NOTE: This text has been updated to reflect changes in the proposed FSMA rules as of October 2014.

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Background

When drafting the Food Safety Modernization Act (FSMA), Congress included provisions to reduce the paperwork and recordkeeping burden of the new food safety regulations.  Specific to the produce safety standards, Congress required the Food and Drug Administration (FDA) to comply with the “Paperwork Reduction Act” and minimize the paperwork burden and collection of new information resulting from the new regulations on businesses.  FSMA also prohibited FDA from requiring that farms and other food facilities hire outside consultants to write food safety plans, and from duplicating the requirements – including recordkeeping requirements – of the National Organic Program regulations.

Currently there are no traceability requirements mandated of raw agricultural commodities such as fruits and vegetables.  FDA is implementing requirements around product traceability through a separate rulemaking process and has not yet issued those proposed regulations.  NSAC will be closely following that rulemaking process to ensure that a number of provisions, particularly around farm identity-preserved products, are correctly implemented.

Proposed Recordkeeping Requirements

The proposed recordkeeping requirements apply to farms that will have to comply in full with the entire Produce Rule.  In contrast, farms subject to modified requirements are not required by the proposed rule to comply with the proposed recordkeeping requirements, but FDA is requesting comment on whether it should require documentation from those farms and if so, which type of documentation should be required (see section below, “FDA Needs to Hear from YOU…”).

Generally, FDA has proposed to require recordkeeping when:

• Records facilitate verification and compliance with standards;
• Identification of a pattern of problems is important to minimizing the likelihood of contamination; and
• Maintenance of detailed information is needed by the operator in order to minimize the risk of contamination and demonstrate compliance.

Although in the preamble of the proposed rule FDA recommended that farmers develop and keep food safety plans, FDA is not requiring that farmers keep food safety plans unless the farm is subject to the proposed Preventive Controls Rule.  Farmers subject to the Preventive Controls Rule would have to keep a food safety plan for their food facilities.  However, FDA is considering whether it should require farmers to write and keep food safety plans under the Produce Rule.

FDA is also considering whether it should require farms that pack and hold produce from another farm to maintain records.  Specifically, FDA is considering whether the supplying farm should be required to provide the receiving farm with its name, complete business address, and description of the produce in any individual shipment.  And, if so, for how long should the receiving farm be required to maintain the record.

What the Proposed Standards Require

In the proposed Produce Rule, FDA establishes both general recordkeeping requirements and specific recordkeeping requirements to show compliance with certain standards in the proposed Produce Rule.  The general recordkeeping standards require records to include:

• Name and location of the farm;
• Actual values and observations collected during monitoring activities;
• An adequate description of the produce applicable to the record (e.g., commodity name, specific variety, or other identifier, such as a lot number);
• Location of the growing area or other area applicable to the record; and
• Date and time that an activity was performed or observed.

The records must be taken at the time an activity is performed or observed, must be accurate and legible, and must be dated and signed by the person doing the activity.

More specifically, FDA is requiring farmers to establish and keep records to show compliance with the following standards in the Produce Rule:

• Personnel qualifications and training
• Agricultural water
• Biological soil amendments of animal origin (e.g., manure and compost)
• Equipment, tools, buildings, and sanitation
• Sprouts

In addition to documenting compliance with the standards, FDA is requiring farmers to document actions taken when one of the above standards is not met.  FDA is requiring that a supervisor or responsible party sign certain records, including records documenting testing, monitoring, sanitizing, and corrective action activities.

FDA is proposing that farmers keep records for two years past the date the record was created, and that farmers retain records documenting the general adequacy of equipment and processes for at least two years after the that equipment or process was last used.  FDA is allowing offsite storage of records six months after the record was created, provided that the record can be retrieved and brought onside within 24 hours of a request by FDA.

FDA will accepts records that are original, true copies, or electronic.  FDA is not requiring farmers to duplicate or recreate records that they already have if they contain all of the information that is required in these standards.  While FDA prefers that all of the information be kept in one set of records, FDA is allowing farmers to keep additional information to existing records needed in order to comply with these standards separately or combined with existing records.

FDA is proposing that farmers make all records required available and accessible.  If records are offsite, they must be available within 24 hours of a request.

In terms of confidentiality, a number of policies and laws govern the protection and release of information.  These include FDA’s regulations, the Freedom of Information Act, the Trade Secrets Act, and the Food, Drug, and Cosmetics Act.  The information kept in these recordkeeping requirements would be subject to disclosure under these policies and laws.  Hence, for instance, they could potentially become public information through the Freedom of Information Act.

What the Proposed Standards Do Not Require

Although in the preamble FDA recommends that farmers develop and keep food safety plans, FDA is not requiring that farmers subject to the Produce Rule keep food safety plans.  Specifically, FDA is not requiring farms to conduct operational assessments or to develop food safety plans similar to those for food facilities or those required by FDA’s juice or seafood Hazard Analysis and Critical Control Points regulations.  Please note, however, that some farms are subject to the proposed Preventive Controls Rule and thus would be subject to mandatory food safety plans for their food facilities.  Moreover, FDA is seeking public comment on whether it should require farmers to write and keep food safety plans, indicating they still view this as an open question.