01-001 DEPARTMENT OF AGRICULTURE, CONSERVATION AND FORESTRY

1. Chapter 213: RULES FOR THE SALMONELLA ENTERITIDIS RISK REDUCTION AND SURVEILLANCE PROGRAM FOR COMMERCIAL EGG-TYPE FLOCKS

1. STATUTORY AUTHORITY

1. The statutory authority for the Maine Salmonella enteritidis Risk Reduction and Surveillance Program for commercial egg-type flocks is found in 7 M.R.S.A. § 1758.

1. SUMMARY

1. The Maine Salmonella enteritidis (“SE”) Risk Reduction and Surveillance Program for commercial Egg-Type Flocks is intended to prevent SE-contaminated eggs from entering the commercial food supply. Its provisions are an enhancement of the US Food and Drug Administration’s (“FDA”) Final Rule on the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation. All commercial egg-producing facilities are required to participate in the program. Adherence to the program rules will be monitored by Department of Agriculture, Conservation and Forestry Staff.

   The purpose of this program is to:

1. Prevent SE-contaminated eggs from entering the food chain;
2. Ensure SE-clean birds reside and produce in SE-clean houses; and
3. Control and eradicate SE contamination if it is found within a commercial egg-type flock.

1. DEFINITIONS
   1. Authorized Agent: A person approved by the Commissioner to collect official samples for submission to an authorized laboratory in accordance with this chapter and the FDA Egg Safety Rule (“ESR”) sampling methodology described in 21 CFR 118.
   2. Authorized Lab: A laboratory that is qualified to perform official salmonella monitoring assays in accordance with this chapter and FDA ESR testing methodology described in 21 CFR 118.
   3. Commercial Egg Producer: A producer that owns or leases 3,000 or more adult laying hens at a given time in the State of Maine, and whose eggs will be consumed in part or in whole by humans.
   4. Commercial Egg-Type Flock: A group of birds owned or leased by a commercial egg producer that reside within a single enclosure or on a single parcel of land for free range birds.
   5. Department Staff: Staff members of Maine’s Department of Agriculture, Conservation and Forestry directed by the commissioner or the commissioner's duly authorized agent to carry out these rules.
   6. Enclosure: A building, other structure, or separate section within a structure used to house poultry. For structures comprising more than one section containing poultry, each section that is separated from the other sections is considered a separate enclosure.
   7. FDA: The United States Food and Drug Administration.
   8. FDA Egg Safety Rule: The Final Rule on the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation as laid out in 21 CFR 118.
   9. Flock: Any group of birds that reside within a single enclosure or on a single parcel of land for free range birds.
   10. Molted: The life stage during which hens stop laying eggs and shed their feathers.
   11. Producer: A person who owns and/or operates a poultry house containing laying hens which produce shell eggs for human consumption.
   12. SE: Salmonella enterica serotype Enteritidis.
2. PROGRAM CRITERIA
   1. Applicability: These rules apply to all commercial egg producers that are producing eggs in Maine.
   2. FDA Rule Compliance: All commercial egg producers must adhere to all provisions of the FDA’s Egg Safety Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, 21 CFR Parts 16 and 118, July 9, 2009, which is being adopted herein by reference.
   3. NPIP Compliance: All birds utilized for egg laying in a commercial egg-type flock must originate from hatcheries certified as SE Clean under the National Poultry Improvement Plan (“NPIP”) or pullets reared under SE monitored conditions.
   4. Record sharing: Accurate records, as required by the ESR and this chapter, shall be maintained by the commercial egg producer and provided to Department Staff upon request. Records should include original observations and data collection that is maintained and sufficient to establish traceability of SE test results, including sample handling, storage, and analysis.
   5. Sample Collection: Official samples must be collected in accordance with this chapter by an Authorized Agent and submitted to an Authorized Lab. Sampling methodology must be in accordance with the protocols of the FDA’s Egg Safety Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, 21 CFR Parts 16 and 118, July 9, 2009, adopted herein by reference, appropriate to the poultry house layout. Suspect positive or positive samples must be reported to the State Veterinarian or designated Department Staff within 24 hours.
   6. Vaccination: Commercial egg producers must implement a poultry vaccination program to protect against infection with SE which includes a minimum of two attenuated live vaccinations and one killed or inactivated vaccine, or a demonstrated equivalent SE vaccination program as determined by a licensed veterinarian and approved by Department Staff.
      1. If flocks are molted and returned to production they shall be vaccinated prior to the molt.
      2. Serology testing shall be conducted at an Authorized Lab to confirm seroconversion. A seroconversion rate of at least 85% must be maintained in all flocks.
      3. If flocks have a seroconversion rate of less than 85%:
         1. The producer’s vaccination protocols shall be reviewed, and if deemed necessary by the Department the flock must be revaccinated.
         2. The flock in question must be revaccinated if they are housed in an enclosure that has been found to have a positive SE result within the past 5 years.
3. ENVIRONMENTAL SE TESTING
   1. Commercial egg producers must engage in environmental SE testing in accordance with this section. Mandatory samples include:
      1. Meconium SE testing for Maine-based pullet flocks;
      2. 14 -16 weeks of age SE environmental testing;
      3. 40-45 weeks of age SE environmental testing;
      4. 4-6 weeks post molt SE environmental testing;
      5. End of Production/Empty House SE environmental testing; and
      6. Monthly Feed Mill SE environmental testing:
         1. 10 distinct sites must be sampled monthly at each feed mill owned or leased by a commercial egg producer that is being utilized to feed commercial egg-type flocks.
         2. A single sample of the feed dust must be sampled monthly from each feed mill owned or leased by a commercial egg producer that is being utilized to feed commercial egg-type flocks.
         3. Where the feed mill is not owned or leased by the commercial egg producer, all feed for the commercial egg-type flock must be obtained from facilities that follow accepted feed industry “Good Manufacturing Practices” including a specific program for SE monitoring and control.
4. END OF PRODUCTION/EMPTY HOUSE
   1. Once a flock has been removed from the poultry house, the following criteria shall be adhered to:
      1. All feed and visible manure must be removed from the depopulated enclosure and properly disposed of;
      2. The empty enclosure must pass inspection for wildlife exclusion, rodent and insect population control;
      3. End of Production/Empty House SE environmental testing shall be conducted after enclosure cleaning, inspection and rodent/insect baiting activities are complete; and
      4. Management records documenting the above events and inspections must be maintained and provided to Department staff upon request.
5. RESPONSE TO SALMONELLA POSITIVE SAMPLES
   1. Any Group D positive sample identified by an Authorized Lab shall be confirmed and serotyped at National Veterinary Services Laboratory.
   2. The response to confirmation of SE in a commercial egg type flock will follow the guidelines of the FDA’s Egg Safety Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, as described in 21 CFR Parts 16 and 118, July 9, 2009, adopted herein by reference.
   3. Where a poultry house or enclosure tests positive for SE, that enclosure must remain empty a minimum of 10 days after the last bird is removed.
   4. A poultry flock with a positive SE test result is not eligible for import to Maine.
6. VIOLATIONS
   1. As provided for in 7 M.R.S.A. § 1758, any violation of these rules may be enforced as a civil violation for which fines of up to $1,000 per violation may be assessed. Such violations include, but are not limited to:
      1. Failure to provide any information required or requested as described in 4D and 4E by the Department for purposes of enforcing the Maine Salmonella enteritidis Risk Reduction and Surveillance Program for commercial egg-type flocks or these rules;
      2. Providing false, misleading or incorrect information to the Department by any means, including but not limited to information provided in any report or record required or maintained for purposes of the Maine Salmonella enteritidis Risk Reduction and Surveillance Program for commercial egg-type flocks or these rules; or
      3. Failure to comply with any other requirements of this chapter.

STATUTORY AUTHORITY: 7 M.R.S. § 1758

EFFECTIVE DATE:

July 20, 2024 – filing 2024-144