WARNING LETTER

Cargill Incorporated MARCS-CMS 589386 — January 27, 2020

Delivery Method:: VIA UNITED PARCEL SERVICE
Product:: Animal & Veterinary
Food & Beverages

Recipient:: Recipient Name

David W. MacLennan; Recipient Title

CEO; Cargill Incorporated; 15407 McGinty Rd.
Wayzata, MN 55391
United States

Issuing Office:: Division of Human and Animal Food Operations East III; United States

January 27, 2020

Ref: CMS #589386

WARNING LETTER

Dear Mr. MacLennan:

The U.S. Food and Drug Administration (FDA) inspected your licensed animal food manufacturing facility located at 9150 Statesville Boulevard in Cleveland, NC between June 4 and 11, 2019. This inspection was conducted as a follow-up to your firm’s voluntary recall of multiple animal foods due to the presence of aflatoxin at levels that exceed FDA’s action level for the intended uses. The inspection revealed violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements, located in Title 21 of the Code of Federal Regulations part 507 (21 CFR Part 507), which cause your products to be adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act).¹ The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under the FD&C Act.² You may find the Federal Food, Drug, and Cosmetic Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.

In addition, the inspection revealed violations of the Current Good Manufacturing Practice (CGMP) requirements for medicated feeds, located in 21 CFR part 225. Such violations cause the medicated feed labeled as Southern States Traditions Chick Start & Grow manufactured at your facility between May 30, 2018 and January 14, 2019 to be adulterated within the meaning of the FD&C Act.³

At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. FDA acknowledges the receipt of your firm’s responses dated July 1, 2019, and December 18, 2019.

We have reviewed your responses and we discuss your significant violations and your corrective actions below.

You also failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of becoming aware that an animal food is a reportable food for which there is a reasonable probability that the use of, or exposure to, such animal food will cause serious adverse health consequences or death to animals.⁴

We acknowledge your voluntary May 6, 2019 recall and May 26, 2019 expanded recall of animal food manufactured between October 31, 2018 and March 1, 2019 that included:

Southern States Traditions 2-Grain Scratch (CN)
Southern States Flock Balancer 20% Booster (CN)
Southern States Calf Developer Plus (DEC) (CN)
Southern States Sheep Feed Pellets (CN)
Southern States Sporting Bird Flight Developer (BMD) (CN)
Southern States Genetic Expression 14% Jump Start (BVT) (CN)
Southern States Custom Formulas
Southern States Traditions Chick Start & Grow (AMP) (CN)
Southern States 16% Sweet Goat Feed (CN)
Southern States Triple 10 (CN)
Southern States Coarse Screened Cracked Corn (CN)
Southern States Intensity 22% Calf Starter (BVT/CF) (CN)
Southern States All Grain Start-N-Grow (CN)

Livestock, horses, goats, sheep, poultry and other birds exposed to elevated levels of aflatoxin are at risk of exposure to several health effects, including aflatoxicosis and liver damage. The level at which adverse health consequences start to occur varies by species. Immature animals are more sensitive to aflatoxins. However, aflatoxicosis has the same acute and chronic adverse effects and health consequences across all species and age classes (immature and mature). Acute aflatoxicosis may result in generalized hemorrhage, bloody diarrhea, and death. In addition, aflatoxin toxicity can cause reduced food intake, reduced weight gain, liver damage, jaundice, and death. FDA has provided action levels in Compliance Policy Guide (CPG) Sec. 683.100 Action Levels for Aflatoxins in Animal Food, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-683100-action-levels-aflatoxins-animal-feeds, as guidance on FDA’s current understanding of levels of aflatoxin that do not present a danger to the health of these animals or a risk to consumers of food derived from the exposed animals based on animal feeding trials. The presence of aflatoxin above these action levels could pose adverse health consequences in animals or a risk to consumers of food derived from the exposed animals. The action level for aflatoxins in animal food ingredients intended for immature animals, species not listed, or when the intended use is unknown is 20 parts per billion (ppb).

Adulterated Animal Food Due to Violation of Animal Food Hazard Analysis and Risk-Based Preventive Controls Requirements

Your facility is subject to the hazard analysis and risk-based preventive controls requirements for animal food (21 CFR part 507, subparts C and E). During our inspection of your facility, FDA Investigators noted violations of the Hazard Analysis and Risk-Based Preventive Controls requirements for animal food found in 21 CFR part 507, subpart C. These violations render your animal food products adulterated according to the FD&C Act.⁵ Violations observed during the inspection include, but are not limited to, the following:

1. Your facility failed to sufficiently assess the probability that a hazard will occur in the absence of a preventive control as required by 21 CFR 507.33(c)(1). Specifically:

a. Your reliance on prerequisite programs in your food safety plan failed to reduce the probability that the presence of an unsafe level of aflatoxin will occur in the absence of a preventive control. Your facility’s (b)(4). However, the prerequisite programs identified in your hazard analysis are not operating in a way that reduces the probability of occurrence, as evidenced by (b)(4) animal food samples collected by the North Carolina Department of Agriculture and Consumer Services (NCDA) between November 26, 2018 and March 11, 2019 that reported aflatoxin levels ranging from (b)(4), including samples that tested above the FDA action level of 20 ppb for their intended use. These levels are also above your facility’s acceptance level of 20 ppb, as reported in your facility’s Draft Investigation/Root Cause and Corrective Action Report for Barber Facility Aflatoxin Issue. In addition, third-party testing of retain samples from finished animal food products manufactured from November 2018 to February 2019 revealed (b)(4) samples that tested over the FDA action level for the pertinent species and animal life stage and an additional (b)(4) that tested above your facility’s acceptance level of 20 ppb.

In your July 1, 2019 written response, you state that your Food Safety Team and Preventive Controls Qualified Individual (PCQI) identified aflatoxin in corn as a hazard requiring a preventive control with plans to implement a preventive control by August 1, 2019. You provided a draft procedure (b)(4). We are unable to fully evaluate your corrective actions because the corrective action includes procedures that are in draft status or under development. Furthermore, no timeframe was provided for when this corrective action will be completed. FDA will verify your corrective actions during the next inspection of your facility.

b. Your reliance on a (b)(4). Your facility identified (b)(4). The (b)(4). Your (b)(4).

In your July 1, 2019 written response, you state that your Food Safety Team and PCQI conducted a reanalysis of the Food Safety Plan on June 17, 2019 and did not identify metal as a hazard requiring a preventive control. Your response refers (b)(4). We are unable to fully evaluate your corrective actions because there was no supporting documentation or timeframe provided for completion of this corrective action. FDA will verify your corrective actions during the next inspection of your facility.

2. You failed to conduct a reanalysis of your food safety plan as appropriate after an unanticipated food safety problem in accordance with 21 CFR 507.42(b), or whenever your food safety plan as a whole is deemed ineffective as required by 21 CFR 507.50(b)(3) and (4), respectively.

Specifically, you were notified by the NCDA on December 27, 2018, of an aflatoxin level of (b)(4) in a lot manufactured on November 9, 2018—your first notice of an unanticipated food safety problem or ineffectiveness of your food safety plan. Your food safety plan did not include corrective actions for addressing elevated levels of aflatoxin. You updated the tag to state that the animal food was intended for mature poultry. NCDA notified you on January 30, 2019, of an aflatoxin level of (b)(4) in a lot manufactured on December 18, 2018. You notified retail customers that had purchased the lot. On February 20, 2019, NCDA notified you that a lot manufactured on December 20, 2018, had an aflatoxin level of (b)(4). Your root cause analysis conducted on or before February 25, 2019, determined the corn from your single supplier was the cause of the aflatoxin contamination. As a result, your facility discontinued receiving corn from the implicated source and contacted retailer customers who had purchased the lots.

On March 20, 2019, NCDA notified you of aflatoxin levels of (b)(4) in animal food manufactured in February 2019. You contacted retail customers of the specific lots. NCDA notified you on March 29 and April 2, 2019, of aflatoxin levels of (b)(4) in more animal food manufactured in February 2019. You contacted retail customers who had purchased the animal food and destroyed the remaining animal food at your facility that had been manufactured with corn in February 2019. NCDA requested a retailer notification and market withdrawal and notified FDA of the elevated aflatoxin levels on April 25, 2019. On May 6, 2019, your

facility began a voluntarily recall, which was later expanded on May 25, 2019, to include all products manufactured between October 31, 2018, and March 1, 2019, that were labeled for use in species and age classes (immature and mature) that are susceptible to acute and chronic adverse effects of aflatoxin levels greater than 20 ppb.

As of the initiation of the FDA inspection on June 4, 2019, your facility had not performed a reanalysis of your food safety plan. 21 CFR 507.50(c) requires you to complete the reanalysis before any change in activities (including any change in preventive control) at the facility is operative or when necessary to demonstrate the control measures can be implemented as designed. Specifically, you were required to complete the reanalysis prior to changing your supplier.

In your July 1, 2019 written response, you state that your Cleveland Food Safety Team and PCQI conducted a reanalysis of the Facility Food Safety Plan on June 17, 2019 as well as prepared a written justification for the timing for conducting the reanalysis. You provided this written justification in your December 18, 2019 response. In addition, you stated that Cargill is working on (b)(4). We are unable to evaluate your corrective actions because the corrective action includes procedures that are in draft status or under development. Furthermore, no timeframe was provided for when this corrective action will be completed. FDA will verify your corrective actions during the next inspection of your facility.

Adulterated Animal Food Due to Violation of CGMPs for Licensed Medicated Feedmills

During our inspection of your facility, FDA Investigators noted a violation of the medicated feed CGMP regulations for licensed medicated animal feed manufacturers (21 CFR 225.1-225.115). This violation renders your animal food product adulterated according to the FD&C Act.⁶ Violations observed during the inspection include, but are not limited to, the following:

1. You failed to implement a corrective action when assay results outside of the permissible assay limits were received, and you subsequently failed to discontinue distribution of a medicated feed that failed to meet its labeled drug potency as required by 21 CFR 225.58(d) and (e).

Specifically, your facility manufactured and distributed Traditions Chick Start & Grow containing (b)(4), which showed the samples of Traditions Chick Start & Grow containing lot (b)(4). The Traditions Chick Start & Grow is formulated to include (b)(4). The assay limits are 80% to 120% of the labeled amount under 21 CFR 558.4, but your supplier’s reports showed samples with (b)(4). You also received sample results from the NCDA dated November 1, 2018 that showed out of specification assay results for (b)(4) in Southern States Traditions Chick Start & Grow, lot N8096.

On or before June 29, 2018, your facility initiated a Product Investigation in response to the initial out of specification notification received from your supplier on May 30, 2018. In this investigation you determined all records indicated correct manufacturing, no irregularities, and excess variance appeared to be the result of non-manufacturing issues. Your facility further elected to submit a portion of the lot’s retained sample and a sample of the next production batch for assay. Then your facility initiated a Supplier Corrective Action Request on December 13, 2018 in response to the out of specification notification received from NCDA on or after November 1, 2018. After being informed by your supplier (b)(4). Your facility’s Action Plan was initiated on January 2, 2019. However, your facility failed to implement this corrective action and discontinue distribution of a medicated feed that failed to meet its labeled drug potency because your facility (b)(4). Records collected during the FDA inspection found your facility continued to manufacture and distribute Traditions Chick Start & Grow, including, but not limited to, two instances between January 2, 2019 and February 22, 2019.

In your July 1, 2019 written response to the FDA Form 483, you state Cargill implemented (b)(4). Although you provided the procedure, a copy of (b)(4) was not provided. The implementation of the (b)(4) appears to provide an established process for evaluating medicated feeds that are manufactured at your facility in the future. As a result, it is difficult to evaluate your corrective action for this observation, including how you will be handling investigations for out of specification results. The (b)(4). However, (b)(4) is not an adequate corrective action and FDA would not consider subsequent test results within specifications to negate the original out of specification assay result.

FDA will verify your corrective actions during the next inspection of your facility.

Reportable Food Registry

You failed to report a reportable food to the Reportable Food Registry within 24 hours of becoming aware of a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals, as required by the FD&C Act.⁷ Specifically, you were informed of aflatoxin levels ranging (b)(4) by NCDA on six occasions between December 27, 2018 and April 2, 2019, but you did not file any reportable food reports until May 15, 2019, which was more than 24 hours after becoming aware of the reasonable probability of serious adverse health consequences. Based on our review of the scientific literature and reports of animal deaths, we have determined that the presence of aflatoxin in the following examples of your animal foods creates a reasonable probability of serious adverse health consequences or death to humans or animals:

Animal Food Name	Intended species/age	Manufacture date	Sample date	Date reported by NCDA	Analysis results
Southern States Sporting Bird Flight Developer	Other animal species (water fowl/wildlife)	Feb. 4, 2019	Feb. 27, 2019	March 20, 2019	(b)(4)
Southern States 16% Sweet Goat	Other animal species (goat)	Feb. 12, 2019	Mar. 7, 2019	April 2, 2019	(b)(4)
Southern States Course Screened Cracked Corn	Unspecified species/age	Feb. 22, 2019	Mar. 7, 2019	April 2, 2019	(b)(4)

The Reportable Food Registry was established to provide a reliable mechanism to track patterns of adulteration in food (including animal food) to support efforts by FDA to target limited inspection resources to protect the public health. It requires a “responsible party” to file reportable food reports. The responsible party is the person who submits the registration under section 415 of the FD&C Act for a food facility that is required to register, at which the reportable food was manufactured, processed, packed, or held.⁸ The responsible party is required to file a notification within 24 hours of determining that an article of food is a reportable food.⁹ Failure to submit a required reportable food report is a prohibited act under the FD&C Act.¹⁰

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Comments
• Your facility identified mycotoxins as a hazard in your hazard analysis but did not specifically identify aflatoxins, which are a type of mycotoxin. We encourage you to update your hazard analysis to identify all specific mycotoxins that are known, or reasonably foreseeable hazards associated with your animal food and animal food facility. Aflatoxins are a known chemical hazard in raw corn and corn-based finished animal foods.

• We note that out of specification assay results must be reported to the FDA as required in 21 CFR 510.301(a)(2).

• In addition, your facility did not include a notification to bulk customers to determine the impact on their animals of the elevated aflatoxin levels in the corn included in the finished animal foods they received during the period associated with recalls initiated on May 6, 2019 and expanded on May 26, 2019. Even though you may have determined your bulk product may not have been available and edible at the time of the recall, your firm still should have informed your bulk customers of the elevated aflatoxin levels in animal food they received so that your customers may assess their animals for any negative effects that may have been caused by the animal food. Although Cargill has conducted an audit of the reorder data for the bulk animal food and determined the bulk animal food manufactured during the recall period was used up well before the recall was launched, we do not consider this corrective action adequate as there does not appear to have been any communication sent to the bulk customers.

• For more information on the Current Good Manufacturing Practice requirements of 21 CFR part 507, subpart B please see FDA’s Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals, at:
https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM499200.pdf.

• For more information on the Hazard Analysis and Risk-based Preventive Controls requirements of 21 CFR part 507, subparts C and E please see FDA’s draft Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, at:
https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM592870.pdf.

Next Steps
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time frame within which you will complete the correction. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Section 743 of the FD&C Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

Your firm’s response should be sent to Janice L. King, Compliance Officer, 60 Eight Street, NE, Atlanta, GA 30309. If you have questions regarding any issues in this letter, please contact Ms. King at 843-746-2990, x16 or Janice.King@fda.hhs.gov.

Sincerely,
/S/

Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations – East Division 3

Cc:
Mr. Glen A. Fisher, Plant Manager
Cargill, Inc.
9150 Statesville Blvd.
Cleveland, NC 27013

Cc:
George R. Ferguson, Feed Administrator, NC Animal Feed Program
North Carolina Department of Agriculture and Consumer Services
1001 Mail Service Center, Raleigh, NC 27699-1001

________________________________

1 Section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
2 Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
3 Section 501(a)(2)(B) of the FD&C Act [21 U.S.C § 351(a)(2)(B)] and 21 CFR 225.1(b)(1).
4 Section 417(d)(1) of the FD&C Act [21 U.S.C. § 350f(d)(1)].
5 Section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
6 Section 501(a)(2)(B) of the FD&C Act [21 U.S.C. § 351(a)(2)(B)].
7 Section 417(d)(1) of the FD&C Act [21 U.S.C. § 350f(d)(1)].
8 Section 417(a)(1) of the FD&C Act [21 U.S.C. § 350f(a)(1)].
9 Section 417(d) of the FD&C Act [21 U.S.C. § 350f(d)].
10 Section 301(mm) of the FD&C Act [21 U.S.C. § 301(mm)].