FDA posts final rule of Standards for Growing, Harvesting, Packing, Holding

The final rule contents of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption segment of the Food Safety Modernization Act were posted online Friday, Nov. 13, in a PDF format at https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-28159.pdf

The document is scheduled for publication in the Federal Register on Nov. 27. OnionBusiness.com has extrapolated sections that are onion-specific, which we are providing here. We work to keep the context clear, but the document is several hundred pages long. Please reference the web posting for the full document. Comments have been bolded; responses are in normal text.

From Section XIII

“1. Research (Comment 174) Several comments state that further research is needed to determine appropriate standards for water quality, and recommend that FDA partner with various land grant universities, and other agencies, including NRCS and EPA, utilizing both funded research programs and incentive-based programs to promote safe water management practices. Some comments suggest that FDA conduct a risk assessment based on research findings and seek public comment on the results of the risk assessment, prior to finalizing a standard(s) for the quality of agricultural water. Other comments offer various suggested topics for future research, including some comments that maintain that landscapes, weather patterns, and water sources vary significantly and, therefore, further research should be done to understand the physical differences of the national landscape as it pertains to produce safety.

“(Response) We do not agree that more research, followed by a risk assessment based on that research, is needed for us to finalize the provisions of this rule relating to agricultural water. As discussed in the 2013 proposed rule, the supplemental notice, and in the paragraphs that follow, there is sufficient scientific information from which we conclude that the requirements in this rule minimize the risk of serious adverse health consequences and death, and are reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into produce and to provide reasonable assurances that produce is not adulterated. In addition, as discussed in section V of this document, we have conducted a qualitative assessment of risk of hazards associated with produce production, which indicates that agricultural water is a potential route of contamination of produce during growing, harvesting, and on-farm postharvest activities and that use of poor agricultural practices could lead to contamination and illness even where the potential for contamination is relatively low. The science-based minimum standards established in subpart E of part 112 address this on-farm route of contamination.

“However, we do support additional research as a means of facilitating implementation of this rule and continuing advancement of scientific knowledge in this area. As discussed in the 2013 proposed rule, we are pursuing regulatory science and research activities in collaboration with various partners. We have supported extramural research and collaborated with other federal agencies, academic institutions, and industry-supported entities to leverage research efforts, expertise, and resources (such as experimental stations for field research). For example, we are working with USDA to conduct research of mutual interest in key areas, including agricultural water.

“In addition, FDA has provided funding to develop a produce safety research network at the Western Center for Food Safety (WCFS) at the University of California, Davis. Research studies at WCFS include projects related to the microbiological quality of irrigation water in catchments and distribution systems; evaluation of agricultural water quality parameters and the cost-benefit of farm-level interventions; and microbial water quality of moving surface waters. We intend for these collaborative efforts to result in the collection of data that will help advance the state of scientific knowledge on the safe use of agricultural water. WCFS also partnered with the Center for Produce Safety to provide seed money through a competitive grants program to fund produce safety projects focused on agricultural water issues that are topical and/or region specific. WCFS has further partnered with academic institutions located in various regions in the United States, including in California, Florida, Hawaii, Oregon, and Washington, to conduct research on a variety of commodities including apples, citrus, and onions. We intend to disseminate useful scientific information obtained from these efforts, when available. We support additional research as a means for forming a basis for possible future rulemaking in this area.”

Also: “3. Scope of “Agricultural water” and Applicability of Subpart E (Comment 178) Several comments request clarification on whether the requirements in subpart E apply to water used during growing of various types of crops. For example, some comments ask whether subpart E applies to water used to irrigate root crops, such as onions and carrots, using drip irrigation. Some comments also ask us to clarify whether and how subpart E applies to water used during growing those commodities, such as tomatoes, cantaloupe, or cucumbers, where the produce may contact the ground or be in a splash zone versus those commodities, such as tree crops, that do not come in contact with the ground or irrigation water. One comment suggests produce grown using drip irrigation or otherwise not directly exposed to irrigation water should not be covered under subpart E.

“(Response) Section E establishes requirements applicable to agricultural water. Whether or not water used during the growing, harvesting, packing, or holding of covered produce is subject to the requirements of subpart E depends on whether the specific use of the water fits within the definition of “agricultural water.” If a specific use of water does not fit within the definition of agricultural water, then the provisions of subpart E do not apply to that specific use of water. Because irrigation practices vary widely, we do not believe it is necessary or appropriate to categorize specific commodities or types of irrigation, generally, as being subject to or not subject to the requirements of subpart E. In addition, we note that subpart E applies to more than just water used during growing (e.g., irrigation water).

“For purposes of this rule, we define agricultural water as water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food- contact surfaces, including water used in growing activities (including irrigation water applied using direct water application methods, water used for preparing crop sprays, and water used for growing sprouts) and in harvesting, packing, and holding activities (including water used for washing or cooling harvested produce and water used for preventing dehydration of covered produce). Related to this definition is our definition of “direct water application method,” which means agricultural water used in a manner whereby the water is intended to, or is likely to, contact covered produce or food-contact surfaces during use of the water (§ 112.3(c)).

“Water that is intended to or likely to contact covered produce that is a root crop, including water used for drip irrigation of root crops, fits within the definition of “agricultural water” and the definition of “direct water application method.” For example, irrigating carrots using drip irrigation that is intended to filter through the soil and contact the carrots growing underground is agricultural water applied using a direct water application method because the water is intended to, and likely to, contact the covered produce. Similarly, water used to make a crop protection spray applied to tree fruit just before harvest is agricultural water applied using a direct water application method. However, irrigation water that is neither intended to nor likely to contact covered produce, such as water used for drip irrigation of tree crops that grow high above the ground and are not likely to touch the ground, is not “agricultural water” and, therefore, not subject to subpart E.”

Also: “(Comment 220) Some comments question the need to subject water that is used in the growing of dry bulb onions using a direct water application method to the testing requirements in proposed § 112.45, particularly in light of the microbial die-off and removal provisions in proposed § 112.44(c)(1) and (c)(2). These comments find the testing requirements burdensome and unnecessary for water used in the growing of dry bulb onions because harvest typically occurs weeks or months after irrigation. One comment suggests a 6-day time interval between last irrigation and harvest would be sufficient to account for a “worst case scenario of 20,000 CFU generic E. coli /100 mL” water quality, and that dry bulb onion farms should be allowed to “opt out” of testing requirements for untreated surface water in proposed § 112.45(b), if they allow 6 days to elapse between last irrigation and harvest.

“(Response) We recognize that covered farms growing dry bulb onions typically have an extended period between last irrigation and harvest and between harvest and end of storage, which should help them comply with the microbial water criteria in final § 112.44(b) for agricultural water that is used during growing of dry bulb onions using a direct application method. However, unless untreated surface water that is used during growing in a direct application method is tested, there would be no way to determine whether there is a need to apply a time interval between last irrigation and harvest and, if so, the appropriate time interval. Therefore, when required under final § 112.46, agricultural water testing and calculation of the GM and STV must be done to inform and determine the appropriate way(s) in which the water may be used. To take advantage of the die-off and/or removal options in § 112.45(b)(1), you must first characterize the water quality by testing in accordance with § 112.46(b) and calculate a GM and STV. Moreover, under § 112.45(b)(1)(i), the use of the microbial die-off rate of 0.5 log per day between last irrigation and harvest is limited to four consecutive days (see Comment 218). At a rate of 0.5 log per day and a maximum of four days, the die-off option provided in § 112.45(b)(1)(i)(A) could not, on its own, effectively achieve the microbial quality criteria for water containing 20,000 CFU generic E. coli /100 mL if this value represents the GM, as presented in the comment. You may instead apply an alternative microbial die-off rate under §§ 112.45(b)(1)(i)(B), 112.49(b), and 112.12. To do so, you must have adequate scientific data and information to support your conclusions, as required in those provisions, and you must determine an accompanying appropriate maximum time interval associated with your alternative die-off rate, similar to the 4-day maximum under § 112.45(b)(1)(i)(A). Also, under § 112.45(b)(1)(ii), you may apply a microbial die-off rate between harvest and end of storage, and/or a microbial removal rate for activities such as commercial washing, that is relevant to your covered produce and dependent on practices and conditions on your farm, provided you have adequate scientific data or information to support your conclusions (see also corresponding documentation requirement in § 112.50(b)(5)). As for the die-off or removal rates in § 112.45(b)(1)(ii), you must also determine an accompanying maximum time interval or log reduction associated with these die-off rates, similar to the 4 day maximum under § 112.45(b)(1)(i)(A). See Comment 216.

“While these flexible options make it less likely that a dry bulb onion farm will find that its untreated surface water cannot meet the § 112.44(b) criteria, the fact that each of these die- off or removal rates may have a maximum appropriate application limit means that they cannot be presumed to reduce the GM and STV of the most contaminated water sources to a level compliant with § 112.44(b). Testing must be conducted to determine the quality of the water and determine whether it is usable within the requirements of the rule.”

Also: “(Comment 221) In the supplemental notice, we asked for comment on whether we should require farms to establish and maintain any documentation in relation to the option to apply a time interval between last irrigation and harvest. One comment recommends requiring records to be maintained on the time interval applied, how the time interval was calculated, and/or the dates of last irrigation and harvest corresponding to that time interval. The commenter also notes, however, that such records should be required only in the case where the agricultural water tested in accordance with proposed § 112.45 does not meet the microbial quality criteria established in proposed § 112.44(c).

“(Response) We agree that documentation of the time interval applied, calculation of the time interval based on water testing results, and the dates of last irrigation and harvest corresponding to that time interval, must be prepared and maintained, when the provision in § 112.45(b)(1)(i) is applied to achieve the microbial quality criteria in § 112.44(b). Likewise, records must be made and kept of the time interval or calculated log reduction applied, calculation of the time interval or log reduction based on water testing results, and the dates of harvest and end of storage or other relevant activities corresponding to that time interval or log reduction, when the provision in § 112.45(b)(1)(ii) is applied to achieve the microbial quality criteria in § 112.44(b). Such records would be required only when such a time interval or log reduction is applied, in accordance with § 112.45(b)(1), and not when no such time interval(s) is applied. We are adding this records requirement in new § 112.50(b)(6) (corresponding with our elimination of proposed § 112.161(b)), which requires you to document any actions you take in accordance with § 112.45. This new section also provides specifically that you must prepare and maintain documentation of any time interval or (calculated) log reduction applied in accordance with § 112.45(b)(1)(i) and/or (b)(1)(ii), including the specific time interval or log reduction applied, how the time interval or log reduction was determined, and the dates of corresponding activities (such as the dates of last irrigation and harvest, the dates of harvest and end of storage, and/or the dates of activities such as commercial washing).”

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