Cold Smoked Salmon Recalled for Clostridium botulinum Concern Due to Insufficient Salt Concentration

Seabear Company of Anacortes, Washington is  recalling 1,225/ 3 oz. units of Cold Smoked Wild Coho Salmon Lox, Gerard & Dominique Seafoods brand because it has the potential to be contaminated with Clostridium botulinum.  "The recall was initiated because the product's water phase salt testing below 3.5%. Labeling instructions state to freeze or refrigerate, once thawed they can be kept unopened in the fridge for up to 30 days. Because the water phase salt is under 3.5% the product must remain frozen until ready to consume. Keeping in the refrigerator after thawing in a reduced oxygen package has the potential to be contaminated with Clostridium botulinum."

The FDA Seafood Guidance Chapter 13 document provides information on this detailing a critical limit of 3.5.   Applicable sections below:

"The strains of C. botulinum can be divided into two groups, the proteolytic group (i.e., those that break down proteins) and the nonproteolytic group (i.e., those that do not break down proteins). The proteolytic group includes C. botulinum type A and some of types B and F. The non-proteolytic group includes C. botulinum type E and some of types B and F."

"Packaging conditions that reduce the amount of oxygen present in the package (e.g., vacuum packaging and modified atmosphere packaging) extend the shelf life of a product by inhibiting the growth of aerobic spoilage bacteria. There is a safety concern with these products because there is an increased potential for the formation of C. botulinum toxin before spoilage makes the product unacceptable to consumers."

"The minimum temperature for growth and toxin formation by C. botulinum type E and nonproteolytic types B and F is 38°F (3.3°C).  As the shelf life of refrigerated foods is increased, more time is available for C. botulinum growth and toxin formation. As storage temperatures increase, the time required for toxin formation is significantly shortened. You should expect that at some point during storage, distribution, display, or consumer handling of refrigerated foods, safe refrigeration temperatures will not be maintained (especially for the non-proteolytic group). Surveys of retail display cases indicate that temperatures of 45 to 50°F (7 to 10°C) are not uncommon. Surveys of home refrigerators indicate that temperatures can exceed 50°F (10°C). "

 There are a number of strategies to prevent C. botulinum growth and toxin formation during processing, storage, and distribution of finished fish and fishery products.  These secondary barriers help in addition to refrigeration.  One of those is smoking fish with a salt brine.

Refrigerated (not frozen), reduced oxygen packaged smoked and smoke-flavored fish
Achieving the proper concentration of salt and nitrite in the flesh of refrigerated, reduced oxygen packaged smoked and smoke-flavored fish is necessary to prevent the formation of toxin by C. botulinum type E and non-proteolytic types B and F during storage and distribution. Salt works along with smoke and any nitrites that are added to prevent growth and toxin formation by C. botulinum type E and non-proteolytic types B and F. Note that nitrites should be used only in salmon, sable, shad, chubs, and tuna, according to 21 CFR 172.175 and 21 CFR 172.177 , and should not exceed a level of 200 ppm in salmon, sable, shad, chubs and 10 ppm in tuna.

The interplay of these inhibitory effects (i.e., salt, temperature, smoke, and nitrite) is complex. Control of the brining or dry salting process is clearly critical to ensure that there is sufficient salt in the finished product. However, preventing toxin formation by C. botulinum type E and non-proteolytic types B and F is made even more complex by the fact that adequate salt levels are not usually achieved during brining. Proper drying during smoking is also critical in order to achieve the finished product water phase salt level (i.e., the concentration of salt in the water portion of the fish flesh) needed to inhibit growth and toxin formation by C. botulinum.

CRITICALCONTROLPOINTBrining
SIGNIFICANTHAZARD(S)C. botulinum toxin formation in the finished product
CRITICAL LIMITS FOR EACH PREVENTIVE MEASURE

• Minimumbrining time:6 hoursMaximum brinetemperature: 40ºF
• Minimum salt concentration of brine at the start of brining: 60°salinometer
• Minimum ratio of brine to fish:2:1
• Maximum fishthickness 1½ in.Note: To produce a minimum water phase salt level in the loin muscle of 3.5%

https://www.fda.gov/Safety/Recalls/ucm606308.htm
Seabear Company Issues a Voluntary Recall of Cold Smoked Wild Coho Salmon Lox Because of Possible Health Risk
For Immediate Release
May 1, 2018

Contact
Consumers  Seabear Company  (800) 338-9903

Announcement
View Product Photos

Seabear Company of Anacortes, Washington is voluntarily recalling 1,225/ 3 oz. units of Cold Smoked Wild Coho Salmon Lox, Gerard & Dominique Seafoods brand, affected lot # CSCO-17339, Pack Date 17-340, because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

No illnesses have been reported to date.

The recall was initiated because the product's water phase salt testing below 3.5%. Labeling instructions state to freeze or refrigerate, once thawed they can be kept unopened in the fridge for up to 30 days. Because the water phase salt is under 3.5% the product must remain frozen until ready to consume. Keeping in the refrigerator after thawing in a reduced oxygen package has the potential to be contaminated with Clostridium botulinum.

Cold Smoked Wild Coho Salmon Lox, with the affected lot # CSCO-17339, Pack Date 17-340, was distributed directly to distributors in CA, MD, and WA between 12/8/17 and 4/10/18 and it may have been further distributed and sold through retail stores at least in these states.

Cold Smoked Wild Coho Salmon Lox was packaged in a reduced oxygen packaging, net wt. 3 oz. (85g), and has the UPC 7 52047 92635 4.

Consumers are advised to keep product frozen until used and thaw under refrigeration immediately before use. If the consumer has refrigerated product, dispose of immediately even if it does not look or smell spoiled. Consumers with questions may contact the company at (800) 338-9903, Monday-Friday, 8am-5pm PST.

This recall is being made with the knowledge of the U.S. Food and Drug Administration.