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38607-1-At

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Notify the residue monitoring staff when grants of Inspection are issued so that the sampling frame can be updated to include new plants.

Consider seasonal variations in slaughter in the sampling plan to allow each animal an equal chance of selection.

Perform a periodic reconciliation of samples analyzed at the
laboratories to sample data entered into MARCIS. Include
controls to ensure that all residue monitoring results are
communicated to
the national office
as part of the quality
control (QC) procedures currently being developed.

Take the following actions to improve the development of data needed to support the prosecution of violators of drug and residue laws (see Detail 4):

8. Work closely with FDA and EPA to coordinate responses to specific residue contamination incidents and to develop a unified approach to monitoring, surveillance, and enforcement. Develop a standard form for the Certified Calf Program. This form should reference U.S.C., Title 18, Subsection 1001, and warn producers of the consequences of false statements.

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c.

Coordinate with the Packers and Stockyards Administration to ensure that adequate consideration is given to provisions that will allow for the successful prosecution of those who Intentionally file false certifications.

Issue press releases or other public notifications in all Class I recalls. (See Detail 5.)

Supplement the Recall Strategy outlined in FSIS Directive 8080.1 with provisions to (see Detall 5):

a. Compare distribution information provided by the recalling firm with data developed during FSIS's effectiveness checks.

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Obtain explanations of any discrepancies identified and initiate prompt actions το seize products In instances where firms cannot provide reasonable assurance that Adulterated products have been removed from commerce.

Provide guidelines to recalling firms detailing their responsibilities for notification of consignees.

Establish a formal, documented system of reviews or other internal administrative control procedures το ~nsure consistency and accuracy of labeling decisions. When errors are discovered, expand the procedures to determine if similar problems exist with other labels. (See Detail 6.)

Continue to encourage establishments to use the "Standards and Labeling Policy Book" as a guide in preparing applications for label approval.

(See Detail 6.)

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Ensure consistent application of IPI policies and regulations by (see Detail 7):

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Implementing a tracking system to provide assurance that all
deficiencies identified by FSIS personnel are corrected
timely manner.

Implementing internal administrative controls to ensure that
inspectors are enforcing the provisions of MPI Bulletin 83-13
and delaying operations when poultry plants do not maintain
acceptable levels of preoperative sanitation.

Instructing inspectors to make a periodic, documented review of all chemicals, pesticides, and lubricants used in plants to ensure that they are approved for use in a food processing environment. Require plant management to keep a current list of chemicals. Have inspectors make spot checks to determine the completeness of the lists.

d. Require plant management to document pesticides used by both professional exterminators And plant personnel. Require Inspectors to evaluate their suitability by checking the "List of Proprietary Substances and Nonfood Compounds Authorized for Use under USDA Inspection and Grading Programs." Keep a written record of this review.

Consider implementation of risk-based intermittent inspection in small processing plants with simple operations in conjunction with the reevaluation of current methods of inspection. (See Details 1 and 7.)

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Audit of Food Safety and

Status Report of Actions Taken on Recommendations:
Inspection Service Meat and Poultry Inspection Program, #38607-1-At

We are pleased to provide you with a progress report of actions taken in response to the subject audit report. Some of the initiatives are still in the process of being implemented. Accordingly, we will provide you with the current status of the recommendations, including an updated projected completion date, if appropriate. We have organized this update around the recommendations appearing in the audit report.

Recommendation 1 calls for a reevaluation of current methods of inspection and consideration of new approaches which provide consumer protection more efficiently and effectively.

Recommendation la refers to FSIS continuing its efforts to pursue legislative changes to eliminate the continuous inspection provisions of the Federal Meat Inspection Act. On November 10, 1986, the President signed into law FSIS-supported amendments to the Act that permit FSIS to vary the intensity of inspection coverage in processing plants (Enclosure 1). The statute mandates FSIS to distribute its inspection resources based on appropriate factors, including the plant's operations, the adequacy and reliability of processing controls and sanitary procedures, and the history of compliance with inspection requirements. FSIS is currently developing the criteria and parameters by which this periodic inspection system can be implemented in meat and poultry processing plants. The impact of the new inspection authority will be large and far-reaching within the Agency and the industry. Therefore, it will be some time before implementation is complete.

The amendments also include strengthened enforcement authorities which are now in effect. Additionally, as our September 5, 1986, memorandum noted, FSIS intends to actively seek to employ all enforcement options available to us which have the same intent as OIG's recommendations in this area. Since fiscal year 1984, the number of enforcement actions taken by FSIS has increased yearly. For example, compliance cases referred to the Office of the General Counsel have increased from 36 in FY 1984, to 57 in FY 1985, to 69 in FY 1986. Cases under FSIS authorities forwarded from OGC to the U.S. Attorney's office increased from 25 in FY 1985 to 34 in FY 1986. In both FY 1984 and 1985, the number of inspection withdrawal actions numbered eight.

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This increased to 12 withdrawal actions in FY 1986. Unless OIG indicates otherwise, we assume our continuing actions in this area are sufficient to close recommendation la.

Recommendations lb and lc propose that FSIS establish a statistically valid, compliance-based inspection system designed to provide assurance of consumer protection at a specified confidence level, along with a fee system to recover the costs of increased levels of coverage above an established baseline. Policy officials at the Department level are aware of these recommendations, and we await further guidance from that level as to whether or not FSIS should develop legislative proposals. We will use this occasion to again seek guidance in this area. In the meantime, the President's budget for FY 88 will ask the Congress to authorize full recovery of FSIS costs through user fees applied to all plants. None of the guidance from within the Administration has indicated an intent to recover fees only from plants with compliance problems. Recommendation ld proposed increased use of objective laboratory analysis to assess the degree of plant compliance. At present, the Agency is in the process of developing a streamlined inspection system for cattle and swine. In addition, progressive industry members will be encouraged to apply quality control concepts to their operations. Also, a cooperative government-industry system utilizing computer technology for poultry inspection is scheduled to be field-tested next year. New technologies using ELISA (Enzyme Labeled Immunosorbent Assay) for trichina will soon be used in a swine plant in North Carolina. Once the new technologies are proven, plans are to expand them for use in the detection of other diseases of food animals at slaughter. For example, the use of ultrasound for detecting abscesses in livers and cysts in cattle will be tested in 1987. In addition, use of the catalase enzyme test verifies that cooked roast beef products have been cooked to a minimum internal temperature of 145 degrees Fahrenheit. Also in 1987, the Agency will propose to use laboratory-based microbiological standards on a voluntary basis to improve the quality of the meat and poultry supply. Our policies and planned actions should be sufficient to close this particular recomendation.

Recommendation 2 proposes that FSIS request legislative authority to impose administrative sanctions including a sliding scale of fines. The

recommendation has already been directed to policy officials at the Department level for consideration, and FSIS has no activity currently underway. However, we will again seek guidance in this area.

Recommendation 3 covers the implementation of internal administrative controls to improve the domestic Residue Monitoring Program.

The Agency has launched a major restructuring of its residue control efforts as a result of the OIG audit. The draft residue program directive (Enclosure 2) focuses on these changes. It delineates science and operations functions by redefining the staff functions within Science and the operational functions within Meat and Poultry Inspection Operations and International Programs. The directive focuses the efforts of Science personnel on planning; review,

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evaluation and analysis of residue data; development and evaluation of epidemiologic information from monitoring and surveillance data; publication of data and the annual plan; and carrying out oversight responsibilities for the National Residue Plan. The directive identifies the operational and line responsibilities for carrying out the inspection and compliance requirements, assuring that regulatory standards are properly enforced and that the FSLS response is coordinated in emergency situations. Additional work to clarify these responsibilities and functions is needed, and is underway.

Procedural sections of current directives are now being reorganized to reflect these functional changes. The revised procedures will be issued as an appendix to the final directive. Staffing adjustments and organizational changes will be required to properly administer line responsibilities contained in this draft directive. Science will develop the coordinating controls to be administered by operations management to ensure that samples requested are actually taken or otherwise accounted for, the sampling frame is updated, and the annual residue plan is implemented. There are numerous unanswered questions about the appropriate numbers and levels of staff that are sufficient to carry out the increased responsibilities within operations. Work is underway to prepare the needed guidelines. We expect that completing all administrative actions needed to establish organizational improvements will result in some delays in publishing the final directive. We will forward a copy of the final directive when it is officially issued.

With regard to your specific recommendations, Recommendation 3a proposes that residue monitoring data be analyzed promptly and also recommends periodic reporting.

PSIS is committed to placing a high priority on prompt publication of summary reports. Procedures are now in place to speed publication of annual data summary reports. Currently the CY 84 and CY 85 annual data books are in the printing and clearance process, and the CY 86 data book is to be published by May 1, 1987.

The Residue Monitoring Program's first quarterly data summary (Enclosure 3) provides the percent violative samples for the period specified, with the upper 95 percent confidence limit. However, we are concerned the report may be misleading, since the residue monitoring program is not designed to provide precise estimates of percentages of carcasses containing violative levels of residues nor are confidence levels meaningful, particularly on a quarterly basis. To make quarterly reporting more suitable, the residue monitoring data will be integrated with professional knowledge to project possible trends. Quarterly data reviews will compare results from four preceding quarters, when available. Any apparent changes will be noted in the quarterly report. In addition, special data reports such as a monthly swine sulfa data report, will be provided as required. In the future we plan to complete assembly of calendar year summary residue data by March 1, review and evaluate the data by April 15, and publish final reports by May 1 each year.

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