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From: TSS ()
Subject: REVISED DOCUMENTATION RELATED TO SPECIFIED RISK MATERIALS (SRMs) AND OTHER REGULATIONS FSIS NOTICE 05-07 1/23/07
Date: January 23, 2007 at 12:06 pm PST

FSIS NOTICE 05-07 1/23/07

REVISED DOCUMENTATION RELATED TO SPECIFIED RISK MATERIALS (SRMs)
AND OTHER REGULATIONS

This notice cancels FSIS Notice 01-07, Documentation Related to Specified Risk Materials (SRMs) and Other Regulations, and reissues its content to present a clearer example of an SRM noncompliance.

The purpose of this notice is to emphasize the importance of citing every relevant regulation on FSIS Form 5400-4, Noncompliance Record (NR), and, in particular, stresses that inspection program personnel are to always cite the appropriate sections of 9 CFR 310.22 when a noncompliance involves SRMs.

Inspection program personnel are to cite 9 CFR 310.22 in the Relevant Regulation section of every noncompliance record (NR) for an establishment that does not meet the regulatory requirements for controlling SRMs. In addition to selecting 9 CFR 310.22, inspection program personnel are to select all other regulations with which there has been noncompliance.

For example, while performing the 03C02 procedure the IIC observes spinal cord on previously cut semi-boneless steaks, and the establishment cannot demonstrate the spinal cord was from an animal that was younger than 30 months at the time of slaughter. The IIC cites 9 CFR 417.2(c)(4) and 310.22(b) in the Relevant Regulations section on the Procedure Results NR screen. The IIC notifies the appropriate establishment official of the finding. The IIC also verifies that the corrective actions implemented by the establishment meet the requirements of 9 CFR 417.3(a) before issuing the NR.

Inspection program personnel are to describe the noncompliances in the Narrative Section, block 10, of the NR. The narrative should include a complete description of the SRM noncompliance, including the type of SRM and any other information relevant to the noncompliance. The narrative should also address each of the other regulations that inspection program personnel cite in the Relevant Regulations section on the NR screen. The statements in block 10 of the NR are to support completely and adequately the regulatory noncompliances cited.

For every NR that inspection program personnel issue, it is important that they cite all relevant regulations. These citations provide data that are the basis for critical, risk-based decisions that the FSIS must regularly make when working to ensure that meat and poultry products are safe. Thus, it is not appropriate for inspection program personnel to cite only one regulation if other regulations are also violated by the noncompliance that is the subject of the NR.

Inspection program personnel with technical questions related to the use of PBIS, or who experience technical problems, should contact the FAIM Help Desk at 1-800-473-9135. They should contact the Technical Service Center at 1-800-233-3935 for policy-related questions.

Philip S. Derfler /s/


Assistant Administrator
Office of Policy, Program, and Employee Development

DISTRIBUTION: Inspection Offices; T/A Inspectors; Plant Mgt; TRA; ABB; TSC; Import Offices NOTICE EXPIRES: 2/1/08 OPI: OPPED

http://www.fsis.usda.gov/regulations_&_policies/Notice_05-07/index.asp

> For every NR that inspection program personnel issue, it is important that they cite all relevant regulations.


miracles never cease to amaze me. ...tss


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

THE SEVEN SCIENTIST REPORT ***


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf


PAUL BROWN M.D.

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf


9 December 2005
Division of Dockets Management (RFA-305)

SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf

Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm

Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm


03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf


03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf


Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf


In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf

Terry S. Singeltary SR.
P.O. Box 42
Bacliff, Texas USA 77518



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