Let the record reflect –Are you keeping the records required by the FSMA Produce Safety Rule?

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Womble Bond Dickinson

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As part of the Food Safety Modernization Act (FSMA), the Produce Safety Rule outlines the regulatory requirements that apply to entities that grow, harvest, pack or hold fresh produce. Depending upon the amount of their annual revenues and the vegetables and fruits they grow, commercial farms may be subject only to part(s) of the Produce Safety Rule.

A number of record keeping regulations are at the core of ensuring compliance with the Produce Safety Rule. Certain records must be kept, while others should be kept. Commercial farms from large conglomerates to family farms that sell at farmers markets and in front yard stands either already have or, in the next few years will have, a variety of record keeping requirements. This is the first in a series of articles outlining the regulatory structure of record keeping for these commercial farms.

What produce is grown on the farm is the first question posed in order to determine what record keeping requirements of the Produce Safety Rule apply. The Produce Safety Rule applies to “covered produce.” “Produce,” as defined by the Produce Safety Rule, does not include:

· food grains (21 CFR §112.3(c)); if you grow only food grains, then you will not have record keeping requirements under the Produce Safety Rule.

· a list of vegetables and fruits that the FDA has determined are rarely consumed raw, such as asparagus, beans varieties (e.g., black beans, navy beans, lima beans, kidney beans, etc.), beets, okra, coffee, pumpkin, sweet potatoes, horseradish, and so on (see 21 CFR §112.2(a)(1) for the complete list).

· produce consumed on the farm where it is grown or on a related farm.

· produce sold to a commercial processor that will treat the produce in a manner that will kill any bacteria that may be on the produce.

If the produce grown by the farm is not “produce” as defined by the Produce Safety Rule, then the record keeping requirements of that Rule will not apply.

Since the first question is what the farm grows, that is the first record that must be kept. There is no particular format in which the records must be kept. However, the farm must document what crop(s) it plants.

Next, a farm should keep a map of the farm. The map will help to identify various food safety risks which may trigger a variety of record keeping requirements. The map should include:

· every field where produce covered by the Produce Safety Rule is grown,

· locations of any bodies of water or wells,

· schematics of water distribution systems, including irrigation systems,

· locations of any septic systems on the property,

· the location(s) of areas where animals on the farm are kept or have access to,

· the land contiguous to the farm and how it is used (such as does the farm share a border with a cattle ranch or anything else that is a potential source of contamination of produce grown on the farm),

· locations where produce is washed and/or packed,

· locations where produce is stored prior to shipping,

· locations of restrooms and handwashing stations.

Dates on which crops were planted in which fields should be kept because it will be helpful in ensuring compliance with other record keeping requirements that arise later in the growing and harvest cycle.

Assuming that the farm grows “produce” as defined by the Produce Safety Rule, the farm must keep records which detail the amount of its annual sales. The Produce Safety Rule has increasingly more comprehensive regulatory requirements, including record keeping requirements, based upon the amount of the farm’s annual sales.

· The largest farms, classified as “other businesses” are those with annual sales over $500,000. “Other businesses” are subject to the most regulatory, including record keeping, requirements.

· Farms with annual sales between $250,000 and $500,000 are “small businesses” under the Produce Safety Rule. Small businesses qualify for certain regulatory exemptions compared to “other businesses” and, consequently, have fewer record keeping requirements.

· Farms with annual sales of no more than $250,000 are defined as “very small businesses” under the Produce Safety Rule. Very small businesses have the fewest regulatory requirements and the fewest record keeping requirements.

If a farm wants to claim exemptions from regulatory requirements as a small business or a very small business, it will have to be able to establish that it meets the definition of a small business or a very small business. Records documenting annual sales are necessary to establish those exemptions.

All businesses covered by the Produce Safety Rule, including small businesses and very small businesses, will eventually have to comply with regulations (including record keeping regulations) related to water use, but small businesses and very small businesses will have longer to comply with water use regulations. For very small businesses, compliance with water related regulations will be the most significant regulatory imposition they face under the Produce Safety Rule.

Record keeping requirements related to water use will be the topic of the next post, so — stay tuned.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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