"No Objection Letter" Not Required for Use of Cloth Sampling Procedure for STEC Testing

FSIS would like to clarify that establishments wishing to adopt the cloth sampling method (i.e., manual sampling device or continuous sampling device) for Shiga Toxin-producing Escherichia coli (STEC) testing of raw beef products no longer require a “No Objection Letter (NOL)” from FSIS. Additionally, these establishments will not have to collect additional microbiological data when validating the cloth sampling method, if using the same parameters as their supporting documentation (see examples below).

Establishments interested in implementing cloth sampling will still need to support the two elements of validation, i.e., scientific support and in-plant data, as they would for other routine changes. These elements are outlined on page four of the FSIS HACCP Systems Validation guideline.

For element one, scientific support, establishments could use the article in the Journal of Food Protection, which describes the cloth sampling method validated by the Agricultural Research Service. Or, establishments could use FSIS Directive 10,010.1, Sampling Verification Activities for Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef Products, which outlines the cloth sampling method used by FSIS.

FSIS does not “approve” cloth manufacturers, and the adoption of the cloth sampling method is not an endorsement of a specific cloth manufacturer. Establishments must support that their sampling and testing methods can detect STEC, which may be present at a very low level. One way to support this is to ensure that the cloth is consistent with the one used in the supporting documentation for the sampling method used (size, material, etc.). Any departure from the process or critical operational parameters specified in the published support may require additional support or validation. For example, the cloth sampling method has not been validated by FSIS for use on frozen beef trim.

Establishments will also need to meet element two of validation, which is the in-plant data showing they can meet the specific parameters of the scientific support. Validation requirements of cloth sampling are the same for the validation of any other changes that affect the hazard analysis and critical control point (HACCP) system. Since FSIS has adopted the cloth sample collection methodology as robust, there is no longer an expectation for establishments to do side-by-side testing comparisons of the cloth and the N60 excision (or N60+ shaver) method. Instead, the establishment must document that they have incorporated and are achieving the parameters identified in their scientific support. One key difference between the method cited in the Journal of Food Protection article and the FSIS method is the addition of neutralizing buffered peptone water by FSIS to facilitate microbiological recovery after shipment of the cloth to the FSIS laboratories. Establishments that ship to an off-site laboratory without using a transport buffer would need to support that decision (i.e., support that a lack of neutralizing buffer does not result in reduced recovery).

Questions regarding the use of cloth sampling by establishments can be submitted through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select sampling as the inquiry type.

FSIS Posts Updated Quarterly Humane Handling Datasets

On April 18, 2023, the quarterly humane handling inspection datasets were updated on the FSIS website. The datasets include: (1) the number of administrative enforcement actions taken, (2) the number of humane handling verification tasks performed, (3) the number of humane handling verification tasks that resulted in a noncompliance record, and (4) the number of hours spent observing and verifying the humane treatment of livestock. This posting contains the most recent four quarters of data by district, HACCP size, and quarter.

Upcoming Events

• May 16 10 a.m.-12 p.m. ET: NACMCF Public Meeting
• June 21-22: NACMPI Public Meeting

Available for Public Comment

FSIS seeks public comments on proposed rules and notices, which are viewable on the FSIS Federal Register & Rulemaking webpage. FSIS is currently seeking comments on the following:

• Until May 1: Notice of Request To Renew an Approved Information Collection: Advanced Meat Recovery
• Until May 1: Notice of Request To Renew an Approved Information Collection: Voluntary Destruction of Imported Meat, Poultry, and Egg Products
• Until May 1: Notice of Request To Renew an Approved Information Collection: Nutrition Labeling of Major Cuts of Single-Ingredient Raw Meat or Poultry Products and Ground or Chopped Meat and Poultry Products
• Until May 1: Notice of Request To Renew an Approved Information Collection: Sanitation SOPs and Pathogen Reduction/HACCP
• Until May 8: Notice of Request To Renew an Approved Information Collection: Procedures for the Notification of New Technology and Requests for Waivers
• Until June 11: Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims
• Until June 12: Notice of Request To Renew an Approved Information Collection: Laboratory Assessment Requests
• Until June 13: Notice of Request To Revise an Approved Information Collection: State Meat and Poultry Inspection Programs
• Until June 13: Notice of Request for Revision of an Approved Information Collection: Public Health Information System

Policy Update

FSIS notices and directives on public health and regulatory issues are available on the FSIS Policy webpage. The following policy update was recently issued:

FSIS Notice 16-23 - Quarterly Establishment Information Letters

FSIS Notice 17-23 - Use of New Cut Resistant Gloves

FSIS Notice 18-23 - List of Electronic Communications Operations Persons

Export Requirements Update

The Library of Export Requirements has been updated for products for the following:

• Tunisia
• Curacao
• Morocco
• Mauritius
• Benin
• Namibia
• Ecuador
• Japan
• Costa Rica
• Solomon Islands
• Western Samoa (Samoa)
• New Caledonia
• Hong Kong
• India
• Egypt
• Cuba
• Nicaragua
• Canada
• Korea
• French Polynesia (Tahiti)
• Singapore
• European Union
• Vietnam
• New Zealand
• Colombia
• Chile
• Guatemala
• Jamaica
• Turks & Caicos Islands
• El Salvador

Complete information can be found at the FSIS Import & Export Library.