IA #21-01 - REVISED 3/2/07, IMPORT ALERT #21-01, *** "INCREASED SURVEILLANCE
OF GREEN AND BLACK OLIVES"
Revisions are bracketed by ***
NOTE: *** This alert is revised to update the title and to modify the alert
language. ***
TYPE OF ALERT : *** Increased Surveillance ***
PRODUCT : Green and Black Olives
PRODUCT CODE : 21G[][]09 (olives)
21G[][]12 (stuffed olives)
HARMONIZED
CODE : 0711
PROBLEM : *** Inadequate Ph
Inadequate PROC ***
PAC FOR 03003 (Low Acid Canned Foods)
COLLECTION : 03003A (Acidified Foods)
COUNTRY : All
MANUFACTURER/
SHIPPER : All
MANUFACTURER/
SHIPPER I.D.# : N/A
IMPORTER'S
I.D. # : N/A
CHARGE : *** If the product has a process filed as an
acidified food and the product is determined to have
a pH above 4.6, the product is subject to detention
utilizing the following charge:
For Inadequate pH or for Inadequate - PROC
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that the product appears to have been
prepared or packed under insanitary conditions whereby it
may have been rendered injurious to health due to
inadequate acidification [Adulteration, 402(a)(4)]." ***
RECOMMENDING
OFFICE : Division of Import Operations and Policy, HFC-170
REASON FOR : Although green olives are generally fermented foods,
Alert inadequate fermentation/processing of this product may
result in a product with a pH above 4.6 or may allow for
the growth of microorganisms that raise the pH to a level
that is conducive to the growth of microorganisms such as
C. botulinum. Therefore, green olives with a pH above 4.6
would be a low-acid canned food and represent a potential
health hazard if they are not thermally processed properly
or the pH values are above 4.75.
Most black ripe olives have a pH greater than 4.6 and must
be thermally processed as low acid canned foods and comply
with the low-acid canned food regulations. Some black ripe
olives are fermented and may be referred to as "Greek
Style" black olives; they may be distinguished by a
wrinkled appearance and soft texture. However, if there is
any doubt, pH levels should be below 4.6. "California
Style" black ripe olives are partially fermented and
thermally processed as low-acid canned foods since they
generally have a pH above 5.0.
Be alert to shipments from countries where olives are not
native (e.g. Canada) since these products are easily and
often repackaged from bulk containers. Repacking of black
olives may be used as a mechanism to disguise the original
unsuitable nature of the goods and may itself contribute to
adulterated or unsafe food.
On August 11, 1994, CFSAN issued a letter to the Embassy of
Greece informing them that review of information submitted
on the processing of Greek olives had been completed. The
review concluded that the following products are normally
naturally fermented to a pH of 4.6 or below and therefore
are not subject to the requirements of 21 CFR 108
(registration and scheduled process filing), 21 CFR 113
(LACF regulations), and 21 CFR 114 (Acidified Foods
regulations):
1. Greek Black Olives in Brine
2. Calamata (Kalamata) Olives in Brine
3. Greek Green Olives in Brine (Unpitted)
4. Greek Green Cut (or Cracked) Olives in Brine
5. Greek Green Pitted (or Stuffed) Olives in Brine
In March 2004, sixteen (16) suspected cases of botulism
were reported to the Italian National Institute of Health
by hospitals in three (3) adjoining regions in central and
southern Italy (Molise, Campania, and Puglia). *** Both
epidemiologic evidence and information obtained by the
Italian government regarding preparation of the olives
strongly suggest that they were the likely source of the
outbreak. This outbreak highlights the previously
documented risk associated with improperly prepared olives.
Reference: Amy Cawthorne, Lucia Pastore Celentano, et al:
Botulism and preserved green olives, Emerging Infectious
Diseases: Vol. 11, No. 5, May 2005, European Programme for
Intervention Epidemiology Training, Rome, Italy; and
Istituto Superiore di Sanit…, Rome, Italy
http://www.cdc.gov/ncidod/EID/vol11no05/04-1088.htm
*** GUIDANCE *** : *** Increased surveillance of green olive shipments
is warranted. Shipments should be examined and/or
sampled to check for abnormal containers as well as
pH and water activity levels.***
In addition, increased surveillance of imported
thermally processed black ripe olives is appropriate
to insure the product complies with the Low Acid
Canned Food (LACF) Regulations and/or the olives are
not decomposed.
Detain entries of green olives found to have a pH
above 4.6 if the firm has not registered and/or filed
a scheduled process. If pH values at or above 4.6
are found and the firm has registered and filed a
scheduled process, submit the analytical worksheets
to HFS-606 for review.
Detain entries of black olives (except "Greek Style"
black olives) if the manufacturer has not registered
and/or filed a scheduled process (21 CFR 108).
*** Submit recommendations to place firms on Import
Alert 99-04 for elevated pH and insufficient Aw to
CFSAN/OC/DE through DIOP in accordance with the
instructions provided in the Import Acidified and
Low-Acid Canned Foods Compliance Program, (7303.003A)
and CPG Sec. 520.300 (Acidified Low-Acid Canned Foods
Adulteration Due to pH). ***
PRIORITIZATION
GUIDANCE : II
FOI : No purging required.
KEYWORDS : green olives, black olives, ripe olives, olives,
LACF, *** acidified ***
PREPARED BY : Sammi L. Hadden, DIOP, 301-594-3853
Angel Suarez, CFSAN, 301-436-2146
DATE LOADED
INTO FIARS : March 2, 2007
*** Attachment A : Firms/products Subject to Detention Without Physical
Examination*** 3/14/07
MANUFACTURER/ PRODUCT/ REASON/
SHIPPER PRODUCT CODE CHARGE CODE
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