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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Petaluma Farms 9/5/12

  

Department of Health and Human Services logoDepartment 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 

WARNING LETTER

VIA UPS
Signature Required
 

September 5, 2012
 

Steven P. Mahrt
Petaluma Farms
700 Cavanaugh Lane
Petaluma, CA 94952
 

Dear Mr. Mahrt:

The United States Food and Drug Administration (FDA) inspected your shell egg production facilities located at 2400 Fallon Road and 700 Cavanaugh Lane, Petaluma, California, between March 27th and April 9th, 2012. During the inspection, FDA found that your facilities 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 CPR 118). Failure to comply with the provisions of 21 CPR 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. 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 were 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, during our inspection your SE prevention plan, titled "Salmonella Enteritidis Prevention Program for Shell Eggs," dated February 18, 2012, failed to include the following required SE prevention measures:

Pullets

• At the time of your inspection, your February 18, 2012 SE prevention plan failed to provide for testing the pullet environment for SE when pullets are 14 to 16 weeks of age, as required by 21 CFR 118.4(a)(2). Your plan also 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).

At the conclusion of our inspection, you submitted amended SE prevention plans to our investigators, each titled "Salmonella Enteritidis Prevention Program for Shell Eggs," (one for each farm location) and dated April 9th, 2012. In addition, your written response to the FDA 483, received May 1, 2012, included updated SE prevention plans, also dated April 9th, 2012, but further described as "Version 2." We have reviewed your most recent SE prevention plans (Version 2). We note that the updated SE prevention plans address testing the pullet environment for SE when pullets are 14 to 16 weeks of age. However, your updated plans do not specifically describe the cleaning and disinfection procedures for an SE-positive pullet house.

Biosecurity

• At the time of the inspection, your SE prevention plan, dated February 18th, 2012, failed to include measures to protect against cross contamination when equipment is moved among poultry houses, as required by 21 CFR 118.4(b)(2); measures to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, as required under 21 CFR 118.4(b)(4); and a requirement that employees not be allowed to keep birds at home, as required by 21 CFR 118.4(b)(5).

We note that the updated SE prevention plans (Version 2), dated April 9th, 2012, submitted in your written response includes the measures cited above. But overall, the biosecurity measures included in your revised SE prevention plans lack details about what controls are in place and what records you maintain to document your adherence to those controls. We recommend revising these sections of your SE prevention plans to include more descriptive information about these measures and to identify corresponding records.

Rodents, Flies, and other Pest Control

• At the time of the inspection, your SE prevention plan, dated February 18th, 2012, failed to provide details about how you monitor for unacceptable rodent activity within a poultry house, as required by 21 CFR 118.4(c)(1). Specifically, your plan did not indicate a threshold-such as a specific number of rodents at a specific monitoring frequency-for when you consider rodent activity to be unacceptable. In addition, 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).

We have reviewed the updated SE prevention plans (Version 2), dated April 9th, 2012, included in your written response. The updated SE prevention plans continue to lack parameters by which you define unacceptable rodent activity within your poultry houses.

Furthermore, we note that your updated SE prevention plans indicate that you monitor for rodents via visual inspection and mechanical trapping; however, your plans do not describe how many traps are used per house or where the traps are placed. We recommend revising these sections of your SE prevention plans to include these details.

We further note that your SE prevention plans identify a fly threshold of (b)(4) pots per card per month to indicate satisfactory fly control under 21 CFR 118.4(c)(2). We recommend that you lower your fly threshold; however, we acknowledge that your fly control monitoring records do not appear to indicate high levels of fly activity in your houses.

Cleaning and Disinfection

• At the time of the inspection, your SE prevention plan, dated February 18th, 2012, failed to include measures addressing the cleaning and disinfection of poultry houses after an environmental test or an egg test is positive for SE, as required by 21 CFR 118.4(d).

We note that the updated SE prevention plans (Version 2), dated April 9th, 2012, submitted in your written response includes a description of your cleaning and disinfection procedures after an SE-positive environmental test. However, the updated plans fail to address the cleaning and disinfection procedures after an SE-positive egg test. Furthermore, while your updated plans seem to imply that you intend to (b)(4) after an SE-positive environmental test, rather than (b)(4) this element of your plan should be described more clearly.

2. You failed to procure pullets that are SE monitored or to raise pullets under SE monitored conditions, as required by 21 CFR 118.4(a). SE monitoring includes testing the pullet environment for SE when pullets are 14 to 16 weeks of age, as required by 21 CFR 118.4(a)(2)(i). Specifically, our investigators learned from your test records that the pullets used to populate Laying Houses (b)(4) and (b)(4) at your 2400 Fallon Road location had never been subjected to SE environmental testing while being held at your pullet facility. In addition, the pullets used to populate the following laying houses were not environmentally tested for SE within the required 14 to 16 weeks of age time frame:

2400 Fallon Road
• House (b)(4)-testing conducted at 20 weeks of age
• Houses (b)(4) and (b)(4)-testing conducted at 18 weeks of age

700 Cavanaugh Lane
• Houses (b)(4) and (b)(4)-testing conducted at 21 weeks of age
• Houses (b)(4) and (b)(4)-testing conducted at 18 weeks of age
• Houses (b)(4) and (b)(4)-testing conducted at 17 weeks of age

Your written response, received May 1, 2012, states that Houses (b)(4) and (b)(4) were populated with pullets that had not undergone the required environmental testing for SE between 14 to 16 weeks of age due to an employee illness. In response to this failure, you collected environmental samples on April 2, 2012. This corrective action is inadequate in that the environmental sampling conducted on April 2, 2012 was not conducted on the pullet environment, since the pullets had already been moved into Houses (b)(4) and (b)(4). We note that your current SE prevention plans address the requirement to test the pullet environment for SE when pullets are 14 to 16 weeks of age. During our next inspection, we will review your environmental testing records to ensure your adequate implementation of this element of your plans.

3. You failed to perform environmental testing for SE when laying hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, our investigators learned from your test records that you failed to conduct environmental testing at the required time in Houses (b)(4) and (b)(4) at your 2400 Fallon Farm location and Houses (b)(4) and (b)(4) at your 700 Cavanaugh Lane location. According to your records, House (b)(4) was tested when the laying hens were approximately 53 weeks of age and House as tested when the laying hens were approximately 47 weeks of age. Furthermore, during the inspection, Houses (b)(4) and (b)(4) contained laying hens that were approximately 60 weeks of age; however, no environmental testing had been conducted.

Your written response received May 1, 2012, states that environmental sampling was conducted on Houses (b)(4) and (b)(4) on April 4, 2012, during our inspection. Even though your response includes sample test records, the records do not reference the laying house from which the samples were taken.

4. You failed to remove vegetation and debris outside a poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically, our investigators observed grass vegetation, as high as 12 inches, in contact with, or in close proximity to the following poultry houses at your 2400 Fallon Road location: Along the south side of House (b)(4) along the east and west sides of Houses (b)(4) and (b)(4) along the east side of House (b)(4) and along the west side of House (b)(4). During the inspection, our investigators also observed piles of debris outside Houses (b)(4) and (b)(4) however, our investigators confirmed that the debris was removed during the inspection.

Your written response, received May 1, 2012, states you have removed the vegetation from around the houses referenced above; however, no photos of corrections were included with your response. FDA will verify your corrections during the next inspection.

This letter is not meant to be an all-inclusive list of deficiencies 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.

In addition to the above violations, we also have the following comments:

• During our inspection, you stated that our environmental sampling method includes "pooling" a maximum of (b)(4) environmental swabs in any given house into (b)(4) whirlpak-type bag, rather than placing each swab in a separate whirlpak-type bag as indicated by the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses," April 2008. Please note that you must conduct testing to detect SE in environmental samples using the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses," April 2008, or an equivalent method in accuracy, precision, and sensitivity in detecting SE, as required by 21 CFR 118.8(a). If you intend to continue using a sampling protocol other than that which is described in the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses," we encourage you to submit additional documentation to FDA, so that we can determine if your sampling protocol allows for a testing methodology that is equivalent in accuracy, precision, and sensitivity in detecting SE.

Your written response, received May 1, 2012, states that your method of pooling samples is in line with the guidelines from the California Egg Quality Assurance Program. Please note that you are required to comply with all applicable FDA laws and regulations, regardless of whether you are in compliance with other sets of guidelines.

• We note that your firm appears not to have signed your revised SE prevention plans in accordance with 21 CFR 118.10(b)(3). Specifically, we did not locate the signature(s) of the person(s) who administers the plan as described in 21 CFR 118.9. We will verify that your SE prevention plans are appropriately signed and dated during our next inspection.

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 updated SE prevention plans. 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.

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).

Your written response 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.
 

Sincerely,
/S/
Barbara J. Cassens
Director
San Francisco District
U.S. Food and Drug Administration
 

Cc:
State of California
Branch Chief
Food and Drug Branch
California Department of Public Health
(via email)
 

Maurice Pitesky DVM, MPVM
California Dept. of Food and Agriculture
Animal Health Branch
1220 N Street
Sacramento, CA 95814