01-9196. Performance Standards for the Production of Processed Meat and Poultry Products-Notice of Technical Conference and Public Meeting; Extension of Comment Period

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice of technical conference and public meeting.

SUMMARY:

The Food Safety and Inspection Service (FSIS) will hold a technical conference on May 8, 2001, in Washington, DC. The purpose of the conference is to discuss scientific research and new technologies relevant to the recently proposed regulatory requirements for processed meat and poultry products, “Performance Standards for the Production of Processed Meat and Poultry Products.” FSIS is soliciting papers and presentations from government agencies, academia, consumer organizations, and other interested parties.

Additionally, on May 9 and 10, 2001, FSIS will hold a public meeting in Washington, DC, to provide information and receive public comments specific to the proposed regulations. FSIS is extending for an additional 30 days the comment period for the proposed regulations, previously scheduled to close on May 29, 2001. Comments now must be received by June 28, 2001. FSIS is extending the comment period to provide ample opportunity for the public to comment on issues raised at the technical conference and public meeting.

DATES:

FSIS will hold the technical conference on May 8, 2001, and the public meeting on May 9-10, 2001. Comments on the proposed regulations published on February 27, 2001, at 66 FR 12590, must be received on or before June 28, 2001.

ADDRESSES:

Both the technical conference and the public meeting will be held at the Washington Plaza Hotel, 10 Thomas Circle, NW., (at Massachusetts Avenue and 14th Street), Washington, DC 20005.

Papers and presentations for the technical conference should be to sent to: Matthew Michael, Regulation and Directive Development Staff, OPPDE, FSIS, USDA, Room 103 Cotton Annex, 300 12th Street, SW., Washington, DC 20250; by fax to: [phone]; or by electronic mail to: [e-mail]. Because of time restrictions, FSIS may not be able to schedule time for all interested parties to give papers or make presentations. Regardless, FSIS will make available at the conference submitted papers and other presentation materials, if requested by the author.

To register for the public meeting, contact Ms. Mary Harris by telephone at [phone], FAX to [phone], or E-mail to [e-mail]. If a sign language interpreter or other special accommodation is necessary, contact Ms. Harris at the above numbers by May 1, 2001. If you are planning to present an oral comment at the public meeting, please submit a copy of the prepared comment to the FSIS Docket Clerk, Docket No. 97-013P, Room 102 Cotton Annex, 300 12th Street, SW, Washington, DC 20250-3700.

Send all written comments on the proposed regulations to: FSIS Docket No. 97-013P, Department of Agriculture, Food Safety and Inspection Service, Room 102, 300 12th Street, SW., Washington, DC 20250-3700. All comments received will be considered part of the public record and will be available for viewing in the Docket Room between 8:30 a.m. and 4:30 p.m. Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Daniel Engeljohn, Ph.D., Director, Regulations Development and Analysis Division, Office of Policy, Program Development, and Evaluation, Food Safety and Inspection Service, Room 112 Cotton Annex, 300 12th Street, SW., Washington, DC 20250. Telephone number [phone], fax number [phone].

SUPPLEMENTARY INFORMATION:

On February 27, 2001, FSIS published a proposed rule “Performance Standards for the Production of Processed Meat and Poultry Products” (66 FR 12590). In that document, the Agency proposed food safety performance standards applicable to all ready-to-eat (RTE) and all partially heat-treated meat and poultry products, as well as environmental testing requirements intended to reduce the incidence of Listeria monocytogenes in RTE meat and poultry products. FSIS also proposed to convert to performance standards the existing regulatory requirements for thermally-processed, commercially sterile (most often canned) meat and poultry products and to rescind certain requirements requiring the elimination of trichina from products that contain pork.

FSIS is holding a technical conference to facilitate the submission and discussion of scientific research and technological data relevant to these proposed regulations. In the proposal, FSIS identified additional needs for data that if addressed could strengthen the scientific foundation of any final action. It is extremely important that the regulations be based on sound science and common sense measures.

Selection of papers and presentations, as well as the forthcoming conference agenda, will ensure adequate discussion of all of the identified topics. FSIS also will try to accommodate presentations of relevant data not specifically requested in the proposal or below. FSIS requests that submissions for the technical conference concern scientific research and technological developments relevant to the proposed regulations, rather than merely be comment on the proposed regulations themselves. After FSIS has selected papers for presentation, it will make the technical conference agenda available on the Internet. At the public meeting also announced in the document, FSIS will provide information and accept public comments specific to the proposed regulations.

FSIS intends to divide the public meeting to receive comments on the proposed regulations into four three-hour sessions, organized as follows:

Tentative Agenda for the FSIS Public Meeting on the Proposed Rule, “Performance Standards for the Production of Processed Meat and Poultry Products”

May 9, 2001	Morning	Lethality and stabilization performance standards
	Afternoon	Requirements for the control of L. monocytogenes
May 10, 2001	Morning	Revisions to the regulations governing the elimination of Trichina from pork products and governing commercially-sterile (canned)products
	Afternoon	Economic impact of the proposed regulations and cost/benefit data needs

FSIS invites interested parties to make oral comments or presentations at the public meeting. Please register in advance with Ms. Mary Harris and submit a written copy of your comments to the FSIS Docket Room (See ADDRESSES above). FSIS may revise the above public meeting agenda, depending on interest expressed in the various proposed regulations. As with the final agenda for the Technical Conference, FSIS plans to publish the final agenda for the Public Meeting on the Internet.

Also, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will meet on May 7, 2001. This meeting also is open to the public. FSIS invites Committee members to attend the technical conference and public meeting announced in this document.

FSIS is extending the comment period on the proposed regulations to provide ample opportunity for the public to comment on issues raised at the technical conference and public meeting.

Specific Scientific Information and Data Needs To Be Discussed at the Technical Conference

Testing for Listeria spp.

FSIS proposed to require that each establishment that produces RTE meat and poultry products conduct testing of food contact surfaces to verify that its Sanitation SOPs are eliminating Listeria spp. from food contact surfaces, unless it has developed a CCP within its HACCP plan for the control of L. monocytogenes. FSIS is confident that will result in sanitation improvements that will lead to reductions in the contamination of RTE meat and poultry products by L. monocytogenes. However, FSIS is not aware of any research that correlates specific amounts or types of testing with specific remedial actions or reductions in contamination and welcomes the submission of any data. FSIS also requests comment as to whether other types of environmental testing, regular product testing, or some combination may be more effective in detecting L. monocytogenes contamination problems.

FSIS has proposed required frequencies of testing that ensure very minimal levels of regular testing based on establishment size. FSIS is aware of no research linking volume of production with the likelihood of product adulteration by L. monocytogenes, but considers it reasonable that insanitary establishments producing higher volumes of RTE meat and poultry products would be more likely to adulterate more product and thus pose more risk to the public health. As a result, FSIS has proposed a progressive series of testing frequencies intended to protect consumers from adulterated product. These testing frequencies also should minimize the costs of testing accrued by small business.

FSIS requests any data that could bear on adjustments to the proposed frequencies, suggest other testing frequencies, correlate contamination risk with volume of production, or indicate what types and frequencies of testing for L. monocytogenes are most effective in detecting insanitation and possible adulteration of RTE meat and poultry products. Also, FSIS requests data regarding the relationship between Listeria spp. and L. monocytogenes and how that relationship should affect any requirements. For example, does a food contact surface positive for Listeria spp. scientifically necessitate product testing and what would negative product test results mean?

FSIS also requests data regarding the costs and benefits of the proposed testing provisions, as well as other testing protocols. FSIS seeks any data correlating testing, reductions in establishment contamination, and consequent reductions in listeriosis that could be used to improve the Agency's cost/benefit analysis.

Lethality Performance Standards

FSIS is proposing lethality performance standards for the pathogen Salmonella derived from the Nationwide Microbiological Baseline Data Collection Program. Using the positive samples in the baseline data, FSIS derived hypothetical worst case raw products and then determined the levels of pathogen reduction (lethality performance standards) that, if met, would render these worst case raw products ready-to-eat and unadulterated with a specific margin of safety. FSIS also translated the results of the application of the lethality performance standards into probabilities of remaining pathogens in finished RTE product. Consequently, an establishment that demonstrates that its incoming raw product is consistently less contaminated than the worst case could apply a lower lethality than proposed, as long as it achieves the corresponding probability of remaining pathogens in finished RTE product.

It is possible that better data are available for deriving hypothetical worst case products and corresponding performance standards. For the lethality requirements concerning Salmonella, FSIS is unaware of any human health risk assessments that could be used to correlate changes in the performance standards with changes in public health benefits. Higher or lower lethality performance standards may be necessary in all or specific processing contexts. FSIS specifically requests any data that would support requiring different lethality performance standards to achieve certain public health benefits.

The lethality performance standards for Salmonella already apply to numerous RTE meat and poultry products and FSIS believes that many establishments that produce RTE products not now subject to the proposed standards already meet them. It is likely, however, that some establishments will have to alter their processing methods to meet the proposed standards, i.e., to achieve higher levels of lethality in their RTE products. Further, manufacturers of RTE meat patties now only are required to comply with time/temperature regulations that yield a lesser level of lethality than what FSIS is proposing for all RTE meat products. FSIS requests information on the costs meat patty manufacturers and other establishments may accrue if required to meet the proposed lethality performance standards for RTE meat and poultry products.

FSIS also requests scientific information relative to the proposed lethality performance standards for E. coli O157:H7 in fermented RTE products that contain beef, especially information that indicates a different worst case and lethality performance standard for this pathogen may be warranted.

Stabilization Performance Standards

Also under the proposal, all RTE meat and poultry products, other than thermally processed, commercially sterile products, and all partially heat-treated products, must be processed so as to prevent multiplication of toxigenic microorganisms such as C. botulinum and to allow no more than 1-log₁₀ multiplication of C. perfringens within the product. Stabilization is commonly achieved by rapidly cooling product after cooking. It also can be achieved by the addition of a curing agent. These regulatory stabilization standards already apply to numerous RTE and partially-heat treated meat and poultry products.

Researchers have suggested to FSIS that there may be some inevitable growth of C. botulinum during a 1-log₁₀ relative growth of C. perfringens and, therefore, compliance with the proposed zero growth standard for C. botulinum could in fact effectively require establishments to meet a more restrictive standard than that for C. perfringens. FSIS requests comment and scientific data relative to whether the Agency should revise the existing and proposed stabilization performance standard for controlling these two pathogens, as well as data on corresponding public health benefits.

Other Topics

As mentioned above, FSIS welcomes the submission of papers and presentations on scientific and technical topics relevant to the proposed regulations, but not specifically mentioned above or in the proposal.

Done in Washington, DC on April 10, 2001.

Thomas J. Billy,

Administrator.