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.

(To sign up for a free subscription to Food Safety News,click here)

No additional cases have been identified at this time.

Public Health recommends hepatitis A vaccination for patrons who consumed food or beverages from Panda Express between July 21–Aug. 4, 2023. Vaccination must be given within two weeks after exposure to be effective. Vaccination is not necessary for people who previously completed the hepatitis A vaccine series or are known to have had a past infection.

Hepatitis A vaccinations might be available through local pharmacies or physicians’ offices. In addition, Public Health will be offering free hepatitis A vaccinations to exposed persons at:

Antelope Valley Health Center
335 E Ave K 6 B
Lancaster, CA 93535
Monday, Aug. 14, 12:30 p.m. – 4:30 p.m.
Tuesday, Aug. 15 through Friday, Aug. 18, 8 a.m. – 4:30 p.m.

Most people will have protective levels of antibody after one dose of the Hepatitis A vaccine but can choose to visit their primary care provider to complete the series with a second dose 6 months after receiving their first dose.

Hepatitis A is a liver infection caused by the hepatitis A virus. Hepatitis A is highly contagious and can be spread from person-to-person through the fecal-oral route (when contaminated feces from an infected person are somehow ingested by another person during close personal contact) or by eating or drinking contaminated food or water). Most adults with acute hepatitis A will have symptoms that may include fever, fatigue, nausea, vomiting, abdominal pain, dark colored urine and jaundice (yellowing of the skin or eyes). Symptoms vary from mild to severe. There is no specific antiviral treatment. While prompt vaccination is likely to prevent infection, infection may occur in those who receive vaccination too late. Patrons who develop symptoms should call their provider and for a Hepatitis A test.

Vaccination is the best way to prevent disease. In addition, infection can be prevented by vaccination after a known exposure to a person with infectious hepatitis A. Older adults and people with weakened immune systems might benefit from receiving immune globulin (IG) in addition to hepatitis A vaccination for prevention after an exposure. For any questions about hepatitis A or the need for immune globulin, Public Health recommends that you speak to your primary care provider. If you do not have a regular provider, call 2-1-1 for assistance.

Public Health will continue monitoring all known individuals who may have been exposed to individuals ill with hepatitis A.

For more information, contact: http://publichealth.lacounty.gov/acd/diseases/hepa.htm

(To sign up for a free subscription to Food Safety News,click here)

The Court’s state’s rights philosophy upheld the animal housing requirements of Proposition 12 but left pork producers and the National Farm Bureau wondering what happened.

And it left rural America to come up with a “big government” solution, which they say is needed to preserve the rights of state and local governments.

But animal activists say the EATS Act could jeopardize more than a thousand public health, safety, and welfare laws, according to a new research report. 

A new report analyzing the “Ending Agricultural Trade Suppression Act” (“EATS Act”) and its potential widespread consequences was released Wednesday by the Brooks McCormick Jr. Animal Law & Policy Program at Harvard Law School.

The 48-page report reveals that the likely negative impacts of the EATS Act could range far more widely than its sponsors envision – threatening states’ rights, consumer safety, and farmers’ livelihoods. 

The report also raises several questions about the constitutionality of the EATS Act itself. This research builds upon Harvard’s 2018 report on the Protect Interstate Commerce Act by outlining the EATS Act’s legislative history and legal background, providing a section-by-section legal analysis of the bill, and identifying a range of regulatory areas the EATS Act could disrupt. The report additionally provides a 100-page state-by-state index listing of more than 1,000 state laws and regulations that potentially could be challenged and invalidated if the EATS Act becomes law.

The “Ending Agriculture Trade Suppression or EATS Act” is the so-called solution.   Rural Republicans are signing on to the legislation. They think the EATS Act would overturn the Supreme Court’s ruling on Prop 12 and prevent California from imposing its will on farmers and ranchers outside the Golden State.

As the report details, if enacted either on its own or as part of the U.S. Farm Bill, the EATS Act could create a regulatory race to the bottom by substantially curtailing the ability of state and local governments to regulate the production and sale of agricultural products – potentially nullifying over a thousand state laws and likely many more.

Senator Roger Marshall and Rep. Ashley Hinson stated that they introduced the latest EATS Act (S.2019/H.R.4417) in direct response to the U.S. Supreme Court’s May 2023 decision in National Pork Producers Council v. Ross to uphold California’s farmed animal confinement law, Proposition 12. 

“The language of the EATS Act leaves open significant questions, and each of these unresolved questions has the potential to disrupt entire industries and billions of dollars of investment,” says Kelley McGill, Regulatory Policy Fellow with the Brooks McCormick Jr. Animal Law & Policy Program, and author of the new report. “If enacted, the legislation would spawn substantial litigation through its citizen suit provision, likely subjecting state and local governments to countless costly lawsuits. It could be years before courts are able to provide a functional understanding of the EATS Act. Even for producers who initially might benefit from the EATS Act, this uncertainty and disruption could be extensive.”

The EATS Act stems from legislation initiated by former Iowa Rep. Steve King which unsuccessfully sought to counter state animal protection laws.

The report outlines several specific concerns with the EATS Act. One is that key terms such as “standard,” “condition,” and “preharvest production” are not defined anywhere in the bill – while other terms such as “agricultural products” are defined so broadly as to include vaccines, vitamins, and even narcotics potentially. The EATS Act’s Rule of Construction also attempts to freeze future legislative progress by preventing any further regulation of agricultural products where none currently exists. Lastly, the EATS Act tries to create a citizen suit provision that essentially would permit anyone to legally challenge any regulation of any agricultural product sold in interstate commerce. This private right of action also would invert longstanding burdens of proof by placing the onus on states to prove they likely would prevail at trial and suffer irreparable harm in order to prevent their laws from being enjoined.

For some agricultural products, the Harvard study claims the EATS Act threatens to create regulatory voids or regulatory ceilings where none existed before, leaving entire sections of industries unregulated. A number of laws the EATS Act could obstruct were drafted for the benefit of consumers, so without these protections, product quality, transparency, and safety may suffer.

“The EATS Act could tip the balance of states’ rights and circumvent decades of settled constitutional jurisprudence by federally overriding the expressed will of U.S. voters – shifting agricultural oversight away from states and localities toward federal administrative agencies and the federal judiciary,” said Chris Green, the Harvard program’s executive director who supervised and edited the report. “Our report seeks to bring an informed perspective to the conversation around such legislation and identify a range of very real unintended consequences that could result from the EATS Act’s passage or inclusion in the U.S. Farm Bill.”

The report also finds that while some agricultural producers may face less oversight because of the EATS Act, those same producers could suffer negative consequences from the federal legislation. A significant portion of the laws and regulations the EATS Act potentially could prohibit indeed were enacted to safeguard agricultural production itself. Such regulations related to importing and inspecting livestock and plants into states exist to protect producers from costly diseases and pests such as highly pathogenic avian influenza, African swine fever, and the emerald ash borer. The EATS Act’s potential invalidation of these regulations could jeopardize entire sectors of the agricultural economy and threaten the livelihoods of local producers. If the EATS Act were adopted, producers who already have made significant investments in updating infrastructure in response to state measures such as Prop 12 could also see those investments’ economic value plummet without receiving compensation for their losses.

(To sign up for a free subscription to Food Safety News, click here.)

Approved unanimously by the LGMA Advisory Board, the study aims to collect and analyze pathogen test data for romaine lettuce from LGMA members, encompassing both pre-harvest and post-harvest testing.

Jan Berk, LGMA Chair, expressed the significance of “Romaine Test & Learn,” stating, “This program will allow our members’ individual testing data to collectively provide meaningful, aggregated data to better understand potential risks.” According to LGMA,  the study was Inspired by the Aviation Safety Information Analysis and Sharing program that revolutionized commercial aviation through data aggregation and sharing.

Tim York, LGMA CEO, emphasized the importance of data sharing in improving safety, citing the airline safety model. He stated, “That is why we are embarking on this project – to make lettuce even safer for consumers to enjoy.”

While testing is not mandatory for LGMA members, those who conduct tests will need to adhere to minimum protocols for sample collection and testing. It is estimated that over 90 percent of LGMA members already perform romaine lettuce pathogen testing.

To ensure comprehensive data collection, LGMA members will anonymously input their testing data into GreenLinkTM data sharing and data analytics platform managed by Western Growers. The collected data will include sample size, sample date, sample stage, sampling region, commodity description, organisms tested, test result, and organism type if applicable.

Industry experts and third-party scientists will conduct a scientific analysis of the data to identify key learnings. The analysis will focus on the frequency of pathogen detection per region, differences in pathogen positivity rates based on the location and timing of sample collection, alignment of test results with the risk profile associated with leafy greens, and indications for potential changes to the current LGMA food safety standards.

About LGMA 

The California LGMA is a food safety program that brings farmers together to enhance the safety of lettuce and leafy greens. LGMA members responsible for producing more than 70 percent of the nation’s lettuce and leafy greens, totaling more than 30 billion servings annually. The California LGMA verifies food safety practices, enforces through government audits, and promotes continuous improvement.

(To sign up for a free subscription to Food Safety News, click here.)

If a New Farm Bill passes Congress before the end of 2023, it’s unlikely that it will be used to overturn California’s Proposition 12. It’s been tried before and did not get anywhere then. The content of Farm Bills usually involve consensus, not overkill. The EATS Act could upset up to 1,000 state laws, much like the so-called King Amendment did before 2018.

Much opposition to Prop 12 involves the one-time cost to the pork industry for more space for breeding pigs. California had its role in regulating goods sold within its borders affirmed, meaning its “humane and commonsense” animal housing standards can take precedence over the more extreme confinement practices favored by some national pork producers.

If it had been added to the Farm Bill back then, the King Amendment would undermine numerous state agriculture laws and infringe on states’ fundamental role in establishing regulations within their own borders.

One last attempt to stop Prop 12 is being made with a bill titled: “The Ending Agriculture Trade Suppression Act,” or the EATS Act. Whether on a stand-alone basis or inclusion in the New Farm Bill, the EATS Act attempts to bring down Prop 12.

The order thus allows for continued sell-through and distribution of noncompliant pork produced before July 1, so long as the product is in commerce by July 1. The order does not provide any allowances for products produced after July 1, 2023, nor does it provide any allowance for pigs on the ground but not yet harvested before July 1, 2023.

The May 11 ruling by the U.S. Supreme Court on California’s Proposition 12 is not taking effect until at least next year. That’s because the Sacramento Superior Court is permitting pork in the supply chain as of July 1 to continue to be sold in California through Dec. 31 this year.

Proposition 12 imposes minimum confinement standards for egg-laying hens, veal calves, and pigs used to produce shell eggs, liquid eggs, whole veal meat, and whole pork meat sold anywhere in California. The law means that those products produced in other states are not eligible for sale in California unless the provisions of the California law are met.

The law further restricts the sale of these products in California if they are derived from animals not raised in compliance with the state animal housing standards. 

(To sign up for a free subscription to Food Safety News, click here.)

The amendment, which means the bill will need another vote by the California Assembly, appears to only add “human consumption” as a requirement for when certain substances are banned by AB-418.

The food safety bill says that “commencing Jan. 1, 2025, a person or entity shall not manufacture, sell, deliver, distribute, hold, or offer for sale in commerce a food product for human consumption that contains any of the following:

(1) Brominated vegetable oil (CAS no. 8016-94-2).

(2) Potassium bromate (CAS no. 7758-01-2).

(3) Propylparaben (CAS no. 94-13-3).

(4) Red dye 3 (CAS no. 16423-68-0).

(5) Titanium dioxide (CAS no. 13463-67-7).

The human consumption amendment was reported by the Senate Committee of Health’s chairman and was added by AB-418’s author, Rep, Jesse Gabriel. It was then read a second time, amended, and re-referred to the Senate Committee on Health.

As it went to the California Senate, legislative staff provided an analysis of AB 418 that included the following pro and con arguments.

Arguments in Support
Supporters such as the EWG, Consumer Reports, and Breast Cancer Prevention Partners state the chemicals this bill prohibits are chemicals associated with serious health risks, such as increased risk of cancer, harm to the reproductive system, and harm to the immune system. But because of the FDA’s inaction and regulatory loopholes, these chemicals are found in many food products, such as snacks, candy, and soda consumed by children in California and the United States.

EWG and Consumer Reports also state:

1. This bill does not interfere with ongoing federal regulation of food additives and federal law does not preempt state action on these additives;
2. Federal reviews of food additives are neither comprehensive nor active and regularly allow hazardous additives to be sold to consumers. The GRAS (Generally Recognized As Safe) loophole, originally meant for common ingredients, is exploited by companies who appoint industry-favoring panelists to designate chemicals as safe;
3. The FDA regularly fails to respond to petitions and meet other federal statutory requirements to restrict additives that pose public health risks. For example, Red dye no. 3 has been banned from cosmetics since 1990 and yet it continues to be allowed in food;
4. Existing California law does not restrict these toxic chemicals in food; and,
5. Ingredient and warning labels are insufficient alone to protect consumers.

Arguments in Opposition
A coalition of opposition that includes the Consumer Brands Association, the International Association of Color Manufacturers, the National Confectioners Association, and the American Bakers Association oppose this bill. The opposition indicates the federal government has a comprehensive food safety process that reviews food additives. In addition, California has several laws that require removing chemicals from foods, attaching warning labels, and checking alternatives if those food additives are unsafe or expose consumers to allergies. All five of these additives have been thoroughly reviewed by the federal and state systems and many international scientific bodies and continue to be deemed safe. They also claim that the food safety process is active and should be allowed to continue the appropriate review of these five and all additives. Several substances this bill proposes to ban are subject to petitions to these government entities initiated by many organizations supporting this bill. Scientific regulators work through these processes and make determinations to establish recognized safe thresholds. Then, when appropriate and supported by peer-reviewed scientific evaluations, they require additional labels or removal from the market. Additionally, the opposition points out that there is a comprehensive system that requires ingredient labeling allowing consumers to make informed decisions. The opposition concludes that the federal government and California have developed one of the world’s most robust and protective systems for food safety.

Pro or con, the analysis reports that according to the Assembly Appropriations Committee, the Department of Justice (DOJ) anticipates minor and absorbable costs as a result of this bill but notes as numerous bills this session may result in no significant impact on DOJ, should an aggregate of these bills become law, DOJ would need to request additional resources to process the increase to its workload.

(To sign up for a free subscription to Food Safety News, click here)

Jessie Burmester, an epidemiologist from the health department, told KSBY news that 97 cases have been confirmed in connection with the outbreak earlier this month. While Burmester did not disclose the name of the restaurant involved, she revealed that the investigations consistently pointed to the same establishment.

“Our primary objective during investigations is to identify a common source or exposure point,” Burmester said. “Thus far, all individuals reporting illness have consistently provided the name of the restaurant.”

On May 15, the Public Health Department officially declared an outbreak after receiving more than two reports of the same exposure source. Further investigations indicated that some affected individuals began experiencing symptoms as early as May 11.

Upon identifying the outbreak, the Public Health Department took action to prevent further spread of the norovirus. They required the restaurant to initiate intensive cleaning and disinfection measures and launched an investigation to determine the source of the illnesses, according to Burmester.

Burmester provided some insight into the prevalence of norovirus outbreaks in California. “In California alone, we witness around 2,500 norovirus outbreaks every year.”

The San Luis Obispo County Public Health Department urges individuals who suspect they may have contracted norovirus to seek medical attention and report their illness to local public health departments. Furthermore, they emphasize the importance of taking necessary precautions to minimize the risk of infection, especially in settings where food is prepared and consumed.

Symptoms of norovirus infection may include severe vomiting and/or diarrhea, nausea, muscle aches, fever, and headache, according to the U.S. Centers for Disease Control and Prevention. Symptoms typically start 12 to 48 hours after exposure and can last for one to three days. Most people recover without treatment, however, some may need medical attention for dehydration.

Norovirus is highly contagious and infected people can spread the infection easily to others. The virus can live on surfaces for long periods of time. Droplets in the air from the vomiting of infected people can also spread the virus to people and contaminate surfaces.

To prevent others from getting sick always wash hands carefully with soap and warm water after using the bathroom, changing diapers or caring for potentially infected people. Use soap and water to clean toilets or other areas that may be soiled with feces or vomit. 

Wash soiled clothing and bedding in hot water and detergent. Soft surfaces that cannot be laundered can be steam cleaned.

(To sign up for a free subscription to Food Safety News, click here)

I must admit, in 30 years of doing food safety, I seldom recall a health department withholding from the public the source of an outbreak – even Norovirus.

I am reminded by a story some 10 years ago – After Food Safety News broke the story that Taco Bell was the mysterious “Restaurant Chain A” linked to a Salmonella outbreak that sickened 68 people in 10 states, ABC Evening News praised Food Safety News for shining light on this story and the issue of the government’s lack of transparency when businesses make people sick.  Other media, such as the LA Times, Reuters, Daily Mail, The Consumerist, CBS News,Huffington Post, Fox News, and MSNBC, also hailed Food Safety News for shinning the light on the mystery taco restaurant.  Most recently, Barry Estabrook wrote a piece for The Atlantic detailing Food Safety New’s muckraking skills, but praised me and not the people who did all the work.

The San Luis Obispo Tribune reports that an outbreak of norovirus stemming from a North County restaurant has sickened close to 100 people, according to the San Luis Obispo County Public Health Department. SLO County Public Health Epidemiologist Jessie Burmester said 97 people have been reported sick as part of a confirmed norovirus outbreak earlier this month. Burmester said the Public Health Department traced the “unusual, very large community outbreak” back to a North County restaurant, though she did not disclose the name of the business.

“When we perform our investigations, we’re really looking for a common source or exposure point,” she said. “Individuals have provided the name of the restaurant consistently for all the individuals that have reported on behalf of the 97 people so far.” Burmester said the Public Health Department reached its threshold for an outbreak — two reported cases in separate households — on May 15. That day, the agency received more than two reports about the same exposure source, she said. Follow-up investigation showed some people experiencing symptoms of norovirus tied to that facility as early as May 11, Burmester added.

Once it was identified, the Public Health Department began working to help eliminate further spread by pushing “mass cleaning and disinfection” of the restaurant, as well as attempting to track where the cases originated. The restaurant in question has been cleaned three times since the outbreak was first reported, she said. “This has been particularly challenging outbreak,” Burmester said, “but it is not abnormal to see norovirus spread like this, because it doesn’t take much of the virus to spread at all.”

Norovirus is a nasty bug.

Noroviruses are estimated to cause 23 million cases of acute gastroenteritis (commonly called the “stomach flu”) in the U.S. each year, and are the leading cause of gastroenteritis. In addition, norovirus outbreaks may be the most common foodborne illness outbreaks. Noroviruses can cause extended outbreaks because of their high infectivity, persistence in the environment, resistance to common disinfectants, and difficulty in controlling their transmission through routine sanitary measures.

The norovirus is transmitted primarily through the fecal-oral route and fewer than 100 norovirus particles are said to be needed to cause infection. Transmission occurs either person-to-person or through contamination of food or water. Transmission can occur by:

· Touching surfaces or objects contaminated with norovirus and then placing that hand in your mouth
· Having direct contact with another person who is infected with norovirus and showing symptoms
· Sharing foods or eating utensils with someone who is ill
· Exposure to aerosolized vomit
· Consuming food contaminated by an infected food handler.

Juicer Connections Inc.
Los Angeles, CA

A company in California is on notice from the FDA for serious violations of the Hazard Analysis and Critical Control Point (HACCP) and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation, as well as misbranding violations.

In an April 11, 2023, warning letter, the FDA described an Oct. 24 through Nov. 25, 2022,  inspection of Juicer Connections, Inc.’s facility in Los Angeles, CA.

The FDA’s inspection revealed that the firm was not in compliance with FDA regulations and resulted in the issuance of an FDA Form 483. 

Some of the significant violations are as follows:

Hazard Analysis and Critical Control Point (HACCP):

1. The firm did not fully implement the monitoring, verification and recordkeeping procedures listed in their HACCP plan.

2. The firm did not validate their HACCP plan is adequate to control food hazards at least once within 12 months after implementation.

3. The firm must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with the current good manufacturing practice requirements, that are both appropriate to their plant and the food being processed. However, they failed to monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with CGMPs in the following areas:

a) On Oct. 26, 2022, they failed to monitor handwashing with sufficient frequency to ensure that hands are washed thoroughly at any time when the hands may have become soiled or contaminated. This is related to prevention of cross contamination from insanitary objects to food.

b) On Oct. 26, 2022, they failed to monitor all plant equipment used in manufacturing, processing, packing, or holding food to ensure it was adequately maintained to protect against contamination. This is related to prevention of cross contamination from insanitary objects to food. The hose installed above the fruit washing tank was observed to be leaking and dripping water directly into the fruit washing tank during production when washing watermelons. The hose was also observed to have a buildup of debris. Their employee stated that this hose is also used for the water ingredient in the reconstitution of juice concentrates.

c) On Oct. 26, 2022, they failed to monitor plumbing with sufficient frequency to ensure that it was adequately maintained to provide adequate floor drainage. This is related to prevention of cross contamination from insanitary objects to food. The only floor drain in their production room was observed to be clogged, and standing water was observed under and around the fruit cutting table during production.

d) On Oct. 26, 2022, they failed to monitor for the presence of pests in the food plant with sufficient frequency to ensure that pests are not allowed in any area. This is related to the exclusion of pests from the food plant. Multiple fly-like insects were observed in the production room during production.

e) On Oct. 26, 2022, they failed to monitor the conditions and practices during processing with sufficient frequency to ensure that cleaning and sanitizing of utensils and equipment was conducted in a manner that protected against contamination of food, food-contact surfaces, or food-packaging materials. This is related to prevention of cross contamination.

i) While an employee was observed using a hose to spray the bottling machine, subsequent splashing was observed going onto the table with exposed gallon bottles staged for filling. Subsequently, the same bottles were filled with watermelon juice. The bottles were not washed or rinsed prior to being filled.
ii) The firm’s employees used (redacted) (as measured by our FDA-issued test strips) to pre-rinse the food contact surfaces of their fruit bath tank, fruit grinder/blender, production utensils, and bottle filling machine. They did not conduct a water rinse or allow the (redacted) to air dry on food contact surfaces prior to use; after the pre-rinse with (redacted), they immediately proceeded to use the aforementioned equipment to manufacture watermelon juice.

f) On Oct. 24, 2022, they failed to monitor the conditions and practices during processing with sufficient frequency to ensure that drip or condensate from fixtures, ducts and pipes does not contaminate food. This is related to the safety of water that comes into contact with food. Ice buildup was observed in the freezer on both the ceiling and floor. Drip condensate was observed dripping from the freezer ceiling onto a bucket of fruit punch concentrate with a broken lid.

Misbranding Violations

1. The firm’s “The Juice Connection Liquid Gold Watermelon Juice 16 oz. and 128 oz.” and “The Juice Connection Liquid Gold Carrot Juice 16 oz.” products are misbranded in that they are false and misleading because the vignette depicts many fruits and vegetables, most of which are not ingredients in or present as flavors in these products. For example, the product labels use a graphic that depicts lemon, lime, orange, kiwi, tomato, artichoke, pineapple, mango, banana, green onions, grapes and possibly star fruit but the only watermelon or carrot juice is used in their production.

2. The firm’s “The Juice Connection Liquid Gold Watermelon Juice 16 oz. and 128 oz.” and “The Juice Connection Liquid Gold Carrot Juice 16 oz.” are misbranded in that they purport to be pasteurized products because the labels bear the statement “pasteurized for your safety.” However, these foods have not been subjected to a safe process or treatment that is prescribed as pasteurization for such food in a regulation nor have they submitted a notification to the Secretary, including effectiveness data regarding the process or treatment as required by that section. Specifically, these juices are not pasteurized, but are instead subject to high pressure processing (HPP).

3. The firm’s “The Juice Connection Liquid Gold Watermelon 16 oz, and 128 oz,” “The Juice Connection Liquid Gold Carrot 16 oz,” “Simply Wholesome Watermelon 16 oz,” and “Simply Wholesome Carrot 16 oz” products are misbranded in that the products are fabricated from two or more ingredients and each ingredient is not declared on the label by its common or usual name and they purport to be beverages containing vegetable or fruit juice but fail to bear a percentage.

4. The firm’s “The Juice Connection Liquid Gold Watermelon 16 oz, and 128 oz.,” “The Juice Connection Liquid Gold Carrot 16 oz,” “Simply Wholesome Watermelon 16 oz.,” and “Simply Wholesome Carrot 16 oz.” products are misbranded in that the nutrition facts information is not provided in accordance with regulation. 

5. The firm’s “The Juice Connection Liquid Gold Carrot Juice 16 oz.,” “Simply Wholesome Watermelon 16 oz.,” and “Simply Wholesome Carrot 16 oz” products are misbranded in that the product labels fail to bear the common or usual name of the food. 

6. The firm’s “The Juice Connection Liquid Gold Watermelon 16 oz, and 128 oz.” and “The Juice Connection Liquid Gold Carrot 16 oz” products are misbranded in that the product labels fail to include the place of business of the manufacturer, packer or distributor. Specifically, the products list the name of the firm and the telephone contact information but fails to include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.

Label Comments

• The labels fail to provide the net quantity of contents statement in terms of fluid measure which is required if the food is liquid. Instead, the labels provide this declaration in terms of weight (oz.). In the case of liquid measure, declaration of the net quantity of contents is to be in the largest whole units (quarts, quarts and pints, or pints, as appropriate) with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart.
• If ascorbic acid or citric acid are used as preservatives, they must be declared in the ingredient list stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention.”
• The name and address of the responsible firm is not declared on the information panel on the Simply Wholesome Carrot 16 oz and the Simply Wholesome Watermelon 16 oz labels. If there is insufficient space on the information panel for all required information, the Nutrition Facts label can move to any alternate panel.

HACCP Comment

FDA inspection found that the firm has one HACCP plan for all the juice products they process titled “HACCP Plan for Ready to Drink Refrigerated High Pressure Processed (HPP) Apple and Fruit Juices from Concentrates and Fresh Fruit Products” with “Date: June 24, 2019”. However, the HACCP plan does not list and is not specific to each type of juice they process. The plan may only group types of juice products together, or group types of production methods together, if the food hazards, critical control points, critical limits and procedures required to be identified and performed are essentially identical, provided that any required features of the plan that are unique to a specific product or method are clearly delineated in the plan and are observed in practice.

The full warning letter can be viewed here.

(To sign up for a free subscription to Food Safety News, click here.)

La Aldea Distributors Inc.
San Antonio, TX

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

In a Jan 27, 2023, warning letter, the FDA described an Oct. 20 through Nov. 1, 2022, Foreign Supplier Verification Program (FSVP) inspection of La Aldea Distributors Inc in San Antonio, 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. 

The significant violations are as follows:

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

• Quince paste imported from (redacted)
• Honey from imported from (redacted)
• Guava jam imported from (redacted)

The full warning letter can be viewed here.

Five Star Trading IL Inc.
Chicago, 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 March 29, 2023, warning letter, the FDA described a Nov. 21 through Dec. 12, 2022, Foreign Supplier Verification Program (FSVP) inspection of Five Star Trading IL, Inc. in Chicago, 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. 

The significant violations are as follows:

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

2. The firm did not meet the requirement to conduct and document (or obtain documentation of) one or more of the supplier verification activities for each foreign supplier before importing the food and periodically thereafter. Specifically, they did not conduct and document (or obtain documentation of) one or more such supplier verification activities for their foreign suppliers (redacted) and (redacted), both located in (redacted), before importing dried black peppercorn and dried black fungus, respectively, and periodically thereafter. During the inspection, they provided their FSVP for dried black peppercorn, which lists the verification activities that are to be conducted, including review of the following documents: Food Safety Plan or HACCP plan ((redacted) or upon reassessment); GMP program, SSOP, and third-party audits ((redacted)); certificate of analysis (microbiological and chemical) ((redacted)); and finished product testing (biological, chemical, physical) ((redacted)). However, while they provided records of finished product testing for dried black peppercorn, they did not document that they conducted any of the other listed verification activities. In their FSVP for dried black fungus, they documented that they determined verification activities were a review of the following documents: HACCP plan ((redacted) or upon reassessment); GMP program, SSOP, and third-party audits ((redacted)); certificate of analysis ((redacted)), and finished product testing (biological, chemical, physical) ((redacted)). However, in their email responses dated Dec. 27, 2022, their documentation of verification activities for dried black fungus included only copies of the foreign supplier’s HACCP plan and Sanitation Standard Operating Procedures.

3. The firm did not promptly document their review and assessment of the results of a verification activity that was conducted by another entity. Specifically, they did not have documentation that they reviewed and assessed the food product testing laboratory report for their dried black peppercorn imported from (redacted), and their foreign supplier’s HACCP plan and Sanitation Standard Operating Procedures for their dried black fungus imported from (redacted).

4. The firm must make all records required under this subpart available promptly to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, they must provide within a reasonable time an English translation of records maintained in a language other than English. However, they did not provide an English translation of the following FSVP document after the investigator’s request of the referenced document in English: finished product laboratory report for dried black peppercorn imported from (redacted). To date they have still not provided the requested translation of this document.

The full warning letter can be viewed here.

Santa Cruz Produce Inc.
Nogales, AZ

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

In a March 8, 2023, warning letter, the FDA described a Nov. 14, 2022, Foreign Supplier Verification Program (FSVP) inspection of Santa Cruz Produce, Inc. in Nogales, AZ.

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, the firm did not develop an FSVP for any of the foods they import, including each of the following:

  a. Fresh Mango, imported from (redacted)
  b. Fresh Kabocha Squash, imported from (redacted)
  c. Fresh Kabocha Squash, imported from (redacted)

The full warning letter can be viewed here.

Milky Way International Trading Corporation
Norwalk, CA

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

In an April 14, 2023, warning letter, the FDA described a Nov. 4 and Nov. 17, 2022, Foreign Supplier Verification Program (FSVP) inspection of Milky Way International Trading Corporation in Norwalk, CA.

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. Specifically, the firm did not develop an FSVP for the following foods:

• Mushroom, Common (Agaricus Bisporus), Pieces And Stems, Sliced imported from (redacted)
• Artichoke (Microgreen) and Artichoke (Leaf & Stem Vegetable) imported from (redacted), located in (redacted)
• Asparagus (Microgreen) and Asparagus (Leaf & Stem Vegetable) imported from (redacted), located in (redacted)
• Jerusalem Artichoke (Root & Tuber Vegetable) imported from (redacted), located in (redacted)
• Corn (Vegetable) imported from (redacted), located in (redacted)
• Orange (Citrus) imported from (redacted), located in (redacted)
• Pear (Core Fruit) imported from (redacted), located in (redacted)
• Peach (Pit Fruit) imported from (redacted), located in (redacted)
• Asparagus (Microgreen) and Asparagus (Leaf & Stem Vegetable) imported from (redacted), located in (redacted)
• Orange (Citrus) imported from (redacted), located in (redacted)
• Orange (Citrus) imported from (redacted), located in (redacted)
• Fruit Cocktail, Mixed Fruits imported from (redacted), located in (redacted)
• Peach, Jam, Jelly, Preserves, Marmalade, Butter Or Candied imported from (redacted), located in (redacted)
• Other Fruits And Subtropical/Tropical Fruit, Mixed, Toppings And Syrups imported from (redacted), located in (redacted)
• Mixed Fruit, N.E.C. imported from (redacted), located in (redacted)
• Peach (Pit Fruit) imported from (redacted), located in (redacted)
• Horseradish, Prepared imported from (redacted), located in (redacted)
• Bamboo Shoots (Microgreen) and Bamboo Shoots (Leaf & Stem Vegetable) imported from (redacted), located in (redacted)
• Heart Of Palm (Leaf & Stem Vegetable) imported from (redacted), located in (redacted)

2. The firm did not meet the requirements to perform foreign supplier verification activities for the products they import. Specifically, they did not meet the requirement to, before importing a food from a foreign supplier, determine and document which verification activity or verification activities, and the frequency with which such verification activity or activities must be conducted, are needed to provide adequate assurances that hazards requiring a control in the food they import have been significantly minimized or prevented. Their FSVPs for Strawberry Syrup and Blueberry Syrup imported from their foreign supplier (redacted), located in (redacted) and their FSVP for their Canned Coconut Cream imported from their foreign supplier (redacted), located in (redacted), require that their suppliers provide certain information, including food safety audit information, as part of their supplier verification activities. However, none of these FSVPs indicate the frequency with which this verification activity must be conducted. Further, when we asked if they documented the frequency of their verification activities, they did not provide an answer or any further records of this verification activity. In addition, while they may rely on third-party food safety audits as part of their foreign supplier verification activities, they must ensure the audit considers applicable FDA food safety regulations. For their foreign supplier (redacted), located in (redacted), which is their supplier for their Strawberry Syrup and Blueberry Syrup products, they provided an audit certificate performed by (redacted). While the certificate states that their supplier met the requirements of “Global Standard for Food Safety Issue 6: July 2011”, there is no indication that the audit considered applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations. Additionally, there is no indication that they reviewed or assessed the results of this audit using a qualified individual. The firm must also promptly review and assess the results of any third-party audit that constitutes a verification activity, document their review and assessment of the results of such activity, and take appropriate action if the results do not provide adequate assurances that the hazards requiring a control have been significantly minimized or prevented. The field in their FSVP for their Strawberry Syrup and Blueberry Syrup products, imported from their foreign supplier (redacted), located in (redacted), which indicates whether such products have an applicable food safety audit or certification, was not completed. FDA notes that the audit certificate for this supplier lists an expiry date of Jan. 19, 2021. When FDA investigators inquired about the expired audit certificate, the firm informed them that this was the most updated third-party audit and that they did not have other documents of verification activities for these products.

The full warning letter can be viewed here.

(To sign up for a free subscription to Food Safety News, click here.)

The quarantine order came following the confirmed detection of the bacteria Campylobacter jejuni in the farm’s packaged raw whole milk sampled and tested by the California Department of Food and Agriculture.  

CDFA found the campylobacter bacteria in a routine sample collected at the Raw Farm, LLC packaging facility

Raw whole cow milk produced and packaged by Raw Farm, LLC of Fresno County is the subject of a statewide recall and quarantine order announced by California State Veterinarian Dr. Annette Jones.

Recalled product:  

• The order applies to “Raw Farm Whole Raw Milk” distributed in half-gallon (64 oz) and gallon (128 oz) plastic jugs with a code date marked on the container of BEST BY 05/05/2023.

As of the posting of this recall, no illnesses have been reported. 

Consumers are strongly urged to dispose of any product remaining in their refrigerators, and retailers are to pull the product immediately from their shelves.

(To sign up for a free subscription to Food Safety News, click here.)

That’s a question raised by California Assembly Bill 418, introduced by Rep. Jesse Gabriel and Rep, Buffy Wicks. Gabriel and Wicks are both Democrats in California’s Assembly, which is controlled by Democrats, 62-18. Democrats also dominate the Senate, 32-8.

Gabriel, D-Encino, and Wicks, D-Oakland haven’t yet gotten AB 418 heard by a committee in more than a month since it was introduced. But they’ve come up with another way to get their bill’s attention.

Existing law provides for the regulation of the safety of food products, including adulterated and misbranded food, wholesale food, and food in retail food facilities. They are holding a virtual news conference on Zoom to discuss the legislation.

The event will feature Chef Andrew Zimmern, Senior Consumer Reports Scientist Michael Hanson, and the Environmental Working Group’s Scott Faber.

Iris Myers at [email protected] is the RSVP contact. The Zoom event will run from 11:15 a.m. to 11:45 a.m. on Thursday, March 16, 2023.

AB 418, commencing Jan. 1, 2025, would prohibit a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale, in commerce a food product that contains any specified substance, including, among others, brominated vegetable oil and red dye 3. The chemicals that would be banned include:

a) Brominated vegetable oil (CAS no. 8016-94-2)

(b) Potassium bromate (CAS no. 7758-01-2)

(c) Propylparaben (CAS no. 94-13-3)

d) Red dye 3 (CAS no. 16423-68-0)

(e) Titanium dioxide (CAS no. 13463-67-7)

AB 418 would prohibit any person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale any food product that holds these substances. Gabriel and Wicks say these chemicals are currently banned by the European Union and many other jurisdictions “due to scientific studies that have demonstrated significant public health harms including cancer and behavioral health issues in children.”

Gabriel represents the San Fernando Valley, and Wicks’ District 15 includes the cities of Berkeley, Emeryville, Piedmont, Richmond, San Pablo, and El Cerrito in the East Bay.

(To sign up for a free subscription to Food Safety News, click here)

The narrow and fast-moving corridor of water vapor in the atmosphere is expected to bring intense precipitation. Central and southern California are likely to be hit with vast amounts of rainfall, which could result in flash floods.

Residents should follow the steps below to reduce the risk of foodborne illness during this or other emergency events:

Plan Ahead If You Can

• If possible, raise refrigerators and freezers off the floor, putting cement blocks under their corners.
• Move canned goods and other foods that are kept in the basement or low cabinets to a higher area.

Food Safety After a Flood

• Use bottled drinking water that has not come in contact with flood water.
• Do not eat any food that may have come in contact with flood water.
• Discard any food that is not in a waterproof container if there is any chance it may have come in contact with flood water. Food containers that are not waterproof include those with screw caps, snap lids, pull tops, and crimped caps.
• Also, discard cardboard juice/milk/baby formula boxes and home canned foods if they have come in contact with flood waters. They cannot be effectively cleaned and sanitized.
• Inspect canned foods; discard any food in damaged cans. Can damage is shown by swelling, leakage, punctures, holes, fractures, extensive deep rusting, or crushing/denting severe enough to prevent normal stacking or opening with a manual, wheel-type can opener.
• Discard wooden cutting boards, plastic utensils, baby bottle nipples, and pacifiers that may have come in contact with flood waters. There is no way to safely clean them.
• Thoroughly wash metal pans, ceramic dishes, and utensils (including can openers) with soap and water (hot water if available). Rinse and sanitize them by boiling in clean water or immersing them for 15 minutes in a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water.
• Thoroughly wash countertops with soap and water (hot water if available). Rinse and then sanitize them by applying a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water. Allow air-drying.
• Note: If your refrigerator or freezer was submerged by floodwaters — even partially — it is unsafe to use and must be discarded.

If the Power Goes Out  
Cold temperatures slow the growth of harmful bacteria. Keeping food at safe temperatures is key to reducing the risk of foodborne illnesses.

• Keep refrigerator and freezer doors closed as much as possible. The refrigerator will keep food cold for about 4 hours, and a full freezer will keep the temperature for approximately 48 hours (24 hours if half full) if the doors remain closed. 
• Use ice (dry, block ice, or ice cubes) and frozen containers of water or gel packs to keep your refrigerator and freezer as cold as possible.

When Power is Restored
Before eating any food after a power outage, check the temperatures inside your refrigerator and freezer.

• If the power was out for no more than 4 hours, refrigerated food should be safe as long as the doors were kept closed. When the power comes back on, check the temperature in the refrigerator or of the food. Perishable foods such as meat, poultry, seafood, milk, eggs, or leftovers with temperatures that are 45 degrees F or below, as measured with a food thermometer, should be safe but cook and consume them as soon as possible.
• Discard any perishable food that has been at temperatures above 40 degrees F for 4 hours or more.
• If the freezer thermometer reads 40 degrees F or below, food is safe and may be refrozen. If you did not have a thermometer in the freezer, check each package to determine its safety; you can’t rely on appearance or odor. If the food still contains ice crystals or is 40 degrees F or below, it is safe to refreeze or cook.
• Be aware that perishable foods that are not kept adequately refrigerated or frozen may cause food poisoning if eaten, even after they are thoroughly cooked.

If you have questions about food safety during severe weather, or any other food safety topics, you can call the USDA Meat and Poultry Hotline at 1-888MPHotline or chat live with a food safety specialist at AskKaren.gov. These services are available in English and Spanish from 10 a.m. to 6 p.m. Eastern Time, Monday through Friday. Answers to frequently asked questions can also be found 24/7 at AskKaren.gov.

(To sign up for a free subscription to Food Safety News, click here.)

The recall was the result of a routine sampling program by the State of Hawaii which revealed that the finished products contained Listeria monocytogenes. 

According to the company announcement posted by the FDA, the recalled Enoki Mushroom product was distributed in California to small local produce distributors or wholesalers for further distribution to retail stores within California and Hawaii.

Recalled product:

• The Enoki Mushroom comes in a 200g/7.05oz clear plastic package with the following description “Taiwan Best Quality Enoki Natural Mushroom***Manufacturer: Changhua County Mushrooms Production Cooperative” in English. 
• There is a green lettered “Premium” Printed with two QR scan codes and UPC 8 51084 00835 8 on the back side of a package
•  There is a Lot Code #3779 outside of box.

As of the posting of this recall, no illnesses have been reported to date in connection with this problem. The distribution of the product is suspended.

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

Consumers should return enoki packages to the place of purchase for a full refund. 

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any of the recalled product and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled product should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

(To sign up for a free subscription to Food Safety News, click here.)

Gold Coast Distributors Inc. dba Shah Distributors
Stockton, CA

Owners of a food firm in California are on notice from the United States Food and Drug Administration (FDA) after rodents, cat urine, bats, oriental and Turkistan roaches, Indian meal moths and more were found in their facility.

In a Nov. 02, 2022, warning letter, the FDA described a May 9-27, 2022, inspection by the FDA of Gold Coast Distributors Inc.’s ambient and frozen warehouse and re-packing facility in Stockton, CA.

The FDA’s inspection revealed that the firm had serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, 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 packing and holding areas and to protect against the contamination of food on the premises by pests. Specifically, rodent, insect, and animal activity was observed throughout their facility including, but not limited to the following:

Rodent Activity observed:

Dry storage room at (redacted) end of warehouse

• On May 9, 12, 16, and 17, 2022, numerous rodent excreta pellets (REPs) and several rodent gnawed cardboard co-mingled cases containing various food products (including spices) were observed on pallets and on the floor up against the north, east, and southwest sides of the room. REPs were on floor, on the ledges of the windows along the north wall, and on shelves in an adjacent room (where labels and equipment were stored) at the (redacted) of the room.
• On May 9, 12, 16, and 17, 2022, two rodent gnawed cardboard cases, having rodent rub marks, REPs, and nesting material that each contained at least (redacted)/2 oz. retail bags of (redacted) paprika spice, were observed on the center pallet against the west wall. One dead rodent was observed in between one of the cases of paprika spice and another case of spice products. At least (redacted) bags within each case were rodent gnawed where paprika spilled out and onto other bags within the box. REPs, rodent hairs, and rodent nesting material were observed in each box and on, around, and inside (redacted) of paprika.
• On May 9, 12, 16, and 17, 2022, one rodent gnawed cardboard case having REPs and rodent rub marks contained at least (redacted)/4 oz. retail bags of (redacted) Cumin Seeds. Inside of the box there were at least 2 rodent gnawed bags, and at least 50 REPs, rodent nesting material, and a dead and decayed rodent all nestled within the bags of cumin seeds. The box was located on a pallet at the southwest corner of the room.
• On May 9, 12, 16, and 17, 2022, one cardboard case was observed to contain 10 packs of 6/50g boxes of Shan Seasoning Mix Fish Biryani (mix for Spicy Fish Pilaf). At least 5 boxes had rodent gnaw marks. At least 40 REPs were on and in between boxes of the seasoning. All boxes had rodent rub marks and rodent urine stains that made the labeling of the products mostly illegible. The case was located on a pallet against the west wall of the room.
• On May 9, 12, 16, and 17, 2022, at least 2 rodent gnawed holes, rodent rub marks, and at least 30 REPs were observed on 1 cardboard case containing at least (redacted)/24 oz. bags of (redacted) brand Wheat Pelted (Whole). Within the case, there were at least 5 bags that had rodent gnaw marks where wheat pellet product had spilled out and onto other bags. REPs and rodent nesting material were in the case and inside the rodent gnawed bags. This case was located on boxes along the southwest corner of the room.
• On May 9, 12, 16, and 17, 2022, one rodent gnawed cardboard case was observed to contain at least (redacted)/4 oz. retail bags of (redacted) Granulated Garlic. Within the box there were at least 2 bags that had rodent gnawed holes along with at least 15 REPs on and in between bags. The case was located on the pallet at the southwest wall of the room.
• On May 9, 12, 16, and 17, 2022, one cardboard case located on the floor (along with other cases of food products) at the south wall contained at least 5 rodent gnawed bags of (redacted) tea sweetener and at least 9 rodent gnawed boxes labeled (redacted) brand. REPs and rodent nesting material were inside every bag, as well as on and in between every box. Rodent rub marks and rodent urine stains on the boxes made the labeling of most boxes illegible.
• On May 9, 12, 16, and 17, 2022, one cardboard case was observed with at least three apparent rodent gnaw marks containing approximately (redacted)/6 pack shrink wrapped packages of (redacted) boxes of Shah brand Punjabi Yakhni Pilau. Within this case, there were at least five boxes that had apparent rodent gnaw marks. And at least 20 REPs and apparent rodent urine staining were observed on at least 16 boxes. The case was located along the south wall of the room.
• On May 9, 12, 16-19, and 23, 2022, a large hole (approximately 2’ x 4”) surrounded by sagging sheet rock with black and brown stains was observed in the ceiling above pallets of packaged food product and paper records at the east end of the room. At least 50 REPs, rodent nesting material (including wads of pink insulation) and apparent rodent hairs were on and within 3 opened boxes of paper records below this hole.
• On May 19, 2022, after all food products were removed from the storage room, hundreds of REPs, spilled spice products, fragments of rodent gnawed food packing, and rodent nesting material were on the floor of the room. One dead rodent was on the floor at the north wall near the entrance to the room. Two holes, each 3” x 3” and each containing REPs and rodent nesting material, were observed in the south and west walls. These holes were not observed previously during the inspection due to pallets of boxes of spice products stored next to each other and up against walls.

Southwest side of the warehouse

• On May 9, 12, 16-19, and 23, 2022, at least 200 apparent REPs were observed on a box of incense sticks on the top layer of a pallet containing (redacted) boxes. At least 10 REPs were found on a box of the (redacted) layer of this pallet. The pallet was located at the north end of the warehouse and immediately adjacent to pallets of spice products, including Shan brand Fish Marsala.

Northwest side of the warehouse

• On May 23, 2022, three apparent REPs were observed on 40 lb. bags of (redacted) brand basmati sela rice on a pallet containing (redacted) bags. One bag on this pallet had an apparent rodent gnawed hole approximately 3” x 3” that was surrounded by yellowish stains.

Inside (redacted) freezer at the northwest end of warehouse

• On May 17, 2022, an apparent rodent urine stain, approximately 1/2” x 2”, was observed on the floor below returned food products along the southwest wall. Within the (redacted) freezer, pallets of boxes of food products were stored up against walls and immediately adjacent to each other within the aisles of the pallet racks. There were no aisles in between the pallets and the racks, making the center and the entire north wall inaccessible for a visual inspection.

Southeast end of the warehouse

• On May 9, 12, 16-19, and 23, 2022, one dead rodent was found in tin cat #23 located at the entrance to the warehouse from the administrative offices at the southeast side.

Insect activity observed:

• On May 12, 2022, live and dead insects in winged, crawling and larvae forms as well as moth webbing were observed on every bag of every layer of (redacted) pallets each containing (redacted)/55 lb. bags of (redacted) (split chickpeas). Insect bored holes were observed in at least 4 bags of each pallet. (redacted) product below the bored holes appeared clumped with insect eggs and had crawling insects. These pallets were located on the (redacted) of pallet (redacted) in the warehouse.
• On May 9, 12, 16-19, and 23, 2022, live and dead insects in winged, crawling and larvae forms were observed on and inside several opened bags of products including cashews, cumin spice, curry spice, fennel, bay leaves, legumes, and cinnamon that were in a pile with other food products on the floor of the repack room located at the south end of the warehouse.
• On May 23, 2022, an opened, unlabeled cardboard case (3’ x 3’) containing yellow legumes had live and dead insects on the legumes and on the plastic wrap that lightly covered the box. This box was located near the entrance to the repack room at the south end of the warehouse.
• On May 9, 12, 16-19, and 23, 2022, live and dead insects in flying, crawling, and larvae forms were observed on and in between bags of expired Swarna brand whole wheat flour that were on (redacted) pallets each containing at least (redacted)/20 lb. bags. Live and dead flying and crawling insects were observed on and in between the bags and shrink wrap of all (redacted) pallets. Two opened bags contained at least 6 winged and crawling insects. The (redacted) pallets were located next to pallets of boxes and bags of food product including basmati rice at the north end of the warehouse.
• On May 23, 2022, at least 5 dead insects were observed around a 1” x 1” hole in a 25 lb. bag of expired (redacted) brand desiccated coconut. The bag was on a pallet of (redacted)/25 lb. soiled and dirty bags located between roll up doors 2 and 3 at the east end of the warehouse.
• On May 9, 12, 16-19, and 23, 2022, pallets of boxes of food products (including soup mixes and (redacted) brand drinks) returned from a customer that were observed damaged, dirty, and showing insect activity were commingled with food products intended for sale along the east and west sides of the warehouse.
• On May 9, 12, 16-19, and 23, 2022, dead and/or live cockroaches were found in 18 tin cats staged round the inside perimeter of the warehouse. These included 34 live and dead cockroaches in tin cat #4 located between roll up doors 2 and 3 along the east wall; 30 live and dead cockroaches in tin cat #10 at the north wall; 70 live and dead cockroaches in tin cat# 14 at the west wall; and 49 live and dead cockroaches in tin cat #17 at the southwest wall.
• On May 16, 2022, live and dead insects in winged, crawling and larvae forms were found on and around boxes and bags of various food products (including basmati rice) located at each pallet rack within the center of the warehouse.

Animal activity observed:

• On May 9, 12, 16-19, and 23, 2022, piles of cat feces were observed on the floor at the north wall, northeast corner, south wall, southeast corner, west wall, and northwest corner of the warehouse. A pile of cat feces was also observed under pallet (redacted) beneath boxes of soft drink beverage products.
• On May 17, 2022, at least 4 empty bags of dried cat food were observed in the room above the repack room. Animal paw prints were observed on dusty boxes (holding food products such as (redacted) instant mix) located at the north, south, and southwest ends of the warehouse. Animal paw prints were observed on boxes of (redacted) brand cookies located on a pallet near the entrance to the dry storage room.
• On May 12, 2022, cat urine was identified on 2/55 lb. bags of (redacted) (split chickpeas) that were located on layers (redacted) pallet containing (redacted)/55 lb. bags. This pallet was located on the (redacted) of pallet (redacted). A bag of (redacted) product on the top layer was found saturated with cat urine.
• On May 18, 2022, at approximately 11:00 AM, one live apparent bat was observed flying in circles and landing in the seam between two concrete slabs and a wooden ceiling joist along the south wall between the dry goods storage room and the west wall of the warehouse.

Pest control records:

In addition to visual observations, FDA investigators conducted a review of the firm’s third-party pest control provider inspection reports which revealed the following:

• Report dated 11/20/2019 showed the technician observed “Gaps on all exterior doors – All man doors and roll up doors have gaps at the bottom of the entrance allowing insect and rodent presence.”
• Report dated 04/30/2020 showed the technician observed “food product all over the floor that is giving insects and rodents a food source, weeds around the structure, damaged food inside multiple opened containers and pallets of food located on the north and west side of the building, and multiple pallets stored too closely to the north wall of the facility giving rodents and insects harboring areas.” The technician recommended that the firm “clean up the property.”
• Report dated 06/05/2020 showed rodent activities and cat activities inside the warehouse. Technician noted no changes to the containers (doors kept open) and improper storage throughout the perimeter wall and exterior of the building as observed on 04/30/2020. Technician also noted “heavy pigeon activity and droppings” and that he found a litter of cats inside of the warehouse that were being fed by employees. It was noted that areas were not being cleaned and sanitized as needed and that there was a need to re-evaluate the account to continue to provide their services to this site.
• Report from 08/07/2020 showed rodent activity and cat feces throughout the facility. Technician observed and noted a cat sleeping on “expired pallets” and heavy cat droppings on the west side of the building between the cooler and the west side interior walls. Technician noted that there were still pallets and shipping containers with damaged and outdated product being stored outside that needed to be removed.
• Reports in 2021 consistently showed rodent activities, cat droppings in the warehouse, pallets with food leading to pest harborage/attractant, in addition to activities of Oriental and Turkistan roaches, ants, and bats. On 06/14/2021, the technician noted that he “found a pallet of cornmeal near trap 7 that was infested with stored product pest” and that “this pallet should be removed immediately.” Also, on 08/26/2021, the technician noticed “Indian meal moth activity that is most likely coming from old, expired product that is sitting in the warehouse.” On 10/25/2021 and 11/23/2021, the technician noted some of the traps were inaccessible for inspection.
• Reports dated 04/22/2022, 03/22/2022, 02/22/2022, and 01/24/2022 showed the technician repeatedly stated: “Gaps on all exterior doors[.] [A]ll pedestrian doorways and roll up doors have gaps at the bottom of the entrance allowing insects and rodent presence. Food product throughout the warehouse[.] [T]here is food product all over the floor that is giving insects and rodents a food source. Damaged food on the north and west side of the building[.] [T]here are multiple shipping containers that are opened with damaged food product[,] and there are multiple pallets that are damaged with food product on it. On the north side of the facility there are multiple pallets that are too close to the structure giving rodents and insects harboring areas.”

Samples

FDA collected several samples during the inspection. These samples were submitted to FDA labs for analysis. Results demonstrate that submitted product [including (redacted) (split chickpeas) and (redacted) brand Paprika] were contaminated with rodent/mouse hairs, cat hair and urine, urine stains (on packaging), gnaw marks, REPs as well as various species of larval, pupal, and adult insects. Further, a sample had evidence of insect penetration and damage to packaging and product as well as urine stains and yeast. The filth samples further demonstrated the presence of rodents and insect activity throughout the facility through the presence of rodent hairs, teeth marks, in pellet morphology and nesting materials as well as confirmation of various species of insects at larval, pupae and adult stages.

 The firm failed to properly store equipment, remove litter and waste, and cut weeds and grass that may constitute an attractant, breeding place, or harborage for pests within the immediate vicinity of the plant. Specifically,

• On May 9, 12, 16-19, and 23, 2022, piles of damaged pallets, pipes, garbage and boxes of food products (including (redacted) brand mango juice drinks and (redacted) brand mango fruit nectar drinks) were along the north side of the building, by the dumpsters in the parking lot at the east end of the warehouse
• On May 12, 17-19, and 23, 2022, at least (redacted) pallets of boxes of food product (including (redacted) brand fun snacks rice bites and Shan brand Shoop Instant noodles) were located at the northwest end. Bird feces was on the concrete pavement around the pallets of products.
• On May 12, 17-19, and 23, 2022, several piles of broken pallets, unused equipment, and garbage were all along the fence line outside the west end of the firm.
• On May 12, 17-19, and 23, 2022, three opened shipping containers, located outside at the west and northwest ends of the warehouse, each contained pallets of dirty and damaged boxes and bags of food products. Some bags and boxes were torn open where food product spilled out on to the floor and outside of the containers. All products within all three containers were haphazardly arranged, immediately adjacent to each other, and up against the sides of the containers. There were no aisles between products that would allow for a visual inspection within any of the containers.
• On May 9, 12, 16-19, and 23, 2022, overgrown weeds spanned along the fence lines at the north and northwest sides of the warehouse.
• On May 17, 2022, one live adult cat and 5 kittens were observed on top of a pallet of boxes of Falak brand basmati rice stored in an opened shipping container located outside of the warehouse at the west end.

In addition, on May 12, 2022, the following food products slated for destruction were located outside on their grounds:

• (Redacted) pallets containing boxes of prepackaged drinks were observed stored outside at the northeast wall.
• (Redacted) pallets of boxes of food products (including (redacted) Brand fun snacks rice bites and Shan brand Shoop instant noodles) were observed outside at the northwest wall.
• (Redacted) opened shipping containers, (redacted) at the northwest wall and (redacted) at the west wall, all containing stacks of bags of dirty, dusty food products including legumes and pallets of boxes of food products including basmati rice that were observed immediately next to each other and up against the walls. There were no aisles in between products that would allow for a visual inspection of the containers. The firm did not start destroying products until May 23, 2022, after CDPH placed their  firm under a blanket embargo on May 17, 2022.

The firm’s Inventory Controller could not provide an estimate as to how long the food slated for destruction had been kept outside. This employee stated that dumpsters were ordered but could not give a time frame as to when they would arrive.

Further, on May 23, 2022, hundreds of apparent REPs were found around all 6 downspouts of the gutter drainage systems outside and along the south wall of the firm. At least 100 apparent REPs were found around the downspout nearest to the visitor’s entrance of the firm. At least 300 apparent REPs were found around the 3rd downspout located at the center of the south wall. Apparent rodents were heard moving about the inside of the piping system that led this downspout.

The firm did not provide employees with adequate, readily accessible, and clean toilet facilities to prevent a potential source of contamination of food, food-contact surfaces, or food packaging materials. Specifically:

• On May 9, 12, 16, 17 and 23, 2022, the faucet, located inside the restroom, of the designated handwashing sink was covered with plastic wrap obstructing the use of the sink. There were no soap, towels, or other means to dry hands at this sink.
• On May 9, 12, 16, 17 and 23, 2022, within the janitorial area, between the 2 toilets in the room, there was a sink, located in the restroom, that did not have towels or other means to dry hands, and there was no soap but rather a bottlxe of shampoo next to the faucet.

The full warning letter can be viewed here.

(To sign up for a free subscription to Food Safety News, click here.)

Follow the steps below to reduce the risk of foodborne illness during this or other emergency events:

Plan Ahead If You Can

• If possible, raise refrigerators and freezers off the floor, putting cement blocks under their corners.
• Move canned goods and other foods that are kept in the basement or low cabinets to a higher area.

Food Safety After a Flood

• Use bottled drinking water that has not come in contact with flood water.
• Do not eat any food that may have come in contact with flood water.
• Discard any food that is not in a waterproof container if there is any chance it may have come in contact with flood water. Food containers that are not waterproof include those with screw-caps, snap lids, pull tops and crimped caps.
• Also discard cardboard juice/milk/baby formula boxes and home canned foods if they have come in contact with flood waters. They cannot be effectively cleaned and sanitized.
• Inspect canned foods; discard any food in damaged cans. Can damage is shown by swelling, leakage, punctures, holes, fractures, extensive deep rusting or crushing/denting severe enough to prevent normal stacking or opening with a manual, wheel-type can opener.
• Discard wooden cutting boards, plastic utensils, baby bottle nipples, and pacifiers that may have come in contact with flood waters. There is no way to safely clean them.
• Thoroughly wash metal pans, ceramic dishes, utensils (including can openers) with soap and water (hot water if available). Rinse and sanitize them by boiling in clean water or immersing them for 15 minutes in a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water.
• Thoroughly wash countertops with soap and water (hot water if available). Rinse and then sanitize them by applying a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water. Allow to air-dry.
• Note: If your refrigerator or freezer was submerged by floodwaters — even partially — it is unsafe to use and must be discarded.

If the Power Goes Out  

Cold temperatures slow the growth of harmful bacteria. Keeping food at safe temperatures is key to reduce the risk of foodborne illnesses.

• Keep refrigerator and freezer doors closed as much as possible. The refrigerator will keep food cold for about 4 hours, and a full freezer will keep the temperature for approximately 48 hours (24 hours if half full) if the doors remain closed. 
• Use ice (dry, block ice or ice cubes) and frozen containers of water or gel packs to keep your refrigerator and freezer as cold as possible.

When Power is Restored

Before eating any food after a power outage, check the temperatures inside your refrigerator and freezer.

• If the power was out for no more than 4 hours, refrigerated food should be safe as long as the doors were kept closed. When the power comes back on, check the temperature in the refrigerator or of the food. Perishable foods such as meat, poultry, seafood, milk, eggs or leftovers with temperatures that are 45 degrees F or below, as measured with a food thermometer, should be safe but cook and consume them as soon as possible.
• Discard any perishable food that has been at temperatures above 40 degrees F for 4 hours or more.
• If the freezer thermometer reads 40 degrees F or below, food is safe and may be refrozen. If you did not have a thermometer in the freezer, check each package to determine its safety; you can’t rely on appearance or odor. If the food still contains ice crystals or is 40 degrees F or below, it is safe to refreeze or cook.
• Be aware that perishable foods that are not kept adequately refrigerated or frozen may cause food poisoning if eaten, even after they are thoroughly cooked.

If you have questions about food safety during severe weather, or any other food safety topics, you can call the USDA Meat and Poultry Hotline at 1-888MPHotline or chat live with a food safety specialist at AskKaren.gov. These services are available in English and Spanish from 10 a.m. to 6 p.m. Eastern Time, Monday through Friday. Answers to frequently asked question can also be found 24/7 at AskKaren.gov.

(To sign up for a free subscription to Food Safety News, click here.)

The ruling in NPPC v. Ross will ultimately decide if Prop 12 can ever be enacted, The American Farm Bureau Federation and the National Pork Producers Council are challenging the constitutionality of California’s Prop 12.

The Superior Court of Sacramento had enjoined the state’s implementation of Prop 12 until 180 days after final rules were issued. Final implementation rues were issued on Sept. 1, 2022. That action suggested Feb. 28, 2023 would be the first day for compliance and enforcement.

Proposition 12 was a ballot initiative passed by voters in 2018, which seeks to impose its farm animal confinement rules on surrounding states by closing the California market to products not raised under Prop 12 standards.

If Prop 12 is enacted, it would ban the sale of veal from calves, pork from breeding pigs and eggs from laying hens when the animals are confined to areas below minimum square feet requirements. California would dictate minimum space requirements based on square feet for calves raised for veal, breeding pigs, and egg-laying hens.

California raises few breeding pigs, but accounts for 13 percent of the market for bacon, which suggests it would be imposing its confinement standards over many other states.

(To sign up for a free subscription to Food Safety News, click here)

Whole-head romaine lettuce and products containing romaine lettuce such as bagged salads that were produced in the four Salinas Valley counties of Santa Cruz, Santa Clara, San Benito, and Monterey must “submit an attestation form and Certificates of Analysis for each shipment to demonstrate that the romaine lettuce does not contain detectable levels of E. coli O157:H7,” according to the Canadian Food Inspection Agency (CFIA). 

The requirements are the same as fall 2021, but the enforcement timeframe has shifted. The 2022 requirements now come into effect on Sept. 28 and will end on Dec.22. Pre-harvest sampling and testing will be permitted again in 2022.

Products originating from other areas of the US must “declare that the product does not originate from the implicated counties of Santa Cruz, Santa Clara, San Benito and Monterey in the Salinas Valley, California, U.S.,” according to the CFIA. This declaration can take the form of a letter printed on company letterhead.

Complying with the requirements is the responsibility of the Canadian importer or U.S. non-resident importer. In 2021, a delegate was allowed to be assigned to complete the attestation form.

In recent years foodborne illness outbreaks have been associated with romaine grown in California and Arizona. Some of the lettuce was shipped to Canada where it caused additional illnesses.

(To sign up for a free subscription to Food Safety News,click here)

The incident did not involved any of the attendees, according to a statement released by local health officials. It is believed that the shuttle bus drivers ate at a common facility where meals were provided for them. Officials say the catering was unaffiliated with the festival but they have not yet identified the provider of the food.

Drivers came from a wide area, so there could be additional sick people who did not seek treatment at the hospitals closest to the event, according to statements from public health investigators on Tuesday.

News Channel 3 reported 23 drivers were treated at Eisenhower Hospital; 12 at Desert Regional Medical Center; and 11 at JFK Memorial Hospital.

“Our objective, if we can, is to find the source of the illness,” Riverside County spokesperson Jose Arballo said a statement to media “Part of this is also interviews with those who became ill to try and get a good idea of what might be the source of the sickness.”

Riverside County officials are working with public health departments throughout Southern California and the California Department of Public Health about the incident so potential patients can be interviewed.

“This could involve hundreds of interviews, but it is important to gather as much information as possible so that we can determine what happened and try to prevent it from happening again,” said Kim Saruwatari, director of Riverside County Public Health.

The drivers had nausea, vomiting, and other symptoms consistent with food poisoning.

(To sign up for a free subscription to Food Safety News, click here)

The funds will support CPS’s work to identify produce safety questions, call on researchers to answer them, and then share the learnings to industry, government, public health and other stakeholders.

 When asked what motivated one of the citrus company’s, Sunkist, to support the CPS, President and CEO Jim Phillips pointed to his company’s history of leadership.

 “As the longest-standing agricultural cooperative in the nation, it’s important to us that we are always delivering a safe product to consumers,” Phillips said. “Sunkist is doing our part to represent California citrus at the highest level, by supporting critical food safety research.”

 President Zak Laffite of Wonderful Citrus noted the citrus industry’s commitment to consumer health and well-being motivated the industry’s repeat contribution to CPS.

 “Our company’s promise is simple: To provide the safest, freshest-quality citrus, today and tomorrow. Ensuring that we lead on food safety practices is one way we make food safety paramount,” said Laffite. “Similarly, as an industry, investing in Center for Produce Safety is an industry-wide food safety best practice.”

 Since its founding in 2007, CPS has invested $22 million to date in 187 produce-centric food safety research projects at 44 research institutions in the United States and four other countries. Most projects are completed in 1-2 years; learnings are posted on CPS’s website for all to access. CPS’s current research priorities include evaluating agricultural water treatments, mitigating and preventing listeria, cleaning and sanitizing facilities, organic produce safety and more.

 CPS spreads its research learnings through a range of tools, including an online research database, emails and webinars, columns in trade media outlets, social media and an annual Research Symposium – held virtually via webinars in 2020 and 2021.

 Sun Pacific Shippers President Al Bates stressed the importance of supporting the science of food safety and approaching it from a practical, industry-centric standpoint.

 “Food safety is a fundamental part of our business, Sun Pacific has incorporated it into all farming, harvesting and packing operations,” Bates said. “Center for Produce Safety has been instrumental in researching and communicating various issues to the food safety auditing community that has allowed produce operations like ours to continue to operate efficiently and effectively while also complying with current food safety guidelines. I encourage all suppliers, industry groups and retailers to support CPS so the produce community can strive to deliver the safest food supply in the world to our consumers,” Bates said.

 CPS launched its latest research fundraising campaign publicly in January 2021.

A current list of contributors can be viewed here.

  About CPS

The Center for Produce Safety is a 501(c)(3) nonprofit organization. CPS is a collaborative partnership that leverages the combined expertise of industry, government and the scientific and academic communities to focus on providing research needed to continually enhance food safety. This level of collaboration allows CPS to fill the knowledge gaps on produce food safety and address both research priorities and immediate industry needs.

(To sign up for a free subscription to Food Safety News, click here)

The proposed change in  the FDA agricultural water rule for produce growers regarding food safety measures will change the face of public health even though it will also eliminate some water testing requirements, according to Yiannas.

“These changes will result in a major shift in what industry has been doing,” he said.  The proposed rule regarding agricultural water safety will use effective, modern, science-based measures designed to prevent foodborne outbreaks. A key difference in the proposed rule is that much of the pre-harvest pathogen testing of irrigation water will no longer be required. Instead, growers would be required to annually assess a variety of possible problems and implement ways to resolve them.”

Mutual reliance agreements mark a coordinated effort between the FDA and individual states with goals to reduce human foodborne illness outbreaks, reduce duplication of regulatory oversight, and increase public health protection by focusing on areas of higher risk.

“Foodborne illness outbreaks are largely preventable but can have devasting consequences for consumers,” said Erik Mettler, assistant commissioner for partnerships and policy in the FDA’s Office of Regulatory Affairs (ORA).

“The FDA is committed to keeping Americans safe. As part of our commitment, we are using these partnerships to strengthen our relationship with our state regulatory partners and improve industry compliance with applicable food safety requirements to reduce foodborne illness outbreaks.”

These new mutual reliance agreements help the FDA to work in cooperation with the states of California, Florida, Utah and Wisconsin to rely on, coordinate with, and leverage one another’s work, data, and actions to achieve a safer national food supply. As envisioned in the FDA Food Safety Modernization Act (FSMA), the Partnership for Food Protection, and the New Era of Smarter Food Safety blueprint, the mutual reliance agreements will enhance the existing relationships with states and government counterparts, moving the nation toward an Integrated Food Safety System.

“A strong, integrated system is essential to a safe food supply. Mutual reliance between the FDA and individual states is one example of the many actions the agency is taking to address our nation’s increasingly complex food production and distribution systems,” said Michael Rogers, assistant commissioner for the Office of Human and Animal Food Operations in the FDA’s ORA.

“We expect that as more states sign mutual reliance agreements, it will help reduce redundancy and duplication of effort, optimize the impact of our collective oversight, and allow us to build on the long-standing relationships that we have with our state regulatory partners. This is truly a step forward toward achieving a seamlessly integrated food safety system between the federal and state regulators.”

The FDA will collaborate with partner states on data sharing, risk prioritization, inspections, outbreak investigations, development and monitoring of key metrics, and laboratory capacity, among many other key focus areas. The domestic mutual reliance framework provides opportunities for the FDA and partners to jointly identify needs to better protect the public and leverage work from other regulatory programs. In addition, it will provide knowledge to build quality management systems and infrastructures to support national regulatory standards, including those related to resource allocation, training, outreach, and information exchange.

The FSMA was signed into law in January 2011 and enables the FDA to focus on the prevention of foodborne illness rather than relying primarily on reacting to problems after they occur. The Act provides the FDA with the authority to achieve higher rates of compliance with prevention and risk-based food safety standards. In addition, the FDA has the authority to better respond and contain food safety concerns when they do occur.

(To sign up for a free subscription to Food Safety News, click here.)

The California Department of Health reported illegal levels of Campylobacter jejuni found by the state’s Department of Food and Agriculture in raw cow milk produced and bottled by the company. In addition to the recall, there is a quarantine in place, according to a statement from state officials.

As of the posting of the recall and quarantine notice no illnesses had been reported. People who have consumed the milk or served it to others should monitor themselves for symptoms of Campylobacter infections.

The agriculture department said Campylobacter jejuni can cause diarrhea, abdominal cramps and fever, but most people recover completely. The symptoms usually occur two to five days after exposure and last about a week. Children and elderly people or people with compromised immune systems can develop severe infections and require hospitalization.

“The raw cow milk is distributed in one-gallon (128 oz) and half-gallon (64 oz) plastic jugs with brown colored bottle caps and labeled as ‘Valley Milk Simply Bottled Raw Milk’ or ‘DESI MILK Raw Milk.’ The recall order applies to products marked on the container with expiration code dates of SEP 26 2021 through OCT 03 2021, according to the state agriculture department.

“Consumers are strongly urged to dispose of any product remaining in their refrigerators, and retailers are to pull the product immediately from their shelves. Products from the firm marked with other expiration code dates or with bottle caps of a different color than brown are not subject to the recall order.”

Reached by phone Wednesday by the Modesto Bee, the owner of the dairy, Joe Bento, said independent testing has not found the source of the problem in the livestock feed or other parts of the operation.

The recall and quarantine this week comes after a recall of raw goat milk in late August this year. The unpasteurized, raw goat milk was produced by Valley Milk Simply Bottled of Stanislaus County, according to a recall notice posted by State Veterinarian Dr. Annette Jones. The same producer had recalls in 2019 and 2020 because of Campylobacter in its raw milk.

(To sign up for a free subscription to Food Safety News, click here.)

The unpasteurized, raw goat milk was produced by Valley Milk Simply Bottled of Stanislaus County, according to a recall notice posted by State Veterinarian Dr. Annette Jones. The same producer had recalls in 2019 and 2020 because of Campylobacter in its raw milk.

“The quarantine order came following the confirmed detection of the bacteria Campylobacter jejuni in the farm’s packaged raw whole goat milk sampled and tested by the California Department of Food and Agriculture,” according to the recall notice.

“Consumers are strongly urged to dispose of any product remaining in their refrigerators, and retailers are to pull the product immediately from their shelves.”

As of the posting of the recall notice, the state had not received any confirmed reports of human illnesses. Unpasteurized milk can be contaminated with a variety of bacteria, parasites and viruses.

The recall and quarantine order applies to “Valley Milk Simply Bottled Raw Goat Milk” distributed in half-gallon — 64-ounce — plastic jugs with a code date marked on the containers of AUG 28 2021.

There is concern that consumers may still have the milk in their homes because the best-by date has not yet passed. Anyone who has consumed the milk or served it to anyone, especially young children or elderly people, should monitor themselves for symptoms of infection.

Symptoms of campylobacteriosis include diarrhea, abdominal cramps, and fever. Many people with camplylobacteriosis recover completely. Illness usually occurs two to five days after exposure to campylobacter and lasts about a week. The illness is usually mild and some people with campylobacteriosis have no symptoms at all.

However, in some young children, elderly people and people with compromised immune systems, it can cause a serious, life-threatening infection. A small percentage of people may have joint pain and swelling after infection. In addition, a rare disease called Guillian-Barre syndrome that causes weakness and paralysis can occur several weeks after the initial illness.

(To sign up for a free subscription to Food Safety News, click here.)

Wismettac Asian Foods, Inc.

Santa Fe Springs, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of import violations. The FSVP inspection was initiated as part of a Salmonella Stanley multi-state outbreak investigation. 

In an April 29 warning letter, the FDA described a Sept.28-30, Oct. 2, 5-6. 9 and 13 2020, Foreign Supplier Verification Program (FSVP) inspection of FSVP records submitted to the FDA electronically by Wismettac Asain Foods Inc. 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 firm’s significant violations of the FSVP regulation are as follows:

1. The firm did not meet the requirements to evaluate their foreign supplier’s performance for the products they import. Specifically, for their foreign supplier of Black Fungus (Kikurage), (redacted), they did not evaluate their foreign supplier’s performance and the risk posed by the food or document their approval of their foreign supplier on the basis of the evaluation.

During FDA inspection the firm provided a Supplier Approval Assessment, dated February 27, 2018, for (redacted). However, this entity is not the foreign supplier of Black Fungus (Kikurage). Foreign supplier means, for an article of food, the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature.

(Redacted) does not meet the definition of foreign supplier because (redacted) did not manufacture/process or grow the food.

For the actual foreign supplier, (redacted), the FDA acknowledges that they provided a Food Safety HACCP Plan dated July 24, 2020, including a hazard analysis and a Supplier Approval Questionnaire, dated Sept. 28, 2020. However, they did not provide records showing that they conducted the evaluation required or the approval based on the evaluation required. In their response to the FDA 483a, the firm stated they no longer purchase mushroom products from this foreign supplier, and they are not able to conduct a supplier assessment until they complete corrective actions including a root cause analysis, in response to the Salmonella outbreak.

The firm further stated their Shanghai office is working with the supplier and they list steps the supplier is taking to minimize contamination. They provided environmental and product sample analysis from the supplier. The firm indicated if their supplier is not able to take corrective actions, they will consider changing suppliers or will “switch the product from dried fungus product to fully cooked dried fungus (Ready-to-Eat product)”. While the FDA appreciates the steps they have taken, the fact remains they imported Black Fungus (Kikurage), which were found to be the source of an outbreak of foodborne illness, without conducting the required evaluation of their foreign supplier’s performance and the risk posed by the food prior to importation.

Because the firm’s response indicates their ongoing evaluation of this supplier of their Black Fungus (Kikurage), the FDA would like to clarify that they consider their Black Fungus (Kikurage) a ready-to-eat (RTE) food. It is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards. Additionally, in light of the Salmonella findings in samples of their Black Fungus (Kikurage), Salmonella would be a known or reasonably foreseeable hazard that may be present in the food and that they should address in their FSVP.

2. The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for the following products on the “List of foods with no FSVP – Wismettac Asian Foods Inc. 10-12-2020:”

• Eggplant, imported from (redacted)
• Seaweed, imported from (redacted)
• Chestnut, imported from (redacted)
• Agar Agar (Gelatin) imported from (redacted)
• Rice flours, imported from (redacted)
• Flavored or Party crackers, imported from (redacted)
• Rice grain snack, imported from (redacted)
• Citrus, mixed jam jelly preserves, imported from (redacted)

The firm’s response to the 483a stated that these foods will be the subject of forthcoming FSVPs. For this latter category, they stated that they planned to develop the FSVPs by November 30th. However, they did not provide documentation that would otherwise allow us to verify their corrections. If they have completed corrections, they may submit documentation of such in response to this letter. Otherwise, the FDA will verify their corrections during the FDA’s next inspection.

3. The firm must conduct a hazard analysis to determine whether there are any hazards requiring a control. A hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury. A hazard requiring a control means a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the probability that the hazard will occur in the absence of controls or measures and the severity of the illness or injury if the hazard were to occur), establish one or more controls or measures to significantly minimize or prevent the hazard in a food and components to manage those controls or measures (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the control or measure and its role in the facility’s food safety system. However, during FDA inspection which concluded October 13, 2020, the FDA provided their hazard analysis for Shiitake mushroom from their foreign supplier, (redacted), which did not identify biological hazards, or pathogens, as hazards requiring a control. The firm’s evaluation of the hazard analysis (on form “Supplier Approval Assessment Sheet”) states, “This product is not Ready to Eat food. Biological hazard is controlled by (redacted).” At the (redacted) acceptance processing step, their hazard analysis listed pathogenic bacteria, mold, and parasites as potential biological hazards and states the (redacted) may bring “(redacted) bacteria or pollution in the storage and transportation due to insects, animals, and environmental pathogens.” It has been demonstrated that pathogens, including Salmonella, can survive and persist for extended periods of time in low moisture foods. Further studies demonstrate that microorganisms can survive on dried mushrooms. However, the hazard analysis determines that these are not significant hazards. Although their hazard analysis identifies biological hazards on raw materials, it does not identify them as hazards requiring a control at any step during production.

The FDA acknowledges that in their response to the FDA 483a, the firm submitted a revised HACCP Plan, including a revised hazard analysis, from their foreign supplier for their Shiitake mushroom from manufacturer (redacted). However, they did not document their review and assessment of the revised hazard analysis. The FDA acknowledges that they also stated that they stopped importing Shitake mushrooms from (redacted) pending their review of the revised HACCP plan and a report of an audit conducted by (redacted) on 10/26/2020. However, the fact remains that they imported the product without complying with FSVP requirements.

The full warning letter can be viewed here.

(To sign up for a free subscription to Food Safety News, click here.)

And in a letter to Secretary of Agriculture Tom Vilsack and Attorney General Merrick Garland, California congressional Democrats said they want the Biden Administration to tell the Supreme Court that it should not take up the appeal of the case.

“Prompt withdrawal of these briefs is imperative as they directly undermine decades of federalism and constitutional law precedent that preserves the states’ power to serve as laboratories of democracy, whether they can advance new politics to protect their citizens,” says the letter.

A petition for certiorari from the North American Meat Institute is currently pending in the Supreme Court, challenging the constitutionality of Prop 12. Amicus curiae briefs supporting NSMI were filed in March by 20 states.

The states said there are constitutional questions that cry out for an answer from the high court. A big  question is:

“Whether the Constitution permits California to extend its police powers beyond its territorial borders by banning the sale of wholesome pork and veal products imported into California unless out-of-state farmers restructure their facilities to meet animal-confinement standards dictated by California.”

If approved, Prop 12 would dictate confinement rules for animals outside  California by prohibiting the sale of their products from any states that do not follow its ways. A U.S. district court and the 9th U.S. Circuit Court of appeals upheld Prop 12.

The  Ninth Circuit ruled that California may regulate “extraterritorial commercial conduct so long as it does not use price-control or price-affirmation statutes.” The 20 states filing the amici say the 9th’s ruling “is wrong” and “presents an issue of enormous doctrinal and practical importance.” 

“The court’s precedents squarely establish that the Commerce Clause prohibits states from directly regulating any commercial conduct — not merely pricing — that occurs entirely in other states,” the state’s brief says.

“The Ninth Circuit’s contrary decision here departs not only from those precedents but also from the decisions of five other federal circuit courts. And this lopsided circuit split means most states are at a regulatory disadvantage compared to the states of the Ninth Circuit. The decision below therefore not only threatens economic balkanization among States but also upends the fundamental principle of equal state sovereignty. “

(To sign up for a free subscription to Food Safety News, click here.)

Editor’s note: This story was updated to clarify when the amicus curiae briefs were filed.

The new law was overwhelmingly approved in 2018 by California voters as Proposition 12. It covers breeding pigs, veal calves, and egg-laying hens kept on farms.

California voters first passed Proposition 2 in 2008, giving egg-laying hens in the state enough room to lie down, stand up, fully extend their legs and wings, and turn around without bumping into other hens or the barrier. Prop 2 took effect in 2015. It did not explicitly require that eggs produced for the California market be cage-free.

Veal calves and egg-laying hens can in 2020 be deemed to be confined in a cruel manner if they are housed, respectively, with less than 43 square feet per calf, and less than 144 square inches per hen, which is equivalent to one square foot per hen.

Cruel confinement in 2022 will include any breeding pigs with less than 24 square feet per sow, giving the animals pens that are about 4 feet by 6 feet. And in 2022, the United Egg Producers 2017 housing guidelines for cage-free confinement must be followed.

United Egg Producers cage-free standards include 144 square inches per hen with free to roam and enrichment areas, including scratch area, perches, nest box, and dust bathing.

Farmers found in violation of Prop 12 can be found guilty of a misdemeanor with fines of up to $1,000 and six months in jail.

California, however, is tardy with Prop 20 regulations, which were supposed to be in place by Sept 1 this year. The rules are supposed to cover funding, enforcement, and other issues.

Federal Judge Christina Snyder of the Central District of California last month decided to allow Prop 12 to become law. The Washington D.C. based North American Meat Institute (NAMI) wanted Snyder to issue a preliminary injunction, blocking Prop 12 from becoming law until its constitutionality could be fully tested in federal courts.

NAMI could challenge Snyder’s ruling in the U.S. Court of Appeals for the 9th Circuit.

Out of state plaintiffs have so far failed to challenge California’s restrictions to its market based on its animal welfare laws. Challengers that have gone away without success include major egg-producing states.

Food products not produced under the new requirements also cannot be sold in California. Judges have upheld California’s market restrictions for not being discriminatory and not being protectionist because they are equally applied.

Since California’s Prop 12 was embraced by voters in 2018,  the Legislatures in both Oregon and Washington State have passed laws requiring cage-free hen housing by 2024.  Oregon and Washington have passed nearly identical laws during their 2019 legislative sessions.

Eggs produced by caged birds cannot be sold by commercial egg farms in Oregon or Washington State after 2024.  Cages must be removed by the end of 2023 and egg farms will be required to provide facilities that allow hens to exhibit natural behaviors such as scratch areas, perches, nest boxes, and dust bathing areas.

The two states exempt farms with fewer than 3,000 egg-laying hens.

Northwest egg farms say the transition will cost thousands of dollars as they replace old caging systems with new ones.  The industry negotiated over the bills in Oregon and Washington State with the Humane Society of the United States.

AWERS Inc. of Bellevue, WA, says the Grained Salmon Caviar 95g was distributed in California, New York, Oregon, Washington and product may have further distributed to other states and Canada.

As noted in a CFIA report Aug. 15, and according to the most current recall notice posted by the FDA, the product was reviewed by the Canadian Food Inspection Agency (CFIA) and sent to a lab for testing.

“The analysis showed a lower than normal salt content, which can foster an anaerobic environment which is necessary to breed the Clostridium botulinum bacteria.” Although no Clostridium botulinum bacteria was detected in product, consumers are warned not to use the product even if it does not look or smell spoiled,” according to the FDA.

No illnesses have been reported to date as of the posting of the Aug. 15 recall notice.

According to the recall notice, the recalled product is packed in a metal tin with Cyrillic lettering. The tin is green, with red and white writing with an easy open pull lid. The “BEST BEFORE OCT 07 2020” is printed on the bottom on the tin.

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

Food contaminated with Clostridium botulinum toxin may not look or smell spoiled but can still make you sick. Symptoms in adults can include paralysis of breathing muscles, facial paralysis or loss of facial expression, unreactive or fixed pupils, difficulty swallowing, drooping eyelids, blurred or double vision, difficulty speaking or including slurred speech, and a change in sound of voice, including hoarseness.

Additionally, symptoms of foodborne botulism in children can include difficulty swallowing, slurred speech, generalized weakness and paralysis. In all cases, botulism does not cause a fever.

In foodborne botulism, symptoms generally begin 18 to 36 hours after eating a contaminated food, but they can occur as soon as six hours or as long as 10 days after exposure.

Anyone who has eaten any of the recalled Grained Salmon Caviar product and developed symptoms of botulism poisoning should immediately seek medical attention and inform their doctors about the possible exposure.

According to the recall notice, consumers must inform AWERS, Inc. if they possess any Grained Salmon Caviar 95g tins with “BEST BEORE OCT 07 2020”. Additionally, customers must ship remaining affected product back to the firm or destroy it with permission from AWERS, Inc. for a full refund.

Consumers can contact AWERS, Inc. at 425-747-7866.

(To sign up for a free subscription to Food Safety News, click here.)

The firm received two complaints of extraneous materials from retailers on July 17, 2019, and July 18, 2019, leading to the recall.

The ready-to-eat polish sausage with beef items was packaged on June 17, 2019, and June 20, 2019. The recalled products include:

• 36-oz. packages containing three 12 oz. individually wrapped pieces of “TETON WATERS RANCH COOKED UNCURED POLISH SAUSAGE MADE WITH BEEF” with a “Use/Freeze By SEP 16 2019” or “Use/Freeze By SEP 19 2019” marked on the package.

The recalled products bear the establishment number “EST. 5694” inside the USDA mark of inspection or printed on the package. These items were shipped to retail locations in California and Utah.

There have been no confirmed reports of adverse reactions due to the consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

FSIS is concerned that some product may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

(To sign up for a free subscription to Food Safety News, click )

Like burning toast, roasting coffee beans produces trace amounts of acrylamide, a chemical that’s always been present when some foods are heated, but it went undetected until 2002.

A year ago, a state court issued a ruling that requires a cancer warning on coffee under California’s Proposition 65. But the California Office of Environmental Health Hazard Assessment (OEHHA) decided the acrylamide dose in coffee is too low to be a carcinogenic risk.

The office runs the Prop 65 regulatory process, and after the court ruling, it initiated the rule that will now take effect on Oct. 1, exempting coffee from warning labels. It means that Starbucks, Target, 7-Eleven, and other coffee retailers that were subject to the court order are off the hook.

The U.S. Food and Drug Administration supports the new OEHHA rule. The FDA found the Prop 65 warning would do more to confuse consumers than to inform them. And because scientific studies show health benefits to drinking coffee, the notice the court wanted to impose might be misleading.

“Misleading labeling on food violates the Federal Food, Drug and Cosmetic Act,” according to FDA. “No state law can require food to bear a warning that violates federal law.”

Recent reports about the health benefits of drinking coffee include defense against Parkinson’s disease, type 2 diabetes, liver disease, and liver cancer. Other claims state coffee also improves cognitive function and reduces the risk of depression. A study was reported this week that found the heart can handle 25 cups of coffee daily as effortlessly as it does one.

Hanging over coffee since 1991 was it being classified as “possibly carcinogenic to humans” by the International Agency for Research on Cancer (IARC), an offshoot of the World Health Organization (WHO). However during a June 2016 re-evaluation, an international working group of 23 IARC scientists agreed coffee should not be classified as carcinogenic.

“After reviewing more than 1,000 studies in humans and animals, the Working Group found that there was inadequate evidence for the carcincgenically of coffee drinking overall,” IARC reported onJune 15, 2016.

The world body found coffee had no effect, or results were inconclusive, on more than 20 cancers for which there were studies.

Litigation under Prop 65 was brought against almost 100 coffee retailers by the Council for Education and Research and Toxics, a nonprofit organization. After last year’s state court ruling, a handful of coffee retailers agreed to pay the stiff Prop 65 fines and post warning labels.

However, the National Coffee Association with Starbucks and others decided to fight. The litigation remained on hold so that the regulatory process could run its course.

California voters adopted Prop 65 in 1986 by a 2-to-1 margin. It is also known as the Safe Drinking Water and Toxic Enforcement Act. Any employer of 10 or more employees with brands, manufacturing, or distribution in the state is subject to Prop 65 labeling and signage requirements.

Non-governmental organizations and attorneys are empowered to bring Prop 65 enforcement actions, which can trigger noncompliance fines of up to $2,500 per day. A 60-day notice against offending retailers, brands, or manufacturers initiates Prop 65 provisions.

Prop 65 actions have increasingly targeted food companies since amendments to the act in 2018. Any known risks of cancer or reproductive toxins requires Prop 65 product warning signs and labeling.

Under the new amendments, notices must include the yellow warning triangle symbol, specific fonts, and the OEHHA website for more information.

OEHHA maintains a list of about 900 chemicals knows to cause cancer, birth defects, or other reproductive harm, which is updated at least annually.

Coffee beans and toast are not the only foods that can form acrylamide from higher cooking processes such as frying, roasting, and baking.

Plant-based foods, such as potato chips, and products from grains are more likely to accumulate acrylamide than dairy, meat or fish products. It is not necessary to avoid eating foods with acrylamide, according to FDA.

(To sign up for a free subscription to Food Safety News, click here.)