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Pesticide Registration (PR) Notice 94-3: How to Obtain Information from OPP
Resources
June 9, 1994
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
Attention: Persons Responsible for Registration of Pesticide Products
Subject: How to Obtain Information from OPP
The Office of Pesticide Programs (OPP) wants to provide timely and consistent information to the public. This notice provides general guidance on how to obtain general information from OPP, and reflects OPP's commitment to improving communications with registrants and others.
I. BACKGROUND
Registrants and others frequently call EPA to ask questions about general pesticide regulatory policies, the implications of new decisions or policies for specific pesticide products, the status of pending actions, general information about pesticides, etc. Sometimes the callers are not sure where to direct their questions, whether they are getting an answer from the right person or whether the answer is official.
Most inquiries to OPP fit one of the following four general categories: requests for OPP records or publications; requests for the status of pending applications for registration or reregistration; requests for the status of decisions affecting specific chemicals or products; or explanation or interpretation of current OPP policy.
To assist registrants and the public to obtain the best available information and authoritative answers to specific questions, EPA is providing the following general guidance.
II. GUIDANCE
A. Requests for OPP Records or Publications
Requests for records or publications are typically handled by either the Public Response and Program Resources Branch (PRPRB) or the Communications Branch in OPP's Field Operations Division.
The Public Response and Program Resources Branch responds to Freedom of Information Act (FOIA) requests and maintains the public docket on EPA's rulemaking activities, special reviews, and reregistration actions. The docket includes background documents and public comments on these activities. In addition, special dockets are created when OPP expects that a particular issue will generate considerable public interest.
The Pesticides Docket
The Office of Pesticide Programs (OPP) Public Docket consists of the Federal Register Docket, and the Special Review, Registration Standard, and Special Program Dockets.
- The Federal Register Docket houses background documents and public comments on proposed rulemaking activities announced by the Office of Pesticide Programs in the Federal Register. These activities include revisions to 40 CFR Parts 152 to 186, the granting of pesticide registrations, tolerances, experimental use permits and emergency exemptions, and the issuance of Reregistration Eligibility Documents (REDs).
- The Special Review Docket contains notification letters, position documents and Federal Register notices issued by the Agency during the course of a Special Review. Data evaluations and other science support documents are on file as background information. The docket also houses comments, correspondence and any other materials submitted to EPA by outside parties following initiation of the Special Review. Minutes of meetings with outside parties are also on file.
- The Registration Standard Docket contains comments, correspondence and any other materials submitted to EPA by outside parties during the course of registration standard development. Minutes of meetings with outside parties are also on file. Relevant Federal Register notices and the final Registration Standard and supporting science chapters are placed in the docket upon issuance.
- A Special Program Docket is created when an OPP program office wants to place a set of documents concerning a particular issue on public display, such as the implementation of an acute worker risk strategy.
U.S. Environmental Protection Agency OPP Public Docket (7506C) 401 M
Street, S.W.
Washington, D.C. 20460
Most docket records are available in paper copy; some are available on microfiche. Users may request to be placed on the mailing list to receive, at no charge, the "Monthly Index of Additions to the Registration Standard, Special Review, and Special Program Dockets."
Freedom of Information
Most of OPP's records not specifically prepared for routine public distribution fall within the scope of the Freedom of Information Act (FOIA), the statutory mechanism for providing the public access to Agency records. Under the FOI Act, OPP makes the fullest possible disclosure of its records while protecting both business information entitled to confidential treatment and the rights of individuals to privacy. The types of pesticide program records handled under FOIA include, but are not limited to, FIFRA health and safety data, internal data reviews or memoranda, administrative files for registered products, and policy and guidance documents. FOIA requests must be submitted in writing to: Freedom of Information (1105), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, D.C. 20460; Fax (202) 260-0295.
FOIA requests should specify the information requested as clearly as possible. Any known EPA identifiers should be included, such as the EPA Registration Number, active ingredient or chemical code, Master Record Identification Number (MRID), submitter, subject, etc. Prior to formulating a FOIA request, a requestor should check the public availability of records as noted below under "Non-FOIA Resources." If a request is made for a publicly available record, the requestor will be directed to the appropriate source.
The staff of the Public Response and Program Resources Branch (PRPRB) can assist individuals in formulating their inquiry and can explain FOIA procedures and fees. They can be reached as follows: Public Response and Program Resources Branch, FOD, Office of Pesticide Programs (7506C), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, D.C. 20460; Telephone (703) 305- 5229; Fax (703) 305-5558.
Please note that registrants should not use FOIA to obtain copies of records regarding their company's registrations. Rather, this information should be obtained from the assigned Product Manager (PM) within the Registration Division.
Non-FOIA Resources
Much information does not need to be requested under FOIA. In addition to records that are available through the public docket, records that are clearly releasable and readily available, such as publications, press releases, or information sheets prepared for general distribution, can also be obtained from the sources discussed below.
OPP has prepared a "Catalog of OPP Publications and Other Information Media." To obtain single copies of the catalog, provide your name, phone number, address, and the document title to the following address: National Center for Environmental Publications and Information (NCEPI), Attn: Publications Orders P.O. Box 42419, Cincinnati, Ohio 45242; Telephone: (513) 891-6561; Fax: (513) 891-6685.
The Communications Branch provides information on recent pesticide announcements and copies of non-technical brochures, booklets, and fact sheets on a variety of pesticide topics. The Communications Branch responds to both phone and mail requests, and can be reached as follows: Communications Branch, FOD, Office of Pesticide Programs (7506C), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, D.C. 20460; Telephone: (703) 305-5017; Fax: (703) 305-5558.
Many OPP technical documents are available from the National Technical Information Service (NTIS). The documents include but are not limited to position documents, registration standards, reregistration eligibility documents (REDs), fact sheets, the compact label file, and standard evaluation procedures. For information on these documents, contact the National Technical Information Service, 5285 Port Royal Road, Springfield, Virginia 22161; Telephone: (703) 487-4650; Fax: (703) 321-8547.
The National Pesticide Information Retrieval System (NPIRS) on-line database is available by annual subscription through Purdue University. NPIRS allows users to access information on registered pesticide products, pesticide tolerances, chemical information fact sheets, pesticide document management system (PDMS) study listings, and material safety data sheets. Selected NPIRS information is also available in CD-ROM or book format. Further information can be obtained from the NPIRS Project Manager on (317) 494-6616.
In addition, the National Pesticides Telecommunications Network (NPTN), a toll-free telephone service, provides general information to the public about pesticides. Using a number of data bases, NPTN has access to the most recent literature published on virtually any chemical or pesticide. The service operates Monday through Friday, 8:00 a.m. to 6:00 p.m. Central Time. The phone number is (800) 858-7378.
B. Requests for Status of Pending Applications for Registration or Reregistration
Inquiries about the status of specific pending applications for registration or reregistration of pesticide products should be directed to the responsible Product Manager (PM) in OPP's Registration Division (RD). These questions should be handled by telephone and do not need to be submitted in writing.
C. Requests for Status of Decisions Affecting Specific Pesticide Chemicals or Products
Most regulatory actions on pesticide chemicals (active ingredients) are managed by OPP's Special Review and Reregistration Division (SRRD). Questions regarding chemicals (including those concerning the reregistration status of a chemical, call-ins of data to support reregistration, or the special review of a chemical), should be directed to the appropriate Chemical Review Manager (CRM) in SRRD. Questions regarding compliance with a specific Reregistration Eligibility Decision or concerning productspecific data requirements for reregistration should also be referred to the staff of the Planning and Reregistration Branch of SRRD.
The CRM's and PM's are the Office of Pesticide Programs' experts on the status of chemicals and products assigned to them. They are familiar with data requirements, study review status, and the general review process. The attached organization charts list the names and telephone numbers of the Product Manager Team Leaders in RD and the Chemical Review Managers in SRRD. (These lists are periodically updated by the Registration Division (703/305-5447) or the Special Review and Reregistration Division (703/308-8000)).
D. Questions about Policy Decisions
Policies and regulations may be developed by several groups within OPP, especially the Registration Division and the Special Review and Reregistration Division. It is not always obvious where to seek information on current and evolving policies.
The following guidance may be useful:
- If the query concerns a particular document or action (e.g., a Federal Register or PR Notice), call the contact person listed in that document. All OPP documents should contain such an information contact.
- The Policy and Special Projects Staff in the Director's office has overall responsibility for the development and maintenance of broad generic policies, those that cross Division boundaries, and for keeping current on policy developments elsewhere in OPP. Staff in PSPS can direct queries to appropriate people in OPP Divisions. If in doubt about who to call about policies, regulations, interpretations, or other generic information, contact Debby Sisco, at 703-305-7102, or write to Policy and Special Projects Staff (7501-C), at the Agency address.
- The Policy and Special Projects staff is responsible for several broad areas of policy, such as legislation and related Congressional affairs, Delaney policy, ground water policies and international pesticide activities. In addition, PSPS is generally responsible for coordinating pesticide policies with other parts of EPA, and should be consulted when questions concern policies involving other EPA programs and media, such as air, water, or waste. PSPS staff listed in the attachment to this notice can assist you these areas or by directing you to appropriate EPA offices.
- If the query is about policy specific to the functions or activities
of a particular Division, contact that Division. Much policy work relates
to the registration and reregistration activities of OPP, and questions
should be directed as follows: a. In the Registration Division, policy
questions may be directed to Richard Mountfort, who has been designated
as "ombudsman" for registration related matters. He may be reached at
703-305-5446, or in writing at the Registration Division (7505C), at
the EPA address. The "ombudsman" is not a substitute for the Product
Managers, who oversee regulation of specific products and who manage
the day-to-day contacts with registrants and the public about specific
products.
b. In the Special Review and Reregistration Division, questions may be directed to Jay Ellenberger, Chief of the Accelerated Reregistration Branch. He may be reached at 703- 308-8100, or in writing to the Special Review and Reregistration Division (7508W), at the EPA address. Questions about specific chemicals should first be directed to individual CRMs, if known.
5. Although OPP makes every effort to provide accurate and informative responses to telephone inquiries, registrants are strongly encouraged to submit questions concerning policy, procedures, interpretations, guidance, regulations, and data requirements in writing to obtain an official Agency response. All requests for waivers or extensions of deadlines must be submitted in writing.
III. FURTHER INFORMATION
Questions regarding this notice can be directed to Margie Fehrenbach (703) 305-5017.
Daniel M. Barolo, Director Office of Pesticide ProgramsWHERE TO OBTAIN INFORMATION FROM OPP
SPECIAL REVIEW &FIELD OPERATIONS REGISTRATION REREGISTRATION DIVISION DIVISION DIVISIONRecords (FOIA) Product-Specific Reregistration Publications Registrations Studies Public Docket Temporary Tolerances Special Review
Agency Announcements Uses Compliance with
Fact Sheets Restricted Use REDClassification Compound Trade Names Section 18's Section 24's Transfer Status Formulation Changes Experimental Use PermitsPOLICY & SPECIAL PROJECTS STAFF
Regulations
Legislation and Congressional interactions International activities
Ground water activities
General food safety issues
Delaney clause activitiesNOTE: Paper copies of the attachments to this notice will be available in a few weeks. To obtain copies of the attachments, contact Amy Breedlove on 703-305-6231 in a few weeks or you can call before if you want to xerox your own copy.