NSAC analyses produce and preventive controls FSMA rules

They include analysis on FSMA’s produce rule and preventive controls rule geared toward small and mid-sized farms and local businesses, analysis on exemption for retail establishments and questions for farmers to help them determine whether and to what extent the rules apply to their operations.

NSAC said as compliance timelines approach, it hopes the reports provide a resource for farms, food businesses and organizations providing education and outreach.

Not all farms will be subject to the new rules; some will be exempt from all requirements and some may be eligible for modified requirements.

The reports break information into three sections: (1) exempt farms/facilities, (2) qualified exempt farms/facilities, and (3) fully covered farms/facilities.

NSAC advocates for federal policy reform supporting the long-term social, economic and environmental sustainability of agriculture, natural resources and rural communities.

Produce rule analysis​

The Produce Rule applies to covered farms​ doing covered activities​ on covered produce, according to the “Understanding FDA’s FSMA Rule for Produce Farms​” report.

A covered farm annually grosses more than $25,000 in sales of produce, averaged across a rolling three-year period, and adjusted for inflation (with 2011 as the baseline year).

A covered activity means growing, harvesting, packing, or holding covered produce on a farm.

Based on what the FDA considers “produce” if the operation only grows grain, then this rule does not apply because grain is not considered “produce.”

If a site grows produce found on FDA’s list of “rarely consumed raw,” then it does not apply, because is not considered “covered” produce.

If an operation grows grains and covered produce, or both covered and not-covered produce, then these requirements would apply to the covered produce grown.

A farm eligible for modified requirements is subject to some provisions in the Produce Rule.

To be considered a qualified exempt farm and be eligible for modified requirements, you must have less than $500,000 in sales of all food (not just produce) based on an average of the previous three years and adjusted for inflation and sales to “qualified end users” exceed sales to other purchasers.

FDA does not require registration, food safety plans and audits.

The compliance date for very small businesses is January 2020, for small businesses it is January 2019 and farms that gross more than $500,000 annually in produce sales it is January 2018.

For each category it is an extra two extra years to come into compliance with the agriculture water standard components related to the microbial water quality standard and testing frequencies.

How FDA will verify compliance is still not entirely clear but inspections and third party audits will play a role, said NSAC.

“As we’ve noted before, NSAC has urged caution in relying on third party audits as indicators of compliance, and this language in the Produce Rule only adds to the concerns that third party audits could become a default regulatory requirement for all farms and small food businesses under FSMA.”​

Preventive Controls Rule​

Exemptions from the Preventive Controls Rule include farms (not all) and retail establishments (stores, restaurants, etc), according to the “Understanding FDA’s FSMA Rule for Food Facilities​.”

It is also possible to be exempt from certain portions due to small sales volume or the types of value-added processing on the farm.

The Preventive Controls Rule updated current good manufacturing processes (CGMPs) and established prevention-oriented requirements (Hazard Analysis and Risk Based Preventive Controls, or “HARPC”).

The HARPC requirements must be written and documented in a food safety plan at a facility. They are based on a “HACCP” – Hazard Analysis and Critical Control Points – approach.

The plan must include hazard analysis; preventive controls; supply chain program; recall plan; procedures for monitoring the implementation of the preventive controls; procedures for taking corrective actions and verification procedures.

NSAC said the rule contains some contradictory language regarding whether a third party audit is required – or if some alternative will suffice – in satisfying the supply chain program requirements.

“NSAC has urged FDA to avoid placing outsized reliance on third party audits as indicators of compliance, and this onsite audit requirement only compounds the concerns that third party audits could become a default regulatory requirement for all farms and small food businesses under FSMA.”​

Facilities that are small businesses have two years to come into compliance (September 17, 2017) with the majority of the rule. All other facilities have one year (September 17, 2016).

The supply chain requirements have a staggered timeline based on who the supplier is.

The next report later this year will focus on conservation compliance, the set of conservation requirements that apply to certain farms that receive federal commodity, crop insurance, or conservation program benefits.