Document ID: FDA-2021-N-0584-0032
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2022-07-15T04:00Z

Instructions for completing aggregate data reports for Produce Farm Inventory, Sprouts Inventory, and Education and Technical Assistance

Quick Guide
General Instructions	1
Produce Farm Inventory tab	1
Table Rows	2
Table Columns	3
Sprouts Inventory tab	4
Education & Technical Assistance tab	4

General Instructions
This spreadsheet contains three tabs; the Produce Farm Inventory tab, Sprouts Inventory tab, and Education & Technical Assistance tab. This spreadsheet must be completed and submitted in ORAPP by all CAP grantees by Dec 1; Feb 1; May 1; and Sept 1 annually. Please save your file locally before you upload it to ORAPP. Use the File Naming Convention: (state abbreviation_grant number last 4_YYYYMMDD_Document Title); Example: AL_1234_20211201_Inventory Aggregate Data. 
Inventory data reported will be current cumulative data, as close to the report due date as possible. 
Education & Technical Assistance data will be reported for the corresponding reporting period only, as follows:
      Jul 1 - Oct 31 data will be reported on Dec 1
      Nov 1 - Dec 31 data will be reported on Feb 1
      Jan 1 - Mar 31 data will be reported on May 1
      Apr 1 - Jun 30 data will be reported on Sept 1
Please only enter numeric data into the spreadsheet without making any other changes to the spreadsheet; please do not include `NA' in cells, please do not rename the tabs, or add any cells, rows, columns. Where cells are greyed, please do not put an entry; a grey cell indicates this would not be an applicable entry. If you have a note or explanation about your submission, please provide that in a separate email correspondence to your Office of Partnerships (OP) Project Manager. 

Produce Farm Inventory tab 

The following resources may be used to report the aggregate data:
 Your farm inventory database/records
       The Data Element ID from the Farm Inventory Data Elements Catalog is included below as a reference to show where you can find the information to be reported in the aggregate data table and where that data point was derived. The Farm Inventory Data Elements Catalog outlines the data elements to be collected in each grantee's inventory. The Farm Inventory Data Template was intended to be a template that grantees could use to maintain their farm inventory information. The documents were provided and presented to all CAP grantees in April 2017.  The Farm Inventory Data Elements Catalog and corresponding Farm Inventory Data Template excel spreadsheets are located on FoodSHIELD. 
All data entered in this tab should reflect the cumulative total of verified produce farms in the state's farm inventory. Inventory data reported will be current cumulative data, as close to the report due date as possible. This aggregate data table includes required, recommended, and optional inventory data elements (see the Farm Inventory Data Elements Catalog) that are expected to be verified either during the inventory development process, or that would be verified during an inspection of a covered farm. The recommendation is that FDA and States review/verify and update their farm inventory information/(required/recommended/optional) data elements during an inspection of a covered farm. Consequently, FDA and States should have additional details on covered farm characteristics as more inspections are completed. Note that this data table is limited to farm inventory/farm characteristic data only and does not include farm inspectional findings or compliance/enforcement data.  The data included in this aggregate data table should be a cumulative "snapshot" of the produce landscape/farms in the state.

It is assumed that if you are counting/reporting a farm within a cell, then you have the corresponding information in order to be able to accurately count/categorize the farm into that cell within the table. Verified farm inventory data should have been reported directly by the farm via phone, email, in-person, registry or document submitted by the farm, etc. 
This table will not capture non-produce farms or out of business/inactive farms or tribal farms. If you would like to share tribal farm information with FDA, please discuss this with your ORA PSN representative. We understand that this information may captured within a state's inventory records in order to understand the full farming landscape. This information can be useful to include in the grantee's reporting documents to explain complete efforts to develop a farm inventory and/or explain fluctuations in the farm inventory data. 

Please note that all rows and some columns are identified as (mutually) exclusive, meaning that farm should not be counted in any other row or column, as specified.

Table Rows 
        Farms counted in each row are mutually exclusive, meaning that farm should not be counted in any other row (e.g., for a small farm that is qualified exempt, please count the farm only as "Qualified Exempt," and not as a "Small Farm"). 
        Dual covered sprout/produce farms should be counted in the Produce Farm Inventory Aggregate Data tab where applicable for covered produce other than sprouts. If it is only a sprout farm do not include in the Produce Farm Inventory Aggregate Data tab.
        The "FSMA Inflation Adjusted Cut Offs" only applies to farms categorized in Row 7 and Row 8.  See FDA's webpage FSMA Inflation Adjusted Cut Offs for more information on FSMA Inflation Adjusted Cut Offs for the Produce Safety Rule.  
Table Rows "Farm Categories":
Row 4 - Large Covered Farm: a covered farm as defined in the Produce Safety Rule (21 CFR Part 112.4) and, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $500,000. 
Data Element Catalog references: 
Data Element ID DE032= Large (Over $500k)
Data Element ID DE041=Yes; the farm grows, harvests, packs, and/or holds any covered produce either currently or for the upcoming season (e.g., if in between a growing season). 

Row 5 - Small Covered Farm: a covered farm as defined in the Produce Safety Rule (21 CFR Part 112) and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $500,000; and the farm is not a very small business as defined in 21 CFR 112.3. 
Data Element Catalog references: 
Data Element ID DE032= Small ($250 - $500k)
Data Element ID DE041=Yes; the farm grows, harvests, packs, and/or holds any covered produce either currently or for the upcoming season (e.g., if in between a growing season). 

Row 6 - Very Small Covered Farm: a covered farm as defined in the Produce Safety Rule (21 CFR Part 112) and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $250,000. Does not include farms that are not covered by the Produce Safety Rule because they have less than $25,000 average annual monetary value of produce. 
Data Element Catalog references: 
Data Element ID DE032 = Very Small ($25k - $250k)  
Data Element ID DE041=Yes; the farm grows, harvests, packs, and/or holds any covered produce either currently or for the upcoming season (e.g., if in between a growing season). 

Row 7  -  Current Total Covered Farms: Cell C6 will auto-sum based on cells C4, C5, and C6; do not put an entry in this cell. 

Row 8 - Farms Not Covered based on Produce Sales <$25K: Farms that are not covered by the Produce Safety Rule because they have less than $25,000 average annual monetary value of produce. 
Data Element Catalog references: 
Data Element ID DE032 = Exempt (Less than $25k) 
Data Element ID DE041=Yes; the farm grows, harvests, packs, and/or holds any covered produce either currently or for the upcoming season (e.g., if in between a growing season). 

Row 9 - Qualified Exempt farm: A farm is eligible for a qualified exemption if:
(1) During the previous 3-year period preceding the applicable calendar year, the average annual monetary value of the food (as defined in 112 .3(c)) the farm sold directly to qualified end-users (as defined in 112.3(c)) during such period exceeded the average annual monetary value of the food the farm sold to all other buyers during that period; and
(2) The average annual monetary value of all food (as defined in 112.3(c)) the farm sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.
Data Element Catalog references: 
Data Element ID DE034=<$500,000 AND DE036=YES AND DE037= >50%)
Data Element ID DE041=Yes; the farm grows, harvests, packs, and/or holds any covered produce either currently or for the upcoming season (e.g., if in between a growing season). 

Row 10 - Commercial Processing Exempt (CPE): This row reflects farms that are growing, harvesting, packing and/or holding produce that is otherwise covered, but are eligible for a processing exemption. This row should only include farms where 100% of their covered produce are eligible for processing exemption. 
Data Element Catalog reference: Data Element ID DE049 = "processing with a pathogen elimination step" applies to each/all covered produce commodity.

Row 11 - Farms with only produce under Enforcement Discretion for wine grapes, hops, almonds, or pulses : This row should only include farms where 100% of their produce is under Enforcement Discretion for wine grapes, hops, almonds, or pulses, as outlined in Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds. 
Data Element Catalog reference: Data Element ID DE042-DE047.

Row 12 - Farms (all sizes) with only Rarely Consumed Raw produce: Report in cell C11 produce farms that only perform a covered activity on produce that is listed in 21 CFR 112.2(a)(1) as rarely consumed raw. 
Data Element Catalog reference: Data Element ID DE041=No

Row 13  -  Current Total Produce Farms: Cell C13 will auto-sum based on cells C7-C12; do not put an entry in this cell. 

Table Columns 
Column C  -  Report the number of verified farms by farm category identified in Column B. 

Note: Columns D-Q are not mutually exclusive, meaning that a farm can be counted in more than one column in columns D-Q. Columns D-Q will further categorize the farms reported in Column C. 

Column D, E, F, G, H, I, J, K, L  -  National Priority Commodity: Report the number of farms from Column C that are conducting covered activities on a national priority commodity. Farms that conduct covered activities on more than one priority commodity category should be counted in each applicable priority commodity column. Do not count a farm more than once within each priority category column (e.g. a farm that grows kale, spinach and cucumbers, would count for "1" in Column D and "1" in Column E). FDA Priority Commodities for inspection can be found in the most current Produce Safety Inspections Program guidance documents document. Two "Other Priority Commodity" Columns K and L are included to accommodate potential addition of new priorities at a later date. The current FDA Produce Safety Inspection Program guidance documents will list specific commodities for these rows when applicable. If no specific commodity has been identified please leave these rows blank. It is encouraged to gather this data during farm inventory development to better assist with work planning prioritization.

Column  M, N, O, P, Q, R  -  Report the number of farms from Column C that are conducting the specified activity on covered produce as defined in the Produce Safety Rule (21 CFR 112.3). Additional information on descriptions of these activities are included in the draft guidance (published August 2016) "Classification of Activities as Harvesting, Packing, Holding or Manufacturing/Processing for Farms and Facilities: Guidance for Industry". Please refer to FDA's website or the Produce Safety Network for the most up to date descriptions on this topic. These columns reflect the activities being conducted on covered produce on the farm. 
Data Element Catalog reference: Data Element ID on DE051 = Activity(s) conducted by the farm (growing, harvesting, packing, holding, processing) on covered produce. 

            Column M  -  Growing: Farms Growing Covered Produce
            Column N  -  Harvesting: Farms Harvesting Covered Produce
            Column O  -  Packing: Farms Packing Covered Produce  
            Column P  -  Holding: Farms Holding Covered Produce
            Column Q  -  Retailing Covered Produce: Farms that have any retailing of covered produce (as defined in 112.3) that is direct to consumer sales on or off the farm. Examples: U-pick; CSA; internet sales direct to consumers; delivery/pickup direct to consumers; farm stand; farm market.
            Column R  -  Farms Processing (outside of farm definition): Farms that are conducting any processing outside the farm definition on covered produce. Farms that only conduct manufacturing/processing activities that are allowed within the farm definition (see 21 CFR 112.3) should not be reported here. These farms may or may not require food facility registration depending on whether their annual food sales are primarily wholesale or retail. Additionally, the Small Entity Compliance Guide: Registration of Food Facilities MAY 2018 provides guidance of which entities must register as a Food Facility, as per 21 CFR Part 1 Subpart H.
    
Column S - Farm mixed-type facility: Of the farms reported in Column C; report the number of farm-mixed type facilities. A mixed-type facility means an establishment that engages in both activities that are exempt from registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be registered as a Food Facility. An example of such a facility is a ``farm mixed-type facility,'' which is an establishment that is a farm, but that also conducts activities outside the farm definition that require the establishment to be registered as a Food Facility (Mixed-type facility definition reference 21 CFR 112.3). Additionally, the Small Entity Compliance Guide: Registration of Food Facilities MAY 2018 provides guidance of which entities must register as a Food Facility, as per 21 CFR Part 1 Subpart H.
Currently, there is no Data Element Catalog reference. 

Sprouts Inventory tab

FDA is leading the inventory development and inspections under the Produce Safety Rule for sprouts farms/operations. While it is not an expectation of the CAP to conduct inventory activities for sprout farms, if you have sprout farm information in your inventory, please report it in this tab. For dual produce/sprout farms, the inventory data will also be reported in the Produce Farm Inventory tab.
Data Element Catalog reference: 
      Data Element ID DE041=Yes for covered produce.
      Data Element ID DE032 for farm size.
      Data Element ID DE043 for commodity.

Education & Technical Assistance tab

Education & Technical Assistance data will be reported for the corresponding reporting period only. We understand that the submission due date may overlap with the upcoming reporting period, but only report data for the reporting period for the associated due date.   
 Jul 1 - Oct 31 data will be reported on Dec 1
 Nov 1 - Dec 31 data will be reported on Feb 1
 Jan 1 - Mar 31 data will be reported on May 1
 Apr 1 - Jun 30 data will be reported on Sept 1

We do ask that you complete row 3 with your corresponding data conducted from July 2016  -  June 30, 2021.
Below are some clarification points for reporting in this tab:
 All reported data refers to accomplishments using CAP funds. 
 PSA refers to Produce Safety Alliance
 On Farm Readiness Review (OFRR) are conducted according to the OFRR manual. 
 Technical Assistance refers to an activity (other than an OFRR) to provide individual remote or on-farm technical assistance to interpret and apply the regulation; conducted primarily to prepare a farm for a Produce Safety Rule inspection. Please be sure the numbers you are reporting here are technical assistance activities.  
 Education activities other than PSA grower trainings can be explained and reported in your Progress Report. Outreach activities can be explained and reported in your Progress Report.