The key points of this warning letter are in BOLD below:
WARNING LETTER 638042
Dear Mr. Smucker:
The U.S. Food and Drug Administration (FDA) and the Kentucky Cabinet for Health and Family Services Food Safety Branch (CHFS-FSB) jointly inspected your manufacturing facility located at 767 Winchester Road, Lexington, KY 40505-3728 from May 19, 2022, through June 9, 2022. The inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella Senftenberg (S. Senftenberg) illnesses linked to your ready-to-eat (RTE) peanut butter. According to the Centers for Disease Control and Prevention (CDC), 21 people from 17 states were infected with the outbreak strain of S. Senftenberg. On May 20, 2022, your firm recalled all peanut butter manufactured at this facility from October 1, 2021, to May 20, 2022, due to potential contamination with Salmonella.
CDC and FDA have determined, based upon the epidemiologic, laboratory, and traceback evidence, that peanut butter manufactured at your facility was the source of this multistate S. Senftenberg outbreak. Further, the evidence establishes that you introduced adulterated peanut butter into interstate commerce as prohibited by section 301(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 331(a)].
During the joint inspection, FDA and CHFS-FSB investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on our inspectional findings, we have determined that the RTE peanut butter manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that it was prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.
At the conclusion of the inspection, FDA (hereinafter, we) issued a Form FDA 483 (FDA 483), Inspectional Observations. We received your responses to the FDA 483 dated July 1, 2022, August 1, 2022, August 16, 2022, and October 4, 2022, describing the corrective actions taken and planned by your firm, including training records associated with your implemented corrective actions. After reviewing the inspectional findings and your responses, we are issuing this letter to advise you of FDA’s continuing concerns and provide detailed information describing the findings at your facility.
Multistate Outbreak of Salmonella Senftenberg linked to Jif Brand Peanut Butter:
During routine monitoring of the whole genome sequencing (WGS) National Center for Bioinformatics database, FDA identified five recent 2022 clinical isolates (samples collected from ill people) which matched over one hundred third-party peanut butter and environmental isolates from Kentucky collected from 2014 to 2017. Shortly thereafter, FDA and CDC began investigating a multistate outbreak of Salmonella infections. On May 19, 2022, five out of five patients who were interviewed, reported peanut butter exposure with four specifically reporting consuming Jif brand peanut butter. FDA reviewed information from inspections and identified a 2010 FDA environmental sample of S. Senftenberg collected from your facility. WGS was conducted on the 2010 environmental sample, and it was found to match the growing cluster of S. Senftenberg clinical isolates from the outbreak of Salmonella infections and the peanut butter and environmental isolates from Kentucky. The presence of the same S. Senftenberg strain in your facility since 2010, which matched the clinical cluster, is indicative of a resident strain. On May 19, 2022, we notified you of these findings via teleconference. On May 20, 2022, you initiated a voluntary recall of Jif brand peanut butter. In addition, CDC deployed a supplemental peanut butter focused questionnaire to identify possible clinical exposures. In total, this outbreak included 21 cases from 17 states. Of 13 cases with information, all reported Jif brand peanut butter exposure (100%).
Epidemiological, laboratory and traceback data show that you introduced adulterated peanut butter into interstate commerce as prohibited by section 301(a) of the Act (21 U.S.C. § 331(a)). Specifically, the evidence supports that the peanut butter responsible for this outbreak was manufactured in your Lexington, KY facility.
Your finished product testing records from January 1, 2021, to February 23, 2022, indicate that you detected Salmonella in your RTE peanut butter on numerous occasions, i.e., October 22 and December 15, 2021; and February 4, 9, 10, 20, and 21, 2022, and that your corrective actions were not sufficient to address the root cause of the contamination.
For example, on February 17-18, 2022, you identified a leak in the air intake vent of the cooling chamber of Roaster (b)(4), as a source of water entering your equipment, and stated you immediately repaired the vent. However, on February 20, 2022, after the repair was completed, you detected Salmonella in (b)(4) of the (b)(4) lots on Line (b)(4) ((b)(4), and (b)(4)) using your standard (b)(4) samples per lot sampling program. Subsequently, per your practice, you “collect[ed] [and tested] (b)(4) samples ((b)(4)sample composites) from the lot[s] produced immediately prior to and after the product that tested positive.” After testing (b)(4) lots that initially tested negative for Salmonella, you identified two additional positive lots:
- (b)(4), Salmonella detected in 2 of (b)(4)-sample composites
- (b)(4), Salmonella detected in 2 of (b)(4) sample composites
The next day, on February 21, 2022, you detected Salmonella in a (b)(4) lot on Line (b)(4) using your standard (b)(4) samples per lot sampling program. Similar to February 20, after testing (b)(4) lots that initially tested negative for Salmonella you identified additional positive lots:
- (b)(4), Salmonella detected in 5 of (b)(4)-sample composites
- (b)(4), Salmonella detected in 4 of (b)(4)-sample composites
- (b)(4), Salmonella detected in 5 of (b)(4)-sample composites
- (b)(4), Salmonella detected in 4 of (b)(4)-sample composites
You indicated that “[e]ven when the additional samples test negative, we destroy all (b)(4) production lots to provide further assurance we have bracketed and eliminated any potential contamination.” However, your positive test results for lots for which Salmonella was previously not detected show the limitations of reliance on your testing program to identify contamination as a way to prevent contaminated products from reaching consumers. Further, the S. Senftenberg outbreak shows that neither your corrective actions nor your finished product testing was adequate to prevent contaminated product from reaching consumers and causing illnesses.
In your letter dated May 27, 2022, you stated that the outbreak of S. Senftenberg was likely due in part to Salmonella introduced to your production process through cooling air supply vents that were installed incorrectly on Roaster (b)(4) on December 10, 2021, allowing unfiltered air and a small amount of rainwater to enter the cooling section of the roaster where the peanuts are RTE. Preventing water in dry processing environments for low moisture foods is essential to control environmental pathogens such as Salmonella.
In your response dated July 1, 2022, you stated that you updated your finished product testing procedures to include a “(b)(4) Hold” in the event a single positive result is detected in your RTE peanut butter. This (b)(4) Hold includes holding “(b)(4) Lots” produced (b)(4) hours before and (b)(4) hours after the affected (i.e., positive) lot and performing further testing using (b)(4) samples from only the (b)(4) lots on “each extreme of the bracketed window” (i.e., only the (b)(4) or (b)(4) lot on either end of the held product). You stated that “this conservative approach provides a safety factor to ensure any potential contamination is included [in the held product].”
We are concerned that your use of this approach in response to a contamination event would not ensure all affected product would be identified and prevented from entering commerce. We are not aware of any data or scientific rationale to support how your (b)(4)Hold would be an effective approach to identify all product affected by a contamination event in your continuous production of RTE peanut butter. As part of your response to this letter, we ask that you provide support for your approach.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not identify and evaluate the hazard of contamination with environmental pathogens, such as Salmonella spp. at certain post-roasting processing steps, as a known or reasonably foreseeable hazard to determine whether it requires a preventive control, to comply with 21 CFR 117.130(c)(1)(ii).
Specifically, your hazard analysis, “Hazard Analysis – Process for the ‘Jif Lexington’” plant, dated March 2022, for your RTE peanut butter, did not consider the hazard of recontamination with environmental pathogens, such as Salmonella spp., at post-roasting processing steps from blanching to sorting and milling (including (b)(4)). In-process RTE peanuts are exposed to the environment at these steps, and the food does not receive further treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.
Your July 1, 2022, response discussed actions your facility has taken to address the deficiencies with your food safety plan, including adding environmental recontamination with Salmonella as a hazard requiring a sanitation preventive control at all steps where RTE product is exposed to the environment and will not receive an additional kill-step. However, you did not provide a revised hazard analysis or food safety plan for our evaluation. As part of your response to this letter, we request that you provide your current food safety plan (including your hazard analysis).
2. Your corrective action procedures did not ensure appropriate action was taken, when necessary, to reduce the likelihood that environmental contamination will recur, as required by 21 CFR 117.150(a)(2)(ii), when you detected Salmonella in your facility’s environment.
During FDA’s February 2018 inspection, you indicated that your environmental monitoring program included collecting (b)(4) environmental samples from zones (b)(4), and (b)(4) located throughout the manufacturing and packaging areas of the facility. All samples were sent to your third-party testing laboratory and analyzed for Listeria monocytogenes, E. coli, and Salmonella. You stated that your corrective actions for positive samples included increased cleaning and sanitizing to the subject area until (b)(4) negatives are obtained.
Your environmental monitoring records from July 24, 2018, November 26, 2018, October 9, 2019, and November 4, 2019, revealed four Salmonella positive environmental swabs located at roaster (b)(4), stairs leading to platform “(b)(4)”, floor of the entrance to the blanch nut tank rooms (b)(4) and (b)(4), and the floor broom in the roaster (b)(4). You determined that the root causes for each Salmonella positive environmental swab were roof leaks or increased foot traffic during repairs in response to roof leaks, and you took immediate action to repair roof leaks and to correct foot traffic issues. Your records indicate that you suspended production until you could clean and sanitize the areas and take other corrective actions, such as adding (b)(4) and replacing utensils, as appropriate.
Your environmental monitoring records from 2021 revealed five Salmonella positive environmental swabs in your facility on July 6, July 8, July 12, September 3, and November 16, 2021. These Salmonella positive swabs were found on the floors near your blanch nut tank rooms, roaster booth (b)(4), the stairs at the top level of the nut house (b)(4), and the stairs leading to platform “(b)(4)”. The detection of Salmonella in your facility in 5 locations in 2021, many of which were similar to locations where you detected Salmonella in 2018 and 2019, show that your corrective action procedures in response to environmental contamination in 2018 and 2019 were not sufficient to reduce the likelihood that environmental contamination would recur, as required by 21 CFR 117.150(a)(2)(ii).
In your response dated July 1, 2022, you indicated that you conducted root cause investigations on the 2021 Salmonella findings in your facility, and you implemented corrective actions consistent with your environmental monitoring procedures. However, the outcomes of these investigations (e.g., your root cause determinations) were not provided in your response.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
In addition, we have the following comments:
We are concerned that the history of contamination events associated with water in your facility and results from the WGS database suggest that Salmonella may be resident within your production facility. As an example of the continuing problems with water in the facility, we note that on February 17-18, 2022, you found a puddle of water, measuring approximately 4 feet by 8 feet in the bottom of cooling zone (b)(4) in Roaster (b)(4) and a puddle of water measuring approximately 4 inches by 4 inches in the bottom of cooling zone (b)(4) in Roaster (b)(4). After you found the puddles of water, you collected environmental swabs from Roaster (b)(4), which were found to be indicative of microbial growth. Your investigation found a defective flange on the zone (b)(4) cooler inlet of Roaster (b)(4), which allowed rainwater and unfiltered air to enter the roaster’s cooling zones and contact the roasted peanuts after the roasting/kill step. Your corrective actions included repairing the defective flange and cleaning and sanitizing the roasters.
In your July 1, 2022 response, you stated that you will verify that there are no conditions conducive for bacteria growth on equipment due to the presence of water/moisture before beginning a production run. Specifically, you provided your “Right to Run (b)(4)Inspection” procedure which you state is a supplement to the overall Plant Food Safety program to ensure the plant does not continue production with critical food safety risks present (i.e., “external conducive conditions related to water penetration and other adverse environmental factors that could yield product contamination”). You also implemented (b)(4) inspections and sanitation of the roofs and ceilings according to your Master Sanitation Schedule.
While these procedures may help to identify events which would introduce water into your processing environment, constant vigilance is needed to ensure water does not become a source or route of cross-contamination in your dry processing environment. Further, to prevent Salmonella from spreading in your facility and adulterating your products, it is essential to identify the areas in your food manufacturing plant where Salmonella survive and take corrective actions as necessary to eradicate the organism.
In addition, we recommend that you consider incorporating WGS as a tool to investigate pathogen isolates obtained in your environmental monitoring program and/or your finished product testing program. The use of WGS to analyze and investigate any pathogen isolated from your production environment or RTE peanut butter will provide the most complete information available to identify and implement appropriate and effective corrective actions, including steps to prevent the contamination from recurring and steps to ensure contaminated product does not enter commerce.
Furthermore, we note that during the inspection and in your response dated July 1, 2022, you stated that on “very rare instances you find Salmonella in finished product when a Salmonella organism survives our validated thermal process.” Specifically, you stated this in reference to the detection of Salmonella in your peanut butter produced on October 22, 2021, and December 15, 2021. You added that you have a “robust finished product testing program specifically because of this possibility, as even a validated kill step, such as the roasters that are validated to deliver over a (b)(4) kill, does not eliminate the potential that Salmonella could survive the roasting process on rare occasion.” We evaluated your roasting process parameters during the inspection and disagree with your position that a properly validated and implemented process control at your peanut roasting step would allow for the survival of Salmonella such that the pathogen would be detected in your finished product because it survived the roasting step.
In addition, you stated in your July 1, 2022, response that after detecting Salmonella in your RTE peanut butter on February 4, 9, and 10, 2022, you used a (b)(4) to remove peanut butter from the lines between the (b)(4) to the (b)(4). (b)(4) piping and other equipment used to process peanut butter contaminated with Salmonella, although effective at removing large amounts of peanut butter from the equipment, are not an effective means of eliminating possible Salmonella contamination from that equipment.
Please respond in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to United States Food & Drug Administration; Attn: Allison Hunter, Compliance Officer via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or 550 Main Street, Suite 4-930, Cincinnati, Ohio 45202. If you have questions regarding this letter, please contact CO Hunter by telephone at (513) 322-0629, or via email at email@example.com.
Steven B. Barber Director, Division V
Office of Human & Animal Food Operations-East
Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands. The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce. Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health. The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.
Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:
Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce. Any person who commits a prohibited act violates the FDCA. A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.
A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation. Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.
The legal jargon aside, if you are a producer of food and knowingly or not manufacturer and sell adulterated food, you can (and should) face fines and jail time.