Import Alert 21-01
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 21-01
Published Date: 03/18/2011
Type: DWPE with Surveillance
Import Alert Name:
"Incresed Surveillance of Green and Black Olives"
Reason for Alert:
Although green olives are generally fermented foods, 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
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 hermally 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).
In addition, increased surveillance of imported hermally 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).
Product Description:
Green and Black Olives
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)]."
OASIS charge code - NEEDS ACID
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)]."
OASIS charge code - NEEDS ACID
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(21 G - - 09) Olives (Pit Fruit)
(21 G - - 12) Stuffed Olive (Pit Fruit)
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