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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Interagency Pesticide Referrals Between EPA and FDA

Subject:
Interagency Pesticide Referrals Between EPA and FDA
Area:
Program Management
Date Revised:
December, 16 1992

 

 

PURPOSE

To improve management controls and response to illegal pesticide residue case referrals between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA).

 

GUIDANCE

1. Referrals from FDA to EPA

To improve the quality of referrals from FDA to EPA, the field is directed to refer cases of suspected pesticide misuse to EPA only when the following conditions are met:

a. FDA has evidence clearly demonstrating that the pesticide was used on food or feed in a manner contrary to its EPA registered use and labeling.

b. FDA laboratory results show residues of a pesticide for which FDA regulatory action would be initiated against the food or feed because;

(1) the tolerance for the pesticide is exceeded; or

(2) no tolerance (or exemption from tolerance) has been established and the level of residues appears to be due to purposeful use as opposed to environmental or some other unavoidable source of contamination.

c. The misuse occurred while the food or feed was in domestic production, shipment, or storage.

Note: Import products found to contain illegal pesticide residues at time of entry are not to be referred to EPA.

d. The person(s) or firm which misused the pesticide is known or suspected.

2. Referrals from EPA to FDA

The nature and location of EPA inspections make it unlikely that many referrals of potential illegal residues will be made from EPA to FDA. However, when EPA discovers situations which might result in illegal residues, they should be referred to the FDA district office so that the crop or product can be intercepted and tested as necessary. Examples of situations which might result in illegal residues include accidental pesticide spills, excessive pesticide use on a crop nearing harvest, fruit or grain fumigation exceeding the prescribed rates, and pesticide misuse in a food processing facility.

        3. Referrals by EPA to State Agencies

When EPA responds to an FDA illegal residue referral, it often suggests that the appropriate state lead pesticide agency be notified in accordance with EPA's state program. The state will evaluate the referral as it would any complaint and determine what response is appropriate. More serious situations, falling within the annually-established priority area, will be monitored by EPA as part of that agency's oversight activity.

In all cases, however, EPA has suggested to its field offices that the interagency referral tracking form be used to make a formal referral to the state. The state will be requested to complete the form and return it to EPA so that EPA can inform FDA of the results of the referral. The state may also wish to inform FDA directly.

4. Formal Referrals, Reports and Files

Copies of reports, sample analysis, sample documentation, and other evidence should be provided whenever a formal referral is made between the agencies.

The referral should include two copies of the Interagency Referral Tracking form (Attachment A). If a State agency is also involved in the investigation, the name of the agency and contact person should be included on the referral form.

Each FDA district or station should establish three new files.

The first file should contain current referrals received from the other agency. The second file should contain matters referred to the other agency and should be checked periodically, perhaps at 90 day intervals, to see if there are any referrals for which notification of follow-up action by the receiving agency is still pending. All completed referrals should be placed in a third file for historical purposes; a separate copy of each referral may also be placed in the appropriate company or facility file. Similar files will be retained in EPA's regional offices.

5. Emergency Situations

These instructions apply only to formal referrals which arise in the course of each agency's routine field work, and which warrant only routine follow-up. Emergency situations may arise which require immediate interagency action, such as serious pesticide misuse in a food processing facility which is likely to have contaminated food already in commerce. In these instances, agencies should be notified immediately by telephone with all information that is readily available so that the hazardous situation can be corrected promptly.

NOTE: This procedure should not interfere with your normal exchange of information with EPA.

 

Attachment A

Interagency Referral Tracking Form*

1. REFERRAL TO 2.  REFERRED BY
Agency:

Location:

 

Agency:

Referring Official:

Phone Number:

3.  DATE REFERRAL FORWARDED 4.  OTHER AGENCIES NOTIFIED
Date Mailed:

Advance Telephone Notification Given:

_____ No

_____ Yes                 Date:

                                  To Whom:

Other Agencies Notified and Contact Person in Each:

5.  DESCRIPTION OF INCIDENT/REASON FOR REFERRAL

 

 

 

6.  FIRM RESPONSIBLE 7.  FIRM (INDIVIDUAL) AFFECTED
Name and Location of Firm Responsible for Problem:

 

 

Name and Location of Firm or Individual Affected by Problem:
8.  DATE REFERRAL RECEIVED 9.  REVEIWING OFFICIAL
Date of Telephone Notification:

Date Received by Mail:

Name/Title of Person Responsible for Determining Response to Referral:

Phone Number:

10. FOLLOWUP DECISION
_____  Immediate Followup                                                    _____   No Followup
                                                                                                            Reason:

_____  Non-Immediate Followup                                                       

_____  Referred to Another Agency
  Specify Agency and Contact:

                                                                                             Date Followup Decision Made:

11. Action Taken
Decribe followup and results:

 

12.  Feedback Report
Send a copy of completed form to this address at referring agency:

* Referring Agency:    Complete Blocks 1-7 and 12

   Receiving Agency:    Complete Block 8-11, and send to address in Block 12