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In addition to the final version of the "National Residue Program" Directive, we will need either a final draft of the interim rule, "Sulfanomide and Antibiotic Residues from Young Veal Calves; Modified Testing Procedures," as cleared by OGC or a copy of the new Calf Certification form, as cleared by OMB. This will allow us to document the inclusion of warnings to producers about the consequences of false statements connection with the Certified Calf Program.

Recommendation #7

Please provide

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documentation of the duties of PARB and details as to how its studies are to be conducted. Additionally, we will need information concerning the audit controls systems developed and implemented to monitor activities and evaluate the degree of accuracy and consistency in policy application. Our review of these materials will allow us to determine whether the new system will ensure the consistency and accuracy of labeling decisions to the degree necessary to close the

recommendation.

Recommendation #9a

In order to confirm our understanding of your new tracking system, please provide us with the instructions for completing FSIS Form 8110-2a. It would also be helpful to include a copy of the revised glossary referred to in your response.

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Subject: Status of FSIS Actions Taken in Response to OIG Audit of FSIS Meat and Poultry Inspection Program (150-Plant Audit), #38607-1-At

We are pleased to provide you with an update of actions taken on the
recommendations stemming from the above-referenced audit. We have organized
our response according to whether each recommendation was considered unresolved
or resolved in your February 19, 1987, memorandum to us. Please let me know if
any recommendation remains unresolved after you have reviewed our response.

Unresolved Recommendations

Recommendation 5: To resolve your recommendation that we provide a policy statement regarding public notification of recalls, we are providing you with a copy of our policy statement dated March 12, 1987, (Enclosure 1). Many situational possibilities exist in the recall area, and our stated recall policy enables Agency officials to make judgments pertinent to each recall situation. We must be able to operate within general parameters that permit actions to be taken on a case-by-case basis. For this reason, we have elected to state our recall policy as it appears on the enclosure. We hope our action resolves this recommendation.

Recommendation 6: In response to your recommendation on documentation of
compliance officers' findings during recall effectiveness checks, the
Compliance Program issued a revised recall training guide. This training guide
is an effective internal operating guideline to assist compliance officers with
product recalls. It is fully consistent with the provisions of FSIS Directive
8080.1 dated August 4, 1983, "Recall of Inspected Meat and Poultry Products,"
which outlines the Agency's official policy with regard to product recalls.
The new guidelines also require written explanations for discrepancies and make
necessary changes regarding the effectiveness checks. A copy of the draft
training manual was provided to you in our January response.

The first product recall under the new procedures involved Establishment 8577,
Latalia Provision Corporation, Wilkes Barre, Pennsylvania, Emergency Programs
Case Number 7005. The recall has been completed. Within three weeks, we
will be furnishing you with a final report that shows the results of the newly
implemented procedures.

FSIS 2630-5(12/791

Neither the Federal Meat Inspection Act nor the Poultry Products Inspection Act provides for mandatory product recalls. Fortunately, most companies do not want ́ adulterated or misbranded products in the marketplace and usually agree to a voluntary recall. In the most extreme example, if a company refuses to voluntarily recall adulterated or misbranded products, the Acts provide the authority to detain and seize. Companies can also be prosecuted under the Acts for knowingly distributing adulterated or misbranded products in commerce. Such action is rarely required but would be initiated in appropriate situations. In light of the above, we do not believe issuance of additional notices or directives is necessary.

Recommendation 9: To assist in the resolution of Recommendation 9b, which pertains to preoperational sanitation, we are enclosing the current draft of the Preoperational and Operational Sanitation Inspection Directive (Enclosure 2). You also requested that we provide specific information about the internal controls in place to ensure that the revised preoperative sanitation inspection procedures are enforced.

One internal control being established is a new preoperative sanitation training program. Two staff members from each regional office have been trained to be the primary training team for their region. Their training included classroom lectures and an in-plant exercise. The training team will be responsible for uniform training and enforcement of policy within the regions. The trainers' presentations to the area supervisors are currently being critiqued. They will then train Inspectors-in-Charge(IIC's) and establish pilot programs in a total of 20 establishments. After three weeks of operation in the establishments, the 20 programs will be reviewed by the regional representatives. Adjustments will be made as necessary. The regional training teams will then proceed to train the IIC's in all poultry plants. addition, the proposed system emphasizes the establishment's responsibility in maintaining standards for sanitation, provides for daily review of the inspection records, and for on-site supervisory review of the inspection activity once per week.

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The issuance of the directive in its final form will be necessary to initiate the IIC's development of programs that comply with the proposed directive. The directive is currently in the review process that precedes publication. Complete implementation of the directive in poultry slaughter plants is targeted for June 1, 1987.

FSIS addresses Recommendation 9c through the draft Pest Control Directive which provides for a documented review of chemicals and pesticides used in official establishments. The directive requires plant management to provide a list of chemicals and pesticides intended for use to the IIC for review and verification. The directive also addresses your concerns in Recommendation 9d by requiring documentation of pesticide use by both professional exterminators and plant personnel, as well as requiring IIC's to evaluate suitability of chemicals in use by checking them against the "List of Proprietary Substances and Nonfood Compounds Authorized for use Under USDA Inspection and Grading Programs."

Meat and Poultry Inspection Technical Services (MPITS) is currently working with Meat and Poultry Inspection Operations (MPIO) to determine if the Inspection System Work Plan (ISWP) provides the necessary written records for tracking the documentation for pesticide use by both professional exterminators and plant personnel. ISWP is now in the pilot phase in each of the five MPIO regions. Any actions needed to provide for better tracking of pesticide use will be taken if the pilot testing reveals any weaknesses in this area.

The Pest Control Directive will be published this summer. It will also be placed into the rulemaking process, for publication anticipated in September 1987. Drafting of a companion directive and regulation are underway to address the full range of chemicals, such as cleaning compounds and lubricants, used in official establishments. The time frame for publication of the chemicals directive and for the regulation is late summer and early FY 88, respectively. Recommendations Resolved but not Closed

Recommendation 3: To assist you in closing the appropriate portions of this recommendation, we are enclosing a copy each of the final versions of the draft National Residue Program Directive (Enclosure 3) and the 1987 Compound Evaluation and Analytical Capability National Residue Program Plan (Enclosure 4).

With regard to Recommendation 3a, procedures are now in place to speed publication of the annual summary reports. A computer program on the Agency's HP 3000 containing the Microbiological and Residue Control Information System (MARCIS) data base is able to query the data and generate reports. The MARCIS system is directly accessible through the microcomputers in the Residue Evaluation and Planning Division (REPD), making access to the data convenient and timely. This removes the necessity of depending on other divisions for data summaries and printed reports.

Terminals in REPD query and download data from MARCIS and send it directly to graphics software for automated graphics production. The only manual step performed is the addition of new titles. These capabilities have reduced the publication of data summary reports from months to days.

Enclosure 5 (3 sections) contains a copy of the quarterly residue data report, associated reviews, and the swine sulfa data report. Along with the improved system for generating the annual summary reports as described above, these materials should help close Recommendation 3a.

You also requested that we provide a copy of the revised directive which modifies procedures to follow the status of investigation of Unidentified Microbiological Inhibitors (UMI's). After a thorough review of the directive, we believe that the current instructions for handling UMI's are adequate.

In addition, the draft directive of the National Residue Program will provide for better followup of UMI's in the description of duties of the Field Services Laboratory (FSL) Director. The Director is responsible for assuring that all analyses are completed promptly and that results are transmitted to MARCIS within 30 days after sample collection. In addition, the Director of the FSL assures that all analyses for the year are complete and that the results are transmitted to MARCIS by January 31 of the following year.

In order to close Recommendation 3d, we are providing examples (Enclosure 6) of the reports that the Science staff will produce to reconcile scheduled monitoring sampling with the responses received. The principal report is organized for each area of the country, and includes samples scheduled but not analyzed, and the reason for non-analysis. The other portions of the enclosure provide a variety of management summaries. The sample reconciliation system is currently being converted from an IBM compatible system to one designed to operate on the FSIS HP 3000 computer system. The new system will produce reports similar to those produced by the old system, and is expected to be operational by May 1, 1987.

Enclosure 7 is a copy of the Statement of Work for the Common On-Line Reference for Establishments (CORE). We have identified the most serious and urgent data needs of Science concerning establishment, slaughter, and processed product information, with particular attention focused on the establishment and slaughter data. The needs will be reviewed and priorities for resolution will be assigned by Science and MPITS.

Concerning the independent verification of data entry of all violative samples, the enclosed September 29, 1986, and January 20, 1987, memoranda and operator instructions (Enclosure 8) implement routines to be followed to improve the quality and timely availability of data, including violations, entered into MARCIS.

Recommendation 4: To assist in closure of Recommendations 4a, 4b and 4c, we are enclosing a copy of the interim final rule published in the January 20, 1987, Federal Register, on Sulfonamide and Antibiotic Residues in Young Veal Calves; Modified Testing Procedures (Enclosure 9). In it, FSIS requires the inspector to establish the testing rate for each establishment based primarily on the residue condemnations of animals slaughtered by the establishment; discontinues the testing of animals condemned for pathological reasons; permits establishment personnel to assist inspection personnel in conducting the tests; clarifies that the certification of the animals must be in writing; and clarifies that the veterinary medical officer can authorize the reduction of line speeds to allow sufficient time for performing tests.

Recommendation 7: Recommendation 7 calls for establishment of formal, documented reviews to ensure consistent labeling policy decisions. You requested that we provide additional documentation of the duties of the Program Analysis and Review Branch (PARB). Presently, the PARB is developing

documentation of duties and study methods. We will keep you apprised of these items as they become available.

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