The Environmental Protection Agency is responsible for pesticide registration and the establishment of tolerances for pesticide residues in foods. The FDA is responsible for enforcing the tolerances for foods (except for meat and poultry). As part of this responsibility, the FDA also collects and uses data on the incidence and levels of pesticide residues in foods for planning and evaluation purposes. These monitoring data are also provided to the EPA for evaluation of pesticide registrations, tolerances and other regulatory limits. Additionally, such data are sought by persons outside the agency (e.g., Congress, consumer groups) to assess the adequacy of the FDA's programs in protecting consumers from unsafe pesticide residues in foods.

The FDA's actions to remove foods which contain pesticides or other industrial chemical residues of regulatory significance from commercial channels include encouraging voluntary compliance (through meetings/correspondence), initiating direct regulatory action (seizure, etc.), and working with state and local agencies where much of the control activity is accomplished. For example, where the FDA and state work together to ban commercial fishing in a given body of water, violative products are prevented from entering commercial channels.

In order to improve the value of the information obtained, several features have been incorporated into the program in recent years, including:

On September 21, 1993, Commissioner Kessler, along with the Administrator of EPA and the Deputy Secretary of USDA, gave testimony before the Subcommittee on Health and The Environment, Committee on Energy and Commerce, U.S. House of Representatives, regarding the Administrations's views on important issues relating to food safety, pesticide use, and pesticide regulation. The hearing focused in large measure on a June 1993 report by the National Academy of Science entitled "Pesticides in The Diet of Infants and Children," which presented data concerning the levels of pesticide residues in foods commonly consumed by infants and children. The FDA will continue to emphasize coverage of pesticide residues in foods consumed by infants and children.

Objectives:

1. To sample and analyze fresh and processed domestic foods for pesticide residues and industrial chemicals, and to initiate enforcement action for shipments found to contain illegal residues.

2. To generate information on the incidence and levels of pesticide residues in domestic foods.

   Program Management Instructions

   The field's approach to this program is regulatory in nature with emphasis on intelligence gathering, selective sampling, and aggressive compliance follow-ups. Maintain surveillance sampling to cover gaps in intelligence information, but emphasize finding residues of regulatory significance and taking action to control the immediate problem and deter future violations.

   Based upon the district's past experience, identify farmers or growing areas (including bodies of water) which have been associated with regulatory problems in the past involving foods of dietary significance.

   Pesticide Coordination Team: The investigator/compliance officer/analyst team should coordinate the district's pesticide and other industrial chemical activities (plan and conduct sample collections and investigations; review LMS reports, and review data from sources other than the FDA). Report time expended on intelligence gathering activities, such as meeting with state/local officials or gathering data on pesticide usage patterns, as coordination/technical assistance (see PODS Manual).

1. Operations

   IOM 570 provides guidance concerning pesticide intelligence gathering operations. Also, conduct follow-up sampling and analysis as appropriate based on reporting by USDA/AMS of "presumptive tolerance violations" identified by USDA's Pesticide Data Program. Report all follow-up sampling and analysis results to CFSAN/Office of Plant and Dairy Food and Beverages/HFS-300.

   1. Domestic Sample Collections

      Samples may be official or INV. Compliance samples should be official. Strict adherence to IOM requirements is necessary when sampling products for compliance (legal) actions.

      Develop sampling plans based upon the criteria below, which are listed in descending order of importance.

      1. Sample commodities of dietary importance identified in Attachment B. Do not sample products such as parsley and spices that have little impact on total dietary intakes. Monitoring of these types of food will be directed by headquarters initiated surveys as needed.
         • Commodities of local origin are preferred for surveillance sampling.

         • Base coverage on past violative samples, current analytical findings, information obtained through intelligence gathering activities, and on recent pesticide usage reports distributed by CFSAN or obtained locally.

         • Cover the use of pesticides (particularly fungicides) on crops produced in indoor areas such as greenhouses, hydroponic facilities and mushroom beds.

      2. Coordinate with state/EPA offices to cover pesticides applied under experimental or emergency use as warranted. Districts should not ordinarily extend sampling coverage to commodities subject to an experimental use permit.

      3. Headquarters-initiated assignments related to emerging problems, or other needs, may be issued during the year.

      4. Develop information not available from previous years with respect to specific pesticides and commodities.

      5. Do not collect surveillance samples at the retail level. Growers or packing sheds are the preferred sites for fruits/vegetables.

   2. Commodities - Specific Requirements

      Each district should:

      1. *Collect shell eggs, milk and/or cheese samples only if district intelligence indicate there is a pesticide usage problem with these products or if the state lack a viable pesticide program covering these commodities.*

         Give dairy products which are made from non-pasteurized milk or milk which is not Grade "A" a higher sampling priority than other dairy items. Sampling nonpasteurized milk or non-Grade "A" milk ingredient in lieu of the finished cheese is suggested if feasible.

         Collect milk and cheese, if not packaged, in clean quart (standard screw-top ring closure) glass jars. Use special Teflon 70mm diameter lid liners to prevent the jar lid from contaminating the samples. If the Teflon liners are temporarily not available, use double layers of contaminant-free aluminum foil. Lid sealing material must not contact the sample.

         Ensure that milk samples are refrigerated or frozen, since spoilage adversely affects analysis for some analytes.

      2. Note that coverage of pesticide residues in foods consumed by infants and children will again be emphasized. These include apples, apple juice, pears, bananas, carrots, green beans, oats/oatmeal, oranges/orange juice, peaches, peas, rice and wheat products (e.g., farina). *If at all possible, districts should direct at least 50% of their pesticide sampling resources toward these products. *

      3. Based upon local usage, collect and analyze raw agricultural products for:

         1. carbamates with emphasis on aldicarb and carbofuran

         2. synthetic pyrethroids

         3. benomyl and thiophanate-methyl (where post-harvest application of the fungicides is indicated)

         4. EBDCs

            Note that if analysis of potentially high residue-containing animal feed components (e.g., apple pomace, cannery wastes) under the Center for Veterinary Medicine's program 7371.003 reveals illegal residues, sample the milk and eggs (if any) from herds/flocks which consumed such feed.

      4. Residues of persistent pesticides (e.g., dieldrin, heptachlor) present in food processing by-products utilized in animal feed may result in illegal residues in milk/eggs.

      5. Collect fresh produce samples at the early stages of the harvesting season to facilitate compliance follow-up sampling if illegal pesticide residues are found. Sample the products of various growers unless previous experience suggests the need to resample at a particular grower.

   3. Sample Size/Handling

      IOM Sample Schedule Chart 3 lists minimum sample sizes. Refer to IOM 452 for sample handling details.

      * Note: District's have the option to collect 1 intact shipping case or a total of 20 lbs. from one or more large containers of fresh produce from packing sheds or large produce warehouses. This "one case" option may be used on domestic Pesticide Surveillance Samples, IF the collector can be assured that the "one case" collected is representative of the lot or field. Refer to IOM Sample Schedule Chart 3, Fresh Produce, for additional information. *

      Collect samples in the container in which the dealer is packaging the product. If no packaging is done, use paper bags, boxes, etc. Contaminant-free plastic bags should be used if samples are to be analyzed for metals.

      DO NOT MAINTAIN the identity of individual subs for other surveillance or compliance samples except when samples are collected from crops growing in the field to document pesticide drift.

   4. Sample Shipment

      Submit samples to your Pesticide Servicing Lab except where otherwise instructed in Part IV Analytical. Refer to IOM 454 for sample shipment details.

2. Reporting

   *Report resources utilized for pesticides and dioxins into the FACTS as appropriate using the following Problem Area Flags (PAF) and PACs:

   PAC	PAF	FUTURE PAF	PAF Description
   04004A	PES		Pesticide analysis
   04004D	PES	DIO	Dioxin analysis will be reported under the "PES" PAF until FACTS version 3 is out

   Flag "Sample Basis" in FACTS either "Pesticide Surveillance" or "Pesticide Compliance." "Pesticide Compliance" samples are collected for a known or suspected problem. All other samples, whether they are collected for pesticides or industrial chemical analyses, are "Pesticide Surveillance." DO NOT USE ANY OTHER CODES.

   When available, report pesticide usage information on the FDA-464 to assist laboratory and compliance personnel.

   • List names and address of the grower/processor if different from the shipper.

   • Report information regarding which crops were grown and pesticides used in fields adjacent to the field, which produced the sampled food.

   • For selective samples collected from crops growing in the field only to document drift, diagram the field location of each sub on the FDA-464 or FDA-464a.

     For compliance samples collected because of suspected industrial chemical contaminants, report where the commodity was produced with respect to the suspected contaminant source. It is imperative that the FDA-464 list what chemicals or chemical classes are suspected.

     When assigned to collect a soil sample, report what pesticides or other chemical contaminants are suspected. DO NOT routinely collect soil samples.

     In accordance with Field Management Directive No. 129 (based on an MOU between FDA and EPA), FDA districts are to notify the EPA regional offices when FDA investigations or sample analyses reveal pesticide misuse. For this reason, consider the need to collect additional samples or other evidence documenting pesticide misuses when violative residues are encountered. Include information concerning whether misuse has occurred or the potential for drift exists in the "Remarks" section of the FDA-464. Where the information cannot be obtained, so indicate.

   • Report the episode number in Block 1 of the Collection Report to identify samples pertaining to a single incident, grower, etc. Refer to IOM, Section 439.1(j) for additional information.

Analyzing Laboratories

• Pesticide Laboratories: NRL, SRL, ARL, PRL-SW and PRL-NW.

• Sulfites: Pesticide Servicing Laboratories except for: MA region - NRL; MW region - ARL

• All 2378-Substituted dioxins and furans: Arkansas Regional Laboratory

• Carbamates: All Pesticide Servicing Laboratories

1. Procedural Requirements

   1. A sample considered for regulatory action must be check analyzed by a second analyst. A method reagent blank must be run by the check analyst concurrently with his or her analysis. Perform appropriate recovery determinations.

      Pesticide residue identity (and quantity when possible) must be confirmed by independent test or tests such as: derivatization, element-selective GLC detector, mass spectrometry, etc., as deemed necessary by the laboratory director. Identity of residues that are being reported for the first time or are unusual or of particular significance should also be confirmed. See PAM I,103E for additional guidance.

      Use black ink for chromatograms and similar records so that the document can be FAXED to CFSAN if the sample findings warrant Center review.

      All analytical packages for actionable samples must meet the "Criteria for Analytical Packages to Support Regulatory Action on Pesticide Residues" dated October 18, 1995 (contact CFSAN Program Contact, HFS-636 if additional copies are needed).

   2. In the initial stages of product/area coverage, examine pesticide surveillance samples for as many classes of chemicals as is practicable. At a minimum, examine the sample for organohalogen, organophosphorus, and PCB residues. Consider using two or more multiresidue and single residue methods to provide broader coverage for pesticide residues.

      Analyze samples:

      • for chemicals applied under emergency exemptions, as appropriate

   3. For the pesticides listed in Attachment D, "Pesticide Reanalysis Criteria," a finding by multiresidue methodology at or above the specified percentage of the tolerance requires reanalysis by a method (such as PAM II) for "total" residues or for complete recoveries.

   4. Routinely prepare and analyze raw agricultural commodities on a whole product basis except where impractical (e.g., removal of pits or stones from fruits). Follow the "raw agricultural commodity" definitions and guidance in PAM I 102. Conduct analyses as soon after collection as practical to minimize the potential for residue deterioration and loss.

2. Methodology

   NOTE: For all PAM I citations, refer to the 3rd edition.

   1. Organohalogen, Organophosphorus & PCB Residues

      1. Analyze samples using appropriate PAM I modules in sections 302, 303, or 304.

         Use PAM I 302 for fresh fruits and vegetables.

      2. Use PAM I 303 E3 or 302 E4 for low moisture-low fat products.

      3. For fish and shellfish samples, refer to PAM I 303 and 304. Report residue findings in finfish and mollusks on the edible portion basis. Residue findings in prawns/shrimp should be reported on the whole product basis.

      4. Evaluate chromatograms of all samples for PCBs and pesticides. If presence of PCBs is indicated, complete analysis using the necessary treatment of extract prior to GLC determination. See PAM I, 304 C3 or C4.

      5. When multiresidue GLC methods are used, determine the pesticides and PCB residues by GLC with electron capture and FPD detection systems (PAM I) and/or halogen, P, S and N selective GLC detection systems. Refer to PAM I, 105 for determining limits of quantitation for pesticides and PCBs.

      6. Analyze all milk, milk products, and shell eggs for chlorinated hydrocarbons using PAM 1, 304 or other appropriate methods.

   2. Carbamate Residues

      Carbamate residues amenable to gas chromatography can be determined by PAM I, 302 and a N-selective detector (PAM I, 302 DG4, DG5, DG17, and DG23. PAM I tables 302a and 302b lists compounds recovered by these methods.

      N-methylcarbamate residues in fruit and vegetable samples may be determined by the following HPLC methods:

      1. PAM I, 401, or 302 (E1-E3 plus C3 or C4 and DL1)

         N-methylcarbamate analyses must be conducted on a minimum of 10% of all fresh fruits and vegetables and on 25-50% of all potato/sweet potato and Florida citrus samples.

   3. Benomyl and Thiophanate-methyl

      Where application on fruits/vegetables is indicated, analyze for the common degradate, carbendazim (methyl 2-benzimidazole carbamate) using PAM I, 404. Consider coverage of produce for post-harvest application of benomyl.

   4. Malathion

      Examine grains, peanuts and soybeans using the 50% Florisil elution or elute 3 described in PAM I, 303 C1 or C2 when section 303 extractions and cleanup methods are used.

   5. Ethylenebisdithiocarbamates (EBDCs) and Ethylenethiourea (ETU)

      Analyze for EBDCs using JAOAC 54, 528 (1977) (CS2 evolution method), and for ETU using JAOAC 72, 975 (1989).

      When residues of EBDCs exceed an established tolerance, in addition to the check analysis, the district must determine the presence of ETU. Other permitted dithiocarbamates may be erroneously reported as EBDCs without an ETU confirmation.

   6. Pyrethroids

      Use PAM I, 302 extracts for the analysis of certain pyrethroids as described in PAM I, 302, DG10 or DG12.

   7. Phenylurea Herbicides

      Use PAM I, 403.

   8. Sulfite Residues (Grapes)

      Appropriate screening techniques may be used to determine residual sulfites. However, since all screening techniques may not give results equivalent to the Modified Monier-Williams method, contact the ORA scientific contact for approval before use.

      Conduct check analysis on any samples containing 10 ppm sulfur dioxide or greater using the Modified Monier-Williams method, Fed. Reg., Vol 51., No. 131, p. 25017-20, dated 7/9/86, except DO NOT BLEND GRAPES.

3. Sample Classification/Data Reporting

   Some confusion concerning classification of pesticide samples has existed in the past. Be guided by the examples below for pesticides and PCBs.

   Sample Class "1": The sample contains no residue or contains residues that are within the limits of an established tolerance or guideline.

   Sample Class "2": The sample contains a confirmed residue for which no tolerance or guideline in the sampled food has been established, but the residue level is of no regulatory significance.

   Sample Class "3": The sample contains a confirmed residue that exceeds a tolerance or guideline or contains a residue at a significant level for which no tolerance or action level in the sample food has been established.

   [NOTE: For samples coded as Class 3, each violative residue found must have the appropriate code entered into the violative residue field (i.e., "X" for exceeds tolerance, "N" for no tolerance, or "A" for at or above action level). The code must be entered into the data records for both the original and check analyses.]

   For samples analyzed under a special emphasis survey, the residue code for each pesticide of interest in the survey must be entered, regardless of whether or not the pesticide was found.

   Samples which contain other industrial chemical contaminants (confirmed) above the trace level should be coded "2".

   Use the LMS Compliance Data Reporting System - Pesticides and Metals in Foods and Feeds record format. Follow reporting instructions provided in the LMS Codes Manual. Report all method performance data (recoveries, control blanks, duplicate analyses, etc.) according to

   *Analytical Reporting *

   Report all analytical results for pesticides and dioxins into the FACTS as appropriate using the following Problem Area Flags (PAF) and PACs:

   PAC	PAF	FUTURE PAF	PAF Description
   04004A	PES		Pesticide analysis
   04004D	PES	DIO	Dioxin analysis will be reported under the "PES" PAF until version 3

1. *In determining the regulatory significance of pesticide residues in food, districts must adhere to the provisions of the Food Quality Protection Act (FQPA), which amended the adulteration provisions related to pesticides in the Federal Food, Drug and Cosmetic Act (FD&C Act). The FPQA also amended the provisions in section 408 of the FD&C Act in reference to pesticide residues resulting from use of pesticides under section 18 of the Federal, Insecticide, Fungicide, and Rodenticide Act (FIFRA) and residues of cancelled pesticides.

   The published Compliance Policy Guide (CPG) 7141.01, section 575.100, which outlines FDA's enforcement policy for pesticides in food is under revision to reflect the amendments in the FPQA. Until the CPG is revised, the districts should use the current CPG coupled with the guidance given below to ensure compliance with the new provisions of the FD&C Act.

   Charge for illegal pesticides in food:

   Now all pesticide residue violations would be considered adulteration under section 402 (a)(2)(B) of the FD&C Act. Pesticide residues in processed foods are now subject to the same adulteration section as pesticide residues in raw agricultural commodities. Accordingly, when any food is found to contain an illegal pesticide residue as defined in the CPG, the district must charge that "it is adulterated under 402(a)(2)(B) in that it bears or contains a pesticide chemical residue that is unsafe within the meaning of

   Section 18 of FIFRA

   EPA is now required to set time-limited tolerances to provide for emergency uses of pesticides under section 18 of FIFRA. Section 18 tolerances now apply to both the domestic and foreign users. As a practical matter, FDA will apply the tolerances to a commodity that is covered by the Section 18 tolerance regardless of its origin. The districts should direct any question associated with section 18 exemptions to the regulatory contact.

   Unavoidable pesticide residues

   The FQPA required EPA to set tolerances for unavoidable pesticide residues in food, such as those now covered by an action level published in the CPG. EPA has not yet initiated the process for reviewing the existing action levels for conversion to tolerances. Until such time as EPA publishes tolerances for these pesticides, the districts should continue to use the action levels in the CPG for enforcement consideration.
   

   
   

   Direct Reference Authority for Regulatory Actions

   The direct reference authority for regulatory actions involving pesticide residue violations in the current version of the CPG was amended in the August 23, 1995 and October 18, 1995 documents sent to the field by Gerald Vince (Attachment H). Please refer to these documents for specific guidance when processing enforcement actions.*

2. * Each sample classified "3" should result in either a meeting with the grower/shipper to discuss corrective action, the issuance of a Warning Letter or other corrective action unless the compliance unit determines that the residue is of no regulatory significance. *The most effective way to remove food adulterated with pesticides from domestic channels has been through voluntary recalls. Where voluntary corrective actions are not effective, consider seizure if there is a seizable size lot under embargo or voluntary hold.

   Preliminary injunctions should be considered only as a last resort because the time required to process such cases usually exceeds the period of time where the food could be sold. Consider injunctions only when the firm has a large inventory of the adulterated food for sale over a few months.

   Note: Compliance Achievement Reporting System (CARS) should be updated if the firm voluntarily corrects the problem.*

3. Immediately notify the regional EPA office when investigation reveals possible misuse of pesticides. See Memorandum of Understanding, CPG 7155b.04 and FMD 129

4. The final disposition of each violative shipment and the action taken MUST BE REPORTED into the Shipment Disposition System for all Class 3 samples.
   
   
   

ATTACHMENTS

Attachment A - FDA-State Cooperation in the Pesticides and Chemical Contaminants Program

Attachment B - Domestic Foods for FDA Monitoring

Attachment C - Destination Point Sampling

Attachment D - Pesticide Reanalysis Criteria

Attachment E - Seafood Obligation

Attachment F - Criteria for Direct Reference Seizure or Detention Involving Pesticide Residues

REFERENCES

USDA, Weekly Summary Shipments-Unloads, Fresh Fruit and Vegetable Market News.

USDA, Usual Planting and Harvesting Dates for Fresh Market and Processing Vegetables (Agriculture Handbook No. 507).

USDA, Pesticide Review.

USDA, Domestic Pesticide Usage Data (NASS)

CONTACTS: The area code for all CFSAN contacts is 202; for ORA it is 301.

Compliance Program Inquiries: Raphael A. Davy, Domestic Programs Branch, HFS-636, 205-9450, Fax 205-9670.

Regulatory Action Inquiries: Crystal McKenna, Case Processing Branch, HFS-607, 205-5235

Center Scientific Inquiries: Young H. Lee, Contaminants Standards Monitoring and Programs Branch, HFS-308, 260-0292.   Marion Clower, Division of Pesticides and Industrial Chemicals, HFS-335, 205-4036.

ORA Scientific Inquiries: Charlie Parfitt, Division of Field Science, HFC-141, 827-1033

ORA Investigations Inquiries: Barbara Marcelletti, Investigations Branch, HFC-132, 827-5635,   Linda Wisniowski, Policy and Enforcement Branch, HFC-172, 443-6553

Data Input Inquiries: LMS: Judy Lee, HFS-605, (202) 205- 4771

PODS: Mary Ann Strong, Program Evaluation Branch, HFC-42, (301) 443-2155

The Office of Plant and Dairy Foods and Beverages will prepare an annual report for publication of the findings of this program.

The Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine have designated individuals to coordinate exchange of residue data and other appropriate information, since residue findings in feeds and in foods derived from animals are often interrelated.

FDA-State Cooperation in the Pesticides and
Chemical Contaminants Programs

PURPOSE

To provide guidance to FDA field offices for the establishment of cooperative FDA-State pesticides and chemical contaminants programs. Such programs enhance FDA and state monitoring and enforcement activities, achieve optimal coverage of human foods and animal feeds, and provide for the most efficient use of available resources.

BACKGROUND

The FDA has a long history of cooperation with state agencies on a variety of food and feed safety issues. As part of this relationship, we routinely share information and are involved in cooperative programs or *partnerships* with states in the area of pesticide and other chemical residues in food and feeds. Prior to the FDA's establishment of the regional pesticide sampling plan process in FY 1988, some FDA districts had already established these mutually beneficial programs with their respective states. In view of the GAO's statements in its 1986 report encouraging FDA/State cooperation in the pesticide area, the FDA decided that the agency should make a greater effort to promote and establish such cooperative programs or *partnerships. * This guidance provides the groundwork for each district to establish FDA/State cooperative programs or *partnerships. *

APPROACH

This document provides a fairly comprehensive matrix for FDA/State cooperative programs or *partnerships* in the pesticide area, including a step-by-step procedure from initial contact with State agencies through actual joint planning, work sharing, and data exchange. While all field offices have progressed beyond the initial stages, it is useful to periodically consider whether some of the first steps need repeating as personnel turnover occurs.

It is imperative that FDA districts establish and maintain close, mutually beneficial working relationships with their state counterparts. Viable, comprehensive FDA/State cooperative programs or *partnerships* should be the goal for each district. At the very least, districts should establish with each State within district boundaries, a system of communication and information exchange on domestic food monitoring and, if appropriate, imported foods

1. General

   1. Make contact with agencies or organizations in a state that are involved in monitoring food and/or feed commodities for pesticides and industrial chemicals or regulate pesticides or industrial chemicals. These state agencies or organizations may include: health, environmental protection, agriculture, fisheries and university or college extension services.

   2. Obtain information on each agency's responsibilities regarding pesticides and industrial chemicals and their applicable state laws and regulations. Describe the FDA's responsibility and how a cooperative program can benefit all organizations and ultimately improve consumer protection.

   3. Follow-up meetings and contacts should be scheduled to formulate the program with those state agencies that have expressed an interest in this cooperative effort. It may be appropriate at this point to include regional EPA and USDA personnel in these meetings.

   4. Prepare a listing of contact persons from each of these involved agencies and the FDA that include address, work and home telephone numbers. Copy all agencies.

   5. Use meetings, newsletters and committees of AFDO regional associations, (e.g., CASA and AFDOSS), and AAFCO, to publicize FDA/State cooperative programs or *partnerships* and to encourage participation of states not yet involved. Seminars, workshops and committees of these associations can be effective tools for information and data sharing, laboratory methods discussions, etc.

   6. Request and acquire pesticide usage reports from state contacts.

   7. Provide assistance as may be requested by state and USDA personnel who are participating in the recently initiated USDA Pesticide Data Program.

2. Joint Planning

   1. Schedule at least one planning meeting annually with the involved agencies. The following information should be considered each year in formulating FDA/State monitoring of domestically produced foods and feeds:

      1. Pesticide usage information, both historic and recommendations for the coming year, including possible experimental uses and emergency exemptions (county extension offices may be a useful source of this information);

      2. Predicted insect and other pest problems;

      3. Crop production data, including approximate harvest times;

      4. How to handle specific types of operations, e.g., hot house and hydroponic facilities, aquaculture, etc.;

      5. Landfills and hazardous waste sites that may affect crops, food

      6. animal grazing areas or commercial fishing or other FDA regulated operation;

      7. Special surveys to be done by the state and/or FDA;

      8. Coordination with State/USDA programs.

      9. Seafood consumption advisories.

   2. Utilize joint planning for maximum coverage of commodities (i.e. foods and feeds for food producing animals) and pesticides. Do not ignore foods or feeds that have not had a past problem. Consider both short and long-term planning to assure comprehensive coverage.

   3. Ensure that sampling procedures and analytical methods are as consistent as feasible. A laboratory quality assurance program is an excellent way to assure consistency among laboratories. This can be accomplished by agreeing to split one or more samples collected each year for analysis by different laboratories using the same method. Joint FDA and state sampling can be one method to obtain consistency in sampling procedures.

   4. Use imaginative approaches to make the best use of available state and FDA resources. For example, states that do not have laboratory facilities to analyze samples of food or feed may be willing to collect samples for FDA analysis with the results shared with those states. Or, state labs may have the capability of conducting certain types of pesticide analyses but not others. In this situation analytical work could be shared.

   5. An FDA district/state-sampling plan should be formulated using all available information and incorporating all aspects of agreed upon cooperation. This plan should be in writing and include the reason behind the selection of foods or feeds for sampling.

   6. Establish a system for exchange of information during the year such as information on violative samples (including actions taken), periodic feedback on non-violative results, new regulations or policies, emergency situations, i.e., drift reports, spills, etc.

3. Program Monitoring and Coordination

   The district's pesticide coordination team (PCT) (described in Field Management Directive 134) serves as the focal point for the district's pesticide sampling and analytical activities, including primary contact with state, county and local government agencies.

   The pesticide coordination team should be responsible for the day-to-day monitoring and coordination for the district's FDA/state pesticide sampling cooperative program. This responsibility may include but is not limited to the following:

   1. Ensuring that the joint sampling plan is being followed or appropriate revisions are being made.

   2. If changes are made in the sampling plan, assuring that the changes are justified and have been discussed with cooperating state agencies.

   3. Coordinating follow up inspections to violative samples and necessary regulatory action.

   4. Tracking accomplishments, including analytical and inspection results, compliance and other activities.

   5. Planning and scheduling meetings as necessary.

   6. Coordinating training.

   7. Providing the region with district/state sampling plan information.

4. Compliance Activities

   Regulatory activities of each agency will be in accordance with each agency's statutory authority and regulatory policies. Actions taken by one agency do not preclude another agency from taking action. The following items should be considered:

   1. If possible and appropriate, establish a system whereby inspection and/or analytical results can be used to eliminate or minimize duplicative efforts.

   2. Establish a system that provides for the immediate notification of cooperating agencies when a sample is found to contain a violative residue. Coordinate follow-ups to remove the commodity from the market, determine if other shipments or food or feed producers are affected, and obtain evidence for possible action against the producer.

      The USDA/State Pesticide Data Program includes a mechanism to advise FDA districts when violative samples are found. Districts should make arrangements with states participating in this program (currently 6-10 states) to receive such information in a timely manner.

   3. Regulatory action will not always be available to the FDA because of lack of interstate movement or some other reason. However, action can often be taken by state agencies.

   4. Such action should be encouraged. Keep in mind that there may be agencies other than a state health or agricultural department that can take an appropriate action (e.g., a state agency that regulates pesticides has the authority to fine producers or remove a pesticide applicator's license).

      In addition to FDA and state regulatory action, alternative means to promote compliance should be considered using the cooperative program.

   The following examples can be used to, among other things, inform growers and applicators of the FDA/state regulatory action taken against violators:

   1. Bulletin or newsletter issued by state agriculture agencies or county agents;

   2. Training sessions given by extension services;

   3. Food and feed producer meetings.

5. Training

   Cooperative training programs have a number of benefits and should be considered as a part of the overall cooperative FDA/state programs. When necessary and resources and personnel are available, training can be given or received by the FDA or state personnel such as:

   1. Training courses on pesticides and industrial chemicals;

   2. Sampling and inspection procedures; and

   3. Methods of analysis and laboratory techniques.

      Training identified in the annual training needs survey can be conducted by the FDA's Division of Federal-State Relations. Other training needs may be met through development of local courses by the FDA regional or district offices and the states through the regional affiliates of AFDO or AAFCO.

6. Data Exchanges

   1. In those cases where states log their program findings by computer, the states should be encouraged to have compatible information fields with the FDA's data fields so that data can be extracted from one system and coded into another.

   2. States that collect and analyze samples should be encouraged to enter data in FEEDCON (for animal feedstuffs). These are ongoing systems for compiling state monitoring data on pesticides and industrial chemical residues in foods and animal feeds.

   3. Any state monitoring data entered into FDA LMS must be identified as data generated by the state.

   4. FDA and state analytical data should be freely exchanged among cooperating agencies on a routine basis.

   5. Actions taken by the FDA or a state as follow-up to a violative sample must be tracked and recorded under the Shipment Disposition Data System.

7. End of Year Summary of Accomplishments - Regional Pesticide Plans

   In prior fiscal years, headquarters has used pertinent information contained in progress reports to modify the national plan. Recent modifications to the national plan have made it possible to generate progress reports directly from LMS data, eliminating the need for HARD COPY progress reports (midyear and end of year) from the regions.

   Besides accomplishment data, the progress reports provided other information that is critically important to the operation and growth of the national pesticide plan (e.g., summaries of problems encountered and/or situations/ideas that should be included in future compliance programs). This type of information is still needed by headquarter units for planning and evaluation of the pesticide plans. In place of the progress reports, each district/region will submit a summary report covering their fiscal year pesticide plan. This summary will be due October 31 after the conclusion of the fiscal year.

   The Summary Report should cover the following types of information:

   1. A summary of the district/regional plan accomplishments including: the number of samples collected compared to the number planned, the number of product/state added/removed from the plan during the year; results of a district's initiated surveys; a summary of actionable samples and any problems encountered during the year that affected the operation of the pesticide plan.

   2. Recommendations for improving the regional/district plans and suggested modifications that can be incorporated into the pesticide plan instructions contained in the compliance program.

   3. Other data the districts/regions would like to include that relates to their pesticide plan/program.

Except when advised otherwise by headquarters, the FDA's sampling of domestic foods for pesticide residues on a surveillance basis should be directed toward the following food commodities list (list is not in priority order), which may be in either the raw or processed form:

Root and Tuber Vegetables: beet (garden and sugar), carrot, potato, radish, sweet potato, yam, rutabaga, turnips, artichokes and cassava (bitter or sweet).

Bulb Vegetables: onion and garlic.

Leafy Vegetables: celery, lettuce (all varieties), cress, endive spinach and asparagus.

Brassica Vegetables: broccoli, Brussels sprouts, cabbage, cauliflower, collards, mustard greens and kale.

Legume Vegetables: succulent and dried form of beans and peas (all varieties).

Fruiting Vegetables: eggplant, pepper, okra, tomatillo and tomato.

Cucurbit Vegetables: cucumber, melons (cantaloupe, honeydew, muskmelon and others), pumpkin, squash (summer and winter), and watermelon.

Citrus Fruits: grapefruit, lemon, lime, orange, tangelo, clementine and tangerine.

Pome fruits: apple, pear

Stone Fruits: apricot, cherry (sweet and sour), nectarine, peach, plum, and prune.

Small Fruits and Berries: blackberry, blueberry, boysenberry, cranberry, grape, raspberry, and strawberry.

Tropical/Subtropical Fruits: avocado, mango, olive, pineapple, papaya, guava, and banana.

Tree Nuts: almond, pecan, and walnut (black and English). (Analyze primarily for post harvest fumigants).

Cereal Grains: barley, corn, oats, rice, wheat, rye, wild rice, and farina.

Oilseeds: soybeans and peanuts.

Refined Vegetable Oils: shipped in bulk and examined primarily for industrial chemicals due to contamination during transit.

Fish and Shellfish: locally produced of commercial significance including aquaculture species (see Part III, Page 2) plus Gulf Coast finfish, Sand Sea trout, Silver Sea trout, Spot, Gulf Coast Crabs, Chesapeake Finfish (Striped Bass and Spotted Sea trout) and California marine species (Cod, Sablefish and Rockfish-sebastes species).

Aquaculture Products: Commercially significant species (e.g., Catfish, Crawfish, Trout) from aquaculture producers throughout the district's geographical area.

Milk Products: cheese

Miscellaneous: mushrooms and kiwi

These procedures are designed to insure the effective and efficient handling of regulatory actions against foods bearing illegal pesticide residues that may degrade rapidly. "Destination point sampling" is not required for pesticide residues for which there is no tolerance or when misuse is documented. (These procedures apply only when the origin district collects the official sample that is used as the basis for the seizure recommendation.)

The originating district is responsible for recommending the seizure action to Sonia Delgado Chief, Case Processing Branch, (CPB), HFS-607, and for alerting CPB when the recommendation is being prepared for submission. Where CPB assistance is required other than during normal working hours, contact CPB as indicated in the emergency procedures.

Once the origin district decides to recommend seizure, they will request the destination point district to collect and analyze a sample of the lot to corroborate the original findings while the seizure recommendation is being processed.

Seizure recommendations should include all the necessary documents, such as the investigational findings and a complete analytical package for the official sample collected at origin.

CPB will process the seizure recommendation and transmit the seizure documents to the Office of Enforcement (HFC-200) if tentative approval is granted. The tentative approval will be conveyed by telephone. HFC-200 and GC will process the seizure recommendation on the basis of the tentative approval. The seizure will be transmitted to the destination district for filing after CPB grants final approval, which will be based on analytical results, obtained for the destination sample.

The servicing laboratory for the destination point district is responsible for conducting a single analysis (no check analysis necessary) to corroborate the initial findings and for providing the analytical results directly to CPB, first by telephone, and then by submission of the analytical package for Center review.

CPB will notify the destination and origin districts and HFC-200 of the final decision based on the analytical results for the destination point sample.

Consider recommending an injunction when seizures or notices of adverse findings have not been effective in deterring violations.

1. For various reasons, certain pesticides are only partially recovered using commonly employed multiresidue methodology. As a general guideline, when the residue level determined by the multiresidue method (#) of the tolerance level, the sample should be reanalyzed using alternate elution systems, higher or lower column temperatures or other methods such as those in PAM II, which give acceptable recoveries.

   Because of their frequent occurrence, or toxicological concern, the above guideline applies particularly to the following pesticides:

   PAM I Methods Used Initially	Pesticide
   303, 304	linuron dicloran methidathion
   304	dialifor hexacholorobenzene (HCB)
   303	captafol chlorothalonil chlorobenzilate
   302	methamidophos

2. Metabolites of the following pesticides are of significant toxicological concern, are expected to constitute major portions of the total residues covered by the tolerance, and are only partially recovered (or are not recovered) by commonly used multiresidue methodology. Perform reanalysis by a method for "total residues" such as that given in PAM II whenever the pesticide or any one of its metabolites is found at the indicated percentage of tolerance. (This list is restricted to those pesticides of most concern, and does not include all pesticides posing the problem of incomplete determination of regulated metabolites.)

   Pesticide	Metabolites	(#)
   pronamide	those which can be converted to methyl-3,5 dichlorobenzoate using acid reflux	(#)
   phorate	sulfoxide; sulfone; O-analog; O-analog sulfoxide; O-analog sulfone	(#)
   disulfoton	sulfoxide; sulfone; demeton-S (O-analog of disulfoton); demeton-S sulfoxide; demeton-S sulfone	(#)
   demeton	-O sulfoxide; demeton-O sulfone; demeton-O; O-analog; demeton-S sulfoxide; demeton-S sulfone	(#)
   fenamiphos	sulfoxide; sulfone	(#)
   terbufos	sulfoxide; sulfone; O-analog; O-analog sulfoxide; O-analog sulfone	(#)
   nitrofen	metabolites containing the diphenylether moiety	(#)
   alachlor	metabolites containing the 2,6-diethylaniline moiety	(#)
   diuron	those which can be converted to 3,4-dichloroaniline by alkaline hydrolysis	(#)
   linuron	those which can be converted to 3,4-dichloroaniline by alkaline hydrolysis	(#)

   U.S. registration of nitrofen has been canceled. Foreign use is believed to be still extensive.

   Seafood Obligation (FY '00-02)

   All Districts (#) should collect at least seven (7) samples of fish and/or shellfish locally produced (as close to their origin as possible) of commercial significance. A review of domestic seafood sampling results developed since 1993 shows that there is a near total absence of measurable pesticide residues in many ocean species (e.g., cod, flounder/sole, halibut, mackerel, pollock, tuna and whiting). The same can also be said for domestic and imported shrimp. As a result of these findings, ocean fish and shrimp need not be sampled for pesticide residues. Locally produced seafood, especially non-migratory bottom feeders that may be affected by local pollution should be targeted instead. Species harvested close to shore, pollution sources, prior problems, or areas where states have issued advisories due to pesticide pollution should also be considered. In Addition, locally produced shellfish should also be targeted.

   The following should be used as additional guidance:

   1. Choose fresh fish, if available.

   2. Do not maintain the identity of individual subs of fresh or frozen whole fish.

   3. NYK should collect an additional seven (7) samples of locally produced marine species for PCB and organohalogen analyses.

   4. NOL and FLA should collect an additional eighteen (18) and seven (7) samples, respectively, of Gulf Coast finfish for organohalogen and PCB analyses. Samples should consist of Sand Sea trout, Silver Sea trout, and Spot. Furthermore, DAL should collect an additional ten (10) samples of seafood, consisting of Gulf Coast crabs, snapper, and black drum for organohalogen and PCB analyses.

   5. LOS should collect an additional ten (10) samples of locally produced California marine finfish (e.g., Croaker, Sablefish, Rockfish - sebastes species, and Sole) for pesticides and PCB analyses.

   6. SEA should collect and additional four (4) samples of Pacific Salmon for pesticides and PCB analyses.

   7. BLT should collect an additional fourteen (14) samples of Chesapeake finfish (7 samples each of Striped Bass and Spotted Sea trout) for organohalogen and PCB analyses.

Direct reference seizure for domestic food or detention of imported food, without prior consultation from CFSAN, is authorized under the following conditions.

1. General Requirements

   1. The sample of food was collected in accordance with all instructions provided in the Investigations Operations Manual, Sample Schedule, Chart 3; or other CFSAN guidance documents, i.e. assignment/Compliance Programs(CP);

   2. The portion of food commodity analyzed was in accordance with PAM Volume I;

   3. The analytical methods used for the analyses are contained in the PAM, Volume I or II or the Official Methods of Analysis of the Association of Official Analytical Chemists, or the method cited in the appropriate Compliance Program, e.g.,
      CP 7304.004, or assignment;

   4. The residue amount determined in both the original and check analyses agree within + 15%. An exemption is made for chlorothalonil where the original and check analyses may agree within 30%.;

   5. The pesticide residue was measured and the level was calculated in accordance with the applicable tolerance or action level;

   6. The identity and amount of the residue in either the original or check analysis sample was quantitated and confirmed in accordance with PAM, Volume I;

   7. The analytical work and work sheets must conform with the "Criteria for Analytical Packages" outlined in the attachment;

   8. The district must provide CFSAN's Case Processing Branch (CPb, HFS-607) with a copy of each notification of warning letter or seizure documents for all direct reference cases as soon as the action is taken.

2. Tolerances or an Action Level Exists for a particular Pesticide/Commodity combination.

   In addition to the General Requirements, the lower of the residue amounts determined by either the original or check analysis must exceed the established tolerance or action level by a least 15%.

   NOTE: For cases where a tolerance or action level is exceeded, but the criteria for direct reference seizure authority have not been met, e.g., a finding less than 15% above tolerance or action level, refer the case to CPB for consultation and approval. Enclose the complete analytical worksheets and other pertinent documentation.

3. No Tolerance or Tolerance Exemption Exits

   1. The district must determine that no applicable tolerances exits in 40 CFR 180 for the individual pesticide/food combination or for the crop group to which the individual food belongs. To determine whether a food belongs to a particular crop grouping refer to 40 CFR 180.1(h) and 180.34(f). The district must also determine that no Section 18 Emergency use exemption is in effect for the use of the pesticide in a region. If a Section 18 exemption is in effect, and the residue found exceeds EPA's tolerance, refer the case to CPB.

   2. The General Requirements under A must be met.

   3. The residue amount by boh original and check analyses must exceed 0.05 ppm and also exceed the limit of quantitation by at least 15%. The limit of quantitation must be determined in accordance with PAM Volume I.

      NOTE: For cases where the residue is not covered by a tolerance or tolerance exemption, but the criteria for direct reference seizure have not been met, refer the case to CPB for consultation and approval. Include the complete analytical worksheets and other pertinent documentation.

The analytical package provides complete documentation of the analysis. It supports the identity and amount of each residue of possible regulatory significance, documents "chain of custody" for the sample, and permits independent reconstruction of the analysis. The criteria below supplement and expand on the general requirements outlined in the Laboratory Procedures Manual (LPM),Chapters 2 (Sample Analysis) & 12 (Analyst Records) and provide specific guidance for cases in which the analytical method uses either gas chromatography (GC) or liquid chromatography (LC) as the determinative step. Application of these criteria, in conjunction with the attached summary form and data checklist, will help ensure that the analytical work supports the intended regulatory action. If the criteria do not apply to particular sample, target pesticide residue or appropriate method of analysis, contact either the Division of Field Science/ORA or the Division of Pesticides and Industrial Chemicals/CFSAN for guidance.

Analytical Methodology

Official methods, when available, must be used for either the original or check analysis (LPM,2.5) and must be appropriate for both the commodity and residue. Methods in Official methods of Analysis of the AOAC International and Pesitcide Analytical Manaual, Volumes I & II are official. Miniaturized versions of these methods are considered equivalent to the official version.

Identification of Residues

Residues of possible regulatory significance must be conclusively identified. Both confirmatory procedures below must be used. GC-mass spectrometry must also be used when a residue can be determined by GC and is being reported for the first time of if selective detection is not available.

• Obtain retention data on at least two different chromatographic systems (e.g., GC and LC) or columns. When a second column is used, the retention time relative to a marker compound should be significantly different. The second column must be capable of distinguishing the probable residue from potential interferants on the primary column.

• Use a selective detection system, (e.g., heteroatom or functional group) for qualitative and quantitative determination of residues.

  Quantitation of Residues

  Residue levels must equal or exceed the Limit of quantitation (Lq) of the target pesticide and be determined using the guidelines in the PAM I, 504 (GC) and 606 (LC) by both the original and check analysts

• Match sample and standard peak responses as closely as practical. Limit response differences to +25% and time between sample and standard injections to less than 1 hr. Begin and end the injection sequence for quantitation with a standard.

• Levels of residues determined in both original and check analysis must be equal to or greater tan the limit of quantitation for the individual chemical. The Lq is defined and discussed in grater detail in PAM I, 105. For example, the Lq for pesticide chemicals determined on GC systems that use chlorpyrifos as the marker compound is calculated as:
  
  
  

Lq

=

(ng 50% fsd) / (20 mg X 5)

Quality Control Measures

The analytical package must include, at a minimum, the following quality control measures to validate the analytical process and findings
(PAM I, 206 and LPM, 2.3).

• A check analysis performed by a competent and qualified analyst (LPM,2.3.3.1).

• A reagent blank run concurrently with either the original or check analysis.

• Independently prepared standard solutions and reagents (LPM, 2.3.3.1).

• Recovery information for the food commodity and residue found. Recovery information must include concurrent analysis of an unfortified test portion and a test portion fortified at or near the level found. Analysis must be conducted by either the check or original analyst(s) using the same methodology. The fortification may be performed on another test portion of the regulatory sample which has been fortified at twice the level determined in the original analysis.

Attachments: Analytical Package - Summary

Analytical Package - Data Checklist

Hypertext updated by saw/cjm 2000-DEC-21