TO:From: Danny Hughes [dhughe@arlpc.org] Sent: Tuesday, December 21, 2004 2:29 PM To: Dockets, FDA Subject: FDA, Docket Nos. 1996P-0418, 1997P-0197, 1998-0203, and 2000N-0504; RIN number 0910-AC14 TO: FDA, Docket Nos. 1996P-0418, 1997P-0197, 1998-0203, and 2000N-0504 RIN number 0910-AC14 fdadockets@oc.fda.gov FROM: Deanna Baldwin, Maryland Department of Agriculture baldwidl@mda.state.md.us Danny Hughes, Arkansas Livestock and Poultry Commission dhughe@arlpc.org DATE: December 21, 2004 Overall FDA’s proposal to require SE prevention measures for egg production would provide for an effective nationwide program to reduce SE. The prevention measures outlined in the proposal have proven to be effective in the existing state programs. Our comments on the specifics of the program follow, organized by topic. Federal Egg Safety Regulatory Agencies and Authorities The regulatory authority of the federal agencies could potentially leave gaps in the proposed rules to require SE prevention measures for shell egg producers, packers and processors. Nest run eggs are not always sold directly by a producer to a packer of shell eggs. There are persons purchasing nest run eggs, hatchery culls and other eggs for resale to packers or processors of eggs that may not be covered by either the USDA or FDA portions of the egg safety rules/proposed rules. The primary area of concern would be the lack of refrigeration during storage or transport by these “egg handlers”. Also, this could provide a gap allowing eggs not in compliance with FDA’s proposed rules into the table egg market. For example, an “egg handler” could pick up hatchery culls (eggs not suitable for hatching - too small, double yolks, etc. not incubator rejects) from several sources and take them back in an unrefrigerated truck to an unrefrigerated storage facility. The eggs were produced without SE prevention measures as they were not originally intended for the table egg market. These eggs could then be sold to a packer of shell eggs for the table egg market. Shell Egg Producers Covered by Proposed 21 CFR Part 118 The exemption for producers with less than 3,000 chickens leaves a gap in the SE prevention plan. Producers in this category are less likely to ship eggs interstate and this could be the reason FDA is unaware of any outbreaks attributed to small producers. Regulating such a large number of producers would be a difficult burden. There are two options that could provide SE illness prevention without significantly increasing the regulatory burden. One would be to reduce the number to 500 chickens instead of 3,000. Producers with 3,000 chickens would have approximately 200 or more dozen of eggs to sell per week. It is unlikely they would be able to sell all of these directly to consumers. These eggs are probably being sold to local restaurants and grocery stores increasing the risk of SE illness. The other option would be to require all producers not selling directly to consumers to comply with the SE prevention measures. Chicks and Pullets FDA should require that producers certify that pullets they procure have come from a facility that has an SE-monitoring program. The introduction of SE free chickens into multiple house complexes is critical to preventing SE. Pullet houses should be subject to environmental tests for SE for each flock at approximately ten (10) weeks of age. If the test is positive, the producer could still accept the pullets but should be required to test environmentally after placement. The pullet house should be required to clean and disinfect after a positive environmental test prior to placement of the next pullet flock. In addition to requiring testing of chicks and pullets, FDA should require testing for birds used to backfill and older flocks that are moved to another facility. Cleaning and Disinfection The Maryland Egg Quality Assurance Program and other state egg quality assurance programs require an inspection after a facility tests positive environmentally and it cleaned and disinfected. Given the importance of cleaning and disinfecting to reducing the SE in the environment, FDA should consider requiring an inspection to verify proper cleaning and disinfecting. Also, additional research needs to be conducted to determine the most effective methods of cleaning and disinfecting (wet wash, dry cleaning, types of disinfectants). Rodents, Flies, and Other Pest Control FDA has indicated that in addition to rodents, flies can be a source of SE in layer houses. One of the measures discussed to control rodent populations is to clean out all manure in the house when it is depopulated. Although this is effective in controlling rodents, it has the opposite effect on controlling flies. Total clean out will destroy biological controls for flies (such as parasitic wasps). Also, many producers remove manure from the houses when they can immediately apply it to fields. This can only be done during certain times of the year to minimize fly populations. In developing guidelines for controlling rodents, flies or other pest, FDA should allow producer flexibility to avoid unintended consequences. Indication of the Effectiveness of the SE Prevention Measures: Testing A testing based regulatory scheme would not be effective in preventing illnesses from SE. Testing only indicates the status of the house at the time of the test. Flocks in environmentally positive houses vary greatly in the production of SE contaminated eggs. Many of the proposed SE prevention measures would have an impact on the number of contaminated eggs produced and on the ability of the producer to reduce SE in the houses. Not requiring an SE prevention plan until a producer has a positive environmental test increases the risk of producing SE positive eggs that are distributed into the table egg market prior to the test and increases the difficulty of the producer reducing or eliminating SE from the environment and the flock.. Administration of the SE Prevention Measures The proposal indicates that one qualified individual at each farm have training equivalent to a standardized curriculum recognized by FDA or be otherwise qualified through job experience to administer the SE prevention measures. Many producers employ a qualified individual that oversees the SE prevention measures at multiple farm locations. In general, this person has more experience and training than the on-site employees and can provide better oversight on developing and implementing SE prevention measures. With the limited number of employees in an egg laying facility, the requirement should be a qualified individual responsible for each farm not one at each farm. Recordkeeping Requirements for the SE Prevention Measures During several sections of the proposal, FDA discusses their intention to prevent SE illness by implementing prevention measures. We believe the prevention measures proposed by FDA will be effective in controlling SE illness, however, only requiring testing records does not place the emphasis on prevention. In fact, without the records it would be impossible for FDA to determine if a producer had an SE prevention plan or not. The recordkeeping requirements of the Maryland Egg Quality Assurance Plan have been very useful in conducting inspections of facilities to determine compliance with program requirements and for identifying problems in the producers plan when a test is positive. Producers should be required to keep records concerning compliance with all aspects of the prevention plan. Examples of records that should be kept: 1. Written SE prevention plan. 2. Monitoring for rodents (rodent indexing) and flies. 3. Pest control records (what was used, when it was used) 3. Visitor log for biosecurity purposes. 4. Cleaning and disinfecting after positive environmental - invoice or record for disinfectant used, fumigation, etc. 5. Records of training received by employees in plan oversight and implementation. 6. Temperature log for on farm storage of eggs. In addition to being useful in determining compliance with FDA’s SE prevention requirements, these records would be essential for a producer to determine if their plan was effective and making adjustments to improve their plan. The proposal indicates producers not complying with the SE prevention measures or producers with positive egg tests will be required to have records indicating all of the eggs will receive a treatment such as a contract with an egg-breaking facility or an in shell pasteurization facility. The proposal does not mention hard cooked operations as an acceptable method of diversion. Hard cooking should also be an acceptable method of diversion. The required records also leave a gap in that even though the purchaser may be a egg-breaking facility, in shell pasteurization facility, hard cooked operation or other facility where the eggs could be treated, there is no follow up to ensure the purchaser will treat the eggs and not resell them as nest run. Records should be required to be maintained by the purchaser (egg-breaking facility, etc.) indicating that eggs diverted by the producer were treated. As part of recordkeeping, FDA is requesting comment on registration of producers who must comply with SE prevention measures. The majority of producers are not currently registered with any state or federal agency unless they pack eggs for the consumer at the same location. Very few states have complete information on the location of producers. Registration of all producers covered by any of the SE prevention measures, would be the most efficient method of obtaining the information needed to conduct annual inspections and allocate resources. This registration should include not only the producers that are required to comply with all of the SE prevention measures, but also those that are not required to comply as they are selling all of their production to a facility that will treat the eggs. Inspections should be conducted at these facilities as well to verify the diversion of eggs and compliance with refrigeration requirements. Transportation of Shell Eggs Refrigeration should be required throughout distribution. If refrigeration is required on the farm, it becomes even more important to refrigerate during transport from producer to packer, from packer to packer and from handler to packer. If eggs are held at 45EF on the farm and are transported on a non refrigerated truck or stored unrefrigerated, the eggs will “sweat”. Since the eggs would not have been washed and sanitized the “sweating” would increase the likelihood of bacteria penetrating the pores in the shell. Another gap exists in the storage of nest run eggs at the packer’s facility. USDA only requires refrigeration at the packer’s facility after packing for the consumer. Nest run eggs and restricted eggs are not required to be refrigerated. To maintain the maximum benefit of SE illness reduction from refrigeration, eggs should be refrigerated throughout the distribution chain. Enforcement of On-Farm SE Prevention Measures for Shell Eggs Inspections and enforcement by State Departments of Agriculture would be the most effective method of implementing the SE prevention regulations. Many states have been conducting similar inspections to ensure compliance with state egg quality assurance programs and have the expertise and knowledge to conduct inspections for FDA. Another advantage of utilizing State Departments of Agriculture is to increase biosecurity for the facilities by limiting the number of inspectors that visit a facility. Unfortunately, most State Departments of Agriculture do not have adequate funding to conduct these inspections. To assist the states, FDA should provide reimbursement to the states for the costs of conducting these inspections. Handling and Preparation of Eggs by Retail Establishments The provisions of the 2001 model food code should be federally mandated. In addition to mandating these provisions, FDA should require the safe handling statement on cases of loose eggs. Currently FDA only requires the safe handling to be on the invoice or delivery ticket for cases of loose eggs. The employees receiving and using the eggs do not see or maintain the invoice or deliver ticket. The case has ample room for the safe handling statement. FDA should also reconsider the use of the Grade B restricted egg tolerances. The food code says “using raw eggs that are clean, sound and meet the restricted egg tolerances for U.S. Consumer Grade B. The restricted egg tolerance is 10% cracked eggs. There should be a lower tolerance for cracked eggs. Also, Grade B eggs can be old - as eggs age they lose their antimicrobial properties. FDA should require the use of eggs meeting the tolerances for U.S. Consumer Grade A. Miscellaneous FDA and USDA both mention in shell pasteurization as an alternative diversion method for producers. Additional research is needed to determine if this is a viable alternative that not only reduces SE but does not affect the quality of the eggs. The testing described in the proposal would be conducted by the producer. To verify the producer’s results, random testing should be done occasionally as part of the annual inspections. The practice of washing eggs on the farm is not widespread and most farms do not wash all of the eggs produced. The problem is significant though as some producers use small immersion washers to clean excessively dirty eggs. The combination of using an immersion washer and the amount of bacteria on excessively dirty eggs creates a significant risk of contamination. This practice is fairly common for off line producers. The use of immersion washers is also common for producers with 500 to 5,000 chickens. Non immersion washers are extremely expensive and primarily made for larger producers. To eliminate this risk, immersion washers should be prohibited. Egg testing should be based on flock size. Although we recognize FDA’s desire to test enough eggs to achieve a certain level of assurance, the range in flock size is too great to make a standard number of eggs fair to all producers. A producer with only 3,000 chickens would be testing over 50% of a day’s production while a producer with 100,000 chickens would only be testing 1%. The number of eggs to be tested could be established based on a range of flock size. For example, if a producer has between 3,000 and 10,000 chickens test 100 eggs, between 10,000 and 50,000 test 500 eggs, etc.