New FDA Produce Regulations

[dominiquer60]

Here we go the FDA is on a roll now, but there is still time for public comment on a limited amount of the regulations.

I have just started reading the summary and here is a brilliant highlight, apparently despite all of the scientifically based rules, the scientist don’t realize that one needs to cultivate with draft animals and not just keep them on “a separate path.” Here is part of the summary

Domesticated and Wild Animals: Subpart I

The proposed rule identifies possible routes of microbial contamination of produce and sets requirements to prevent or reduce the introduction of pathogens. Domesticated and wild animals are one possible route of contamination because pathogens can be introduced into fruit and vegetable production systems via animal feces.

Background

The proposed rule balances the need to prevent contamination with the need to be practical and flexible with the diversity of operations and ensure that prevention measures are in harmony with resource and wildlife conservation efforts whenever possible. The proposed rule is consistent with sustainable conservation practices; it does not require animals to be harmed, farms to be fenced, animal habitats to be destroyed or farm borders to be cleared.

Requirements

(Proposed § 112.82) If animals are allowed to graze or are used as working animals in fields where produce is grown, and under the circumstances there is a reasonable probability that grazing or working animals will contaminate covered produce, you would be required to do the following:
Wait an adequate amount of time between grazing and harvesting any growing area that was grazed to ensure the safety of the harvested crop, and
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.
(Proposed §§ 112.83 and 112.112) If under the circumstances there is a reasonable probability that animal intrusion will contaminate covered produce, you would be required to monitor for evidence of animal intrusion immediately prior to harvest and, as needed, during the growing season. If you see evidence of animal intrusion, such as significant quantities of animals, animal excreta, or crop destruction via grazing, you must evaluate whether the covered produce can be safely harvested. For example, if you see evidence of bird excreta on a head of lettuce, you would not be allowed to harvest it.

Full summary with link to the full text for your reading pleasure. http://www.fda.gov/Food/FoodSafety/FSMA/ucm334552.htm#I

[Mark Cowdrey]

AAARRRRRGGGGHHHH!!!!!!
Mark

[Andy Carson]

Several comments.

1. I believe many food borne illnesses are a result of people or organizations not following current food safety precautions. I do not think we need more laws, we just need to enforce those we have and consumers need to take a more active role in understanding where their food comes from.

2. Producers who average less than $500,000 in sales per year and sell most of their produce to end users are “partly exempt” from this rule if they clearly label thier produce. Great, but I am not clear on what “partly exempt” means… exempt from which parts? Not clear…

3. One interpretation of “establish and maintain horse paths that are segregated from produce” is that you should walk your horse between crop rows (the “path”) exactly as you normally would when cultivating. There is an ackowledgement that some people will use draft animal for produce production in this rule, which is wonderful, and an ackowledgement that these animals will enter the field. If I were interpretting this rule, I would say it means you shouldnt drive your horse over your veggies. No one wants to do this anyway. Problem is, I am not interpretting this rule and it may be in the hands of buearocrats with no knowledge and a lot of power. The law should be more clear.

4. Part of the justification from making this law was to create enforcable rules, yet many these rules are completely impossible to enforce. Who is going to loom over your shoulder to make sure you don’t harvest the lettuce with bird poo on it? Who is going to watch you work your animals to make sure they stay between crop rows? Are we living in a police state? This is not practical.

[near horse]

Laughable to the point of ridiculous. The bird poop thing is so out of touch it makes me wonder if these people have ever been outside of a climate controlled building. How come there was no mention of monitoring flies landing on produce? They certainly carry pathogens from place to place.

[dominiquer60]

I don’t find the bird poop thing ridiculous, enforcing it yes, but I have always been of mind that if there is feces on something, it is best not to sell it. Now if there were bird droppings on the out leaf of a broccoli plant I would cut the head, but dead center on a head of lettuce, I will leave it to feed the soil instead of a human.

Andy, I did think about how to interpret the “segregated path,” such language may mean the wheel tracks between rows of veg, but if that was the case I picture them making us use diapers like a carriage horse in the city.

The real problem I have with all this is that trying to read all this stuff is like shopping for a mattress, all of these documents look similar and say similar things but every time I turn around I can’t find the one that I want or was just reading.

I thought that I read that we have to wait 9 months from an untreated manure application until we can harvest, it used to be 120 days was the recommendation, but now I can’t find where it states that.

One thing that I thought would be interesting to bring up again it the Equicert program. They are GAP certifying horse powered farms for the plain clothes community so that they can sell at auction and wholesale.

http://equicert.biz/

I am going to see if he may be able to write something for our Spring newsletter.

[dominiquer60]

Maybe we will be forced to follow EU rules and start plowing like this, http://www.youtube.com/watch?feature=endscreen&NR=1&v=lQ_us0UFf_U. I want to see how he cultivates raised beds like this with his horse.

[fogish]

I will read through the regulations today. This is the type of wording used in the GMP – Good Manufacturing Practice. That is a set of federal guidelines for quality control and production. It is written in a way that is supposed to encompass as many different facilities and types of production and as many possibilities in one fell swoop. I can’t describe how crazy some of them are. I made arguments over wording with inspectors all of the time so I could run the facility how I wanted. As long as I could show it it fit the wording I was allowed. I was able to convince them that wedding rings and headphones for music can be exempt from loose items and jewelry because a person would notice them falling off and they would not fit inside the containers on the production line. In the GMP it only refers to “loose items and jewelry” but not any specific items, so it is totally open to interpretation.

“For example, if you use draft horses, you could establish and use horse paths that are segregated from the produce. If under the circumstances there is a reasonable probability that animal intrusion will contaminate covered produce, you would be required to monitor for evidence of animal intrusion immediately prior to harvest and, as needed, during the growing season.” (I will read Proposed §§ 112.83 and 112.112)

Basically we need to take steps to keep the horses from contaminating the food and watch for contamination throughout the growing season and harvest. It goes on to stipulate that if there is intrusion (contamination or damage) from any animal source you can not use it for human consumption and must take steps to keep it from occurring.

If for some reason you do get inspected you get an opportunity to explain/convince them that the chance of contamination is low with how you run your farm. If they bring up your horse needing a manure bag you can argue you can see where his droppings go and you know what food is contaminated. That may address their concern, it all depends on the situation. An inspector may decide your horse needs to be brushed, including any feathering, before working but not care or even think about a manure bag. Maybe he is only worried about your horse stepping on the food. Now you can see why it is vaguely worded, it covers and allows for a wide set of situations.

[fogish]

Dominique, if this change goes through 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.

If it’s composted, depending on how it is done, there are 2 different rates of application – 0 days or 45 days.

“You may establish and use alternatives to the composting treatment processes established in §112.54(c)(1) and (c)(2), and for the minimum application intervals established in § 112.56(a)(1)(a) and in § 112.56(a)(4)(a), provided you have adequate scientific data or information to support a conclusion that the alternative would provide the same level of public health protection as the composting treatment processes and the minimum application intervals established in the proposed rule and would not increase the likelihood that your covered produce will be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act.”

I will have to read the existing law to find out about when you can harvest after an application.

[fogish]

“For example, under the new USDA organic certification program the raw animal manure must either be composted, applied to land used for a crop not intended for human consumption, or incorporated into the soil at least 90 d before harvesting an edible product that does not come into contact with the soil and at least 120 d before harvesting an edible product that does come into contact with the soil. Composted plant or animal materials must be produced through a process that achieves a temperature between 131 °F (55 °C) and 170 °F (76 °C) from 3-15 d depending on the composting system.” 2.1.2.2.1. Regulations

More manure treatment and application guidelines.2.2.1 and 2.2.2

This Link is from Cornell and sums up the whole Good Agriculture Practices program. The GAP is similar to the GMP program that I had to deal with at my last job.

[dominiquer60]

Fogish,

Your insight has been helpful, I am just having a hard time understanding what is up or down and what is set and what they are still taking comments on. If they can’t dazzle us with brilliance, they will drown us with documents.

I have always used the 120 days before harvest when applying raw manure, I have never had access to proper compost.

I am going to try to get into a GAP workshop at some point just so that I can keep up to date with what I should be doing if I am not already, or so I can learn how to justify my actions to the feds.

[fogish]

According to the existing laws that I have read so far you aren’t supposed to let any domestic animals near the fields once you have planted the crop, at least in the case of vegetables. So the proposed law adds an exception for domestic animals as long as steps are taken to protect the crops and even specifically states draft animals as an example.

Also the proposed laws define more clearly what is and is not treated manure. 131 F. for 3 days if static or 131 F. for 15 days with a minimum of 5 turnings. Both must be followed by “adequate curing” and proper insulation. I can read through the proposal and find out what that means if you would like. Conversely you can increase the PH instead of “heating” it. There are also guidelines for treating slurry.

Chances are you will have to document when you apply raw manure and when you harvest. It depends on size of farm, amount of annual sales, # of employees, other factors, if they will take your word or want it on paper. So if you are documenting application of row manure you could also document the temperature of a manure pile. Sat for X days and if/when you turned it. How long it was covered for and of course the application date and date of harvest. Most of this is already recommended (required?) for large farms. The reason for documentation is so you don’t make a horrible mistake and if an inspector shows up you look like a responsible farmer. Documenting the really important things like routes of contamination will make an inspector happy. I used to keep portions of the laws printed and hi-lighted to make sure I was within the guidelines and in case the inspectors said I was not in compliance. Of course we would get inspected frequently, I don’t know if that is something you experience.

“If they can’t dazzle us with brilliance, they will drown us with documents.” I think you are talking about the amount of documents you have to go through and understand just to be a farmer but that statement is more true than you know. I am a very happy person since I left my previous job. Thankfully they aren’t making agriculture and small processors implement HAACP. Learning it and using the concept is great, but the amount of paperwork involved would ruin a small farm. We had 9 employees including the owner, secretary, accountant and part timers. We had to hire someone full time to do paperwork once we implemented HAACP.

[fogish]

To make things crazier up to this point the rules we have discussed are actually recommendations; except for the organic certification laws. If the proposed regulations go into effect they will become a minimum standard for everyone. So your organic farm has the application to harvest restriction of 90d or 120d but the farm down the road only has it as a recommendation. He can apply a week before if he wanted to. He is still liable for any sickness from it but it is not actually illegal for him to apply. Now that is only in the areas of the law that deal with application and contamination that I have read. There may be an actual law against a specific % of contamination hidden in the cosmetics part of the law or at the least implementing a fine and being shut down.

There is also a difference between the existing federal recommendations, organic rules, state law and local law. Farming is easy right?

I love reading through laws but it’s easy to miss something with how they end up being fragmented after years of minor changes. So I will stop flooding this thread with posts. Hopefully Cornell/GAP has a lot of info on the law, the federal recommendations, and points out which is which.

[dominiquer60]

It is tough enough just trying to farm, let alone getting regs straight, so I treat all manure no matter how long or how many times mixed as raw manure and wait the 120 days till harvest. That way if a turning is forgotten or not written down I am within the guidelines no matter what happens. I generally apply manure in the fall to a cover crop or to establish a cover crop, I haven’t wanted to risk it.

One thing that I have not been able to find yet is how close livestock can be adjacent to a vegetable field. The National Leafy Greens Act was encouraging CA farmers to take out all hedgerows to discourage birds from flying over, I was expecting something like that in this monstrosity. We have a heifer pasture 25′ from my strawberries, it is a good fence and they never get out, but I wonder what the feds think of that.

[fogish]

OK, so this is what I hate and love, it’s an “it depends” situation. This is directly from the document that determines the GAP protocol: “Growers should determine whether surrounding fields and farms are used for animal production. Growers may need to consider measures to ensure that animal waste from adjacent fields or waste storage facilities does not contaminate the produce production areas during heavy rains, especially if fresh produce is grown in low-lying fields or orchards. Measures might include physical barriers, such as ditches, mounds, grass/sod waterways, diversion berms, and vegetative buffer areas.” 3.0 Animal Feces

This from an analysis on safe practices relating to microbial contamination of fresh and fresh-cut produce. “Run-off prevention and diversion structures, such as collection channels, diversion berms, and vegetated buffer areas can help divert run-off away from the water source. To protect on-farm water sources, farm agent extension recommendations range from distances of 30 to 400 feet between potential contaminants and a water source. Greater distances are strongly advised for sources near concentrated animal facilities and manure storage areas.” 2.2.2.3. Protection of water sources 4th paragraph down.

The entire analysis is something that is used as a resource and guideline for those involved in HACCP. Part 3 gives you a simple example of the HACCP process, just scroll down a short distance.

Mostly it is governed by state law and they determine it not by distance but by a sample of ground water and levels of different contaminants.

[dominiquer60]

I think I am good. My strawberries are on the highpoint at the edge of the vegetable field and the heifer pasture is below that, the feeding/holding and manure storage area is 200′- 250′ away. Water always runs down hill from the strawberries to all other locations. between the strawberries and the heifers is a wide grass lane way that acts as a buffer and harvest lane, it is a 2′ drop from the laneway into the heifer pasture. Thankfully the water in the heifer pasture never runs towards the veg because of this berm and lane way.

Thanks for your help Fogish!

[Author]

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