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FY18 FDA Surveillance Sampling Program

Frozen Berries

What samples will be collected?


Individual frozen berries including strawberries,
blueberries, raspberries, or blackberries in
closed retail packages OR mixed frozen berries
in closed retail packages that include two or more
of the frozen berries previously mentioned will
be collected.

What will not be collected?


Frozen berries that contain other frozen fruit
such as bananas, peaches, pomegranates, etc.;
unpackaged, loose frozen fruit; and fresh berries
will NOT be collected.

What hazards will be analyzed?


Hepatitis A Virus (HAV) and Norovirus (NoV)

Where will the samples be collected?


• Domestic Samples: Manufacturer/processors,
distribution centers, warehouses, or retail
locations
• Import Samples: Importer's warehouses, other
storage facilities, or points of entry

When will the samples be collected?


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 in one
year, however the FDA will strive not to exceed 3 collections every 6 months from the same manufacturer/
processor. The FDA will closely monitor allocations at the country and firm level to minimize impact on trade.

How many samples will be collected?


1,510 samples of frozen berries will be collected (755 domestic and 755 import)

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.

Samples will be stored frozen prior to shipment. Samples will be shipped per IOM 4.5.3.5.1 “Shipping Frozen
Samples” and temperature will be controlled to prevent thawing per IOM 4.5.3.5.2 “Control.”  
 
Documentation will include product name, address of manufacturer, collection site, country of origin
for imported product or origin for domestic product, or other supple chain information including food
identification code (if available).

When feasible, photos might be taken of the product collected and retail box (including label, firm name, etc.).
Per Field Management Directive 147, Procedure for Release of Analytical Results Pursuant to Section
704(d) and Situations When Dealer is Voluntarily Holding Product, if a sample is found to be contaminated
with pathogens, the collecting FDA Division (s) will promptly furnish a copy of the results of such analysis to
the owner, operator, or agent in charge. 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.

General Timeframes for Results

General Timeframes for Results (after receipt by lab)

Microorganism Negative and Positive Results

Norovirus 3 Business Days

Hepatitis A Virus 3 Business Days

Why frozen berries?


Berries, which are very delicate and usually harvested by hand, can become contaminated with HAV and NoV if
they are exposed to a sick worker or exposed to contaminated water; the viruses are further preserved during
the freezing process. Although viruses are usually killed with heat or a cook step, frozen berries are often
used ‘ready to eat’ and are not typically cooked prior to consumption. Globally, there have been multiple HAV
outbreaks with various types of frozen berries identified as likely vehicles. Additionally, 1997 to 2016, FDA has
reported three HAV outbreaks and 1 Norovirus outbreak associated with frozen berries in the United States
(U.S.). The HAV outbreaks resulted in a total of 405 foodborne cases with 53 hospitalization and no deaths; the
Norovirus outbreak in this instance resulted in 136 cases. Objectives of this assignment include estimating
and comparing the prevalence of Hepatitis A Virus and Norovirus in domestic and imported frozen berries, to
take appropriate regulatory action for positive findings, and determine if there are any common factors such
as country of origin associated with positive findings.

Follow-up and Enforcement


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.

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