That is good news for the California Food Safety Act, which is on the State Senate’s third reading calendar. Assembly Bill 418, introduced in February by Assemblymember Jesse Gabriel, D-San Fernando Valley,  seeks to ban harmful food additives already prohibited from use in the European Union. 

 The bad news is that the law bans certain substances as food ingredients and has to compete for Senate floor time with nearly 300 Assembly bills also looking for final passage.

It needs only a favorable Senate vote and the Governor’s sign-off to become law.

AB 418 has been amended on the Senate side, removing one substance from its banned food ingredient list. That substance is titanium dioxide, often added to foods to enhance white coloring or opacity.

To be added to food, titanium dioxide as an additive must achieve 99 percent purity. That still leaves room for small amounts of potential contaminants like lead, arsenic, or mercury.   Chewing gum, candy, pastries, chocolates, coffee creamers, and cake decorations are among food items that may contain titanium.

The U.S. Food and Drug Administration considers titanium dioxide safe, and apparently, so does the California Senate in that it’s been removed from the AB481’s list of banned substances.

Four ingredients remain on the banned list. They are Brominated vegetable oil, Potassium bromate, Propylparaben, and Red dye No. 3.

The first-time fine for anyone found violating the new law is $5,000, with each subsequent violation going to $10,000. California’s Attorney General and city and country attorneys are all empowered to bring charges under the statute.

By closing its marketplace to foods containing these substances, California will likely force many manufacturers to change recipes for foods distributed nationwide. This is not unlike the national change California is bringing about by closing its market to poultry and pork producers who do not meet its animal housing standards.

After Jan.1, 2027, under the bill, it will be illegal in California to manufacture, sell, deliver, distribute, hold, or offer for sale any food product for human consumption that contains any of the four products.

Two powerful consumer and environmental organizations, Consumer Reports and the Environmental Working Group have been helping move AB418 in Sacramento.

Senate summary of assembly bills

As of Sept. 7, 2023

Third Reading File AB 418 — Gabriel et al. An act relating to food.
2023

May 15 — Read the third time. Passed. Ordered to the Senate. (Ayes 54. Noes 12.)

May 16 — In Senate. Read the first time. To Com. on RLS. for assignment. May 24 — Referred to Coms. On Health and E.Q.
May 26 — From committee chair, with author’s amendments: Amend and re-refer to committee. Read a second time, amend, and re-referred to Com. on Health.
Jun. 29 — From committee: Amend, pass as amended, and re-refer to Com. on E.Q. (Ayes 10. Noes 0.) (June 28).
Jul. 3 — Read the second time and amend. Re-referred to Com. on E.Q. Jul. 12—From committee: Do pass and re-refer to Com. on APPR. (Ayes5. Noes 1.)

(July 12) — Re-referred to Com. on APPR.
Aug. 14 — From committee: Be ordered to second reading according to Senate Rule 28.8.
Aug. 15 — Read the second time. Ordered the third reading.
Sep. 1 — Read the third time and amend. Ordered to second reading. Sep. 5—Read a second time. Ordered the third reading.

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The Texas Restaurant Association said the more streamlined regulations offer cost savings and new opportunities to enhance the customer experience. 

The Texas Department of State Health Services (DSHS) introduction to the new laws says the goal is to prevent foodborne illness in Texas.

“This endeavor requires the help of all public health regions, state and federal agencies, local and city health departments, private industry, and the public,” the state’s introduction says. Through teamwork and diligent effort, we can accomplish our mission:  

“To protect public health through the efficient operation of a comprehensive retail food protection program focusing on education, training, and oversight, which will ultimately reduce the potential for foodborne illness in Texas.” 

“Food safety is serious business in Texas,” it adds.

 Here is an overview of each bill:

SB 577 —Local Food Regulations and the Local Food Regulation Registry

SB 577 provides clarity to food establishments and licensing authorities regarding the enforceability of health regulations.

Municipalities and public health districts impact:

• DSHS must create a registry for local health ordinances or regulations that differ from state law or DSHS rules or orders. The legislation is specific to municipalities and public health districts. Local enforcement cannot begin until 60 days after the local public health entity submits applicable local health ordinances or regulations to the DSHS registry.

Local public health entity impact:

• A county or a municipality that is part of a public health district cannot collect licensing fees for alcoholic beverage sales and for certified food manager (CFM) certificates in certain circumstances:
  • A county or municipality cannot collect fees for the licensing of a location to sell alcoholic beverages if:
    • The establishment already has a Retail Food Permit from the county or municipality; and
    • The establishment is already licensed with the Texas Alcoholic Beverage Commission
  • A local health jurisdiction cannot require a person to obtain or pay a fee for a local CFM certificate if that person is already a CFM through a DSHS-accredited program.

Local public health entities (including municipalities, counties, and public health districts) and DSHS impact:

• Local public health entities and DSHS cannot penalize a retail food establishment for not meeting “easily cleanable surface requirements for wall and ceiling surfaces, decorative items, or attachments in a consumer area [i.e., a dining area], provided the surfaces, items, or attachments are kept clean.”
  • There is an exception:  tables, bar tops, and other similar surfaces where food is regularly prepared or consumed must meet easily cleanable surface requirements.
  • This is similar to language in the 2017 FDA Food Code, Section 6-201.17(B): “In a consumer area, wall and ceiling surfaces and decorative items and attachments that are provided for ambiance need not meet this requirement [i.e., “easily cleanable”] if they are kept clean.”
• Local public health entities and DSHS cannot restrict the type or quantity of packaging, utensils, or straws provided to a customer by a licensee.
  • There is an exception: the Food Code requirements for food-contact surfaces, including packaging and utensils, still apply.

DSHS implementation activities:

• DSHS is establishing the process for municipalities to submit ordinances or regulations that deviate from the Texas Food Establishment Rules or Texas law. DSHS plans to update its website with instructions and a link to the registry as soon as possible.

Local public health entities had to comply with the new legislation beginning Sept. 1.

SB 812 —Food Allergen Awareness

SB 812, the “Sergio Lopez Food Allergy Awareness Act,” includes requirements for food service employees and managers to be more aware of food allergies and to know how to mitigate and respond to potential allergic reactions.

Food Service Establishment Impact

• Every food service establishment must post a food allergy awareness poster in an area of the establishment that is regularly accessible to the establishment’s food service employees.
  • The poster must include information about:
    • Risks of an allergic reaction to a food allergen
    • Symptoms of an allergic reaction
    • A list of major food allergens, as determined by the FDA, and
    • Appropriate responses for assisting an individual who is having an allergic reaction
  • DSHS will develop a model poster and include it on this website by December 2023.
  • Food establishments must comply by Sept. 1, 2024.

Certified Food Manager and Food Handler Course Impact

• Every DSHS-accredited certified food manager and food handler training and examination must include food allergen awareness. This applies to certificates that are issued or renewed on or after Sept. 1, 2024.

Local public health entity impact:

• Local jurisdictions cannot adopt or enforce orders, ordinances, rules, or any other measures that are inconsistent with these requirements. 

“As the second-largest private-sector employer in Texas, foodservice operators rely on our legislators to make our business environment as strong as possible,” Emily Williams Knight, president and CEO of the Texas Restaurant Association, said. “The Texas foodservice industry is resilient, but the past few years have created enormous challenges for our industry in particular. By working with our state’s officials to make government more efficient, and to plan for future growth, we continue to find enormous success helping restaurants overcome their challenges and thrive.”

This summer, Texas restaurants have experienced a decline of dine-in customers because of the extreme heat. According to OpenTable, Texas’ seated diner traffic has decreased 3 percent to 5 percent compared to Summer 2022. At the same time, food and labor costs are both up more than 20 percent compared to pre-pandemic levels. For these reasons, regulatory relief, cost savings and new tools to enhance the customer experience come at a great time for Texas restaurants.

Among the dozens of new laws that will impact restaurants, major themes include:

• Regulatory consistency and predictability
• Fewer permit fees
• Clearer health codes
• Property tax relief
• Workforce development

“After the difficulties restaurants have faced since the COVID-19 pandemic, we started the legislative session with a strong agenda that incorporated feedback from operators across the state,” Kelsey Erickson Streufert, chief public affairs officer of the Texas Restaurant Association, said. “We were determined to deliver immediate relief and long-term security for the entire foodservice industry — from single-unit restaurants to chains, franchisees, employees and customers. Many of these plans take effect with the new laws, creating new opportunities for restaurants and the millions of Texans who depend on them.”

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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Victory Trading Company Inc.
Greenland, NH

A food firm in New Hampshire is on notice from the FDA  for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. These violations include the presence of pests in their warehouse.

In an April 17, 2023, warning letter, the FDA described a Dec. 12, 2022, to Jan. 13, 2023 inspection of Victory Trading Company’s ambient, refrigerated and frozen food warehouse in Greenland, NH.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

Current Good Manufacturing Practice:
1. The firm did not take effective measures to exclude pests from their holding areas and to protect against the contamination of food on the premises by pests. Specifically, rodent activity was observed throughout their warehouse facility including the following:

Rodent Activity Observed

(Redacted)

• On Dec. 12, 2022, during a bag-by-bag examination of (redacted) pallets of (redacted) White Rice, lot # “(redacted)”, stored in the (redacted) corner of their warehouse, apparent rodent excreta pellets (REPs) too numerous to count (TNTC), apparent rodent gnaw holes in the bags of rice, and yellow stains on the bags of rice which smelled like urine and fluoresced UV light. An additional (redacted) pallets of (redacted) White Rice had an odor of urine and apparent REPs.
• On Dec. 13, 2022, an apparent decomposed dead rodent in the (redacted) corner of the warehouse outside the big cooler.
• On Dec. 19, 2022, an apparent decomposed dead rodent in the (redacted) corner of the warehouse outside the freezer.
• On Dec. 15, 2022, apparent REPs TNTC on an empty pallet in pallet location (redacted) in the center of the (redacted) area of the warehouse.
• On Dec. 15, 2022, approximately 10 apparent REPs on the floor below a pallet of bagged dried chili peppers among apparent rodent gnawed material in pallet location (redacted) in the center of the (redacted) area of the warehouse.
• On Dec. 15, 2022, apparent REPs TNTC on the floor behind a pallet of dried noodles in pallet location (redacted) in the center of the (redacted) area of the warehouse.
• On Dec. 15, 2022, approximately 15 apparent REPs on a pallet of BBQ sauce, and apparent rodent urine stains and apparent nesting materials on the floor directly next to pallet in pallet location (redacted) in the center of the (redacted) side of the warehouse.
• On Dec. 15, 2022, approximately 6 apparent REPs on a pallet of plastic cups in pallet location (redacted) in the center of the (redacted) side of the warehouse. The pallet also appeared to contain apparent rodent urine stains, and boxes of cups appeared to have bird excreta on them.
• On Dec. 15, 2022, approximately 13 apparent REPs on the floor in pallet location (redacted) in the center of the (redacted) side of the warehouse.

(Redacted)

• On Dec. 14, 2022, two apparent dead rodents in a glue trap in the (redacted) corner of the warehouse.
• On Dec. 14, 2022, an apparent dead rodent in a glue trap along the (redacted) wall of the warehouse under racks of bags of powdered drink mixes and seeds in pallet location (redacted).
• On Dec. 14, 2022, an apparent dead rodent in a glue trap in the (redacted) corner of the warehouse underneath racks of bagged powdered drink mixes in pallet location (redacted).
• On Dec. 14, 2022, apparent REPs TNTC on the floor at the corner junction of the (redacted) wall of the (redacted) area of the warehouse directly next to pallet location (redacted).
• On Dec. 14, 2022, apparent REPs TNTC on the floor along the (redacted) wall of the (redacted) corner of the warehouse in pallet location (redacted).
• On Dec. 14, 2022, apparent REPs on the floor along the (redacted) wall of the (redacted) corner of the warehouse in pallet location (redacted).

(Redacted)

• On Dec. 15, 2022, an apparent decomposed dead rodent on the floor along the (redacted) wall of the warehouse where bagged rice was stored.
• On Dec. 15, 2022, apparent REPs TNTC on the floor and support beams along the back (redacted) wall where bagged rice was being stored.
• On Dec. 13, 2022, apparent REPs TNTC and apparent nesting material observed in the (redacted) section of the warehouse on the floor touching and directly next to pallets of (redacted) White Rice.
• On Dec. 14, 2022, apparent REPs on the floor in the (redacted) area of the warehouse (next to the employee bathroom) in pallet location (redacted).
• On Dec. 14, 2022, apparent REPs and apparent rodent urine stains which fluoresced under UV light along the (redacted) wall of the (redacted) area of the warehouse in pallet location (redacted).
• On Dec. 14, 2022, apparent REPs on the floor in the (redacted) corner of the (redacted) area of warehouse in pallet location (redacted).
• On Dec. 14, 2022, approximately 6 REPs on the floor directly next to a pallet of rice sticks in pallet location (redacted) in racks along the (redacted) wall of the (redacted) side of the warehouse.
• On Dec. 14, 2022, approximately 20 apparent REPs on a pallet of vinegar in pallet location (redacted) in racks along the (redacted) wall of the (redacted) side of the warehouse.
• On Dec. 14, 2022, approximately 5 apparent REPs on the floor approximately 6” from a pallet of maltose in pallet location (redacted) in racks along the (redacted) wall of the (redacted) side of the warehouse.
• On Dec. 14, 2022, apparent REPs TNTC on a pallet which contained jasmine tea in pallet location (redacted) in storage racks along the (redacted) wall in the (redacted) side of the warehouse.
• On Dec. 15, 2022, apparent REPs TNTC on a pallet of plastic take-out containers in pallet location (redacted) in storage racks along the (redacted) wall in the (redacted) side of the warehouse.
• On Dec. 14, 2022, approximately 20 apparent REPs on the floor scattered directly next to a pallet of dried seaweed in pallet location (redacted) in storage racks along the (redacted) wall in the (redacted) side of the warehouse.
• On Dec. 14, 2022, a live insect and apparent REPs TNTC on a pallet of dried spices in pallet location (redacted) in storage racks along the (redacted) wall in the (redacted) side of the warehouse.
• On Dec. 14, 2022, approximately 8 apparent REPs on a pallet of rice sticks in pallet location (redacted) in storage racks along the (redacted) wall in the (redacted) side of the warehouse.

(Redacted)

• On Dec. 18, 2022, apparent REPs TNTC on the floor and on support beams along the (redacted) wall behind coolers (redacted) and (redacted).
• On Dec. 19, 2022, approximately 10 apparent REPs on a table holding shrink wrap stored along the (redacted) wall.
• On Dec. 19, 2022, approximately 15 REPs along the (redacted) wall upstairs in the equipment storage room (redacted) main office. Additionally, the rodent station (redacted) was missing from its designated wall location.
• On Dec. 19, 2022, approximately 14 apparent REPs at the top corner of the stairs leading to the equipment storage room (redacted) main office located at the (redacted) wall of the warehouse.
• On Dec. 19, 2022, approximately 25 apparent REPs in the (redacted) corner of the equipment storage room (redacted) main office located at the (redacted) wall of the warehouse.
• On Dec. 19, 2022, approximately 15 apparent REPs along the (redacted) wall of the equipment storage room (redacted) main office located at the (redacted) wall of the warehouse.
• On Dec. 14, 2022, apparent REPs TNTC on the floor at the corner junction of the (redacted) wall and the big cooler in the (redacted) side of the warehouse where bagged sugar was being stored.
• On Dec. 19, 2022, approximately 2 apparent REPs on the floor in the walk-in freezer closest to the big cooler along the (redacted) wall in the (redacted) area of the warehouse.
• On Dec. 14, 2022, apparent REPs TNTC on the floor in the center aisle of the warehouse in pallet location (redacted) of the (redacted) area of the warehouse.
• On Dec. 14, 2022, approximately 11 apparent REPs on a pallet of (redacted) noodles and approximately 15 REPS in a center food storage rack in the (redacted) side of the warehouse in pallet location (redacted).
• On Dec. 13, 2022, apparent REPs TNTC on a rack in pallet location (redacted) and (redacted) of the central aisle storage racks in the (redacted) area of the warehouse used to hold (redacted) Brown Rice in paper bags and (redacted) Potato Starch in paper bags. Additionally, apparent rodent paw prints and tail marks were observed in spilled product on the racks.
• On Dec. 14, 2022, approximately 10 apparent REPs on the floor behind a pallet of bagged rice in pallet location (redacted) of the central aisle storage racks in the (redacted) area of the warehouse.
• On Dec. 14, 2022, apparent REPs on the floor along the (redacted) wall of the (redacted) area of the warehouse in pallet location (redacted) directly below and next to bags of palleted rice.
• On Dec. 14, 2022, apparent REPs TNTC were observed on the floor along the (redacted) wall and under a food storage rack on the left-hand sides of cooler (redacted) in the (redacted) area of the warehouse.

Samples
FDA collected several samples during the inspection. These samples included a food product sample ((redacted) White Rice) and filth samples. These samples were submitted to FDA labs for analysis. Results demonstrate that the (redacted) White Rice and sample 1209823 were contaminated with rodent excreta pellets (REPs), and sample 1209822 was contaminated with rodent excreta pellets and rodent nesting material. The filth samples further demonstrate the presence of rodents throughout the facility.

2. The firm did not maintain their plant in a clean and sanitary condition and keep their plant in repair adequate to prevent food from becoming adulterated. Specifically, insanitary conditions were observed throughout their facility demonstrating that sanitation, cleaning, and maintenance operations were inadequate. The following observations reflect potential areas for pest harborage and attractants for pests:

(Redacted)

• On Dec. 13, 2022, a 24″ x 8″ rip in the insulation liner of the (redacted) wall exposing insulation. The exposed insulation had been partially removed and apparent REPs TNTC were observed inside the insulation.
• On Dec. 13, 2022, an approximate 1/4″ hole through the wall to the outside and an approximate 12″ x 12″ rip in the insulation liner of the (redacted) wall. An empty beer bottle was observed in the hole.
• On Dec. 15, 2022, an approximate 2-3” gap along the entire length of the (redacted) wall creating a potential ingress for pests.
• On Dec. 15, 2022, an approximate 1” wide crack in the floor approximately 12” from pallet location (redacted) creating a potential ingress for pests near the (redacted) wall in the warehouse.
• On Dec. 15, 2022, an approximate ½” gap in the floor approximately 6” from pallet location (redacted) in the (redacted) area of the warehouse. There appeared to be hollow space beneath the gap.

(Redacted)

• On Dec. 13, 2022, two overhead doors on the (redacted) side of the warehouse occupied by a moving and storage company were left open for an extended period during the day creating a potential ingress for pests.

(Redacted)

• On Dec. 13, 2022, spilled unknown white powder product on a pallet of soybean oil stored in the (redacted) section of the warehouse.
• On Dec. 15, 2022, an approximate 1” gap closest to the (redacted) wall of the warehouse creating a potential ingress for pests. The area below the gap appeared to be hollow.
• On Dec. 13, 2022, two approximate 1” gaps around electrical conduits in the (redacted) wall of the warehouse creating an opening to the outside.

(Redacted)

• On Dec. 12, 2022, the plastic liner of the dividing wall in the center of the warehouse in the (redacted) side contained what appeared to be rodent gnaw holes and apparent REPs inside the insulation in the wall. Apparent rodent nesting materials were observed on the ground, and gnaw marks were observed on a wooden post of the dividing wall.
• On Dec. 14, 2022, red onions in a bag made of plastic netting stored directly on the floor within 6” from where apparent REPs were observed outside the main office in the (redacted) side of the warehouse.
• On Dec. 14, 2022, stagnant clear liquid on the floor of coolers (redacted) and (redacted) creating a potential attractant for pests and a potential harborage area for bacteria in the (redacted) area of the warehouse.
• On Dec. 19, 2022, what appeared to be apparent rodent-gnawed material, apparent REPs TNTC, and insulation used as apparent rodent nesting material in the equipment storage trailer that is permanently affixed to the outside of the (redacted) wall.

3. The firm did not maintain their facility’s grounds in a condition adequate to protect food from becoming contaminated. Specifically, on Dec. 14, 2022, an overgrowth of weeds and vegetation were observed outside on the eastern and northern sides of the warehouse, creating potential harborage areas for pests.

The full warning letter can be viewed here.

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The majority of topics highlighted at a recent World Trade Organization (WTO) meeting on food safety had already been discussed before.

At the WTO Committee on Sanitary and Phytosanitary (SPS) Measures meeting in July, members addressed specific trade concerns relating to food safety and animal and plant health.

The one new area was Canada’s restrictions on Brazilian pork from internationally recognized foot and mouth free zones without vaccination.

Ukraine shared information on the current functioning of its SPS infrastructure and other aspects of the food security situation. Russian officials said discussions about the war were outside the scope of the WTO.

U.S concern over Chinese rules

The United States repeated that it remains “deeply concerned” with China’s lack of explanation on how two decrees address food safety and public health. The United States said China has not provided the scientific basis or risk assessment that informed their development. 

The European Union gave information on proposals around plants obtained by certain new genomic techniques and their food and feed, which sets out rules for the use of such plants as part of EU sustainability initiatives. The EU also reported on recommendations to combat antimicrobial resistance as part of the One Health approach.

Australian officials said they had confidence in the process that led to the decision to release the treated water and the move was also supported by the United States and United Kingdom.

The next meeting of the SPS Committee is scheduled for mid-November 2023.

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According to the FDA, this action is occurring within the context of its ongoing commitment to enhance regulatory oversight and reflects the agency’s determination to ensure optimal conditions for producing infant formula. These letters, arising from inspections carried out over several months, cite violations of the Federal Food, Drug, and Cosmetic Act and the FDA’s Infant Formula regulations. The issuance of these warnings coincides with recalls conducted by the manufacturers in December 2022, February 2023 and March 2023 to remove potentially contaminated Cronobacter sakazakii-tainted products from the market.

Despite these actions, the FDA does not advise parents and caregivers to avoid specific infant formulas. According to the FDA, no confirmed contamination has been reported in distributed products, and the recalls have been effective in removing potentially unsafe batches from the market. Furthermore, these warning letters are not tied to ongoing recalls, and as such, they are not expected to affect the availability of infant formula.

2021-2022 Cronobacter outbreak
Between December 2021 and March 2022, the US FDA received two reports of infant deaths linked to powdered infant formula produced by Abbott Nutrition in Michigan. These reports were part of 128 complaints. While two deaths were connected to a confirmed outbreak of Cronobacter sakazakii, others were reported through the FDA’s consumer complaint system, with two mentioning Salmonella. An additional 25 incidents were categorized as life-threatening, and 80 as non-life-threatening. A variety of symptoms were reported, such as fever, vomiting, diarrhea, and blood in stool. Investigations revealed Cronobacter sakazakii in Abbott’s manufacturing environment, although genetic matches weren’t found for the strains infecting the babies. All affected infants had consumed Abbott powdered formula.

Summary of warning letters
The issuance of these letters aligns with the FDA’s customary regulatory process and aims to reinforce the significance of implementing and maintaining appropriate corrective actions in the presence of pathogens. Manufacturers are required to conduct thorough root cause investigations, subsequent cleaning and sanitation activities, and comprehensive evaluations of cleaning and sanitation practices before releasing products. Each manufacturer is allotted 15 working days to provide the FDA with an explanation of the corrective actions they are taking. The agency will review the responses and evaluate the adequacy of corrective measures during its next inspection of each facility.

ByHeart Inc.
New York, NY

An infant formula producer in New York is on notice from the FDA  for significant violations of the Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications. 

In an Aug. 30, 2023, warning letter, the FDA described a Dec. 21, 2022, through Feb. 17, 2023, inspection of ByHeart Inc.’s powdered infant formula facility in (redacted).

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. The firm did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment. Specifically:

a. On Oct. 17, 2022, the firm notified (redacted) that a batch of ByHeart Whole Nutrition Infant Formula finished product had tested positive for Cronobacter spp. and was later confirmed as Cronobacter sakazakii (“C. sakazakii”). The infant formula base, which was a component of the contaminated finished product, was manufactured during a continuous production campaign at the (redacted) facility from July 13, 2022, through Aug. 23, 2022. The infant formula base from this campaign was then blended and packaged as a finished product at one of their third-party contract manufacturer’s facilities from Sept. 15, 2022, through Oct. 7, 2022.

In response to the finished product positive, (redacted) conducted a root cause analysis. (Redacted) root cause analysis concluded that post-production sample handling by a third-party laboratory was the source of the contamination, essentially resulting in a laboratory error. However, the third-party laboratory provided an “OOS Result Investigational Report for Microbiological Testing” regarding the C. sakazakii findings in finished product, which concluded that “Laboratory error was not found or supported.” The third-party laboratory reached this conclusion after reviewing its internal protocols and testing conditions, finding no basis to attribute the sample results to laboratory error. Typically, a conclusion of lab error within an RCA is supported with confirmed evidence, such as written confirmation from the third-party laboratory attesting to the error. Here, there is no attestation; there is evidence to the contrary.

Despite the discrepancy between the third-party laboratory and the internal conclusion within (redacted) root cause analysis, neither the firm nor their subsidiary company, (redacted), took any additional efforts to evaluate other routes of contamination that may have contributed to this event. FDA’s review of their records obtained during the (redacted) inspection show that they did not work with their third-party contract manufacturer to further investigate the origins or root causes of the finished product positive findings.

In response to the C. sakazakii finished product findings, the firm directed their third-party contract manufacturer to hold and destroy the lot of product that tested positive for C. sakazakii and the first pallet of the subsequent lot in the same production campaign. However, they directed the release of all other ByHeart Whole Nutrition Infant Formula finished product manufactured as part of their third-party contract manufacturer’s continuous production campaign. Upon further evaluation of (redacted) sanitation and production records, and following discussions with FDA, their firm subsequently conducted a voluntary recall of the remaining five lots of ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron from the same Sept. 15, 2022 – Oct. 7, 2022 campaign that they had previously released into U.S. commerce.

The full warning letter can be viewed here.

Reckitt/Mead Johnson Nutrition
Parsippany, NJ

An infant formula producer in New Jersey is on notice from the FDA for significant violations the Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications at two of their facilities.

In an Aug. 30, 2023, warning letter, the FDA described a  Feb. 7-23, 2023, inspection of Reckitt/Mead Johnson Nutrition’s Zeeland, MI, powdered infant formula manufacturing facility and a Nov. 28, 2022, through Jan. 9, 2023 inspection of their Wanamingo, MN, facility.

Both of the FDA’s inspections revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. The firm did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment. Specifically:

Zeeland Facility
a. On Sept. 4, 2022, a batch of the firm’s Enfamil Prosobee Simply Plant-Based Infant Formula (Prosobee) powder product, tested positive for Cronobacter sakazakii (“C. sakazakii”). The Prosobee product that tested positive was manufactured in a continuous production campaign that ran from Aug. 29, 2022, through Sept. 1, 2022, which produced three batches of the Prosobee product. The Prosobee product that tested positive for C. sakazakii was produced in the first batch of this continuous campaign. The firm’s Critical Deviation Investigation Report, which includes their root cause analysis, concluded that their third-party manufactured base powder, Prosobee Lipil Synergy, was the source of the contamination. While they identified a probable source of contamination, the FDA noted that their root cause analysis did not include further investigation of the finished product isolate or the environmental isolates recovered from the facility of their third-party supplier responsible for manufacturing their base powder.

Wanamingo Facility
d. On Oct. 15, 2022, the firm’s third-party customer notified them that a finished product, non-exempt milk-based powdered infant formula tested positive for C. sakazakii. This product was blended at the firm’s facility on thier (redacted) line between Sept. 15 – 20, 2022, and then packaged on Packaging Line #1 between Sept. 30 – Oct. 7, 2022.

Upon receiving notification of this result, the firm failed to conduct an independent root cause analysis or investigation and they did not evaluate whether other products may have been impacted by this contamination event. 

The full warning letter can be viewed here.

Perrigo Wisconsin, LLC
Eau Claire, WI

An infant formula producer in Wisconsin is on notice from the FDA  for significant violations the Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications. 

In an Aug. 30, 2023, warning letter, the FDA described a March 6 through April 26, 2023  inspection of Perrigo Wisconsin, LLC’s powdered infant formula manufacturing facility (Gateway facility) in Eau Claire, WI.

Based on the information the firm provided to FDA investigators during their inspection, Perrigo Company PLC (“Perrigo”) purchased the Gateway facility from Nestle on Nov. 1, 2022. The acquisition included the facility along with the U.S. and Canadian rights to the Good Start infant formula brands. Nestle remains responsible for Nestle’s current WIC contracts, with Perrigo supplying product through the Gateway facility for those contracts. Both Perrigo and Nestle indicated they will be working closely together in the transitional period following the purchase of the Gateway facility.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. The firm did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment Specifically:

a. The firm identified Cronobacter spp. in the following finished products:

i. During a continuous production campaign that ran from Oct. 23, 2022, to Nov. 2, 2022, two products tested positive for Cronobacter spp. The positive products were identified as Parent’s Choice Infant Formula Milk-Based Powder with Iron, which was spray dried on Oct. 26, 2022, and packaged on Oct. 27-28, 2022, and Parent’s Choice Infant Formula Milk-Based Powder with Iron, which was spray dried on Nov. 2, 2022, and packaged on Nov. 2, 2022.

Prior to the initiation of this production campaign, on Oct. 21-23, 2022, the firm conducted a major clean-in-place (CIP)/Top Down 4-Step Cleaning. On Nov. 2, 2022, when the firm received notification of the positive Cronobacter spp., they ceased production and packaging operations, placed all products on hold, and immediately initiated cleaning and sanitation activities, which entailed a major CIP/Top Down 4-Step Cleaning. FDA investigator’s review of their sanitation records indicated that there were no intervening sanitation breaks during this production campaign.

ii. During a continuous production campaign that ran from Jan. 3, 2023, through Jan. 18, 2023, a batch of their Gerber Good Start Soothe Pro powder product tested positive for Cronobacter spp. The positive product was spray dried on Jan. 11, 2023, and packaged on Jan. 12, 2023.

Prior to the initiation of this production campaign, on Dec. 31, 2022, to Jan. 2, 2023, the firm conducted a major CIP of the dryer equipment and a Top Down 4-Step Cleaning of the packaging equipment. On Jan. 18, 2023, when they received notification of the positive Cronobacter spp., they ceased production and packaging operations, placed all products on hold, and immediately initiated cleaning and sanitation activities, which entailed a major CIP/Top Down 4-Step Cleaning. FDA investigator’s review of their sanitation records indicated that there were no intervening sanitation breaks during this production campaign.

iii. During a continuous production that ran from March 26, 2023, through April 5, 2023, a batch of the firm’s Gerber Good Start Plus Iron and Calcium Fortified Milk-Based (“Gerber Good Start Plus”) powder product tested positive for Cronobacter spp. The positive product was spray dried on March 26, 2023, and packaged on March 27, 2023.

Prior to the initiation of this production campaign, on March 22, 2023, to March 26, 2023, the firm conducted a major CIP of the dryer equipment and a Top Down 4-Step Cleaning of all tote areas and the packaging room. On April 5, 2023, when they received notification of the positive Cronobacter spp., they ceased production and packaging operations, placed all products on hold, and immediately initiated cleaning and sanitation activities, which entailed a major CIP/Top Down 4-Step Cleaning. FDA investigator’s review of their sanitation records indicated that there were no intervening sanitation breaks during this production campaign.

The full warning letter can be viewed here.

Comments from the FDA
In a written statement, Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, emphasized, “Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns.” The FDA aims to proactively identify and address issues before they escalate to the level of concern that triggered the significant recalls and contributed to the infant formula shortage observed last year.

The actions represent the FDA’s continuing endeavors to reinforce the safety and robustness of the infant formula supply chain in the United States. In November 2022, the FDA outlined a prevention strategy to curb Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula. This approach involves collaborating with Congress to enhance regulatory tools and funding for oversight of the infant formula industry. Additionally, the FDA has partnered with the U.S. Centers for Disease Control and Prevention to support the addition of invasive Cronobacter infections among infants under one year of age to the Nationally Notifiable Conditions List. To further strengthen regulatory oversight, the FDA has begun hiring staff to establish an Office of Critical Foods and a dedicated cadre of infant formula investigators.

Recommendations for parents
For parents and caregivers, the FDA underscores the importance of adhering to manufacturer instructions when preparing powdered infant formula. The CDC recommends using ready-to-feed liquid infant formula for babies under 2 months old, those born prematurely, or those with weakened immune systems. Alternatively, extra precautions can be taken when preparing powdered formula by heating water to at least 158 degrees F or 70 degrees C to counteract pathogens, adding powdered infant formula, mixing, and then cooling the formula to body temperature before feeding.

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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Th e Office of Investigation, Enforcement, and Audit (OIEA) conducts detention actions for Meat, Poultry and Egg products.  During the third quarter, OIEA detentions totaled 106,520 pounds, much lower than the previous two quarters when detentions hit 281, 143, and 250,246 pounds. So far for the fiscal year, there have been 330 detentions for 637,909 pounds.

The pressure was off a  bit due to slightly reduced activity during the federal fiscal third quarter that ended the third quarter.  Still, USDA’s Food Safety and Inspection Service remained busy with enforcement actions, including those where it pursued either civil or criminal actions.  

The Office of Field Operations (OFO) is the largest FSIS unit. It issued two “prohibited activity notices” during the third period, bringing the total to seven for the year.

FSIS “prohibited activity notices” may include any of the following:

• Failure of a recalling establishment or firm to notify its consignees of a recalled product
• Failure of a consignee to notify its customers of the recalled product
• Recalling establishment, firm, or consignee found offering a recalled product for sale

When FSIS determines that an establishment or firm has not taken responsibility to remove or control adulterated, misbranded, or unsafe products in commerce or to advise its consignees of a product subject to recall, it may issue prohibited activity notices to the establishment or firm. 

“Prohibited Activity Notices” during the third quarter were issued to Abie’s Place, Abie, NE; La Autentica Foods (two notices), Hialeah, FL; Old Town European Market, Springfield, MO; Prime Food USA, Edison, NJ; Walgreen Co. Store 7718, Fayetteville, AR; and Walmart, Baden, PA.

Through 10 district offices,  OFO carries out FSIS’ food safety mission in processing and slaughter facilities across the country. OFO is also responsible for managing all certification work including export verification.

FSIS also took a variety of administrative actions against 34 businesses it regulates. And among FSIS’s  “large establishments,” only seven faced administrative action and six of those involved inhumane treatment during slaughter.

On May 24, 2023, an administrative hearing found King of Basturma LLC and its owner Abbas Sachem, both of Westland, MI, as being unfit to receive federal meat inspection services. The reason is the owner’s felony and fraud convictions. He did not appeal and the decision became final.

In a civil injunction action, Ashif Saeed entered into a Consent Decree from the U.S. District Court for Eastern New York to resolve violations of the meat and poultry acts. The owner of a Jamaica, NY business, Saeed agreed to not misbrand products or offer misbranded products for sale. The decree includes enforcement provisions.

A Consent Decree was also agreed to in the District Court for the Southern District of New York involving the owners of N and M Wholesale Supply in New York, NY.  It resolves alleged violations of the Meat and Poultry Acts. It requires the owners to get training and keep proper records. And its meat and poultry products must pass proper inspections.

Finally, a 2020 case that opted out of a jury trial appears to have settled with plea bargains that came together during the quarter. There remains an October sentencing hearing for Rhode Island Beef, but not owners Michael and Joel Quattrucci as individuals.

They were charged with defrauding customers by using an illegally obtained official mark of inspection, defrauding customers with claims that their beef was inspected and that it had passed, and falsely claiming it had met federal inspection requirements.

The owners were fined and placed on probation in exchange for plea agreements.

The probation term is 1 to 5 years, with fines of $10,000 each.  The October hearing will be limited to Rhode Island Beef as a corporate entity.

Editor’s note: A previous reversion of this story carried the wrong byline. Editor Dan Flynn wrote this story.

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Eco Food Distribution LLC
Schiller Park, IL

An import company in Illinois is on notice from the FDA for not developing an FSVP for the foods they import.

In a May 25 warning letter, the FDA described a Feb. 28 through March 29 Foreign Supplier Verification Program (FSVP) inspection of Eco Food Distribution LLC in Schiller Park, IL.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:

1. The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for the foods they import from the foreign suppliers indicated.

2. The firm did not conduct a written hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. Specifically, for the chocolate-covered gingerbread apple they import from (redacted) and the carrot nectar they import from (redacted), they did not provide a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards for the food they import to determine whether there are any hazards requiring a control, as required.

3. The firm did not approve their foreign suppliers based on an evaluation of the foreign supplier’s performance and the risk posed by the food, and document their approval. Specifically, for the chocolate-covered gingerbread apple they import from (redacted) and the carrot nectar they import from (redacted), they did not provide documentation that they have evaluated their foreign supplier’s performance and risk posed by the food or their approval of these suppliers.

4. The firm did not perform foreign supplier verification activities. Specifically, for the chocolate-covered gingerbread apple they import from (redacted) and the carrot nectar they import from (redacted), they did not determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food they obtain from the foreign supplier is produced in accordance with regulation. In addition, they did not conduct and document (or obtain documentation of) one or more of the supplier verification activities for each of these foreign suppliers before importing these foods and periodically thereafter.

The full warning letter can be viewed here.

Moises Gardea
Albuquerque, NM

An import company in New Mexico is on notice from the FDA for not having FSVPs for a number of imported food products.

In a June 12 warning letter, the FDA described a March 9-24 Foreign Supplier Verification Program (FSVP) inspection of Moises Gardea in Albuquerque, NM.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Asadero Cheese, Solid imported from (redacted), located in (redacted)
• Mennonite Cheese imported from (redacted), located in (redacted)
• Asadero Cheese, Tortilla Style imported from (redacted), located in (redacted)

The full warning letter can be viewed here.

FVD Produce LLC
Pharr, TX

An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Aug. 15 warning letter, the FDA described a Feb. 8 and March 9 Foreign Supplier Verification Program (FSVP) inspection of FVD Produce, LLC in Pharr, TX.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Fresh tomatoes, husk tomatoes, carrots and various onions from (redacted), located in (redacted)
• Carrots from (redacted) located in (redacted)

The full warning letter can be viewed here.

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South Dakota’s “lone voice” in Congress explained:

“Consumers don’t know where their beef comes from. It could be South Dakota, Brazil, or Canada,” said Johnson. “U.S. producers raise better beef, and they’re not getting the credit for it. My bill takes a step in the right direction to get accurate labels back on these products to increase consumer confidence in American-made and grown products.”

The Beef Origin Labeling Accountability Act:

• Directs the United States Trade Representative and Secretary of Agriculture to work together to determine a process of reinstating Mandatory Country of Origin Labeling (MCOOL) for beef compliant with World Trade Organization rules.
• Requires the two agencies to report to Congress on their progress in determining a trade-compliant means of MCOOL, including any recommendations for legislation that may be necessary and any engagement with international governments on the matter.
• Directs the USTR to consult with the Canadian and Mexican governments to resolve the outstanding MCOOL trade disputes the two countries have open against the U.S.

Johnson has been a leader on cattle policy during his time in the U.S. House. In 2023, Johnson’s Cattle Contract Library was implemented by the U.S. Department of Agriculture to increase transparency in the market. Additionally, in 2021, Johnson successfully secured a pilot program to supply grants to small cattle processors to expand competition in the packing industry.

Background on Mandatory Country of Origin Labeling:
In 2008, the Farm Bill implemented MCOOL and labeling for beef products from cattle born, raised and harvested in the United States. Canada and Mexico quickly filed a dispute with the World Trade Organization, claiming MCOOL violated WTO agreements. The U.S. lost multiple appeals to WTO rulings against MCOOL, and in December 2015, the WTO authorized more than $1 billion in tariffs against U.S. products from Canada and Mexico.

On December 18, 2015, Congress repealed MCOOL. The WTO cases remain active today, with Canada and Mexico keeping the cases open to put pressure on the U.S. to prevent any attempt at reinstating MCOOL. If the U.S. were to implement a new MCOOL program, Canada and Mexico could immediately retaliate. Johnson’s Beef Origin, Labeling Accountability Act seeks to close these open cases from Canada and Mexico to move forward on reinstating MCOOL. 

Entire bill text here.

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Caffeinated energy drinks are beverages or mixtures that include added caffeine, often accompanied by various other ingredients like vitamins, minerals, taurine and herbal elements. These products can also contain natural caffeine sources such as guarana and yerba mate. In Canada, these drinks are allowed to have a maximum caffeine content of 180 mg per serving.

Consumers are urged to carefully review product labels to ascertain the caffeine content per serving, the number of servings in the container, and the recommended daily consumption. It is advised that CEDs should not be consumed by individuals younger than 14 years old, pregnant or breastfeeding women, or those sensitive to caffeine. Adults aged 18 and over are cautioned not to exceed a daily caffeine intake of 400 mg.

Excessive caffeine consumption can result in adverse health effects including insomnia, irritability, headaches, and nervousness. The CFIA has recently recalled certain caffeinated energy drinks because of excessive caffeine levels and improper labeling, including missing cautionary statements. Consumers are encouraged to report any consumption-related incidents to the CFIA and can also reach out to the manufacturers directly.

To ensure safety, the CFIA recommends that children, pregnant or breastfeeding individuals, and those sensitive to caffeine refrain from consuming caffeinated energy drinks. Others are advised to limit their intake and adhere to the cautionary instructions on the product labels.

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The only thing that might keep the EATS Act from blowing up the Farm Bill is that the 2023 Farm Bill does not yet exist, even in draft form though the current 5-year Farm Bill expires Sept. 30.

Farm state congressional delegations do not expect the 2023 Farm Bill to be passed by that Sept. 30 deadline; instead, the best hopes are for the $1.5 trillion bill to be passed and signed by the President by the end of 2023.  The bill supports farmers and ranchers and provides nutritional assistance for low-income people.

In the meantime, a heated dispute about the EATS Act continues.

On Monday,  171 bipartisan members of Congress sent a letter to House Ag Committee Chairman Glenn Thompson, R-PA, and Ranking Member David Scott, D-GA., opposing the inclusion of the  EATS Act in the upcoming Farm Bill. The letter was organized by Republican Rep. Brian Fitzpatrick from Pennsylvania and Oregon Democrat Rep. Earl Blumenauer. 

“We write today expressing our strong opposition to including H.R. 4417, the Ending Agricultural Trade Suppression (EATS) Act, or any similar legislation in the 2023 Farm Bill. Modeled after former Representative Steve King’s amendment, which was intensely controversial and ultimately excluded from the final 2014 and 2018 Farm Bills, the EATS Act could harm America’s small farmers, threaten numerous state laws, and infringe on the fundamental rights of states to establish laws and regulations within their borders,” the Congressional letter says.

“This is not a case of California imposing its standards on other states. Producers in any state can choose not to supply another state’s consumers or to segregate animals for different markets. Pork industry economists noted this in an amicus brief, writing, ‘Only those producers for which compliance with Proposition 12 is economically beneficial will choose to do so, while all others will continue to supply the vast majority of the North American pork market beyond California’s border and face little or no economic impact,’” it continued.

Animal activists oppose the EATS Act because they don’t want to lose ground. They won in 2018 and since by voters and affirmed earlier this year by the U.S. Supreme Court.  The EATS Act came in response to the conservative  Court’s 5-to-4 ruling that California may restrict access to its market on non-discriminatory terms.

The EATS Act opposition is warning congressional leaders to keep it would the Farm Bill, less it becomes a “Poison Pill.” 

Sen. Roger Marshall, R-KS, and Rep. Ashley Hinson, R-IA, are sponsors of the EATS Act.  Marshall has said radical animal rights activists want California to tell Kanas or Iowa farmers how to raise pigs.  Next, Marshall says they will be “telling us we can’t grown GMO corn.”

But those animal activists point to at least one study claiming that the EATS Act could “overturn” troves of state laws, creating an oversight regulatory vacuum

The EATS Act negates state laws that impact other states’ agriculture operations.

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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Koi CBD, LLC
Norwalk, CA

In a June 18 warning letter, the FDA described a review of Koi CBD, LLC’s website at the internet address koicbd.com from June 2023 through July 2023.

The FDA determined that the firm’s products, Koi brand “Delta 8 Gummies” and Hemp Living brand “Pot Rocks,” are adulterated because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce adulterated food into interstate commerce.

The FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 

1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put public health at risk; 

2) FDA has received adverse event reports involving Delta-8 THC containing products; 

3) Delta-8 THC has psychoactive and intoxicating effects; 

4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 

5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. 

Adulterated Human Foods
According to the firm’s product labeling, their Koi brand “Delta 8 Gummies” and Hemp Living brand “Pot Rocks” are foods to which Delta-8 THC has been added.

There is no food additive regulation that authorizes the use of Delta-8 THC. FDA is not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction. Furthermore, they are not aware of any basis to conclude that Delta-8 THC is generally recognized as safe (GRAS) for use in conventional foods. FDA’s regulations describe the criteria for eligibility for the classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.

The FDA knows of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food prior to Jan. 1, 1958. Based on FDA review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of Delta-8 THC in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from Delta-8 THC. FDA review of published scientific literature identified potential for adverse effects of Delta-8 THC on the central nervous and cardiopulmonary systems. In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on FDA review, the use of Delta-8 THC in the products does not satisfy the criteria for GRAS status.

The full warning letter can be viewed here.

Northland Vapor Company, LLC
Fargo, ND

In a July 7 warning letter, the FDA described an inspection of the firm’s Wonky Confections, LLC facility, which manufactures ready-to-eat (RTE) human food products containing Delta-8 tetrahydrocannabinol (THC) in Nov. 8-9, 16, 28, and Dec. 7, 2022

Based on the inspection, a review of the product labels collected during the inspection, and laboratory analysis of the firm’s products, the FDA has determined the “Death by Gummy Bears” and “Wonky Weeds” gummy bear products they manufactured in their facility are adulterated because they bear or contain an unsafe food additive. Additionally, the FDA has determined that the RTE food products manufactured in their facility are adulterated, in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.

At the conclusion of the inspection FDA issued a Form FDA-483, Inspectional Observations, listing the deviations found at the facility. 

FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 

1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 

2) FDA has received adverse event reports involving Delta-8 THC containing products; 

3) Delta-8 THC has psychoactive and intoxicating effects; 

4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 

5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. 

Adulterated Human Foods
According to the firm’s product labeling, their “Death by Gummy Bears” and “Wonky Weeds” gummy bear products are foods to which Delta-8 THC has been added. In addition, the FDA confirmed through laboratory analysis that samples of these products contain Delta-8 THC.

Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe, and causes the food to be adulterated. Introduction of an adulterated food into interstate commerce is prohibited.

There is no food additive regulation that authorizes the use of Delta-8 THC.

Adulterated Human Foods
The firm’s RTE food products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby the food products may have become contaminated with filth, or whereby they may have been rendered injurious to health. During FDA inspection of their establishment, FDA investigators found violations of the Current Good Manufacturing Practice regulations for human foods. The significant violations are as follows:

1. The firm did not take reasonable precautions and measures to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) after each absence from the workstation and at any other time when hands may have become soiled or contaminated. Specifically, on Nov. 8 and Nov. 9, 2022, (redacted) employees were observed not washing and sanitizing hands prior to donning gloves before separating by hand the RTE gummy candy products from excess sugar and hand-packing the products into finished product packaging.

2. The firm did not provide (redacted) facilities designed to ensure that an employee’s hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature. Specifically, their facility is equipped with only one (redacted) sink, located in the employee restroom, which is inaccessible during bathroom occupancy and shared by approximately (redacted) employees. This (redacted) sink is in a separate area that is approximately (redacted) feet away from the production area.

3. The firm did not clean food-contact surfaces in a manner that protects against allergen cross-contact and contamination. Specifically, on Nov. 9, 2022, employees were observed washing equipment and utensils used in the production of the RTE gummy candy products with detergent but not sanitizing them. Cleaned utensils are placed onto a metal drying rack; however, a measuring pitcher was observed on the drying rack not inverted and containing pooled water. The pitcher also contained residual material that they identified as THC distillate.

The full warning letter can be viewed here.

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For the August recess, which actually does not end until Congress goes back to the national capitol in September, more verbal bombs have gone back and forth than usual.

Attorney generals for 16 states posted a letter to the U.S. Congressional leadership on Aug. 9, urging the passage of the Ending Agricultural Trade Suppression (“EATS”) Act. The EATS Act seeks to preserve states’ rights by limiting their ability to impose agricultural regulations on other states.

According to the states, the Commerce Clause of the Constitution of the United States provides the federal government with the duty to regulate interstate commerce. 

“Consistent with that duty, this bill prevents states from impeding Ag trade from other states within the U.S.,” the letter says. “States should have the power to command their destiny regarding agriculture production practices. And this bill preserves the State and Local government units’ right to regulate farming and ranching within their own state.”

California’s burdensome regulations will put small, medium, and possibly even large pork producers out of business, according to opponents. And, American consumers won’t be able to afford bacon for breakfast, the letter added.

“California’s radical-drafted requirements for farmers are hog wild,” the Attorneys Generals wrote. “Justice Kavanaugh recognized that California’s requirements might even worsen animal health and welfare. And because California buys about 13 percent of the nation’s pork, it is prohibitively expensive for farmers to separate California-approved pork from the rest.”

The EATS Act would overturn the Supreme Court’s May 11, 2023, ruling that, with a 5-to-4  vote, found states have the right to regulate products sold within their state.  Known as Proposition 12, it is the measure California uses to impose its 2018 farm animal confinement standards on conditions for selling products in California.

“Solving the problems Prop 12 creates requires understanding what went so wrong. California’s unscientific approach to raising pork follows from the fact that Californians barely raise any pork themselves,” they charge.

The pork-producing states do not think California even knows what it is doing.

The attorneys general and governors who’ve gone on record supporting the EATS Act often mention their concerns about the “activists,” referring to animal activists raising the confinement issue.

And these activists also have been very busy during the August recess. They had a virtual press event Wednesday to roll out a  new report by the Center for a Humane Economy and Animal Wellness Action showing that a diversified pig production sector already in place can meet the modest demand created by Prop 12 in California and Question 3 in Massachusetts for more humanely raised pork.

A State can always try to lead by example — passing laws to regulate agricultural production within its borders. But that is not what California did, instead it continued. “Californians voted to impose their radical agenda on out-of-state farmers and ranchers — and in doing so, raise food costs for Americans across the country. Their approach is an attack on States’ authority. As a result, many small- and medium-sized pork producers may go out of business. All in support of California’s out-of-touch activist agenda.”

The report also claims that In promoting the EATS Act, the National Pork Producers Council (NPPC) and some of its legislative allies have falsely stated that California “doesn’t like bacon,” that the farm-animal ballot measures ban farrowing crates, and that the two ballot measures will require that farmers in Iowa and Kansas must change their production practices and conform to California’s rules. 

The report reveals that the industry has been in transition for more than two decades since Florida banned the use of gestation crates in 2002 and has the existing capacity to supply gestation-crate-free pork in two states.

It claims that nearly 40 percent of breeding sows are already in group housing systems rather than gestation crates, and market analysis shows that California and Massachusetts together will require just 6 percent of total U.S. pork production to come from facilities that allow the sows an opportunity to lie down, stand up, and turn around. 

It says those false claims are debunked in the new report released today, with the analysis conducted by two agricultural veterinarians steeped in animal agriculture and based in the Midwest.

“The National Pork Producers Council is spinning an enormous yarn,” said Dr. Jim Keen, D.V.M., Ph.D., director of veterinary science for the Center for a Humane Economy and the primary author of the new report.

Keen worked for two decades at the U.S. Meat Animal Research Center in Clay Center, NE, and as a faculty member of the University of Nebraska College of Veterinary Medicine and Biomedical Sciences.

The new report, which can be viewed here, notes that EATS, or the Exposing Agricultural Trade Suppression (EATS) Act, would not only unwind two landslide state elections but would undo more than 1,000 other state laws according to an analysis from a team of legal analysts at Harvard University.

The report notes that the pork industry, as a matter of law, is already selling pork from the offspring of overcrowded, immobilized breeding sows in 48 states and 139 nations without any animal welfare restrictions or minimum space allotments.

“The trade association has exaggerated the market impact of ballot measures in California and Massachusetts by 300 percent,” he said. “A highly diversified pork industry has ample capacity right now to accommodate the market demand for Prop 12 and Question 3 without any meaningful changes to the current animal housing setups.”

The report notes that Prop 12 and Question 3 exempt all combined and canned pork products, which represent about 42 percent of pork sales in California and Massachusetts, meaning that nearly half of the pork sold in these two states need not come from farms providing some ample living space to the sows.

 It also notes that nearly 40 percent of sows are already in group housing. Minor adjustments on these farms would allow producers to sell whole pork cuts to California and Massachusetts.

“The EATS Act has the perverse effect of nullifying U.S. elections and benefitting a foreign government that wants no humane standards in agriculture. China is building high-rise factory farms that bear no resemblance to the farming practices that my family has observed for 100 years in southwest Oklahoma.”

“Through its total control of Smithfield Foods, the Chinese Government already controls a quarter of U.S. pig production,” added Dr. Thomas Pool, senior veterinarian with Animal Wellness Action and a former Colonel and U.S. Army Veterinary Command commander. 

Pool is an Oklahoma State University College of Veterinary Medicine graduate.

The report’s authors also conclude that any price increases in pork in California or Massachusetts would be contrived and based on false assumptions by pork industry leaders. The 40 percent of the industry relying on group housing is already competitive on inputs and pricing, with the remainder relying on gestation crates.

Keen and Pool note that the EATS Act can potentially drive thousands more pig farmers out of business by accelerating consolidation in American agriculture and turning many who stay in business into contract farmers answering to Chinese- and Brazilian-owned companies (Smithfield and JBS). These two companies already control 40 percent of the value of the U.S. pork industry (Smithfield 26 percent and   JBS 14 percent).

The report also notes the deep reservoir of public opposition to using gestation crates and the thorough judicial repudiation of the claims that Prop 12 was an unconstitutional intrusion into interstate commerce.

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By their convictions and sentencing, Stewart Parnell, 69, and brother Michael Parnell, 64, respectfully still have 15 and 8 years before their prison release dates.

Their jury convictions and trial judge rulings were all upheld by the Appellate Court in 2018.

Nine deaths were associated with the outbreak.

Those nine had families that miss them to this day. Those families see Stewart Parnell as a despicable character whose reckless disregard for life caused the death of their loved ones.

But for now, about to start its fifth year, Stewart Parnell has played the last card he has left. It’s been called the “Great Writ” of habeas corpus. It is a fundamental right in the Constitution that protects against unlawful and indefinite imprisonment. In Latin, it means “show me the body.” Habeas corpus is supposed to safeguard individual freedom against arbitrary executive power.

Stewart Parnell’s Habeas corpus petition was filed on Sept. 6, 2019. After being denied on. Sept. 23, 2022, by the trial judge for the federal District Court, the 11th Circuit took up Parnell’s Habeas petition on appeal.

And the Appellate Court has issued Parnell a “certificate of appealability” on two issues. Those are jury prejudice and ineffective assistance of counsel. With deep experience in federal appeals, Savannah Attorney Amy Lee Copeland has recently filed a 68-page appellate brief for Stewart Parnell and followed it with a few hundred pages of appendix.

The Parnell appeal includes mounds of local, state, and national media stories to illustrate the climate from the outbreak through the trial.  Copeland said about 8,000 were in the jury pool in the Court’s Albany Division at the time of the trial.   

This is a lot to digest, but it all boils the case down.

“The nine deaths did not come into evidence at trial,” Attorney Copeland writes.  “The government agreed not to introduce that evidence.” Two who knew about the deaths entered the jury and into juror deliberations.

It breaks down into whether those nine deaths couldn’t be put aside in a community with the peanut industry too damaged by the Salmonella outbreak blamed entirely on Stewart Parnell’s Peanut Corporation of America. 

Criminal charges were not brought for four years after the outbreak, but .jury selection showed that 60 percent of the prospective jurors knew about the case.

In testimony two years ago, an Albany peanut broker said the Salmonella outbreak at PCA “devastated” the industry. “The sentiment in the local community was ‘under attack by the media,’ especially after reports of death resulting from the salmonella ‘hit the fan,’ ” according to the appellate brief.

Parnell’s trial attorneys did not seek a change of venue for the original jury trial. His defense team members all testified at an evidentiary hearing two years ago. They thought Albany would be the friendliest venue for the PCA trial, but they may have misread the public badly.

The 2014 jury trial was held in Albany, GA, where 60 percent of America’s peanuts are grown within a 150-mile radius. PCA’s peanut processing plant in Blakely, GA, was 65 miles away.

A change of venue is not required if prospective jurors are merely exposed to facts of a case, but only if “inflammatory, prejudicial pretrial publicity “ pervades or saturates the community making a fair trial “virtually impossible.”

Parnell has established “a presumption of jury prejudice,” according to Copeland. “The Sixth Amendment secures criminal defendants the right to trial by an impartial jury,” she said.

And when the deaths were not allowed to be even mentioned at trial, Copeland says jurors were using terms like “fry them” and “hang” and “exact a pound of flesh” as they convicted Parnell on 67 of 68 counts against him.

Many of us remember from our Civil War history that President Lincoln suspended the Writ so certain Rebels could not escape the military’s jurisdiction. The Lincoln suspension ended after four years when the Civil War was over. Parnell’s Writ, however, will go on a bit longer.

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It’s a “twofer” because Marler Clark’s new comments were submitted under two dockets — the FSIS Salmonella in Certain Not-Ready-to-Eat Stuffed (NRTE) Chicken projects and the petition the Seattle law firm previously submitted calling for “Outbreak” Salmonella serotypes to be listed as adulterants. If a food is deemed adulterated it cannot be sold.

Salmonella is so frequently found in U.S. poultry that some food scientists say it is a biological hazard in consumers’ kitchens. FSIS denied Marler Clark’s 61-page petition to address all Outbreak strains. The petition was submitted on behalf of families damaged by Salmonella and several consumer organizations.

The new Marler Clark comments support FSIS’s proposal to regulate Salmonella at levels of 1 colony forming unit (CFU) in NRTE breaded stuffed chicken. It says, “we maintain that the Agency must adopt more robust measures to tackle the Salmonella problem effectively.”

“FSIS’s proposed determination on Salmonella in breaded stuffed chicken products was supported by various factors, one being the investigation of 14 Salmonella outbreaks and 200 illnesses linked to these products since 1998. But according to CDC, Salmonella bacteria cause a staggering 1.35 million illnesses, resulting in 26,500 hospitalizations and 420 deaths in the United States every year,” Marler Clark’s Aug. 14 letter says.

The new comments clarify that the law firm wants a response, not just a denial, to its previous petition. The petition was not an “all or nothing” request but presented 31 Salmonella serotypes that scientific fact or statutory law would justify adulterant status.

FSIS responded “in a serotype-specific” way for three serotypes, but the agenda was silent about the other 28. Marler Clark says denying its petition “was insufficient as a matter of law.”

FSIS said it could not “justify issuing the broad interpretive rule” that “would declare all Salmonella” as added substances in all products.

On behalf of its clients, Marler Clark may seek judicial review of the FSIS denial.   Marler Clark’s latest comments say an agency that is “incomplete and evasive” isn’t given deference during the review.

Marler Clark says the agency “primarily” used “straw-man” arguments in denying their petition. “Nothing in the Petition asserted that ‘grave health and safety problems’ posed by Salmonella in raw poultry or meat could not be addressed unless thirty-one serotypes were declared adulterant,” the Seattle law firm said.

It points out that FSIS’s data finds five stereotypes are responsible for 60 percent of USDA-regulated products.

USDA recognizes the Salmonella strains are “injurious to health,” but Marler Clark claims the FSIS “offered a laundry list of reasons not to regulate.”  “In the meantime, as the Agency hosts roundtables and ponders an ‘updated’ Salmonella strategy…necessary to reduce such illnesses,” the significant portion of the approximately 1.35 million cases of salmonella that occur each year.

The incidence of salmonellosis from poultry exceeds the CDC’s Healthy People 2030 objective of 11.5 cases per 100,000 population with no substantial deductions in two decades.

The Marler Clark comments conclude by saying “no reasonable interpretation” of FSIS regulations that do not require at least some Salmonella serotypes to be adulterants when present in specific quantities.

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Food Standards Scotland (FSS) and the Food Standards Agency (FSA) issued voluntary industry guidance on glycerol in slush ice drinks after two children fell sick in Scotland in Lanarkshire in 2021 and in Edinburgh in 2022. Both required hospitalization and had symptoms consistent with glycerol intoxication. 

Glycerol is an ingredient in slush ice drinks to prevent the liquid from freezing solid. It is allowed as an additive and there are no limits. Manufacturers can add as much of it as needed to achieve the desired technological function. The level of glycerol in slush ice drinks varies depending on the manufacturer and the product.

Visible warning
The guidance advises that sales of slush ice drinks containing glycerol should be accompanied by a written warning visible at point of sale that states: ‘’Product contains glycerol. Not recommended for children 4 years of age and under.’’

One concern is unlimited refills at theme and activity parks. The FSA said it was aware of a growing number of self-serve options at retail shops, convenience stores, and newsagents. Another problem is that refill offers are often unmonitored. 

Manufacturers are being advised to tell retailers that they should not offer free refill promotions to children younger than 10, to prevent children being from exposed to excessive amounts of glycerol.

An FSA risk assessment found that young children may suffer from headaches and sickness caused by exposure to glycerol. 

At very high levels of exposure – when several products are consumed by a child in a short space of time – glycerol intoxication could cause shock, hypoglycaemia and loss of consciousness. 

Slush ice drinks can contain glycerol as a substitute for sugar to create the slush. The guidance asks businesses to only add glycerol at the minimum quantity technically necessary to achieve this effect. 

Those older than 4 are considered unlikely to suffer ill effects from one slush drink. This is because the effects of glycerol are related to body weight.

Industry action
Adam Hardgrave, FSA head of additives, said while symptoms of intoxication are usually mild, it is important for parents to be aware of the risks – particularly at high levels of consumption. 

“It is likely that there is under-reporting of glycerol intoxication, as parents may attribute nausea and headaches to other factors. We are grateful to those manufacturers who have already taken steps to reduce levels of glycerol, and to those who have already told us they will be adopting our new guidelines,” he said.

One company, Nichols, said it has reformulated Slush Puppie and Starslush products to remove glycerol, as they are predominantly sold in venues popular amongst young children.

The British Soft Drinks Association said members have been working with FSA on the glycerol guidance.

“Our members adhere to all current ingredient legislation including in relation to glycerol, which is authorized as an additive for use in the UK and Europe and has been used for a number of years by manufacturers of slush ice drinks in order to stop the product from freezing. We support this updated FSA communication for the benefit of consumers.”

Food crime assessment
Meanwhile, Food Standards Scotland has launched an online program which allows companies to assess their vulnerabilities to criminality.

The Food Crime Risk Profiling Tool means businesses can assess themselves against a series of statements on topics, such as how they source materials and their supply methods, before being given a report at the end which will highlight areas of good practice as well including guidance on areas they may wish to improve.

Ron McNaughton, head of the Scottish Food Crime and Incidents Unit at FSS, said prevention is the key to winning the battle against food crime.

“Food crime is serious fraud and related criminality in food supply chains. It could include adulteration, substitution or misrepresentation of origin amongst other criminal techniques. So we’ve decided to work with key stakeholders from the food industry and experts who have an interest in tackling fraud in food supply chains to develop an online, food crime risk profiling tool,” he said.

FSS will be holding several free online workshops later this year to help increase authenticity and improve food crime resilience – those who sign up to the tool will receive an invite to the sessions. 

In mid-2022, the FSA also unveiled an online tool to help companies assess their vulnerability to food crime. It was developed by the National Food Crime Unit (NFCU).

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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Porfirios Italian Foods Inc.
Trenton, NJ

A food firm in New Jersey is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

In a June 21, 2023, warning letter, the FDA described a Jan. 13 and 17 and March 17 inspection of Porfirios Italian Foods Inc.’s pasta manufacturing facility in Trenton, NJ.

The FDA determined that the pasta products manufactured in the facility are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. 

At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at their facility. 

Some of the firm’s significant deviation is as follows:

Hazard Analysis and Risk-Based Preventive Controls:

1. The firm did not prepare, or have prepared and implement a food safety plan, as required. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs). The firm’s food safety plan must also include the following:

    1) The written hazard analysis
    2) The written preventive controls
    3) The written supply-chain program
    4) The written recall plan
    5) The written procedures for monitoring the implementation of the preventive controls
    6) The written corrective action procedures
    7) The written verification procedures

However, the firm did not have a food safety plan with any of the required elements. For example, they did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control. Also, they did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system. The firm must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system. Specifically:

a) The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Their facility manufactures pasta products containing allergens such as wheat, milk, and egg. The facility also manufactures a seafood pasta product – ravioli containing the lobster allergen. Additionally, they use shared equipment (i.e., (redacted) and (redacted) filler, and pasta sheeter) and utensils to manufacture pasta products containing different allergen profiles. Therefore, allergens are a known or reasonably foreseeable hazard. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact, including during storage, handling and use, and for labeling to ensure that all food allergens required to be stated are included on the label.

The firm does not have appropriate controls in place for the allergen cross-contact hazard. Their sanitation of the (redacted) mixer and (redacted) filler consists of scraping manually, blowing with compressed air, and wiping with a bleach sanitizing solution. This sanitation practice does not include cleaning with detergent between pasta products containing different allergenic ingredients. For example, they manufacture cheese ravioli, which does not contain seafood such as lobster, on the same (redacted) and (redacted) filler used to manufacture lobster ravioli without cleaning with detergent between products.

b) The firm did not identify and evaluate metal as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. Metal screening in the bottom of wooden-framed sifters was observed to be broken and was missing metal pieces. They do not have metal detectors and are not implementing any other programs, such as visual inspection, to control the metal hazard.

c) The firm did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Their facility manufactures pasta products containing wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON).
The full warning letter can be viewed here.

STC India Private Limited
Mumbai, India

A food firm in India is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

In a July 21, 2023, warning letter, the FDA described a Jan. 12-17 inspection of STC India Private Limited’s food manufacturing facility in Mumbai, India.

The FDA determined that the ready-to-eat (RTE) mouth fresheners (mukhwas) manufactured in the firm’s facility are adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health.

At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at their facility. 

Some of the firm’s significant deviation is as follows:

Hazard Analysis and Risk-Based Preventive Controls:

1. The firm’s hazard analysis for their RTE mukhwas products dated May 10, 2022, did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control, as required. Specifically, their hazard analysis indicated “(redacted)” for biological hazards at the (redacted) step. However, the facility manufactures various mukhwas products which contain ingredients including seeds such as fennel, flax, coriander, watermelon, sesame, and pumpkin, and spices such as cumin, coriander, and black pepper, which have been associated with the hazard of Salmonella. Therefore, the pathogen of Salmonella is a known or reasonably foreseeable hazard. The hazard may be controlled during processing or at suppliers.

The firm’s Feb. 2 response included a revised Food Safety Plan and Preventive Control Plan dated Jan. 19, 2023. However, their revised hazard analysis did not identify bacterial pathogens, such as Salmonella, in ingredients such as seeds and spices as requiring a preventive control. It also does not appear that a (redacted) step has been identified. Their revised food safety plan indicates that “(redacted)”, which appears to indicate this is not a (redacted) step. Further, they did not identify any process or supply-chain preventive controls to address the hazard of Salmonella in these ingredients.

Current Good Manufacturing Practice

2. The firm did not take effective measures to exclude pests from their processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, as required. Specifically, rodent activity was observed throughout their facility as follows:

• On Jan. 12 the investigator observed apparent rodent excreta pellets in storage rooms where raw materials, including fennel seeds, awla, shredded coconut, and various semi-finished mukhwas, were stored and on the terrace where additional raw materials including fennel seeds, sesame seeds, amaranth seeds, pumpkin seeds and awla were stored. Specifically, the investigator observed:

    o at least (redacted) apparent rodent excreta pellets on bags of fennel seeds (coated and uncoated) stored on the shelf close to the wall in the storage rooms on the (redacted) side, and extensive spillage of semi-finished product and raw materials (including Rajwadi mukhwas, Orange mukhwas, and Softy Takada) on the shelf and on the floor
    o at least (redacted) apparent rodent excreta pellets on the floor close to the wall where they stored white plastic containers and blue drums in each storage room on the (redacted) sides.
    o jute bags containing Awla chura (Indian gooseberry powder) stored on the east side storage area with holes exposing the product; apparent rodent excreta pellets were found approximately (redacted) feet from the bags
    o a glue pad placed on the floor for pest control in the (redacted) room storage room on the (redacted) side (second floor), extensively laden with numerous apparent rodent excreta pellets and sprinkled over with raw materials and semi-finished mukhwas

• On Jan. 17, 2023, the investigator observed at least four apparent rodent excreta pellets in the attic space where Fresh Mint Mukhwas are manufactured, along with spilled coconut in that area.

3. The firm did not maintain their plant in a clean and sanitary condition and keep their plant in repair adequate to prevent food from becoming adulterated, as required. Specifically, the investigator observed conditions that may serve as an attractant to pests and may restrict inspection/cleaning activities including:

• bags and plastic drums containing raw and in-process materials including sesame seeds, amaranth, and pumpkin seeds touching the wall in the storage area of the second floor and terrace
• clutter of plastic drums, plastic containers, and bags containing raw and in-process materials on the (redacted) side of the terrace
• clutter of boxes, empty woven polystyrene bags, plastic bags, and other materials on the (redacted) side of the (redacted) roaster
• dried food residue on dirty equipment including cover of the hopper where finished muskhas are processed, ribbon blender, and fill and seal machine
• extensive food residues in the bucket elevator, near the floor

The full warning letter can be viewed here.

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The FDA’s actions regarding PHOs address artificial sources of trans fat. Still, trans fat will not be completely removed from the food supply because it occurs naturally in meat and dairy products and is present at very low levels in other edible oils.

Hydrogenated oil comes in two forms: partially or fully hydrogenated. One use of hydrogenated oil is to preserve the shelf life of food. Partially hydrogenated oil contains trans fat that can raise cholesterol and result in health complications.

The direct final rule: 

• Revises regulations to no longer include PHOs as an optional ingredient in the identity standards for peanut butter and canned tuna. 
• Revises FDA GRAS affirmation regulations to no longer include partially hydrogenated forms of menhaden and rapeseed oils.   
• Revokes the regulation for partially hydrogenated fish oil as an indirect food substance  
• Revokes pre-1958 authorization for using PHOs in margarine, shortening, bread, rolls, and buns. This authorization occurred before the enactment of the Food Additives Amendment of 1958, so these uses of PHOs could not be regulated as food additives. 

In the 2015 final determination, the FDA indicated that there were outdated references to PHOs in regulations that the FDA would address separately. With respect to removing PHOs from the food supply, the FDA established Jan. 1, 2021, as the final compliance date to allow manufacturers time to reformulate foods and ensure an orderly transition in the marketplace.

The FDA is issuing these amendments directly as a final rule because it anticipates no significant adverse comments. After all, FDA declared PHOs no longer GRAS for any human food in 2015. However, the agency is issuing a companion proposed rule in the same issue of the Federal Register in case the direct final rule is withdrawn because significant adverse comments are received, and the agency needs to move forward with a proposed rule to put these changes in place. 

The FDA is accepting comments on both the direct final and proposed rules. Comments must be submitted by 75 days after publication in the Federal Register.

Submit electronic comments at https://www.regulations.gov/. 

Submit written comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

The direct final rule would be effective 135 days after the date of publication in the Federal Register.  

• Federal Register Notice: Direct Final Rule on Revocation of Uses of Partially Hydrogenated Oils in Foods (August 2023) 
• Federal Register Notice: Companion Proposed Rule on Revocation of Uses of Partially Hydrogenated Oils in Foods (August 2023)  
• Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat)

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The state Legislature approved a measure this year making the sales possible, but it specifically bans the sale of unpasteurized, raw milk to wholesalers or retailers. The new law also reinforces the federal ban on the interstate sale of raw milk.

The law also makes it illegal to donate raw milk.

The sale of raw milk products such as cream, cheese or yogurt remains illegal.

Raw milk producers selling direct to consumers are exempted from other dairy, food handling or consumer protection laws.

Public health officials across the nation and most state health and agriculture departments advise that raw milk is dangerous because without pasteurization to kill bacteria and viruses it can cause severe illness. Pathogens often found in raw milk include E. coli, Salmonella and campylobacter.

The sale of raw milk under the new law does not give any liability protections if someone consumes it and becomes ill. Anyone harmed by consuming foods with microbial pathogens may have the option to take legal action to claim monetary damages for their injuries or wrongful death.

Sellers of raw milk should contact an insurance agent and legal counsel for more information on liability and liability protection, according to a statement from the state.

Raw milk has many advocates and consumers, despite the known food safety risks. The North Dakota Department of Agriculture is exempted from, and does not provide, any regulatory oversight of a raw milk facility, and does not provide any assurances for milk safety of a raw milk producer selling to the end consumer.

The state has posted a cautionary statement for consumers. “The Food and Drug Administration has posted many resources for individuals, providing factual information about raw milk and misconceptions about its purported benefits: https://www.fda.gov/food/buy-store-serve-safe-food/raw-milk-misconceptions-and-danger-raw-milk-consumption

“Pasteurized milk is a proven safe product that provides the essential nutrients of a healthy diet, without the risks associated with raw milk,” according to the statement.

The state of North Dakota has published information for raw milk sellers that includes:

• Milk is produced on dairy farms, an environment that naturally contains a plethora of microorganisms, including yeasts, molds, viruses and bacteria. 

• Healthy animals can carry disease-causing germs such as e. coli O157:H7, campylobacter jejuni, and pathogenic serotypes of salmonella. 

• People have also contracted tuberculosis, undulant fever and Q fever from consuming raw milk.

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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La Yongjia Trade Co.
Vernon, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 19 warning letter, the FDA described a Feb. 15-23 Foreign Supplier Verification Program (FSVP) inspection of La Yongjia Trade Co. in Vernon, CA.

The inspection was initiated because of findings of Listeria monocytogenes in samples of fresh enoki mushrooms from the firm’s foreign suppliers, (redacted), located in (redacted), (redacted), located in (redacted), (redacted) and (redacted), located in (redacted), (redacted), located in (redacted), and (redacted), located in (redacted), collected and analyzed by FDA and imported by their company. The firm’s foreign suppliers, (redacted) were placed on Import Alert # 99-23, Detention Without Physical Examination of Fresh Produce Due to Contamination with Human Pathogens, on July 18, 2022, Sept. 23, 2022, June 17, 2022; Feb. 3, 2023, and Sept. 23, 2022, respectively. Fresh enoki mushrooms from their foreign supplier (redacted) were placed on Import Alert # 99-35, Detention Without Physical Examination of Fresh Produce that Appears to have been Prepared, Packed or Held under Insanitary Conditions, on June 14, 2022, respectively. The FDA also notes that fresh enoki mushrooms from their foreign suppliers (redacted) and (redacted) were placed on Import Alert #99-35 on March 13, 2023.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Fresh Enoki Mushrooms from foreign manufacturer and supplier (redacted), located in (redacted).
• Fresh Enoki Mushrooms from foreign manufacturer (redacted) and foreign manufacturer and supplier (redacted), located in (redacted).
• Fresh Enoki Mushrooms from foreign manufacturer (redacted) and foreign manufacturer and supplier (redacted), located in (redacted).
• Fresh Enoki Mushrooms from foreign manufacturer and supplier (redacted), located in (redacted).
•  Fresh Enoki Mushrooms from foreign manufacturer (redacted) and foreign manufacturer and supplier (redacted), located in (redacted).

The full warning letter can be viewed here.

Premier Food Supplies LLC
Troy, MI

An import company in Michigan is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 14 warning letter, the FDA described a March 14-23 Foreign Supplier Verification Program (FSVP) inspection of Premier Food Supplies LLC in Troy, MI.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

1. The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for the foods from the foreign suppliers indicated in the attached list.

2. The firm did not meet the requirement to conduct a written hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required. Although they may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, the firm must document their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. Specifically, for the firm’s Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd., located in India, while they obtained the hazard analysis for each of these products from their foreign supplier, they did not document their review and assessment of the hazard analyses or that the hazard analyses were conducted by a qualified individual, as required.

3. The firm did not meet the requirement to evaluate their foreign supplier’s performance and the risk posed by the food, as required, and document their approval of their foreign suppliers based on this evaluation, as required. Specifically, for their Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd. in India, and Cut Mango Pickle with Garlic imported from (redacted), located in (redacted), they did not provide documentation that they have evaluated their foreign supplier’s performance and the risk posed by the food, as required.

4. The firm did not meet the requirement to perform foreign supplier verification activities as required. Specifically, they did not document their determination of the appropriate supplier verification activity or activities, including the frequency with which the activity or activities must be conducted, for their Boondi Plain (Boondi Salted) and Nimbu Masala imported from Haldiram Snacks Pvt. Ltd. and Cut Mango Pickle with Garlic imported from (redacted), as required, nor did they conduct (and document) or obtain documentation of one or more appropriate supplier verification activities for each of these foreign suppliers before importing these foods and periodically thereafter, as required.

The full warning letter can be viewed here.

Nafta Distributors Inc.
Ontario, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 21 warning letter, the FDA described a Feb. 7-21 Foreign Supplier Verification Program (FSVP) inspection of NAFTA Distributors Inc. in Ontario, CA.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Lollipop and Candy Specialties, imported from (redacted)
• Candy, imported from (redacted)
• Blended vegetable oils, imported from (redacted)
• (Redacted) jam, jelly, preserves, marmalade, butter or candied, and candy, imported from (redacted)
• Cookies, caramel, and candy, imported from (redacted)
• (Redacted) and lollipop, imported from (redacted)
• Milk and cream, or candy bar or ieces, imported from (redacted)
• Gelatin, imported from (redacted)
• Candy specialties, chewing gum, imported from (redacted)
• Gelatin, imported from (redacted)
• (Redacted), lollipop, candy specialties, chewing gum, imported from (redacted)
• (Redacted), jam, jelly, preserves, marmalade, butter and candied, caramel candy bar, soft candy, lollipop, candy specialties, imported from (redacted)
• Candy specialties, imported from (redacted)
• Gelatin, imported from (redacted)
• Peanuts, candy bar, marshmallow candy, chocolate candy, imported from (redacted)
• Pepper sauce, imported from (redacted)
• Candy, imported from (redacted)
• Soda water, imported from (redacted)
• Salt, imported from (redacted)

The full warning letter can be viewed here.

Cheshni Foods LLC
Arlington Heights, IL

An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 14 warning letter, the FDA described a March 22 through April 28 Foreign Supplier Verification Program (FSVP) inspection of Cheshni Foods LLC in Arlington Heights, IL.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Fig Jam and cookies (tea biscuits), imported from (redacted) in (redacted) located in (redacted)
• Tahini, imported from (redacted) located in (redacted)

The full warning letter can be viewed here.

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Changes clarify the role and responsibilities of importers when they bring food into the country.

Food importers must conduct a safety and suitability assessment before the food enters New Zealand, make sure food is stored and transported in a safe way, keep proper records for at least four years, and have a recall plan in case anything goes wrong.

Importers who fail to follow safety rules can face fines of $500,000 ($304,000) for a company, while an individual can be fined $100,000 ($60,800) and jailed for up to two years.

Ensuring safer food imports
Vincent Arbuckle, New Zealand Food Safety deputy director-general, said the move would make food from abroad safer for consumers.

“Most food importers won’t have to make any changes to comply with the new rules, some will have to make minor tweaks, and a small number will have to dramatically improve their procedures,” he said.

“Food importers have always had to ensure their food is safe and suitable; the new rules provide them with clarity on what they need to do to meet their responsibilities.

“We’re sure importers and retailers would like to avoid expensive recalls, like those seen recently with frozen berries and tahini, and complying with these new rules will help them to ensure their food is safe and minimize the likelihood of things going wrong. This means that consumers can be confident that all imported food is subject to consistently high safety standards.”

New Zealand Food Safety began consultations with industry about the revised rules in June 2022 and has been in contact since with importers. Changes were detailed in a previously issued food notice.

All shipments are checked at the border. Unregistered importers will have consignments held until they obtain food importer registration. Some foods present a greater risk to consumers, these are known as foods of high regulatory interest or foods of increased regulatory interest.

These items require food safety clearance and are monitored for specific hazards. 

Requirements follow rules that came into force in July, stating that most businesses have to do a simulated food recall every year. It applies to all firms with a plan or program under the food, wine, or animal products Acts. It also covers food importers and exporters.

The first simulated recall must be done by June 30, 2024, and once every 12 months afterward, unless the company was involved in a genuine recall that shows traceability and procedures were effective.

Updated Salmonella rules
In other developments, chicken producers in the commercial supply chain must have a registered risk management program (RMP) no later than November 2023 to manage the risk of Salmonella Enteritidis.

An RMP is a documented program designed to identify and control hazards in relation to the production and processing of animal materials and products, monitoring and record-keeping and actions if something goes wrong.

The new rules apply to those who produce breeder chickens, day-old chicks (hatcheries), fertile eggs from breeder chickens, layer chickens, rearer laying chickens, and broiler (meat) chickens. They do not cover producers with less than 100 birds that sell chickens or fertile-eggs direct to the consumer or end user only.

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Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

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The measures will be in effect from Sept. 28 to Dec. 20.

According to the CFIA, this action was taken to address the recurring outbreaks of foodborne illnesses related to E. coli O157:H7 in romaine lettuce imported from the United States. Investigations by U.S. authorities have traced the source of the outbreaks to the California Salinas Valley counties of Santa Cruz, Santa Clara, San Benito, and Monterey.

During the designated period, importers of romaine lettuce and salad mixes containing romaine lettuce from the U.S. must adhere to one of the following requirements:

• Declare that the product does not originate from the Salinas Valley counties of California mentioned above, or
• Submit an attestation form and Certificates of Analysis for each shipment, confirming that the romaine lettuce is free from detectable levels of E. coli O157:H7.

The CFIA emphasizes that these temporary SFC license conditions are in addition to existing import requirements. Importers must also comply with other Canadian legislation and fulfill specific conditions at the time of import.

To import romaine lettuce from outside the specified California counties, importers are required to provide Proof of Origin indicating the state and county where the romaine lettuce was harvested.

For romaine lettuce originating from the Salinas Valley counties, the following conditions must be met:

• An attestation, using form Importer’s Attestation for Romaine Lettuce Products from the Salinas Valley, California, United States (CFIA/ACIA 5961; 2023/06), confirming that sampling was conducted in accordance with the temporary SFC license conditions and that E. coli O157:H7 was not detected.
• Certificates of Analysis for each romaine product in the shipment, issued by an accredited laboratory, showing negative results for E. coli O157:H7.

Importers must ensure that romaine lettuce from California has been handled by a certified member of the California Leafy Greens Marketing Agreement (LGMA). Similarly, romaine lettuce from Arizona must be handled by a shipper certified by the Arizona LGMA.

The sampling and testing for E. coli O157:H7 can be performed using two options: finished-product sampling or pre-harvest sampling. In either case, the laboratory conducting the tests must be accredited by an accreditation body conforming to the requirements of ISO/IEC 17025:2017 for specific tests.

The CFIA urges importers to strictly adhere to the sampling requirements to ensure the safety of romaine lettuce shipments to Canada. Failure to comply with the temporary license conditions and import requirements may result in enforcement action taken by the CFIA.

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The deal between the Public Ministry of Minas Gerais (MPMG) and Cervejaria Três Lobos deals with compensation for sickened victims after consuming a beer produced by the company, Cervejaria Backer.

Ten people died, and dozens of others were affected with blindness and facial paralysis.

The agreement covers medical and other treatment costs, salary payments before illness, loss of earnings, food and transport costs, and money for other expenses incurred.

To be entitled to compensation, the causal link between the beer contaminated by diethylene glycol and/or mono ethylene glycol and the damage to each person’s health must be recognized and confirmed by a unit of the MPMG.

Cervejaria Três Lobos will pay R$500,000 ($105,000) to each victim and R$150,000 ($31,500) to each qualifying relative.

The factory in Belo Horizonte was shut down in January 2020. In 2022, MAPA allowed production and sales to restart. The company replaced the refrigerant fluid in its process with a hydroalcoholic solution that contained water and alcohol.

Another party, Empreendimentos Khalil, will allocate 244 lots of its property, located in Perdigão, to contribute to payments. The majority of proceeds from the sale of properties will be used to pay the victims, forming part of the fund managed by the Associação das Vítimas de Intoxicação por Dietilenoglicol.

Source of contaminated beer
Investigations by police in the state of Minas Gerais confirmed the presence of diethylene glycol, used in the beverage cooling process, in samples of the Belorizontina brand beer. The company said it never bought diethylene glycol but did use mono-ethylene glycol. A hole in a tank caused a leak that allowed the coolant liquid circulating in an external system to mix with the drink inside the container.

Fernando Ferreira Abreu, the consumer protection prosecutor of Belo Horizonte, said the agreement ends the complex civil action resulting from the traumatic event.

“Far from repairing the most intimate damage to the victims and their families, due to absolute physical impossibility, the agreement ensures . . . the right to pay compensation, the only existing means of repairing the damage,” he said.

As part of a proposed recovery plan, Cervejaria Três Lobos will maintain a fund corresponding to 5 percent of its net income as an alternative to paying victims in full. It must also pay R$ 1.5 million ($320,000) to the State Fund for Consumer Protection and Defense.

Public prosecutors filed a complaint against 11 people about the incident, and while some hearings have been held, this criminal process is ongoing.

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The decision covers consignments of beef, poultry, and meat products and preparations exported from Brazil to England, Scotland, and Wales. It comes after an audit of Brazil’s sanitary and phytosanitary controls.

Following allegations of fraud in Brazil in 2017 during Operation Carne Fraca, measures were implemented for enhanced checks on certain imported animal products.

For beef and poultry meat products from Brazil, exports to Great Britain no longer need enhanced pre- and post-import testing for Salmonella or the added attestation attached to health certificates confirming Salmonella sampling, methods of analysis used, and results.

The number of microbiological non-compliances in Brazilian poultry products was three in 2020, five in 2021, and four between January and October 2022. In 2022, Brazil exported U.S. $282.2 million in poultry meat and around $134.5 million in beef to the UK. Since Brexit, Brazilian agricultural exports to the UK have increased by 67 percent, reaching $1.8 billion in 2022.

A report sets out the conclusions and recommendations of the audit led by the Department for Environment, Food and Rural Affairs (Defra) in October 2022. The visit reviewed the enhanced Salmonella checks in place for exports of poultry meat and of poultry and beef meat products and preparations.

Post-import physical checks for poultry and beef products will be reduced from 100 percent physical and 20 percent microbiological sampling. Brazil can now re-list certain poultry and beef sites for export to Great Britain.

Auditors visited central and regional authorities, two certification centers, eight slaughterhouses, four other businesses, two farms, and four laboratories. The Ministry of Agriculture, Livestock, and Supply (MAPA) leads official controls and certification of exports of animals and animal products. The Department of Inspection of Animal Products (DIPOA) is responsible for managing the Brazilian Federal Inspection Service (SIF).

Main audit findings
Brazilian authorities have made “significant” progress in correcting the systemic failings in the framework of controls and their application that led to enhanced Salmonella controls. According to Defra, changes to legislation and a restructuring of the authorities have strengthened the regulatory oversight of exports and clarified accountabilities.

However, there was no consistent process for delisting establishments. One site informed authorities it had stopped production in 2020 and requested delisting. At the time of the audit, the list of approved sites for export to Great Britain, published by MAPA, still had this firm as approved, and UK authorities had not been informed.

In beef slaughterhouses, hygienic dressing of carcasses was not done effectively to minimize the risk of contamination, including the risk of Salmonella cross-contamination. Slaughter lines were overcrowded and required constant monitoring and corrective action, such as slowing the line. 

The audit team was told it was a requirement that Salmonella samples in poultry taken for export consignments to Great Britain should be sent to official MAPA labs. However, some results reviewed by auditors suggested this was not always the case. There was also an “inconsistent” understanding and application of Salmonella testing requirements, depending on the frequency of export and product type.

Several pieces of machinery in poultry plants were not cleaned adequately before production started, with feathers and blood residues from the previous processing shift found.

Several recommendations were made around contingency planning and written procedures; delisting establishments; official controls on approved sites; Salmonella controls; and lab capability and microbiological testing.

One recommendation covered the need for plans to ensure sufficient resources are available to undertake inspections at the required frequency, even if changes in risk levels lead to added demand. Another mentioned health marking of beef carcasses being applied inconsistently. In some cases, it was only put on the packaging, not the carcass.

Meanwhile, the Food Standards Agency (FSA) and Food Standards Scotland (FSS) have called for evidence of the UK joining the Comprehensive and Progressive Trans-Pacific Partnership (CPTPP).

Responses will inform FSS and the FSA advice to the Department for Business and Trade, contributing to a report as part of the parliamentary scrutiny process on the Free Trade Agreement. The deadline for submissions is Sept. 10.

Views are wanted on whether and to what extent human health may be affected regarding food safety and nutrition because of provisions in the CPTPP related to trade in agricultural products.

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It continues the 15-year-old jurisdiction of the Eastern District Court over the civil matter involving the concern over RAW FARM LLC, Organic Pasture’s new legal name.

Last March, the U.S. Department of Justice raised possible civil contempt allegations against RAW FARM, Mark McAfee, and Arron McAfee. An evidentiary hearing on that issue was set for Aug. 9, 2023, but has now been canceled by the Consent Decree.

It means that the Court’s jurisdiction continues over the Defendants, and an April 2010 Order remains in effect for all the directors, officers, agents, representatives, attorneys, and others involved.

The RAW FARM defendants, after 60 months, can petition the Food and Drug Administration (FDA) for “relief  from this Decree.”  In the meantime, they must “abide by the decisions of the FDA.”

FDA gets the power of inspections without prior notice. The Decree spells out specific requirements for audits and labeling that must be followed. It includes hiring an independent “labeling expert.”

The Department of Justice reopened the 2008 litigation last March, claiming Organic Pastures, known now as RAW FARM LLC, was violating the April 2010 Permanent Injunction, which imposed restrictions from distributing in interstate commerce unapproved drugs, misbranded food, and raw milk and raw milk products for human consumption.

The production and sale of raw milk by Organic Pastures within California, where it is legal, was not impacted by the April 2010 order. It’s estimated that OP has 60,000 retail customers of raw milk in the Golden State.

In re-opening the case, DOJ said a raw cheese claiming it can cure, mitigate, treat, or prevent human disease, including heart disease, osteoporosis, and viral infections, violates the April 2010 order.  

The Court previously agreed with the DOJ that RAW FARM and the McAfee parties violated the Permanent Injunction Order issued on April 20, 2010.  Before any new testimony was taken, the Defendants agreed to the Consent Decree.

The government also takes issue with RAW FARM’s claim that its raw milk labeled as “pet food” is safe for human consumption.

“Organic Pastures and its principals, Mark and Aaron McAfee, have thus continued their pattern of distributing their products in interstate commerce with unproven claims about the ‘wonders’ of raw milk and its associated products,” said the DOJ petititon.

In that March 2023 petition, the government wanted to hold  RAW FARM/Organic Pastures and McAfee in contempt with contempt sanctions.

While the 2008 civil case was pending, Organic Pastures 15 years ago also faced similar charges in a criminal action involving similar conduct. The criminal matter concluded in settlement by plea agreement on Dec. 22, 2008, and was approved by Magistrate Judge Sandra M. Snyder on Jan. 9, 2009. 

 Pursuant to the plea agreement, Organic Pastures pleaded guilty to two counts of misdemeanor introduction and delivery for introduction into interstate commerce of misbranded food. McAfee entered into a deferred prosecution agreement whereby he agreed to the filing of a two-count information charging him and Organic Pastures with the same violations. 

In these agreements, both defendants admitted that: (1) on two separate occasions “one or more of defendant Organic Pastures’ agents or employees, with the knowledge and consent of Organic Pastures, caused [a] box of raw milk and dairy products, labeled as or otherwise represented to be ‘pet food,’ to be sent by defendant Organic Pastures” into interstate commerce, “knowing that the intended use of such foods and/or dietary supplements was for human consumption;” and (2) Organic Pastures’ raw milk and raw milk products “were foods and/or dietary supplements, and were misbranded when so introduced into or delivered for introduction into interstate commerce, in that they were falsely and misleadingly labeled as, or otherwise represented.

In the April 2010 order, Organic Pastures and McAfee acknowledged violating federal food safety law by introducing and/or distributing raw milk into interstate commerce in 2007. They also conceded that they violated the “unapproved raw drugs” provision of the FDA. 

They did oppose the order as inconsistent with the State of California’s regulation of the raw milk industry.

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