· Manure: 9 month

interval between

application of raw

manure (or grazing

animals) and harvest

· Compost: 45 days

between application of

compost and harvest

Manure: FDA still wants a

day length interval, but

deferring decision. Will work

with USDA and stakeholders

to:

· complete risk assessment

• conduct research
• develop infrastructure

for farms to transition to

compost

Will reopen docket for

comment when above

completed (estimate 5 – 10

yrs)

Meanwhile will not take

exception to NOP 120/90 day rule

• Compost: Removed time

interval between application

of compost and harvest if

compost appropriately

treated.

· Manure: Farms can continue using raw manure for now. FDA not providing an interval, but recommends using NOP 120/90 or GAPs 120 day interval.

· Farms encouraged to use compost in place of raw manure.

· Compost: No time interval required for compost.

· What are the barriers to using compost instead of raw manure?

· What resources will be needed for farms to switch to using compost instead of raw manure?

· Testing every 7 days

· Must discontinue use if

samples reached either:

o geometric mean of 126 CFU E.coli/100 mL

o or a single sample of

over 235 CFU

· Raised E.coli levels for

corrective action to

geometric mean (GM) of

not over 126 CFU, and

Statistical Threshold

Value (STV) of not over

410 CFU E.coli/100mL¹

· If STV over 410, increase

time between application of water and harvest to get 0.5 log reduction in E.coli.²

“Know Your Water” Tiered

Risk Assessment

1. Take 20 samples over 2

yrs to establish baseline

and changes needed

2. After baseline, 5 samples/yr to determine the need to adjust time between irrigation and harvest. FDA will provide tool for determining number of days to wait

3. Re-do baseline every 10

years, using annual data

· Revisions recognize differences between watersheds; allow farmers more flexibility to base practices on the risk of their water.

· Use of STV recognizes

that levels of E.coli will

vary over time

· Instead of having to stop

using surface water if it

surpasses standards,

farmers can wait

between application of

water and harvest based

on how quickly E.coli die-off.

Should FDA establish limit above which water should not be applied until corrective actions are taken?

If so, what would be appropriate maximum level?

Is allowing a time interval between application of water and harvest an appropriate solution if E.coli levels are above designated limits?

Are there alternative data sources that should be used as indicators of water quality?

Is 0.5 log/day die-off rate appropriate?

Should farms be required to keep records of dates of last irrigation and harvest?

What records would be reasonable for farms to document water quality?

· Test at start of growing

season and then test every

three months during

growing season

· First year: At least 4 samples over growing season to determine

baseline

· Thereafter test

1x/growing season

· Number of times farmers test is based on water quality

· Reduces the number of

times water must be tested if risk is low

Application & Harvest

Determines: 1) whether a farm qualifies for a full exemption or 2) is considered a very small business or small business for compliance timelines. Definition of Farms falling under Qualified Exemption cannot be changed.

· Farms covered by FSMA was originally based on sales of all food (produce and meat, milk, grain, eggs, animal feed, etc…)

· This meant farms that

made the bulk of gross

sales from non-produce

food items would be

covered by the

regulations, even if they

only did a small amount of annual gross sales in produce.

· Definition of farms NOT

covered is now based on

annual sales of all

produce averaged over 3

years.³

· “Very small businesses” = no more than $250,000 in annual gross sales for all produce.

· “Small businesses” = no more than $500,000 in annual gross sales for all produce.

Farms under the qualified exemption (doing 50% or more of sales to qualified end users and under $500,000 in gross sales) will still need to base sales on all food (not just produce) ⁴

· Farms with less than

$25,000 average annual

sales in produce are NOT

covered by FSMA

· Very small businesses: 4

yrs from finalization to

comply

· Small businesses: 3 yrs to

comply

Because definition of farms

under Qualified Exemption

cannot be changed, revision will not significantly change

number of covered farms,

but may shift number of

farms in the $250,000 and

$500,000 categories, giving more farms a longer time to comply.

· Is proposal to cover farms with annual gross sales of produce of more than $25,000 appropriate? If not, what would be better?

· Should definition of covered farms be based on averaged annual gross sales of covered produce only instead sales of all produce?

· If the definition should be for covered produce only, how should the monetary threshold be applied?

· A business could only be defined as a farm if all food grown, raised, packed or held on that farm was from that farm or another farm under the same ownership. If a farm packed or held food from a farm not under its ownership it would be considered a “mixed-type facility” and fall under the Preventive Controls Rule.

· Revised definition includes businesses that

pack, hold or label raw

agricultural commodities

(RACs).

· Farms that pack or hold

RACs from a farm under different ownership are no longer considered a “mixed-type facility.”

Farms that buy in produce from other farms for CSA shares, to fill gaps in supply, or pack or hold produce for other farms will still be considered farms and fall under Produce Safety rule, and will not have to comply with the Preventive Controls Rule (PCR) solely for those activities.

However, off-farm activities, such as an off-farm packinghouse do still fall under Preventive Controls Rule – see below)

Should phrase “in one general physical location” be included in definition of farm? Should farms with off-farm packinghouses fall under PCR?

Should farms supplying

produce to second farm

provide name, address & description of produce in individual shipments?

Should on-farm packing houses under cooperative ownership by multiple growers be considered under same ownership as any or all of the growers’ farms?

· The FDA could withdraw

a qualified exemption:

1) in the event of a food

borne illness outbreak

associated with that farm

or

2) if they determine that

it is necessary to protect

the public health and

prevent a food borne

illness outbreak

· FDA must provide notification and opportunity for farm to respond before deciding to withdraw exemption.

· Before withdrawing an exemption, FDA may take alternative actions such as a warning letter, injunction, or a recall and consider steps taken by farmer to correct problem.

· FDA must provide farm with a process for reinstatement of exemption that has been withdrawn.

· The original language did not provide alternatives to withdrawal of exemption. Although there is no requirement that the FDA utilize those options, there are alternative options now, and the FDA must provide notice to the farm of intent to withdraw the exemption, time to respond to the notice, and provide instruction on what is needed to reinstate exemption. Farmers must respond to a notice to withdraw an exemption on the date the notice is received, while the Preventive Controls Rule provides processors 10 days to respond.

· Farmers have 60 days to

come into compliance,

while processors have

120 days from receipt of

order to come into

compliance.

· Should farms be given

120 days from date of

receipt to comply with

an order to withdraw an

exemption so that the

guidelines are consistent

between the Produce

Rule and the Preventive

Controls Rule?

· General feedback on this

approach and suggestions for refinements or

alternatives

· Farms should evaluate whether produce can be safely harvested if there is evidence of animals in production areas.

· Take all measures

reasonably necessary to

identify and not harvest

contaminated produce

· A new provision has

been added that states

that FSMA does not

require measures to

destroy animal habitat or

exclude animals from

outdoor growing areas,

or authorize the “taking”

of threatened or endangered animals.

· This provision is intended to clarify that the FDA encourages co-management of land for wildlife and conservation, and is not encouraging farmers to remove riparian buffers, filter strips, hedgerows or other conservation practices.

· General feedback on this

approach and the new

provision and suggestions for alternatives