Boyd Mahrt and Ingrid Mahrt 2/21/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone (510) 337-6700
February 21, 2013
Mr. Boyd Mahrt and Ms. Ingrid Mahrt
311 McBrown Road
Petaluma, CA 94952
Dear Mr. Mahrt and Ms. Mahrt:
The U.S. Food and Drug Administration (FDA) inspected your shell egg production facility located at 700 Cavanaugh Lane, Petaluma, California, between September 17 and 28, 2012. During the inspection, FDA found that your facility had serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 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 FD&C 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. Our investigators’ observations were noted on form FDA 483, Inspectional Observations, which was issued to you on September 28, 2012. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. You failed to have a written SE prevention plan that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4. Specifically, your SE prevention plan, titled “Salmonella Enteritidis Prevention Program for Shell Eggs – Boyd Ranch (Cavanaugh)” failed to address cleaning and disinfection of the pullet environment in response to an SE-positive environmental test, as required by 21 CFR 118.4(a)(3).
During the inspection, you told our investigators that corrections would be made. However, you did not submit a written response to the FDA 483 or provide any supporting documentation of your corrective actions.
2. You failed to use appropriate rodent monitoring methods, as required by 21 CFR 118.4(c)(1). According to Item 8 of your firm’s written SE prevention plan, your rodent monitoring procedure is to visually check for rodent activity and maintain records to see the activity trends. However, your plan failed to set a threshold level for unacceptable rodent activity at which you would take corrective action. Determining whether the rodent population is acceptable or not is a required component of 21 CFR 118.4(c)(1). Additionally, your SE prevention plan did not include appropriate methods for achieving satisfactory rodent control when monitoring indicates unacceptable rodent activity, as required by 21 CFR 118.4(c)(1).
3. You failed to conduct environmental testing for SE in the pullet environment when the pullets were 14 to 16 weeks of age, as required by 21 CFR 118.4(a)(2)(i). Specifically, records reviewed by our investigators and information provided by your firm indicate that between January 2011 and September 2012, there were four occurrences where the pullet environmental testing was conducted outside of the 14-16 week pullet age time frame. In these instances it was noted that the pullet environmental samples were collected from 10 to 21 days after the time frame established in 21 CFR 118.4(a)(2)(i).
You also failed to conduct environmental testing for SE in the poultry house when laying hens reached 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Your layer house environmental sampling records indicated that in May 2011 there were two occurrences where samples were collected from 16 days before to 9 days after the laying hens reached 40-45 weeks of age.
4. You failed to maintain records documenting rodent and other pest control measures, as required by 21 CFR 118.10(a)(3)(ii). Specifically, you failed to maintain fly monitoring records for the following months in 2012: February, March, May, June, July, and August.
5. You failed to include the name and location of your farm on all required records, as required by 21 CFR 118.10(b)(1). You also failed to include the time of the activity that the record reflects on all of your required records, as required by 21 CFR 118.10(b)(2). Specifically, your rodent and fly monitoring records do not include the name and location of your farm or the time activities were performed.
This letter is not meant to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your shell egg production facility operates in compliance with all applicable statutes and regulations, including the FD&C Act, the PHS Act, and the shell egg regulation. You also have the responsibility to use procedures to prevent future violations of these statutes and regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
In addition to the above violations, we also have the following comments:
- Your SE prevention plan states that a fly threshold of (b)(4) or fewer spots per card per month indicates satisfactory fly control, but this is potentially not consistent with your fly monitoring records, which state that (b)(4) or fewer spots per card is acceptable. Please be aware that monitoring for flies is required under 21 CFR 118.4(c)(2); therefore it is important to be consistent between what is stated in your SE Prevention Plan and your actual monitoring records. We recommend that you use the same threshold for acceptable fly activity through the entirety of your SE prevention plan. However, we acknowledge that your fly control monitoring records do not appear to indicate high levels of fly activity in your houses.
- Your SE prevention plan contains elements labeled (b)(4). Please be aware that 21 CFR 118.10(b)(1) requires you to include your name and the location of your farm on all of your required records.
- Your firm conducted a post-molt environmental test, but your records do not indicate the date for end of molt and do not specify how you determine when the end of molt has occurred. Please be aware that environmental testing for SE after an induced molting period is required under 21 CFR 118.5(b). Therefore, it is important to identify how you determine that the end of molt has occurred. In FDA’s August 2012 Guidance for Industry “Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation,” we state that we consider that the molting process has ended when the layers have reached 50 percent of production. Our guidance is available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm313728.htm.
You should respond in writing within fifteen (15) working days of your receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved, such as an updated SE prevention plan and monitoring records. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed.
Your written response to this letter should be directed to Lawton Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Brandon L. Bridgman, Compliance Officer at 510-337-6794.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration
Maurice Pitesky DVM, MPVM
California Dept. of Food and Agriculture
Animal Health Branch