FOR OFFICIAL USE ONLY

New Mexico Meat and Poultry Inspection Program

FSIS Comprehensive Review

FederaYState Audit Branch Internal Control and Audit Division

Office of Program Evaluation, Enforcement and Review Food Safety and Inspection Service

United States Department of Agriculture June 8,2007

This document is FOR OFFICIAL USE ONLY. It and its contents are not to be distributed outside FSZS, nor duplicated without prior clearance from the Offxe of Program Evaluation, Enforcement, and Review.

Table of Contents

Page Number

... .............................................................................. Summary -111

............................................................................ Introduction -1

............................................................................. Background 1

.......................................................................... Methodology -2

.............................. New Mexico Meat and Poultry Inspection Program 2

................................................... Comprehensive Review Timeline 3

......................... Analysis of New Mexico's Final Corrective Actions 6

............................................... Significant Deficiencies in NMMPIP 9

............................................ HACCP Noncompliance Findings -10

........................................... Sanitation Noncompliance Findings 12

............................................ Sampling Noncompliance Findings 14

Inadequate Enforcement and Compliance Reporting Findings ............ 15

................. Human Resources and Financial Accountability Findings 16

............................................................................. Conclusion 18

..................................................................... Recommendation 19

Appendices

Appendix A: FSIS Directive 5720.2, Revision 3, FSIS Manual for State Meat and Poultry Inspection Program Reviews (August 2006)

Appendix B: New Mexico State Review and Determination Report (January 2007)

Appendix C: Initial On-Site Review Findings (January 23 - February 3,2006)

Appendix D: Corrective Action Plans Submitted by NMMPIP (February 16, March 7, and March 14,2006)

Appendix E: First Verification Review Findings (April 10-14,2006)

Appendix F: First Deferral Letter (May 22,2006)

Appendix G: Second Verification Review Findings (September 11-22,2006)

Appendix H: Second Deferral Letter (December 6,2006)

Appendix I: IPA Assignment Reports (November 1,2006 - December 20,2006)

Appendix J: Clarification Memo (Draft -pending)

Appendix K: Memoranda of Interview Reports (February 22 - March 29,2007)

Appendix L: Final Resolution Letter (April 9,2007)

Appendix M: Individual Establishment Findings throughout the Comprehensive Review

Appendix N: Analysis of New Mexico's Submission (May 14,2007)

Appendix 0: PBIS Data and NR Summary Tables (May 25,2007)

SUMMARY

Under the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and the Humane Methods of Slaughter Act (HMSA), the Food Safety and Inspection Service (FSIS) is responsible for setting a national standard for meat and poultry inspection. Under individual cooperative agreements with FSIS, States may operate their own meat and poultry inspection programs if they meet and enforce requirements "at least equal to" those imposed under the FMIA, PPIA and HMSA. FSIS conducts annual reviews of all State programs to determine if they are meeting and can maintain for the next 12 months an "at least equal to" meat and poultry inspection program.

The annual review of the New Mexico Meat and Poultry Inspection Program (NMMPIP) conducted in January 2006 revealed deficiencies in the execution of the meat and poultry inspection program. Since that time, FSIS has conducted four follow-up on-site reviews, reviewed two self-assessments, engaged in ongoing discussions with New Mexico officials, and conducted extensive corrective action document reviews. In addition, FSIS has provided on-site assistance, constructive feedback, and training to New Mexico personnel; however, NMMPIP has repeatedly demonstrated that it is not meeting the requirements of its laws and regulations which incorporate the requirements of the FMIA, PPIA, HMSA, and all FSIS regulations.

Significant repetitive noncompliances documented by FSIS and communicated to New Mexico officials since the initiation of the first NMMPIP on-site review in January 2006 demonstrate chronic and systemic food safety problems that have not been corrected during the past 16 month comprehensive review period. FSIS found repeated instances across a representative number of establishments where NMMPIP:

Does not provide daily inspection. Does not verify establishments' food safety systems (sanitation standard operating procedures and HACCP regulatory requirements). Does not have adequate pathogen sampling program design or implementation. Does not take appropriate regulatory and enforcement actions. Does not demonstrate adequate supervisory oversight, management control and accountability. Does not have the sufficient number of staff nor the staff with sufficient regulatory knowledge.

While NMMPIP has made some improvements, the Agency's comprehensive review demonstrates that chronic and systemic food safety violations continue. The NMMPIP remains fundamentally unable to implement and enforce a sound food safety regulatory program that assures the production of wholesome, unadulterated, and properly labeled and packaged products. Current conditions dictate that FSIS take necessary actions to protect the health and welfare of consumers and designate the program which consists of 23 State-inspected establishments' (4 red-meat slaughter, 2 red meat slaughter and processing, 7 red meat and poultry processing, and 10 red meat processing establishments), 32 custom exempt facilities and 18 employee positions (2 of which are vacant field positions).

' One establishment voluntarily transferred to the Federal Inspection Program effective June 4,2007.

Introduction

From January 3,2006 through issuance of this report, the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) conducted a comprehensive review of the New Mexico Meat and Poultry Inspection Program (NMMPIP) to determine if the Program was enforcing requirements "at least equal to" those imposed under the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and Humane Methods of Slaughter Act (HMSA). If the final determination is that the NMMPIP is "at least equal to," the Program will continue to operate. If the final determination is that the NMMPIP is "not at least equal to," FSIS will decide the necessary actions to protect the public health and safety of New Mexico consumers by designating New Mexico as a State in which the Federal inspection requirements apply to products produced and distributed intrastate.

This report documents the systemic and chronic food safety problems and the associated risk to public health and consumers in New Mexico. This report synthesizes NMMPIP submissions and FSIS previous review reports for the last 16 months and includes the following information:

Background - discussion of relevant regulations and FSIS policies Methodology - the methodology used to conduct the comprehensive review New Mexico Meat and Poultry Inspection Program - a description of New Mexico's regulations and the establishments under State inspection Comprehensive Review Timeline - significant events and timeframes for review activities Significant Deficiencies in NMMPIP - noncompliances categorized by relevant statute Conclusion and Recommendations.

Background

Under the FMIA and the PPIA, FSIS sets national standards for meat and poultry inspection (MPI). Under a cooperative agreement with FSIS, States may operate their own MPI programs if they meet and enforce requirements "at least equal to" those imposed under the FMIA, PPIA, and HMSA. The FMIA (21 U.S.C. 601 et seq.) and PPIA (21 U.S.C. 451 et seq.) provide that it is essential in the public interest that the health and welfare of consumers be protected by assuring that meat and poultry products distributed to them are wholesome, not adulterated, and properly labeled and packaged.

Cooperative agreements and annual certifications of State MPI programs are dependent upon FSIS determining that each State is enforcing requirements "at least equal to" those imposed under the FMIA, PPIA, and HMSA. FSIS determines whether each State program meets, and can maintain for a period of 12 months, the mandated "at least equal to" standard based on an annual assessment.

The FMIA (21 U.S.C. 661) and PPIA (21 U.S.C. 454) give FSIS the authority to designate a State as one in which the provisions of Titles I and N of the FMIA and Sections 45 1 to 453,455 to 459, and 461 to 467d of the PPIA shall apply to operations and transactions wholly within such State.

The FMIA provides that if a State has failed to develop or is not enforcing requirements at least equal to those imposed under title I and IV of this Act, the Secretary shall promptly notify the Governor of the State of this fact. If, after consultation with the Governor of the State, the Secretary determines that requirements at least equal to Federal requirements have not been developed and activated, the Secretary shall designate the State as one in which the provisions of titles I and IV of the FMIA apply to operations and transactions wholly within the State. The designation is required to be published in the Federal Register. The PPIA contains similar language. 21 U.S.C. 9 454 (c) (1).

Methodology

FSIS policy and procedures for reviewing State MPI programs are described in FSIS Directive 5720.2, Revision 3, dated November 16,2004, State Cooperative Inspection Programs, and the companion FSIS Manual for State Meat and Poultry Inspection Program Reviews (Appendix A, FSIS Directive 5720.2, Revision 3, FSIS Manual for State Meat and Poultry Inspection Program Reviews, August 2006).

The manual divides the State program into the following nine components: (1) Statutory Authority and Food Safety Regulations, (2) Inspection, (3) Product Sampling, (4) Staffing and Training, (5) Humane Handling, (6) Other Consumer Protection, (7) Enforcement, (8) Civil Rights, and (9) Funding and Financial Accountability. FSIS policy is to conduct document reviews of each State's self-assessment submission annually, and on-site reviews of each State's operating program every 3 years. Using the criteria for each component during both self- assessment and on-site reviews as stated in the manual, FSIS determines whether the State's MPI program constitutes an inspection program "at least equal to" the Federal program.

The comprehensive review of the NMMPIP was conducted from January 2006 through May 2007. During this period, qualified FSIS review teams assessed the inspection program's records and other relevant documents, observed the New Mexico program in operation, interviewed all State inspection program personnel, evaluated the findings, and provided ongoing feedback to State inspection program officials. FSIS also extended on-site assistance, provided additional training, and conducted correlation sessions covering a variety of technical topics/issues with State field inspection staff and plant owners/operators.

New Mexico Meat and Poultry Inspection Program

The NMMPIP is administered by the New Mexico Livestock Board (NMLB), Meat and Poultry Inspeetion Division pursuant to Chapter 25 of the New Mexico Statutes Annotated (N.M.STAT.ANN. § 25) (1978). The NMLB's authority to enforce the Federal Acts and Regulations is in N.M.STAT.ANN. 5 25 (1978) Article 3. Further, on July 1,2006, the New Mexico Administrative Code (NMAC), Title 21, Chapter 33, Part 2, incorporates by reference the FMIA, PPIA, HMSA, and 9 C.F.R., Chapter III,300 through 590.970 'as presently in effect and as they may later be modified.'

In January 2006, the NMMPIP reported 36 State-inspected establishments (29 processing-only establishments and 7 combination slaughter and processing establishments) and 32 custom exempt operations.2 The NMMIP workforce consisted of 1 State Veterinarian, 1 State Director (a Public Health Veterinarian), 3 Veterinarian Medical Officers, 2 Enforcement Investigative Assessment Officers (EIAO), 10 Food Inspectors, and 1 Compliance Officer.

As of the date of this report, NMMPIP has 23 State-inspected establishments3 and the same number of custom exempt and inspection personnel to the best of our knowledge. The 23 State- inspected establishments are comprised of 4 red meat slaughter-only establishments, 2 red meat combination slaughter and processing establishments, 7 processing-only establishments producing a combination of both red meat and poultry products, and 10 red meat processing-only establishments. The program's workforce remained the same.

On numerous occasions, New Mexico officials have indicated that they are seeking additional resources for the State MPI program. To date, FSIS has not received information about the status of New Mexico's supplemental funding requests.

Comprehensive Review Timeline

The main activities and timeframes of the comprehensive review are detailed in chronological order below.

FY 05/06 Self-Assessment Submission (November 18,2005) FSIS completed the review of NMMPIP's self-assessment documents for fiscal year 2005-2006 on September 5,2006, and determined that New Mexico's self-assessment documents supported a determination that their MPI program was "at least equal to'' Federal requirements. FSIS considered the information provided to be an accurate portrayal of how the State program system is functioning and would continue to function for the next 12 months. (Appendix B, New Mexico State Review and Determination Report, January 2007)

Initial On-Site Review (January 23 - February 3,2006) The FSIS review team conducted an on-site review at the State office and a representative sample of State-inspected establishments. Reviewers compared data from the recent self- assessment submission with the actual NMMPIP daily operations. In addition, in each selected establishment, ongoing operations, particularly the food safety systems, procedures, and plans, were reviewed for compliance with Federal requirements. After the review, FSIS informed New Mexico officials that their MPI program could not be determined to be "at least equal to" the Federal requirements and that the NMMPIP needed to develop and implement a corrective action plan to address documented deficiencies. FSIS also informed New Mexico officials that FSIS

Between January - June 2007, FSIS provided the NMMPIP further assistance by temporarily transferring, at no cost to New Mexico, 9 of the 36 NMMPIP establishments to the Federal Inspection Program. This transfer allowed the NMMPIP to allocate more resources toward program execution as well as the opportunity to seek additional needed resources.

One establishment voluntarily transferred to the Federal Inspection Program effective June 4,2007.

would defer a decision to designate pending implementation of systemic changes. (Appendix C, Initial On-Site Review Findings, January 23 - February 3,2006)

Corrective Actions (February 3 - March 14,2006) During this period, FSIS held multiple teleconferences with New Mexico officials to discuss the nature and scope of the findings, the importance of implementing effective corrective actions, and the potential consequences of inaction. New Mexico officials submitted three separate written corrective action plans early in 2006. The FSIS review concluded that, as written, the proposed corrective actions were sufficient to correct the deficiencies observed during the initial on-site review. However, until verified, the determination was still deferred. (Appendix D, Corrective Action Plans Submitted by NMMPIP, February 16, March 7, and March 14,2006)

First Verification Review (April 10-14,2006) To confirm implementation of corrective actions, FSIS performed a verification review in seven State-inspected establishments and the State office to determine if all Federal requirements were being met to support an "at least equal to" program. During this review, an FSIS team observed significant public health related conditions (HACCP noncompliances) in all seven establishments reviewed and thus could not determine that product was not adulterated in association with the production of raw, ready-to-eat, and shelf-stable products. Review findings demonstrated that the NMMPIP failed to completely implement and properly execute proposed corrective1 preventive actions. NMMPIP issued noncompliance records for the findings observed during the initial onsite review; however, they did not appropriately verify the establishment's corrective actions. NMMPIP also failed to recognize and document similar HACCP noncompliances not previously reviewed by FSIS. (Appendix E, First Verification Review Findings, April 10- 14,2006)

First Deferral Letter (May 22,2006) FSIS concluded that while New Mexico had made improvements to their program, further corrective action by the State program and follow-up review by FSIS were essential. FSIS gave NMMPIP additional time to completely implement their proposed corrective actions which included additional training for inspection personnel, training of a new public health veterinarian (State Director), training of an Enforcement, Investigation, and Analysis Officer, and the reorganization of NMMPIP to ensure accountability. FSIS issued official written notification to the NMLB Executive Director of the decision to defer the designation. (Appendix F, First Deferral Letter, May 22,2006)

Second Verification Review (September 11-22,2006) FSIS performed its second verification review in eight State-inspected establishments, four of which had been previously reviewed, and four of which had not. An expert FSIS team observed significant unsanitary conditions (SSOP and HACCP noncompliances) in seven of the eight establishments reviewed and thus could not determine that product was not adulterated in association with the production of raw, ready-to-eat, and shelf-stable products. Review findings demonstrated that the NMMPIP failed to verify that State-inspected establishments appropriately implemented proposed corrective/preventive actions. NMMPIP continues not to recognize food safety noncompliances and therefore does not ensure appropriate corrective actions in State- inspected establishments to protect public health. Therefore, NMMPP still did not meet the "at

least equal to" Federal standard. (Appendix G, Second Verification Review, September 11-22, 2006)

Meeting with Under Secretary for Food Safety and New Mexico Officials (October 20,2006) After the second verification review (see above), Dr. Richard Raymond, Under Secretary for Food Safety, met with New Mexico officials on October 20,2006, to discuss the status of the NMMPIP, the FSIS findings, and next steps. This meeting resulted in an extension of New Mexico's status to allow: 1) New Mexico an opportunity to continue its multi-pronged approach (e.g., additional training, staffing, funding) to reach "at least equal to" status; 2) FSIS to provide on-site, real-time instruction covering all inspection program activities; and 3) FSIS to provide ongoing verification that New Mexico was implementing corrective actions and operating an "at least equal to" program that could be maintained in the coming 12 months.

Second Deferral Letter (December 6,2006) FSIS issued written notification to the NMLB Executive Director that FSIS would continue to defer the final decision to designate the NMMPIP. In addition, FSIS agreed to provide an on-site FSIS employee (per the Intergovernmental Personnel Act (PA) Assignments, FSIS Directive 4334.1, dated 07/14/03) to verify NMMPIP's progress towards meeting the "at least equal to" standard. During this same period, FSIS would continue to provide substantive feedback to New Mexico and monitor the implementation of corrective actions and management controls in response to prior review findings. (Appendix H, Second Deferral Letter, December 6,2006)

On-Site Support by IPA Agreement (November 1,2006 - December 20,2006) FSIS detailed a Fede'ral employee to work on-site with NMMPIP officials to provide on-site assistance and training to New Mexico inspection personnel, verify NMMPIP progress in effectively implementing corrective actions, and correlate information exchange activities. The Federal employee assured that all appropriate information was provided to NMMPIP and also provided FSIS with information to determine whether New Mexico was implementing corrective actions and operating an "at least equal to" program. (Appendix I, P A Assignment Reports, November 1,2006 - December 20,2006)

FY 06/07 Self-Assessment Submission (submitted February 7,2007) NMMPIP requested an extension for this submission in order to focus on ensuring implementation of an "at least equal to" program and also to benefit from the P A assignment. FSIS granted an extension until December 3 1,2006, and received the FY 06/07 self-assessment submission on February 7,2007. After review, FSIS determined that NMMPIP submission lacked information and/or supporting documentation to provide sufficient evidence that the program was meeting and would maintain an "at least equal to" status for the next 12 months. (Appendix J, Clarification Memo, Draft - pending)

On-Site Review (February 21-March 29,2007) Two FSIS expert reviewers revisited 15 establishments conducting operations. The team conducted a review of overall on-site program compliance which required ongoing interaction with the NMMPIP State Director, detailed reviews of State-inspected establishments in operation, and interviews with plant officials and inspection program personnel. In addition,

FSIS provided further assistance to the NMMPIP, providing reference and outreach materials to NMLB office and field personnel and all plant managers. Before leaving each establishment, the FSIS reviewers documented and issued memorandum of interviews (MOIs) of the compliance/noncompliance findings to New Mexico officials in attendance. (Appendix K, Memoranda of Interview Reports, February 22 - March 29,2007)

Final Resolution Letter (April 9,2007) FSIS issued written notification to the NMLB Executive Director that the Agency had completed its fact-finding and requested, within 30 business days of receipt of the notification, the NMMPIP's response to the following concerns:

1) Provide evidence and supporting documentation to demonstrate the food safety deficiencies and regulatory noncompliances identified between January 2006 and March 29,2007, with the assistance of FSIS personnel, have or will be corrected; the outcome of any enforcement actions that have been taken where conditions warrant; and the monitoring of verification plans for corrective actions, as well as the development of verifications based on establishments' responses to Notice of Intended Enforcement or suspensions.

2) Provide details of how the NMMPIP's design and execution were adjusted to address the findings identified between January 2006 and March 2007, including staffing, training, and/or supervision issues.

3) Provide details of the NMLB's efforts to increase funding resources to be able to support "at least equal to" inspection for all 36 plants, including 9 State-inspected establishments that FSIS has temporarily transferred to Federal inspection.

4) Provide all overdue financial reporting submissions and supporting documents, including Financial Status Reports (SF-269As), and indirect cost proposals.

(Appendix L, Final Resolution Letter, April 9,2007)

Analysis of New Mexico's Final Corrective Actions (Received May 14. 2007)

NMMPIP submitted final corrective actions in response to the FSIS April 9,2007, Final Resolution Letter. FSIS analyzed the submission and determined that the corrective measures taken by NMMPIP were not adequate to ensure that the public health was being protected. This determination was based on a comparison of the review findings to the requirements in the FMIA, PPIA, and HMSA statutes and accompanying regulations. During the past 16 months, FSIS has identified serious systemic food safety concerns in NMMPIP-regulated establishments.

The following four sections describe the results of FSIS' analyses for each of the concerns identified in the Final Resolution Letter (April 9,2007).

1. Provide evidence and supporting documentation to demonstrate the food safety deficiencies and regulatory noncompliances identified between January 2006 and March 29,2007, with the assistance of FSIS personnel, have or will be corrected; the outcome of any enforcement actions that have been taken where conditions warrant; and the monitoring of verification plans for corrective actions, as well as the development of verifications based on establishments' responses to Notice of Intended Enforcement or suspensions.

A comprehensive response from NMMPIP to this concern was critically important for the following reasons. Significant repetitive noncompliances documented by FSIS and communicated to New Mexico officials since the initiation of the onsite reviews have demonstrated chronic and systemic food safety problems that have not been corrected during the last 16 months by the NMMPIP. These findings include a continued lack of understanding of Hazard Analysis and Critical Control Point (HACCP) concepts by industry and inspection program personnel, an overall lack of regulatory oversight by New Mexico inspection personnel, and a multitude of food safety noncornpliances. Evidence indicates that the NMMPIP is not providing daily inspection for products bearing the mark of inspection, and sufficient financial and human resources to date have not been forthcoming to remedy deficiencies. These repetitive noncompliances demonstrate that NMMPIP-inspected establishments are not in compliance with the laws and regulations and that NMMPIP lacks the ability to recognize noncompliances and take effective regulatory actions. Significant findings from each of 24 on-site reviews are included in Appendix M. (Appendix M, Individual Establishment Findings throughout the Comprehensive Review)

NMMPIP's May 2007 submission did not contain sufficient documentation to demonstrate that noncompliances identified throughout the comprehensive review process have been corrected and whether sufficient enforcement actions had been taken. Since FSIS' last on-site review, only a minimum number of Noncompliance Reports (NRs) are reported in New Mexico's Performance-Based Inspection System (PBIS) and only three Food Safety Assessments have been conducted. (Appendix N, Analysis of New Mexico's Submission, May 14,2007)

2. Provide details of how the NMMPIP design and execution were adjusted to address the findings identified between January 2006 and March 2007, including staffing, training, andlor supervision issues.

NMMPIP's submission did not contain sufficient documentation as to how staffing, training, and supervision issues support an "at least equal to" determination. The information provided contained a stopgap measure to use untrained personnel from other areas of the NMLB to supervise daily activities within the NMMPIP. The program further intends to use EIAO-trained personnel to assist with supervising field personnel. EIAO training does not include supervisory training and the time spent in supervisory activities detracts from the real focus of the positions. New positions have been approved for the NMMPIP but the funding to staff the positions is not forthcoming. The submission contained nothing useful to identify any corrective action plans, or specific plans to address program weaknesses such as increased staffing, improved program supervision, or ongoing training at all levels within the program. (Appendix N, Analysis of New Mexico's Submission, May 14,2007)

3. Provide details of the NMLB's efforts to increase funding resources to be able to support "at least equal to" inspection for all 36 plants, including the 9 State-inspected establishments that FSIS has temporarily transferred to Federal inspection.

NMMPIP has repeatedly asserted that insufficient funds prevent them from fully meeting Federal requirements, yet the May 2007 submission lacks details of NMLB efforts to increase appropriated funds for FY 07 or FY 0 8 ~ that would support an "at least equal to" inspection for all State plants. Since January 2006, FSIS has not been able to support a determination of "at least equal to" Federal requirements. The NMMPIP has failed to effectively implement the MPI requirements and assure that State-inspected establishments were complying with applicable regulatory requirements. FSIS expected NMMPIP to develop corrective action plans to achieve "at least equal to" the Federal requirements. FSIS has not been provided evidence that NMPPIP will have sufficient funds for staffing, training, travel, and program operations. Neither corrective actions nor the NMMPIP commitment to improve the program implementation are reflected in the narrative that accompanies the budget information.

The NMMPIP May 2007 submission includes conflicting financial and budget information covering N 0 6 , FY07 and FY08. NMMPIP reported its actual program expenditures for FY06 as $1,084,000 (S-8 Financial Statement) with no explanation. For FY07 which is just ending, NMMPIP reported operating expenditures as $1,355,000 (S-8 Financial Statement). The N O 7 budget documents provide no explanation of how NMMPIP will use existing or additional funds to strengthen and support its program. In addition, no information was provided to indicate that the New Mexico legislature has been made aware of NMMPIP's status and the need for additional funding to achieve an "at least equal to" Federal requirements.

Dr:Miley Gonzalez, Directorlsecretary, New Mexico Department of Agriculture, orally informed the Deputy Under Secretary of Food Safety on May 10,2007, that New Mexico provided an additional $250,000.00 to fund the NMMPIP in N 0 7 ; however, the additional funding amount is not addressed in the financial documents provided by New Mexico. Furthermore, the financial documents do not include any information about its reallocation of the funds previously targeted to the 9 State establishments that were temporarily transferred to the Federal MPI FSIS and New Mexico officials had agreed that these 9 establishments posed a serious threat to food safety and therefore should be transferred temporarily to FSIS, which would allow NMMPIP to reallocate the freed-up resources to the remaining establishments to address program shortcomings and ensure public health.

The absence of a detailed plan linking NMMPIP implementation to projected expenditures makes it impossible to determine whether NMMPIP has adequate resources or is using available resources in a manner that supports an "at least equal to" program. The financial documentation provided by NMMPIP is incomplete. Consequently, FSIS cannot confirm that NMMPIP activities support "at least equal to" inspection for all regulated plants nor is there sufficient evidence that NMMPIP has the funds or a sound funding plan for reaching "at least equal to" status. Further, NMMPIP has repeatedly asserted that insufficient funds prevent them from fully

4 New Mexico's fiscal year budget cycle is from July 1 through June 30 of each year. One establishment voluntarily transferred to Federal inspection effective June 4,2007.

8

meeting Federal requirements; however, no information was provided indicating a funding shortfall nor documented evidence for justifying a request for future appropriated funds. Finally, New Mexico's May 2007 submission includes only its FYO8 budget request for $1,626,000 but no supporting documentation. Both New Mexico and FSIS officials acknowledge that without sufficient funding and a feasible implementation plan, the NMMPIP can not operate as an "at least equal to" program until adequate funding can be obtained to get to "at least equal to" in all establishments. (Appendix N, Analysis of New Mexico's Submission, May 14,2007)

4. Provide all overdue financial reporting submissions and supporting documents, including Financial Status Reports (SF-269As), and indirect cost proposals.

Based on review of the financial information submitted in response to this request, NMMPIP meets the "at least equal to" component for Funding and Financial Accountability. A nearly complete set of documents was received with only a few minor omissions.

The final FY2006 SF-269A report for FAIM was missing but FSIS has all interim reports.

The indirect cost proposal (ICP) for New Mexico's Fiscal Year 2004 (ending June 30,2004) was deficient regarding Federal funding data. The proposal did not include an updated chart of financial accounts which lists the way in which the actual dollars expended can be related to various programs andlor organization structure. The ICP is prepared by NMLB to substantiate its claim for the reimbursement of indirect costs. This proposal provides the basis for review, audit, and negotiation leading to the establishment of the organization's indirect cost rate(s).

The missing items are not critical enough to change NMMPIP's "at least equal to" status for the funding and financial accountability component. FSIS will request the missing items.

Significant Deficiencies in NMMPIP

Significant repetitive noncompliances documented by FSIS and communicated to New Mexico officials since the initiation of the NMMPIP onsite reviews in January 2006 demonstrate chronic and systemic food safety problems in the NMMPIP. Our reviews also established that NMMPIP has not corrected these problems in the last 16 months covered by the FSIS program review. These findings include a continued lack of understanding of HACCP concepts by industry and New Mexico inspection program personnel, an overall lack of regulatory oversight by New Mexico inspection personnel, and a multitude of food safety noncompliances. Evidence indicates that, at some establishments, NMMPIP is not providing daily inspection for products bearing the mark of inspection. Sufficient financial and human resources to date have not been forthcoming to remedy deficiencies.

The categories of significant findings below are listed in order of importance based on food safety noncompliances. These food safety findings from the FSIS review process show a pattern of food safety problems that have not been addressed by NMMPIP and that a pose serious risk to public health. Because the NMAC incorporated by reference the FMIA and PPIA, significant noncompliances are categorized by relevant FMIAPPLA statute. NMMPIP has incorporated by

reference 9 C.F.R., Chapter III, 300 through 590.970, and cites the 9 C.F.R. regulatory references on noncompliance records as well as other official documents.

HACCP Noncompliance ~ i n d i n ~ s ~

From the first on-site review through the most recent, the majority of New Mexico establishment owners and inspection program personnel demonstrated a poor understanding and inadequate implementation of HACCP. Noncompliances covered all major HACCP components (hazard analysis, critical control points [CCPs], critical limits, monitoring, verification, reassessment, record keeping, failure to have supporting documentation for decisions, and failure to perform pre-shipment reviews) resulting in systemic noncompliances and production of products under questionable control leading to serious public health food safety concerns.

New Mexico inspection personnel exhibited a continued overall lack of regulatory oversight as evidenced by the volume and severity of FSIS findings and the lack of documentation by NMMPIP personnel. FSIS' follow-up reviews reinforced the serious nature of earlier noncompliances and confirmed that corrective actions were not being implemented.

The NMMPIP field personnel's lack of regulatory oversight of State-inspected establishments is evidenced by their inability to evaluate corrective actions proffered by industry personnel. An example of this inability to evaluate corrective actions is provided in the following description. Following the FSIS on-site review in January 2006, an NR was issued at the direction of an FSIS official to an establishment that did not address post lethality exposed, ready-to-eat, shelf-stable products in their HACCP plan (reference 9 C.F.R. 5 430.4, Control of Listeria monocytogenes in post-lethality exposed ready-to-eat products). The noncompliance had not been identified by the NMMPIP inspector assigned to the establishment.

The immediate response proffered by the establishment representative and verified as effective by the NMMPIP inspector states, "Pray for a regulation from someone with the authority and the responsibility to make a regulation happen." Likewise, the proposed planned action by the establishment (again, verified by NMMPIP) states that it, "believes the product is shelf stable because the water activity, after the product is cooked is reduced to a safe level. What we need is a regulation from USDA. A regulation that defines an acceptable water activity level for a preservative free jerky." The response is not adequate and inappropriately references water activity as the reason the NR was issued. The NR was issued for the lack of controls for post lethality exposed ready-to-eat product as required by the regulations which were already in place (9 C.F.R. 5 430.4, June 6,2003).

Other representative examples of findings include: - Major HACCP food safety issues exist in establishments that slaughter and produce heat

treatedfully-cooked shelf-stable products (jerky), heat treatedlnot fully cooked not shelf

21 U.S.C. $5 606,608,62 1 (FMIA); 2 1 U.S.C. 55 455,456,463 (PPIA); 9 C.F.R. 5 417; N.M. STAT.ANN. 5 25- 3-6-- 25-3-21; N.M. Admin.Code 21.33.2

stable products. Many of the same observations were found during all five onsite reviews that FSIS performed since January 2006.

- In several instances, for fully cooked shelf-stable product (jerky), the criteria/controls used to support lethality were not being followed and/or both lethality and stabilization

criteria were either inadequate or were not being followed as required by 9 C.F.R. $5 417.2(c), 417.3(a), 9 C.F.R. $9 417.4(a)(l) & (2), 9 C.F.R. $5 417.5(a) (2) & (3), and 417.5(b).

- Establishments producing jerky products had not validated their HACCP plans/processes for lethality and shelf-stability as required by 9 C.F.R. 5 417.4(a) (1).

- Establishments were not meeting the regulatory requirements for HACCP ongoing verification activities as required by 9 C.F.R. 5 417.4(a) (2).

- Establishments were not monitoring critical limits at the frequencies stated in the HACCP plans. HACCP plans did not comply with 9 C.F.R. 5 417.3(a).

- Serious public health noncompliances were observed in two establishments. One establishment owner admitted to producing ready-to-eat product in a processing room used for producing raw product without a HACCP plan as required by 9 C.F.R. 5 417.2. The establishment owner stated that the NMMPIP inspector was aware of this practice and did not take regulatory control actions. Another establishment could not support that lethality was achieved for its ready-to-eat products pursuant to 9 C.F.R. 5 417.5(a)(3), the establishment was not documenting the monitoring of CCPs and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment's HACCP plan.

- Establishments could not provide supporting documentation for decisions made in the hazard analyses and HACCP plans.

- One establishment's hazard analysis and HACCP plan was found lacking in monitoring, record keeping, corrective action, verification, and reassessment in accord with HACCP regulatory requirements within 9 C.F.R. 5 417.

From the May 2007 submission, FSIS is not able to validate that NMMPIP has taken effective regulatory actions to ensure that the food safety concerns noted throughout the FSIS review process have been addressed. There is a continued overall lack of regulatory oversight by New Mexico inspection personnel as evidenced by the volume and severity of FSIS' findings and the lack of documentation by NMMPIP personnel. Additionally, when NMMPIP did initiate Food Safety Assessments of their regulated establishments, NMMPIP did not take appropriate regulatory action for the documented HACCP findings. Some representative examples of findings include:

- From the initial on-site review to the third verification review, FSIS identified eight establishments with HACCP noncompliances. Specifically, the noncompliances were related to the establishments' corrective action procedures for addressing deviations from critical limits within their food safety systems. In four establishments, FSIS observed failures to include all four parts of corrective action (the cause of the deviation is identified and eliminated; the CCP will be under control after the corrective action is taken; measures to prevent recurrence are established; and no product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce) in their HACCP plans required by 9 C.F.R. 5 417.3(a). In the other four establishments, FSIS identified instances where the establishments failed to document or initiate corrective

actions for deviations from critical limits for CCPs. In one establishment, the same noncompliance issue was identified by FSIS during three separate reviews: initial, first verification, and second verification. NMMPIP failed to initiate regulatory actions to address this finding and ensure that the establishment corrected the noncompliance until the second verification review. In another establishment, the same HACCP noncompliance was identified by FSIS one week later.

- FSIS identified instances where another establishment failed to initiate corrective action for deviations from critical limits. One week prior to FSIS' third verification review, NMMPIP performed a food safety assessment at this establishment and identified the establishment's failure to comply with the corrective action requirements in 9 C.F.R. 5 417.3(a). NMMPIP failed to identify that corrective actions were not initiated for deviations from critical limits in completed establishment HACCP records. When FSIS identified these findings, NMMPIP did not initiate regulatory or subsequent follow-up action.

- FSIS observed noncompliances with Listeria monocytogenes (Lm) regulations in seven establishments producing ready-to-eat products. FSIS identified these noncompliances at two establishments during the initial review and continued to observe the same types of Lm noncompliances during subsequent reviews (9 C.F.R. $5 430.4,417.2).

- NMMPIP's Food Safety Assessment reports submitted for eight inspected establishments (January 2007 to the present) identified significant food safety issues; however, NMMPIP issued NRs in only five establishments. NMMPIP did not document regulatory actions for all of the observed HACCP findings. Of the five establishments issued NRs, three failed to respond with any corrective actions to NMMPIP. One establishment documented that it has responded to all findings but failed to provide adequate long-term solutions.

FSIS review of New Mexico's May 2007 submission found that NMMPIP did not provide evidence to show that the HACCP noncompliances have been corrected. (Appendix N, Analysis of New Mexico's Submission, May 14,2007)

Sanitation Noncompliance ~ i n d i n n s ~

Based on evidence provided to date, most New Mexico inspection personnel are not adequately performing their in-plant regulatory responsibilities in regard to sanitation requirements. They have demonstrated a recurring inability to take appropriate regulatory actions in situations that involve significant public healthlfood safety sanitation noncompliances. There is a noted lack of documented sanitation noncompliances compared to FSIS findings throughout the comprehensive review. Similarly, FSIS has noted that New Mexico establishments repeatedly fail to or are unable to execute Sanitation Standard Operating Procedures (SSOPs). Currently, FSIS cannot validate through the May 2007 submission that New Mexico has taken effective regulatory actions to ensure that the food safety sanitation concerns exhibited throughout the comprehensive review process by FSIS do not still exist.

' 21 U.S.C. $5 456,463,606,608,621; 9 C.F.R. 5 416; N.M. STAT.ANN. 5 25-3-13; N.M. Admin.Code 21.33.2

A representative number of the repeated instances of sanitation and SSOP noncompliances from the most recent verification review are noted below:

- In one establishment, management and the NMMPIP inspector failed to note and correct seven unsanitary pieces of equipmentlareas during pre-operational sanitation inspection in violation of 9 C.F.R. 5 416.13. (Appendix K, Memoranda of Interview Reports, February 22 - March 29,2007)

- In an establishment that operates only 2 days a week, records indicated that pre- operational and operational sanitation were checked and marked acceptable 5 days a week in violation of 9 C.F.R. $5 416.13,416.16. (Appendix K, Memoranda of Interview Reports, February 22 - March 29,2007)

- In one establishment, plant personnel failed to observe and correct 14 noncompliances during pre-operational sanitation inspection prior to releasing the area to NMMPIP in- plant inspection personnel for pre-operational sanitation verification inspection as provided by 9 C.F.R. 5 416.13. NMMPIP in-plant inspection personnel never observed the noncompliances during their pre-operational sanitation verification inspection (9 C.F.R. 5 416.17). (Appendix K, Memoranda of Interview Reports, February 22 - March 29,2007)

- In one establishment, rodent droppings were observed in several locations, including the preparation/cooking room (9 C.F.R. 5 416.2(a)). Appendix K, Memoranda of Interview Reports, February 22 - March 29,2007)

- In one establishment, the recorded corrective actions to plant-identified pre-operational SSOP deficiencies did not meet the regulatory requirements of 9 C.F.R. 5 416.15(b).

FSIS analysis of New Mexico's May 2007 submission demonstrated that NMMPIP continues to fail to take appropriate regulatory control actions. Examples of these failures include:

- In three establishments, the SSOP either was not signed and dated or not signed and dated when revisions occurred (9 C.F.R. g 416.12).

- In one establishment, there was evidence of rodents within multiple processing and non- processing areas (9 C.F.R. 5 416.2(a)).

- Several establishments were not maintaining documentation that sanitizing solutions being used are safe in a food-producing environment (9 C.F.R. 5 416.16).

- In multiple establishments, SSOP procedures were not being performed at the frequency stated in the SSOP (9 C.F.R. 9 416.13).

- In three establishments, corrective actions were either not documented or not documented in a manner required by 9 C.F.R. 5 416.15.

- In several establishments, records were not maintained to document the implementation and monitoring of the sanitation SSOP procedures (9 C.F.R. 5 416.16).

Samvlinrr Noncompliance ~indings*

FSIS has noted multiple violations for product sampling (E. coli 0157:H7, Salmonella, and Listeria monocytogenes) during each verification review. New Mexico's May 2007 submission lacked documentation/information about the execution of their sampling programs and is further evidence that New Mexico's sampling programs are not "at least equal to" Federal requirements.

For example, sampling for E. coli 0157:H7 was not being conducted at all eligible establishments and sampling methods were not "at least equal to" the Federal program. The May 2007 submission does not provide evidence that all establishments producing raw ground beef products, and raw ground beef components and beef patty components were being tested, nor did the submission indicate whether samples were being collected in retail establishments as required by Federal regulations.

Samples for Salmonella performance standards were not being collected in all eligible establishments thereby not meeting "at least equal to" requirements. The May 2007 submission does not provide evidence that Salmonella performance standard samples are being collected in all applicable establishments nor how test results are analyzed to determine percent positive results (including serotypes commonly associated with human illness) and trends as a measure of the effectiveness of establishments' food safety systems in eliminating or reducing Salmonella contamination in slaughter and grinding processes.

NMMPIP also was not in compliance with applicable Federal requirements with regard to Lm. The NMMPIP sampling protocol lacked documentation that verification samples of Lm were collected as required in post-lethality exposed ready-to-eat products. The establishments producing post-lethality exposed ready-to-eat products were not meeting the regulatory requirements for control of Lm per 9 C.F.R. 5 430. HACCP plans at several jerky plants were not reassessed to address control of Lm in post-lethality exposed ready-to-eat products. All Federal- and State-inspected establishments producing post-lethality ready-to-eat products are required to reassess their HACCP plans per 9 C.F.R. 5 417.4(a) (3) to determine whether Lm is a hazard reasonably likely to occur. Establishments that do not reassess their HACCP plans to identify Lm as a hazard reasonably likely to occur could pose a serious risk to public health.

The May 2007 submission did not include NMMPIP's action plan to direct inspection personnel to control affected products, determine the need for recall of unsafe product(s) in commerce, and verify establishments' corrective actions in the event of positive results. Follow-up and targeted testing to verify establishments' corrective measures are not addressed in the submission.

Specific examples of NMMPIP's failure to take appropriate regulatory control actions in response to observed sampling noncompliances are provided below:

Ready-to-Eat (RTE) Product Sampling:

21 U.S.C. $5 455,456,463,606,608,621; 9 C.F.R. $9 310.25,381.94,430; N.M. STAT.ANN. 5 25-3-13; N.M. Admin.Code 21.33.2

- NMMPIP is not meeting their sampling protocol, dated 5/1/06, for RTE product by analyzing samples for both Lm and Salmonella. Sample summary information provided by NMMPIP indicates that from "January 2007 to date," 14 RTE samples have been analyzed for Lm; however, only 7 have been analyzed for Salmonella. For ready-to-eat samples collected in calendar year 2006, 84 were analyzed for Lm while only 33 were analyzed for Salmonella.

- NMMPIP has not verified that all RTE State-inspected establishments producing post- lethality exposed RTE products provided the rationale for their testing frequency ensuring effective control of Lm or indicator organism under Alternative 1, Alternative 2, and Alternative 3 as required by 9 C.F.R. 5 430.4.

- NMMPIP indicates that for samples testing positive for Lm in product or when an establishment has positive Lm or Listeria spp. positive findings on product contact surfaces or environmental surfaces, an NMMPIP EIAO will conduct sampling of post- lethality exposed food contact surfaces. However, NMMPIP provides no information on conducting follow-up sampling of product or the post-lethality environment as a result of positive Lm findings.

E. coli 0157:H7 Sampling: - NMMPIP did not provide the rationale for collecting ground beef samples four times

annuallyor if, in an establishment producing >90,000 lbslyr, six samples are collected annually.

- NMMPIP does not indicate if each establishment producing ground beef is sampled at the frequency stated above.

Inadequate Enforcement and Compliance Reporting ~ i n d i n n s ~

NMMPIP personnel have been unable to effectively and consistently assess establishments' compliance and take appropriate regulatory or enforcement actions needed to carry out an inspection program "at least equal to" the Federal program. NMMPIP has failed to meet its commitments to FSIS to implement corrective actions during the 16-month review process in spite of repeated notices, follow-up, and collaborative efforts by FSIS. As evidenced by the fact that no regulated establishments were under enforcement actions (i.e., Suspensions, Suspensions held in Abeyance, or Notice of Intended Enforcement), enforcement and compliance reporting protocols were not being implemented as indicated in New Mexico's self-assessment submission. Some examples are cited below:

- The Activity Report of Compliance Program and Planned Compliance Program protocols were not implemented.

- The Reports of Apparent Violation cases were closed without an action, and information was omitted from Notice of Warning cases.

- New Mexico meat and poultry inspectors did not recognize and document noncompliances nor take appropriate regulatory control actions in response to the issues observed.

2 1 U.S.C. $5 455,456,458,461,462,463,467A, 606,608,610,642,671,672,673,674,676; 9 C.F.R. Part 500

- Minimal compliance work is being performed in New Mexico. The compliance employee is used as a relief inspector and spends large amounts of time working in the State headquarters office.

During the on-site reviews, FSIS observed numerous food safety concerns and requested that NMMPIP take appropriate enforcement actions. NMMPIP failed to identify and take appropriate enforcement actions prior to the on-site reviews.

The following actions were not taken until they were initiated in response to FSIS findings: - An NOIE was issued to a firm after FSIS identified numerous HACCP, SSOP, and Lm

(ready-to-eat) noncompliances. The noncompliances included an inaccurate thermometer calibration for processing ready-to-eat products, monitoring the CCP for lethality outside the official premises (at retail rather than in the state plant), and the potential for cross- contamination between raw and ready-to-eat products.

- A Suspension without Prior Notification was issued to a fm after FSIS identified rodent droppings in various rooms utilized for production, including the preparationlcooking room, and other food safety concerns.

- An NOIE was issued to a firm after FSIS identified serious food safety concerns that included insanitation, inadequate HACCP hazard analysis, CCP documentation deficiencies, incorrect thermometer calibration, and lack of decision-making documents to support the validity and implementation of intervention steps for controlling E. coli 0157:H7 in raw ground beef products, among many others.

- NMMPIP issued an NOIE, which was followed by a Letter of Suspension, and subsequently a Letter of Suspension in Abeyance to an establishment after FSIS identified serious food safety concerns involving 16 separate noncompliances and inadequate SSOP and HACCP systems. The submitted documentation indicated that this establishment was issued a verification plan, and the verification plan was completed as of March 26,2007. NMMPIP issued a Letter of Warning of March 29,2007, officially closing the regulatory action. The documents did not include the corrective and preventative measures taken by the establishment to achieve compliance; therefore, FSIS cannot determine what NMMPIP verified prior to closing the regulatory action.

- Numerous NRs were issued to most establishments after FSIS identified serious food safety concerns; these were predominately SSOP- or HACCP-related.

The food safety findings observed by FSIS during the review process demonstrated that NMMPIP had not adequately addressed a pattern of food safety noncompliances and that NMMPIP has failed to provide an accurate and complete corrective action plan.

Human Resources and Financial Accountabilitv Findings

To date, New Mexico field inspection personnel have not demonstrated sufficient regulatory knowledge to perform their in-plant verification and enforcement duties. They have demonstrated a recurring lack of ability to take appropriate regulatory actions in situations involving significant public healthlfood safety noncompliances. Equally significant is the lack of daily inspection coverage noted on four occasions during FSIS' on-site reviews. Unfortunately,

NMMPIP's May 2007 submission provides no evidence that these deficiencies have been corrected.

NMMPIP personnel show an inadequate sense of urgency in taking regulatory actions to prevent potentially adulteratedfunsafe products from being produced and shipped. On multiple occasions, FSIS advised NMMPIP officials to act immediately to correct noncompliances involving public healthlfood safety concerns. FSIS requested documentation from New Mexico regarding the regulatory actions taken in response to observed deficiencies. Only after repeated requests from FSIS did NMMPIP provide documentation of corrective actions. However, subsequent on-site review findings revealed that not all corrective actions were implemented as reported.

NMMPIP has a shortage of supervisory personnel to adequately oversee field inspection personnel and ensure that they are performing responsibilities as required. On multiple occasions FSIS requested, to no avail, that New Mexico provide a competent supervisor to travel with FSIS reviewers.

NMMPIP has not implemented a performance evaluation system, equivalent to FSIS' In-Plant Performance System (IPPS), to provide supervisory oversight and feedback to field inspection personnel. The IPPS system assesses field inspection personnel's performance to ensure that they are appropriately recognizing, documenting, and taking regulatory control actions in response to noncompliance situations.

FSIS' review of the May 2007 submission indicates a continued inability of NMMPIP to effectively manage its resources to ensure food safety. Specifically, NMMPIP has not adequately assigned resources to meet the hiring needs for new supervisory and in-plant inspection personnel to ensure daily coverage and necessary management controls. The budget submission does not adequately address apparent ongoing budget shortages and future funding requirements.

Based on current information, NMMPIP continues to lack sufficient supervisory oversight to ensure adequate implementation and execution of an inspection program adequate to protect public health and food safety. NMMPIP State inspection personnel are not identifying and documenting noncompliances and are not taking appropriate regulatory control actions on an ongoing basis. Even with the additional training that has occurred over the last 16 months, NMMPIP inspection personnel lack the regulatory knowledge and abilities to ensure appropriate regulatory oversight and verification are being administered in State-inspected establishments.

Finally, NMMPIP has not implemented necessary management controls to ensure that daily coverage occurs in establishments producing State-inspected product and that daily coverage occurs (in a relief capacity) when assigned in-plant inspection personnel call in sick or take leave. There still appears to be no sense of urgency by NMMPIP to implement the necessary and immediate management controls and systems that would provide assurances for the effective delivery of a State MPI Program that is "at least equal to" Federal requirements.

The following analysis of NR data from 3 of the 24 plants (taken from the PBIS readers and copies of NRs provided in New Mexico's May 2007 submission) confirms FSIS' concern of an impending serious public health problem:

During three separate FSIS 1-day reviews of one ready-to-eat processing establishment, 20 NRs were written yet only 2 NRs were written during the approximately 160 days of plant operation (assumption: 10 operating days per month for 16 months) from January 1,2006 - May 23,2007. During four separate FSIS 1-day reviews of one ready-to-eat processing establishment, 34 NRs were written yet only 16 NRs were written during the approximately 160 days of plant operation (assumption: 10 operating days per month for 16 months) from January 1,2006 - May 23,2007. During one FSIS 1-day review of one processing establishment, 18 NRs were written yet only 7 NRs were written during the approximately 160 days of plant operations (assumption: 10 operating days per month for 16 months) from January 1,2006 - May 23,2007.

An analysis of all NR data from 22 New Mexico establishments (2 of the 24 were not reviewed) during the 16-month comprehensive review shows a similar pattern. As a result of FSIS review findings during their 43 one-day on-site plant reviews (Appendix M, Individual Establishment Findings throughout the Comprehensive Review), New Mexico in-plant personnel wrote 191 NRs (approximately 4.5 NRs per 1-day review). During this entire 16-month period, only 260 NRs (Appendix 0, PBIS Data and NR Summary Tables, May 25,2007) were written during the 3520 days of the establishments operating (assumption: 160 days x 22 plants = 3,520) under NMMPIP (less than 1 NR per month, 260 NRs/16mos/22 plants = .74).

This analysis reflects serious shortcomings with the implementation and execution of the NMMPIP: 1) a failure by NMMPIP in-plant inspection personnel to verify regulatory compliance, 2) lack of regulatory knowledge by both in-plant inspection personnel and supervisory personnel, 3) lack of supervisory oversight, and 4) lack of management controls sufficient to ensure plants are inspected on a day amenable product is produced. (Appendix 0, PBIS Data and NR Summary Tables, May 25,2007)

Conclusion

NMMPIP has not made significant improvements or corrected all identified establishment deficiencies since the initial FSIS on-site review performed in January 2006. NMMPIP does not meet and cannot maintain "at least equal to" requirements over the next 12 months. The food safety findings from the FSIS review process (January 2006 through May 2007) show a serious pattern of food safety noncompliances that has not been adequately and appropriately addressed within NMMPIP; therefore, current conditions do not demonstrate that the health and welfare of consumers are assured and that meat and poultry products are wholesome and not adulterated or misbranded.

Recommendation

FSIS recommends that the Governor of New Mexico be notified that the State has failed to enforce, with respect to the establishments within its jurisdiction, requirements equal to those imposed under the FMIA (21 U.S.C. 5 661) and PPIA (21 U.S.C. 5 454)' and of the Department's intent to designate the State of New Mexico.

Honorable Governor Bill Richardson Office of the Governor 490 Old Santa Fe Trail Room 400 Santa Fe, New Mexico 87501

Dear Governor Richardson:

This letter provides official notification of the Department of Agriculture's decision to designate the New Mexico Meat and Poultry Inspection (MPI) Program because New Mexico is not enforcing requirements "at least equal to" those imposed under the Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA).

The determination that New Mexico does not have an "at least equal to" MPI Program is based on the results of a comprehensive review (January 23,2006 through present) by the Food Safety and Inspection Service (FSIS). Review findings establish that there are chronic and systemic food safety problems across a representative number of establishments in which the New Mexico MPI Program is not providing daily inspection and is not verifying establishments' food safety systems. Moreover, the New Mexico MPI Program does not have adequate pathogen sampling program design or implementation, does not take appropriate regulatory and enforcement actions, does not demonstrate adequate supervisory oversight, does not have a sufficient number of staff nor staff with sufficient regulatory knowledge, and does not provide evidence of necessary funding. These conditions pose serious risks to public health that do not appear to have any immediate remedy. The FSIS Comprehensive Review Report is enclosed for your information.

As required by law, we will publish the designation in the Federal Register. New Mexico establishments will be subject to Federal inspection 30 days after publication of the notice in the Federal Register (21 U.S.C. 3 661(c)(l) and § 454(c)(1)).

Sincerely,

Mike Johanns Secretary

Enclosure New Mexico Meat and Poultry Inspection Program, FSIS Comprehensive Review

cc: Dr. Miley Gonzalez DirectorISecretary New Mexico Department of Agriculture MSC 3189 Box 30005 Las Cruces, NM 88003-8005

Mr. Daniel Manzanares, Executive Director New Mexico Livestock Board 300 San Mateo Blvd. NE Suite 1000 Albuquerque, NM 87 108-1500

Dr. Dave E. Fly, State Veterinarian New Mexico Livestock Board 300 San Mateo Blvd. NE Suite 1000 Albuquerque, NM 87 108- 1500

Dr. Joe B. Baker, Public Health Veterinarian Meat and Poultry Inspection Division New Mexico Livestock Board 300 San Mateo Blvd. NE Suite 1000 Albuquerque, NM 87 108-1500

bcc : Richard Raymond, Under Secretary, USDA David Goldman, Acting Administrator, FSIS Bryce Quick, Deputy Administrator, FSIS William Milton, Assistant Administrator, OM Terri Nintemann, Assistant Administrator, OPAEO Kenneth Petersen, Assistant Administrator, OF0 William C. Smith, Assistant Administrator, OPEER Jane Roth, Deputy Assistant Administrator, OPEER Philip Derfler, Assistant Administrator, OPPED

June 8,2007

New Mexico Meat and Poultry Inspection Program Next Steps in Designation Process

The Under Secretary briefs the Secretary about the New Mexico Meat and Poultry (MPI) Program's inability to meet "at least equal to" status and recommends designation.

If the Secretary agrees, the following steps will be undertaken to complete the designation process:

o FSIS will prepare a letter for the Secretary's signature advising the Governor of New Mexico that he has designated the State.

o OPPED will prepare, clear, and publish a Federal Register notice announcing designation of New Mexico's MPI Program.

o The designation will be effective 30 days after publication in the Federal Register. All State-inspected establishments and custom exempt operations within the New Mexico MPI Program will officially transfer to Federal inspection and jurisdiction.

o Within the 30 day "effective date" timeframe, OF0 will collect information about all State-inspected establishments and custom exempt operations in the New Mexico MPI Program. This information will determine which plants are required to operate under Federal inspection and will identify minimum staffing required for inspection.

o OF0 personnel will provide information regarding designation procedures and will allow plant operators to ask questions or discuss situations specific to their operations.

o The procedures and protocols within FSIS Directive 5710.1, "Designation of States for Federal Meat or Poultry Inspection" (2127184) will be followed.

Relevant Directives

o Directive 5710.1, "Designation of States for Federal Meat or Poultry Inspection" (2127184)

o Directive 5720.2, Rev. 3, "State Cooperative Inspection Programs" (1 1/16/04)

Federal Register I Vol. 72, No. 134 I Friday, July 13, 2007 / Rules and Regulations 38467

Dated: July 9, 2007. List of Subiects in 7 CFR Part 1214 Amiculture as s~ecified in the Federal Lloyd C. Day, Administrative practice and Administrator, Agricultural Marketing procedure, Advertising, Consumer Service. Information, Marketing agreements, [FR Doc. E7-13580 Filed 7-12-07; 8:45 am] ~ i ~ i f r u i t , fiomotion, ti^^ and BILLING CODE WIW-P recordkeeping requirements.

PART 1214+REMOVED] DEPARTMENT OF AGRICULTURE

Accordingly, under the authority of 7 Agricultural Marketing Service U.S.C. 7461-7473,7 CFR part 1214 is

removed. 7 CFR Part 1214 Dated: July 9,2007.

[Doc. No. AMS-FV-07-0052; FV-06-70741 Lloyd C. Day, Administrator, Agricultuml Marketing

Kiwifruit Research, Promotion, and SeMce' Consumer Information Order; [FR Doc. E7-13546 Filed 7-12-07; 8:45 am] Correction BILLING CODE .w~o-o~-P

AGENCY: Agricultural Marketing Service, USDA. DEPARTMENT OF AGRICULTURE

ACTION: Correcting amendment. Food Safety and Inspection Service

SUMMARY: The Agricultural Marketing Service (AMS) is removing from the Code of Federal Regulations (CFR) its procedural regulations regarding the Kiwifruit Research, Promotion, and Consumer Information Order (Order), a program never implemented. EFFECTlVE DATE: July 14, 2007. FOR FURTHER INFORMATION CONTACT: Marlene M. Betts, Research and Promotion Branch, Fruit and Vegetable Programs, Agricultural Marketing Service, USDA, Stop 0244,1400 Independence Avenue, SW., Room 06344 , Washington, DC 20250-0244, telephone (202) 720-9915, fax (202) 205-2800, or e-mail Morlene.Betts@usda.gov.

SUPPLEMENTARY INFORMATION: The Agricultural Marketing Service (AMS) is removing from the Code of Federal Regulations (CFR), 7 CFR part 1214, Kiwifruit Research, Promotion, and Consumer Information Order (Order). The Order was authorized by the National Kiwifruit Research, Promotion, and Consumer Information Act (7 U.S.C. 7461-7473). The proposed Order was published in the Federal Register on October 17, 1997, 162 FR 543141 and then again on November 10,1998, (63 FR 629641 but never finalized. Nevertheless, final referendum procedures were published in the Federal Register on October 17, 1997, 162 FR 543101 and added to the CF'R in Subpart C, along with reserved parts, Subpart A and Subpart B at 7 CFR part 1214. This action is needed to remove 7 CFR part 1214 from the CFR since the program was never implemented. This document provides for the removal of 7 CFR 1214 in its entirety.

9 CFR Parts 331 and 381

[Docket NO. FSIS-2007-0023]

RIN 0583-AD29

Designation of the State of New Mexico Under the Federal Meat lnspection Act and Poultry Products lnspection Act

AGENCY: Food Safety and Inspection Service, USDA. ACTION: Final Rule.

SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing that it is designating the State of New Mexico as a State to receive Federal inspection with respect to operations and transactions involving meat and poultry products within the State because representatives of the State have requested such designation. In response to the State's request, FSIS will assume responsibility for the meat and poultry inspection programs in the State of New Mexico on August 13,2007. Therefore, FSIS is amending the Federal meat and poultry products inspection regulations by adding New Mexico to the list of designated States. DATES: This final rule will be effective on August 13,2007. FOR FURTHER INFORMATlON CONTACT: Ron Eckel, Chief Federal State Audit Branch, Internal Control Division, Office of Program Evaluation, Enforcement, and Review, Food Safety and Inspection Service, USDA, 1299 Farnam Street, Suite 300, Landmark Center Building, Omaha, Nebraska 68102; telephone 402-344-5000. SUPPLEMENTARY INFORMATION: FSIS has been delegated the authority to exercise the functions of the Secretary of

~ i a t ~ n s ~ e c t i o n ~ c t (FMIA) (21 U.S.C. 601, et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq.). These statutes provide that FSIS is to protect the public by verifying that meat and poultry products are safe, wholesome, unadulterated, and properly labeled and packaged.

Under these statutes, a State may administer meat and poultry inspection programs provided that it has developed and is effectivelyenforcing inspection requirements at least equal to those imposed under titles I and IV of the FMIA and sections 14,6-10, and 12- 22 of the PPIA. If States can no longer effectively enforce meat and poultry inspection requirements at least equal to the Federal requirements, they must be "designated" by the Secretary to receive Federal inspection (21 U.S.C. 661(c) & 454(c)).

The Governor of New Mexico sent a letter to the Secretary of the United States Department of Agriculture, dated June 22,2007, requesting the designation of New Mexico for purposes of allowing FSIS to conduct food safety inspections of meat and poultry products within the State of New Mexico. Consequently, the Secretary of Agriculture is designating the State of New Mexico under 21 U.S.C. 661(c) of the FMIA and 21 U.S.C. 454(c) of the PPIA. On and after August 13,2007, the provisions of titles I and IV of the FMIA and sections 1 4 , 6 1 0 , and 12-22 of the PPIA will apply to operations and transactions involving meat and poultry products within the State of New Mexico, unless exempt under 21 U.S.C. 623 or 661(c)(2) of the FMIA or 21 U.S.C. 454(c)(2) or 464 of the PPIA.

Owners or operators of New Mexico's meat and poultry establishments wishing to continue operations after August 13, 2007, must contact the FSIS District Office in Denver, CO, in order to receive Federal inspection. This office will provide information concerning requirements and exemptions under the FMIA and the PPIA, applications for inspection, and requests for surveys of establishments. Address correspondence to Denver ,

Federal Center, P.O. Box 25387, Building 45, Denver, CO 80225. Phone number: (303) 236-9800.

The Acting Administrator, FSIS, has determined that there is good cause for issuing this final rule without prior notice and opportunity for public comment. FSIS has determined that it is in the public interest to ensure a smooth, orderly and expeditious transition to Federal inspection. Representatives of the State of New Mexico have requested that the State be

72, No. 134/Friday, July 13, 20071 Rules and Reeulations 38468 Federal Register I Vol.

designated to receive Federal inspection with respect to operations and transactions involving meat and poultry products within the State. The Agency is mandated by law to assume the responsibility for administering the New Mexico meat and ~ou l t rv ins~ection a .

programs. It is necessary, therefore, to designate the State of New Mexico, in accordance with the FMIA (21 U.S~C. 661(c)) and the PPIA (21 U.S.C. 454(c)), in order to carry out the Secretary's responsibilities under the FMIA and the PP~A.

In addition, it does not appear that new. relevant information would be made available to the Secretarv bv public participation in this ruie&aking. Accordinalv, under the administrative proceduriiin 5 U.S.C. 553, FSIS finds good cause to conclude that notice and other public procedures are unnecessary and contrary to the public interest.

Executive Order 12866 and Regulatory Flexibility Act

This final rule has been determined to be not significant under Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

The Acting Administrator, FSIS, has determined that this final rule will not have a significant economic impact on a substantial number of small entities. FSIS, pursuant to law, is assuming the responsibility, previously held by the State of New Mexico, of administering the meat and poultry inspection programs with respect to operations and transactions within the State of New Mexico. This action will affect approximately 25 meat and poultry establishments. Most, if not all, are very small establishments. In addition, there are approximately 30 custom exempt facilities in New Mexico, all small entities. However, this is not a substantial number of either very small establishments or custom exempt facilities. There are approximately 5,070 very small meat and poultry establishments nationwide, which are either federally or State inspected, and approximately 3,135 custom-exempt facilities nationwide. In addition, it is not anticipated that significant costs will be incurred by these establishments in New Mexico as a result of these actions.

Executive Order 12988 This final rule has been reviewed

under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings

before parties may file suit in court challenging this rule. However, the administrative procedures specified in 9 CFR 306.5 and 381.35 must be exhausted prior to any judicial challenge of the application of the provisions of this rule, if the challenge involves any decision of an FSIS employee relating to inspection services provided under the FMIA or the PPIA.

Paperwork Requirements

This final rule has been reviewed under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and the Agency has determined that it imposes no new paperwork requirements.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that the public and in particular minorities, women, and persons with disabilities, are aware of this notice, FSIS will announce it on-line through the FSIS web page located at http:// www. fsis. usda.gov/regulations/ 2007-Interim-&Final-Rules-Zndex/ index.asp.

FSIS also will make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is communicated via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The update also is available on the FSIS Web page. Through Listserv and the Web page, FSIS is able to provide information to a much broader, more diverse audience.

In addition, FSIS offers an e-mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://uww.fsis.usda.gov/ news-and-even Wemail-subscription/. Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves and have the option to password protect their account.

List of Subjects

9 CFR Part 331

Meat inspection.

9 CFR Part 381

Poultry and poultry products. w Accordingly, 9 CFR parts 331 and 381 are amended as follows:

PART 331-SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH AND FOR SUCH DESIGNATED ESTABLISHMENTS

1. The authority citation for part 331 continues to read as follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2 .53 .

5 331.2 [Amended]

2. The table in S 331.2 is amended in the "State" column by adding "New Mexico" as the entry immediately above "New York" and in the "Effective date of application of Federal provisions" column, by adding "August 13,2007" on the line with "New Mexico."

PART 381-POULTRY PRODUCTS INSPECTION

3. The authority citation for part 381 continues to read as follows:

Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 4 5 1 4 7 0 ; 7 CFR 2.18, 2.53.

5 381.221 [Amended]

w 4. The table in S 381.221 is amended in the "States" column by adding "New Mexico" as the entry immediately above "New York" and in the "Effective date of application of Federal provisions" column, by adding "August 13, 2007," on the line with "New Mexico."

Done at Washington, DC, on: July 10,2007. David P. Goldman, Acting Administrator. [FR Doc. E7-13650 Filed 7-12-07; 8:45 am] BILLING CODE 9410-DM-P

NUCLEAR REGULATORY COMMISSION

10 CFR Part 72

RIN 315CLA113

List of Approved Spent Fuel Storage Casks: NAC-MPC Revision 5, Confirmation of Effective Date

AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule: Confirmation of effective date.

SUMMARY: The Nuclear Regulatory Commission (NRC) is confirming the effective date of July 24, 2007, for the