People become infected with Cyclospora by ingesting sporulated oocysts, which are the infective form of the parasite. This most commonly occurs when food or water contaminated with feces is consumed. An infected person sheds unsporulated (immature, non-infective) Cyclospora oocysts in the feces. The oocysts are thought to require at least 1–2 weeks in favorable environmental conditions to sporulate and become infective. Therefore, direct person-to-person transmission is unlikely, as is transmission via ingestion of newly contaminated food or water.
In the United States, foodborne outbreaks of cyclosporiasis have been linked to various types of imported fresh produce, such as raspberries, basil, snow peas, mesclun lettuce, and cilantro; no commercially frozen or canned produce has been implicated to date.So while many may blame the restaurant, that restaurant was unlikely to have had much impact on removing the parasite if already on the produce. And this is the challenge with Cyclospora. Last month, a panel was put together to investigate how this parasite can be controlled. While some preventive measures were discussed, no specific source was identified.
"..food manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu))."The inspection of the company found that they...:
Specifically, you identified vitamin and mineral toxicity and deficiency as a hazard requiring a preventive control in your food safety plan. However, as evidenced by the toxic levels of vitamin D found in some of your dog foods, you failed to implement adequate preventive controls to ensure your inclusion of vitamin D did not result in a nutrient toxicity or deficiency.
Your hazard analysis determined that a preventive control was not necessary at ingredient receiving for “wrong levels” of vitamins in ingredients due to your “internal programs.” .........
Your “internal programs” consist of SOP number (b)(4) and SOP number (b)(4).” With regard to micro ingredients, SOP (b)(4) states that “all bagged raw materials will provide a Certificate of Analysis (COA), which will be maintained in the ingredient purchasing office.” (b)(4) says that “it is the policy of Sunshine Mills that all incoming shipments of raw materials used in our products, including bulk grains, bulk protein and other meals, bulk fats and tallows, salt, packaged vitamin and mineral supplements, color additives, and other ingredients will be examined at the time of receipt to assure that they are of good quality and meet product specifications. This examination will consist of a visual inspection for identity and gross visible defects, a test for moisture content as may be indicated, and sampling for assay of protein, fiber, vitamin and mineral levels or other purchase specifications, and also to check for contaminants.” It is also your policy that “vendors, from time to time, provide a COA for such things as vitamin and mineral content when this is part of the puce-chase [sic] specifications.”
However, these SOPs did not ensure that vitamin D levels in incoming ingredients met established ingredient specifications. For example, the vitamin D levels were not analyzed at a laboratory facility on a routine basis to ensure that the vitamin D met your firm’s pre-set formulation. You did not question any difference in appearance of the packaging or the ingredient. In addition, your firm did not obtain Certificates of Analysis (COA) upon receipt of each shipment of vitamin D. Furthermore, there is no indication of who is responsible for performing these actions listed in the SOPs or verifying that they have been performed or what steps are to be taken if an incoming ingredient does not meet specifications.
Your “batching/mixing” preventive control includes no measures that would prevent the use of an ingredient that is the wrong concentration.
Consequently, you used five shipments of an ingredient that you were unaware contained a higher concentration of vitamin D (500,00 IU/g) instead of the vitamin D with a lower concentration (7,500 IU/g) consistent with your firm’s formulation.
2. ......Your firm failed to conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed or held at your facility to determine whether there are any hazards requiring a preventive control, in accordance with 21 CFR 507.33(a)(1).
Specifically, your firm manufactures cat food that includes thermal processing (extrusion) as a manufacturing step. Your hazard analysis did not identify inadequate thiamine in extruded dry cat food as a known or reasonably foreseeable hazard.
This is followed by a sanitation stepSOAKING & CLEANING: When Server Clears A Finished Drink, They Should Collect The Straw, And Place It In A Tub Of Hot Soapy Water To Soak. If The Straw Was Used For A Drink That Might Have Pulp Or Other Beverage Reside, Then It Should Be Scrubbed With A Cleaner Brush To Remove Any Such Debris. Rinse The Straws Thoroughly In Clean, Hot Water, To Remove All Soap.
Cleaning your own straw is not an issue, but in foodservice operations where hundreds of straws may need to be cleaned, then proper sanitation (cleaning and sanitizing) can be a major task.SANITIZING: Soak Straws For At Least One Minute In Tube Filled With An Approved Restaurant Sanitizing Cleaning Formula. This Step Is Recommended For Commercial Establishments Cleaning Any Type Of Reusable Utensil — Including Spoons, Forks And Knifes — To Assure That Any Germs Are Destroyed.
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| Metal straws and cleaning brushes |
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| pipet cleaner |
