Potential Questions and Concerns on FSMA

Salad Garden at the marketWhile food safety is extremely important, our concern is that the FDA may have missed something in creating these rules that end up have a negative impact on the farm while not making the consumer any safer.  That is why the FDA has opened this comment period, lasting until May 16th: to give us a chance to express concerns and offer changes.  Below are a few starter ideas to consider.

Got questions or concerns?  Head to the NYFC forum on FSMA to discuss and to give us your input. 

As we get closer to the FDA deadline, NYFC will be wrapping together everything that is brought up to write an organizational comment. You can of course also issue a comment yourself – head to the FDA dockets directory.

For an overview of the section relating to produce growers, read the NYFC fact sheet on FSMA. The proposed rule in its entirety is available here.

Some potential questions to get you rolling:

  • Exemptions: Complete exemptions are provided for farms with annual sales under $25,000.  Farms with sales under $250,000 and under $500,000 annually are partially exempt, meaning that they are still held to certain labelling requirements.  The former have four years to comply and the latter have three.  Farms with sales over $500,000 are fully held to the new guidelines, with two years to come into compliance.  Are these monetary limits what they should be?  Where does your farm fit in?
  • Compliance Time Frame: Large farms (those with sales over $500,000 per year) have two years to comply with the new rules, while “small businesses” ($500,000 or less in annual sales) have three years and “very small businesses” ($250,000 or less in annual sales) have four years.  Are these compliance timelines enough time?  Those farms without the partial exemption potentially have a lot of changes to make.  Do you think this will allow enough time?
  • Training: Subpart C deals with employee training.  Specifically, it requires all employees who contact harvested food be trained in food safety, that the farm keep records of trainings, and that a supervisor on the farm complete food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the FDA.  Do these requirements (found on page 3555 of the proposal) make sense?  What restrictions need to be in place to make sure your farm isn’t unnecessarily hampered by these regulations?
  • Hygiene: Section 112.32(b)(3)stipulates the need for farmworkers to regularly wash hands. The concern is that workers’ hands are getting dirty outside and then they are harvesting food, some of which will be consumed raw.  What do you think should be required for hand-washing stations?  How can this requirement be made without forcing farmworkers to run inside to wash up after every time their hands touch the dirt?
  • Hygiene: Section 112.33(b) would require that you provide a handwashing station for farm visitors (since they may come in contact with food to be harvested, and thus transmit disease).  Will this be difficult for your farm?  (Think about CSA members coming to pick up their shares…)
  • Water Testing: Proposed Section 112.45 refers to agricultural water.  For water that could come in contact with food (water used for washing, post-harvest cooling, hand-washing, as well as overhead sprinkling), you are required to regularly test for pathogens. This means that testing at the beginning of each season and every three months after.  Farmers who treat their water or get their water from a public source are exempt.
  • Compost Tea: In subpart F, which deals with soil amendments and animal manure, there are restrictions on using untreated compost tea.  If you use compost tea, what exceptions should be included to make sure your farm isn’t unnecessarily hindered?
  • Use of Manure: Section 112.56(a)(1) refers to the use of raw manure.  In situations where produce will come in contact with soil (for example, where almonds are harvested by intentionally dropping to the ground) after application of the raw manure, the use of raw manure can’t be applied less than nine months before harvest.  (This refers to untreated manure only).  How will this affect your farm?  Note that organic standards stipulate 120 days for this situation.
  • Soil Amendments: Many section of subpart F could impact the way your farm uses animal-based amendments.  Although it’s long, you should take a look at this section if you think your practices may need to be altered to comply with the new rules.
  • Draft Power: Proposed Sec.  112.82(b) would require that, if you use working animals in a growing area where a crop has been planted, you must take measures to prevent the introduction of known or reasonably foreseeable hazards into or onto covered produce. For example, if you use draft horses as working animals in your covered produce fields, you could establish and use horse paths which are segregated from covered produce plantings, and minimize entry of the horses into covered produce plantings, thus minimizing the opportunity for horse excreta to contact covered produce or food contact surfaces.  How do you think this rule should be written to not have too heavy an impact on a draft-horse-based farm?
  • Food Touching the Ground: Proposed Sec.  112.114 would prohibit you from distributing produce that drops to the ground before harvest (excluding crops that grow in the ground – ie, carrots, things that grow on the ground – ie, melons – and a few other exemptions).  How would this affect your harvesting practices?  Do you regularly place harvested vegetables (or bunches) on the ground as you go along a row?
  • Cleaning Equipment: Proposed Sec.  112.123(b)(1) would establish that equipment and tools you use must be installed and maintained in a manner that facilitates cleaning of the equipment and of all adjacent spaces.  These refers to things like conveyor belts, sinks, etc.  Are there exemptions that should be made here?
  • Cleaning Equipment: Subpart L deals with cleaning equipment – both things that come into contact with food and things that don’t (but could indirectly spread contaminates).  What restrictions should be put in place to make sure your farm isn’t unnecessarily  hindered (e.g., do you wash your harvest knives after every use?)?
  • Sprouts Production: Subpart M deals with sprout production.  For example, section 112.142(a) would require that you grow, harvest, pack, and hold sprouts in a fully-enclosed building.  Do you do this now?
  • Sprouts Production: Proposed section 112.142(c) would require you to treat seeds or beans that will be used to grow sprouts using a scientifically valid method immediately before sprouting to reduce microorganisms of public health significance.  Does this impact your business?
  • Further Questions: Finally, Section IX of the proposed rules contain a long list of areas that the FDA has identified as possibly requiring further comment.  Although the above questions are a good start (and especially focus on small and beginning farms), you could take a look at this longer list from the FDA (it begins on page 3617) and think about other issues you’d like to comment on.
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