New FDA Produce Regulations

[dominiquer60]

NEW FOOD SAFETY REGULATIONS PROPOSED FOR FRESH PRODUCE GROWERS
By Dr. Luke LaBorde, Department of Food Science, Penn State University

On January 4, 2013, the U.S. Food and Drug Administration (FDA) released
a draft Produce Safety Rule as required under the Food Safety
Modernization Act (FSMA) of 2011. This proposed regulation would
establish mandatory practices that farmers must take to prevent
microbial contamination of fresh produce. Below are highlights of
requirements FDA would issue in the final regulation.

Worker Health and Hygiene ‐ Farm and packing house workers who harvest
or handle fresh produce, and their supervisors, must receive training on
personnel hygiene and health conditions that can increase the risk for
food contamination. Growers are required to show proof of training by
keeping written records. Toilet facilities have to be readily
accessible, kept reasonably clean, and supplied with toilet paper.
Hand‐washing stations must be close to toilet facilities and supplied
with potable running water, hand soap, and clean single use towels.

Agricultural Water ‐ Growers must be able to demonstrate that the water
they use for rrigation, pesticide preparation, cooling and washing, etc.
is safe for its intended use. Maximum average E. coli levels of 126
cells per 100 milliliters have been proposed for irrigation water that
can contact the edible part of the crop. Water used for post‐harvest
operations face more stringent standards; no detectable levels of E.
coli are allowed.

Biological Soil Amendments ‐ At least a 9 month interval (270 days)
would be required between application of raw animal manure to produce
fields and harvesting if there is a possibility that the manure may
contact the produce. Composted animal manures can be applied from 0 to
45 days before harvest depending on whether or not it can contact the
crop. Growers, or commercial compost suppliers, must provide proof
through laboratory testing that the composting process was adequate to
make it safe to use. No human waste is allowed on fields except in the
case of sewage sludge biosolids that are treated according to already
existing regulations.

Domesticated Animals ‐ Working animals, such as mules and horses, are
allowed in produce fields as long as the grower can demonstrate that
they have taken adequate measures to prevent contamination. If animals
are allowed to graze in areas intended for produce growing, the waiting
period specified for application of raw manure (270 days) would apply.

Wild Animals ‐ FDA recognizes that it is impossible to keep all wild
animals away from produce fields. If the situation is out of control and
there is a reasonable probability that wild animals can contaminate
produce, growers would be required to monitor their fields for signs of
animals and take some kind of preventative measure to keep them out or
discourage them from entering.

Equipment, Tools, and Buildings ‐ Equipment and tools need to be kept
reasonably clean. Sanitation standards for packing buildings requires
good water drainage, control of dripping condensation, a pest control
program, and regular clean‐up of trash. Partially‐enclosed packing
buildings are acceptable if the grower or packer takes precautions to
prevent birds and other pests from becoming established in the buildings.

Here are some important points that need to be made about the proposed
rule. The proposed rule covers only fresh produce that is sold
commercially. It does not apply to produce used for personal
consumption, such as home gardens. The focus of the new regulation is on
fruits, vegetable, nuts, herbs, mushrooms, and sprouts that are
typically eaten raw, not commodities that are generally cooked or
further processed. For example, potatoes, eggplant, winter squash,
beets, and beans for drying are exempt.

Not all farms that grow fresh produce are required to comply with the
rule. Farms with gross food sales under $25,000 are exempt. Farms with
gross food sales over $500,000 are generally required to comply. Those
with total sales of between $25,000 and $500,000 may or may not receive
exemptions, depending on what kind of marketing channels are used. For
instance, if a farmer sells than more than half of his/her strawberry
crop directly to consumers, such as at a farmers market, farm stand, as
a CSA, or if he/she delivers it directly to a grocery store or
restaurant, they are exempt from the regulation. However, to receive
this exemption, these kinds of direct sales must be to buyers in the
same state as the farm, or if out of state, no farther than 275 miles
from the farm. If a crop is mostly sold through wholesale outlets, such
as through distributors, warehouses, or fresh‐cut processors, the farm
is not exempt and is covered under the rule. Exemptions can be cancelled
if FDA determines that a farm may be a source of contaminated produce.
And finally, keep in mind that growers of any size who sell at least
some of their crop through wholesale marketing channels, even if
technically not covered by the federal regulation, have been facing and
will to continue to face standards at least as stringent as anything in
the final FDA regulations.

Remember, this is a proposed rule. It is not a final regulation. This
means that growers have an opportunity to comment on any part of the
rule they do not understand or object to. The draft ruling is available
for viewing at http://www.fda.gov/Food/FoodSafety/FSMA/ucm304045.htm.
The public will have the opportunity to submit comment on the draft rule
until May 16, 2013. Before this date, FDA will be holding public
meetings to explain the proposal and to provide additional opportunity
for input. There are two ways to send comments. You may submit comments
through the internet at http://www.regulations.gov. Once you are on the
site, follow the instructions for submitting comments. For written
comments, you may fax them to FDA at 301‐827‐6870 or mail them to:
Division of Dockets Management (HFA‐305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All written
submissions received must include the Docket No. (FDA‐2011‐N‐0921).

So my question is if you apply raw manure, and work it in, say with a plow, or a harrow, is there a risk of it coming into contact with the produce, after such procedures?

Also
“as long as the grower can demonstrate that
they have taken adequate measures to prevent contamination.”
How does a teamster take adequate measures to prevent contamination when working in a vegetable field?
Personally I don’t harvest where I stopped the horses and one made a deposit, it didn’t make sense to even before this bill, but is it “adequate?”

[fogish]

To answer the first question you need to ask: Does this process have the chance of raw manure coming into contact with the produce? The 270 day period between application and harvest is to make sure all the bacteria from the raw manure has died or is at negligible level. From the FSMA fact sheet:
“An untreated application of soil amendment of animal origin applied in a manner that does not contact covered produce during application and minimizes the potential for contact with covered produce after application. Can be applied every 9 months.

An untreated application of soil amendment of animal origin applied in a manner that does not contact covered produce during or after application. Can be applied at any interval – 0 days.”

Adequate measures to prevent contamination. That depends on the inspector. Some would say having wide enough paths for the horse to walk down is enough, others may want a manure bag, maybe even putting a flag in the ground wherever they urinate or defecate would be enough. “Implement measures to prevent the introduction of hazards onto covered produce from working animals if working animals are used in a growing area where a crop has been planted. For example, if you use draft horses, you could establish and use horse paths that are segregated from the produce.” Don’t walk your horses on your crops and anything they relieve themselves on or near is not suitable to be sold as food for human consumption. I’m fairly certain you already follow the example they give.

[dlskidmore]

@dominiquer60 39611 wrote:

Wild Animals ‐ FDA recognizes that it is impossible to keep all wild
animals away from produce fields. If the situation is out of control and
there is a reasonable probability that wild animals can contaminate
produce, growers would be required to monitor their fields for signs of
animals and take some kind of preventative measure to keep them out or
discourage them from entering.

This is the part that concerns me the most. Unless your garden is in the middle of the city, when is it ever an unreasonable probability that wild animals can contaminate produce? Do we have to fence out all wildlife? Can’t keep a guard dog in the corn field to chase them away because the dog’s illegal too.

Although this may be another marketing angle for small farms. If farmers that sell direct to consumer are not covered by this restriction, then you can advertise how much more wildlife friendly your veggies are than grocery store produce. (Right next to the “Wash Your Veggies” note.)

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