After consulting with David Ingram, Consumer Safety Officer with the FDA Division of Produce Safety, the PSA can offer the following supplementary information to benefit our discussions in Atlanta. The PSA also submitted the questions to Leanne Skelton who is a Liaison for FSMA-PSR issues (Senior Policy Analyst) from USDA AMS Specialty Crops Program area to FDA CFSAN Division of Produce Safety. She also provides administrative oversight to the PSA cooperative agreement. The comments from AMS are incorporated into this updated document.
If you have purely a microbial culture without any other ingredients and add molasses to it, are there regulatory concerns?
The answer would depend on how the application was made. If the mixture is applied as a foliar application for disease or pesticide control, then the EPA would regulate this product. If the mixture is applied to the soil in a manner that contacts the harvestable portion of the crop, then it would depend on how the microbial culture was grown. If the culture was grown using BSAAO, for example beef broth, it would be considered a BSAAO and the broth would need to be pathogen free and the mixture would need to meet the more stringent microbial standards for BSAAO found in 112.54a. If the mixture was of animal origin and meets the definition of agricultural tea*, then the addition of molasses would make this mixture an untreated BSAAO.
*Agricultural Tea is defined by FDA as a water extract of biological materials (such as stabilized compost, manure, non-fecal animal byproducts, peat moss, pre-consumer vegetative waste, table waste, or yard trimmings), excluding any form of human waste, produced to transfer microbial biomass, fine particulate organic matter, and soluble chemical components into an aqueous phase. Agricultural teas are held for longer than one hour before application. Agricultural teas are soil amendments for the purpose of this rule.
Is there a plan for FDA, or anther government agency like NRCS, to fund infrastructure for growers who wish to transition to compost from raw manure? Is there a possibility of incentives for transition?
This is something that has been suggested at all three Soil Summits and is being explored by FDA. In the short-term FDA is exploring options for educating growers on producing FSMA compliant compost.
The 2018 Farm Bill under the Local Agriculture Market Program provisions expand the eligible activities of AMS Farmers Market Promotion Program and Local Food Promotion Program (FMLFPP) and Rural Development Value Added Producer Grants (VAPG) to include covering expenses relating to costs incurred in obtaining food safety certification and making changes and upgrades to practices and equipment to improve food safety. Updates to and purchases of equipment for these purposes are allowable up to $6,500 per grant. Grants are differentiated by which entities are eligible to apply to each. For VAPG, producers and producer groups, farmer or rancher cooperatives or other majority-controlled producer-based business ventures will be eligible for grants. For FMLFPP, agricultural cooperatives or other agricultural business entities or a producer network or association would also be eligible to apply, as would other entities working on local and regional food systems. It is possible that farmers could receive funding through projects awarded to those non-farm entities.
Additionally, there are quite a few other programs that might be helpful.
- USDA Risk Management Agency offers insurance and funding to help producers reduce risk in the marketplace.
- USDA NRCS offers cost share programs and technical assistance to help producers implement practices to improve environmental sustainability.
- USDA FSA Farm Loan Programs, including farm operating loans, farm ownership loans, microloans, and guaranteed loan programs, may be helpful for financing infrastructure upgrades or changes on your farm.
The Small Business Innovation Research program is a highly competitive program that encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization.
Will there be funding for the face-to-face technical assistance that will be required for growers to transition?
This is something that FDA is exploring with the United States Composting Council. A series of on-farm national composting workshops is being considered.
How does FDA intend to inform or provide outreach to composters?
In addition to composting workshops, FDA is leveraging the Produce Safety Network staff to provide individualized technical assistance where needed. Several Universities also provide information and technical assistance for compost producers (e.g., University of Georgia, University of Arkansas, and the Cornell Waste Management Institute, to name a few). FDA has also supported Regional Centers to build a collaborative infrastructure to support FSMA training, education, extension, outreach, and technical assistance as it relates to the produce industry. The Northeast Center has developed a Clearinghouse, which serves as a national depository of resources helpful to the industry.
What is the plan for consistency among organizations? (FDA, NRCS, EPA, USDA, others)
FSMA has stimulated the largest governmental effort to harmonize guidance on all FSMA topics. In addition, on January 30, 2018, a formal announcement was made to publicize the ongoing commitment to collaboration between USDA and FDA. This announcement also established a Workgroup comprised of FDA and USDA leadership and technical staff. The Workgroup has met several times and is focused on three priority areas: (1) aligning the USDA Harmonized GAP program with the FDA PSR technical components (complete); (2) outreaching to cooperative extension so they are better informed of FSMA in general and PSR in particular; and (ongoing) (3) outreaching to the international community to encourage PSR compliance for farms exporting to the US (ongoing). Regarding the alignment project, an associated activity is to provide reciprocal training opportunities for USDA GAP auditors and FDA PSR inspectors, so each distinct group is aware of the others’ program. Two USDA GAP audit program leaders completed the January 28, 2019 session of FDA’s FD226 course with the intent to revise the USDA GAP auditor training class to incorporate appropriate elements from FD226. USDA shared its 2019 GAP auditor training class schedule for consideration by FDA staff.
The alignment project team included FDA staff. The outcome was alignment of the technical components and alignment of related material in the auditor instruction manual. USDA staff is also considering how to incorporate the recently issued PSR Guidance into the USDA GAP program.
USDA’s NRCS is represented on the Produce Safety Alliance Executive Committee and NRCS staff have reviewed/commented on FDA materials with a goal of providing awareness to their staff and to FDA staff. In addition, NRCS created “USDA Cross Training Programs: NRCS Conservation Programs” available to others within USDA as a means to provide awareness training in their conservation programs.
Does FDA plan on making distinctions in its risk assessment between types of manure (e.g., exotic, fish, cow, pig)?
The risk assessment is ongoing, however, manure type seems to be an important variable in pathogen prevalence and persistence in the environment where manure is added to soils.
Is vermicompost considered treated regardless of inputs?
When vermicompost follows USDA NOP guidelines, then that product would be considered treated, regardless of the inputs into the vermicomposting system.*
*This information is in conflict with draft guidance published on November 27, 2018. Please look for additional clarification from FDA regarding the status of vermicomposting.
Is there a plan to develop a standard for how to validate composting protocols?
FDA is not aware of any standardized validation protocol under development. Because each system is different, FDA anticipates it will require a case by case analysis.
Is there an agency responsible for verifying compost is done properly or some sort of process authority?
There is not a federal agency responsible for verifying compost. The United States Composting Council has a program called Seal of Testing Assurance (STA). It is important to note that the STA program goes above and beyond what FDA will require under the PSR.
Is rotational grazing considered as a BSAAO delivery system or it is an animal intrusion event?
No, rotational grazing is not considered a BSAAO delivery system, nor is it considered an animal intrusion event unless the crop is present during grazing. However, the risk assessment of the practice (rotational grazing) and consideration of follow-up practices are key to mitigating any resulting hazard. FDA encourages co-management practices as long as careful attention is given to the safety of produce. Grazing practices will need to be assessed on a case by case basis and take into consideration whether or not the crop is present during grazing. Risk assessment should be based on the number of animals per acre and the time between grazing and planting. High numbers of animals on small acreage removed close to planting of a short growing crop would be the highest risk situation because of the concentration of manure and short amount of time for pathogen die-off. The NOP standards can be used as a guide until more information is available. At this time, FDA does not expect rotational grazing practices to be a food safety concern.
Is there a way for FDA to fund farmers to actively participate in research?
FDA and USDA have provided funds for outreach and education to growers through the Food Safety Outreach Program, but these funds cannot currently be used for research. USDA SARE and USDA NIFA have funds available for on-farm research and researchers are often looking for farms with which to collaborate on these projects. The Small Business Innovation Research program encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization. Often for USDA research, outreach to farmers is done through Extension to invite participation from a specific region.