FSPCA Annual Conference - Preventive Controls for Human Foods and other Updates

The Food Safety Preventive Controls Alliance, or FSPCA, is the FDA funded alliance charged with the development of training programs to support companies achieve FSMA compliance though the development of their Food Safety Plans (PCHF or PCAF), Foreign Supplier Verification Program, and Plan to prevent intentional adulteration (IA rule).  The FSPCA had their annual conference this week where discussions were held on programmatic issues as well as compliance to the regulations as determined by FDA

What were my takeaways from this conference?

• FDA inspections have slowed during COVID, but they look to pick back up as soon as they can.  Companies must continue to achieve compliance and not be lulled into inaction because there has not been many inspections.
• A large percentage of FSVP audits have found that importers do not have plans at all.  Many of the audits had been conducted virtually, and the plan is to continue to reach more importers.  Being virtual, FSVP audits are not impacted by COVID as much.
• FDA will continue to conduct facility audits for Food Safety Plans with a focus on mission critical inspections (for cause).  GMP inspections will also be continue to be conducted and comprise a high percentage of the number of audits conducted by FDA for food facilities.
• Portions of the audits may be conducted virtually/remotely. 
• For IA (Food Defense), there have not been any audits, but FDA is looking to ramp up evaluation, and this will probably be done as part of other audits.  The key here is to make sure that companies continue to develop their programs.
• Finally, the PCHF curriculum is undergoing an update. Look for this (hopefully) in 2022. 

US FDA Release Pesticide Residue Monitoring Program Report for 2019

FDA released their annual report for pesticide monitoring, this covering the 2019 fiscal year. "In FY 2019 (October 1, 2018 through September 30, 2019), FDA analyzed 4,327 human food samples (1,258 domestic and 3,069 import samples) in its regulatory monitoring program. FDA collected domestic human food samples from 45 states and Puerto Rico and import human food samples from 84 countries. FDA found that 98.7% of domestic and 89.1% of import human foods were compliant with federal standards. No pesticide chemical residues were found in 42.4% of the domestic and 49.4% of the import samples.

As part of a hazard analysis, it is generally accepted that domestic produce will not have pesticides as a chemical hazard concern. With imported produce and food products, it is dependent upon the item and where that product is from.


Link to Report PDF - https://www.fda.gov/media/153142/download
Pesticide Residue Monitoring Program
Fiscal Year 2019 Pesticide Report

October, 2021

Executive Summary

Growers often use pesticides to protect their products from insects, weeds, fungi, and other pests. U.S. regulators help ensure that food produced with the use of pesticides is safe to eat by setting allowable levels called tolerances for pesticide chemical residues and by monitoring foods in the market to determine if those levels are being exceeded. The role of the Environmental Protection Agency (EPA) is to establish pesticide tolerances on the amount of a pesticide chemical residue a food can contain. The Food and Drug Administration (FDA) is responsible for enforcing those tolerances for domestic foods shipped in interstate commerce and foods imported into the United States (U.S.).*

Virginia - Update on Hepatitis Outbreak Linked to Local Restaurant Chain

In Virginia, local health authorities are reporting that as of 10/20/21, there have been 44 cases of Hepatitis infection with at least 26 hospitalizations and one death, all associated with 3 retail locations of Famous Anthony's. It had been reported that one ill employee had worked in all three locations.

The Roanoke Department of Health has been providing vaccines following this outbreak.  There is a short window of time after exposure where the vaccine can provide immunity.

From the CDC

• Hepatitis A vaccine can prevent hepatitis A.  A person who has not previously received hepatitis A vaccine and who has direct contact with someone with hepatitis A should get hepatitis A vaccine as soon as possible and within 2 weeks after exposure.
• Hepatitis A is a serious liver disease. It is usually spread through close, personal contact with an infected person or when a person unknowingly ingests the virus from objects, food, or drinks that are contaminated by small amounts of stool (poop) from an infected person.
• Most adults with hepatitis A have symptoms, including fatigue, low appetite, stomach pain, nausea, and jaundice (yellow skin or eyes, dark urine, light-colored bowel movements). Most children less than 6 years of age do not have symptoms.
• A person infected with hepatitis A can transmit the disease to other people even if he or she does not have any symptoms of the disease.
• Most people who get hepatitis A feel sick for several weeks, but they usually recover completely and do not have lasting liver damage. In rare cases, hepatitis A can cause liver failure and death; this is more common in people older than 50 years and in people with other liver diseases.
• Hepatitis A vaccine has made this disease much less common in the United States. However, outbreaks of hepatitis A among unvaccinated people still happen.

Roanoke Health Department holding hepatitis A vaccine clinics following recent Famous Anthony’s outbreak · NewsKudo
Roanoke Health Department holding hepatitis A vaccine clinics following recent Famous Anthony’s outbreak
ROANOKE, Va. (WFXR) — Following a recent hepatitis A outbreak in the Roanoke Valley tied to the Famous Anthony’s restaurant chain, the Roanoke City Health Department is holding clinics this week to help vaccinate people against the virus.
On Sept. 24, health officials reported that an employee who worked at three different Famous Anthony’s locations tested positive for the highly contagious infection.

Update - Distributors Recall Onions Linked to Salmonella Outbreak

Updated 10-22-21  FDA issued an update for the Salmonella outbreak linked to onions to indicate that two US distributors ProSource Produce and Keeler Family Farms have issued a recall of red, yellow, and white onions imported from the State of Chihuahua, Mexico, with import dates from July 1, 2021, through August 31, 2021.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/prosource-produce-llc-voluntarily-recalls-whole-raw-onions-shipped-chihuahua-mexico-between-july-1
Prosource Produce LLC Voluntarily Recalls Whole Raw Onions Shipped From Chihuahua, Mexico, Between July 1, 2021, and August 31, 2021, Because of Possible Health Risk
Summary
Company Announcement Date: October 20, 2021
FDA Publish Date: October 21, 2021
Product Type: Food & Beverages Produce
Foodborne Illness
Reason for Announcement: Potential Salmonella Contamination
Company Name: ProSource Produce LLC
Brand Name: Big Bull, Peak Fresh Produce, Sierra Madre, Markon First Crop., Markon Essentials, Rio Blue, ProSource, Rio Valley, and Sysco Imperial
Product Description: Whole raw red, yellow, white onions

Fish Dip Recalled for Undeclared Allergens After Customer Finds Product Packed Into Wrong Container

Smilin’ Bob’s is recalling 461 cases of Smilin’ Bob’s Original Smoked Fish Dip was mistakenly packed in Smilin’ Bob’s Natural Smoked Fish Dip cups with a Original Smoked Fish Dip lid.  The issue was discovered when one of our retail customers brought attention that cups had a UPC code that did not match that for the “original” fish dip. As a result, the packaging does not list the presence of a possible egg allergen.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smilin-bobs-issues-allergy-alert-undeclared-egg-smilin-bobs-smoked-fish-dip-products
Smilin’ Bob’s Issues Allergy Alert On Undeclared Egg In Smilin’ Bob’s Smoked Fish Dip Products
Summary
Company Announcement Date: October 21, 2021
FDA Publish Date:  October 21, 2021
Product Type:  Food & Beverages  Prepared Food
Reason for Announcement:  Undeclared egg allergen
Company Name:  Smilin’ Bob’s
Brand Name:  Smilin’ Bob’s
Product Description:   Smoked Fish Dip

Imported Lamb Recalled After Inspectors Find Product Did Not Receive UDSA Reinspection

AFFCO USA, Importer of Record in Jacksonville, Fla., is recalling approximately 24,461 pounds of frozen raw lamb shoulder products that were not presented for import re-inspection into the United States.  The frozen raw lamb shoulder items were imported on July 12, 2021.  The problem was discovered during routine FSIS surveillance activities of imported products.

https://www.fsis.usda.gov/recalls-alerts/affco-usa-recalls-frozen-raw-lamb-products-imported-without-benefit-import
Affco USA Recalls Frozen Raw Lamb Products Imported Without Benefit Of Import Inspection

CA Establishment Recalls Tamales for Undeclared Sesame

Demaiz Inc., doing business as Mex-tamale Foods, a San Jose, California establishment, is recalling approximately 20,759 pounds of pork and beef tamales due to misbranding and undeclared allergen, -  the product contains sesame seeds, an allergen, which is not declared on the final product label.  The problem was discovered when FSIS observed sesame seeds being added to the tamale sauce and determined that sesame seeds were not listed on the product labels.  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

So the food allergen labeling law for sesame goes into affect in 2023?  The food allergen labeling law does not apply to products regulated by FDA, however USDA regulations require an accurate ingredient list and recommend a "Contains' statement.  With Congress declaring sesame an allergen, and this firm not having a correct statement, they are not in compliance.

USDA Recalls
https://www.fsis.usda.gov/recalls-alerts/demaiz-inc.-recalls-beef-and-pork-tamale-products-due-misbranding-and-undeclared
Demaiz Inc. Recalls Beef And Pork Tamale Products Due To Misbranding And Undeclared Allergen

FDA Warning - Salmonella Outbreak Associated with Raw Onions

The FDA, CDC and local agencies are investigating a multistate outbreak of Salmonella Oranienburg infections linked to whole, fresh onions. FDA’s traceback investigation is ongoing but has identified ProSource Inc. (also known as ProSource Produce, LLC) of Hailey, Idaho as a source of potentially contaminated whole, fresh onions imported from the State of Chihuahua, Mexico.

Investigators "identified 20 illness clusters at restaurants where onions were served. Information from these clusters shows that many ill people ate raw onions."  There have been 652 cases reported so far with 129 hospitalizations.  There are cases in 37 different states with TX and OK having the highest numbers.  The last case identified was on September 30, 2021.   But caution is still required because onions can be generally stored for 2 to 3 months.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-oranienburg-whole-fresh-onions-september-2021
Outbreak Investigation of Salmonella Oranienburg: Whole, Fresh Onions (September 2021)
FDA and CDC are investigating illnesses linked to whole, fresh onions. Do not eat, sell, or serve certain onions from ProSource Inc.
October 20, 2021

Case Counts
Total Illnesses: 652
Hospitalizations: 129
Deaths: 0
Last Illness Onset: September 30, 2021
States with Cases: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WI, WV
Product Distribution: Nationwide

Clam Chowder Recalled After Consumer Complaint for Foreign Material - Piece of Plastic

Ivar’s Soup and Sauce Company, Mukilteo, Washington is recalling 14,968 sleeves of refrigerated Kettle Classic Clam Chowder With Uncured Bacon, Costco Item #1270666, packaged in 2-24oz Sleeved Packs, because of the possibility that the product may contain hard, sharp opaque plastic pieces.  The problem was discovered on 10-17-21 when a consumer found a piece of plastic in the container they purchased and notified Ivar’s. No injuries were reported. The piece of plastic found by the consumer is in the shape of a half circle with some of the center missing, with edges that are sharp and pointed. The diameter of the circle is approximately 1 ½”. It is possible that the remainder of the circular plastic is a similarly intact piece or numerous smaller pieces.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ivars-soup-and-sauce-company-recalls-kettle-classic-clam-chowder-uncured-bacon-because-product-may
Ivar's Soup and Sauce Company Recalls Kettle Classic Clam Chowder with Uncured Bacon Because the Product may Contain Hard Plastic Pieces
Summary
Company Announcement Date:  October 19, 2021
FDA Publish Date:  October 19, 2021
Product Type:  Food & Beverages  Soup
Reason for Announcement:  Potential for hard plastic opaque pieces
Company Name:  Ivar’s Soup and Sauce Company
Brand Name:  Ivar’s
Product Description:  Kettle Classic Clam Chowder with Uncured Bacon