I. PURPOSE

This directive sets out the process for the development and clearance of FSIS Issuances, i.e., FSIS Directives and Notices. FSIS is reissuing this directive to update the directive numbering system, provide an e-mail address that program areas may use to submit requests for issuance development or revision, establish time limits for program area review of draft issuances, and make other changes to the issuance development and clearance process.

II. CANCELLATION

FSIS Directive 1230.1, FSIS Issuance System, 6/19/13

III. DIRECTIVES AND NOTICES

A. FSIS Directives provide specific instructions Agency personnel are to follow to implement FSIS regulations and other Federal requirements, such as Office of Personnel Management (OPM) policy and Departmental regulations. Directives provide instructions only to FSIS personnel, not to the public or industry. Directives are effective until canceled by another directive or notice.

B. FSIS Notices provide clarifying or temporary instructions to FSIS personnel. Notices expire one year after issuance. When notices are issued to provide instructions that ultimately will be included in a directive, the work on the new or revised directive is to begin as soon as possible after FSIS has issued the notice.

IV. NUMBERING FOR DIRECTIVES AND NOTICES

A. FSIS Directives are numbered within 14 series, organized by topic:

1,000: FSIS Infrastructure. This series provides general information on FSIS organizational structure, information resource management, audits, and communications.

2,000: Administrative Services. This series provides information about FSIS administrative activities, such as purchasing, property management, and records management.

3,000: Budget and Finance. This series addresses all aspects of the FSIS budget process, as well as accounting, travel, and disbursements and collections.

4,000: Personnel. This series addresses all FSIS human resource and personnel functions.

5,000: Program Services. This series addresses inspection and other procedures related to grants of inspection, HACCP, and State cooperative programs.

6,000: Slaughter Inspection. This series addresses ante-mortem and post-mortem inspection, including issues involving zero-tolerance for fecal material, use of anti-microbials, carcass spraying, and humane handling.

7,000: Processed Products and Labeling. This series addresses inspection activities related to the processing of products, and labeling issues.

8,000: Compliance, Investigations, and Enforcement. This series addresses in-commerce surveillance, investigations, documentation of investigations, recalls, detentions, seizures, and enforcement actions.

9,000: Exports and Imports. This series addresses inspection and audit procedures related to exports and imports.

10,000: Laboratory Services. This series addresses inspection procedures related to sampling and testing programs and sample seals, laboratory procedures, and scientific seminars.

11,000: Equipment and New Technologies. This series addresses inspection procedures related to establishments’ use of new technologies.

12,000: Voluntary Inspection. This series addresses voluntary reimbursable inspection services.

13,000: Public Health Information System (PHIS). This series includes instructions related to PHIS.

14,000: Fish of the order Siluriformes. This series includes instructions related to inspection activities for fish of the order Siluriformes.

B. Notices are assigned two numbers separated by a dash. The first indicates the order in which the notice was signed within a calendar year and the second, the calendar year it was signed (i.e., 12-20, 13- 20).

V. DIRECTIVE AND NOTICE DEVELOPMENT

A. The Regulations Development Staff (RDS) in the Office of Policy and Program Development (OPPD) manages the development, clearance, and issuance of directives and notices. Every issuance is assigned an RDS representative who will work with FSIS program area contacts and subject matter experts (SMEs).

B. Program areas (defined here as the offices under Assistant Administrators and the six offices with directors under the Office of the Administrator (OA)) are to submit requests for the development of new issuances or for the revision of an existing issuance to this e-mail address: IssuanceRequest@usda.gov. The request is to include:

1. A detailed description of the new issuance or the specific revisions to an existing issuance (this may or may not be a draft of the actual issuance);
2. A statement or other documentation showing that the requesting program area’s Assistant Administrator or Director has cleared the request;
3. Any time constraints or deadlines; and
4. The name of the program area contacts and SMEs who will or should assist in the development of the issuance.

C. When either a new issuance is initiated or revisions to an existing issuance are needed, the RDS Director will assign an RDS representative to work on the project and identify one or more program area contacts.

D. The program area contact, the RDS representative, and FSIS program SMEs will work together to develop the issuance, ensuring that it meets the needs of FSIS program areas and resolving any conflicts it might cause with current FSIS practices. The RDS representative is responsible for keeping the SMEs involved and informed about the status of the issuance’s development and clearance.

E. Program contacts and SMEs are responsible for keeping their program area supervisor informed about the development and status of issuances on which they are working.

VI. CLEARANCE PROCESS

A. RDS is responsible for managing the directive or notice through the clearance process, obtaining clearance in the following order:

1. OPPD Directors;
2. OPPD Assistant Administrator (AA)/Deputy AA;
3. All FSIS program areas; and
4. OA.

NOTE: When significant or complex inspection issues are addressed by new or revised directives or notices, RDS may ask the FSIS Office of Field Operations Policy Advisory Group (PAG) for clearance prior to OPPD Director review, to ensure that the instructions to inspectors are clear, accurate, and have the appropriate level of detail.

B. RDS will provide program areas at least five (5) business days to:

1. Clear with or without comments;
2. Reject with comments; or
3. Request additional review time up to another 5 business days.

NOTE: There are circumstances when RDS will submit issuances for expedited or limited program area review. RDS will provide instructions specific to expedited or limited program area review on an ad hoc basis.

C. During program area review, program areas are to focus on content rather than formatting or stylistic issues.

D. The RDS representative is responsible for addressing comments received on the issuance during the clearance process and is to work with the program area contact and SMEs to address any comments. The RDS representative also is to explain to program areas why any of their suggested changes are not incorporated.

E. If a program area does not respond, RDS communicates that to OA on the clearance sheet accompanying the issuance.

F. If a program area rejects a draft issuance with comments, RDS will respond to the program area’s comments and return the issuance to the program area for further discussion, review, and concurrence.

G. After all program areas clear the issuance or decline to respond, RDS provides the issuance to OA for review and clearance. The RDS representative and, as necessary, the program area contact and SMEs, are responsible for responding to OA comments.

H. After OA clears the issuance, RDS sends the issuance to the OPPD AA for signature.

I. Upon signature of the issuance by the OPPD-AA, RDS e-mails it to FSIS employees and the Web and Digital Communications Staff posts the issuance on the FSIS web site at: Regulations, Directives, and Notices.

VII. QUESTIONS

Refer questions regarding this directive through supervisory channels.