FDA Samir Assar FDA
A lot of the comments I recievd that day were actually taken into account
Key aspects The idea here is a prevention based model. We basically built off of
what industry has done already.
We are taking advantage of uidance documents that convey food safety principles.
We also understood the need to be risk-based and flexible. We also need to
recognize that there are resources available to large frims that are not available to
small farms. It is important to note as part ofour outreach
We sought out input. We had 500 meeting around the U.s. and met with agencies
outside the U.S. We had four meetings in Ohio as we developed the proposed rules.
We are looking for commnets. These are 700 page documents each. There is a
reason for that. Along with the rules themselves, we provided the justification for
those rules. We’re not saying this is the way it is going to be and we are seeking your
input on what these rules should be. There are fact sheets covering the major
provisions of the rule.
Rules considers risk posed by practices and commoditioes there are common routs
of contaminiation that routinely come up. We are also looking at the aspects of
commodity consumption and what can get different produce in a lower risk
category.
We have also built into this some flexibility and additional time for small farms to
comply with the rules. There are also alternatives built in for water and soil
ammendments that exceed FDA suggestions.
We had to take into account the diversity of the stakeholders. We also took into
account the lack of history that FDA has with doing inspections with farmers on the
farm.
Science is emerging all of the time and we want to keep this a current and open as
possible to allow for emerging science.
Farms with annual sales over $25,000 a year
Produce doesNOT include grains
This does not cover produce for personal consumption produce that is rarly
consumed raw
Agricultural water is likely to contact the harvestable portion of produce and it must
be safe and of adequate quality or it must be treated. Alternatives are permitted as
longa s they are the same or better than he standards permitted.
Biological soil ammendments of anmal origin
Worker health and hygiene
Equipment tools and buildings
Domesticated/wild animals
We are not banning the us of working animals. We ask that there be prevention of
contamination of working aniamals by segregating the working animals to minimize
the risk of contamination of that produce. We wanted to minimize the potential
impact that this rule could have on wildlife. We took a very light approach here. If
tehr eis feces on your produce, don’t harvest it.
Sprouts have more specific requirments because they are grown in environments
favorable to pathogens
Record keeping is required but not burdensome
As we developed the rule, we have done a quality assessment of risk that provides
abackbone of the regulatory approach. We are asking for commonts on the
qualitative assessment of risk.
Compliance dates are staggered for small firms it would be three years fro small
farms four years There woul be five years for some farms to comply with the water
standards. That also allows for firms to do the studies that they need to meet te
requirementsHazard Analysis PPC
www.regulations.gov for comment
We really need your specific feedback through informed comments. This is not a
done deal and it doesn’t happen overnight. We are asking question about what
directions we should go with these proposed regulations. 120 day comment period
We will continue to do outreach and let people know what is happening. We are
committed to doing public meetnings.
We can’t dot his on our own. We need help from this broad stakeholder set.
Doug Doohan OSU OARDC
Consequences of 2,4-D and Dicamba tolerant field crops
Drift happens and there is no more
The degree to which the technology is adopted will influence the amount of risk
there is. Dow Agrosciences have made progress on drift mitigation. In the case of
2,4_D and Dicamba, it is much more important to get that technology out there.
Glphosate is the most widely used herbicide, but 2,4-D is a close second or third and
it is already being used in your vicinity 1990s had major studies into toxicity of 2,4D. Dicamaba also has a clean bill of health.
2,4-D introduced shortly after WWII and shortly after that we started to see lawsuits
for drift damage to grape, cotton and tomats. Banvel (Dicamba) is a realatively
volatile formulation and led to a number of claims
In the last decade there was cloning of detoxifying bacterial genes that led ot
thedevelopment of resistant crops
2,4-D and dicamba are more toxic to broadleaf crops than glyphosate by 75 to 10
times
in 2005 there were 1700 drift incients reported in the U.S. and only 5% to 10% of
drift incidences actually are reported. In Ohio there are around 30 incidents a year
reported to Ohio. Of these, only 15% have any action taken because they cannot find
the active ingredient. The one thing that fruit and vegetable growers might be
thinking is that, if I get drifted on, I can just sue. But just calling your lawyer is not
necessarilty going to solve the problem.
2,4-D is acorss the board the most common herbicide reported in drift incidents. It
does not drift more, it is just more toxic. It takes just a very small amount ot cause a
lot of damage.
Tank contamination, drift creates tremendous uncertainty for a fruit and vegetable
grower who has been drifted on. You’ve already spent a lot of money and you see
problems. And you will not find dicamba or 2,4-D unless there is a ttremendous
amount of injury. For a processing vegetable producer a drift incident can be
devastating. Sometimes you actually can get a yield increase, but it can be delayed
and it is no use for meeting the eneds of your supplier.
There are currently not tolerances established for dicamba residues ofr fruit and
vegetable crops. We’re trying to get the EPA to nopt let these traits go forward until
we do have ome tolerances for dicamba residue on fruit and vegetable crops.
Also concern that plants that support pollinators will be hurt
Also concerns with water contamination. 2,4-D and dicamba are mobile in the oil
and there is the potential for them to get into the water and into irrigation water for
fruit and vegetable crops. Research has not been done on this but that potential is
out the and we need to do more work on this. Save our Crops is lobbying for
tolerances to be established for dicama.
Some of us have had some sleepless nights from dealing withd rift.
Weeds resistant to glyphosate are no small matter. Resistant marestail plants are
showing up in our vineyards and orchards too. And, we have an ideal situation in
vegetable fields for glyphosate reistant weeds to show up as well. This is a big deal
in the use of no-till vegetable production. Plamer amaranth can very uickly develop
resistance to glyphosate and it is moving north. This weed is terrifying weed
scientists the most because it can spread so quickly. Monsanto was in a state of
denial for a number of years and that really did not help the situation with
glyphosate resistant weeds.
Enlist weed control system by Dow is based on trait for 2,4-D resistance This is
amazing technology for corn and soybeans These bacterial genes are cloned
intocornand metabolize the 2,4-D immediately upon entering the plant
Monsanto and BASF teaming up with Extend Crop system to combine glyphosate,
Liberty and fucilate
Up until two or three days ago, Dow was planning on relaseing Enlist in corn in
2013, but that has been delated. Soybea relase was tagerted for 2014
Roundup Ready Extens in soybean and cottom planned for 2014, so we need to get
ready for this. Save oUr Crops is just working to slow this process down so we can
get some checks and blances in place before these technologies are approved
The things that we do today have a cost for tomorrow. With any technology, there
are externalities that someone else gets to pay for in the future.
Nearly 50 million acres get sprayed each year with 2,4-D about have that with
Dicamba
The use of 2,4-D and Dicamba will shift from the West to the Midwest with this
technology and annual use rate could increase from typically one application to as
amny as three. Application rates will also likely increase. New 2,4-D and Dicamba
formulations will actuially drift less than typical herbicidies, but due to the toxicity,
it is my opinion that we will see more drift. There will not be more drift, we will just
see more results of drift. There is no question that grian farmers need help and
needhelp quickly. And, it will help keep some of those resistant weeds out of no-till
vegetable fields.
Marestail seed resistance 1 in a billion naturally resistant to 2,4-D, but 405,000
arestail seeds per acre
Wind speedm tmospher, air temperature
BASF, Monsanto and Dow have taken some great steps with improving their labels
You would be surprised about the
It is very difficult to clean these spray tanks completely and you need to be aware of
that. And, volitaizationo fherbicides can cause big issues.Gases don’t go up. They go
up a few feet, they move horizontally. Volatility of a product of the chemical’s
structure.
Enlist’s new formulation greatly reduces the volatily of these herbicides and BASF
has doen similar work with Engenia
Banvel will be illegal to use. The new formulations will be Engenian and Carity
which are much less volatile than Banvel. BASF has managed to largely eliminate
volatility, but unfortunately, most drift is not the result of volatility, it is the result of
spraying in the wind. But, droplet drift has been greatly reduced as well by
thickening the viscosity of they spray. Nozzels are also very important compnents of
this. Big droplets don’t drift
Weather and the human dimension
Droplet drift is avoidable. Farmers spray glyphosate right next to vegetable fields
every year with no damage, but you can’t spray in the wind.
Buffer zones can also help
LABEL CHANGES, GROUND Speed at less than 15 mph lower boom high. Here is
published research that has shown herbicide has moved up to 10 miles
If you are growing fruits and vegetables, you need to be talking to your neighbors. If
they are not spraying, talking to their commercial applicators. They need to know
that there is a sensitive crop growing nearby and you need to do this every year. Do
everything to prevent drift on your own farm. Document what you are doing so that
you can show your plants are symptom free from what ou are doing. Keep excellent
records. Register with the sensitive crop registry. Know sysmptoms of injury and
check regularly and act quaickly. You only have about three days where you can get
a sample of tissue that will show evidence of herbicide injury. The plant is more
sensitive than any analytical device we have. You need to document the prpobelm
and take pictures. Don’t wiat
Pricing approaches
One proce for everything
All ticketed/tokens
Hybrid of an upfront charge with additional fees for extras
Tim woods university of Kentucky
Commodities and differentiated products are usually the difference between price
makers and price takers
Producers must develop the ability to negotiate prices by knowing the costs of
production, particularly with restaraunts
Have to take into account cost of distribution
Signs and zoning
City zoing try t be nice and get along with them so they let you get what you want.
Counties and townships have no power to regulate agriculture on lots 5 acres and
larger. If you have less than one acre the twoship or county can regulate all
agriculture. 1-5 ars the can regulate ag buildings and structure
If you’re in a subdivision they can regulate you.
You can do marketing of ag products when those activities are conducted in
conjunction with but secondary to agricultural production
Farmers markets also have their own zoning
For signs: Three questions
Is the sign a structure?
If farm is more than 5 acres you can have a structure sign, but you should adverstise
the farm generally and not specific product
Less than 5 acres and create sign inconjuction with regulations
Farm market, can advertise whatever as long as it is at least 50% income from
products you produced
Reading through the statues can be really helpful
ON a state highway, the state can limit signage due to driver distraction concerns.
May want signs further back from the road
Maria Anthony with O-media group