Surveillance Sampling Outreach

DRAFT FY17/18 FDA Surveillance Sampling Program: Processed Avocados/Guacamole Assignment
(Information in this document is draft and subject to change)

SURVEILLANCE SAMPLING EXECUTON: 800 Domestic samples and 800 Import samples will be collected.
How many samples should be collected?

What samples will be collected?





Processed avocado including fresh cut (cut, sliced, or diced) and frozen
(cut, sliced, or diced)
Puree (only avocado & not intended for beverage or further processed)
Refrigerated or frozen pulp with additives
Guacamole



Processed Avocado

Type of Sample

# of sample units (subs)

Subsamples Sample Size

Processed avocado &
guacamole

20
(10 Salmonella, 10 L.
monocytogenes)

Salmonella: 75 g/sub
L. monocytogenes: 25
g/per sub

What will NOT be collected?



Whole avocados (in tact, with skin) will NOT be collected. Samples
will NOT be collected from farms or growers.
Avocado indicated as intended for beverage or product that has
undergone pathogen kill step will NOT be collected.



Whole Avocado, Avocado
intended for juicing

Sampling Guidelines

Where and when will samples be collected?
Where:
 Domestic samples will be collected from a variety of establishments: Manufacturer//Processor,
Distributor/Warehouse, and Retail. Import samples will be collected at ports of entry.
When:
 Samples will be collected Monday - Thursday.
 Throughout the year, across all seasons.
 Samples might be collected from the same establishment or the same importer multiple times
throughout the assignment. FDA will closely monitor allocations at the country and firm level to
minimize impact on trade.

How will samples be collected?


Samples will be collected aseptically per normal sample collection procedures found in IOM,
Chapter 4. Section 4.5 Sampling: Preparation, Handling, Shipping



Documentation will include variety, name and address of manufacturer, country of origin for
imported product or origin for domestic product, or other supply chain information including food
identification code (if available).



Samples will be stored in cooler with adequate coolant.



Photos might be taken of the product collected and retail box (including label, firm name, etc.).



Per FDA Field Management Directive 147, if the sample is found to be contaminated with
pathogens, the collecting FDA Districts will promptly furnish a copy of the results of such analysis
to the owner, operator, or agent in charge of the product. In addition, if the firm indicates to the
FDA investigator that the firm is voluntarily holding products pending FDA results, the FDA
investigator will make a notation on the Collection Report and FDA will notify the firm of the
results as soon as they are available.

How will States be involved?






The Divisions, ORA/Office of Partnerships and Operational Policy , and ORA/Office of Regulatory
Science will coordinate State involvement, which may be performed under contract, cooperative
agreement, partnership agreement, or other collaborative efforts.
FDA does not anticipate State participation in sample collection or analysis at this time.
Upon request, FDA Divisions will share the assignment with Commissioned state regulatory
counterparts.
FDA Divisions will notify the State regulatory agency officials of positive, CRO, and pending CRO
results (confirmed positives and negatives).

Who will analyze samples?




FDA Servicing Laboratories will analyze samples under this assignment.
FDA lab capacity will be closely monitored.
FDA does not anticipate FERN lab participation at this time.

General Timeframes for Negative/CRO/Confirmation Results (after receipt by lab)

Inspections

•

There are no
initial
inspections
required under
this Surveillance
Sampling
Program
Assignment for
processed
avocados.

Why Processed Avocados?

Listeria monocytogenes

Negative or Cannot Rule Out

Final Confirmation

3-4 business days

Additional 6-8 days

3-4 business days

Additional 6-8 days

• Processed avocado products, including avocado that is fresh cut, refrigerated and frozen can be

•

•

packaged and consumed without a “kill-step” applied prior to consumption. Processing fresh produce into
fresh-cut products increases the risk of bacterial growth by breaking the natural exterior barrier of the
produce and allowing for the spread and potential growth of any harmful pathogens that may be present.
Avocados have high concentrations of lipids and moisture content, low carbohydrates, and non-acidic pH,
providing an excellent growth medium for pathogens such as Salmonella and L. monocytogenes.
According to CDC, from 2005-2015 there have been 12 foodborne outbreaks related to avocado,
avocado products, or guacamole products; 9 of the outbreaks involved Salmonella and 3 involved E.coli
(2 STEC [O157:H7] and 1 EHEC unknown) resulting in 525 illness, 23 hospitalizations. Though no
Listeria outbreaks were reported from 2005 to 2015, a recent large-scale, FDA sampling assignment
detected L. monocytogenes in samples collected from the exterior skins and internal pulp of avocados.
There is a lack of prevalence data available for Salmonella and L. monocytogenes associated with
processed avocado and processed avocado products.

Follow-Up & Enforcement

Microorganism
Salmonella

•

•

•

A follow-up inspection and environmental sampling may be conducted at the domestic
manufacturing site if multiple samples yield nearly identical pathogenic strains, based on
WGS or one or more samples yielding a current outbreak strain of Salmonella or L.
monocytogenes.
If a positive product is found that has been distributed, FDA will consider its regulatory and
enforcement options to address the public health impact, including possible follow-up
inspections. Enforcement steps could include encouraging voluntary recall, ordering a
mandatory recall, administrative detention, or issuing public warnings.
FDA’s response to positive analytical results relative to imported samples, collected in import
status at the port of entry, will be as per standard operating procedure, i.e., current shipments
may be detained and refused, future entries will be subject to Import Alert (detention without
physical examination) when warranted.