Comment on produce safety rules by Dec. 15

AFP Correspondent

WASHINGTON (Dec. 9, 2014) — The comment period on the Food and Drug Administration’s supplemental proposed rules on produce safety ends at 11:59 p.m. Dec. 15, 2014.
After receiving numerous comments on the original proposals on Sept. 19, FDA revised several of the proposals to make them more flexible and to provide clarity.
These re-proposals include manure and compost usage, agricultural water standards, certain animal provisions, farm size and definition and qualified exemptions.
Manure and compost: The original proposal that required a nine-month interval between manure application and crop harvest drew considerable discussion from farmers. Recognizing the shorter period provided in the National Organic Product Standards, FDA says it is currently pursuing additional risk assessments with USDA and the agricultural community, and will issue appropriate application time interval standards at a later time, hopefully within five years.
In the meantime, FDA says it does not intend to take exception with farmers who comply with the NOP standards.
These call for a 120-day interval between manure application and harvest for crops which contact the soil and 90 days for crops not in contact with the soil.
Regarding the compost requirement, FDA proposes to eliminate the 45-day interval for compost if it is processed to meet certain microbial standards, or if the application method minimizes contact with the produce.
FDA says properly composted manure is safer than raw manure for both public health and the environment.
Agricultural water: In the supplemental proposal, FDA revised the standard to be consistent with the Environmental Protection Agency criteria for recreational water quality. It also simplified the requirements, but some stakeholders report it is still too complicated.
Because it is detailed, growers need to study the specifics in the proposal, accessible at the FSMA website,
This re-proposal requires growers to establish a profile of the water source and conduct sampling and testing. Because untreated surface water is the most likely source for contamination, those standards are more stringent.
In general, the geometric mean of samples is not to exceed 126 colony forming units of generic E. coli per 100 mL of water. Also, the statistical threshold value of samples is not to exceed 410 colony forming units of generic E. coli in 100 mL of water.
FDA says when the rule is finalized, guidance documents to assist education and training will be issued. An online tool for growers to calculate the geometric mean and the statistical threshold value of the required samples will be part of the guidance.
Animal provisions: The supplemental proposal, in order to alleviate concerns raised about threatened or endangered species in the original proposal, clarifies the issue.
The re-proposal assures that the final produce rule would not authorize or require covered farms to take measures to exclude animals from outdoor growing areas or destroy animal habitat.
Farm size: FDA originally proposed that farms having less than $25,000 in total food sales per year would be excluded from the produce safety rule. The supplemental proposal specifies that farms having less than $25,000 in produce sales would not be covered by the rule.
That change would also affect the classification of business size, which affects the dates of compliance. Very small businesses ($25,000 to $250,000 annual sales) generally have four years to comply. Small businesses ($250,000 to $500,000) have three years. Others have two years. All sizes have an additional two years to comply with the agricultural water quality standards and testing.
Farm definition: Because the original definition of ‘farm’ was easily confused with ‘farm facility’ which would be also subject to the preventive controls rule, FDA revised the definition. Under the supplemental proposal, a farm that packs or holds produce on other farms would not necessarily be subject to both rules. Again, growers should study the proposal for details.
Withdrawal and reinstatement of qualified exemption: The original produce safety proposal made a farm eligible for a qualified exemption and modified requirements based on sales and users. Farms qualified if the average annual value of food sold during the previous three years was less than $500,000 and if the food sold to ‘qualified end users’ exceeded the average annual value of food sold to all other buyers. Qualified end user is defined as a consumer, restaurant or retail food establishment in the same state as the farm or not more than 275 miles from the farm.
The original proposal established that FDA could withdraw this qualified exemption from a farm if it was directly linked to an active investigation of a foodborne illness outbreak, or if FDA determined it necessary to prevent or mitigate an outbreak based on the farm’s food safety conduct or conditions.
The supplement proposal would require FDA to consider other actions before withdrawing an exemption. A warning letter, recall, administration, or seizure are examples of such actions. In addition, FDA would notify the farm of the circumstances that jeopardized the exemption, provide the farm an opportunity to respond, and consider actions taken by the farm to address the issues.
Also, the FDA would set forth reinstatement provisions.
The FSMA website,, includes links to the proposals, the full law, background information, fact sheets, activity to date and FDA updates.
The Produce Safety Alliance hosted a webinar with FDA’s produce safety staff on the changes by the supplemental proposal. The recording and slides are accessible at
How to comment: Farmers may wish to express their opinions on how these proposals affect their operations. As noted, comments will be accepted by December 15, 2014 11:59 p.m. Eastern time. Electronic submissions may be submitted at
The docket number for the produce rule supplement is FDA-2011-N-0921-0973, and the RIN is 0910-AG35. The docket number must be on the comments.
Written comments may be submitted by mail, hand delivery or courier. Direct paper or CD-ROM submissions to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.