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Western Growers - Traceability
1.
Is your company required to comply with Section 204 of FSMA?
Yes
No
2.
Is your company currently PTI compliant?
Yes
No
Other (please specify)
3.
Does your company currently scan products today? If so, please provide an estimate of the annual cost for scanning products.
Yes. (Please provide annual scanning costs including labels, equipment, labor)
No. We are not currently scanning products.
Other
4.
Does your company perform any of the following functions? Please check all that apply.
Growing
Harvesting
Packing
Cooling
Shipping
Receiving
Transforming produce (manufacturing/processing or commingling, repacking or relabeling)
5.
Does your company sell any of the following products? Please check all that apply.
Cheese (other than hard cheese)
Cucumbers (fresh)
Fruits (fresh cut)
Herbs (fresh)
Leafy Greens (fresh)
Leafy Greens (fresh cut)
Melon (fresh)
Nut butters
Peppers (fresh)
RTE Deli salads
Shell Eggs
Sprouts (fresh)
Tomatoes (fresh)
Tropical Tree Fruit (fresh)
Vegetables other than leafy greens (fresh cut)
6.
What is your company’s annual revenues?
<$10 million
$10 - $49.9 million
$50 - $99.9 million
$100 - $499.9 million
$500 million - $1 billion
>$1 billion
7.
Do you have buyers requiring FSMA Section 204 data input into a specific software system or using specific software? If so, please name the buyer and the software and/ or software system and the required compliance date.
Buyer 1 - name
Buyer 1 - Software and/ or software system
Buyer 1 - Required compliance date
Buyer 2 - name
Buyer 2- Software and/ or software system
Buyer 2 - Required compliance date
Other Buyers name(s), software and compliance dates
8.
Is the software or software system that buyers are requiring your company to use for traceability data entry the same one you currently use for entering food safety audits and other compliance data?
Yes
No
Other (please specify)
9.
Are your buyers requiring compliance with Section 204 for products you sell that are not on the food traceability list? If yes, please specify the product(s).
No
Yes
Please specify the product(s).
10.
Are you currently capturing KDEs?
Yes, but not all the elements we need to capture. (Please list the elements you are capturing and the ones you still need to capture.)
Yes. We are capturing all element we need to capture. (Please list the elements you are capturing.)
No. (Please list the elements you need to capture.)
11.
Will your company need to hire new employees to become Section 204 compliant? If yes, how many employees?
Yes (please add the number of employees.)
No
Other
12.
Please provide an estimate what it will cost your company
to become compliant
with Section 204 by category if possible. If not, please provide an estimate of total costs under "Other" below.
IT system changes
Labor costs - new hires and consultants
Software - Initial cost to access to third-party software/ software systems for data reporting
Hardware - costs for compliance (scanners, printers, labels, etc.)
Labeling changes
Recordkeeping (collecting data and compiling FDA records)
Supplier onboarding and data access
Training
Total costs
13.
Do you have an estimate of what your company’s
ongoing traceability compliance costs
will be? Please provide your best estimate of costs below.
Cost per product sold (ex. $.04 per head of lettuce or 10% increase in cost of head of lettuce) or a percentage of the company's total annual revenue.
Other cost estimate. Please explain.
14.
What are the three main concerns you have with complying with Section 204?
Concern 1
Concern 2
Concern 3
Other
15.
Is there any specific flexibility you would like FDA to allow to facilitate compliance with this rule? Please select all that apply
Allow modified requirements for spot purchases (e.g., give growers/shippers the option to assign a TLC, similar to exempt entities, allow them to assign the TLC when it is not included in shipping KDEs)
Ensure that any flexibility given to other parts of the supply chain doesn’t impact other parts (e.g., allowing a range of lots without any data verification in place/relying on data from growers/shippers)
Exempt intracompany shipments from some recordkeeping requirements
Other (please specify)
16.
Do you have any other comments or concerns about Section 204 compliance that Western Growers can use with their response to the FDA about Requirements for Additional Traceability Records for Certain Foods?
Thank you for your help,
Sonia Salas