considers them as a type of chemical 

hazard. (We have considered them as part of our consideration of chemical 

hazards, and we focused in the final RA on the chemical hazards most likely 

to require a preventive control.)

V 9 Updated Table 6 (now Table 9) on inherent controls for biological hazards 

to include additional foods.

V 11 Updated the examples in Table 8 (now Table 11) of activities that can 

introduce, or increase the potential for, biological hazards to better reflect 

activities relevant to the final RA (e.g., we removed washing fruits and 

vegetables, as this activity falls within the farm definition).

V N/A Deleted information on oxidation-reduction potential as not needed based on 

the foods included in the final RA.

VI 18 Revised and merged the two draft RA tables addressing whether an 

activity/food combination is low risk (Table 18 in the final RA) to reflect the 

revised list of foods and activities in Table 1 of the final RA.

VI 19 Revised the table describing why certain activity/food combinations are not 

low risk (Table 19 in the final RA) to reflect the decisions made in Table 18.

VII N/A Revised the answers to the questions posed in the RA and the list of low-risk 

activity/food combinations to reflect the outcome of the final RA.

Appendices N/A Deleted the draft appendices that focused on categorizing the low-risk 

activity/food combinations according to the regulatory framework.

Appendices N/A Added new appendices on: 

• the definitions of “farm” and activities relevant to the “farm”

definition (i.e., “harvesting,” “holding,” “manufacturing/processing,” and 

“packing,” and

• the chronology of technical and scientific reviews of the RA.

Throughout N/A Revised terminology for consistency with revisions to the preventive 

controls for human foods rule, e.g., food allergen hazards rather than 

allergen hazards.

Throughout N/A Updated several references and added additional ones.
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II. Public Comments and FDA/CFSAN’s Responses

A. Comments on Activity/Food Combinations 

Table 2. Comments on Activities

Public Comment: 2012 Draft 

Assessment

Risk FDA/CFSAN's Response 

Comments stated that it is not clear how Washing raw agricultural commodities (RACs) is 

certain high- or moderate-risk practices within the “farm” definition (e.g., when washing is 

(e.g., washing), which are necessary to done during harvesting or in an on-farm packinghouse 

move product from the field, will affect on intact RACs) and is therefore out of the scope of this 

exemptions. Comments state that future risk assessment. When washing is done as part of 

risk assessments should examine the manufacturing/processing (e.g., washing fruits and 

impact of these practices by commodity vegetables as part of freezing them), it is considered in 

and volume of intact fruits and vegetables this risk assessment as part of the 

marketed through small and very-small manufacturing/processing and not as a stand-alone 

farm mixed-type facilities. activity. 

Comments ask us to expand the list of onfarm low-risk packing and holding 

activities to include packing and holding 

of food products not expressly covered by 

the proposed exemption. 

FDA modified Table 1 of the risk assessment to list 

more types of food categories so as to make it clearer 

when a particular food is encompassed within a 

particular activity/food combination. For example, 

Table 1 of the risk assessment lists food categories such 

as baked goods, milled grain products, and other grain 

products that are processed foods, in place of the 

original category “grain products.” We also expanded 

the list of foods considered in the risk assessment based 

on comments submitted. As a result, the list of on-farm 

low-risk packing and holding activities was also 

expanded. (See Section III of this document). 

Comments ask us to include in the 

exemption a single list of low-risk 

manufacturing/processing activity food 

combinations applicable to farm mixedtype facilities conducting activities on 

their own RACs and farm mixed-type 

facilities conducting activities on others’ 

RACs.

The revised “farm” definition no longer distinguishes 

between activities conducted on a farm mixed-type 

facility’s own RACs and activities conducted on others’ 

RACs. As a result, the comment’s request is moot.
6

Public Comment: 2012 Draft Risk

Assessment

FDA/CFSAN's Response 

Comments ask us to expand the list of 

activity/food combinations in the 

exemption. 

FDA evaluated specific additional activity/food 

combinations provided in the comments within the 

qualitative risk assessment to determine whether they 

satisfied the criteria for a low-risk activity/food 

combination and added additional activity/food 

combinations where appropriate based on the 

conclusions of the risk assessment (see Section III, 

Table 7 and Table 8 of this document (packing and 

holding) and Section IV, Table 9 and Table 10 of this 

document (manufacturing/processing)). 

Comments stated that FDA should not 

automatically exclude on-farm activities 

that require refrigeration and/or freezing 

for safety from the “low risk” category. 

Similarly, FDA should not automatically 

exclude activities that require 

measurement of cooking times from being 

considered “low risk”. 

FDA disagrees with these comments and the risk 

assessment continues to consider foods requiring 

time/temperature control for safety to be out of scope of 

the risk assessment. However, in revising the risk 

assessment, FDA determined that freezing intact or cut 

fruits and vegetables with pH <4.2 is a low-risk 

activity/food combination. See the discussion in 

sections I.B, I.C, and I.E and Tables 18 and 19 of the 

risk assessment. 

Comments stated that FDA should expand 

the risk assessment to consider dietary 

ingredients.

FDA revised the qualitative risk assessment to evaluate 

foods such as chopped fresh herbs, chopped or ground 

dried herbs, and herbal extracts, which may be used as 

dietary ingredients. FDA also added a category “Any 

other processed food that does not require 

time/temperature control for safety” in the list of onfarm low-risk packing and holding activities, and 

considered vitamins, minerals, and dietary ingredients 

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

form as examples of such foods.
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B. Comments on Hazards 

Table 3. Comments on Hazards 

Public Comment: 2012 Draft Risk

Assessment

FDA/CFSAN's Response

Comments stated that FDA should include 

Toxoplasma gondii, Cyclospora 

cayetanensis, other pathogenic E. coli, as 

well as antibiotic residues, heavy metals 

and other environmental contaminants 

such as cadmium and lead in the list of 

hazards reasonably likely to occur in 

foods being considered.

FDA has incorporated additional text on relevant 

hazards in foods as they relate to risks from 

activity/food combinations.

C. Comments on Data and Data Sources

Table 4. Comments on Data and Data Sources

Public Comment: 2012 Draft Risk

Assessment

FDA/CFSAN's Response

Comments stated that FDA should reexamine its data sources in assessing 

commodity-specific risks, as it is likely 

that many will be found to be low risk. 

FDA disagrees that it should re-examine its data 

sources in assessing commodity-specific risks, because 

the risk assessment focused on the risk of activity/food 

combinations rather than separately considering the risk 

of specific food categories. See the discussion in 

section I.B of the qualitative risk assessment.

Comments stated that the Centers for 

Disease Control and Prevention should 

expand its data analysis effort (see Painter 

et al. 2013, Attribution of Foodborne 

Illnesses, Hospitalizations, and Deaths to 

Food Commodities by Using Outbreak 

Data, United States, 1998-2008, Emerging 

Infectious Diseases, 19:407-415).

The Painter et al. 2013 paper is the most up-to-date 

publication available, and more finely grained data for 

additional commodities are not currently available. 

Comments stated that FDA should rely on 

more recent data on aflatoxin 

contamination and should consider longterm exposures.

FDA has updated the references on aflatoxins in the 

risk assessment and has added text on long-term 

exposures to aflatoxins and their potential effects. 

Comments stated that FDA should 

consider the disproportionate impact that 

some of the hazards have on more 

susceptible populations in its risk 

assessment.

FDA has included text regarding the data limitations, 

including absence of data to conduct a dose-response 

assessment for specific susceptible populations.
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Public Comment: 2012 Draft Risk

Assessment

FDA/CFSAN's Response

Comments express concern that 

conclusions drawn regarding risk 

categories, and exemptions made based on 

this qualitative risk assessment do not 

account for consumer risk from 

consumption of activity/food products.

The results of the qualitative risk assessment are based 

on consumer risk to the extent practicable, consistent 

with the inherent data limitations.

Comments stated that FDA should justify 

why certain activities are considered lowrisk activities, since they provide 

opportunities for spread of biological 

hazards. 

FDA evaluated each of the requested activity/food 

combinations that was within the scope of this rule 

within the qualitative risk assessment to determine 

whether it satisfied the criteria for a low-risk 

activity/food combination. See the description of the 

criteria for whether an activity/food combination is low 

risk in section I.E of the qualitative risk assessment and 

the explanation for why FDA concluded that certain 

activity/food combinations are not low risk in Table 19 

within the risk assessment.

Comments stated that the risk assessment 

should not rely on the Food Processing 

Sector study but instead collect data from 

large-scale surveys of actual farm mixedtype facilities and their activities. 

We revised and extended the results of our earlier Food 

Processing Sector study by expanding our data sources 

and by including representatives from USDA’s 

Economic Research Service, USDA’s Agricultural 

Marketing Service, and the American Farm Bureau to 

help oversee the revised study. To better account for 

farms that perform processing activities, we included 

Census of Agriculture data both to provide a count of 

total U.S. farms and to estimate the number of farms 

conducting food processing activities. We also 

included the Agricultural Resource Management 

Survey data. In addition, we obtained estimates from 

commodity specialists at trade associations, USDA, and 

universities with in-depth knowledge of the processing 

activities for specific agricultural commodities and 

reached out to directors of promotion and marketing 

boards. FDA disagrees that we need to conduct largescale surveys to collect additional information in light 

of the opportunities for broad public input regarding the 

activity/food combinations conducted on farm and farm 

mixed-type facilities (see Appendix 2 of the risk 

assessment, Chronology of Technical and Scientific 

Reviews of the Qualitative Risk Assessment) and the 

new data sources and input provided to the Food 

Processing Sector study.
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D. Comments on Definitions

Table 5. Comments on Definitions

Public Comment: 2012 Draft Risk

Assessment

FDA/CFSAN's Response

Comments state that FDA should provide 

a definition for “low moisture food” and 

should take moisture levels into account 

more consistently in the draft risk 

assessment. (Comments stated that low 

moisture food should be defined as any 

food, whether in liquid, solid, or semisolid 

form, having a water activity lower than 

0.85.)

We did not use the term “low-moisture food” in the 

qualitative risk assessment, so there is no need to 

provide a definition. We evaluated a number of foods 

that could be classified as low-moisture foods, and 

identified a number of low-risk activity/food 

combinations for such foods; however, we did not 

evaluate low-moisture foods as a category because 

there are differences in the way these foods are 

manufactured/processed and not all meet the criteria for 

low-risk activity/food combinations.

Comments stated that FDA needs to be 

more transparent when defining terms 

such as “hazards RLTO,” “too rare,” and 

criteria used to determine severity of 

biological hazards with respect to 

hospitalizations and deaths. 

FDA has made revisions to better define terminology 

used in the risk assessment where appropriate. For 

example, we use the term “known or reasonably 

foreseeable hazard” (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) as more appropriate for the risk assessment 

we conducted. We did not use the term “too rare.” We 

explain the criteria used to determine severity of 

biological hazards with respect to hospitalizations and 

deaths in VI.B Qualitative Risk Characterization of 

Biological Hazards, in which we ordered information 

related to frequency and severity and grouped them as 

“low,” “medium,” and “high,” which seemed most 

appropriate given the data available. 

E. Comments on Organization 

Table 6. Comments on Organization 

Public Comment: 2012 Draft Risk

Assessment

FDA/CFSAN's Response

Comments stated that FDA should present 

information more clearly, particularly 

information intended for a public 

audience. Comments stated that data from 

Appendix 2 should be moved into the 

main document.

FDA has clarified text in the risk assessment for the 

intended public audience. We deleted the draft 

appendices because they no longer reflect the “farm” 

definition as a result of regulatory changes in that 

definition. 
10

Public Comment: 2012 Draft Risk

Assessment

FDA/CFSAN's Response

Comments stated that use of 3 regulatory 

groups to categorize different types of onfarm activities is confusing and would 

benefit from clarification. Comments 

stated that FDA should address common 

scenarios such as on farm processing 

activities for products from other farms, 

such as farmer owned cooperatives, food 

hubs, and CSA operations. 

We deleted the draft appendices because they no longer 

reflect the “farm” definition as a result of regulatory 

changes in that definition. (See Appendix 1 in the risk 

assessment for the definition of “farm” and the 

definitions of “harvesting,” “holding,” 

“manufacturing/processing,” and “packing.”) These 

definitions do not distinguish whether activities are 

performed on foods from the farm conducting them or 

from other farms. We do not address scenarios for 

business types such as cooperatives, food hubs and 

CSA operations because the purpose of this risk 

assessment is to identify which activity/food 

combinations subject to the preventive controls rule are 

low-risk activity/food combinations when performed 

on-farm. In many cases the activities of farmer owned 

cooperatives, food hubs, and CSA operations will not 

be subject to the preventive controls rule, for example, 

if they fall within the farm definition. 

F. Comments on Opportunity for Public Comment

 Table 7. Comments on Opportunity for Public Comment

Public Comment: 2012 Draft Risk

Assessment

FDA/CFSAN's Response

Comments stated that FDA should revise 

the draft risk assessment and make it 

available for additional public comment. 

The draft risk assessment was subjected to peer review 

in accordance with the OMB Final Information Quality 

Bulletin for Peer Review before it was made available 

for a broader public comment period that exceeded 10 

months. The additional iterative process recommended 

is not necessary and would go beyond the processes 

routinely applied for public input on a risk assessment. 
11 

III. Packing/Holding Activities

The first column in Table 7 lists the food or food category that comments ask us to include in the 

exemption for on-farm, low-risk packing and holding activities. The second column lists the 

regulatory citation for the relevant exemption for on-farm packing and holding. Importantly, the 

full regulatory text of the exemption includes some limitations that were not specified in the 

comments, and Table 7 should not be viewed as equating the requests of the comments with the 

final regulatory text of the exemption. For example, § 117.5(g)(2)(ix) specifies that the food 

category “baked goods” includes processed food products such as breads, brownies, cakes, cookies, 

and crackers, but does not include products that require time/temperature control for safety (such as 

cream-filled pastries). 

Table 8. Requested Food or Food Category and Relevant Exemption for On-Farm Low-Risk 

Packing and Holding Activities 

Food or Food Category Requested in the 

Comments

Relevant Regulatory Section (§) 

• Barley malt syrup

• Barley malt extract 

• Other concentrated grain malt products in 

liquid or powder form 

• 117.5(g)(3)(xix)--Sugar 

• 117.5(g)(3)(xx)--Syrups 

• 117.5(g)(3)(xxii)--Vinegar

• 117.5(g)(3)(xxiii)--Any other processed food that does not 

require time/temperature control for safety

• Birch sap and syrup

• Cane syrup 

• Coconut sap and sugar

• Date sugar

• Palm sap and sugar

• Sorghum juice and syrup

• Other concentrated natural sweetener having 

a water activity lower than 0.85 and made with 

an adequate microbial reduction step

• 117.5(g)(3)(xix)--Sugar 

• 117.5(g)(3)(xx)--Syrups

Chips 117.5(g)(3)(xiii)--Other fruit and vegetable products

• Crackers 

• Bread crumbs

• Dry bread 

117.5(g)(3)(i)--Baked goods

Crude “dietary ingredient botanicals” in cut, 

chopped, or powdered form

• 117.5(g)(3)(xiii)--Other fruit and vegetable products

• 117.5(g)(3)(xv) Other herb and spice products

• Dried cereal

• Dried pasta

117.5(g)(3)(xiv)--Other grain products

Dried herbs and spices, chopped or ground 117.5(g)(3)(xv)--Other herb and spice products

Dry legume products (e.g., chickpea flour) 117.5(g)(3)(xiii)--Other fruit and vegetable products

Dry, unsulfited, fruits and vegetables in cut, 

chopped, sliced, shredded, or other form

117.5(g)(3)(xiii)--Other fruit and vegetable products

Gums and resins 117.5(g)(3)(vii)--Gums, latexes, and resins that are 

processed foods

Herbal extracts (e.g., in solvents such as 

glycerin, alcohol and oil)

117.5(g)(3)(xv)--Other herb and spice products

• Honey infused with dried herbs or spices

• Oil and/or vinegar infused with dried herbs 

or spices

117.5(g)(3)(xv)--Other herb and spice products

Jerky 117.5(g)(3)(vi)--Game meat jerky

Molasses and treacle 117.5(g)(3)(xi)--Molasses and treacle

Potato starch 117.5(g)(3)(xiii)--Other fruit and vegetable products

Popcorn 117.5(g)(3)(xiv)--Other grain products
12 

Food or Food Category Requested in the 

Comments

Relevant Regulatory Section (§) 

Salt, baking powder 117.5(g)(3)(xxiii)--Any other processed food that does not 

require time/temperature control for safety

Vitamins, minerals, and processed dietary 

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

granular, or other solid form

117.5(g)(3)(xxiii)--Any other processed food that does not 

require time/temperature control for safety

In Table 8, we list those foods or food categories, requested by comments, that are not included in 

the exemption for on-farm, low-risk packing and holding activities, and explain why. 

Table 9. Why Certain Requested Food Categories Are Not Included in the Exemption for OnFarm Low-Risk Packing and Holding Activities

Food or Food Category Requested in the 

Comments

Why the Food or Food Category is Not Listed in the 

Exemption

Barley malt and other grain malts Malting increases the potential for a hazard, e.g., growth of 

microbial pathogens such as Salmonella, during the germination 

process. (However, the risk is mitigated when malting is done in 

conjunction with making sugar, syrups or vinegar.) 

Crude “dietary ingredient botanicals” in 

whole, form

These are RACs, so packing and holding them is within the 

farm definition.

Dates (RACs) These are RACs, so packing and holding them is within the 

farm definition.

Dried intact herbs and spices Although these are processed foods, packing and holding them 

is specifically included within the farm definition.

Dried legumes Although these are processed foods, packing and holding them 

is specifically included within the farm definition. 

Gums, resins, and exudates in solid, 

powdered, granular, or paste form

Gums, resins and exudates (including latexes such as chicle) are

RACs, so packing and holding them is within the “farm” 

definition. These products are made into processed foods in 

some cases, such as by boiling or cutting. The powdered, 

granular and paste forms from further processing are considered

in the risk assessment as “any other processed food that does not 

require time/temperature control for safety.” 
13 

IV. Manufacturing/Processing Activities

The first column in Table 9 lists the activity/food combination that comments ask us to include in 

the exemption for on-farm, low-risk manufacturing/processing activity/food combinations. The 

second column lists the regulatory citation for the relevant exemption for an on-farm 

manufacturing/processing activity/food combination. Importantly, the full regulatory text of the 

exemption includes some limitations that were not specified in the comments, and Table 9

should not be viewed as equating the requests of the comments with the final regulatory text of 

the exemption. For example, § 117.5(g)(2)(ix) specifies that the food category “baked goods” 

includes processed food products such as breads, brownies, cakes, cookies, crackers, but does not 

include products that require time/temperature control for safety (such as cream-filled pastries). 

Table 10. Requested Activity/Food Combinations and Relevant Exemption for On-Farm 

Low-Risk Manufacturing/Processing Activities

Activity/Food Combination Requested in 

the Comments

Regulatory Section (§) Listing the Exemption

Baking activities involving grain products 117.5(h)(3)(ix)--Making baked goods from milled grain 

products (e.g., breads and cookies)

Chopping, coring, cutting, peeling, pitting, 

shredding, and slicing: 

• Crackers, dry bread, bread crumbs

• Dry cereal, popcorn 

• Gums, resins and exudates 

• Jerky 

117.5(h)(3)(ii)--Chopping, coring, cutting, peeling, pitting, 

shredding, and slicing: 

• Baked goods

• Other grain products

• Gums/latexes/resins

• Game meat jerky

Cooking low-moisture foods with dry heat 117.5(h)(3)(xxv)--Roasting and toasting baked goods

Drying/dehydrating cut fruits and vegetables 

that are immediately moved into a drying 

process

117.5(h)(3)(iv)--Drying/dehydrating (that includes 

additional manufacturing or is performed on processed 

foods) other fruit and vegetable products with pH less than 

4.2, and other herb and spice products (e.g., chopped fresh 

herbs, including tea)

• Distilling mint 

• Extracting virgin olive oil

• Extracting oils from seeds (e.g., sunflower 

seeds, flax seeds)

• Making liquid botanical extracts from dry 

botanical raw material with solvents such as 

glycerin, ethanol, vinegar, honey 

117.5(h)(3)(v)--Extracting (including by pressing, by 

distilling, and by solvent extraction) from: 

• Dried/dehydrated herb and spice products 

• Fresh herbs

• Fruits and vegetables 

• Grains

• Other herb and spice products

Grinding/milling/cracking/crushing:

• Crackers, dry bread, bread crumbs

• Dry cereal, dry pasta, popcorn

• Dry legumes

117.5(h)(3)(vii)--Grinding/milling/cracking/crushing:

• Baked goods

• Other grain products

• Dried/dehydrated fruit and vegetable products

Mixing

• Honey infused with dried herbs or spices

• Oil and/or vinegar infused with dried herbs 

or spices

117.5(h)(3)(xxii)—Mixing other herb and spice products

Making maple cream, maple sugar, and 

molded maple candy

117.5(h)(3)(x)--Making candy

Making molasses and treacle from sugarcane 

and sugar beets

117.5(h)(3)(xiv)--Making molasses and treacle
14 

Activity/Food Combination Requested in 

the Comments

Regulatory Section (§) Listing the Exemption

• Making apple syrup

• Making syrups from sorghum, rice

• Making syrups from malted barley 

• Making syrups such as birch and walnut 

syrup

117.5(h)(3)(xix)--Making sugar and syrup from:

• Fruits and vegetables

• Grains

• Other grain products

• Saps

Making vinegar, including infused and 

flavored vinegars

• 117.5(h)(3)(xxi)—Making vinegar from fruits and 

vegetables, other fruit and vegetable products, and other 

grain products

• 117.5(h)(3)(xxii)—Mixing other herb and spice products

Processing tea • 117.5(h)(3)(iv)--Drying/dehydrating (that includes 

additional manufacturing or is performed on processed 

foods) other fruit and vegetable products with pH less than 

4.2, and other herb and spice products (e.g., chopped fresh 

herbs, including tea) 

In Table 10, we list those activity/food combinations, requested by comments, that are not 

included in the exemption for on-farm, low-risk manufacturing/processing activity/food 

combinations, and explain why. 

Table 11. Why Certain Requested Activity/Food Combinations Are Not Included in the Exemption for OnFarm Low-Risk Manufacturing/Processing Activities

Activity/Food Combination Requested in the 

Comments

Why the Activity/Food Combination is Not Listed in 

the Exemption

Acidifying, pickling, and fermenting low-acid fruits 

and vegetables made in compliance with CGMPs

Acidifying, pickling, and fermenting activities control 

microbial hazards and, thus, are not low-risk activities.

Cucumbers, garlic scapes, peppers, and other lowacid foods that are preservedThe production of low-acid processed foods must control 

the microbial hazard C. botulinum and, thus, is not a lowrisk activity.

Drying/dehydrating tea leaves (e.g., by withering) Drying/dehydrating tea leaves is within the “farm” 

definition.

Fermentation of vegetables Fermenting activities control microbial hazards and, thus, 

are not low-risk activities.

Food processing conducted in compliance with 

relevant State regulation

It is the risk associated with the activity/food combination, 

not the regulatory oversight by a State, that is relevant to

this exemption. 

Freezing fruit juices Fruit juices are outside the scope of the RA based on the 

statutory framework of FSMA.

Low-acid fruits and vegetables manufactured in

compliance with CGMPs under the FD&C Act

The production of low-acid processed foods must control 

the microbial hazard C. botulinum and, thus, is not a lowrisk activity.

Making pickles and salsa The processes for making pickles and salsa must control 

microbial hazards and, thus, are not low-risk activities.

Roasting grains for animal feed This activity involves the production of animal food, 

which is subject to the animal preventive controls rule 

rather than the human preventive controls rule.