WARNING LETTER
Lone Pine Farm
MARCS-CMS 654161 —
June 26, 2023
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Elmer H. K. Beechy
Recipient Title
Owner
Lone Pine Farm
25251 Highway O
Flemington
,
MO
65650
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
June 26, 2023
Reference CMS #: 654161
WARNING LETTER
Dear Mr. Elmer H. K. Beechy:
This is to advise you that the Food and Drug Administration (FDA) inspected your shell egg farm located at 25251 Highway O, Flemington, Missouri 65650 on February 27-28, 2023. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (the Shell Egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR Part 118). Failure to comply with the provisions of 21 CFR 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 U.S.C. § 264(a). In addition, these violations render your shell eggs adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the FD&C Act, the PHS Act and Shell Egg regulation through links on FDA’s home page at www.fda.gov.
At the conclusion of the inspection, FDA investigators issued you an FDA Form 483 (FDA-483), Inspectional Observations. We received your written response postmarked March 15, 2023, that stated that you are “sending [eggs] to the breaker market again.” However, you did not specifically indicate that all your shell eggs will be sent to a breaker and that none will be sold to the table egg market (unless sold directly to consumers). Further, as explained below, some requirements of part 118 (refrigeration and registration) are applicable to you even under those circumstances.
Based on review of the inspectional findings and your response, we are issuing this letter to advise you of our continuing concerns and to provide detailed information describing the findings at your farm.
Your significant violations are as follows:
1. You did not implement your written Salmonella Enteritidis Prevention Plan (“SE Plan”), as required by 21 CFR 118.4. Specifically, you signed and dated your SE Plan on February 19, 2019. However, you ceased implementing your SE plan in August 2022, as further described below:
a) You did not procure SE monitored pullets, as required by 118.4(a)(1) and 118.4(a)(2). Specifically, your SE Plan states that all pullets would be sourced from an SE monitored flock or raised under SE monitored conditions, and the 14–16-week environmental test would be supplied by the pullet producer. However, on or around January 15, 2023, you purchased
(b)(4)
layers from a broker and added this group to your existing flock. You did not have any supporting records documenting that this group was sourced from an SE monitored flock, raised under SE monitored conditions, and that environmental testing was performed when the pullets were 14–16 weeks of age.
Further, we note that you estimated the age of the
(b)(4)
birds at about
(b)(4)
of age at the time of placement. However, you did not provide any documentation that the environment of these layers was tested at 40-45 weeks, as required by 21 CFR 118.5(a).
b) You did not monitor for the presence of rodents by appropriate monitoring methods, as required by 21 CFR 118.4(c)(1). Specifically, your SE Plan states that you will monitor rodent activity
(b)(4)
using a total of 12 live catch traps inside/outside the poultry house and three bait stations outside of the poultry house. However, you last monitored rodent activity on July 18, 2022, and have not maintained the traps or bait stations within and outside of your poultry house as evidenced by:
a. Two live catch trap traps were located approximately six feet outside the poultry house and appeared to be rusted shut.
b. No bait stations were observed located outside the poultry house.
c. One of six live catch traps was located inside the poultry house, and you indicated that the remaining may be buried within the house.
Further, records stored within this poultry house also showed evidence of rodent activity including gnaw marks, apparent rodent extra pellets, and apparent urine stains. You stated that you were aware of a rodent problem and were throwing bait under the slats where the mice lived.
c) You did not monitor for the presence of flies by appropriate monitoring methods, as required by 21 CFR 118.4 (c)(2). Specifically, your SE Plan states that you will monitor for fly activity using
(b)(4)
each
(b)(4)
; however, you stated that you last monitored fly activity on July 11, 2022 and are not currently monitoring fly activity.
d) You did not hold or transport eggs at or below 45F ambient temperature beginning 36 hours after the time of lay, as required by 118.4(e). Specifically, your SE Plan states that cooler temperature must be held at 45F and to document the cooler temperature
(b)(4)
; however, you do not have a refrigeration unit on site and stated that prior to July 2022, shell eggs were routinely picked up within 36 hours of lay. Currently, you do not ensure your eggs are refrigerated within 36 hours from time of lay, as you stated that shell eggs are collected
(b)(4)
and stored at an ambient temperature until they are collected by your customer. However, there is not a routinely scheduled pick-up time or date, nor do you maintain any records documenting temperature.
2.
(b)(3)(A)
, as required by 21 CFR 118.11(a). Specifically,
(b)(3)(A)
. Since your farm has 3,000 or more laying hens and at the time of the inspection was producing shell eggs for the table market and not selling all of the eggs directly to consumers, you must comply with the shell egg registration requirement.
As noted above, your response indicated that you are sending eggs to a breaker for an undisclosed amount of time. We note that per 21 CFR 118.1(a)(2), if all your eggs receive a treatment, as defined in 21 CFR 118.3, you must still comply with the registration requirements in 21 CFR 118.11 and with the refrigeration requirements in 21 CFR 118.4(e) for production of eggs on your farm.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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 your firm complies 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.
In addition to the following violations, we also offer the following comment:
During the inspection, you stated that your practice is to dispose of dead hens “in the woods”. We encourage you to remove and dispose of dead birds within the poultry house in a manner that will not create potential harborage for pests including rodents, insects or other animals on your farm.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Bruce E. Taylor, Compliance Officer. If you need additional information or have questions, please contact CO Taylor at 913-495-5114 or at the above address or via email at: bruce.taylor@fda.hhs.gov.
Sincerely,
/S/
LaTonya M. Mitchell, Ph.D.
Program Division Director,
Office of Human and Animal Food
Division West II
Content current as of:
08/22/2023
Regulated Product(s)
Food & Beverages