I.  PURPOSE

A.  Upon issuance of this notice, inspection program personnel (IPP) in establishments that slaughter any cattle are to complete the “Raised Without Antibiotic (RWA) Labeling Claims Questionnaire” in the Public Health Information System (PHIS). The purpose of this questionnaire is to collect information on establishments that slaughter cattle and are producing products that bear certain RWA claims on the labels.  FSIS will use results of this questionnaire to direct future sampling related to these claims.

B. IPP are to complete the questionnaire in PHIS no later than August 18, 2023.

II.  BACKGROUND

1. Labeling claims are required to be truthful and not misleading (9 CFR 317.8(a), and 381.129) to protect consumers from misbranded and economically adulterated meat and poultry products. Labeling claims often convey specific qualities or attributes regarding a product that some consumers may find desirable for a variety of reasons including perceived health, environmental, animal welfare, or flavor benefits (i.e., no hormones added, raised without antibiotics, free range, or grass fed). Currently, FSIS conducts an exploratory sampling program, FSIS Notice 07-23, FSIS Sampling for Labeling Claims Verification, in order to verify industry's compliance with the Agency's labeling regulations. Under the current exploratory program, for ground raw meat and poultry products, FSIS only samples ground beef labeled with a negative claim for hormone use and nutritional labeling requirements when the consumer ready packaging bears a nutrition facts panel. 
2. To inform future sampling, FSIS is collecting information through an establishment profile questionnaire to identify establishments slaughtering cattle whose products will be labeled with RWA special claims such as “No Antibiotics,” “No Antibiotics Ever,” “Raised Without Antibiotics,” “Antibiotic Free,” “No Antibiotics Administered,” or related claims. Instructions regarding future sampling will be issued in future FSIS issuances.

DISTRIBUTION: Electronic

NOTICE EXPIRES: 8/1/24

OPI: OPPD

III.  ELIGIBILITY

1. IPP at all cattle slaughter establishments are to submit information on establishment use of RWA claims through a PHIS Establishment Profile questionnaire.  Applicable RWA special claims include:
2. “No antibiotics;”
3. “No Antibiotics Ever;”
4. “No antibiotics added;”
5. “No antibiotics administered;”
6. “Raised without antibiotics;”
7. “Antibiotic free;”
8. "No Added Antibiotics;”
9.  "No Antibiotics in feed, water, or intra-muscular injection;”
10. “Raised without antibiotics, pesticides, or added growth hormones;”
11. “No added antibiotics or added hormones;”
12. “No antibiotics administered, no growth stimulants or added hormones;”
13. “No Antibiotics – No Added Hormones; and
14. Other applicable claims indicating no antibiotic use.

IV.  IPP RESPONSIBILITIES

1. The questionnaire appears in PHIS as a PHIS Profile Questionnaire and can be found in the Establishment Profile Header under the “Questionnaires” tab. The Profile Questionnaires page displays a grid listing questionnaires available for an establishment.
2. IPP are to complete and submit the questionnaire during their next scheduled PHIS Establishment Profile task as instructed in FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System or schedule a directed PHIS Establishment Profile task to complete this questionnaire prior to the deadline of August 18, 2023.

NOTE: Instructions for accessing and completing the PHIS profile questionnaire are available in PHIS Help under FSIS Application. Select PHIS Domestic Tutorials, Establishment Profile, and then Questionnaires.

1. IPP may view or print the questions before completing the questionnaire. To view or print the questions IPP are to:
2. Open the “Raised Without Antibiotic (RWA) Labeling Claim” questionnaire;
3. Select Reports;
4. Select Full Questionnaire Report (indicated by the green oval) to generate a PDF file for viewing or printing. Next select Go Back to Questionnaire (indicated by the red arrow);
5. Select “YES” or “NO” for the question;
6. Select Save & Close; and
7. Submit the questionnaire in the PHIS Profile Questionnaire.

V.  QUESTIONNAIRE

1. The following questionnaire will appear under the Profile Questionnaire tab for establishments slaughtering all cattle subclasses, as explained in Section II. B. The questionnaire contains three questions regarding RWA special claims, current use of the special claim, and how often cattle whose products will be labeled with RWA claims are being slaughtered. IPP are to be aware that the product with the labeling claim may only be produced infrequently.   IPP are to respond “yes” to question 1 if the product was produced at the establishment at any time in the past 12 months, even if it is not being produced on the day the questionnaire is being completed.

NOTE: If IPP respond ‘No’ to question 1 because the establishment does not have an approved label for the applicable special claim or the establishment has not used an approved RWA label claim within the last 12 months, the questionnaire will stop, and IPP will not have to respond to the remaining non-applicable questions.

1. In the last 12 months, has the establishment slaughtered any cattle whose final product has been approved by the Labeling and Program Delivery Staff (LPDS) to bear a label with a special claim that antibiotics are NOT present (i.e., ‘Raised without Antibiotics, No Antibiotics Ever, No Antibiotics Administered’), (list not all inclusive see FSIS Notice 36-23,  Section III. A. for additional examples)?
   • Yes
   • No
2. If the response to question #1 is yes, to what cattle subclasses did the label with a special claim that antibiotics are NOT present apply? Select all that apply.
   • Dairy cow
   • Beef cow
   • Bull/Stag
   • Steer
   • Heifer
   • Heavy calf
   • Veal (includes bob veal, non-formula fed veal, formula fed veal)
3. Considering the last 12 months, how often did the establishment slaughter eligible cattle subclasses for the approved special claim that antibiotics are NOT present
   • Daily
   • Weekly
   • Monthly
   • Less than monthly, but routinely scheduled (e.g., quarterly, annually, holidays, or in association with a specific state fair or other regularly scheduled event)
   • Less than monthly, but not routinely scheduled (e.g., intermittent, irregular, at an undefined frequency, or due to special circumstances that do not regularly occur)

VI.  DATA ANALYSIS

The Office of Policy and Program Development will analyze the data collected from this questionnaire. The data will primarily be used to direct future sampling programs related to RWA labeling claims.

VII.  QUESTIONS

Refer questions regarding this directive to your supervisor or as needed to the Office of Policy and

Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a

question, complete the web form and select Sampling for the Inquiry Type. For labeling questions select Labeling for the Inquiry Type.

NOTE:  Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.