Inspections, Compliance, Enforcement, and Criminal Investigations
Easy Moon, Inc. - Ramona Egg Ranch 7/3/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
July 3, 2014
Mr. Duraid Zaia, President
Easy Moon, Inc.
Ramona Egg Ranch
91 East Old Julian Road
Ramona, CA 93307
Dear Mr. Zaia:
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at 91 East Old Julian Road, Ramona, CA on January 15 to 17, 2014. We found that you 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 January 17, 2014. 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 all of the SE prevention measures required by 21 CFR 118.4. Specifically, although you procure pullets (b)(4) your written SE plan dated January 22, 2013, does not address procurement of SE monitored pullets as required by 21 CFR118.4(a). Furthermore, under 21 CFR 118.4(b), your written SE plan must include steps you take to ensure that there is no introduction of SE into or among poultry houses. Our investigators observed a foot bath being used to sanitize shoes at the entrance to your farm; but this foot bath is not mentioned in your written SE plan.
In your response dated January 24, 2014, you state that you have added language to your written SE plan that includes a statement about pullet testing at 14-16 weeks and that all pullets will be raised under SE monitored conditions. A revised written SE plan was not included in your response so we will evaluate the adequacy of your corrective action during our next inspection of your farm.
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 monitored” means, among other things, that the pullet environment is tested for SE when pullets are 14 to 16 weeks of age, as required by 21 CFR 118.4(a)(2)(i). At the time of FDA’s inspection your flock consisted of two groups of laying hens, which were hatched on May 22, 2012, and July 6, 2012, respectively. While the pullets were still located at (b)(4) brooder facility in (b)(4) their pullet environment was tested for SE on September 19, 2012, and November 16, 2012, respectively. This was 8 and 21 days, respectively, after the 14-16 weeks of age required testing period time.
3. You failed to have and implement a written SE Prevention Plan that includes an appropriate monitoring method for rodents and flies and that provides that when monitoring indicates unacceptable rodent or fly activity within a poultry house, you will use appropriate methods to achieve satisfactory rodent or fly control, as required by 21 CFR 118.4(c)(1) and 21 CFR 118.4(c)(2). Specifically, according to your SE Prevention Plan, rodent counts from traps are to be monitored to establish a baseline for acceptable levels and an increase in rodent counts above acceptable levels or visual observation of excess rodent activity triggers a reevaluation of the rodent control program. Similarly, your plan indicates that fly monitoring may be done with two alternative methods and that the baseline trigger points for corrective actions differ between the two. However, your plan fails to define what level of rodent and fly activity is acceptable. We note that FDA’s December 2011 “Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” recommends procedures for characterizing levels of rodent and fly activity. We also note that our investigators observed numerous dead rodents (58 counted) and live rodents (9 counted) in your poultry house.
Furthermore, your SE Prevention Plan states that rodent holes that are found in your dirt floors will be filled in or left open and baited. Our investigators observed too-numerous-to-count rodent holes in the dirt floor of your egg laying house. These holes had not been filled in, and you did not have any record of these holes having been baited.
4. You failed to remove debris within the poultry house and vegetation and debris outside the poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically:
a. Investigators observed equipment stored above empty cages within the laying house and piled up at the exterior of the laying house.
b. The south side interior of the egg laying house had approximately 2 feet high weed-like vegetation growing into the first three rows of empty chicken cages. Furthermore, the first row of cages in this area was underneath a collapsed metal roof.
c. The exterior wall of the south-west side of the egg laying house had weed-like vegetation measuring over 6 feet tall.
d. Approximately 2 feet high weed-like vegetation was growing the length of the exterior side of the north wall of the egg laying house.
e. The exterior east side of the egg laying house had cluttered debris such as egg crates and two 5 gallon pails filled with a green liquid. One of these pails contained a floating dead rodent.
f. Piles of debris including tubing directly adjacent to the exterior of the west side of the egg laying house.
g. Dead chicken carcass in an advanced state of decomposition found inside the egg laying house, indicating it had been there for some time.
h. Cow manure in relatively close proximity to the laying house.
Investigators observed numerous dead rodents (58 counted) in the egg laying house, and live rodents (9 counted) walking under chicken cages and running in and out of too-numerous-to-count holes in the dirt floor of the egg laying house. These observations suggest that the vegetation and debris in and around your poultry house are providing harborage for pests.
We note that your response dated January 24, 2014, states that you removed the observed equipment and cut the vegetation to less than 6 inches within 3 feet of the building’s exterior. We will evaluate the adequacy of your corrective action during our next inspection. However, you did not address the remainder of the above observations, or how you plan to prevent recurrence of these deficiencies.
5. You failed to prevent wild birds from entering the poultry house, as required by 21 CFR 118.4(b)(4). Specifically, our investigators observed at least 20 wild birds in your poultry house on January 16, 2014. These birds were observed landing on and flying through empty cages which were adjacent to where egg-packing cartons were stored on racks. The birds were observed to enter and exit the laying house through unobstructed openings in the house roof.
In your January 24, 2014 response you note that you have an open house design which is part of a ventilation system that keeps the hens alive and that during the hotter months the doors must be opened. Additionally you state that covering the open vents will not prevent wild bird access. You state that you are not using the building walls as a physical barrier, but rather limiting the fecal-oral mode of SE transmission between chickens through the use of cages, regarding which you reference language from the section on “physical barriers” in FDA’s December 2011 “Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” We find your response to be inadequate, because the language you quote from the 2011 guidance does not address the requirement that you prevent wild birds from entering the poultry house. Furthermore, we note that your cages are not serving as physical barriers with respect to wild birds, as wild birds were observed flying into the cages, indicating they could have direct contact with hens. In order to prevent wild birds from entering your poultry house, we note that you could utilize methods that would not adversely impact your ventilation system. For example, you could utilize wire mesh walls that allow ventilation while preventing wild bird entry, or you could net open areas with a type of netting small enough to keep wild birds and animals out while still allowing free air flow for ventilation purposes.
6. You failed to maintain records documenting compliance with biosecurity measures as required by 21 CFR 118.10(a)(3)(i). Your SE plan states that visitors will not have visited poultry from a different company on the same day that they visit your poultry. However, during the inspection our investigators observed that you do not maintain records documenting that visitors have not visited another poultry farm on the same day as they visit your farm. Similarly, your SE plan states that vehicles and equipment that arrive on your farm from other poultry operations will be disinfected prior to entry. However, during the inspection our investigators observed that you do not maintain records documenting that vehicles were disinfected prior to entry on the farm. Furthermore, as is discussed above, you appear to be using a foot bath as a biosecurity measure; but you do not maintain records documenting your use of this foot bath, such as records regarding the maintenance and sanitizer strength of the foot bath.
We note that you state in your response dated January 24, 2014, that you have added a sign-in sheet for drivers to indicate that they have disinfected their vehicles. We will verify this corrective action during the next inspection. However, your response did not address the remainder of the above observations.
7. You failed to maintain records documenting compliance with refrigeration requirements, as required by 21 CFR 118.10(a)(3)(iv). Specifically, your firm did not have records documenting compliance with refrigeration requirements for the recently installed cooler that had been in operation for two weeks.
In your January 24, 2014 response you indicate that your farm recently built a processing plant and that a record of egg collection is now being kept, an on farm cooler has been added and daily temperature log is being kept. You also state that you have modified your SE plan to reflect these changes. We will evaluate these corrective actions during our next inspection of your farm.
The above violations are 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.
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 comment:
• The “Environmental Sampling” portion of your written SE Prevention Plan states that you will pool up to four environmental swabs in one bag. This procedure differs from the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” April 2008, which involves placing each swab in a separate whirlpak-type bag. 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).
Your response, dated January 24, 2014, indicates that you are changing your sampling plan “to mirror the FDA’s plan” and that your plan will now state that “all occupied rows will be sampled with two swabs/row.” It is not clear whether each of the swabs will be placed into its own whirlpak-type bag or whether you intend to continue pooling the samples. 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," April 2008, 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.
Please notify this office, in writing, within fifteen (15) working days of the 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. If you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention:
Director Compliance Branch
Los Angeles District
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact Robert McNab, Compliance Officer at 949-608-4409.
Alonza E. Cruse, Director
Los Angeles District
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435
California Department of Food and Agriculture
Animal Health Branch
Attn: Tony Herrera
1220 N Street
Sacramento, CA 95814