United States
Environmental Protection
Agency
Prevention. Pesticides
Toxic Substances
(EN-342)
EPA 722-B-92-003
November, 1992
Standard Operating Procedures
for Enforcement Case Review for
Regional Offices and Headquarters
o
CO
a
CO
-------
-------
««0
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
NOV I 3 1932
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Completion of the Standard Operating Procedures
for Enforcement Case Reviews
FROM: Michael M. Stahl, .Director
Office of Compliance Monitor iSng
Douglas D. Campt, Director
Office of Pesticide Programs
TO: Addressees
Attached is the final version of the standard operating
procedures that will be used to expedite the processing of
enforcement case reviews received from the Regions. These
procedures were carefully developed between the Office of
Pesticide Programs, the Office of Compliance Monitoring, and the
Regions. These procedures strive to provide the Regions with
concise guidance which will allow them to sufficiently pre-screen
their requests, avoid unnecessary requests, and therefore receive
a timely, high quality product for those requests that are
submitted.
We praise the efforts shown by all parties to
complete this document, thereby enhancing the quality of
enforcement efforts initiated in the regional offices. In
addition, this effort has substantially promoted improved
communications among all of the participatory offices, and we
look forward to implementation of the new procedures.
Attachment
cc: Michael F. Wood, OCM
Lawrence Culleen, OPP
Richard Parkin, Region 10
Diane Callier, Region 7
Don Lott, Region 3
Regional Branch Chiefs w/full attachments
-------
-------
Disclaimer
This document was prepared by the U.S. Environmental Protection Agency with
editorial assistance from Science Applications International Corporation (SAIC)
under EPA Contract 68-C8-0066, Work Assignment C4-84. Neither the U.S.
Environmental Protection Agency nor its employees makes any warranty, express
or implied, or assumes any legal liability for any third party's use* of or the
results of such use of any information, product, or process discussed in this
document. Mention or illustration of company or trade names, or of commercial
produces, does not constitute endorsement by the U.S. Environmental Protection
Agency.
-------
Acknowledgements
These procedures were compiled by a workgroup of representatives from the Headquarters' Office of
Compliance Monitoring and Office of Pesticide Programs and Regions 10, 7, and 3. Assistance,
comments, and suggestions were also provided by other Regional and Headquarters personnel. The
primary workgroup contacts are identified below:
Office of Compliance Monitoring
Co-Chair: Jerry Stubbs, Chief, Case Support Branch
Rebecca Torchia
Brian Dyer
David Stangel
Office of Pesticide Programs
Co-Chair: Juanita Wills, Chief, Antimicrobials Branch
D. Jean Jenkins
Susan Parker
Bruce Mann
Regional Contacts
Region 10 (Lead):
Region 7:
Region 3:
Richard Parkin
Lyn Frandsen
Cora Churchill
Diane Callier
Diana Reid
DonLott
JimLohr
-------
Enforcement Case Review SOP
Table of Contents
I.
Table of Contents
Introduction , _ ^ ««
1.1 Purpose 1-1
1.2 Scope . . . • 1-1
1.3 Definition of an Enforcement Case Review ' 1-1
1.4 Background . . . -. ... 1-2
1.5 Implementation 1-2
2. Regional Office Procedures 2-1
2.1 Label Review 2-1
2.1.1 Obtainment Copies of Accepted Product Labels 2-1
2.1.2 Comparison of Accepted Labeling and Sample Labeling
for Substantive Differences or Deficiencies 2-3
2.1.3 Interpretation of Labeling Defects 2-4
2.2 Summarizations/Conclusions Regarding Scientific Test Results 2-4
2.3 Determination of Basic Registration Status, Supplemental Registration
Status (Distributor), and Pending Application Status 2-5
2.3.1 Status of Basic Registration 2-5
2.3.2 Status of Supplemental Distributor Registration 2-5
2.3.3 Status of Pending Applications 2-5
2.4 Determination of Status of Product as a Pesticide or Device Under FIFRA 2-6
2.4.1 Reference to Regulatory Documents 2-6
2.4.2 Reference to Precedent-Setting Documents, Policy Documents,
and Interpretive Documents 2-6
2.4.3 Referral to RD Representatives 2-6
2.5 Obtainment of Additional Documentation and/or Availability of Expert Witness
for Legal Proceedings 2-7
2.6 Processing of Emergency/Expedite Requests 2-8
3.0 Headquarters Procedures 3-1
3.1 Label Review 3-1
3.1.1 Provision of Copies of Accepted Product Labels
for Regional Office Use : .. . 3-1
3.1.2 Provision of RD Support for Substantive Label Defect Review 3-1
3.1.3 Interpretation of Labeling Defects 3-2
3.2 RD Support for Assessing Significance of Scientific Test Results 3-2
Final
October 29,1992
-------
Enforcement Case Renew SOP
Table of Contents
3.3 OPP Support for Determination of Basic Registration Status, Supplemental
Registration Status, and Pending Application Status 3-2
3.3.1 Status of Basic Registration , 3-2
3.3.2 Status of Supplemental Distributor Registration 3-3
3.3.3 Determination of Product Registration Status 3-3
3.3.4 Quarterly Reports 3-3
3.4 RD Support for Determination of Status of Product as Pesticide/Device
Under FIFRA 3-3
3.5 Provision of Additional Documentation and/or Availability of Expert Witness
for Legal Proceedings 3-3
3.6 RD Support for Processing Emergency/Expedite Requests 3-4
3.7 Recordkeeping 3-4
Appendix: Resource Information A-l
References A-I
Regulatory, Policy, and Other Pertinent Documents A-2
List of Figures
Figure 1 Enforcement Case Review Cycle 1-3
Figure 2 OCM's ECR Request Memorandum . 2-2
Final
ii
October 29, 1992
-------
Enforcement Case Review SOP Introduction
1. Introduction
This guidance manual establishes the procedures to be used by Regional Offices (ROs), U.S.
Environmental Protection Agency (EPA) Headquarters' Registration Division (RD), and EPA
Headquarters' Office of Compliance Monitoring (OCM) in all instances in which data concerning Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) enforcement case information are sought. The
procedures are detailed and differ depending on the type of data sought from RD (e.g., label
determinations versus laboratory findings indicating a product is violating FIFRA), as well as on
determinations made by ROs upon receipt of data (e.g., whether a comparison between its product label
and its sample label reveals a substantial defect necessitating RD review and concurrence).
The remainder of mis introduction presents the purpose of this manual, scope of the procedures,
definition of an Enforcement Case Review (ECR), background information, and implementation of the
procedures with respect to ECRs. Figure 1, at the end of this section, presents a flow chart illustrating
the procedures described hi Sections 2 and 3 of this manual. Sections 2 and 3 describe the Regional and
Headquarters procedures for numerous potential enforcement issues (e.g., labeling defect decisions,
determination of product status as pesticide or device), respectively. The appendix contains a reference
list and regulatory and policy documents to help Regions make enforcement determinations.
1.1 Purpose
The purpose of this document is to establish standard operating procedures and guidance to help EPA
personnel in the Regions review enforcement cases pertaining to FIFRA. This guidance manual is also
intended to delineate the circumstances and conditions for which RD should provide the necessary
registration information to the ROs. Finally, the guidance identifies the circumstances under which
enforcement cases wilt be referred to Headquarters for RD review.
1.2 Scope
These procedures cover all enforcement cases concerning all types of pesticide products and devices in
or under the purview of all ROs.
13 Definition of an Enforcement Case Review
An ECR is a review of information pertinent to determining whether a violation exists under FIFRA.
Reviews are undertaken at the request of Case Development Officers in the Regions or in OCM. The
reviews, which include various types of information, are performed under the auspices of the Office of
Pesticide Programs (OPP). The requests generally seek application of OPP's technical expertise in many
areas, including the following:
Fined 1-1 October 29,1992
-------
Enforcement Case Review SOP
Introduction
• Pesticide Determinations
• Pesticide Registration Information (e.g., reviews of confidential statements of formula, as needed;
names of subregistrants; and canceled or suspended products)
* Efficacy Determinations
• Conformance to Labeling Requirements
* Conformance to Use in a Manner Consistent with Labeling
• Determination of Appropriate Testing
• Pest-Control Device Determinations
• Chemistry-Review Determinations
• Conformance with Regulatory and/or Policy Requirements.
This information, along with any accompanying documentation, serves as the Agency's position on the
issue and as the basis of any allegation of violation. If a determination of violation is made, further
supporting documentation, such as certified statements, accepted labels, and oral testimony, may be
required to substantiate the allegation in a civil administrative proceeding.
1.4 Background
Generally, ECRs are followup reviews to enforcement investigations and inspections. The review
generally involves assessing the labels and/or information collected by enforcement personnel in the
Regions for possible violations of FIFRA. ROs, RD, and in some cases, OCM's Policy Division conduct
the assessments (i.e., ECRs) to ensure compliance/enforcement consistency. The OCM coordinator is
responsible for tracking ECRs and contacting the appropriate RD staff person to check on the status of
the response and for reviewing the final response to ensure that all issues raised by the RO have been
adequately addressed.
These SOPs provide the general procedures to be followed by ROs, RD, and OCM in processing ECRs.
They are designed to minimize or reduce the paper flow between Regions and the RD, to expedite the
distribution of necessary registration information to ROs, and to assist the ROs by providing guidance
to enable them to perform their own ECRs, in particular to close out routine cases.
1.5 Implementation
These procedures are effective immediately.
Final
1-2
October 29, 1992
-------
Enforcement Case Review SOP
Introduction
CJ
IM
Final
1-3
October 29,1992
-------
Enforcement Case Review SOP
Introduction
THIS PAGE INTENTIONALLY BLANK
Final
1-4
October 29, 1992
-------
Enforcement Case Review SOP
Regional Office Procedures
2. Regional Office Procedures
2.1 Label Review
2.1.1 Obtainment Copies of Accepted PrfttftlTt I
-------
Enforcement Case Review SOP Regional Office Procedures
Figure 2. OCM's ECR Request Memorandum
(Region's Letterhead)
Date:
Memorandum
Subject: Request for Enforcement Case Review
Sample No. \
Registrant
EPA Reg. No.
From:
Regional Case Development Officer
To:
HQ Regional Coordinator
This jacket is being submitted for the following enforcement case review.
Labeling
Copy of latest accepted label
Full review and comment on differences in comparison to label accepted ,
specifically as highlighted on the accepted sample label
Registration status
Claims
Device
Other
Specific comments/details regarding this request are discussed below:
Please contact me at if you have any questions.
Attachment: Sample Jacket
Final 2-2 October 29, 1992
-------
Enforcement Case Renew SOP
Regional Office 'Procedures
requests, the RO will proceed as in Step l(b) to obtain requested labels from RD. The RO will receive
a response within 30 working days of the original submittal to the OCM coordinator. This timeframe
provides RD 21 days for review and OCM 9 days for tracking and supplementary review. RD will
inform die OCM coordinator of any delays. The OCM coordinator will keep the RO informed of any
problems or delays.
2.1.2 Comparison of Accepfytf
Deficiencies
and Samle Labelin tar Substantive Differences or
Step 1. The inspector or Regional Office shall compare labels for substantive differences,
deficiencies, or defects using the following general criteria:
(a) Differences in wording, format, or organization of a label that do not affect the actual
substance of die label are straightforward decisions that do not require RD concurrence.
(b) Differences in measurements for using the product that do not affect the end-use
concentration or dilution or do not affect the end-use dosage are straightforward decisions
that do not require RD concurrence. For example, recommending 2 ounces of product
per gallon of water rather than 1 ounce of product per half gallon of water is not a
substantive difference.
(c) Omission of or incorrect establishment number, current company address, or correct
registration number or omission of certain use patterns and/or claims from distributor
labeling, are, in most instances, straightforward differences, deficiencies, or defects that
do not require RD concurrence. The inspector or RO shall consult FIFRA Section 3
regulations and the Enforcement Response Policy for appropriate action.
(d) The following may constitute substantive label defects requiring RD review: total or
partial omission of ingredient statements, product names, precautionary information, and
directions for use, and label claims, ingredient statements, precautionary statements, and
directions for use that differ from those accepted in connection with the registration. In
such cases, the inspector or RO may contact the following RD personnel by telephone
to determine if a formal referral is indicated:
Antimicrobials:
Insecticides/Rodenticides:
Zig Vaituzis (currently)
(703) 305-7470
Richard Mountfort (currently)
(703) 305-6502
Final
2-3
October 29,1992
-------
Enforcement Case Review SOP Regional Office Procedures
• Fungicides/Herbicides: Carl Grabie (currently)
(703) 305-6900
• Child Resistant Packaging: Rosalind Gross (currently)
(703) 305-5971
(e) At the inspector's or RO's discretion, the enforcement case may be sent to Headquarters
for OCM or OPP concurrence. The inspector or RO will forward the case to the specific
OCM Regional Coordinator under the correct ECR Request Memorandum identifying the
precise substantive defect in question. Once the ECR is entered into the OCM tracking
system, the review shall be forwarded to the specific product branch responsible for the
review. The enforcement case will be referred to Headquarters in sufficient advance time
of anticipated Regional Office enforcement action. The RO will receive a response
within 30 working days of the original submittal to the OCM coordinator. This
timeframe provides RD 21 days for review and OCM 9 days for tracking and
supplementary review. RD will inform the OCM coordinator of any delays. The OCM
coordinator will keep the RO informed of any problems or delays.
2.1.3 Interpretation of
The Enforcement Response Policy and the Regional ECR Training Manual provide general guidance as
to which defects, such as those listed in Section 2.1.2, Steps l(a) through (e), are considered violative
and what enforcement actions are warranted. Inspectors and/or Regional Offices shall consult such
documents for appropriate guidance. If additional RD assistance is needed, Section 2.5 of Regional
Offices Procedures shall be followed.
2.2 Summarizations/Conclusions Regarding Scientific Test Results .
Regional Offices shall request their servicing laboratories to provide summaries/conclusions in their
technical reports on the results obtained in their analytical procedures. These summaries/conclusions shall
serve as the basis for enforcement actions as listed in the Enforcement Response Policy for the results
obtained. However, like the RD, the laboratories should not be put in a position of making
recommendations on appropriate enforcement actions.
Enforcement cases containing laboratory findings indicating the product is violative may be referred to
the appropriate RD representative listed in Section 2. 1 .2, Step l(e), through the assigned OCM Regional
Coordinator for RD assessment to determine whether the appropriate testing was conducted and whether
the product chemistry and/or biological performance are unsatisfactory. In reviewing the laboratory data,
RD will also note all deviations and assess the reliability of the test. Such referrals shall be submitted
to OCM in sufficient advance time of anticipated Regional Office enforcement action. The RO will
Final 2-4 October 29, 1992
-------
Enforcement Case Review SOP
Regional Office Procedures
receive a response within 30 working days of the original submitted to the OCM coordinator. This
timeframe provides ED 21 days for review and OCM 9 days for tracking and supplementary review.
RD will inform the OCM coordinator of any delays. The OCM coordinator will keep the RO informed
of any problems or delays.
23 Determination of Basic Registration Status, Supplemental Registration Status (Distributor),
and Pending Application Status
23.1 Status of Basic Registration
Step 1. For a preliminary check regarding active or canceled status*by registration number, the
RO accesses the Pesticide Product Information System data base directly from the mainframe at
Research Triangle Park. For EPA mainframe support, contact the National Computer Center
(NCC) Customer Support Help Line at 800-334-2405.
Step 2. For an official confirmation regarding any pending cancellation actions or to pursue
questions about cancellation actions or orders, including those under FIFRA Section 6(f)(l), the
RO will call OPP/PMSD/ISB (currently Jim Hollins at 703-305-5761).
SJsp_2. For an official confirmation regarding suspension status (under Sections 3 and 4 of
FIFRA) by registration number, the RO should call OCM/Laboratory Data Integrity Assurance
Division (LDIAD)/Program Support Referral Branch (PSRB) (currently Steve Brozena at 703-
308-8267).
2.3.2 Status of Supplemental Distributor Registration
Step 1. To check the status of supplemental distributor registration by three-element registration
number, the RO will consult the appropriate quarterly computer listing(s) currently described in
the appendix to this manual.
Step 2. To further pursue the issue, the RO will call OPP/PMSD/ISB (currently Jim Hollins at
7030305-5761).
233 Status of Pending Applications
Step 1. To check the status of pending applications, the RO directs a prepared list of EPA file
symbols, product names, and applicant names to the OCM Regional Coordinator who then looks
Final
2-5
October 29,1992
-------
Enforcement Case Review SOP Regional Office Procedures
up products in the Pesticide Regulatory Action Tracking System (PRATS). Such lists will be
transmitted to OCM in sufficient advance time of anticipated Regional Office enforcement.
Step 2. If determination of product status cannot be made using Step 1, the OCM Regional
Coordinator will then forward the ECR to:
Donald Stubbs, Chief
Registration Support Branch
Registration Division.
The RO will receive a response within 30 working days of the original submittal to the OCM coordinator.
This timefnune provides RD 21 days for review and OCM 9 days for tracking and supplementary review.
RD will inform the OCM coordinator of any delays. The OCM coordinator will keep the RO informed
of any problems or delays.
2.4 Determination of Status of Product as a Pesticide or Device Under FIFRA
2.4.1 Reference to Regulatory Documents
For determining the status of product samples under FIFRA, the inspector and/or RO shall refer to the
appendix for descriptions of die regulatory documents and references that define pesticides and devices
and indicate what is and is not subject to FIFRA.
2.4.2 Reference to Precedent-Setting Documents. Policy Documents, and Interpretive Documents
The inspector and/or Regional Office shall refer to the listed precedent-setting documents, policy
documents, and interpretative documents concerning prior determinations of the status of certain use
patterns, chemicals, claims, etc., under FIFRA for determining the status of product samples under
FIFRA.
2.43 Referral to RD Representatives
If, after reference to Sections 2.4.1 and 2.4.2, the inspector or RO cannot determine the status of a
product as a pesticide or device under FIFRA, the case may be referred to the following RD
representatives in the specific discipline that appears to be involved:
• Antimicrobials: Zig Vaituzis (currently)
(703) 305-7470
Final 2-6 October 29, 1992
-------
Enforcement Case Review SOP
Regional Office Procedures
• Insecticides/Rodenticides: Richard Mountfbrt (currently)
(703) 305-6502
Fungicides/Herbicides:
Child Resistant Packaging:
Carl Grable (currently)
(703) 305-6900
Rosalind Gross (currently)
(703)305-5971
Their referral should be made through the OCM Regional Coordinator under the correct ECR
memorandum of request mat indicates the type of review requested, such as:
• Labeling
Copy of latest accepted label
Full review and comment on differences in comparison to label accepted (date)
specifically as highlighted on the accepted sample label
• Registration Status
• Claims
• Device.
Such cases shall be referred to OCM in sufficient advance time of anticipated Regional Office
enforcement action. The RO will receive a response within 30 working days of the original submittal
to the OCM coordinator. This timeframe provides RD 21 days for review and OCM 9 days for tracking
and supplementary review. RD will inform the OCM coordinator of any delays. The OCM coordinator
will keep the RO informed of any problems or delays.
2.5 Obtainment of Additional Documentation and/or Availability of Expert Witness for Legal
Proceedings
In cases in which the RO has initiated or anticipates initiation of legal proceedings involving Sections 2.1
through 2.4 discussed previously and additional documentation and/or an appropriate expert witness are
necessary, the RO shall contact the appropriate Headquarters OCM coordinator of the ECR process for
coordination of the specific RD input needed. The Headquarters OCM coordinator shall contact the RD
Branch Chief of the specific product discipline involved (e.g., antimicrobials, insecticides) to effect the
request. The RO will receive a response within 30 days of the original contact with the OCM
coordinator. The RO will inform the OCM coordinator if the additional documentation and/or an expert
witness is needed sooner than the standard 30 days.
Final
2-7
October 29,1992
-------
Enforcement Case Review SOP Regional Office Procedurts
2.6 Processing of Emergency/Expedite Requests
All requests for emergency or expedited actions relating to Sections 2.1 through 2.5 shall be directed
from the RO to the appropriate OCM coordinator for the ECR process for coordination of the specific
RD input needed. The RO will inform the OCM coordinator of the required response time. The OCM
coordinator will then contact the RD Branch Chief of the specific product discipline involved to effect
the request and negotiate an emergency timeframe.
Final 2-8 October 29,1992
-------
Enforcement Case Renew SOP
Headquarters Procedures
3. Headquarters Procedures
3.1 Label Review
3.1.1 Provision of Copies of Accented Product Labels for Regional Office Use
Step I. ISB compiles and -distributes updates to the compact label file on a quarterly basis. The
update contains all accepted labels and associated comments for that quarter. ISB responds to
die RO's previously faxed or telephoned label requests.
Step 2. When OCM receives the RO lists of requested product labels, such lists shall be
immediately entered into the on-line tracking system and forwarded to the appropriate product
branch. The Product Manager Team shall forward a copy of each product label (and
accompanying correspondence) listed to the OCM Regional Coordinator who will log the ECR
out of the tracking system and send the ECR on to the requestor. Unless otherwise designated
by the RO, the latest accepted label for each product listed shall be forwarded. The RO will
receive a response within 30 working days of the original submittal to the OCM coordinator.
This timeframe provides RD 21 days for review and OCM 9 days for tracking and supplementary
review. RD will inform the OCM coordinator of any delays. The OCM coordinator will keep
the RO informed of any problems or delays.
3.1.2 Provision of RD Support for Substantive Label Defect Review
Step 1. Actual RD review shall not be conducted by telephone. If the difference between the
labels appears to be substantive, the RO shall refer the enforcement case to the appropriate RD
Product Branch for review through the assigned OCM Regional Coordinator. (Refer to Section
2.1.2, Steps l(a) through (e), of Regional Office Procedures for general criteria regarding label
defects.)
Step 2. When the Product Branch receives the referred enforcement case, which identifies the
precise substantive defect in question that needs RD review, the requested review shall be
performed. The Product Branch will determine if a product conforms to the labeling
requirements and whether or not the pesticide is used in a manner consistent with its labeling.
OPP will inform OCM of all findings and OCM will then determine the type of enforcement
action to take. The original copy of the review and accompanying ECR shall be sent to the
appropriate OCM Regional Coordinator who will log the ECR out of the tracking system and
mail the ECR to the referring Regional Office. The RO will receive a response within 30
working days of the original submittal to the OCM coordinator. This timeframe provides RD
21 days for review and OCM 9 days for tracking and supplementary review. RD will inform the
Final
3-1
October 29,1992
-------
Enforcement Case Review SOP
Headquarters Procedures
OCM coordinator of any delays. The OCM coordinator will keep the RO informed of any
problems or delays.
3.13 Interretation of
Defects
Refer to Section 2, Regional Office Procedures.
3.2 RD Support for Assessing Significance of Scientific Test Results
The RO refers enforcement cases containing laboratory findings indicating the product is violative (in
cases where the appropriateness/completeness of the testing or the conclusions is questioned) to the
appropriate Product Branch through the OCM Regional Coordinator. Upon receipt, RD will determine
whether the appropriate testing was conducted and whether the product chemistry and/or biological
performance are unsatisfactory. If unsatisfactory, the laboratory findings shall be reviewed further and
an assessment provided as to the significance of the unsatisfactory findings. In reviewing the laboratory
data, RD will also note all deviations from the standard methodology and their impact on the reliability
of the results. The OCM Regional Coordinator shall mail the original copy of the review and
accompanying ECR directly to die referring RO. The RO will receive a response within 30 working days
of the original submittal to the OCM coordinator. This timeframe provides RD 21 days for review and
OCM 9 days for tracking and supplementary review. RD will inform the OCM coordinator of any
delays. The OCM coordinator will keep the RO informed of any problems or delays. A carbon copy
of die review shall be placed in the product registration file.
33
OPP Support for Determination of Basic Registration Status, Supplemental Registration
Status, and Pending Application Status
Status of Basic Reistration
Step 1. OPP/PMSD/ISB (currently Jim Hollins at 703-305-576 1 ) responds to questions from the
RO regarding any pending cancellation actions or existing cancellation actions or orders.
Step 2. OCM/LDIAD/PSRB (currently Steve Brozena 703-308-8267) responds to questions from
the RO regarding product suspension status.
Final
3-2
October 29, 1992
-------
Enforcement Case Review SOP
Headquarters Procedures
3-3-2 Status of Supplemental Distributor Registration
OPP/PMSD/ISB (currently Jim Hollins at 703-305-5761) responds to questions regarding supplemental
distributor registration.
333 Determination of Product Registration Status
The Registration Support Branch (RSB) shall process the RO lists that are referred to the RSB Chief for
determination of product registration. The OCM Regional Coordinator shall log the lists out and mail
the information to die requesting RO. The RO will receive a response within 30 working days of the
original submittal to the OCM coordinator. This timeframe provides RD 21 days for review and OCM
9 days for tracking and supplementary review. RD will inform the OCM coordinator of any delays. The
OCM coordinator will keep the RO informed of any problems or delays.
3.3.4 Quarterly Reports
The Branch Chief of RSB shall immediately, and on a quarterly basis thereafter, provide 10 copies of
each computer list indicated in the appendix for distribution to the ROs. In addition, a copy of each
computer list shall be provided to each RD Product Branch at the same intervals.
3.4 RD Support for Determination of Status of Product as Pesticide/Device Under FIFRA
•
When the Product Branch receives the referred enforcement case for determination of status of the
product as a pesticide or device, the requested review shall be performed, Branch Chief concurrence
obtained, and the original copy of review and accompanying ECR shall be mailed by the OCM Regional
Coordinator to the referring Regional Office. The RO will receive a response within 30 working days
of the original submittal to die OCM coordinator. This timeframe provides RD 21 days for review and
OCM 9 days for tracking and supplementary review. RD will inform the OCM coordinator of any
delays. The OCM coordinator will keep the RO informed of any problems or delays. A carbon copy
of review shall be retained by the Product Branch.
3.5 Provision of Additional Documentation and/or Availability of Expert Witness for Legal
Proceedings
Each RD Branch Chief, upon contact by the OCM coordinator for the ECR process, shall initiate and
complete the necessary steps and arrangements to effect the special request. The RO will receive a
Final
3-3
October 29,1992
-------
Enforcement Case Review SOP
Headquarters Procedures
response within 30 days of the original contact with the OCM coordinator unless the RO has specified
an accelerated timeframe.
3.6 RD Support for Processing Emergency/Expedite Requests
Each RD Branch Chief, upon contact by the OCM coordinator for the ECR Process, shall initiate and
complete the necessary steps and arrangements to effect the special request within the emergency
timeframe agreed upon by the RD Branch Chief and the OCM coordinator.
3.7 Recordkeeping
OCM shall record all ECR interchange between the Regions and RD through the on-line tracking system.
OCM shall submit a monthly statistical report of ECR activity to the OPP Director's Office, reflecting
the distribution and status of ECRs and the types of ECRs sent to each branch (e.g., label requests,
registration status, full review).
Final
3-4
October 29, 1992
-------
Enforcement Case Review SOP
Appendix: Resource Information
Appendix: Resource Information
References
1. Code of Federal Regulations, Title 40
• Part 152 - Pesticide Registration and Classification Procedures
• Part 153 - Registration Policies and Interpretation
• Part 156 - Labeling Requirements for Pesticides and Devices.
2. List of Pesticides and Producer Establishments (integrated Section 7 with OPP registration data)
3. Compact Label File Quarterly Updates '
4. Registration Division Contact Information Sheet
5. Computer Reports - Quarterly
a) Registered Products in Numerical Sequence with Assigned Product Manager Number
b) Registered Products in Numerical Sequence with Product Name
c) Pesticide Companies and Addresses in Numerical Sequence (by Registration Number)
d) Distributor Listing by Basic Registration Number.
1 Note that each report, produced at quarterly intervals, is a new and complete listing of the current
registration records. (For example, a registered product appearing on a 1st Quarterly Report that does
not appear on a 2nd or subsequent Quarterly Report is no longer registered or a registered product
appearing on a 3rd Quarterly Report but not on the 2nd Quarterly Report means that the product was
registered in the intervening quarter. If in a particularly critical case the exact date of registration or
cancellation must be known, the Regional Office can request this information from the Registration
Support Branch. In summary, each quarterly report is a complete recreation of the current .registration
records, rather than just an update or addendum.
Final
A-l
October 29,1992
-------
Enforcement Case Review SOP
Appendix: Resource Information
Regulatory, Policy, and Other Pertinent Documents [The actual documents will be included as an
attachment to the final version.]
(Note: The "Re" remarks in the following references are intended only to give a brief overview of the
information contained within the cited document. Please refer to the document itself for specific
information.)
1. U.S. Environmental Protection Agency. 1992. General Information On Applying For
Registration Of Pesticides In The United States, Washington, DC: Office of Pesticide Programs,
Registration Division.
2. Memorandum - June 23,1972: Status Under the Federal Insecticide, Fungicide, and Rodenticide
Act of U.S.P Products.
Re: Designation of "U.S.P." alone does not constitute a pesticide claim.
3. Memorandum - April 16, 1981: Bleach/Status As A Pesticide.
Re: The status of a product as a pesticide is determined by the intended use of the product.
Such intent may be either expressed or implied. If the product is represented in any manner that
results in it being used as a pesticide, the product will be considered a pesticide (i.e.
recommendation for use as a terminal rinse for eating and drinking utensils).
4. Memorandum - June 13, 1983: Status of The Product DAMP OUT Under FIFRA.
Re: To be considered a pesticide, the product must have a specific pesticidal action (i.e. prevent,
destroy, repel, or mitigate) against an organism designated as a pest.
5. Memorandum - April 21, 1983: Aquatic Treatments Intended to Control Parasites and/or
Diseases of Fish in Ponds or Aquariums.
Re: Products used to sanitize or disinfect aquarium equipment or control algae or bacterial slime
are pesticides. Any claims for control of fish parasites and/or diseases are exempt from FIFRA.
6. Memorandum - March 13, 1973: Implementation of Definitions (k) and (n) of the FEPCA.
Re: (k) Fungus on or in processed food, beverages, or Pharmaceuticals are exempt from FIFRA.
(n) The ingredients statement must contain the name and percentage of each active ingredient and
total percentage of inert ingredients in the pesticide and if arsenic is present in any form, the
percentage of total and water soluble arsenic calculated as elementary arsenic must be stated.
7. Memorandum - March 8, 1979: Oxy-brite Shock Treatment.
Re: Products that are not registered as pesticides cannot be represented as a replacement for
superchlorination. Superchlorination or any proposed substitute is considered to be for a
pesticidal purpose.
Final
A-2
October 29, 1992
-------
Enforcement Case Review SOP
Appendix: Resource Information
8.
9.
Memorandum - March 3, 1977: Consolidated Statement of Registration Policy for Articles and
Materials Impregnated with Antimicrobial Pesticides.
Re: Antimicrobials are products, such as disinfectants, sanitizers, bacteriostats, and sterilizers,
that prevent, destroy, repel, or mitigate viruses, bacteria, or other microorganisms (except
viruses, bacteria, or other microorganisms living on or in living man or other living animals) as
well as fungicides and fungistats that inhibit or destroy pathogenic fungi on inanimate surfaces.
The chemical pesticide used to treat an article or substance to protect it against microbial activity
must be registered but the article or substance itself need not be registered unless it bears
pesticide claims.
Federal Register, September 26, 1984; 49 FR 37992:
Antimicrobial Products.
Labeling Requirements for Certain
Re: Specific claims mat can and cannot be made for the various efficacy categories are given.
10. Federal Register, May 28, 1986; 51 FR 19174: Advocacy of Pesticide Uses Which Do Not
Appear on Registered Pesticide Labels; Amendment to the Statement of Policy.
Re: Concerning antimicrobial products, claims not specifically on the label cannot be made
through any other claim statement (document contains definition of "claim"). Persons with
financial interest in any pesticide cannot make any claims that differ from those on the product's
label.
11. Policy Statement - February 27, 1984: The Use of A Diluent Not Specified On The Product
Label.
Re: Only the diluent on the product's label may be used. If no diluents are listed on the label,
water is the only diluent that may be used.
12. Memorandum - May 2, 1984: Glutaraldehyde-Based Products/Label Improvement Program.
Re: Under the label improvement program, the misuse statement must be present under the
"Directions for Use" heading, and labels must specify use directions and warning and
precautionary statements. Products containing glutaraldehyde must either state that the solution
must be discarded daily or submit efficacy data to support longer timeframes.
13. Federal Register, February 9, 1989; 54 FR 6288: Clarification of HIV (AIDS Virus) Labeling
Policy for Antimicrobial Pesticide Products.
Re: The FR notice clarifies the appropriate AIDS claims. Specific nomenclature for HIV claims
are given plus the restriction that the term "AIDS" can only be used as a parenthetical recognition
term after HIV-1 or HIV-2. Drawing attention to HIV efficacy is prohibited except with
specified areas of use. Specific use directions are given.
Final
A-3
October 29,1992
-------
Enforcement Case Review SOP
Appendix: Resource information
14. Memorandum - September 14, 1979: Label Claims for Control of Legionnaires' Disease
Bacterium in .Water Cooling Towers Which are Part of Air Conditioning System for Public
Buildings and Business Establishments.
Re: Claims for controlling the Legionnaires' disease bacterium in water cooling towers are not
permissible.
15. Memorandum - March 14, 1983: Claims Against Herpes Simplex Virus Type 0.
Re: Virucidal claims must state the specific virus the product is effective against. Specific
nomenclature for the herpes simplex virus is given. The document gives the label requirements
for various efficacy categories.
16. Memorandum - April 1, 1983: Further Guidance on Claims for Herpes Type n Disinfectants.
Re: If a product contains virucida) claims against herpes n, the use directions must state the
required contact time (10 minutes unless data supporting an alternate contact time are submitted)
and the necessity for precleaning surfaces to be disinfected, especially for products where its
nature (e.g., spray) may have an unsupported but implied "on the spot" use pattern.
17. Memorandum - July 3, 1980: Labeling of "Swimming Pool Kits."
Re: The package (kit container) must be labeled to indicate the pesticide contents. The
individual pesticide containers must be fully labeled and in child-resistant packaging when
required.
18. Memorandum • November 9, 1981: Policy on % Quat Formulations Allowed in Household
Products.
Re: Quaternary ammonium compounds of any concentration can be registered for home use
products provided they are strictly labeled for permanent eye injury and require eye and skin
protection, are packaged in child-resistant packaging, and are labeled with accepted use dilutions.
19. Memorandum - April 14, 1981: Substitution of Technical Quats (alternate suppliers) in
Disinfectant Type Products.
Re: The document lists the specific criteria for accepting alternate sources of quaternary
ammonium compounds.
20. Memorandum - June IS, 1987: Use of Iodine for Long-Term Drinking Water Sanitation.
Re: Products using iodine as the active ingredient for water sanitation are limited to short-term
and/or emergency use patterns.
21. Memorandum - March 5, 1986: Registrants of Disinfectants Containing Pine Oil.
Re: Pine oil products containing pine oil as the only active ingredient if used at a dilution must
state their limited properties as a disinfectant. Some products used at full strength can claim a
greater level of disinfection. Specific claim statements are given.
Final
A-4
October 29, 1992
-------
Enforcement Case Review SOP Appendix: Resource Information
22. Federal Register, May 28, 1986; 51 FR 19270: Tuberculocidal Activity Testing Methods for
Antimicrobial Pesticides.
Re: Glutaraldehyde-based products and quaternary ammonium compounds with tuberculocidal
claims must submit verification data based on one of three testing options.
23. Federal Register, November 19, 1976; 41 FR 51065: Pest Control Devices and Device
Producers.
Re: A device does not have to be registered under FIFRA; however, it is subject to regulation
of labeling. The producing establishment of the device must be registered. Labels must bear this
number.
24. Memorandum - December 9, 1980: Notice to All Potential Manufacturers of Water Purification
Devices.
Re: Devices claimed to be water purifiers must eliminate all pathogenic microorganisms.
Purifiers that use chemical action are considered pesticides and must have both product and
establishment registrations. Physical action purifiers are devices and subject only to establishment
registration but must also submit annual production and product distribution data.
25. Federal Register, August 5, 1976; 41 FR 32778: Interim Requirements for Registration of
Bacteriostatic Water Treatment Units for Home Use.
Re: Only filters containing chemical bacteriostatic agents, such as silver, must be registered
under FIFRA. Physical filtering devices are only subject to the labeling requirements.
Misbranding of a pesticide occurs when a label fails to satisfy the requirement of FIFRA, such
as inadequate directions for use and precautionary statements, as well as any false or misleading
information.
26. Policy Statement - December 8, 1981: Exemption for Registration - Antimicrobials Used As
Preservatives in Medical Devices Regulated by FDA.
Re: Antimicrobial agents used solely as preservatives in in-vitro reagents regulated as medical
devices are exempt from FIFRA. However, if they claim an additional pesticidal action (i.e.,
an action against an organism NOT found on or in living man or other animals or in processed
food, beverages, or Pharmaceuticals), the product must be registered under FIFRA.
27. Federal Register, December 22,1971; 36 FR 24234: Agreement Between Department of Health,
Education, and Welfare and Environmental Protection Agency, Notice Regarding Matters of
Mutual Responsibility.
Re: The notice defines EPA's and FDA's jurisdiction in the registration Of products.
Final A-5 October 29,1992
-------
Enforcement Case Review SOP
Appendix: Resource Information
28. Federal Register, September 6, 1973; 38 FR 24233: Agreement Between Department of Health,
Education, and Welfare and Environmental Protection Agency, Notice Regarding Matters of
Mutual Responsibility; Amendment.
Re: The agency (EPA or FDA) with primary jurisdiction will register the product. If the
requirements between the two agencies conflict, the requirements from the agency with primary
jurisdiction will apply. If die product is both a pesticide and a drug, the agency with primary
jurisdiction will register the product but not until notification by the other agency that the product
is in compliance.
29. Memorandum of Conference - August 7, 1972: EPA and Bureau of Veterinary Medicine (FDA).
Re: Clarification of EPA and FDA jurisdiction; EPA-pest control, odor control, inanimate
surfaces; and FDA-fish parasites and diseases, therapeutic claims.
30. Memorandum - September 17, 1982: Biocidal Fuel Additives.
Re: If die use directions for fuel additives contain any reference to aviation fuels or motor
vehicle gasoline, diesel fuel, or engine oil, the registrant must also register with the FAA
(aviation fuels) or the EPA Office of Fuel and Fuel Additive Registration (other fuels). The
product cannot be registered under FDFRA until clearance is given.
31.
32.
Federal Register, March 15, 1979; 44 FR 15768:
Veterinarians.
Pesticide Use and Production By
Re: No person may use or apply a restricted pesticide unless certified as an applicator. FIFRA
requires that a producer register all pesticides produced and the place of production. Producers
include anyone who repackages or changes the container or labeling, as well as those who alter
the product. Provided specific requirements are met, veterinarians are exempt from these
registration procedures.
Federal Register, July 28, 1980; 45 FR 50274: Statement of Policy on the Labeling
Requirements for Exported Pesticides, Devices, and Pesticide Active Ingredients and the
Procedures for Exporting Unregistered Pesticides.
Re: Pesticides intended only for export must have bilingual labeling with the ingredients
statement and precautionary statements and must also state that the product is not registered in
the United States. The label must also identify the producer. The product must have an
acknowledgement from the foreign purchaser asserting knowledge of the product's unregistered
status.
Final
A-6
October 29, 1992
-------
Reference No. 1
-------
-------
v>EPA
United Stales
Environmental Protection
Agency
Office of Prevention,
Pesticides and
Toxic Substances (H-7505C)
August 1992
General Information
On Applying For
Registration Of Pesticides
In The United States
Second Edition
-------
-------
GENERAL INFORMATION
ON APPLYING FOR
REGISTRATION OF PESTICIDES
IN THE
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS.
REGISTRATION DIVISION
SECOND EDITION — AUGUST 1992
-------
-------
PREFACE
This instruction manual, which is divided into 18 chapters,
is intended to provide a general overview and guidance for
persons seeking to register a pesticide in the United States.
Every attempt has been made to make the information contained in
this Instruction Manual accurate and current, however, changes in
the Federal pesticide law [Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) ], regulations, policies and requirements
are an ongoing process. Thus, changes may occur without you
being notified directly, and will take precedence over the
information contained herein. In this respect, changes made in
tbis second edition of the instruction manual make the previous
edition obsolete. Information in the first edition should be
disregarded.
If you wish to obtain more specific details on the laws and
regulations governing the use and sale of pesticides in the
United States, this information is.contained in the Federal
Insecticide, Fungicide and Rodenticide Act, as amended, and in
the Code of Federal Regulations (40 CFR Parts 150-189). Refer to
Chapter 16 for information on the source of these documents.
Applications and registration actions will be measured
against actual regulatory requirements for sufficiency.
Therefore, this manual should be considered as a summary offering
eneral guidance and not as a substitute for consulting
applicable regulations and law.
This second edition of the instruction manual has been
developed in an effort to provide applicants and registrants with
the most recent general guidance on registering pesticides in the
U.S. Draft copies of the second edition of the manual were sent
to a number of people for review and comment. Numerous
suggestions were received and have been incorporated in the final
document. We wish to thank all of those who responded with their
comments and suggestions.
In addition to a general updating of the original
instruction manual we have added the following entries:
1. A glossary of terms (following chapter 18);
2. A general index (following the glossary at the end
of the manual;
3. A paragraph on clearance of adjuvants (chapter 1);
4. A paragraph on clearance of inerts for products
labeled for food crops (chapter 1);
5. A clarification of "fast track" products
(chapters 2, 4);
6. A section on Reregistration Eligibility Documents
(REDs) (chapter 2);
7. A section on Data Waivers (chapter 2);
-------
8. Reference to the Food, Agriculture, Conservation,
and Trace Act (FACTA) of 1990 and the 1991
Amendments of FACTA making a number of amendments
to FIFRA, one of which vas the redesignation of
FZFRA Section 3(c)(l)(D) as Section 3(c)(l)(F)
(chapters 2, 4, 6, );
9. A labeling appendix, with a sample label format
for restricted and non-restricted use products
(chapter 2).
10. A section on final printed labeling (chapter 4);
11. A section on "certification of compliance"
statements under "How to Submit Notifications."
(chapter 4);
12. Reference to PR Notice 91-8 regarding third party
data producers (chapter 6);
13. A note indicating that the data gap option may not
be available to certain applicants (chapter 6);
14. A section on data compensation charges/payment
disputes (chapter 6);
15. The addition of a question on repackaged technical
grade products under the "Questions and Answers"
section of Chapter 6 (question 3, chapter 6) ?
16. The addition of a question on how long data
submitters have to respond to an offer to pay
under the "Questions and Answers" section of
Chapter 6 (question 11, chapter 6);
17. The addition of a question on whether an applicant
is subject to the data requirements of Agency
issued Data Call-ins, Registration Standards, and
Reregistration Eligibility Documents as well as
the requirements of CFR 158 under the Questions
and Answers" section of Chapter 6 (question 18,
chapter 6);
18. A note stating that a temporary tolerance
associated with an Experimental Use Permit is not
required if the treated commodity is to be
destroyed or consumed only by experimental animals
(chapter 7);
19. The discussion of tolerance fees in Chapter 9 has
been moved to Chapter 7;
20. Chapter 9 ("What Fees Are Required For
Registration and Tolerance Petition Activities)
has been redesignated as the "new" Chapter 8 and
chapter 8 (How to Apply For An Experimental use
Permit) has been redesignated as "new" Chapter 9;
21. Inclusion of an "Experimental Use Permit Summary
Worksheet" to new chapter 9;
22. A note warning against the transmittal of
confidential business over FAX machines
(chapter 12);
23. Addition of a section on "Grounds for EPA
Disapproval of State Registrations (chapter 14);
ii
-------
24. The addition of sections on "Shipping
(Transportation) of Pesticides*1 and "Nonindigenous
and Genetically Engineered Hicrobial Products"
regulatory contacts to Chapter 15; and
25. The addition of a facsimile directory to Chapter
18.
We hope the changes we've made to the original manual will
provide you, the reader, with more information and make the
manual easier for you to use. We welcome any comments,
suggestions for changes, or additions that you believe will make
this manual more useful. Your comments should be addressed to
Mr. Herbert S. Harrison, Chief, or Mr. Harvey L. Warnick, Deputy
Chief, Insecticide-Rodenticide Branch, Registration Division,
Office of Pesticide Programs. Their addresses and phone numbers
can be found in Chapter 18 of this manual.
iii
-------
TXBLE OP CONTENTS OF THIS INSTRUCTION MANUAL
CHAPTER 1 - WHO HOST APPLY FOR REGISTRATION
This chapter contains information on who must file, and the
various types of registrations for which you nay wish to apply.
CHAPTER 3 - HOW TO APPLY FOR RBOISTRATION OF A CONVENTIONAL
PESTICIDE
This chapter contains information on how to submit an
application to register a pesticide that you wish to distribute
or sell, and the associated data and labeling requirements.
\
CHAPTER 3 - CONSIDERATIONS POR RBQISTRATION OF A BIOCHEMICAL OR
MICROBIAL PESTICIDE
This chapter contains information on applying for
registration of biochemical and microbial pesticides.
CHAPTER 4 - HOW TO AMEND THE REGISTRATION OF A PRODUCT THAT Ifl
ALREADY REGISTERED
This chapter contains information on 1) how to amend the
registration of your product after it has been registered by this
Agency, 2) changes you may make to your registered product that
do not require notification to the Agency that you have done so,
and 3) changes you may make to your registered product, but which
require prior notification to the Agency that you have done so.
CHAPTER 5 - HOW TO APPLY FOR SUPPLEMENTAL REGISTRATION OT A
REGISTERED PESTICIDE
This chapter contains information on supplemental
registration, that is your distribution and sale of a product
that is registered by another company.
CHAPTER 6 - WHAT ARE THE DATA COMPENSATION
This chapter contains information on data compensation and
how you may comply with these requirements.
CHAPTER 7 - HOW TO SUBMIT AN APPLICATION TO REQUEST A PETITION
POR A TOLERANCE. AN EXEMPTION PROM THE REQUIREMENT OF
A TOLERANCE OR A TEMPORARY TOLERANCE
This chapter contains information on when a petition to
establish a tolerance for residue of a pesticide on food or feed
commodities is required, and how to submit the petition.
iv
-------
CHAPTER 8 - WHAT FEES ARE REQUIRED FOR REGISTRATION AMD
TOLERANCE PETITION ACTIVITIES
This chapter contains information on the fees that are
required to be paid to maintain your registration, and fees for
petitions for the establishment of tolerances.
CttAFTEK
9 - HOW TO APPLY TOR AN KXPERIMENTAIi D8B PERMIT
This chapter contains information on when you may need an
experimental use permit which allows you to test an unregistered
pesticide or a registered pesticide for an unregistered use, and
how to submit the application.
CHAPTER 10 - DEVICES - WHAT 'ARE THE REQUIREMENTS?
This chapter contains information concerning devices.
Although devices may not require registration under Chapter 3 of
FXFRA, they may be subject to other regulatory requirements.
CHAPTER 11 - HOW TO OBTAIN AN EPA ESTABLISHMENT KUMBER
This chapter contains information on the registration of
your pesticide producing establishment with the EPA, when you
need an establishment number, and how to obtain one.
'CHAPTER 12 - HOW TQ SUBMIT DATA AND CONFIDENTIAL BUSINESS
INFORMATION
This chapter contains information on the protection of
information (and data) that you submit to the Agency in support
of your registration, tolerance petition, and experimental use
permits from disclosure or release to other persons, and the
proper format for the submittal of that information and/or data.
CHAPTER 13 - TRANSFER OF REGISTRATIONS AND/OR DATA
This chapter contains information on the procedures and
information required to transfer a registration and/or data from
one company to another.
CHAPTER 14 - STATE REGULATORY AUTHORITY UNDER PIFRA
This chapter contains information on the authority of the
States to issue experimental use permits and special local need
registrations.
-------
15 — QTintR TYPES OF REGISTRATIONS AMP/OR APPROVALS
MAY BE HEEDED FROM OTHER FEDERAL OR 8TATE AGENCIES
OTHER THAN PESTICIDE PROGRAMS
This chapter contains information on the States' regulation
of Federally registered pesticides, the regulation of the use of
pesticides in meat and poultry plants by the U.S. -Department of
Agriculture, and the use of pesticides on food contact surfaces,
for paper and paperboard (food uses), on medical devices, as
human and animal drugs, and in cane-sugar and beet sugar-mills by
both the EPA and the Food and Drug Administration.
16 - PUBLICATIONS AMD HOW TO OBTAIN THEM
This chapter contains*information on the various types of
publications concerning the registration, or regulation of
pesticides and where they may be obtained.
CHAPTER 17 — FORMS AMD HOW TO OBTAIN THBM
This chapter contains information on the forms required for
various types of registration activities and where to obtain
them.
CHAPTER 18 - MAILINQ ADDRESSES MID WHO TO CONTACT FOR ASSISTANCE
This chapter contains a list of specific individuals or
offices to contact, if additional information is needed.
GLOSSARY OF SELECTED TERMS. ABBREVIATIONS AND ACRONYMS
INPE*
vi
-------
A. PBOPPOTS THAT REQUIRE REGISTRATION
Those who develop products to control pests1 are subject to
regulation under several Federal laws. However, only certain
pest control products are subject to registration; The Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) requires that
before any person in any state or foreign country can sell or
distribute any pesticide in the United States, they must obtain a
registration (or license) from the U.S. Environmental Protection
Agency (EPA). The tern "pestieiae", as defined in FIFRA section
2(u), means any substance or mixture of substances intended for
preventing, destroying, repelling, or mitigating any pest, and
any substance or mixture 6f substances intended for use as a
plant regulator, defoliant, or desiccant.
It is important to understand that FIFRA and the
implementing regulations at 40 CFR parts 150-189, are the
governing federal law regarding the sale, distribution and use of
pesticides. Those who are subject to the law are responsible for
understanding and complying with the terms of the law.
Anyone who plans to sell or distribute a product that is
intended to control a pest or manipulate a plant must become
familiar with the definition of pesticide in the law and
regulations. Particular attention should be paid to the terms
"substance" or "mixtures of substances" in the definition of
pesticide. These terms provide the key to separating pesticides
from devices. If the product contains a substance that is
intended to affect a pest or plant by causing a physiological
reaction when the target organism is exposed to. the substance
then the product is considered to be a pesticide and will require
registration unless exempted, as discussed below. On the other
hand, if the pest is controlled by a mechanical action the
product will be considered a device and registration is not
required. However, devices are subject to other provisions of
the law, which are more thoroughly explained in Chapter 10.
IMPORTANT HOTBt The Agency has determined that, since humans are
not pests as defined by FIFRA, it will not register products
whose label bears claims 'for control of humans.
The term "pest**, as defined in FIFRA section 2(t), means
(1) any insect, rodent, nematode, fungus, weed, or (2) any other
form of terrestrial or aquatic plant or animal life or virus,
bacteria, or other micro-organism (except viruses, bacteria, or
other micro-organisms on or in living man or other living animals)
which the Administrator declares to be a pest.
1- 1
-------
It is also important to fully understand the tern "intent*.
Intent under the lav can simply be demonstrated by more than
overt pesticidal claims. As set forth at 40 CFR section 152.15,
a substance is considered to be intended for a pesticidal purpose
requiring registration, if:
a) The person who distributes or sells the substance
claims, states, or implies (by labeling or otherwise)
that 1) the substance (either by itself or in
combination with any other substance) can or should be
used as a pesticide; or 2) the substance consists of or
contains an active ingredient and that it can be used
to manufacture a pesticide; or
b) The substance consists of or contains one or more
active ingredients and has no significant commercially
valuable use as distributed or sold other than 1) use
for pesticidal purpose (by itself or in combination
with any other substance), 2) use for manufacture of a
pesticide; or
c) The person who distributes or sells the substance has
actual or constructive knowledge that the substance
will be used, or is intended to be used, for a
pesticidal purpose.
EXAMPLE; Products that have no claims to control
insects on the product label, but whose name includes
the name of a substance.commonly recognized as having
pesticidal properties will be recognized as a pesticide
because the targeted consumer will know that such a
substance is a well established pesticide.
Additionally, it is important to note that the definition
for a pesticide does not make any reference to the level or kind
of toxicity that a product may exhibit in order to be considered
a pesticide. Therefore, toxicity does not have any place in
determining if a product is a pesticide. Toxicity is taken into
consideration by -EPA when it requires supporting information
(i.e. data) and when it determines if a product can be
registered, and if so what limitations will be placed on it
before it can be registered. Products that have very minimal
toxicity such as garlic, red pepper, eucalyptus, mustard, citric
acid, soap, menthol and cedar wood have been required to be
registered.
It is important to become familiar with the other
definitions in the law and regulations. The definitions for
devices, active and inert ingredients and pests are terms that
will be vital in more fully understanding the definition for a
pesticide.
1- 2
-------
IMPORTANT MOTE; if you need assistance in determining if your
product is a pesticide or device under FIFRA, you aay contact the
appropriate Branch Chief in the Antimicrobial, Herbicide/
Fungicide and Insecticide/Rodenticide Branches in the
Registration Division. The contact should be made in writing and
should include detailed information about what is intended and
what the product is made of. Submission of a proposed label for
the product would also be helpful. The addresses and/or FAX
numbers for the Branch Chiefs are found in Chapter 18. Please
send nothing via FAX that is considered confidential.
B. PRODUCTS OR 8UB8TAKCB8 THAT DO NOT RBOUIRB REQIflTRATIOlt
1. Adjuvaatss An adjuvant is a subsidiary ingredient or
additive in a mixture which contributes to the effectiveness
of the primary ingredient. Adjuvants are most commonly
added to pesticides use dilutions in tank mixes by growers
or applicators prior to application to the crop or site to
be treated. Agricultural chemical adjuvants are grouped
according to their intended purpose in the tank mix and
include but are not limited to the following groups:
acidifying agents, buffering agents, anti-foam agents,
defearning agents, anti-transpirants, color adjuvants (such
as dyes and brighteners), compatibility agents, crop oil
concentrates, oil surfactants, deposition agents, drift
reduction agents, foam markers, feeding stimulants,
herbicide safeners, spreaders, extenders, adhesive agents,
suspension agents, gelling agents, synergists, wetting
agents, emulsifiers, dispersing agents, penetrants, tank and
equipment cleaners, neutralizers, water absorbants, and
water softeners. It is important to note that although
adjuvants are not subject to registration when added in tank
mixes by growers, those adjuvants intended for use in
conjunction with a pesticide in tank mixes for application
to a food or feed crop/site are required to be cleared under
the Federal Food, Drug and Cosmetic Act (FFDCA), prior to
being used. Adjuvants that are to be used with pesticides
are evaluated in a process similar to the one for inert
ingredients. Adjuvants intended for non-pesticidal uses on
a food or feed crop/site are to be cleared with the FDA
prior to being used. Refer to 21 CFR 182.99 and 40 CFR
180.1001(c) and (d).
Registrants sometimes include adjuvants as part of their
pesticide formulations. When an adjuvant is included as part of a
pesticide formulation that ingredient is included in the Agency's
review of the product for registration under 3(c)5 or 3(c}7 of
FIFRA.
•
1-3
-------
2. Devicesi A device is any instrument or contrivance
(other than a firearm) intended for trapping, destroying,
repelling, or mitigating any pest or any other form of plant
or animal life (other than man and other than a bacterium,
virus, or other microorganism on or in living man or living
animals) but not including equipment used for the
application of pesticides (such as tamper-resistant bait
boxes for rodenticides) when sold separately. As stated
above in the previous section, registration is not
applicable for devices, although devices are subject to
other provisions of the lav. Refer to Chapter 10 for
further information.
3. Pesticide Intermediatess Pesticide intermediates are
substances which are' not themselves pesticides, but which
undergo chemical reactions resulting in the formation of a
pesticide. Pesticide intermediates are not subject to
registration under FIFRA but are subject to regulation under
the Toxic Substances Control Act (TSCA). Questions
regarding intermediates should be referred to the Office of
Pollution Prevention and Toxics (OPPT). Pesticide
intermediates include any beginning or intermediate material
which is a chemical precursor to a pesticide active
ingredient, whether produced in situ or obtained from other
sources.
4. Pesticides and pest control organisms that have been
exempted from the registration requirements of FIFRA by the
Agency under 40 CFR Part 152, Subpart B - Exemptions.
a. Pest control organisms such as insect predators,
nematodes, and macroscopic parasites. (40 CFR section
152.20(a)).
b. Those pesticides, such as (1) certain
biological control agents and (2) certain
human drugs, that are exempted because they
are regulated by another Agency. (40 CFR
section 152.20(a)and (b)).
c. Those pesticides, such as (1) pesticide-
treated articles or substances, (2)
pheromones in pheromone traps, (3)
preservatives for biological specimens, (4)
vitamin-hormone horticultural products, and
(5) foods, that are of a character not
requiring regulation under FIFRA. (40 CFR
section 152.25)
d. Pesticides transferred between registered
establishments operated by the same producer.
(40 CFR section 152.30 (a)).
1-4
-------
•. Pesticides transferred between registered
establishments not operated by the sane producer if the
transfer is solely for the purpose of further
formulation, packaging, or labeling into a product that
is registered and only if each active ingredient in the
pesticide, at the tine of transfer, is present as a
result of incorporation into the pesticide of either a
registered product or a pesticide that is produced by
the registrant of the final product. (40 CFR section
I52.30(b)).
f. Pesticides distributed or sold under an
experinental use permit issued under FIFRA section 5 if
the product is labeled in accordance with 40 CFR 172.6.
(40 CFR section 152.30(c)(1)).
g. Pesticides distributed or sold in accordance with
40 CFR 172.3, pertaining to use of a pesticide for
which an experinental use permit is not required.
(40 CFR section 152.30 (c)(2)),
h. Pesticides transferred within the United States
solely for export if the product is prepared and
packaged according to the specifications of the foreign
purchaser. (40 CFR section 152.30(d)). (Refer to
Section D of this chapter for a discussion on the
importation and exportation of pesticides.)
i. Pesticides distributed or sold in accordance with
the terms of an emergency exemption under FIFRA section
18. (40 CFR section 152.30(e)).
j. Unregistered, suspended, or canceled pesticides
transferred solely for purposes of disposal in
accordance with FIFRA section 19 or an applicable
Administrator's order. (40 CFR section 152.30(f)).
k. Distribution and sale of existing stocks of
formerly registered pesticides to the extent and in the
manner specified in an order issued by the
Administrator concerning existing stocks of the
pesticide. (40 CFR section I52.30(g)).
C. PESTICIDES INTENDED FOR USE OK FOOD OR FEED
No person may distribute or sell any pesticide product,
whether produced domestically or imported, that is not registered
under FIFRA, except as noted in CFR 40 sections 152.20, 152.25,
and 152.30. (Refer to Section C. of this chapter for a
discussion of pest management products that are regulated but'
which do not require registration and to Section D of this
chapter for a discussion on the importation and exportation of
1-5
-------
pesticides.) In addition, pesticide products intended for use on
food and/or feed crops are required to have pesticide residue
tolerances established under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
The biologically active component which is called the active
ingredient. In addition to the active ingredient, pesticide
products nay contain intentionally added biologically inactive
components called inert ingredients.
As with active ingredients, inert ingredients in pesticide
product formulations are regulated under both the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended
and the Federal Food, Drug, and Cosmetic Act (FFDCA). If your
proposed labeling bears instructions for use of the product on
food or feed crops, or if the intended use of the product results
or may be expected to result, directly or indirectly, in
pesticide residues in or on food or feed (including residues of
any active ingredient, inert ingredient, metabolite, or
degradation product), you must submit a statement indicating
whether a tolerance, exemption from the requirement of a
tolerance, or a food additive regulation has been issued by the
Agency under section 408 or 409 of the Federal Food Drug and
Cosmetic Act (FFDCA). If a tolerance, exemption from the
requirement of a tolerance, or a food additive regulation has not
been issued for such residues, your application must be
accompanied by a petition for establishment of appropriate
tolerances, exemptions from the requirement of a tolerance, or
food additive regulation in accordance with 40 CFR 180.
D« IMPORTATION AMP EXPORTATION! OF PESTICIDES
Refer to FIFRA section 17 for information concerning the
importation and exportation requirements for pesticides. Except
for the exemptions from the requirements of FIFRA listed under 40
CFR Part 152, Subpart B (see B 1., 2., and 3 above), FIFRA
requires that before any person in any state or foreign country
can sell or distribute any pesticide in the United States, they
must obtain a registration from EPA. Pesticides produced by
foreign manufacturers and imported into the U.S. must comply with
all requirements applicable to domestic producers. In addition,
the regulations require ah importer to submit to EPA a Notice of
The active ingredient in any pesticide product is that
component which kills, or other wise controls, the target pests and
includes any substance (or group of structurally similar substances
if specified by the Agency) that will prevent, destroy, repel, or
mitigate any pest, or that functions as a plant regulator,
desiccant, or defpliant within the meaning of FIFRA section 2(a).
1-6
-------
Arrival of Pesticides and Devices (EPA Form 3540-1) for review
and determination as to whether the shipment should be sampled
and/or permitted entry into the U.S. Applicants for importation
of pesticides should follow the guidance on "How to Apply For
Registration of a Conventional Pesticide" in Chapter 2 of this
manual.
FIFRA section 17 states that no pesticide produced solely
for export to any foreign country, shall be deemed in violation
of FIFRA, when prepared or packaged to the specifications or
directions of the foreign producer, except that producers of such
devices are subject to sections 2(p), 2(q)(l)(A), (C), (C), (D),
(£), (G) and (H)f 2(q)(2)(A),
-------
2« TO OBTAIM A
RBOIBTRATIOM TO DIfll
raonnev1
If you do not wish to register your own product, but
would rather market a product that is currently
registered to another company and you are willing to
enter into an agreement with that company, the basic
registrant may include you as a supplemental registrant
to his registration so that you may market his product
under your name. See Chapter 5 for detailed
instructions on how to submit an application for
supplemental registration of a pesticide product.
3. TO AMEND
GW A PRODBCT YOU
If you have a product that is already registered with
the EPA, and wish to change the formulation or labeling
text (i.e., add, delete or change formulation
components or label precautionary statements, add or
change uses) you must file an application to amend the
registration of your product. There are certain
changes that you may make that do not require an
amendment application but simply require that you
notify the Agency of the change, and other changes that
require no notification at all. See Chapter 4 for
detailed instructions on how to submit an application
for amended registration of a pesticide product.
The Agency has discretion to review applications for
registration under either the unconditional registration
criteria of FIFRA section 3(c)(5) or the conditional
registration criteria of FIFRA section 3(c)(7).
a. UNCONDITIONAL
An application will be
approved under the unconditional registration criteria
only if .the Agency has (1) determined that the
application is complete and is accompanied by all
materials required by FIFRA, including, but not limited
to evidence that the applicant has complied with the
data compensation requirements; (2) reviewed all
relevant data in its possession; (3) determined that no
additional data are necessary to make the
determinations required under FIFRA section 3 (c) (5)
with respect to the subject product; (4) determined
that the composition of the product is such as to
warrant the proposed efficacy claims for it, if
efficacy data are required to be submitted; (5)
determined that the product will perform its intended
function without unreasonable adverse effects on the
1-8
-------
environment, and that when used in accordance with
widespread and commonly recognized practice, the
product will not generally cause unreasonable adverse
effects on the environment;and (6) that the product is
not misbranded according to 40 CFR 152.2 (q) and
40 CFR 156; (7) determined that, if the proposed
labeling bears directions for use on food, animal feed,
or food or feed crops, or if the intended use of the
pesticide results or may reasonably be expected to
result, directly or indirectly, in pesticide residues
of any active or inert ingredient of the product in or
on food or animal feed, all necessary tolerances,
exemptions from the requirement of a tolerance, and
food additive regulations have been issued under FFDCA
section 408, section 409 or both; and (8) if the
product, in addition to being a pesticide, is a drug
within the meaning of FFDCA section 201(q), the Agency
has been notified by the FDA that the product complies
with any requirements imposed by FDA.
b. CONDITIONAL REGISTRATION:
1. Products that do net contain a new active
ingredient: The Agency may approve an application
for registration or amended registration of a
pesticide product, each of whose active
ingredients is contained in one or more other
registered pesticide products, only if the Agency
has determined that (1) it possesses all data
necessary to make the determinations required
under FIFRA sections 3(c)(7)(A) or (B), which
includes at a minimum, data needed to characterize
any incremental risk that would result from
approval of the application; (2) approval Of the
application would not significantly increase the
risk of any unreasonable adverse effect on the
environment; (3) the application is complete and
is accompanied by all materials required by the
Act, including, but not limited to, evidence of
compliance with the data compensation
requirements; (4) the composition of the products
is such as to warrant the proposed efficacy claims
for it, if efficacy data are required to be
submitted; (5) the product is not misbranded
according to 40 CFR 152.2(q) and 40 CFR 156;
(6)determined that, if the proposed labeling bears
directions for use on food, animal feed, or food
or feed crops, or if the intended use of the
pesticide results or may reasonably be expected to
result, directly or indirectly, in pesticide
residues of any active or inert ingredient of the
product in or on food or animal feed, all
1-9
-------
necessary tolerances, exemptions from the
requirement of a tolerance, and food additive
regulations have been issued under FFDCA section
408, section 409 or both; and (7) if the product,
in addition to being a pesticide, is a drug within
the meaning of FFDCA section 201(q), the Agency
has been notified by the FDA that the product
complies with any requirements imposed by FDA.
However, the Agency will not approve the
conditional registration of (1) any pesticide
unless it has determined that the applicant's
product and its proposed use are identical or
substantially similar to a currently registered
pesticide and use or that the pesticide and its
proposed use differ only in ways that would not
significantly increase the risk of unreasonable
adverse effects on the environment; (2) any
pesticide product for a new use if (a) the
pesticide is the subject of a special review,
based on a use of the product that results in
human dietary exposure and (b) the proposed use
involves use on a major food or feed crop, or
involves use on a minor food or feed crop for
which there is available an effective alternative
registered pesticide which does not meet the risk
criteria associated with human dietary exposure
(determined with the concurrence of the Secretary
of Agriculture).
Each registration issued for substantially similar
products and new uses shall be conditioned upon
the submission or citation by the registrant of
all data which are required for unconditional
registration of his product under FIFRA section
3(c)(5), but which have not yet been submitted, no
later than the time such data are required to be
submitted for similar pesticide products already
registered. If a notice requiring submission of
such data has been issued under FIFRA section
3(c)(2)(B) prior to the date of approval of the
application, the applicant must submit or cite the
data described by that notice at the time
specified by that notice. The applicant must
agree to these conditions before the application
may be approved.
1-10
-------
If any condition of the registration of the
product is not satisfied, or if the Agency
determines that the registrant has failed to
initiate or pursue appropriate action toward
fulfillment of any condition, the Agency vill
issue a notice of intent to cancel under FIFRA
section 6(e) and 40 CFR 152.148.
2. Products that contain a new active ingredient;
An application for registration of a pesticide
containing an active ingredient not in any
currently registered product nay be conditionally
approved for a period of time sufficient for the
generation and submission of certain of the data
necessary for a finding of registrability under
FIFRA section 3(c}(5) if the Agency determines
that (1) insufficient time has elapsed since the
imposition of the data requirement for those data
to have been developed; (2) all other required
test data and materials have been submitted to the
Agency; (3) the application is complete and is
accompanied by all materials required by FIFRA,
including, but not limited to evidence that the
applicant has complied with the data compensation
requirements; (4) has reviewed all relevant data
in its possession; (5) that the composition of the
product is such as to warrant the proposed
efficacy claims for it, if efficacy data are
required to be submitted; (6) that the product is
not misbranded according to 40 CFR 152.2(q) and
40 CFR 156; (7) determined that, if the proposed
labeling bears directions for use on food, animal
feed, or food or feed crops, or if the intended
use of the pesticide results or may reasonably be
expected to result, directly or indirectly, in
pesticide residues of any active or inert
ingredient of the product in or on food or animal
feed, all necessary tolerances, exemptions from
the requirement of a tolerance, and food additive
regulations have been issued under FFDCA section
408, section 409 or both; and (8) if the product,
in addition to being a pesticide, is a drug within
the meaning of FFDCA section 201(q), the Agency
has been notified by the FDA that the product
complies with any requirements imposed by FDA;
(9) the use of the pesticide product during the
period of the conditional registration will not
cause any unreasonable adverse effect on the
environment; and (10) the registration of the
pesticide product and its subsequent use during
the period of the conditional registration are in
the public interest.
1-11
-------
Each registration issued for a new active
ingredient shall be conditioned upon the
applicant's agreement to each of the following
conditions: (1) the applicant will submit
remaining required data (and interim reports if
required) in accordance with a schedule approved
by the Agency; (2) the registration will expire
upon a'date established by the Agency, if the
registrant fails to submit data as required by the
Agency. The expiration date will be established
based upon the length of time necessary to
generate and submit the required data. If the
studies are submitted in a timely manner, the
registration will be canceled if the Agency
determines,'based on the data (alone, or in
conjunction with other data), that the product or
one or more of its uses meets or exceeds any of
the risk criteria established by the Agency to
initiate a special review. If the Agency so
determines, it will issue to the registrant a
Notice of Intent to Cancel under FIFRA section
6(e), and will specify any provisions for sale and
distribution of existing stocks of the pesticide
product; (3) the applicant will submit an annual
report of the production of the product.
If any condition of the registration of the
product is not satisfied, or if the Agency
determines that the registrant has failed to
initiate or pursue appropriate action toward
fulfillment of any condition, the Agency will
issue a notice of intent to cancel under FIFRA
section 6(e) and 40 CFR 152.148.
IMPORTANT MOTEt A Data Matrix Chart, identifying
the FIFRA Section 158 data requirements for the
product for which registration is requested, must
be submitted with your application for registra-
tion of a product containing a new active
ingredient or for registration of a new use of a
currently registered product. Failure to submit a
Data Matrix Chart with your application could
result in your application being rejected.
F. WHO TO COMTACT TO* ADPITIOMXL HgQUKATIOH
If you have any questions, or require additional information
concerning your application for registration, contact the Product
Manager assigned to the pesticide in your product. A listing of
Product Managers and a sampling of the pesticides they are
responsible for may be found in Chapter 18.
1-12
-------
Zf you have questions of a general nature that do not
pertain to any specific pesticide, or pertain to a new pesticide
active ingredient for which you have not made an application,
contact the Deputy Branch Chief or the Branch Chief's office for
the type of pesticide (i.e., insecticide, fungicide,
antimicrobial etc.) for which you have a question. A listing of
the various Deputy Branch Chiefs, and Branch Chiefs can be found
in Chapter 18.
If you have any questions concerning devices, whether they
are subject to the Act, or establishment registration, please
contact the Office of Compliance Monitoring, Compliance Division,
(EN-342), Environmental Protection Agency, 401 M St., S.W.,
Washington, D.C., 20460. Telephone (202) 260-7835.
o. REFERENCES ciTBD IN CHAPTER i - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
Part 158 - Data requirements for registration
Part 172 - Experimental Use Permits
Part 180 - Tolerances and exemptions from tolerances
for pesticide chemicals in or on raw
agricultural commodities
2. Code of Federal Regulations, Title 21
Part 182 - Substances generally recognized as safe
3. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 2 - Definitions
Section 3 - Registration of pesticides
Section 7 - Registration of establishments
1-13
-------
-------
A.
The Agency separates pesticides into two general categories,
conventional chemical pesticides and 2) biochemical and microbial
pesticides. Refer to Chapter 3 for information oh registration
requirements for biochemical s and microbial pesticides.
B. TYPES Of PESTICIDE APPLICATIONS
The Agency categorizes pesticide applications as follows:
1. Kev chemical ~ this is an application for
registration of a product containing a new pesticide
(active ingredient) that is not an active ingredient in
a product currently registered with the Agency (40 CFR
152.114).
2. Mev use - this is an application for registration of
a use for an active ingredient ( s) , or formulation type,
not currently included in the directions for use of any
product that contains such active ingredient (s) or
formulation type. New uses are defined in 40 CFR
152. 3 (p) as follows:
a . Any proposed use pattern (i.e., one that would
result in pesticide residues in food or feed
commodities) that would require the establishment of a
tolerance, an increase in an established tolerance, or
the exemption from the requirement of a tolerance, or
food additive regulation under section 408 or 409 of
the Federal Food, Drug and Cosmetic Act (refer to
Chapter 7 for a discussion of tolerances) ,
b. Any aquatic, terrestrial, outdoor, or forestry use
pattern, if no product containing the active ingredient
is currently registered for that use pattern, or
c. Any additional use pattern that would result in a
significant increase in the level of exposure, or a
change in the route of exposure of man or other
organisms to the active ingredient.
3. "Me- too" - a "me-too" is an application for registration
of a pesticide product that is substantially similar or
identical in its uses and formulation to products that are
currently registered. A more detailed discussion of a "me-
too" product is contained in Chapter 6, D. , Question 1.
2- 1
-------
KOTII if you increase the dosage rate of your
product over that which is currently registered, change a
pre-harvest interval (PHZ) or make other changes which might
have an effect on the pesticide residues in food or feed
commodities or exposure to nontarget organisms, your
application is no longer considered to be a "me-too"
application. Changes in the inerts in your formulation,
either by varying the percent or by using inerts not
registered in a similar product, may also be a determining
factor as to whether your product is considered to be a "me-
too". if you include an unregistered source of the active
ingredient (s) in your product, the product may no longer be
considered a "me-too" product.
C. CONTENTS Of APPLICATION
Your application for registration of a pesticide must
include the following information, as applicable. For a more
detailed discussion of this information refer to 40 CFR section
152.50, Contents of Application.
1. Application Form - An original Application for Pesticide
Registration form (EPA Form 8570-1) oust be completed and
submitted with each application for registration. Detailed
instructions on completing the application form are provided
on the back of each form. It is important that you read
these instructions and that the information you provide is
complete and accurate. Be certain that the form has a red
TlUmfctr in the upper right hand corner since only EPA
original forms (forms with a red number in the upper right
hand corner of the document) are acceptable and also be
certain that you sign your application form.
Identit of the
E1B1 - An applicant must identify himself. An
applicant not residing in the United States must also
designate a U.S. agent (see below), to act on his
behalf -on all registration, and if necessary, tolerance
matters .
Address of record - An applicant must provide an
address in the United States for correspondence
purposes. The U.S. address provided will be considered
the applicant's address of record and the Agency will
send certain notices (i.e., those imposing legal
See Chapter 17 of this manual for graphic representation of
EPA Form 8570-1.
2- 2
-------
requirements) and correspondence concerning the
application and any subsequent registration information
to that address. It is the responsibility of the
applicant or registrant to ensure that the Agency has a
current and accurate address.
IMPORTANT MOTBi you must keep the Agency' informed of
your current name and address of record. If the
Agency's good faith attempts to contact you are not
successful, the Agency will issue in the Federal
Register a notice of intent to cancel all of vour
registered product* under FIFRA section 6(b) (refer to
40 CFR 152.122). You should notify the Information
Services Branch (ISB), Program Management and Support
Division (PKSD); of any changes in your company name or
address. Refer to Chapter 18 for the address.
Authorised agent - You may designate a person residing
in the United States to act as your agent. If you vish
to designate an agent, you must send the Agency a
letter stating the name and U.S. address of the agent.
You must also notify the Agency if you change your
designated agent. You may terminate a designated agent
at any time by notifying the Agency in writing.
Authorized Agent notifications are treated by the
Agency the same as company name and address changes.
Correspondence concerning authorized agents should
therefore be sent to the Information Services Branch
(ISB), Program Management and Support Division (PMSD).
2. Confidential statement ef Formula -A Confidential
Statement of Formula (EPA Form 8570-4) must be completed
and submitted with each application for registration.
Detailed instructions for completing the form and providing
acceptable information are provided on the back of the form.
Additional information can be found in 40 CFR 158.150-190.
You should also refer to 40 CFR 158.108 for additional
discussion of the product chemistry requirements.
IMPORTANT MOTE! The Confidential Statement of Formula (CSF)
is generally considered to be a document that contains
Confidential Business Information (CBI) and should not be
transmitted over FAX machines unless the sender wants to
clearly waive his or her CBI rights and states this on the
CSF.
See Chapter 17 of this manual for graphic representation of
EPA Form 8570-4.
*
2-3
-------
3. Draft labeling - The product label is the written,
printed, or graphic material on, or attached to, your
pesticide product. The term "labeling" includes all labels
and all other written, printed or graphic material which
accompanies your product when sold or distributed, or to
which reference is made on the product's label or in
literature accompanying the product.
Five copies of your proposed draft labeling must be
submitted with your application. The draft labeling may be
typed or otherwise printed, but must be legible,
reproducible and on 8 1/2 x 11 inch paper. Zf bilingual
labeling is not required by the Agency and you wish to add
such text to your labeling, you may do so after notification
to the Agency. Implicit in a notification of bilingual
labeling is an assurance that the bilingual text is an
accurate translation of the English labeling text. The
Agency recognizes that translating English language terms to
Spanish may be a problem because Spanish terms from
different parts of the Spanish speaking world may have a
whole different meaning. Registrants should use the
appropriate Spanish translation for their labeling. Note
that the Agency believes the Spanish language translations
to be used for "Caution", "Warning", and "Danger" are
"Precaucion", "Advertencia", and "Peligro", respectively.
Detailed information on labeling requirements, such as the
ingredients statement, warnings and precautionary
statements, and directions for use can be found in 40 CFR
156.10. Guidance for the content and format of labels and
labeling is provided in Appendix 2-1 and Figures 1 and 2,
which are located after section I. of this Chapter.
4. pj&a. - Three copies of all applicable data required to
support the registration of your product must be submitted
with your application. The data must be formatted in
accordance with the requirements which are provided in 40
CFR Part 158.32-34, and in PR Notice 86-5. You should also
refer to Chapter 12 of this manual, for additional guidance
on how to format your data submission. At the very minimum,
most formulated products which are substantially similar or
identical to other registered products, will be required to
submit the product specific chemistry data, which are
discussed in detail in 40 CFR Part 158.150-190. If your
product is not substantially similar or identical to another
registered product, you will also be required to submit, at
the minimum, the acute toxicity data on your product. The
toxicology data requirements can be found in 40 CFR Part
158.340. Additional information can be found in the
Pesticide Assessment Guidelines, Subdivision F. Refer to 40
CFR 158.108 for a discussion of the Pesticide Assessment
Guidelines and their relationship to the data requirements.
2-4
-------
In addition, the source of the active ingredient you use to
formulate your product must be registered, otherwise you
must provide, at a minimum, product chemistry data on the
technical grade of the active ingredient as well as on your
formulated product. It should be noted that although
efficacy data (product performance data) are not routinely
required to be submitted for most insecticide', fungicide or
herbicide products, it is the registrant's responsibility to
ascertain through testing that the product performs in
accordance with its labeling claims. EPA may require the
submission of the product performance data on which claims
are based.
IMPORTANT NOTE* Efficacy data (product performance data) are
routinely required to•be submitted to support products that
control pests of public health significance, i.e. products
to control bacteria, viruses, mosquitoes, ticks, roaches,
fleas, rats and mice. Otherwise, efficacy data may be
required to be submitted on a.case by case basis. (Note:
applicant are required to prove to themselves that the
product is efficacious when used as directed but efficacy
data need only be submitted as described above.) Refer to
40 CFR Part 158.640 for product performance data
requirements.
IMPORTANT NOTEi if you submit data that are not properly
formatted in accordance with PR Notice 86-5, or submit fewer
than the required number of copies, your application will
likely be rejected and returned.
5. riFRA section 3(e)fllfF) fformerlv 3
-------
*• Pata waivers - A waiver of data requirement* occurs when
the data appear to be required by 40 CFR Part 158 but for
some scientific reason in that specific instance it is not
necessary for the data to be generated. There is often
confusion as to what a data waiver is or is not. The
regulations nay say that certain data are not. applicable to
a category of products such as in some of the footnoted
items in the Data Requirement Tables in 40 CFR 158.
Inapplicability of data is not a waiver of data. Or, new
data nay not be necessary because there are other data that
can be substituted to fulfill the data requirement, e.g., an
applicant night submit studies done by the paint industry,
or threshold levels determined by NIOSH/OSHA to fulfil the
requirement for inhalation toxicity data for her/his
product. In this situation data are needed and appropriate,
but are already available fron an existing source. Using
data fron such a source is not a waiver of data.
On the other hand, waivers fron the data requirements
specified in 40 CFR 158, as applicable to a category of
products, nay be requested for an individual product in that
category, if that product has special features which make
the development of such data inappropriate. For example,
sone products nay have unusual physical, chemical, or
biological properties or atypical use patterns which would
make particular data requirements inappropriate, either
because it would not be possible to generate the required
data or because the data would not be useful in the Agency's
evaluation of the risks or benefits of the product. In
these cases the Agency will waive data requirements it finds
are inappropriate, but will ensure that sufficient data are
available to nake the determinations required by the
applicable statutory standards. The Agency will also, on a
case-by-case basis, consider waiving specific data
requirements when an applicant denonstrates in writing that
the specific data are not necessary for the Agency to
address the particular concern in question. The waiver
request should be accompanied by all of the pertinent
information or references to which the applicant refers.
The applicant may, under 40 CFR 152.91, demonstrate
compliance for a data requirement by:
a) claining that a waiver previously granted by the
Agency also applies to a data requirement for her/his
product. To document this claim, the applicant must
provide a reference to the Agency record that describes
the previously granted waiver, such as an Agency list
of waivers or an applicable Registration standard/
Registration Eligibility Document and must explain why
that waiver should apply to his product.
2- 6
-------
b) requesting and being granted a new waiver to satisfy
the data requirement.
An applicant vho plans to request a data waiver should
discuss his plans with the EPA Product Manager responsible
for his product before developing and submitting extensive
support information for the request. To request a data
waiver, the applicant oust submit a written request to the
appropriate Product Manager. The waiver request must
specifically identify the data requirement for which a
waiver is requested, and must provide specific information,
relative to each requirement for the compound in question,
explaining why the applicant thinks the data requirement(s)
should be waived, describe any unsuccessful attempts to
generate the required data, furnish any other information
which the applicant believes would support the request, and
when appropriate, suggest alternative means of obtaining
data to address the concern which underlies the data
requirement. For example, to support a waiver for
inhalation toxicity data, an applicant might submit
information showing that the product is of a nature that
precludes the potential for exposure. The Agency needs
scientifically sound information in order to make a
decisions oa specific data waiver requests. Simply stating
that a product is ubiquitous in nature, or is Generally
Recognised as Safe (GRAB) is insufficient. The specific
waiver must allow the Agency to determine if the kind and
levels of exposure resulting from the proposed pattern of
use is analogous to the submitted information.
The Agency will review each data waiver request and inform
the applicant in writing of its decision. .In addition, for
decisions that could apply to more than a specific product,
the Agency may choose to send a notice to all registrants or
to publish a notice in the FEDERAL REGISTER announcing its
decision. An Agency decision denying a written request to
waive a data requirement shall constitute final Agency
action for purposes of FIFRA section 16(a).
Agency decisions on data waiver requests are available to
the public at the Office of Pesticide Programs' Docket
Reading Room, Room H32, Crystal Mall Building 12, 1921
Jefferson Davis Highway, Arlington, VA 22202 from 8:00 a.m.
to 4 p.m., Monday through Friday, except legal holidays.
7. Certification relating to child-resistant packaging - If
your product meets the criteria which requires child-
resistant packaging (refer to 40 CFR 157.20 - 157.39), you
must submit a certification that the packaging that will be
used for the product meets the child-resistant packaging
standards in 40 CFR 157.32.
2-7
-------
8. Restricted u«e classification - The Agency ha* classified
some or all of the uses of certain pesticides as a
"Restricted Use Pesticide". A restricted use classification
generally restricts the product "For retail sale to and use
only by Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator's certification" [40 CFR
156.10(j)(2)]. The criteria used for determining whether
your particular product requires the restricted use
classification can be found in 40 CFR 152.170. A listing of
those pesticides that the Agency has classified for
restricted use by regulation can be found in 40 CFR 152.175.
Refer to 40 CFR 152.160 - 171 for a detailed discussion on
the classification of pesticides. A listing of all
Restricted Use Pesticides is available from the Pesticide
Information Network. See Chapter 16 for further
information.
9» Compliance With RegeotBtiratloli
Reistration
™ Prior to the FIFRA
Amendments in 1988 , the reregistration program issued
documents called Registration standards. These
Registration Standards provided information similar to
that described under "b" below. Until the existing
Registration Standards are updated by Reregistration
Eligibility Documents, the application is to be
prepared by using the Registration Standard as
instructed under "b".
b. Rereqist ration Eligibility p*»
-------
If a RED and an accompanying data call-in (DCI) have
been issued for the active ingredient(s) contained in
your product, your application for registration oust
address any data, data compensation, and labeling, or
other requirements that are applicable to your product.
D. COMPLETENESS OF APPLICATION
You are responsible for the accuracy and completeness of all
information submitted in connection with your application. The
procedures for submitting a complete application for registration
are discussed below and detailed information is contained in 40
CFR Subpart C, section 152.40 - 152.55, entitled Registration
Procedures.
A separate application for registration must be made for
each pesticide product. A pesticide product registration
pertains to a manufacturing use product or end-use formulation
with only one set of active ingredients. Variations in active
ingredients or their percentage in the manufacturing use or end-
use formulations are considered separate products and require
separate registrations. However, EPA ma£ approve a basic
formulation and one or more alternate formulations where only the
lUfiCfe ingredients vary in a single product registration. In
addition specific types of formulated products require separate
registrations (i.e., liquids, aerosols, baits, dusts, etc.).
Your application will be screened upon receipt to determine
if it is complete. If it is determined to be complete, the
application will be processed and placed in review. Incomplete
applications will be returned without further processing. A
complete application must contain the following information which
consists of two parts, one containing administrative information
and the other containing data. As you read the information
below, you should refer to Appendix 2-2, which is located after
section H. of this Chapter, for a schematic representation of the
various documents that are required to be submitted.
ADMINISTRATIVE PORTION OT APPLICATION: The Administrative portion
of your application consists of the following documentation:
1. A properly completed Application for Pesticide
Registration/Amendment (EPA Form 8570-1, Revised 9-
88)
See Chapter 17 for graphic representation of EPA
Form 8570-4.
2-9
-------
2. A properly completed Confidential Statement of
Formula (EPA Form 8570-4, Revised 2-85)
3. Five legible, reproducible copies of the proposed
draft labeling for your product on 8 1/2" x 11" paper.
4. FIFRA section 3(c)(l)(F)6 data compensation forms,
as applicable. Normally the following two data
compensation forms are required to be submitted with a
typical "me-too" application for registration.
a. A properly completed Certification with
Respect to Citation of Data [EPA Form 8570-
~7 (7-86)],
29
and
b. A properly completed Formulator*s
Exemption Statement [EPA Form 8570-27° (10-
86)].
You should refer to Chapter 6 of this manual for a detailed
discussion of the data compensation requirements and how
they may apply to your application.
IMPORTANT MOTKI only one complete set of the documents in
the administrative portion of your application is required.
This information should not be bound.
IMPORTANT MOTEi The submission of obsolete editions of the
required forms is unacceptable, and will result in your
application -being rejected. Unsigned forms are unacceptable
and will cause your application to be rejected.
See Chapter 17 for graphic representation of EPA
Form 8570-1.
6 The Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) and the 1991 Amendments of FACTA made a number of
amendments to FIFRA. One of those amendments was to redesignate
Section 3(c)(l)(D) as Section 3(c)(l)(F). Therefore, when citing
the data compensation section of FZFRA you should now refer to
3(c)(l)(F) and not 3(c)(l)(D).
7 See Chapter 17 for graphic representation of EPA
Form 8570-29 .
8 See Chapter 17 for graphic representation of EPA
Form 8570-27.
2-10
-------
DXTA PORTION OF APPLICATION! The data portion of your application
•ust address the following types of data.
1. Product specific chemistry data - usually required for
all "me-too" applications.
2. Acute tozieity data - not required to be submitted under
the cite-all Method of data compensation, if your product is
"substantially similar" or "identical*1 to another currently
registered product. Required under the Selective Method of
data compensation unless valid studies applicable to your
product are cited. Refer to footnote in Appendix 2-1.
3. Efficacy data - are routinely required to be submitted to
support products that control pests of public health
significance, i.e. products to control bacteria, viruses,
mosquitoes, ticks, roaches, fleas, rats and mice.
Otherwise, efficacy data may be required to be submitted on
a case-by-case basis. (Note: applicants and registrants
are required to ensure through testing that the product is
efficacious when used as directed but efficacy data need
only be submitted as described above.)
4. Generic data -these data pertain to the active ingredient
(as opposed to the total pesticide product). These data
must be submitted or cited for new uses or products not
formulated with a registered product and new chemicals.
IMPORTANT NOTE i Your application will be rejected if the
required three copies of the data are not properly bound and
formatted in accordance with PR Notice 86-5. Provide a Data
Matrix Chart of the data and corresponding .EPA identifier
numbers if the Selective Method of data support is used.
See page 6-8 and Appendix 6-2.
1. INCOMPLETE APPLICATIONS
If you submit an incomplete application, the processing of
your application will not begin until the deficiencies are
corrected. The application will be returned to you, with the
deficiencies identified for correction.
IMPORTANT NOTE: New Chemical/First Food Use Screening
Process. You should be aware of PR Notice 86-4, issued
April 15, 1986, which announced the Agency policy regarding
incomplete applications for registration of pesticides under
section 3 of FIFRA. Under that policy EPA generally will no
longer accept or process any incomplete application received
after May 1, 1986, for: 1) registration of a pesticide
product containing a new active ingredient or 2)
registration of the first food use of a previously
2-11
-------
registered active ingredient and 3) to petitions to
establish tolerances that accompany applications for
registration of the food uses of such chemicals.
Pfi NOTICE 86-4 REQUIREMENTS POR APPLICANTS. Each
application to which PR Notice 86-4 applies must be
accompanied by a transmittal document which:•1) identifies
the application as being for approval of a new chemical or
the first food use of a previously registered chemical; 2)
lists the studies and other materials required to support
the application in accordance with 40 CFR parts 152, 156,
158, and 162; 3) states that all such required studies and
other materials are submitted with or cited in the
application; 4) states which requirement each study or other
material satisfies; 5) lists the location in the application
where each item may be found; and 6) is signed by the
authorized representative of the applicant. Waivers of
specific data requirements may be requested in the
application, as provided by 40 CFR 158.45, but must be
accompanied by all information necessary to justify a
waiver.
EPA PROCEDURES UNDER PR NOTICE 86-4. 1) Screening of
applications! Before commencing full evaluation of an
application and supporting materials, the Agency will
conduct a two-stage screen of the application. In the first
stage the Agency will determine if 1) all items listed in
the transmittal document are included, 2) all material is
legible and written in English, and 3) all studies and other
materials required by regulations (40 CFR 152, 156, 158, and
162) are included. Applications found to be incomplete will
not be processed further, but will be returned to the
applicant.
Applications found during the screening process to be
incomplete or to include unacceptable studies will not be processed
further. The applicant will receive a statement of the reason(s)
for the rejection and instructions to arrange the retrieval of the
application within 10 days. If the applicant does not retrieve the
application, the Agency will send the material to the Federal
Records Center for permanent storage. The Agency may, however,
decide to retain studies included in an incomplete application for
review to aid in the evaluation of other existing or proposed
registrations.
2-12
-------
If the application submit*ion passes the first-stag* screen,
it vill b« further screened by scientific reviewers to
determine that any included studies appear to be acceptable
with regard to experimental design and conduct (see 40 CFR
158.80). If anv study is found to be unacceptable in thiq
seeond-staac screen the Agency vill take no further action
on the application. The application will be returned to the
applicant.
Zf a rejected application is resubnitted it will again be
screened as previously described.
Agency review tine-tables; The Agency is committed to
perform both screening processes within 15 working days of
receipt of the application by OPP's mailroom. Applicants
will be notified by telephone when an application has been
deemed complete and acceptable for the purposes of detailed
review.
The Agency is committed to completing its review of the
studies contained in applications that pass the screen
within the following timeframes: new chemical applications
for food uses or non-food uses that require chronic toxicity
data, 375 days; new chemical applications for non-food uses
that do not require chronic toxicity data, 250 days;
applications for a first food use product, from 205 to 375
days, depending upon the amount of data that must be
submitted and reviewed. In most cases, this review will
enable the Agency to decide whether each study meets the
guideline requirements and whether there is sufficient
information to conclude that the proposed uses will not
result in unreasonable adverse effects. If the Agency finds
that additional information is required to resolve issues
that arise during its review, more time will be needed to
reach a regulatory decision.
Applications found during the screening process to be
incomplete or to include unacceptable studies will not be processed
further. The applicant will receive a statement of the reason(s)
for the rejection and instructions to arrange the retrieval of the
application within 10 days. If the applicant does not retrieve the
application, the Agency will send the material to the Federal
Records Center for permanent storage. The Agency may, however,
decide to retain studies included in an incomplete application for
review to aid in the evaluation of other existing or proposed
egistrations.
2-13
-------
T.
OT «ME-*OO" XPVLTCXTTOWa VOB BRflTfl'PQ&'FTOM
Section 3{c)(3)(B) of the Federal Insecticide, Fungicide,
and Rodenticide Act requires EPA to expedite the review of "me-
too" applications for registration, i.e., products that are
« substantially similar" or "identical" to other EPA registered
pesticide products. In addition, EPA is required to (1) notify
the applicant within 45 days of receipt of the application
whether or not the application is complete and, if it is found to
be incomplete, deny it, (2) notify the applicant within 90 days
after receiving a complete application if the application has
been granted or denied and (3) if the application is denied,
notify the applicant in writing of the specific reasons for the
denial.
1. Applications Which Qualify for Expedited Review
"Me-too" applications for registration qualify for
expedited registration under section 3{c)(3)(B) of
FIFRA. A "me-too" application for registration is one
that is "substantially similar" or "identical" to
another EPA registered product, not only in the active
and inert ingredients, but also bears the same use
pattern (s) and essentially the same use directions as
another currently registered product. You must provide
the EPA Registration Number of the currently registered
product you believe is "substantially similar" or
"identical" to your product. A "me-too" application
for registration requires only minimal supporting
product chemistry, acute toxicity and, if applicable,
efficacy data.
2. Alications Which DO MOT Qualif for Exedited Review
still ns£ expedite applications for registration of
products for which the formulation or labeling vary
from that of currently registered products, i.e., it is
not "substantially similar" or "identical" to another
EPA registered product. Examples include, but are not
limited to, products that contain (a) inerts
ingredients that do not currently exist in any other
pesticide formulation; (b) significant changes in the
percentage of active ingredient; (c) new formulation
types; (d) directions for controlling new pests; (e)
directions for new dosage rates; (f) directions for
different frequency and timing of applications; (g)
directions for use in different geographical locations
other than those previously registered; and (h)
directions for use on new sites and for new methods of
2-14
-------
application for that active ingredient or ingredients.
These types of changes may increase the risk to humans
or the environment through increased exposure and
therefore require more data to assess the risks.
EPA will nffit expedite applications for "me-too technical-
grade" or "me-too manufacturing-use" products,' since
extensive product chemistry and often toxicology data are
required for these types of applications. These data are
more complex and require more time to review then the data
associated with the "me-too" applications for registration
described above in item 1.
3, H
i Yr "Me- too** Application fog
•ditad
He view
Zf you believe your "me-too" application for
registration qualifies for expedited (fast track)
review , you should print "EXPEDITE* at the top of
the application above the words "Application for
Pesticide Registration" (EPA Form 8570-1) . All
applications must be on the EPA Form 8570-1 which bears
a red unique identification number in the upper right
hand corner. You must also identify in Section II of
the application form, the EPA Registration Number and
name of the product to which you believe your product
is "substantially similar" or "identical". You must
also enclose two self -addressed, stick-on labels for
EPA to use in responding to your application. If you
are resubmitting in response to an objection letter
from EPA, your resubmission (on EPA Form 8570-1) must
be marked "Expedite-Resubmission" at the top of the
application form and must include a copy of EPA's
objection letter.
GUIDELINE FOR DETERMIKIKG AH APPLICATION'S ELIGIBILITY FOR
FAST TRACK REVIEW t A new end-use product application
qualifies for fast track review finlv. if the proposed
pesticide is identical or substantially similar to a
currently registered pesticide or differs only in ways that
would not significantly increase the risk of unreasonable
adverse effects on the environment, cited by EPA Reg. No. ,
in your application.
ti
An explanation of the 45/90-day expedited review process
(fast track) and detailed procedures for processing applications
under it may be found in PR Notice 89-2.
2-15
-------
wn BBS MS-voo APPLiG&VTam TO»T otnt.Tvv MB
Applicant references similar, registered pesticide
product and submits Product Chemistry.
Applicant references similar, registered pesticide
product and submits Product Chemistry, bridging
acutes (not more than 2 studies) and confirmatory
efficacy to confirm similarity.
Applicant is repackaging a registered product.
OF BMP QBE MB-TOO APPLICATIONS THXT DO MOT QUALIFY
FOR FAST TRACK RBVIBW:
Applicant references similar, registered pesticide
product and submits Product Chemistry, and
required Efficacy for Specific Formulation
purposes .
Applicant asserts similarity but does not
reference pesticide product. Submits Product
Chemistry.
Applicant references a similar pesticide product
and submits Product Chemistry and required
nitrogaminc data for Specific Formulation.
Applicant dofifi na£ reference a pesticide product.
Submits Product Chemistry and required nitrosamine
data for Specific Formulation.
Applicant dfififi not reference a pesticide product.
Submits Product Chemistry and the full battery of
Acutes.
Applicant references a similar registered
pesticide product. Submits Product Chemistry, the
full battery of Acutes, and required efficacy
data.
[Mote: Applications For xev Manufacturing use Products,
including *^?haiffal Grade Products, are excluded from fast
track review by FIFRA Section 3(c) (3) (B) (i) (I) .]
2-16
-------
You must direct your application or resubmission to the
appropriate address listed below and identify the type
of application in the address by using the abbreviation
shown below:
(APPL)
By Mail:
12
for an application for new product
registration
12
Document Processing Desk (Appl)
Office of Pesticide Programs (H7504C)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460-0001
By courier or hand delivery:
Office of Pesticide Programs
Document Processing Desk (Appl)
Room 258, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
4. Agency Screening of Your Application for Expedited
Review
A Front End Processing Staff (FEPS) unit has been
formed to screen and process your application for
registration.- The FEPS will provide an initial screen
of your application to determine if (1) it qualifies
for an expedited review in accordance with section
3(c)(3)(B), and (2) it is a complete application, i.e.,
it contains the administrative information and
applicable data identified in section D of this
chapter, and (3) the data are in compliance with the
data formatting requirements of PR Notice 86-5.
If your application passes the initial screening
process, it will be assigned a file symbol and sent to
the appropriate Product Manager Team for further
processing.
OPP uses Distribution Codes to facilitate the delivery of
mail, data submissions, etc., within the program. "APPL" is the
OPP Distribution Code for an application for new product
registration. If you are submitting an application for something
other than an application for new product registration refer to the
Distribution Codes for OPP set forth in Chapter 18 of this manual
or to PR Notice 91-5, Attachment 1. If you are unable to determine
which code is appropriate for your submission, omit the code.
2-17
-------
The Product Manager Team will screen the application
again, to determine that it is indeed a "me-too*
application which qualifies for the expedited review.
In addition, the Product Manager Team will determine if
the efficacy data requirements, which are routinely
required to be submitted to support products that
control pests of public health significance,' i.e.,
products to control bacteria, viruses, mosquitoes,
ticks, roaches, fleas, rats and mice, have been
addressed. If the application is determined to be
complete, the application will be placed in review.
Zf it is determined to be incomplete, the entire
application will be returned to the PEPS. The FEPS
will notify you that the Product Manager Team has
further screened your application and determined that
your application has been determined to be incomplete.
Your application will be returned.
5* Timeframes for Agency Response to Expedited **Me—too**
Application*
a. 45 Day Response - Within 45 days of
receipt of your application, EPA will notify
you whether your application is complete or
incomplete. If your application is
determined to be complete, you will receive a
letter acknowledging receipt and the file
symbol assigned to your application. If your
application is determined to be incomplete,
you will be informed in writing of what is
needed to make the application complete. For
an incomplete application, the entire
application will normally be returned to the
address of record or to the address on the
self-addressed label, if provided. (It is
your responsibility for notifying EPA of any
changes in name or address, or of a change in
designated agent, if any, to avoid
correspondence being sent to the wrong
address). If an application is too large to
be easily mailed, EPA will contact you by
telephone and request that the application be
picked up within 10 days. If the application
is not picked up within 10 days it may be
destroyed.
IMPQRTXMT MQT«t if it is determined that
your application does not qualify for an
expedited review, you will be notified and
the application will be processed according
2-18
-------
to th* regular review procedures.
Resubmissions in response to an Agency denial letter
vill initiate a new 45/90 day response cycle.
b. §0 Day Response - within 90 days of
receipt of your application which qualifies
for expedited review, EPA will conduct a full
review of the application and notify you of
the results of the review. If the initial
application was complete, the reviews are
favorable and no additional information is
required, registration will be granted. If
additional information is necessary in order
to complete our review, the application will
be denied and you will be notified in writing
of the deficiencies.
IMPORTANT NOTE: Although FIFRA requires EPA
to review applications for expedited
registration within 90 days of receipt, this
turnaround time may not be met immediately
due to a continuing backlog of applications.
However, EPA is increasing automated
resources, developing instructional aids
(this manual is one of these aids) for
applicants and making necessary procedural
changes in order to eliminate the backlog and
to meet the 90 day response time for
expedited reviews as soon as possible.
O. WHERE TO SUBMIT YOUR XPPLICATIOM
See section F.3. of this Chapter for the address to be used
in submitting your application for expedited review to the
Agency. Refer to Chapter 18 of this manual for the address to be
used in submitting all other applications to the Agency.
S. WHO TO CONTACT FOR ADDITIONAL IKTQRMATIQM
If you have any questions, or require additional information
concerning your application for registration, contact the Product
Manager assigned the pesticide in your product. A listing of
Product Managers and a sampling of the pesticides they are
responsible for may be found in Chapter 18.
If you have any questions concerning the status of your "Me-
too" Application for Registration within the 45 day timeframe for
the Agency's notifying you of whether the application is complete
or has been denied, you should contact the Front End Processing
Staff, Registration Support Branch. Refer to Chapter 18 for the
telephone number.
2-19
-------
If you have question* of a general nature that do not
pertain to any specific pesticide or pertain to a nev pesticide
active ingredient for which you have not made an application,
contact the Deputy Branch Chief or the Branch Chief's office for
the type of pesticide (i.e., insecticide, fungicide, herbicide,
antimicrobial, etc.) for which you have a question. A listing of
the various Deputy Branch Chiefs and Branch Chiefs 'can be found
in Chapter 18.
I. RerBRBKCEB c^y^P m CHAPTER a - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
Part 153 - Registration policies and interpretations
Part 156 - Labeling requirements for pesticides and devices
Part 157 - Packaging requirements for pesticides and devices
Part 158 - Data requirements for registration
Part 180 - Tolerances and exemptions from tolerances for
pesticide chemicals in or on raw agricultural
commodities
2. Federal Food, Drug and Cosmetic Act, as amended
Section 408 - Tolerances for pesticide chemicals in or on
raw agricultural commodities
Section 409 - Food additives
3. Federal Insecticide, Fungicide and Rodenticide Act, as
amended, October 1988
Section 3 - Registration of pesticides
Section 4 - Reregistration of pesticides
4. PR Notice 86-4 - Submission of Incomplete Applications for
Registration of Pesticides Under Section 3 of
FIFRA. Issued by the Registration Division,
Office of Pesticide Programs, EPA, April 15,
1986.
5. PR Notice 86-5 - Standard Format for data submitted under the
Federal Insecticide, Fungicide and
Rodenticide Act, and certain provisions of
the Federal Food, Drug and Cosmetic Act.
Issued by the Registration Division, Office
of Pesticide Programs, EPA, July 29, 1986.
2-20
-------
6. PR Notice 89-2 - Expedited Review of Applications for
Registration or Amended Registration.
Issued by the Registration Division, Office
of Pesticide Programs, EPA, June 6, 1989.
7. PR Notice 91-5 - Instructions for Transmitting Information to
the Office of Pesticide Programs. Issued by
the Program Management and Support Division,
Office of Pesticide Programs, EPA, September
6, 1991.
7. Listing of Restricted Use Pesticides, compiled by the
Registration Support Branch, Registration Division, Office
of Pesticide Programs, EPA.
8. Listing of Registration Standards and Reregistration
Eligibility Documents (REDs), compiled by the Document
Management Section, Information Services Branch, Program
Management Support Division.
9. Food, Agriculture, Conservation, and Trade Act of 1990,
November 28, 1990
Subtitle H - Pesticides; Sections 1491 through 1499
10. Food, Agriculture, Conservation, and Trade Act
Amendments of 1991, December 13, 1991
Section 1006 - Amendments to FIFRA and Related
Provisions
2-21
-------
APM8MDIT 2-1
PESTICIDE IABELIMO MSQ vTBBItBHTg
EPA*s requirements and policies for pesticide labels and
labeling are specified in 40 CFR 156.10, Pesticide Regulatory
(PR) Notices and various decision documents for specific
chemicals (i.e., Special Reviews, Registration Standards,
Reregistration Eligibility Documents, etc.). Following are
general and specific guidelines for the contents of labels and
labeling. Sample formats are shown in Figures 1 and 2.
General Guidance
Labels and labeling ntust accurately communicate important
precautions and instructions to the user so that each product is
effective without causing unreasonable adverse effects to humans
or the environment. In addition, the label is a legal,
enforceable document. Therefore, labels and labeling must meet
the following general criteria:
* Comply with EPA's regulatory requirements.
6 Be clear and understandable to the user under normal
conditions.
0 Provide accurate precautions and directions that
protect the user, other humans and the environment.
0 Contain no false or misleading statements or implied
Federal Government endorsements.
0 Clearly distinguish between language that is mandatory
and enforceable statements and language that is only
advisory and cannot be enforced.
Specific Guidance
Following is a summary of the specific items that must
appear on the label and/or labeling. The location of these items
is shown in Figures 1 and, 2, which are sample formats for
restricted use and unclassified products, respectively.
Item 1. PRODUCT NAME - The name, brand or trademark is required
to be located on the front panel, preferably centered in the
upper part of the panel. The name of a product will not be
accepted if it is false or misleading. [40 CFR 156.10(b)]
2-22
-------
Item 2. COMPANY HAKE AND ADDRESS - The name and address of the
producer, registrant or person for whom the product is produced
are required on the label and should be located at the bottom of
the front panel or at the end of the label text. [40 CFR
156.10(c)]
Item 3. NET CONTENTS - A net contents statement is required on
all labels or on the. container of the pesticide. The preferred
location is the bottom of the front panel immediately above the
company name and address, or at the end of the label text. Net
contents must be expressed in conventional American units of
fluid ounces, pints, quarts, and gallons. The net contents must
also be expressed in the largest suitable unit, e.g., "1 pound 10
ounces11 rather than "26 ounces." In addition to American units,
net contents may be expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No." or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it. The registration number and
the required identifying phrase must not appear in such a manner
as to suggest or imply recommendation or endorsement of the
product by the Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number,
preceded by the phrase "EPA Est." is the final establishment at
which the product was produced, and may appear in any suitable
location on the label or immediate container. It must also
appear on the wrapper or outside container of the package if the
EPA establishment number on the immediate container cannot be
clearly read through such wrapper or container. [40 CFR
156.10(f)3
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
required, preferably on the front panel immediately below the
product name. The ingredients statement must contain the name
and percentage by weight of each active ingredient and the total
percentage by weight of all inert ingredients, with a total of
100%. It must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the body
of other text. See Figures 1 and 2. [40 CFR 156.lO(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricultural
formulations, the pounds per gallon of active ingredient must be
indicated on the label.
Item 6C. NAMES TO BE USED IN INGREDIENT STATEMENT - The
acceptable common name, if there is one, shall be used, followed
by the chemical name. If no common name has been established,
the chemical name alone shall be used.
2-23
-------
Item 6D. INERT INGREDIENTS RECLASSIFIED AS ACTIVE INGREDIENTS -
If EPA has reclassified chemicals from inert ingredient status to
active ingredient status, registrants of affected products must
change the ingredient statement accordingly .If such pesticides
have food uses, tolerances nay be required to be established if
the percentage of the pesticide in the product formulation
exceeds the limits set in the exemption from tolerance under 40
CFR 180.1001. (Note: If EPA has reclassified chemicals from
active ingredient status to inert ingredient status, registrants
of affected products must also change the ingredient statement
accordingly.) [40 CFR 153.125]
Item 6E. NOMINAL CONCENTRATION - The amount of active ingredient
declared in the ingredient statement must be the nominal
concentration of the product as defined in 40 CFR 158.153(i) and
described in PR Notice 91-2.
Item 7. WARNINGS AND PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together on the label
(preferably within a block outline) so as to appear with
sufficient prominence relative to other front panel text and
graphic material to make then unlikely to be over-looked under
customary conditions of purchase and use. The table below shows
the minimum type size requirements for various size labels.
Size of Label on
Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word
Minimum Type Size
All Capitals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement "Keep
Out of Reach of Children" must be located on the front panel
above the signal word except where contact with children during
distribution, use or storage is unlikely, or in the instances
where the pesticide has been approved for use on infants or small
children. [40 CFR 156.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement. [40 CFR 156.10(h)(l)(i)] The
signal word is also required on the side panel under Hazards to
Humans and Domestic animals (see Item 8A).
2-24
-------
Item 7C. SKULL ft CROSSBONES AMD WORD "POISON" - On product*
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the Word "Poison" shall appear on the label
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word POISON. [40 CFR 156.10(h)(1)(i)(A)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
III. (40 CFR 156.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "see Side (or Back)
Panel for Additional Precautionary Statements" is required on the
front panel of all products unless all required precautionary
statements appear on the front panel. [40 CFR 156.10(h)(l)
fill)]*
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on the
label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that these
statements be surrounded by a block outline. Each of the three
hazard warning sections must be headed by the appropriate
subheadings (8A, 8B and 8C). [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident,
injury or damage. These statements must be preceded by the
signal word. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to non-
target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h)(2)(ii)]
During the reregistration review process the Agency may
require that the Statement of Practical Treatment include toxicity
due to skin and eye effects in addition to oral, dermal or
inhalation effects. The Agency may, in the course of that review
process, also require that the Statement of Practical Treatment
appear on the front panel of the label. These and other labeling
requirements resulting from the reregistration review process will
supersede the instructions in this manual.
2-25
-------
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY -
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
40 CFR 156. 10 (h) (2) (iii) . The requirement is based on the
results of required flashpoint determinations and flame extension
tests submitted for all products. These statements are to be
located in the side/back panel precautionary statements section,
preceded by the heading "Physical/Chemical Hazards. * Note that
no signal word is used in conjunction with the flammability
statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation) . If your
product has been classified for restricted use, then these
requirements apply:
1. All uses restricted. The following statements should be
placed in a box (block outline) at the top of the front panel of
the label and labeling:
a. The statement "Restricted Use Pesticide" must appear at
the top of the front panel of the label. The statement must be
set in type of the same minimum size as required for the human
hazard signal word [see table in 40 CFR 156,10(h) (1) (iv) ] . (The
signal word is determined by the product's toxicity category,
just as it is for general use products.) MO stateMnta of
**e
b. The reason for the restricted use classification should
appear below the RUP statement. Statements may be used in
combination if there is more than one reason for the RUP
classification. Some examples of restricted use reason
statements are listed below:
1. "Acute inhalation toxicity"
2. "Acute dermal toxicity"
3. "Acute oral toxicity"
4. "Acute eye irritation"
5. "Toxic to fish and aquatic organisms"
6. "Toxic to birds"
7. "Toxic to wildlife"
2-26
-------
8. "Potential for groundvat*r contamination11
9. for teratogenicity: "Has been shown to cause birth
defects in laboratory animals"
10. for oncogenicity: "The use of this product nay be
hazardous to your health. This product contains
(Chemical Name}, which has been determined to
cause tumors in laboratory animals" '
11. "Due to the complexity of application and use
directions"
c. A summary statement of the terms of restriction must
appear directly below this reason statement on the front panel.
If use is restricted to certified applicators, the following
statement is required: "For retail sale to and use only by
Certified Applicators or persons under their direct supervision
and only for those uses covered by the Certified Applicator's
Certification."
2. Some but not all uses restricted. If some uses are
classified for restricted use and some are not, several courses
of action are available:
a. If you wish to include both restricted and unrestricted
uses on a single product label, you may do so, but you must label
the product for restricted use.
b. You may delete all restricted uses from your label and
submit draft labeling bearing only unrestricted uses. (Of course
you lose the uses you delete, but you may sell an unrestricted
product.)
c. You may "split" your registration, i.e., register two
separate products with identical formulations, one bearing only
unrestricted uses, and the other bearing restricted uses. To do
so, submit two applications for registration, each containing all
forms and necessary labels. Both applications should be
submitted simultaneously. Note that the products will be
assigned separate registration numbers upon registration.
Item 9B. MISUSE STATEMENT - All products must bear the misuse
statement, "It is a violation of Federal law to use this product
in a manner inconsistent with its labeling." This statement
appears at the beginning of the directions for use, directly
beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a restricted entry interval
(REI) has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
2-27
-------
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are required
to bear storage and disposal statements. These statements are
developed for specific containers, sizes, and chemical content.
These instructions must be grouped and appear under the heading
"Storage and Disposal1* in the directions for use. This heading
must be set in the same type sizes as required for the child
hazard warning. Refer to PR Notices 83-3 and 84-1 to determine
the storage and disposal instructions appropriate for your
product(s).
Item IOC. DIRECTIONS FOR USE - Directions for use must be stated
in terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect.the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment. The directions for use must
include the following: (a) the site(s) of application, i.e.,
crops, animals, areas, or objects to be treated; (b) identifi-
cation of the target pest(s) associated with each site; (c) the
dosage rate associated with each site and pest; (d) the method of
application, including instructions for dilution, if required,
and type(s) of application apparatus or equipment required;
(e) the frequency and timing of applications necessary to obtain
effective results without causing unreasonable adverse effects on
the environment; and (f) any limitations or restrictions on use
required to prevent unreasonable adverse effects, i.e., required
intervals between application and harvest of food or feed crops,
rotational crop restrictions, warnings as required against use
in or adjacent to certain areas or on certain crops, animals or
objects. [40 CFR 156.10(1)(2)]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers or other written, printed or graphic matter which is
referred to on the label or which is to accompany the product are
called collateral labeling. Such labeling may not bear claims or
representations that substantially differ from those accepted in
connection with registration of the product. Collateral labeling
must be submitted along with the application for registration.
USE OF BILINGUAL LABELING
If bilingual labeling is not required by the Agency and you
wish to add such text to your labeling, you may do so after
notification to the Agency. Implicit in a notification of
bilingual labeling is an assurance that the bilingual text is an
accurate translation of the English labeling text. The Agency
recognizes that translating English language terms to Spanish may
be a problem because Spanish terms from different parts of the
Spanish speaking world may have a whole different meaning.
2-28
-------
Registrants should us* the appropriate Spanish translation for
their labeling. Hote that the Agency believes the Spanish
language translations to be used for "Caution", "Warning", and
"Danger" are "Precaucion", "Advertencia", and "Paligro",
respectively.
MATERIAL SAFETY DATA SHEETS (MSDS)
Material Safety Data Sheets (MSDS) are Hazard Communication
Standards required by the U. S. Department of Labor's
Occupational Safety and Health Administration under 29 CFR
1910.1200. They are required for chemicals, other than
pesticides, and serve much like the label on a pesticide product
in conveying safety information about the chemical.
FIFRA Section 2(p)(2)(A) defines labeling as "all labels and
all other written, printed, or graphic matter accompanying the
pesticide or device at any time." Including an MSDS in or on a
carton of pesticide product would meet this definition. However,
EPA does not intend to review Material Safety Data Sheets as
labeling at this time but will instead permit them to accompany a
pesticide product under the provisions of 40 CFR 152.46(b)(3)
which permits registrants to change a product's non-mandatory
labeling or packaging, including additions or changes required by
other Federal statutes or regulations, without notification to or
approval by the EPA, providing such labeling is consistent with
the labeling requirements set forth in 40 CFR Part 156.
Registrants should note that it is possible that information on
an MSDS could conflict with a pesticide label (e.g., protective
clothing recommendations or first aid directions) and that they
should therefore assure that the MSDS and the approved pesticide
labeling are not in conflict. EPA may find a conflict to be a
misbranding violation under FIFRA section 12(a)(l)(E) as defined
in FIFRA section 2(q).
2-29
-------
*»
I
i
4!
IH
KSi
2«5i
fir
T
••M
j
i
§
8
^
•• »• •£
II 8
if i
K h. •*
Si I £
***
E-S-r
§
.1
ie
•K^' &
,Jfr
f?i" ff
s
Al
t
w
g
I
«T
I
-------
8
I.
4*
2
I
m
*
1
%
3
1
6
1
1
o
g
PM.
4
a
•
•«
i
Ml
M
a
Sw
>
tu So
" iPl
^ I^illg
IW
T
MM
1
T
I
i
t
-------
a
*
s
e
|u ..
iii
- s
:i
i
Jig
-------
APPENDIX 2-
COMPLETE APPLICATION FOR REGISTRATION Of a TYPICAL "MB-TOQ"
RBQDIRgg TBB TOLLOWTWfl DOCPMBMTB •••-™-
ADMINIBTRATIVB PORTION OF APPLICATION! (DO HOT BIND DOCUMENTS
OR PAGES TOGETHER)
Application for Pesticide Registration
— (EPA Porn 8570-1)
DOCUMENT 1
DOCUMENT 2
Statement identifying the "substantially
similar" or "identical" product
DOCUMENT 3
Confidential Statement of Formula
(EPA Form 8570-4)
DOCUMENT 4
Draft labeling (5 copies)
Formulator's
Exemption Statement
(EPA Form 8570-27)
IDOCU
SENT 5
Certification with
— Respect to Citation of
Data (EPA Form 8570-29)
DOCUMENT 6
j DOCUMENT_7_ j
Data Matrix
Chart
(Required under
the selective
method of
support ONLY)
DATA PORTION OF APPLICATION! (FORMATTED AS DESCRIBED IN
PR NOTICE 86-5)
Product specific Chemistry
Data (3 copies)
DOCUMENT 1
DOCUMENT
•II
- — — _
IDOCUME)
rr 3
L,-
•
or
Product Specific Acute Toxicity
Data (3 copies) *
(Required under the selective method
of support ONLY)
Efficacy Data (3 copies) if
required (routinely
required for products that
control pests of public
health significance)
* Under the selective method of support these data requirements
may be addressed by either submitting the actual data, or by
referencing EPA's Master Record Identification (MRID) number on
the Data Matrix Chart.
2-33
-------
-------
XICROBIAL PESTICIDE
A. GENERAL IHTORMATIOlff
The following discussion and information is a general
overview of the Agency's policies and regulations as they relate
to biochemical and microbial pesticides.
Biochemical and microbial pesticides are generally
distinguished from conventional chemical pesticides by their
unique modes of action, target species specificity, and natural
occurrence. In addition, low use volumes microbial pesticides
may be capable of growth and reproduction in the environment or
in suitable hosts (40 CFR 158.65). Both naturally occurring and
genetically modified microorganisms are included in the microbial
pesticide group.
Although the administrative contents of an application for
registration of a biochemical or microbial pesticide are the same
as a conventional chemical pesticide, biochemical and microbial
pesticides are subject to a different (generally reduced) set of
data requirements as specified in 40 CFR 158.690 and 158.740.
The Agency has published guidance for developing these data in
the Pesticide Assessment Guidelines, Subdivision H, Microbial and
Biochemical Pest Control Agents (see Chapter 16 of this manual
for a source.) You should also refer to Chapter 2 for general
information on submitting an application for registration, and to
Chapter 9 for additional information concerning experimental use
permits.
The Agency's policies and requirements concerning the
notification and reporting requirements for small-scale field
tests and the experimental use permit and registration
requirements for microbial pesticides under FIFRA were discussed
in detail in the Federal Register Notice of June 26, 1986 (51 FR
23313).
The Federal Register Notice of June 26, 1986, and the 40 CFR
citations provided throughout this chapter should be referred to
for detailed information on these policies and regulations.
IMPORTAUT MOTE: The Agency is developing a separate registration
guidance document specifically for biochemical and microbial
pesticides that may be available by the time you receive this
manual. It is recommended that you contact the appropriate
Product Manager (see section F.) for this document and for
additional guidance prior to initiating testing, or filing an
application for registration of a biochemical or microbial
pesticide.
3-1
-------
IMPQRTMIT MOTES Once you have obtained the data from your EUP,
follow the procedures in Chapter 2 of this manual when filing an
application for registration of a biochemical or microbial
pesticide.
S. PRODUCTS EXEMPT FROM REGISTRATION
The Agency has determined that pest control organisms such
as insect predators, nematodes, and macroscopic parasites are
exempt from the requirements of FIFRA [(see 40 CFR 152.20(a). In
addition, pheromones and identical or substantially similar
compounds labeled for use only in pheromone traps and pheromone
traps in which those chemicals are the sole active ingredient are
not subject to regulation under FIFRA [(40 CFR 152.25(b)].
IMPORTANT NOTE: The use of pheromones in traps in conjunction
with conventional pesticides, or in other application methods
(other than traps) are subject to regulation under FIFRA.
C. BIOCHEMICAL PESTICIDES
Biochemical pesticides include, but are not limited to,
products such as semiochemicals (e.g., insect pheromones),
hormones (e.g., insect juvenile growth hormones), natural plant
and insect growth regulators, and enzymes. When necessary, the
Agency will evaluate products on an individual basis to determine
whether they are biochemical or conventional pesticides.
D. MICROBIAL PESTICIDES
Microbial pesticides are microorganisms and include but
are not limited to bacteria, algae, fungi, viruses, and
protozoa used as pest control agents (40 CFR 152.20).
The data requirements in 40 CFR 158.740 apply to all
microbial pesticides, including those that are
naturally-occurring as well as those that are
genetically modified. Each "new" variety, subspecies,
or strain of an already registered microbial pest
control agent must be evaluated, and may be subject to
additional data requirements.
Genetically modified or non-indigenous microbial.
pesticides may be subject to additional (or lesser)
data requirements or information requirements on a
case-by-case basis depending on the particular
microorganism, its parent microorganism, the proposed
use pattern, and the manner and extent to which the
organism has been genetically modified. Additional
requirements may include information on the genetic
engineering techniques used, the identity of the
inserted or deleted gene segment (base sequence data or
enzyme restriction map of the gene), information on the
3-2
-------
control region of the gene in question, a description
of the "new" traits or characteristics that are
intended to be expressed, tests to evaluate genetic
stability and exchange, and/or selected Tier II
environmental expression and toxicology tests.
B* SMALL-SCALE FIELD TBPTIfffl tf¥BL I REPORTING AMD I,
NOTIFICATION REQUIREMENTS
II
The information provided below is a general overview of the
small-scale field testing requirements for microbial pesticides
as described in the June 26, 1986 Federal Register Notice (51 FR
23313). It is also recommended that you contact the appropriate
Product Manager listed at the end of this Chapter to determine
current policies concerning testing and registration requirements
for microbial pesticides, since these policies and requirements
are currently being revised.
Small-scale field studies are (1) terrestrial field studies
that involve 10 acres or less of land; and (2) aquatic field
studies that involve 1 surface-acre or less of water.
!• l-evel i reporting - Level Z reporting for small-
scale field testing applies to all genetically
engineered or non-indigenous microbial pesticides not
otherwise covered by Level II notification. Detailed
information on the reporting requirements is contained
in the June 26, 1986, Federal Register Notice (51 FR
23303).
The Agency will have up to 30 days to review the above
information reported to make a preliminary determination of
the need for an experimental use permit (EUP). If, on
preliminary assessment, the test raises sufficient concerns
such that the Agency determines that additional information
or monitoring is warranted (e.g., microorganisms for which
there is limited scientific information or regulatory
experience, or that warrant specific environmental
monitoring during the test), then an EUP will be required.
In this case, the applicant has two options:
1) the applicant may apply for a permit providing the
necessary data and information required to support the
application, or
2) the applicant may provide all additional data and
information required under Level II notification.
If the latter option is chosen, the Agency will review the
full notification package and make a determination as to
whether an EUP is required.
3-3
-------
TMPQRTMTT MOCTt Since most microbial pesticides are at least
toxic to the target organism, and therefore are "pathogens", they
cannot be considered under Level I but must instead be submitted
under Level ZZ.
2. Level II notification - Level II notification for small-
scale field testing applies to microbial pesticides:
Microbial pesticides formed by deliberately combining
genetic material from organisms of different genera,
genetically engineered microbial pesticides derived from
source organisms that are pathogens, and non-indigenous
pathogenic microbial pesticides. A pathogen is defined as
an organism that has the ability to cause disease in other
living organisms (i.e., humans, animals, plants, or
microorganisms) ' • •
Notification should include adequate background information
on the microorganism, and description of the proposed test.
Detailed information of the notification requirements is
contained in the June 26, 1986, Federal Register Notice (51
FR 23303). The Agency encourages prospective applicants to
meet with the EPA prior to submission of their notification
to discuss their field test and to determine what specific
data vould be necessary to evaluate the product.
Once the supporting data have been submitted, the Agency has
up to 90 days to review each Level II notification and
determine if an EUP is required.
F. WHO TO CONTACT FOR ADDITIONAL HffORMATIOir
If you have any questions or require any additional
information concerning biochemical or microbial pesticides,
contact Product Manager 18 for insecticide products or Product
Manager 21 for herbicide or fungicide products. A listing of
Product Managers may be found in Chapter 18.
G. REFERENCES CITED III CHAPTER 3 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
Part 158 - Data requirements for registration
2. Federal Register Notice, June 26, 1986 (51 FR 23303)
3. Pesticide Assessment Guidelines, Subdivision M, Microbial and
Biochemical Pest Control Agents, October 1982, (EPA No.
540/09-82-028) Environmental Protection Agency
3-4
-------
IMPORTMJT WPTgt Th« Agency is currently revising the
Subdivision M Guidelines. The draft document dated March,
1989 is available from the Public Docket and Freedom of
Information Section, Field Operations Division, see
Chapter 18 of this manual for a contact point.
3-5
-------
-------
CHXPTBH 4 - SOW TO AMBMD
XUIK1DY
A. QBMSRMi IMTORMATIOM
Except as provided below, any proposed modifications in the
composition, labeling or packaging of a registered product must
be submitted, with an application for amended registration (EPA
Form 8570-1), to the Agency for prior approval. The application
must contain the information required by 40 CFR 152.50, as
applicable to the change requested. If an application for
amended registration is required, the application must be
approved by the Agency before the product, as modified, may be
legally distributed or sold.
B. AMgMPMEMTS THAT REQUIRE A FORMAL APPLICATION TO XKBMD THE
REGISTRATION OF YOUR PRODUCT
The following types of amendments that you may wish to make
to your product registration, require that you 1) submit a formal
application to amend the registration of your product, 2) submit
or cite supporting data, as applicable, and 3) address the data
compensation requirements of FIFRA section 3(c)(l)(F) [formerly
3(c)(l)(D)] to the extent that they apply to your proposed
amendment.
1. "He-Top** Amendments - "Me-too" amendments are those that
you wish to make to your product registration which include
for example, the addition of uses, revised dosage rates, or
application methods that appear on the labeling of other
currently registered products that are substantially similar
or identical to your product. Changes to your basic
formulation, other than those identified in section C. of
this Chapter, also require a formal application (EPA Form
8570-1) and Confidential Statement of Formula (EPA Form
8570-4) to amend your registration. Some of the more
general types of "me-too" amendments are discussed below.
As you read this information, you should refer to the
appropriate Appendices which are located after section H of
this Chapter.
The Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) and the 1991 Amendments of FACTA made a number of
amendments to FIFRA. One of those amendments was to redesignate
Section 3(c)(l)(D) as Section 3(c)(l)(F). Therefore, when citing
the data compensation section of FIFRA you should now refer to
3(c)(l)(F) and not 3(c)(l)(D).
4-1
-------
*-• AdMJ.ni.et rat ive types of BsWBflli
— those
amendments, for example labeling changes (such as a
product name change) or revisions to your products
formulation which do not require supporting data,
require the following documentation. Refer to Appendix
4-1 which follows section H of this Chapter, for a
schematic representation of what documentation is
required with your application.
1) H
ohanres. other than those identified
in section C., require an Application for
Pesticide Amendment (EPA Form 8570-1), and 5
copies of the proposed labeling. Labeling changes
must comply with current regulations, policies and
format. (See Appendices 2-1 and 2-2)
IMPQRTMTT HOTBi The deletion of use patterns,
pests, claims, or sites of use from your
registered labeling can no lonacy be accomplished
as a Notification under PR Notice 88-6. The 1988
revisions to FIFRA [section 6 (f)], require the
Agency to publish in the Federal Register, notice
of receipt of requests to amend a registration by
deleting one or more uses from the product
labeling, in order to provide the public with
knowledge of the potential loss of a product or a
specific use of a product. This provision of the
1988 amended FIFRA supersedes this part of PR
Notice 88-6. • Your application to delete uses from
your labeling must be submitted as a formal
application to amend your registration.
IMPORTANT NOTE: FIFRA section 6(F) does not apply
when a registrant simply chooses to market a
product with a subset of approved uses, but does
not formally delete the uses from its
registration. [40 CFR 152.130.]
Guidance for the content and format of labels and
labeling is provided in Appendix 2-1 and Figures 1
and 2, which are located after section H. of
Chapter 2.
2) Formula changes, revisions to your basic
formulation or alternate formula requests, other
than those identified in section C. , require an
Application for Pesticide Amendment (EPA Form
8570-1) , and a Confidential Statement of Formula
(EPA Form 8570-4). Five (5) copies of draft
labeling will be required if the formula revision
results in a change in the ingredient statement on
the label.
4-2
-------
TMPQRTMIT MOTE* Revisions to the formulation of
pesticide products that control pests of public
health significance, i.e., products to control
bacteria, viruses, mosquitoes, ticks, roaches,
fleas, rats and mice, which routinely require the
submission of efficacy data to support the revised
formulation are not considered to be an
administrative amendment. Refer to the following
section on "me-too" amendments.
b* "Me^too** am
that recniire supporting data —
as indicated in 1. above, these are amendments you want
to make to your product, that already exists on another
currently registered substantially similar or identical
product. Refer -to Appendix 4-2, which follows .section
H of this Chapter, for a schematic representation of
what documentation is required with your application.
Depending upon your proposed amendment, your
application will require an administrative portion and
a data portion.
IMPORTANT KOTO i The discussion provided below
concerning the information to be submitted with a "me*
too" amendment is general in nature and does not cover
all possible types of "me-too" amendments. If you have
any questions as to what information should be
submitted with your application, you should contact the
appropriate Product Manager for your product.
1) Administrative portion — includes the
following:
- Application for Pesticide Amendment (EPA Form
8570-1)
- Statement identifying the "substantially
similar1* or "identical" product (by EPA
Registration No.) that is currently registered and
is labeled for the change you are proposing for
your product.
- Confidential Statement of Formula (EPA Form
8570-4), if required. This is not normally
required unless you are proposing a change in
your formulation.
- Five (5) copies of your proposed draft
label ing. It would make the Agency's review go more
quickly if you highlight those changes on your
proposed labeling. A light colored felt tip
marker could be used to highlight the proposed
changes .
4-3
-------
- Certification with Respect to Citation of Data
(EPA Form 8570-29) .
- Formulator's Exemption Statement (EPA Form 8570-
27) , if needed. [This is not needed if you have
already submitted it and the information is still
current and if your source is registered and your
application is not affected by PR Notice 91-8.}
- Data Matrix Chart. Required if you elect to use
the Selective Method of data compensation. The
data required to support the application may be
addressed by either submitting the actual data, or
by referencing EPA's Master Record Identification
(MRID) number on the Data Matrix Chart.
2} Data portion - includes the following data, as
applicable:
- Acute toxicity data - required if you propose a
change in the precautionary labeling or the
signal word for your product.
- Efficacy (product performance) data - may be
required if you are proposing to add a new pest
to a pesticide product that controls pests of
public health significance, i.e., products to
control bacteria, viruses, mosquitoes, ticks,
roaches, fleas, rats and mice. In addition,
changes to your basic formulation may require
additional efficacy data. You may wish to contact
the appropriate Product Manager to determine if
additional efficacy data are needed to support
your proposed amendment.
- Use specific data - may be required if you
choose not to compensate the original submitter of
the data or if the data are exclusive use.
MOTEI when submitting data, 3 copies -
properly bound and formatted in accordance with PR
Notice 86-5 are required. Refer also to Chapter
12 of this manual for additional information on
submitting data.
c. Expedited Review of "Me-toe" Applications for
Amended Ri
Section 3(c)(3)(B) of the Federal Insecticide,
Fungicide, and Rodenticide Act requires EPA to expedite
4-4
-------
the review of "me-too" applications for registration,
i.e., products that are "substantially similar" or
•identical" to other EPA registered pesticide products.
In addition, EPA is required to (1) notify the
applicant within 45 days of receipt of the application
whether or not the application is complete and, if it
is found to be incomplete, deny it, (2) notify the
applicant within 90 days after receiving a complete
application if the application has been granted or
denied, and (3) if the application is denied, notify
the applicant in writing of the specific reasons for
the denial.
1) ADD!ieations Which Qualify for Expedited Review
"Me-too" applications for amended registration
qualify for expedited registration under section
3(c)(3)(B) of FIFRA. A "me-too" application for
amended registration is one that is "substantially
similar" or "identical" to another EPA registered
product, not only in the active and inert
ingredients, but also bears the same use
pattern(s) and essentially the same use directions
as another currently registered product. You must
provide the EPA Registration Number of the
currently registered product you believe is
"substantially similar" or "identical" to your
product. A "me-too" application for amended
registration would require only minimal supporting
data (provided, of course, that the "me-too"
registrant cites existing data for that use)
depending on the type of amendment: product
chemistry, acute toxicity, or efficacy data, as
applicable.
2) Applications Which DO HOT Qualify for Expedited
Review
- EPA will not expedite applications for amended
registration of products for which the formulation
or labeling vary from that of currently registered
products, i.e., it is not "substantially similar"
or "identical" to another EPA registered product,
unless the amendment is of a nature that review of
scientific data would not be required [see FZFRA
section 3(c)(3)(B)(i)(II)]. Some examples of
products that may not be considered substantially
similar are those which involve inerts that are
(a) not currently included in registered products
or (b) will change the precautions of those
required for "similar" products; changed
4-5
-------
percentages of active ingredient*; new peats; nev
dosage rates; different frequency and timing of
applications; geographical locations other than
those previously registered; new sites; and new
methods of application. These types of changes
nay increase the risk to humans or the environment
through increased exposure and therefore may
require more data to assess the risks.
- EPA will nofr expedite applications for amended
registration of "me-too" products proposing an
unregistered source (s) of the active ingredient,
since extensive product chemistry and often
toxicology data are required for these types of
amendments. These data are more complex and
require more time to review then the data
associated with the "me-too" applications for
amended registration described above in item 1.
- EPA will not expedite applications to amend the
labeling of your registered product to delete use
patterns, pests, claims, or sites of use. The
1988 amendments to FIFRA require the Agency to
publish in the Federal Register a notice of
receipt of such amendments, in order to provide
the public with knowledge of the potential loss of
a product or a specific use of a product.
3)
Sow to flubmifc Your »'M«—too'* AnBli.cafci.on tor
Expedited Review
If you believe your "me-too" application for
registration Qualifies for amended expedited (fast
track) review , you should print "EXPEDITE" at
the top of the application above the words
"Application for Pesticide Registration/Amendment"
(EPA Form 8570-1). All applications must be on
the EPA form 8570-1 which carries a red unique
identification number in the upper right-hand
corner. You must also identify in Section II of
the application form, the EPA Registration Number
and name of the product to which you believe your
product is "substantially similar" or "identical".
You must also enclose two self-addressed, stick-on
labels for EPA to use in responding to your
application. If you are resubmitting in response
An explanation of the 45/90-day expedited review process
(fast track) and detailed procedures for processing applications
under it may be found in PR Notice 89-2 and the examples of fast
track applications on page 4-7 of this section.
*
4- 6
-------
to an objection latter from EPA, your rasubmission
(on EPA Fora 8570-1) must be marked "Expedite-
Resubmission" at the top of the application form
and must includ* a copy of EPA's objaction lattar.
GUIDELINE FOR DgTERKIMINO Ml APPLICATION'S
ELIGIBILITY FOR FAST TKACK REVTEf; Amend-
•ants ara antitlad to fast track review undar
two (2) conditions:
1) Any amendment (end-use product or
manufacturing-use product) that
does not require scientific review
of data;
2) If minimal" data submitted with the
amendment for an end-use product
are for the purpose of confirming
that the changed formula or label
are identical or substantially
similar to a currently registered
pesticide cited in your amendment
application.
Minimal data could include product
chemistry, acute toxicity, or efficacy data.
Vote: If your original application
qualifies for expedited review, a
resubmission of that application will
likely also qualify for expedited
review.
SX1M9LBS 09
Any amendment which asserts that the
proposed change in labeling or formula
is not significant.
Either no data are required to be
submitted or confirming chemistry/
acute/efficacy data are submitted to •
support the assertion.
Any administrative amendment (not
requiring review of data).
4-7
-------
KT&M9IA Ol
DO MOT OHXtTFT VOB TCLBT
TRACK RgVI_--
Any amendment not identified above as
qualifying for fast track review will be
reviewed as a non-fast track submission.
You must direct your application or resubmission
to the appropriate address listed below and
identify the type of application in the address by
using the abbreviation shown below:
• to amend a currently registered
(AMEND)J
product
By Kail:
Document Processing Desk (AMEND)
Office of Pesticide Programs (H7504C)
U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
By courier or hand delivery:
Office of Pesticide Programs
Document Processing Desk (AMEND)
Room 258, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
4) Aaeney screening ef Your ADDlieatfl-PB for
dit«d
A Front End Processing Staff (FEPS) unit has been
formed to screen and process your application for
amended registration. The FEPS will provide an
initial screen of your application to determine if
1) it qualifies for an expedited review in
accordance with section 3(c)(3)(B); and 2) it is a
complete application, i.e., it contains the
administrative information and/or applicable data
OPP uses Distribution Codes to facilitate the delivery of
mail, data submissions, etc., within the program. "AMEND11 is the
OPP Distribution code to amend a currently registered product. Zf
you are submitting an application for something other than an
application to amend the registration of a currently registered
product refer to the Distribution Codes for OPP set forth in
Chapter 18 of this manual or to PR Notice 91-5, Attachment 1. Zf
you are unable to determine which code is appropriate for your
submission, omit the code.
*
4-8
-------
identified in section B.l.b. of this Chapter; and
3) the data are in compliance with the data
formatting requirement* of PR Notice 86-5.
If your application passes the initial screening
process, it will be sent to the appropriate
Product Manager Teaa for further processing.
The Product Manager Team will screen the
application again, to determine that it is indeed
a "me-too" application which qualifies for the
expedited review. In addition, for those
amendments that require efficacy data to be
submitted, i.e., antimicrobial products and
vertebrate pest control products, the Product
Manager Team will, determine if these data
requirements have been addressed. If the
application is determined to be complete, the
application will be placed in review. If it is
determined to be incomplete, the deficiencies will
be identified and the entire application will be
returned.
5) Timefi
XOABOV
to
dlfcad
"Me-too" Applications for Amended Registration
a. 45 Dav Response - Within 45 days of
receipt of your application, EPA will notify
you whether your application is complete or
incomplete. If your application is
determined to be complete, you will receive a
letter acknowledging receipt. If your
application is determined to be incomplete,
you will informed in writing of what is
needed to make the application complete. For
an incomplete application, the entire
application will normally be returned to the
address of record or to the address on the
self-addressed label, if provided. (It is
your responsibility for notifying EPA of any
changes in name or address, or of a change in
designated agent, if any, to avoid
correspondence being sent to the wrong
address). If an application is too large to
be easily mailed, EPA will contact you by
telephone and request that the application be
picked up within 10 days. If the application
is not picked up within 10 days it may be
destroyed.
4-9
-------
TMPORTAMT MQCTi if it is determined that
your application does not qualify for an
expedited review, you will be notified and
the application will be processed according
to the regular review procedures.
Resubmissions in response to an Agency denial
letter will initiate a new 45/90 day response
cycle.
a. «C Day aesponae - Within 90 days of
receipt of your application which qualifies
for expedited review, EPA will conduct a full
review of the application and notify you of
the results of the review. If the initial
application was complete, the reviews are
favorable and no additional information is
required, the amendment will be accepted. Zf
additional information is necessary in order
to complete our review, the application will
be denied and you will be notified in writing
of the deficiencies.
IMPQRTXMT MQCTi Although FIFRA requires EPA
to review applications for expedited
registration within 90 days of receipt, this
turnaround time may not be met immediately
due to a continuing backlog of applications.
However, EPA is increasing automated
resources, developing instructional aids
(this manual is one of those aids) for
applicants and making necessary procedural
changes in order to eliminate the backlog and
to meet the 90 day response time for
expedited reviews as soon as possible.
2. New Use Amendments - These are amendments to add "new
uses'* to your product labeling that are not currently
registered for the active ingredient or combination of
active ingredients contained in your product, for example, a
new food or feed use or a change in use pattern from indoor
to outdoor use. New uses are defined in 40 CFR 152.3(p).
Your application to amend your registration should contain
an administrative portion and a data portion. Refer to
Appendix 4-3 which follows section H of this Chapter, for a
schematic representation of the types of documentation
required with your application. Your proposed amendment
will require an administrative portion and a data portion.
IMPORTAMT MOTBi The discussion provided below concerning the
information to be submitted with a new use amendment is
general in nature and does not cover all possible types of
4-10
-------
new use amendments. If you have any questions as to what
information should be submitted with your application, you
should contact the appropriate Product Manager for your
product. You should also be aware that applications
proposing the registration of the first food use for a
previously registered active ingredient are subject to the
screening procedures in PR Notice 86-4. Under these
procedures if your application is determined to be
incomplete your application will not be processed and will
be returned.
1) Administrative portion of AjBTTlflflient Application
includes the following:
Application for Pesticide Amendment (EPA Form
8570-1).*
Five (5) copies of your proposed draft labeling.
In addition submit one (1) label clearly marked to
show the addition (s), deletion (s), or change (s)
you plan to make on your amended labeling. This
marked up label can be done on a copy of your
proposed label or on the label which was
previously registered. It would make the Agency's
review go more quickly, if you were to highlight
your proposed changes with a light colored felt
tip marker.
IMPORTANT NOTE: All other parts of the label
requiring prior EPA approval and not included in
your proposed amended label must remain as
previously accepted by the Agency.
Certification with Respect to Citation of Data
(EPA Form 8570-29).
Formula tor's Exemption Statement (EPA Form
8570-27).
Data Matrix Chart. Required if you elect to use
the Selective Method of data compensation. The
data required to support the application may be
See Chapter 17 of this manual for graphic representation of
EPA Form 8570-1.
See Chapter 17 of this manual for graphic representation of
EPA Form 8570-29.
6 See Chapter 17 of this manual for graphic representation of
EPA Form 8570-27.
4-11
-------
addressed by either submitting the actual data, or
by referencing EPA's Master Record Identification
(MRID) number on the Data Matrix Chart.
refer to 40 CFR sections 158.202 thru 158.740 to
determine what data are required to support your
proposed use. You may be required to submit data on
both the technical grade of the active ingredient and
on your formulated product. In addition, new food or
feed uses will require a petition for a tolerance or an
exemption from a tolerance. Refer to Chapter 7 of this
manual for a discussion of tolerance petitions.
IMPORTANT NOTEt Efficacy (product performance) data
are routinely required to be submitted to support your
proposed use if you are proposing a new product that
controls pests of public health significance, i.e.,
products to control bacteria, viruses, mosquitoes,
ticks, roaches, fleas, rats and mice. However, for
most uses, i.e., insecticides, fungicides, and
herbicides, the Agency does not require that these data
be submitted. Each registrant must, however, ensure
through testing that its products are efficacious when
used in accordance with label directions and commonly
accepted pest control practices. In order to generate
efficacy data for your proposed new use, it is usually
necessary to conduct large scale testing. It is
necessary to obtain an experimental use permit (EUP) in
order to carry out this testing, and if a food or feed
use is involved, temporary tolerances or exemption from
tolerance are also required. Refer to Chapter 9 of
this manual for a discussion of EUP's. You may wish to
contact the appropriate Product Manager to determine if
additional efficacy data and EUP's are needed to
support your proposed amendment.
IMPORTANT NOTEt when submitting data, 3 copies,
properly bound and formatted in accordance with PR
Notice 86-5 are required. Refer also to Chapter 12 of
this manual for additional information on submitting
data .
C. AMENDMENTS THAT DO NOT REQUIRE
THE RBQIBTRATIOK OF YOUR PRODUCT
A FORMAL APPLICATION TO AMEND
As provided in 40 CFR 152.46, there are certain changes or
amendments that can be made to your registered product that do
not require you to make a formal application to amend your
4-12
-------
registration, and are not subject to the data compensation
provisions of FIFRA section 3(c)(l)(F) . Refer also to PR
Notice 88-6.
1. KOTITICATIOHS - Chances that you can make to vour
registered product that require Aoenev notification, but not
approval.
As provided in 40 CFR section 152.46(a), there are certain
changes, or amendments, you may make to your registration,
provided that you notify the Agency that you have made the
change before the product with the changes is distributed or
sold. You need not obtain Agency approval of such changes,
or amendments, and you may distribute or sell the product,
as changed, as soon as you submit your notification of the
change to the Agency.
You should note, however, that with each notification the
Agency reserves the right to require that you submit a
formal application for amended registration. If a formal
application is required, the Agency will notify you and
state the reasons for requiring a formal application for
amended registration in lieu of your notification. If, as a
result of our request you fail to submit a formal
application for amended registration without good cause, the
Agency may determine that the product is no longer in
compliance with the requirements of FIFRA, and initiate
cancellation proceeding under FIFRA section 6. In addition,
you should be aware that your notification to the Agency is
considered to be a report filed under FIFRA for the purposes
of FIFRA section 12(a)(2)(M). In part, FIFRA section 12
(a)(2)(H) states that it is unlawful for you to distribute
or sell your pesticide product, if you have knowingly
falsified any part of any application for registration
submitted to the Agency.
a. LABELING CHANGES
The following label revisions may be accomplished by
notification. Notification of these changes must be
accomplished by submission of an Application for
Pesticide Registration/Amendment (EPA Form 8570-1)
"Notification".
The Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) and the 1991 Amendments of FACTA made a number of
amendments to FIFRA. One of those amendments was to redesignate
Section 3(c)(l)(D) as Section 3(c)(l)(F). Therefore, when citing
the data compensation section of FIFRA you should now refer to
3(c)(l)(F) and not 3(c)(l)(D).
4-13
-------
1) xdditioii or substitution of frr,ap4 pames- You
may market your product under separate brand names
provided you notify the Agency of the additional
brand name(s) you intend to use. Each name must
differ from the name of any other product that you
have registered, so as to permit clear
identification of the product in case of
emergency. However, you should continue to refer
to the product by its official name of record
(i.e., the name of your product as it appears on
the Notice of Registration, unless a product name
change was approved by the Agency) in all
correspondence with the Agency.
IMPORTANT 'KOTBi The additional brand name must
not be false or misleading. In accordance with 40
CFR I56.10(a)(5) and (b)(2), a product is
considered to be misbranded if its labeling is
false or misleading in any particular way.
Accordingly, product names may not contain words
such as i.e., "safe" or "natural" which are
considered to be implied safety claims. In
addition, product names may not contain words
which imply additional unapproved uses or efficacy
claims that are more promising than the product
can actually produce, such as the kinds of pest
the product will control, i.e., "ABC Fireant
Control" where the product will not control
fireants and fireant is not one of the pests on
the product label; "XYZ Six Month Roach Spray",
where there is no data to support the "six month"
efficacy claim; or "AZ Total Control Insecticide"
where the product does not offer total control.
Where appropriate data exists to support such
claims they may be submitted for consideration to
the appropriate Product Manager as a formal
application for amended registration.
In addition, claims such as "professional
strength", "extra strength" and similar statements
may not be used on your product labeling,
including in the product name. (Refer to PR
Notice 91-7 for more information).
Note that the addition of a brand name should not
be confused with supplemental registration by a
different company under agreement with you (Refer
to Chapter 5 - Supplemental Registration).
4-14
-------
Also note that you nay not change the actual
product name of record (as opposed to the brand
name) without staking a formal application to amend
your registration and receiving approval prior to
sale or distribution.
2) Dse of billmyua.'!
If bilingual
labeling is not required by the Agency, you nay
add such text to your labeling after notification
to the Agency. Implicit in a notification of
bilingual labeling is an assurance that the
bilingual text is an accurate translation of the
English labeling text. The Agency recognizes that
translating English language terns to Spanish nay
be a problem because Spanish terns fron different
parts of the Spanish speaking world nay have a
whole different meaning. Registrants should use
the appropriate Spanish translation for their
labeling. Note that the Agency believes the
Spanish language translations to be used for
"Caution", "Warning", and "Danger" are
"Precaucion" , Aviso", and "Peligro", respectively.
3) changes in warranty. You may, after
notification to the Agency, nake changes in the
warranties or warranty disclainers on the label.
notification to the Agency, nake changes in
labeling language consistent with 40 CFR Part 156,
provided the changes flo not involve changes in the
ingredients statement, precautionary statements or
directions for use*
5) Final printed labeling. After acceptance of a
new product registration or labeling amendment,
final printed labeling must be submitted before
the product is sold or distributed. Such labeling
may be submitted as a notification provided that
three (3) copies of the final labeling are
submitted which incorporate any labeling changes
required by the acceptance letter.
Final printed labeling is the label or labeling
which will accompany the pesticide product when
distributed or sold and includes not only the
container label, but also all accompanying
technical information, brochures, etc. , but does
not include the package of the product, unless the
labeling is an integral part of the package.
4-15
-------
Final printed labeling for the Agency's files
should be of a size that can be stored
conveniently in 8 1/2 x 11 inch files. The label
may be mounted or photoreduced to meet the size
requirements provided the printing is legible and
is of microfilm reproduction quality. Should
photoreduction make any of the text illegible, the
text must be typed out on an accompanying sheet of
paper.
J.abel ing should be submitted as is,
unless it requires photoreduction.
Screen printed labeling should be printed by
taping paper on the container as it goes through
the printing process. The actual container should
not be submitted.
Embossed labeling should be photocopied.
Unusual size labeling, such as large bags or
boxes, must be photoreduced either in one
reduction or in sections so that each section is 8
1/2 x 11 inches.
IMPORTANT NOTE* The following labeling changes cannot
be submitted as a notification. A formal Application
for Amended Registration (EPA Form 8570-1) must be
submitted for Agency approval.
a) The deletion of use patterns, pests, claims, or
sites of use from your registered labeling can not
be accomplished as a notification. The 1988
revisions to FIFRA [section 6 (f)], require the
Agency to publish in the Federal Register, notice
of receipt of requests to amend a registration by
deleting one or more uses from the product
labeling, in order to provide the public with
knowledge of the potential loss of a product or a
specific use of a product. In order to delete
uses from your labeling, other than for the
distribution or sale of a product under labeling
bearing any subset of any subset of the approved
directions for use as provided for under 40 CFR
152.130, you must submit a formal application to
amend your registration and receive Agency
approval .
b) Addition of sites or uses.
4-16
-------
c) Delation of precautionary language or
restrictions.
d) Any actions concerning an unregistered product
or an application for amended registration which
has not been accepted by the Agency.
b. PRODUCT CHEMISTRY CHANGES
The following product chemistry changes nay be
accomplished by notification. Notification of these
changes must be accomplished by submission of a revised
Confidential Statement of Formula (EPA Form 8570-4),
together with an Application for Pesticide
Registration/Amendment Form (EPA Form 8570-1), marked
"NOTIFICATION".
1) Active ingredient - You may change the source
of an active ingredient in your product by
notification to the Agency, provided that the
alternate source(s) is an EPA-registered product.
This applies whether the alternate source is
purchased by you from another company, or is part
of an integrated system [as defined in 40 CFR
158.153(g)] used by you.
IMPORTXKT NOTBi The following changes are not
acceptable as notifications; a formal Application
for Amended Registration (EPA Form 8570-1), and
EPA approval must be obtained prior to sale and
distribution:
a. You may not make any change in the source
of an active ingredient, or any other change
in the formulation, This change will require
a formal application for amended registration
and Agency approval.
b. You may not make any change in the source
of an active ingredient which necessitates
changing either the nominal concentration of
a solvent or that of any other inert
ingredient so that it would exceed its
certified limits. This would be considered
Registrants of products containing or manufactured with
Chlorofluorocarbons (CFCs), Hydrochlorofluorocarbons (HCFCs),
Carbon tetrachloride, or Methyl chloroform should refer to
PR Notice 92-3 "Pesticides and the Clean Air Act: Stratospheric
Ozone Protection", issued March 19, 1992, for instructions
regarding amendment of such labels.
4-17
-------
an alternate formulation and require a formal
application for amended registration and
Agency approval. Such a change may result in
significant changes in the toxicological or
chemical properties of the product.
c. You mav not change to an unregistered
source of an active ingredient without
submitting a formal application for amended
registration, with the required product
chemistry data, and obtaining EPA approval
prior to sale and distribution.
d. You may not add, delete or substitute
active ingredients by notification. The
addition, deletion, or substitution of active
ingredients constitutes a new formulation
which requires a separate registration.
e. You mav not make a change in the stated
nominal concentration of any active
ingredient, or add certified limits not shown
on the previously submitted Confidential
Statement of Formula (EPA Form 8570-4). Such
changes require a formal application for
amended registration and Agency approval.
2) Inert ingredients
a) If for any reason, you have been required
by the Agency to identify the source of an
individual inert ingredient whose identity
and composition are known to you, you may
change the source of that inert ingredient by
notification to the Agency.
If you have not been required by the Agency
to identify the source of an individual inert
ingredient, you may change sources freely,
without notification to the Agency.
b) You may change, by notification, the
stated nominal concentration of any other
Note that the Agency believes that if you go above one-
tenth (1/10) of the concentration of that presently approved the
toxicity of the product may be affected. Appropriate acute
toxicity data may have to be generated to make this determination.
If a change does result labeling revision and data will be required
to be submitted to the Agency as a regula amendment. In some cases
you may be required to submit an application for a new product.
4-18
-------
inert ingredient provided the certified
limits for that ingredient are not exceeded
and the composition of the ingredient is
known to you.
IMPORTANT MQTBi Note particularly that all
of the above changes in a), b), and c) are
limited to inert ingredients vhose complete
identity or specific composition is known to
you, such as specific solvents or common
commodity diluents. Changes in proprietary
ingredients, which generally are composed of
a mixture of ingredients and whose
composition is not disclosed to you, may ng£
be made by notification but must be made by
a formal application for amended
registration and Agency approval. Since you
do not know the composition of such inert
ingredients, the Agency must determine its
acceptability based upon information on its
composition supplied by the producer.
3) Starting materials for integrated system
products
If you produce a product by an integrated system,
[defined in 40 CFR 158.153(g)], you are required
to supply the Agency with the sources of the
starting materials.for each such ingredient. If
you propose to change the source of your starting
materials, you may do so by notification to the
Agency if the change will not result in:
a) a significant increase in the level of any
existing impurity of toxicological concern
(to exceed the upper certified limit of that
impurity), or
b) the formation of any new impurity at a
level greater than 0.1 percent by weight of
the technical grade active ingredient.
4) change in formulation process
You may, by notification, modify a formulating
operation [defined in 40 CFR 158.153(c)], i.e., a
unit operation such as blending, diluting or
drying, as distinguished from a unit process
involving a chemical reaction, provided that the
certified limits of the active and inert
ingredients will not change as a result.
4-19
-------
O. HOW TO SUBMIT NOTIFICATIONS
1) To submit a notification, you must us* the
Application for Registration/Amendment Form (EPA
Form 8570-1), and write the word "NOTIFICATION PER
PR NOTICE 88-6" Prominently in the explanation
part of Section IX. A separate application (EPA
Form 8570-1) must be submitted for sash product
registration for which you are submitting a
notification.
If a product chemistry notification is being made,
a new Confidential Statement of Formula (EPA Form
8570-4) must accompany the notification
application, together with a copy of the latest
accepted Confidential Statement of Formula.
If a labeling change notification is being made,
the revised label text should be included as an
attachment, including "before" and "after" text
for comparison. On the "after" labeling, text
which has been revised should be highlighted,
preferably with a light colored felt tip marker,
for easy comparison. A final printed label and
the latest accepted labeling are required for this
purpose.
2) Certification of Compliance - each notification
must bear in Section II of the Application for
Pesticide Registration/Amendment (EPA Form 8570-1)
the statement "This is to certify that tHis
notification meets every requirement of PR notice
88-6".
IMPORTANT KOTEI only you, the registrant or your
authorized agent may submit a notification. Each
notification must be properly signed and dated.
In accordance with 40 CFR 152.46(a) if the Agency
determines that formal application for amended
registration must be submitted rather than a
notification your application will be returned and
the Agency will require that it be resubmitted as
a formal application for amended registration.
You are also responsible for ensuring that the
labeling of any distributor or supplementally
registered product you may have is in compliance
with FIFRA. (Refer also to 40 CFR section
156.10.)
4-20
-------
2* •OM-MOTiyieXTIOHfl -
to veur registration that
In accordance with 40 CFR section 152.46(b), the following
changes can be made in the product's labeling or packaging
without notification to or approval by the Agency:
a. Correction of typographical or printing errors in
the labeling.
b. Changes in the net contents necessary to accommodate
changing package sizes or contents variability,
provided such changes would not require changes in the
use directions, or the requirement for child-resistant
packaging under'40 CFR Part 157, or other Agency
requirements pertaining to size.
c. The use of metric units in addition to standard U.S.
units for net contents, dosages and other numeric
expressions.
d. Routine changes in the name and address of the
registrant on the label. A registrant is required to
keep the Agency current as to his address of record;
therefore an address change necessitates informing the
Agency. However, such changes may be made on labeling
as soon as they occur. A separate letter must be sent
to the Information Services Branch (ISB), Program
Management and Support Division (PMSD), notifying the
Agency of the changed company name and/or address. See
Chapter 18 for the address.
IMPORTANT KOTBt if you change your name and/or
address, and fail to notify the Agency, and the
Agency's good faith attempts to contact you are not
successful, the Agency will issue in the Federal
Register a notice of intent to cancel all of vour
products under FIFRA section 6(b).
e. Revision, addition, or deletion of non-mandatory
label elements, such as th« following:
1) Inclusion of the DOT hazard diamond when a
shipping container is also the immediate container
offered for sale,
2) Addition of State-required analysis of the
fertilizer component of a pesticide/fertilizer
product,
3) Inclusion of lot or batch codes, or other
production identifiers, or
4-21
-------
4) A date that indicates date of manufacture or
label approval.
5) Addition of State-required analysis of a wood-
preservative product.
IMPORTANT NOTE: Any statement directly or
indirectly implying that the pesticide or device
is recommended or endorsed by any agency of the
Federal Government constitutes misbranding under
FIFRA section (2)(q)(1)(A) and 40 CFR 156.10(a)
(5)(v), and is a violation of section l2(a)(l)(F)
of FIFRA.
f. Redesign of label format that does not modify
approved label text, consistent with the format
requirements of 40 CFR section 156.10. These may
include, among other things, changes in label color,
type size or style, use of space, configuration or
placement of label elements.
IMPORTANT NOT.B t Changes in color or type size should
not reduce the readability of the labeling text or
minimize the precautionary statements.
D. SUBMISSION Or TIHAL PRINTED LABELINO
When submitting final printed labeling for Notifications or
Non-Notifications, you must use the Application for
Registration/Amendment (EPA Form 8570-1). A separate application
must be submitted for each product registration. Indicate the
reason for the submission in the explanation part of Section II.
1. notifications and non-notifications
The final printed labeling for all notifications must be
submitted before the product, as revised, is sold or
distributed. The final printed labeling may be submitted as
the notification, thereby requiring only one submission.
The Agency expects that final printed labeling for a
notification, or a formal amendment under FIFRA section 3,
will include non-notification changes also. However, no
submission of final printed labeling is required for changes
that are only "non-notifications".
2* Labeling for iffTTlfllRfflts reQuiri-mr a formal application to
After approval of an amendment based upon draft labeling,
final printed labeling must be submitted before the product,
as revised, is sold or distributed. The Agency expects that
4-22
-------
this final printed labeling will include non-notification
chang*» that may have been made after submission of the
approved draft labeling, but prior to printing the final
printed labeling for submission to the Agency.
E. INCOMPLETE XPPT.TP*TTQNfl
If you submit an incomplete application, the processing of
your application will not begin until the deficiencies are
corrected. Incomplete applications will be returned, with the
deficiencies identified, for correction.
F. LEGAL COMPLIANCE -
You are reminded that you are entirely responsible for the
content and accuracy of labeling, and for compliance with
labeling requirements, whether or not the Agency chooses to
review and approve labeling changes. Any product that is
misbranded under FIFRA section 2 (q) , or that is in violation of
FIFRA section 12 may be the subject of an enforcement action.
0. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions or require any additional
information as to whether the changes you propose to make under
this chapter are appropriate, contact the Product Manager
assigned to the product in question. A listing of Product
Managers may be found in Chapter 18.
If you have any questions concerning the status of your MMe-
too" Application for Amended Registration within the 45 day
tine frame for the Agency's notifying you of whether the
application is complete or has been rejected, you should contact
the Front End Processing Staff. Refer to Chapter 18 for the
telephone number.
H. REFERENCES CITED IN CHAPTER 4 - Refer to Chapter 16 for
information on the source of these documents.
l. Code of Federal Regulations, Title 40
Part 152 - Pesticide* registration and classification
procedures
Part 156 - Labeling requirements for pesticides and devices
Part 157 - Packaging requirements for pesticides and devices
Part 158 - Data requirements for registration
4-23
-------
2. Federal Insecticide, Fungicide and Rodenticide Act, as amended
October, 1988.
Section 2
Section 3
Section 6
Section 12
Definitions
Registration of pesticides
Administrative review; suspension
Unlawful acts
3. PR Notice 86-4 - Submission of Incomplete Applications for
Registration of Pesticides Under Section 3 of
FIFRA, Issued by the Registration Division,
Office of Pesticide Programs, EPA, April 15,
1986.
4. PR Notice 88-6 - Change in Registration Procedures * Agency
Approval Not Required for Certain Amendments.
Issued by the Registration Division, Office
of Pesticide Programs, EPA, August 12, 1988.
5. PR Notice 89*2 - Expedited Review of Applications for
Registration or Amended Registration.
Issued by the Registration Division, Office
of Pesticide Programs, EPA, June 6, 1989.
7. PR Notice 91-5 - Instructions for Transmitting Information to
the Office of Pesticide Programs. Issued by
the Program Management and Support Division,
Office of Pesticide Programs, EPA, September
6, 1991.
6. PR Notice 91-7 - False and Misleading statements.
Issued by the Registration Division, Office
of Pesticide Programs, EPA, December 30,
1991.
7. PR Notice 92-3 - Pesticides and the Clean Air Act:
Stratospheric Ozone Protection. Issued by
the Office of Pesticide Programs, EPA, March
19, 1992.
4-24
-------
APPENDIX 4-1
UBKLTNfl e*
RJYI8IQH TO THE BASIC FORMPiATioit RBOPTM THE imaflma
A. JMl^mmMXDmmt'mTm MMI.TMI t^g^.
(DO NOT BIND DOCUMENTS OR PAGES TOGETHER)
DOCUMENT 1
Application for Pesticide Amendment
— (EPA Form 8570-1)
DOCUMENT 2
T.
Draft labeling (5 copies)
— 1 marked up copy of label
showing where additions,
deletions, and changes
have been made
S. AMgNDMBNT FOR REVISION TO YOUR BASIC FORMULATION *!
(DO HOT BIND DOCUMENTS OR PAGES TOGETHER)
DOCUMENT 1
Application for Pesticide Registration
— (EPA Form 8570-1)
DOCUMENT 2
Confidential Statement of Formula
(EPA Form 8570-4)
DOCUMENT 3 |
j"r"
Draft Labeling (5 copies),
if required
r
(1 marked up copy of
label if labels are
required)
* Revisions to the basic formulation for antimicrobial and
vertebrate pesticide products generally require supporting
efficacy (product performance) data, and are not considered to be
administrative amendments. (Refer to Appendix 4-2)
4-25
-------
APPENDIX 4-2
A TYPICAL "MB-TOO* APPLICATION TO AMEND THE REGISTRATION OF X
ERED PRODUCT* REQUIRES
PQCUMBHTg
A. ADMINISTRATIVE PORTION OF APPLICATION I (DO MOT .BIND DOCUMENTS
OR PAGES TOGETHER)
DOCUMENT 1
Application for Pesticide Amendment
- (EPA Fora 8570-1)
o-
DOCUMENT 2
• Statement identifying the "substantially
, similar" or "identical" product
DOCUMENT_3_
I
DOCUMENT
Formulator's
Exemption Statement
(EPA Form 8570-27)
DOCUMENT 5
Confidential Statement of
Formula (EPA Form 8570-4),
if required
— Draft Labeling (5 copies)
1 marked-up copy of label
Certification with
Respect to Citation
of Data (EPA Form
8570-29)
—o
DOCUMENT 6
I DOCUMENT 7
Data Matrix
chart
(Required under
the selective
method of
support ONLY)
B. DATA PORTION Of APPLICATION! (FORMAT AS DESCRIBED IN PR NOTICE
1
DOCUMENT 1 |
l
i
i
JDOCUME]
°l~
IT 2 j
i
' i
~
Product Specific Acute
Toxicity Data * (3 copies) if required
Efficacy Date * (3 copies) if
required
* Under the selective method of support these data requirements
may be addressed by either submitting the actual data, or by
referencing EPA's Master Record Identification (MRID) number on
the Data Matrix Chart.
4-26
-------
APPENDIX 4-3
A TYPICAL APPLICATION TO AMEND THE REGISTRATION Of A RRGIflTBRSD
A. ADMINISTRATIVE PORTION OF APPLICATION: (DO HOT BIND DOCUMENTS
OR PAGES TOGETHER)
DOCUMENT 1
Application for Pesticide Amendment
- (EPA Form 8570-1)
DOCUMENT 2
DOCUMENT 3
Formulator's
Exemption Statement
(EPA Form 8570-27)
Draft labeling (5 copies)
1 marked copy of label
Certification with Respect to
Citation of Data (EPA Form
8570-29)
DOCUMENT 4
Data Matrix Chart
{DOCUMENT 5
(Required under the
Selective method of
Support ONLY)
B. DATA PORTION OF APPLICATION! (FORMAT AS DESCRIBED IN PR NOTICE
8«-5)
Data as required by 40 CFR 158.202 thru
158.740 * (3 copies)
Efficacy Data * (3 copies) if
required
DOCU
MENT 1
i
JDOCUI
~"i
1 i*
a
si
ua^a
i n
~~ "1 _
0 | -|
I
IT 2 |
1
* Under the selective method of support these data requirements.
may be addressed by either submitting the actual .data, or by
referencing EPA's Master Record Identification (MRID) number on
the Data Matrix Chart.
4-27
-------
-------
• HOW TO APPLY FOR
i REQIgTRXTTOlf OF A
PESTICIDE
A. GENERAL IMTORMATION
40 CFR 152.132 provides specific information on the
supplemental distribution or supplemental registration of another
registered pesticide. A supplemental registration is also
referred to as a "distributor product."
40 CFR 152.132 states that a registrant may distribute or
sell his/her registered product under another person's name and
address instead of (or in addition to) his/her own. Such
distribution and sale is termed "supplemental distribution" and
the product is referred to as a "distributor product." The
distributor is considered an agent of the registrant and both the
registrant and the distributor may be held liable for violations
pertaining to the distributor product.
IMPORTANT MOTBi i) Supplemental registrations are only an
extension of a currently registered pesticide product. They are
a duplication of the basic registration and must reflect any
changes made to the basic registration within the same time frame
imposed on the basic registration. 2) If the basic registration
is canceled, the supplemental registration is automatically
canceled effective the same date as the basic registration.
B. REQUIREMENTS FOR SUPPLEMENTAL DISTRIBUTION APPROVAL
Supplemental distribution is permitted upon notification to
the Agency if all the following conditions are met:
1. The registrant of the product for which the second
party wishes to obtain supplemental registration has
submitted to the Agency a statement (EPA Form 8570-5,
Notice of Supplemental Registration of Distributor)
signed by both the registrant of the basic registered
product and the second party ("the distributor") . The
following information is required on the application
form:
a. The name and address of the basic
registrant and the registration number of the
registered product;
b. The name and address of the distributor,
the distributor's company number, and the
name of the product to be used on the product
you plan to distribute. If you do not
already have a company number assigned to
your company, a company number will be
assigned by the Agency upon written request,
5-1
-------
to the Registration Division's Registration
Support Branch. Refer to Chapter 18 for the
address.
IMPORTANT NOTE8 The second party (the "Distributor")
must have a company number prior to your notification
to the Agency of supplemental distribution. (See
section D of this Chapter.)
2. The product the "Distributor" intends to distribute
must be produced, packaged, and labeled in a registered
establishment operated by the same producer who
produces, packages, and labels the basic registered
product. /
3. The "Distributor's" product may not be repackaged:
it must remain in the basic registrant's or producer's
original unopened container. However, a "Distributor"
may repackage the registered product for the
distributor's use if he/she has a contract with the
basic registrant to do so, and if the "Distributor" has
his/her establishment registered. Refer to Chapter 11
which explains how to obtain an establishment
registration.
4. The labeling associated with the product the
"Distributor's" wishes to distribute must be the same
as that of the basic registered product, except that:
a. The product name of the "Distributor's"
product may be different from that of the
basic registrant's, but it may not be
misleading;
b. The name and address of the
"Distributor's" company may appear instead of
that of the basic registrant's name and
address;
c. The EPA registration number of the
registered product must be followed by a
hyphen, followed by the "Distributor's"
company number; (For example, if the
registration number of the basic registrant's
product is EPA Reg. Mo. 999999-88888, and
the "Distributor's" company number is 777777,
then the "Distributor's" number that would
appear on the label would be EPA Reg. No.
999999-88888-777777);
5-2
-------
d. The establishment number must be that of
the final establishment at which the
registered product was produced and/or
packaged; and,
e. Any specific claims on the basic
registrant's label, such as the sites of
application or pests to be controlled, may be
deleted from the "Distributor's" label
provided that no changes are necessary in any
of the precautionary or other labeling of the
basic product.
IMPORTANT NOTEi The "Distributor" may not make
additions to the basic registrants label (for example,
add claims, additional sites or pests), nor alter the
precautionary labeling statements or directions for
use.
C. WHERE TO SUBMIT ANAPPLICATION FOR SUPPLEMENTAL REGISTRATION
OF A DISTRIBUTOR PRODUCT
The registrant of the basic product should submit the
completed application to:
Document Processing Desk (DIST)
Office of Pesticide Programs - H7504C
U.S. EPA
401 M St., S.W.
Washington, D.C. 20460
D. WHERE TO RZOPE8T A COMPANY NUMBER AND ESTABLISHMENT
REGISTRATION
If you do not already have an EPA assigned company number,
submit your request in writing to the Registration Support
Branch. Refer to Chapter 18 for the address. If you plan to
enter into a contract to produce a pesticide an establishment
registration for each separate location must first be obtained
from the Agency. Refer to Chapter 11.
E. REFERENCES CITED IN CHAPTER 5 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
2. EPA Form 8570-5
5-3
-------
-------
DXT& COMPKtfflXTTOM
A.
HffORMATION
By the late 1960's the amount of scientific data that was
required to support the registration of a pesticide began to
increase rapidly. Applicants and registrants who were required
to generate these data, which were quite costly, asked Congress
to provide protection for their investment, since by the time
they obtained their registration or amended registration, most of
or all of the pesticide's patent life had expired. Other
registrants were then able to obtain a registration for the same
type of product by relying on the data generated by the original
data submitter, without having to share the burden of the cost of
generating the data. In response to this concern, Congress
amended the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) in 1972. Section 3(c)(l)(D) of the amended FIFRA (which
was changed to 3(c)(l)(F)) placed data compensation
obligations on those applicants for registration of a pesticide
who would use the data submitted by another applicant or
registrant in support of their own application for registration.
In 1978, a second amendment to FIFRA granted "exclusive use"
rights, for a 10 year period, to the original data submitter for
certain data that were submitted to support the first
registration of a product containing a new pesticide (active
ingredient) or combination of active ingredients. An applicant
must satisfy these data compensation requirements to obtain a
registration, reregistration, or amend the registration of a
registered product.
In order for the Agency to evaluate your application for
registration or to amend the registration of a registered
product, data must be submitted to support the application or
amendment. The applicant is responsible for supplying the data
necessary for the Agency to make this evaluation. You may
address the data requirements in several ways. One method is to
develop and submit all of the data necessary to support your
application, a second method would be to rely on data that has
been submitted to the Agency by other applicants in support of
their applications for registration, and a third method would be
to develop some of the data to support your application and to
rely on other's data to complete your data requirements.
The Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) and the 1991 Amendments of FACTA made a number of
amendments to FIFRA. One of those amendments was to redesignate
Section 3(c)(l)(D) as Section 3(c)(l)(F). Therefore, when citing
the data compensation section of FIFRA you should now refer to
3(c)(l)(F) and not 3(c)(l)(D).
6- 1
-------
If you rely on data that were developed and submitted to the
Agency in support of another persons application for
registration, you must comply with the data compensation
provisions of section 3(c)(l)(F) [formerly 3(c)(l)(D)} of FIFRA.
Section 3(c)(l)(D) [now 3(c)(l)(F>] established tvo
categories of data.
1. One category of data pertains to that data submitted in
support of the registration of a pesticide containing active
ingredients that were first registered after September 30,
1978, and to the data submitted with an application to add a
new use to the original registration. These data are termed
"exclusive use" data and the Agency may not consider these
data to support your application for registration for a
period of 10 years after the date of initial registration,
unless you have written authorization from the original data
submitter authorizing the Agency to use these data to
support your application. After the 10 year "exclusive use"
period has expired, you may still be required to offer to
compensate the data submitter for use of the data, but
written authorization from the data submitter is no longer
needed.
2. The second category of data pertains to data submitted
after December 31, 1969, in support of an application for
registration, experimental use permit, or amendment adding a
new use to an existing registration, to support or maintain
an existing registration, or for reregistration. The Agency
may, without the permission of the original data submitter,
consider such data to support an application by another
applicant within the 15 year period following the date the
data were originally submitted to EPA only if the applicant
has certified to the Agency that he/she has made an offer to
compensate the original data submitter.
40 CFR Parts 152.80-99 and 152.116-119 provide detailed
information on how you may comply with the data compensation
provisions of FIFRA section 3(c)(1)(F).
B. WHEN MUST YOU COMPLY WITH THE DATA COKPBNBATIOIJ PRQCBPORlfl?
1. The data compensation procedures apply to the following:
a. Each application for registration of a new product,
and
b. Each application for an amendment of a registration,
except as noted below.
2. The data compensation procedures Ao not apply to the
following types of registration applications:
6-2
-------
a. Applications for experimental use permits, or
b. Applications to make the following amendments to
existing registrations unless it is determined that
scientific data would be necessary:
1) An increase or decrease in the percentage of
one or more of the active ingredients or
deliberately added inert ingredients in a product,
2) A revision of the identity or amount of
impurities in the product,
3) The addition or deletion of one or more
deliberately added inert ingredients,
4) The deletion of one or more active ingredients,
5) A change in the source of supply of one or more
of the active ingredients used in the product, if
the new source of the active ingredient is a
product which is registered under section 3 of
FIFRA,
6) Deletion of approved uses from the label,
7) Redesign of the label format, which involve no
substantive changes in the directions for use,
claims, representations, or precautionary
statements,
8) Change in the product name, or addition of an
additional brand name,
9) Clarification of directions for use,
10) Corrections of typographical errors,
11) Changes in the registrant's name and address,
12) Adding or deleting supplemental registrants
(distributors),
13) Changes in the package or container size,
14) Changes in warranty, warranty disclaimer, or
liability limitation statements, or addition or
deletion of such statements,
15) "Splitting" the label for the purpose of
marketing the product in different geographic
regions with appropriate labels, where each
6- 3
-------
amended label will contain previously approved use
instructions (and related label statements)
appropriate to a particular geographic region, and
16) Any other type of amendment, if the Agency
determines that scientific data would not be
needed in order to approve the amendment.
C. WHAT IKTORMATION MUST YOUSUBMIT WITH YOUR APPLICATION FOR
REGISTRATION OR AMENDED REQIflTHATIOM ?
1* yOSMOIATOR» 8
TOM
(EPA Form 8570-27)
Under FIFRA section 3(c)(2)(D) you are excused (i.e.,
eligible for the formula'tor' s exemption) from the requirement to
submit or cite data pertaining to the safety of any ingredient,
or mixture of ingredients, contained in your product if the
source(s) of each of these ingredients is an EPA registered
product, and you purchase each active ingredient from another
producer.
a. Application for registration - If your product
contains one or more active ingredients eligible for
the formulator's exemption, you need not comply with
the requirements of 40 CFR 152.90 through 152.96, with
respect to any data requirements pertaining to the
safety of these ingredients provided you submit a
completed Formulator's Exemption Statement (EPA Form
8570-27) with your application for registration.
b. Application for amended registration — You are not
required to submit a new Formulator's Exemption
Statement if your current statement on file with the
Agency is complete and accurate. However, if you
change from a registered source of any active
ingredient to an unregistered source, you are required
to submit an application for amended registration,
together with a revised Confidential Statement of '
Formula. If your new source of the ingredient is not
registered, you are no longer eligible for the
f emulators' s exemption for that ingredient.
IMPORTANT VOTE: since data costs associated with EPA's
reregistration program has caused many basic producers
to request the deletion of uses which are important to
many users, special provisions are made available to
third party data producers which may affect the
availability of the femulators1 exemption to certain
registrants. Refer to PR Notice 91-8 for important
details.
6-4
-------
2* Certification With Reaaeet to Citation of Data (EPA fen
8570-29)
The Agency has developed this form to enable you to certify
how you will comply with data compensation requirements
under FIFRA section 3(c)(l)(F). In order to comply with the
FIFRA section 3(c)(l)(F) data compensation requirements, you
must:
a* ffMfrBJfc *** aclcnoifledgemaHt ot reliance on data in
accordance with 40 CFR 152.86(d) you must include an
acknowledgement that for purposes of FIFRA section
3(c)(l)(F) your application relies on the following
data:
*
1) All data submitted with or specifically cited
in your application, and
2) Each item of data in the Agency's files which:
(a) concerns the properties or effects of
your product, of any product which is
identical or substantially similar to your
product, or of one or more of the active
ingredients in your product, and
(b) Is one of the types of data the Agency
would require to be submitted if you sought
initial registration under FIFRA section
3(c)(5) of a substantially similar or
identical product, at the time the Agency
approves your application for registration.
Item 1 on the Certification with Respect to Citation of
Data form (EPA Form 8570-29) satisfies this
acknowledgement requirement.
b. Exclusive use data certification - Effective
beginning September 30, 1978, exclusive use data
pertains to those data that were submitted to the
Agency in support of the registration of a new active
ingredient, a new combination of active ingredients, or
an application to amend the original registration to
add a new use, for a period of 10 years after the
initial registration has been issued. In order for the
Agency to consider these data in support of your
application for registration or amendment, you must in
accordance with 40 CFR 152.86(a) certify to the Agency
that you have obtained from each data submitter listed
on the Data Submitters List, and/or the bibliography of
6- 5
-------
an applicable Registration standard, as an exclusive
use data submitter written authorization which contains
at least the following information:
1) Identification that you are the applicant to
whom the authorization is granted,
2) Written authorization has been granted to you
by the data submitter to allow the Agency to use
all applicable data to satisfy the data
requirements for the application in question, and
3) The signature and title of the original data
submitter or his authorized representative and the
date of authorization.
If the Agency identifies any exclusive use data
submitter not on the Data Submitters List or in the
bibliography of a published Registration Standard, you
will also be required to obtain written authorization
from that person.
(The Data Submitters List is a listing of data
submitters which are listed under the active ingredient
chemical code numbers. Refer to Chapter 16 of this
manual for information on how to obtain the Data
Submitters List. A source of published Registration
Standards and Registration Eligibility Documents (REDs)
is also listed in Chapter 16.)
Item 2 on the Certification with Respect to citation of
Data form (EPA Form 8570-29) satisfies this exclusive
use certification requirement.
IMPORTANT MOTH You must submit with your application a
copy of the letter of authorization from the exclusive
use data submitter authorizing use of these data by the
Agency, to support your application for registration.
c) Data other than exclusive use data - You must, in
accordance with 40 CFR 152.86(b), certify to the Agency
that with respect to each other data submitter on the
Data Submitters List, and/or the bibliography of an
applicable Registration Standard [40 CFR 152.90(a)(1)]
or RED, for the active ingredient in question:
1) You have obtained from that person written
authorization containing the information
identified above under "Exclusive use data" or,
6-6
-------
2) You have furnished to that person:
(a) A notification of your intent to apply
for registration, including the name and a
list of the active ingredients in the
proposed product,
(b) An offer to pay the person compensation,
to the extent required by FIFRA section
3(c)(l)(F), for any data required to support
your application,
(c) An offer to commence negotiations to
determine the amount and terms of
compensation, if any, to be paid for the use
of the data, and
(d) Your name, address, and telephone number.
Item 3 on the Certification with Respect to
Certification of Data form (EPA Form 8570*29) provides
methods for satisfying these requirements.
d. Methods for complying with the data compensation
requirements of FIFRA section 3folfl)fFi - There are
two methods of complying with the data compensation
requirements, these are 1) the "cite-all* method and 2)
the "selective" method of support. These two methods
are described below. In addition, a table (Appendix
6-1 which follows section E of this Chapter) comparing
these methods is also provided.
1) THB CITE-ALL METHOD OF SUPPORT - YOU may comply
with the data compensation requirements under the
cite-all method (40 CFR 152.86) for your
application to register a new product or to amend
a product you already have registered by:
(a) citing all pertinent data in the Agency's
files involving "exclusive use" data only
with the written permission of the exclusive
use data submitter, or
(b) citing all pertinent data in the Agency's
files, no exclusive use data involved, with
permission of the original data submitter or
by offering to pay compensation for use of
the data in accordance with FIFRA section
3(c)(l)(F), and
6-7
-------
(c) submitting to the Agency a general offer
tie pav atatement. in accordance with 40 CFR
152. 90 (c) , in which you state your offer and
agree to pay compensation to other data
submitters to the extent required by FIFRA
section 3(c)(l)(F).
If you check the first box in item 3 of the
Certification with Respect to Citation of Data
form (EPA Form 8570-29), and sign the General
Offer to Pay statement at the bottom of the form,
you are certifying to the Agency that you have
complied with these requirements.
IMPORTANT MOTE: In accordance with 40 CFR 158.99,
an original data submitter may petition the Agency
to deny or cancel your registration if he has
submitted a study that he claims satisfies a data
requirement and for which you have either failed
to receive authorization to use, or have not made
a proper offer to pay compensation.
2) THE SELECTIVE METHOD OF SUPPORT - YOU may
comply with the data compensation requirements
under the selective method by listing the specific
data requirements that apply to your product, its
active ingredients, and use patterns, and
demonstrating compliance with the data
requirements by either submitting the actual
studies, or citing individual studies, or by
demonstrating that no study has been previously
submitted to the Agency (a data gap) . Refer to 40
CFR 152.90 for a detailed discussion of the
selective method, and sections 152.91 through
152.96 for specific procedures for citing or
submitting a study or for demonstrating a data
gap.
IMPORTAMT MOTE: The Data Gap option may not be
available to certain applicants, i.e., those
seeking the registration of a product containing a
new active' ingredient or those seeking to add a
new use pattern to a registered product.
If you chose the Selective Method of complying
with the data compensation requirements you must:
(a) submit the Certification with Respect to
Citation of Data form (EPA Form 8570-29) on
which you have checked the second box in item
3, indicating you have chosen the Selective
Method, and
6- 8
-------
(1) sign the signature block immediately
belov, or
(2) if you are using the cite all option
under the Selective Method to address
specific data requirements [see
b)(2)(iii) and (iv) below], sign the
last signature block on the form.
b) submit a data matrix chart which addresses
the items listed below. Refer to Appendix 6-
2, which follows section E. of this Chapter,
for a sample data matrix format and
instructions on how to complete it.
(1) List of data requirements applicable
to your product [see 40 CFR 152.90(a)].
The list must be based on the data
guidelines in 40 CFR Part 158 - Data
Requirements for Registration, a
Registration Standard or a
Reregistration Eligibility Document
(RED) for the active ingredient(s) in
your product, if applicable. Refer to
Chapter 16 of this manual for a source
of the Registration Standards that have
been issued.
(2) How you intend to satisfy each of
the data requirements identified on the
data matrix chart. There are several
ways to satisfy these data requirements.
(i) Reference data originally
submitted to the Agency by you, the
applicant [See 40 CFR 152.93(a)].
(ii) Reference data previously
submitted to the Agency by someone
other than you and obtain their
permission to cite the data. You
must certify that you have obtained
written authorization from the
original data submitter. For an
exclusive use procedures outlined
in section C.2.a.l), must be
followed. Refer also to 40 CFR
152.93(b)(l).
(iii) Reference data previously
submitted to the Agency by someone
other then you (that is not an
6- 9
-------
exclusive use study) and make a
proper offer to pay to such person
(40 CFR 152.93(b)(2).
(iv) Reference all data in the
Agency's files pertinent to the
specific data requirement and make
a proper offer to pay to all data
submitters on the Data Submitter's
List for those specific data (40
CFR 152.90).
(v) Submit data not previously
t submitted or submit data from the
public literature (40 CFR 152.94).
(vi) Document waivers of data
previously allowed by the Agency
(40 CFR 152.91). Refer to Chapter
15 of this manual for information
on how to obtain information on
chemicals for which data waivers
have been granted.
(vii) Demonstrate that a data
gap(s) exist. Submit a completed
EPA Form 8570-28, Certification of
Compliance with Data Gap Procedures
(see 40 CFR 152.96). Note: The
Data Gap option may not be
available to certain applicants,
i.e., those seeking the
registration of .a product
containing a new active ingredient
or those seeking to add a new use
pattern to a registered product.
IKPORTAMT NOTEi The Data Tables and
bibliography in an applicable
Registration Standard and/or
Reregistration Eligibility Document
can be very helpful in developing a
data matrix.
D. DATA COMMMSATTOM flB-ARGBg/PAYMBIIT DISPUTES
40 CFR 152, Subpart E - Procedures To Ensure Protection of
Data Submitters' Rights [specifically 40 CFR 152.80; 152.86
(b)(2)(iii); 152.93 (b)(2)(iv); 152.95(b)(2)(iv); 152.99 (a)(i)
and 152.99(a)(iii)] describes the procedures by which data
submitters may challenge registration actions which allegedly
failed to comply with FIFRA section 3(c)(1)(F). Applicants
6-10
-------
relying on another person's data to support their registration
are required to certify to the Agency, with respect to each
person on.the Data Submitters List, for the chemical in question,
an offer to commence negotiations to determine the amount and
terms of compensation, if any, to be paid for the use of any
study.
FIFRA sections 3(c)(1)(F)(ii) [formerly 3(c)(1)(D)(ii) and
3 (c) (2) (B) (iii) states that the terms and amount of compensation
may be fixed by agreement between the original data submitter and
the applicant, or, failing such agreement, by binding arbitration
under the procedure and rules of the Mediation and Conciliation
Service. The arbitrator to be appointed from the roster of
arbitrators maintained by such Service. The findings and
determination of the arbitrator shall be final and conclusive,
and no official or court of the United States shall have power or
jurisdiction to review any such findings and determination,
except for fraud, misrepresentation, or other misconduct by one
of the parties to the arbitration pr the arbitrator. All parties
to the arbitration shall share equally in the payment of the fee
and expenses of the arbitrator. Refer to 29 CFR 1440 for details
on the arbitration procedures.
B. QUESTIONS AND ANSWERS
The following questions are those most frequently asked by
interested persons regarding data compensation procedures:
1. Question: What is a "me-too product"?
Answeri The term "me-too product" refers to a pesticide
product that is identical or substantially similar to
another pesticide product that is currently registered
by EPA.
The term "identical product" means a product, when
compared to a currently registered product:
a) Contains the same active and intentionally
added inert ingredients, and in the case of a
technical grade product, the same impurities,
each ingredient being the same percentage,
and
b) Includes identical or substantially
similar uses.
The term "substantially similar product" for a non-
technical grade product, e.g., an end-use product,
means a product when compared to a currently registered
product:
6-11
-------
a) Contains the same active ingredients,
b) The percentages of the active ingredients
and the intentionally added inerts and their
percentages may vary only to the extent that
it is reasonable to conclude that the hazards
are not different from those associated-with
the registered product, and
c) Includes identical or substantially
similar uses.
The term "substantially similar product" for a non-end-
use product, e.g., a manufacturing-use or a
formulating-use only product (including technical grade
products), means a product when compared to a currently
registered product:
a) Contains the same active ingredient,
b) The percentage of the active ingredient
and the impurities and their percentages may
vary only to the extent that it can be
reasonably established that the hazards are
not different from those associated with the
registered product, and
c) Includes identical or substantially
similar uses.
2. Question: when applying for a registration of a "me-too
product" under the Cite-all Method of Support, must I submit
additional information other than 1) a completed and signed
Application for Registration form (EPA Form 8570-1), 2) a
completed and signed Confidential Statement of Formula (EPA Form
8570- 4),3) proposed labeling, and 4) a completed and signed
Certification With Respect to Citation of Data (EPA Form 8570-
29)?
Answers Yes, routinely more information is required.
First, you must tell us the name and EPA registration
number of the currently registered product that you
believe your proposed product is identical with or
substantially similar to. Second, since product
chemistry data are specific to each formulation, you
must submit the product chemistry required in 40 CFR
section 158.20 unless you are certain that your
proposed formulation is identical to the registered
product you have cited to support your "me-too" claim.
Please note however, that short of extensive chemical
analysis, there are only a few ways to be certain that
your proposed formulation is identical to the
1 »
6-12
-------
registered product you cite. These ways include
situations where the cited product's label actually
identifies each active and inert ingredient and
associated percentages, or you produce or repackage
the cited product.
An Application for Amended Registration for an
amendment involving data requirements would be a
situation analogous to an application for registration
of an identical product.
If, during our review of your application, we find that
the product you have cited as the "me-too" is not at
least substantially .similar to your proposed product,
we will inform you that you are not eligible for the
Cite-All Method of Support and will have to either
identify another product as the "me- too1* or proceed
under the Selective Method of Support. If you chose to
proceed under the Selective Method of Support you nay
have to actually generate data to support your
application for registration.
If you are eligible for the femulator's exemption,
usually this will involve a requirement to submit
product chemistry and acute toxicology data.
Occasionally, efficacy data may also be required. In
those cases where new chemicals or changed use patterns
are involved, extensive data requirements may be
imposed.
3. Question8 After reading the regulations, it is my belief that
if I simply repackage a registered technical grade,
manufacturing-use or end-use product and use the same labeling, I
need only claim the femulator's exemption under FIFRA section
3(c)(2)(D) and net submit any other information under the Cite-
all or Selective Method of Support or include any product
specific data, e.g., product chemistry, acute toxicity or
efficacy data.
Answer: You are correct provided you simply repackage
another registered product and do not change the purchased
formulation in any manner.
In this case your application for registration would consist
of an Application for Registration (EPA Form 8570-1), a
Confidential Statement of Formula (EPA Form 8570-4), the
Formulator's Exemption Statement (EPA Form 8570-27) and 5
copies of your draft labeling.
6-13
-------
4. QtiMtient Whan I submit an application for a "Be-too"
amendment to the registration of my product, and data is required
to support the proposed amendment, under the data compensation
requirements do I have to again offer to pay compensation for all
of the data necessary to support the registration of the entire
product, or only offer to pay compensation for the data necessary
to support the amendment?
your entire product is subject to the data
compensation provisions including your amendment.
There are several reasons for this requirement. Data
(either generic data or product specific data) may have
been submitted to the Agency to fill data gaps since
you first offered tp pay compensation with your initial
application for registration for your product, or when
it was last amended. Also, some of the data initially
used to support your registration may have been
determined to be unacceptable and may have been
replaced. As a result, if additional data are required
to support the proposed amendment to your registration,
your entire product including the proposed amendment is
subject to the data compensation requirements of
section 3(c)(l)(F) of FIFRA, within the limits
prescribed by your eligibility under the f emulator's
exemption under section 3(c)(2)(D) of FIFRA.
There are several possible situations, as discussed below,
which are dependent on whether you choose the cite-all or
selective method of support.. It is assumed that you are
eligible for the formulator's exemption for the active
ingredient(s) in your product, and that your labeling
claims, or use patterns, do not exceed those supported by
the labeling of the product from which you are formulating,
Cite—all Method of supporti If you wish to use the
cite-all method of support (and you are eligible for
the formulator's exemption), you must make written
offers to pay to all of the data submitters listed on
the Data Submitter's List who have claimed product
specj^c types of data for each active ingredient in
your product. Since product-specific chemistry data is
generally required to be submitted by you to support
your initial application for registration, and is
unique to a particular formulated product, these data
which were furnished by you would not normally be
subject to the data compensation requirements. Acute
toxicity data would be compensable since these data
could support the registration of any number of similar
or identical products, and are not necessarily product
specific. If EPA has not issued a Registration
Standard or RED for one or more of the active
ingredients contained in your product, you must write
6-14
-------
all of the data submitters on the Data Submitters List
for each of the active ingredients contained in your
product. The offer to pay must identify your total
product as well as your amendment.
Selective Method of 8u.pporfri If you wish to use the
selective method of support (and you are eligible for
the formulator's exemption) you must submit a data
matrix chart with appropriate information as to how
each data requirement is to be satisfied for your total
product as well as for the amendment, talcing into
consideration the most up to date information, i.e.,
the data tables and bibliography in the most recent
Registration Standard or Reregistration Eligibility
Document(if any) or the data tables in 40 CFR Part 158.
Since product-specific chemistry data is generally
required to be submitted by you to support your initial
application for registration, these data would not
normally be required for an amendment to your
registration. Acute toxicity data would need to be
addressed, if additional acute toxicity data were
required to support the amendment or a previously
submitted study was invalidated. If a data matrix
previously submitted in support of the product's
initial registration or amendment is still valid, and
no additional data are required, you may reference that
data matrix in support of your current application for
amended registration. If additional data are required
to support your current amendment request, an updated
data matrix should be submitted.
5. Questions I have obtained letters from companies on the Data
Submitters List who say that they do not want any compensation
for their data. May I use these letters as if they were giving
me permission to use their data?
Answers You may not. The data submitter must
explicitly grant permission and cannot be presumed to
do so. However, only in the case of exclusive use is
explicit permission required. Otherwise, if you go
through the proper data compensation procedures,
permission from the data submitter is not required.
*• Question! I have in my files a number of letters from data
submitters that give me permission to use their data to support
my application for registration. May I use these letters to
support my application without getting new authorization?
Answers Yes, provided those letters are written to
clearly state that they cover your present application
either specifically, or generically and they also give
permission to use the relevant data to support your
6-15
-------
application for registration. If this is the case,
•ay certify to the Agency that you have received
written permission to cite the data.
you
The Agency will honor the terns and conditions of an
original letter of authorization to cite data and will not
accept a letter withdrawing that authorization unless feQ£h
the original data submitter and the registrant(s) or
applicant(s) relying on the data submitter's data agree that
such authorization has been withdrawn. See PR Notice 91-6.
7. Questleat if I have a product that contains multiple active
ingredients, some of which are purchased from registered sources
and others that are not, may I claim a femulator's exemption for
those active ingredients that are purchased from registered
sources?
Answers Yes, you may, unless use patterns on your label
are not supported by your source. See PR Notice 91-8.
Submit a properly completed Formulator's Exemption
Statement (EPA Form 8570-27).
8. Questioni May I use an unregistered source of an active
ingredient to formulate my product.
;: Yes, you may. It is not a violation of FIFRA to
purchase and use an unregistered product in the formulation of
your product. However, you should be aware that administrative
complications and data requirements are reduced if your source of
the active ingredient(s) is registered. Normally it is illegal
under FIFRA to sell or distribute an unregistered pesticide, and
this also pertains to unregistered sources of the active
ingredient. However, in accordance with 40 CFR 152.30, you may
use an unregistered source provided the source is:
a. Reformulated into a registered product within the same
registered establishment.
b. Transferred from one EPA registered establishment to
another EPA registered establishment, both of which are
owned or leased by the sane company.
c. Transferred between two EPA registered establishments not
operated by the same producer if:
1) the transfer is only for the purpose of further
formulation, packaging or labeling into a product that
is registered, and
2) each active ingredient in the pesticide, at the time
of transfer, is present as a result of incorporation
into the pesticide of either:
6-16
-------
i) a registered product; or
ii) a pesticide that i* produced by the registrant
of the final product; and
3) the product as transferred is labeled in accordance
with 40 CFR 156.
d. Transferred by a producer who does not have actual or
constructive knowledge that his product is intended to be
used or is used for pesticidal purposes (40 CFR 152.15(c)}.
Therefore, should you decide to use an unregistered source of an
active ingredient, you need to be aware that you are responsible
for providing any information or data the Agency would need to
accept that new source for registration. If the unregistered
source is to replace the original registered source of an active
ingredient in your currently registered product, it may not be
added to your product until the Agency has approved the new
unregistered source. Finally, you should also be aware that the
use of an unregistered source of an active ingredient will cause
you to be ineligible for the formulator*s exemption provision
under FIFRA section 3(c)(2)(D), at least for the active
ingredient(s) from the unregistered source.
9. Questioni May I use both the Selective and Cite-All Methods of
Support for one product application, if I have more than one
active ingredient in my product?
Answeri Yes, you may.
10. Questioni if I use the Cite-All Method of Support, do I also
have to submit a list of data requirements and references?
;i Ho, the cite-all method requires no accompanying
list (or data matrix) such as that required for the
selective method.
11. Questioni I have sent offers to pay compensation to use data
to support my application for registration or amendment to all
data submitters listed on the most recent Data Submitter's List
and if applicable the most recent Registration Standard or
Reregistration Eligibility Document. I have not received any
replies. How long do the data submitters have to respond to my
offer to pay, and if they do not respond am I still liable to pay
for data compensation?
Answert FIFRA and the regulations in 40 CFR do not require a
registrant to respond to offers within a specific time frame
to preserve data compensation rights. Accordingly, provided
. such data are compensable, a data submitter may request
compensation at any time.
6-17
-------
12. QyMtioni if I writ* to a company on the Data Submitters'
List via certified nail and ny letter is returned with an
indication that the data submitter's company cannot be located,
how much more must I do to find the company?
Answeri It is EPA's position that if you have obtained
a certified or registered mail statement that there is
no known address for that company, you have made a
reasonable effort to notify that company. Of course,
you may pursue the matter further if you wish.
Indicate in your application what you have done to
locate the data submitter. Should a data submitter
wish to challenge a registration in the future because
of not being notified, 40 CFR 152.99 provides for that
situation.
13. Questlent who has to cite or submit residue chemistry data
under the Selective Method of Support?
Answer* Only applicants who flft not qualify for the
formulator's exemption under FIFRA section 3(c)(2)(D) must
satisfy residue chemistry data requirements. Such
applicants must obtain permission or make an offer to pay to
use these data (if data exist), if they choose the Cite-All
Method of Support. There may be exceptions, i.e., where the
source of the active ingredient has not supported the use(s)
you claim in your labeling. In such cases, applicants will
be required to generate the necessary residue data. See PR
Notice 91-8.
There are other cases when residue chemistry data may be
required, for example an applicant for registration of an
end-use product in a substantially different form (e.g., an
emulsifiable concentrate vs. a wettable powder) from that
which is currently registered, may be required to submit
additional residue chemistry data even if they are eligible
for the formulator's exemption.
14. Question! If I am eligible for the femulator's exemption do
I have to submit anything more than the Formulator's Exemption
Statement (EPA Form 8570- 27) and the Confidential Statement of
Formula (EPA Form 8570-4)?
Answeri Yes, in addition to those forms, you must submit
information required for either the Selective or the Cite-
All Method of Support. Usually the data required for those
eligible for the femulator' s exemption are the product
specific product chemistry and product specific acute
toxicology data.
6-18
-------
15. Quest!oni Do I have to get permission from, or make an offer
to pay, to the person who generated the data froa the public
literature that I have cited or submitted?
Answeri No.
16. Questlent If I am the first applicant/registrant to cite or
submit a public literature data source, do I acquire data
submitter's rights?
Answert No, applicants do not need permission to cite
public literature. No one acquires "data submitters1
rights" from public literature submissions.
17. Questiont if I submit' an application in which I declare one
or more data gaps under the Selective Method of Support, without
having waited for the 60 day period to elapse to receive a reply
from all on the Data Submitters* List, will the Product Manager
process my application?
A£sj£ir.t Yes. However, the Product Manager will not
approve your application until you have certified that
you have waited the required 60 days and no one has
disputed your assertion that one or more data gaps
exist as you have declared in your application. You
may wish to await the 60 day period and certification
before submitting your application to the Agency.
18. Question! if i submit an application to register a new
product that contains an active ingredient for which the Agency
has issued a Data Call-In (DCI), Registration Standard (RS), or
Rereg1stration Eligibility Document (RED), am I subject to the
data requirements in those documents as well as those in 40 CFR
158 or just those in 40 CFR 158 and an I subject to the Data
Compensation regulations?
Answeri YOU are subject to the all of the data requirements
and submittal times set forth in 40 CFR 158 as well as the
data requirements and submittal times set forth in any DCI
issued by the Agency in connection with a RS, or RED,
regardless of whether your new product is a technical grade
product, manufacturing use product, or an end use product.
If the timeframe for generating and submitting a given data
set has past, then you must submit those data with your
application or you may cite data submitted by someone else.
If a timeframe has not yet past, then you must submit the
required data by the date specified. If data gaps were
declared in the RS or RED, you may rely on the RS or RED for
the identification of those gaps. But, under the Selective
Method of Support you must still provide a list of the
requirements in accordance with 40 CFR 152.90(a), and may
6-19
-------
not simply cite the RS or RED. You nay, however, indicate
on your list of data requirements that the existence of a
data gap is documented in the RS or RED.
You are also subject to the Data Compensation requirements
under 3(c)(l)(F) [formerly 3(c)(l)(D)) of FIFRA.
Refer to PR Notice 85-3, 40 CFR 152.90 through 152.96 and 40
CFR 158 for full details on data requirements and to FIFRA
Section 3(c)(l)(F) for data compensation information.
19. Question* If I am submitting a complete set of supporting
data with the application, do I need to fill out the
Certification form?
>
Aflswqri No. So long as you are not submitting required data
that has been previously submitted by another submitter. If
you have previously submitted data you should cite those
data rather than submit them again.
20. Questioni Do I have to fill out all items under 2 and 3 on
the Certification form?
Answert Hark only those items that are appropriate for your
application.
21. Questipnt When does the 10 years "exclusive use*1 period
expire for data generated 12 years after the first registrants?
Answeri Data submitted 12 years after the original
registration are n£& covered by exclusive use at all.
Exclusive data rights exist only for the registrant who
obtained the first registration that contains a new active
ingredient or new mixture of active ingredients and only for
that first registration and subsequent amendments to that
original registration for a 10 year period. Data submitted
11 years after the date of the original registration are not
covered by exclusivity. These data are covered by data
compensation rights for another fifty years.
E. GOpp LABORATORY PRACTICE STANDARDS - PHYSICAL AND CHEMICAL
HAZARDS FOR PRODUCT SPECIFIC DATA.
40 CFR 160 sets forth good laboratory practices for
conducting studies that support or are intended to support
applications for registration, amended registration, or
reregistration of a pesticide product, applications for an
experimental use permit, petitions for establishment or
modification of a tolerance or food additive regulation,
exemptions from the requirement of a tolerance or food additive
regulation. Although all studies have to be conducted in
6-20
-------
accordance with some of the good laboratory standards, only
physical and chemical characterization studies to determine
solubility, octanol water partition coefficient, stability
(product chemistry data requirement 63-8, 63-10, 63-13
respectively), volatility, and persistence (such as
biodegradation, photodegradation, and chemical degradation
(environmental fate 163-2, 163-3, 161-1; 161-2; 161-3; and 161-4
respectively) studies are subject to the full good laboratory
practice standards. All other studies are subject only to the
good laboratory provisions set forth in 40 CFR 160.33, 41, 51,
61, 63, 83, 105(e), 107, 120(13) and (14), 130,185(a)(1) through
(4), (9), (11), (13), 190, 195(a),(b),(e),(f),(g),(h),(i).
F. WHO TO CONTACT TOR ADPITIOMXL IKTORMATIOH
t
If you have any questions concerning the data compensation
procedures and whether they apply to your application, please
contact the appropriate Product Manager for your pesticide.
Refer to Chapter 18 of this manual.for a listing of the various
Product Managers and the type of products for which they are
responsible.
O- MFgRBMCBa CITED IM CHAPTER 6 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
Part 152, Subpart E - Procedures to ensure protection
of data Submitters' rights
Part 158 - Data requirements for registration
2. Code of Federal Regulations, Title 29
Part 1440 - Arbitration of Pesticide Data Disputes
3. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 3 - Registration of pesticides
4. Food, Agriculture, Conservation, and Trade Act of 1990,
November 28, 1990
Subtitle H - Pesticides; Sections 1491 through 1499
6-21
-------
7. PR Notice 91-6 -
5. Food, Agriculture, Conservation, and Trade Act
Amendments of 1991, December 13, 1991
Section 1006 - Amendments to FIFRA and Related
Provisions
6. PR Notice 85-3 - Effective Date of Data Compensation
Procedures under FIFRA, Issued by
the Registration Division, Office
of Pesticide Programs, EPA, May 14,
1985.
EPA Policy Regarding Requests to
Withdraw Authorization to Cite
Data, Issued by the Registration
Division, Office of Pesticide
Programs, EPA, December 13, 1991.
Revised Policy to Provide
Applicants Other Than Basic
Manufacturers An Opportunity To
Submit Generic Data and Receive
Data compensation For It, Issued by
the Registration Division, Office
of Pesticide Programs, EPA,
December 31, 1991.
9. Data Submitters' List
10. Listing of Registration Standards
11. Listing of Chemicals for Which Data waivers Have Been
Granted
8. PR Notice 91-8 -
6-22
-------
APPBHDIX 6-1
If an applicant chooses this
can he/she satisfy -a data rec
by the means listed below?
1. Requesting and obtaining
a waiver
2. Submission of a new study
3. Citation of his/her own
study
4. Citation of another
person's exclusive use
study
5. Citation of another
person's study that is
not exclusive use
6. citation of all pertinent
studies in Agency files,
exclusive use studies
involved
7. citation of all pertinent
studies in Agency files,
no exclusive use studies
involved
8. Citation of public
literature study
9. Documentation of a data
gap
juirement
a. With per-
mission
b. With offer
to pay
a. With per-
mission
b. With offer
to pay
a. With per-
mission
b. With offer
to pay
a. With per-
mission
b. with offer
to pay
Cite-all
No V
No l/
No l/
No
No
No
No
Yes
No
Yes
Yes
No
NO
Selective
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
I/ It should be noted that applicants under the cite-all method
will not be precluded from obtaining waivers, or submitting or
6-23
-------
citing their own studies, but that taking these actions would
affect neither their obligation to cite all data, nor the
procedures that require offers to pay or in certain cases,
permission of each previous data submitter. Therefore, as the
table indicates, none of the actions would suffice in and of
itself, to demonstrate compliance under the cite-all method.
Requesting a waiver would be of concern primarily to those who
choose the selective method of demonstrating compliance. An
applicant under the cite-all method might, nonetheless, wish to
establish that a data requirement has been waived in order to
reduce the amount of data needed for an incremental risk
assessment, or to limit his obligation to pay compensation (as
contrasted to his obligation to tender offers to pay
compensation.
Similarly, the submission of a new study or the citation of a
previously submitted study will be of most interest to applicants
under the selective method, which involves meeting individual
data requirements rather than referencing all previously
submitted data. While no applicant is precluded from submitting
his own data, under the cite-all method submission of a new study
or citation of an old study would be in addition to the citation
of all other relevant data in EPA's files. Under the selective
method, however, the applicant may submit his own study to
satisfy a data requirement and thereby can avoid the need to
offer to pay compensation for other studies in EPA's files that
satisfy the same data requirement.
6-24
-------
TOMCAT T
smvmcxm METHOD
The following matrix is a sample of an acceptable aatrix
format that can be used to satisfy the data requirement in 40 CFR
152. 90 (a). Applicants for registration using the selective
method must prepare a list of the data requirements (refer to 40
CFR 158 - Data Requirements for Registration) for their product
and indicate how those requirements are being satisfied. You may
use this sample matrix or you may develop a similar matrix to
satisfy this requirement.
The sample matrix has been developed for a typical product
where the applicant qualifies for the f emulator's exemption. If
you are eligible for the f emulator's exemption you may use the
data requirements shown on this sample matrix as a guide for
determining the requirements for your products.
If you are not eligible for the f emulator's exemption you
may use the single page blank matrix as a guide to develop a list
of the data requirements for your products.
HOW TO COMPLETE THE fift1*1*^ MATRIX
Block l. Insert the name of your product.
Block 2. Insert the EPA registration number or file symbol (if
known) as appropriate, for your product.
Block 3. Indicate whether you are eligible for. the Formulator's
Exemption by checking either yes or no.
Block 4. Fill in the page number for that page as well as the
total number of pages in your listing.
Block 5. Fill in your company's name and address.
Block 6. Insert the date of your application for registration
or amended registration.
6-25
-------
Block 7. List the active ingredient(a) in your product. If you
have more than one active ingredient in your product
and one or more do not qualify for the formulator's
exemption, you must fill out a separate list for each
active ingredient that does not qualify for the
formulator's exemption and one for all of the rest of
the active ingredients that qualify for the
formulator's exemption. If all of the active
ingredients in your product qualify for the
formulator's exemption, you need complete only one set
of forms and list all of the active ingredients in this
box.
Block 8a. Indicate the Part 158 and guideline reference number
for each data requirement applicable to your product.
If a Registration Standard or a Reregistration
Eligibility Document has been issued, the data
requirements and their guideline reference numbers are
listed in the Standard.
Block 8b. Show the name of the test, e.g., Acute oral LD-50 -
rat. Applicants who do not qualify for the
formulator's exemption must cite or submit the acute
toxicology battery of tests for both the active
ingredient and the product as formulated (if they are
different). Those who qualify for the formulator's
exemption need cite or submit tests only for the
product as formulated.
Block 9a. Use this block if you, the applicant, are relying on
your own data to satisfy the requirement. Indicate
whether you are citing or submitting the data. See
"CITING DATA" entry below.
Block 9b. Indicate the date you originally submitted the data to
EPA.
Block 9c. Use this block if you are relying on data submitted by
another company or individual. Insert the name of the
company or individual who has rights to the data.
Block 9d. If you cite data submitted by another company or
individual you must have his permission to use the data
to support your application or you must have made a
proper offer to pay to that person. If you are
certifying to having received permission, you should
write in "P" in this block. If you are certifying to
having made an offer to pay, write in "OTP" in this
block.
6-26
-------
IMPORTAMT MOTS i if the data you are citing are
exclusive use data, you must have permission to cite
the data. You may njj£ comply by making an offer to
pay.
Block 9e. If you are relying on public literature to support
your application check this block. If you check this
block you must submit a copy of the data on which you
rely.
Block 9f. Check this block, if you believe that either (1)
according to Part 158 and the guidelines, the data
requirement is not applicable (NA) or, (2) the data
requirement has been previously waived by EPA for
similar products, or (3) you can satisfy the data
requirements by some other means not provided on the
matrix. You must attach an explanation sheet to
this list which provides the rationale for using this
block.
Block 10. Insert the MRID (EPA's Master Record Identification)
number, EPA accession number, or other EPA
identification number.
CITING DATA
Applicants must indicate whether data submitted with the
application have or have not previously been provided to the
Agency by the applicant. Previously submitted data may not be
resubmitted. Rather, such data should be cited and the following
information given:
a. The title of the study, author(s), data completed, test
substance, identity of the laboratory performing the study
(if any).
b. EPA's Master Record Identification (MRID) Number or EPA's
data catalogue accession number (if known).
c. The identity of the original submitter.
d. The date on which the cited data were originally
submitted to the Agency.
e. One of the following if the data were not originally
submitted by you:
1) Evidence of transfer of ownership of rights to the
data to you.
2) Certification of written permission from the
original submitter to cite the data.
6-27
-------
3) Certification that a proper offer to pay has been
Bade to the original data submitter. (One
certification suffices for all offers to pay.)
6-28
-------
1
ft]
D
CO
a
o
^
£
CO
H
I
I
0!
1
£
X
I
CO
s
H
"
Z
O
H
S
H
Xo
^^
u z
CO
OS
p
§u co
HU
3s-
O W
b CO
M
•»
^4
CO
3
M
v^
•
o
z
•
o
w
fltf
jrf
ft)
«
as
f*
S°
o
a;
fc
.
r-4
CO*
z
W
H
O
ol
z
H
u
^
H
£J
b
O
u
r^
*a
O
g
2°
z
z o
Ou
•^
M El
H ^
<2
3 CO
H
to*
Q
2
«^
H
i
4.*
^<
i
SB
CO
< CO
M U
j S
fti O
ft. Q
«
*
in
K
>
£
9
£.
C
se
5C
i
i*
0!
h
^
g
|
>
b
«
^«
£-
CO
14
E-
b
G
«'
•M
C
CO
«
1 «
CO S
in K
44 a
ga
u <
E-
^ O
,
CO
c
-o
h -H D*
0 co t* e
2 CO O 0 ft
"W • « 44 0
m z * o*--
i
0 40
^^ i .
"•H M
iH 0 0
0 9-H 9
Ok ft) iJ 44
*
0 h ft
44 1 O E-
(0 CO ^-. «. O
•H 8 ft. 44 EH 0 44
O 3 >>i 0 tJ>
Ot CO A Oi>-'
•o
0
4J
0 44
44 -H
• O A
A 9
at co
? i
+* m
44 O
•H >»-H
• ja"° o.
40 9 a
44
a
£4
o
0
a Z
1 l to
"0 0 0 0 A
40 9 "H 0 C 9
a? O-H a ai z
H
g.
«
H O 4J
s e
44 -H
a 00
0 TJ C
M H-H
04
C O
0 O>
•H H «H
44 • 1
(J CO H
0 in to
CQH
1
«M
o c
o
44 -H
C4J
Staten
compos
M
i
H
to
*W
O *w
O CO
C +J
o e c
•H O ttl
CO 44-0
9 « 0
oat
co C o
•HOC
O "M-H
ft
1
f^
to
-
iH pH
10 C
to C
ft] 40
«H
1
C4
(H
o
c
o
•H
44
O
i
£Sl
to
0
4J
M
H
K
a
«n
1
fi
to
44
C
5
a
Q
Z
X
in
i
4*1
to
44
C
"o
ft]
o
c
H
•VN
«o
i
n
to
I
to
-------
C
(S
(L
B
CO
K
1
S
a
co
fa
o
i
04 fS
•
*
2
0
M
B
w
u
CO
O **
t* O
3 If
g|
K 3
O H
fa CO
«n
•«
£
CO
3
H
*
o
*
%
K
<
(X
H
(M
w
S
2
i
g
*»
•
H
1
i
w
X
o
i
w
5
2
^.^
X
I
*"
CO
SB **
Lml M
f_^ *F]
Okt ^^
Q, Q
MM mm
•
m
1
C
u
M
O
fid
i
2
H
S
M
6
<
0
O
J?
«
*"»
a
V
o
gl „
S° S
2
M H
H «<
si e
M CO 2
•J M O
6V.O £
ft. H
««
«
g
S
i
••
0
»-
*•
i
0
u
t
V.
t-
E-
^
CO
<
E-
<
Q
fa
O
CL
8
CO
cn
1 CO
H
to 2
in K
H Z
(8 C
b«<
f% ^
«£
*
CO
c
-o
a 0 fc c
*s° *
3 O - «M
2 O h -H 14
Q JQ 0) C JD
• H < fir w 1
i>i ««
o "c
Vl -H
^J Lj flM
flt Ljj ^gJI
* ^^ *^1 ffHV ^%
»z£t>£
i
O ff
«-i « «
f^i ^
5 3
c
Oh fti
^ 1 O t
0 00 «•* *• G
IO **^ *^ O Cu *O O B
•H • a, +> H a> +>
«w C'-' o a « ki
-HO) h«-O O 0
AJ a. e n _d «4
4» P"N h* w *H "^
. h O«w >«O *O *
•O fl>«w-H «w 0 C C ft
CAUOnOwO-Hc
C^,
0
TJ «
• JQ kl-H
U 3 >i3 »
Ot CO 42 a***
•o
Q)
4J *H
0 fi
•OX]
Xt 3
Ot CO
« C
III f(t
4-* IQ
*J U
• xt *a
03 a
en CO <
4J
n
V
gn
O
0
• (5
JQ 10
eo Z
I l h
JM L* m
V M V
0*0 «H« C3
0) O<-< OS 0) 2
>4
^ ,
Cfl M
H H
g~ 5
5 T3
U V
3 >
EH C *J
U-H —
§*J U
c c
o o I
as a
c o
^•^•1 ^^ Ihhk.
*HI rt n*
44 • 1
U co n
Win
44
•H
>
uC
0 0
-o
>«-H
4>
4J
-H
iH
•H
X)
3
H
0
CO
n
tp
«
h
n
n
0
Vi
Oi
h
PVaoo
Ah
T
n
«P
O
•H
4J
0 JJ
•H e
u «
O4.
n n
4i
•H
•H
Xt
(C
M
n
l
n
VP
e
o
•H
4J
O
0
0
\fc
»
C D
•H C
N-H
•H C
•o a
•HtJ
X 0
0 h
*
i
IP
>
•H
i-
•H
^j
|
fc
in
n
«
>
4J
•H
H
-r4
x»
«
"§
H
Q
M
63
«
1
n
-------
0
b
6
&
CO
U
OS
£
c
£
c
0!
1
I
tl
•^
I
I
CO
"
M°
^ 1
ft «^
, '
*
Z
O
Jg
Xrt
^^
w z
CO
OS
p b co
SC w w
23 >
2u
CO
»
0 a
• << *H J3 X
0
C* Z * 0<-
1
O 0
•H 1.
lO TJ *
• X) *4*H
D 3 >«0 &
to W A ft'*"
•o
0
0-p
• ^J IP
OJW CO
<3 «
tt » •
W
S
ot
1 M
^l»
•^ ^
^^ i'
0 ja
O\ (0
a
o
Ǥ H
H JB
$*
B
O <4
*°
CO
1
os z
1
0
0
mm^
«|"i"i
1
^1
1 M
h 0
TJ 0 0 0 £
••H C «H O B
0 3-H 0 C 3
OS «Z
>
1
i
5
RODUCT
ft
C 0
O (ft
•H H
4J •
O CO
0 in
CO H
~*
3 -H
contin
Viscos
*•'
' oe
i
n
to
•H
H
•H
•H
0
a
•H
a\
f
O4J
Acute
toxici
rt
1
Hi
CO
£j
|
^ C
r
0 >
•Q4J
4) C
|P« IM
•v '
O C
< H
fl
H
CO
-------
C
I
b
to
H
3
I
-
I
1
s
CO
b
•
W
O 1
<
^^ ^tti
•
*
z
0
M
i
Xf\
V
H as
CO
05
S«
r>
«C U
K U U
£eo
*
**
X
co
s
Jk
*
2
*
o
u
OS
g
a
•
p*
••
c
•H
J
!
*
H
*•
to*
i
M
w
i
HI
H
U
^
1^
&
<
b
o
M
Z
o
Id
§1
b<
zo
H 1H
H <
gg
M CO
ijH
£8
<«
*
O
1
H
5
z
*«*
X
i
a>
*••
CO
< CO
O CO
3U
PS
o< o
^s
*
m
^
^
nl
b
>
>
<
Q
£
z
c
£
i
§
0
5
b
OS
O
2
H
£
«
t-
^t
CO
<
E-
C
b.
O
B
ft
g
2
CO
o\
1 (0
H
co Z
in b
•H r
» Part
REQUIRE
i.
CO
C
-o
t* «H 91
0 n fc c
A « O -H
B 0 >i
3 O % «w
^S 0 M*» 0
O £ 0 C£
O g ft, 3 4J -O 3
H 2 w z O-H c
o "c
* &4 *H
0 »4 0
0 h iH
^<-H^ X
CftZ * O-*"
1
O 0
•H 0 0
*2 j 9
•>
0 b CM
tl I ° ft
0 n —» .. o
O-H — »O fti *D 08
•H e & ** H 0 *>
•w C— o n 0 M
•H 0 W — 0 O O
• I A. p in 4^ .MI
• A J-l -H
O 3 >i0 O»
O> CO JQ O**-'
13
0
^^ *H
0 B
A0 3
ON CO
•O 4J
11 i nt
** HJ
*» O
• 5"0 a
09 a
Ox W <
4J
n
0
f*
2 C -H 4J
8-H 1H
*J 0 CJ
H C *>••"
X O 0 M
00 0 C
H"- <*»
C O
o«
•H « n
SCO H
in co
CO t-l
^i
•H
0
fll 4
^* C
0 0
•H
l7«
04J
B-H
-H h
U k
cu-
1
H
CO
rH
i
C
0 C
•a o
•H
N4J
J* 0
0
•H
m
c
$
gc
il
0 0
O M
to
1
BO
to
-------
1
a
M
Q
O
EL
t-
CQ
H
I
at
s
I
x
H
I
a.
5
cu in
KEMPTION
H
CO
ll
3. FORMU1
SELECT
X
CO
3
H
fa
*
M
g
*
1
o
Z
IU
S
o
"
: ANT'S (COMPANY) NAI
IS:
2S
l§
*
••
64
C
INGREDIE!
>P ACTIVE
ca
i
2
tL
i
"a ^
«-> 1.1
APPLICATK
REGISTRAT]
MONTH
*
EL'
a
H
§
ITISFYING RE<
W
4
O
g
5
CO
OI
1 Part 158 -
REQUIREMENTS
0<
00
,§
hl-H U>
IP. !
3! 0 hi -H hi
Q ^£ « C £
• M < m JG « B
O ft ft 9 *»t» 3
H g WSC O*< C
h-^.
0 _C
0 U "fl
0> hiH
• > o» a
^<-HJ3 X
ON Z X O «-»
O 0
•H hi
ON & J *> ,
*
8} &4 Ck
** 1 0 g
« n — . » o
O-H — » O ft< *O 0)C
nH 8 0,4J H O *J
«w C *- O O * hi
•H « hi*"O O 0
•o qi
•A hl-H
ON co A a-*
J3 S
en co
1 8
• t M
5>,J
ON CO <
a
S
o
.g
A 0
CO Z
1 1 hi
•§«£«.!
-------
-------
BXBMPTIOM FROM THff MpPyREMBliT OF A TQMIltMiCT
A. GENERAL UTTQRMATIOH
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the
Environmental Protection Agency (EPA) is responsible for
regulating the amount of pesticide residues that can remain in or
on food or feed commodities as the result of pesticide
application. A tolerance is the legal maximum residue
concentration of a pesticide chemical allowed in food or feed.
If residues of a pesticide exceed the established tolerance, or
no tolerance has been established, the crop may be considered
adulterated and may be sei'zed by the Food and Drug
Administration, the United States Department of Agriculture, or a
state enforcement agency.
Tolerances are set under the.authority of the FFDCA. FFDCA
Section 408 applies to residues on/in raw agricultural
commodities (RACs) and Section 409 applies to pesticide residues
in processed food or feed commodities which exceed the raw food
tolerance.
40 CFR Part 180 - Tolerances and Exemptions from Tolerances
for Pesticide Chemicals in or on Raw Agricultural Commodities,
provides information on definitions and interpretative
regulations, procedures for filing petitions, temporary
tolerances, exemptions from the requirement of a tolerance,
residue data, fee requirements, specific tolerances and
exemptions which have been established for raw agricultural
commodities.
40 CFR Part 177 - Issuance of Food Additive Regulations
provides information on definitions, procedures for filing
petitions for establishment, modification, or revocation of a
food additive regulation, withdrawal of petitions, submission of
scientific and technical information required to support
petitions, and waiver of requirements. In addition, procedures
for filing objections and requests for hearings on food additive
regulations or petition denials under section 409(f) of the I'FDCA
are found in 40 CFR Part'178; rules governing formal evidentiary
hearings under FFDCA section 409(f) are found in 40 CFR Part 179.
40 CFR Part 185 - Tolerances for Pesticides in Processed
Food, provides a listing of tolerances established for residues
of pesticides in processed foods (food additive tolerances)
resulting from pesticide application during the growing process,
direct application to the end food product, or indirect
application to the end food product by treating the processing or
storage area. (Prior to June 29, 1988, 40 CFR Part 185 was
designated 21 CFR Part 193.)
4
7-1
-------
40 CFR Part 186 -
Animal Feeds, provides
residues of pesticides
present as a result of
crops. (Prior to June
21 CFR Part 561.)
Tolerances for Pesticides in Processed
a listing of tolerances established for
in processed animal feeds, which may be
application of the pesticide to growing
29, 1988, 40 CFR Part 186 was designated
B. WHEN ARE PETITIONS FOR TOLERANCES REQUIRED?
foodfeed additive regulations are reuired
eablished
to cover residues result Jay
ities or proc
foody
primary or secondary residues in meat* milk, poultry, and
•gag; residues in processed food resulting from treatment of
the raw commodity and exceeding the raw food tolermoet and
aaepeoted residues in imported food commodities.
Registration of a pesticide is not, however, a prerequisite
fer establishing a tolerance. For example* EPA may
^y^ablish a temporary tolerance under section 408Mi to
permit the experimental use of a non-registered pesticide.
of EPA may efftajbljfh a toleriflof for a pesticide residue
resulting from the use of the pesticide in food or feed
production in a foreigncountry.
3.. Applications for registration or amended
registration - Before a pesticide can be registered
for use on a food or feed crop or for use in a food
processing or storage area under FIFRA section 3, a
tolerance or the exemption from the requirement of a
tolerance must be established. In addition, if you
propose to amend a currently registered use, for
example, by increasing the dosage rates or frequency of
application, which might result in residues higher than
the established tolerance, a petition to amend the
established tolerance may be required.
2. Experimental Use Permits - An application for an
experimental use permit proposing use on a food or feed
crop or for the proposed experimental use in food
processing or storage areas, requires a temporary
tolerance for the proposed use if no tolerances are
currently established, or if the proposed experimental
use might result in residues higher than the
established tolerance or if the commodity is to be
marketed. The petition for the temporary tolerance
must be submitted with the application for the
experimental use permit.
IMPORTANT HOTEt A temporary tolerance is not required if
the commodity is to be destroyed or consumed only by
experimental animals.
7-2
-------
3. Importation of Pesticide Treated yoofl - The requirements
of sections 408 and 409 of the Federal Pood, Drug, and
Cosmetic Act (FFDCA) apply equally to domestically produced
and imported food and feed found to contain pesticide
residues. Therefore, even though the use of a pesticide in
a foreign country is not subject to EPA registration
requirements under the Federal Insecticide, Fungicide, and
Rodenticide Act (FZFRA), a pesticide residue in imported
food or feed must be in conformity with a tolerance,
tolerance exemption, or food additive regulation established
by EPA or, where appropriate an action level established by
the Food and Drug Administration. Shipments of imported
food/feed items found to have pesticide residues for which a
tolerance, exemption from the requirement of a tolerance, or
a food additive regulation has not been issued will be held
up and the importer required to either file for a tolerance
or exemption from a tolerance, or a food additive
regulation; return the shipment to the country of origin; or
destroy the shipment.
4. Inert» - inert ingredients in pesticide product
formulations are regulated under both the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended and the Federal Food, Drug, and Cosmetic Act
(FFDCA). Inert ingredients in products labeled for food use
must be cleared by EPA before the product can be registered.
40 CFR 152.55 requires that inert ingredients, metabolites.
and degradation products, as well as active ingredients, be
cleared by the Agency if your product is to be used on food
or feed crops. If your proposed labeling bears instructions
for use of the product on food or feed crops, or if the
intended use of the product results or may be expected to
result, directly or indirectly, in pesticide residues in or
on food or feed, you must submit a statement indicating
whether a tolerance, exemption from the requirement of a
tolerance, or a food additive regulation has been issued by
the Agency under section 408 or 409 of the Federal Food Drug
and Cosmetic Act (FFDCA). If a tolerance, exemption from
the requirement of a tolerance, or a food additive
regulation has not been issued for such residues, your
application must be accompanied by a petition for
establishment of appropriate tolerances, exemptions from the
requirement of a tolerance, or food additive regulations in
accordance with 40 CFR 177 (food additive petitions) or
40 CFR 180 (tolerance or exemption petitions).
Traditionally, the Agency has recommended against the
establishment of a tolerance for a pesticide product unless
all of the inert ingredients in the product have been
cleared for use on food/feed items. Refer to 40 CFR
180.1001 for a listing of the inert ingredients that have
been cleared for use on food/feed items.
7-3
-------
y. Afl-1 wants - Although adjuvants are not subject to
registration, those adjuvants intended for use in
conjunction with a pesticide in tank mixes for application
to a food or feed crop/site are required to be cleared with
the EPA, under the Federal Food, Drug and Cosmetic Act
(FFDCA) prior to being used. Such adjuvants are evaluated
by EPA as inert ingredients and undergo the 'appropriate
product chemistry review. Adjuvants cleared for use on
food/ feed items are listed in 40 CFR 180.1001.
C. PROCEDURES FOR TILING X PETITIOH
1. general - Procedures for filing a petition
requesting the establishment of a tolerance, a
temporary tolerance', or an exemption from the
requirement of a tolerance or a temporary exemption
from a tolerance, are described in detail in 40 CFR
section 180.7. Additional information concerning
requests for temporary tolerances, or a temporary
exemption from a tolerance, in conjunction with an
experimental use permit can be found in 40 CFR 180.31.
There is no application form for petitions. You must
submit your request in the format provided in 40 CFR
section 180.7.
Procedures for filing a petition for establishment,
modification, or revocation of a food additive regulation
for pesticide residues in or on a particular processed food
or group of such foods are described in detail in 40 CFR
section 177.81. Additional information concerning requests
for amendments or supplements to petitions can be found in
40 CFR 177.92. There is no application form for petitions
for food additive regulations. You must submit your request
in the format provided in 40 CFR 177. 81 (e) .
2. Completeness of Application - The petition must
include the following information in clearly designated
sections as follows:
a. Section A • The name, chemical identit and
composition of the pesticide chemical • To assess the
composition of the pesticide, information is required
on the manufacturing process, chemical analysis of the
active ingredient, certified limits for ingredients of
a product, and analytical methods to determine the
composition of the pesticide. You should also refer to
40 CFR Parts 158.150 - 190, Product Chemistry Data
Requirements and the Pesticide Assessment Guidelines,
Subdivision D - Product Chemistry for more detailed
information.
7-4
-------
iMPORTXirr NQTBi The Agency evaluates the composition
data to determine whether impurities could constitute a
significant component of the residues in food and feed
commodities. Impurities that arise in the manufacture
of pesticides can become a residue problem, if they are
not identified before tolerances are established.
Dioxins and nitrosamines are the best known examples of
significant impurities of toxicological concern. If
impurities are at levels that may lead to
toxicologically significant residues in crops, then
tolerances would be established for them, as well as
for the active ingredient. Once problem impurities are
identified, adjustments to the manufacturing process or
additional purification steps may be necessary to
reduce the impurities to a safe level.
b. Section B ~ Tftf ilfflfrVnt* fretruenev. and time of
application of the pesticide chemical. This refers to
the directions for use, dosage rates, number of
applications, restrictions, prc-harvest intervals, and
times of application that you intend to provide on the
label of the product you intend to market.
e. flection C - Full reports on investigations made with
respect to the safety of the pesticide chemical.
40 CFR Part 158.340, Toxicology Data Requirements,
identifies the types of toxicity data that are needed
to support a petition request. The required data are
identified under the "Food Crop" headings.
d« Section D — The results of tests oa tl|^ flm^unt of
residue remaining, including a description of the
analytical method used. Information on testing for the
amount of residue remaining in the raw agricultural
commodity. or processed food or feed, when the pesticide
is applied according to the proposed label directions,
is provided in 40 CFR Part 180.34 - Tests on the amount
of residue remaining, Part 158.240 - Residue Chemistry
Data Requirements, and the Pesticide Assessment
Guidelines, Subdivision O - Residue Chemistry. (Refer
to Chapter 16 of this manual for a source.)
Submission of analytical methods to EPA for use in
tolerance enforcement - You will need to develop and
submit accurate and precise analytical methods for
identifying and measuring the amount of pesticide
residues in the agricultural commodity and processed
foods. Those methods need to be practical in order to
be used in tolerance enforcement and should meet all of
the requirements for pesticide residue methods
identified in the Pesticide Assessment Guidelines,
Subdivision O - Residue Chemistry. The analytical
7-5
-------
method for enforcement cannot be marked as Confidential
or Trade Secret. In addition, registrants need to
submit to EPA pesticide validation data shoving the
results from their own laboratory as well as the
results from an independent laboratory tryout that
confirms those results. The exact procedure for
conducting an independent laboratory tryout can be
found in PR Notice 88-5.
IMPORTANT NOTE: If EPA does not receive all of the
items identified above, the petition will be considered
incomplete and returned without further notice.
e. section B -, Pr act leal methods.,for, removing residue
that exceeds aav proposed tolerance• Tolerances are
usually set at levels which are adequate to cover
residues that are likely to result from a proposed use
without any special processing of the commodities to
reduce residues to the tolerance level. Information in
this section would provide for a necessary and useful
pesticide treatment which results in residues larger
than a safe tolerance level, but which can be reduced
to the tolerance level by washing or some other means
proposed in the petition.
£. flection 1* - Proposed tolerances for the pesticide
chemical if tolerances are proposed. Tolerances should
be proposed in terms which best represent the total
toxic residues on the raw agricultural commodity,
whether it be the parent pesticide or altered forms of
it, or both.
An exemption from the requirement of a tolerance may be
proposed when appropriate. According to 40 CFR
180.1001(a) " An exemption from a tolerance shall be
granted when it appears that the total quantity of the
pesticide chemical in or on all raw agricultural
commodities for which it is useful under conditions of
use currently prevailing or proposed will involve no
hazard to human health". When an exemption is
proposed, data may need to be presented to show the
level of residues to be expected.
When residues on a processed food derived from the raw
agricultural commodity exceed the proposed tolerance on
the raw agricultural commodity, appropriate tolerances
should also be proposed in this section for the
processed food under FFDCA Section 409.
g« section Q • Reasonable grounds in support of the
petition. This section should include a rationale of
how the. residue data support the proposed tolerance,
-------
brief discussions on the adequacy of the analytical
method with respect to sensitivity and determination of
total toxic residues, an explanation of any aberrant
residue values reported, an explanation for the
omission or substitution of required data or
information, discussion of fate of the pesticide in the
environment (i.e., soil persistence, contamination of
ground water or run-off water) and any residue
considerations applicable to the proposed use. In
addition a summary of the grounds for safety of the
proposed tolerance based on the toxicology data
submitted under Section C, may also be included.
The petition for food additive regulations must include
the following information as set forth at 40 CFR
177.102.
a. The name and composition of the food additive that
is a subject of the petition, and the chemical
composition of each component of the food additive.
The name, chemical identity, and composition of each
pesticide residue that is a subject of the petition.
The identity of the processed food(s) in question.
b. A statement of any conditions of use proposed for
the food additive, including all directions,
recommendations, and suggestions proposed regarding the
use of the food additive, i.e., the amount, frequency,
method, and time of application or other use, and copy
of its proposed labeling.
c. Full reports of investigations made with respect to
the toxicity of the food additive and of its safety for
the proposed use, including full information as to the
methods and controls used in conducting such
investigations.
d. The results of tests to determine the identity and
amount of pesticide residues in or on the processed
food resulting from the proposed use of the food
additive, including a description of the analytical
methods used, and a description of practicable methods
for measuring such pesticide residues.
e. Full reports of investigations made with respect to
the toxicity of such pesticide residues, including full
information as to the methods and controls used in
conducting such investigations.
7-7
-------
f. All r*l*vant data bearing on the physical or other
technical effects such food additive is intended to
produce, and the quantity of such food additive
required to produce such effect.
g. The terns of each food additive regulation
proposed.
h. Any other information relevant to the approval of
the petition known to the petitioner that is
unfavorable to the petition.
i. A statement of why, in the petitioner's opinion, it
would be reasonable for the Administrator to approve
the petition, taking into account the terms of the
FFDCA and FIFRA, 40 CFR Part 177, the petition, the
data and information submitted or cited in support of
the petition, and other information available to the
Agency.
j . An informative summary of the petition and of the
data information, and arguments submitted or cited in
support of the petition, and a statement that the
petitioner agrees that such summary or any information
it contains may be published as a part of the notice to
the public under 40 CFR 177.88 or as part of a proposal
under 40 CFR 177.130. The summary need not refer to
any method or process that is entitled to protection as
a trade secret under FFDCA section 301 (j).
3. Data - Three copies of any data required to be submitted
in support of the petition must be submited in accordance
with the data formatting requirements set forth in PR Notice
86-5.
4» Application for registration **r OTI^HflBTflt under
FIPRA section 3 - Except in certain instances, a
petition request must be accompanied with an
application for registration, an application to amend
the registration of a currently registered product, or
an experimental use permit for the uses proposed in the
petition. A request for an import tolerance generally
would not require an accompanying application for
registration.
5. Fee Requirements - Each petition request must be
accompanied by the appropriate fee as specified in 40
CFR 180.33. It would be helpful if a photo-copy of the
fee check were submitted with the petition request in
case any questions arise concerning whether the fee was
submitted as required.
7-8
-------
The fees will be adjusted annually in accordance with
section 180.33(o). You should refer to the February 7, 1991
Federal Register Notice (56 FR 4946) for a more detailed
discussion of tolerance processing fees.
The fees vary considerably according to type of
petition requested and its complexity. A very brief,
general discussion of some of the fees required for the
more frequently requested petitions follows:
a. For the establishment of a new tolerance or a
tolerance higher than that already established (with
certain exceptions) the fee is $52,000, plus $1,300 for
each raw agricultural commodity more than nine on which
the establishment of a tolerance is requested.
/
b. For the establishment of a tolerance at a lower
numerical level(s) than already established for the
pesticide, or for additional raw agricultural
commodities at the same numerical level as already
established the fee is $11,900 plus $825 for each raw
agricultural commodity on which a tolerance is
requested.
c. For requests for an exemption from the requirement
of a tolerance or repeal of an exemption the fee is
$9,575.
d. For temporary tolerances or a temporary tolerance
exemption from the requirement of a tolerance the fee
is generally $20,775, except as provided below. A
request for an extension or renewal of a temporary
tolerance or temporary exemption requires a fee of
$2,950.
The fee schedule changes annually by the same percentage as
the percent change in the Federal General Schedule (GS) pay scale.
In addition, processing costs and fees will periodically be
reviewed and changes will be made to the schedule as necessary.
When automatic adjustments are made based on the GS pay scale, the
new fee schedule will be published in the FEDERAL REGISTER as a
Final Rule to become effective 30 days or more after publication,
as specified in the rule. Normally the fee schedule for the
current fiscal year will be published in the FEDERAL REGISTER
shortly after the first of the calendar year. However, the
publication of the fee schedule may be impeded by such things as
executive regulatory relief initiatives.
7-9
-------
•. For requests for a temporary tolerance for a
pesticide which has a tolerance for other uses at the
sane numerical level or a higher numerical level the
fee is $10,375 plus $825 for each raw agricultural
commodity on which the temporary tolerance is sought.
f. Waiver or refund request must be accompanied by
a fee of $1,300, which will be refunded if the
waiver is granted. The Agency may waive or refund
part or all of any tolerance petition fee, if it
is in the public interest to do so, or if the fee
would result in unreasonable hardship on the
applicant. A request for a waiver or a fee refund
must be submitted in writing to the Agency in
accordance with 40 CFR section 180.33(m).
/
IMPORTANT NOTE: Fee waiver requests affect the
processing times for the petition since the fee waiver
request must be processed before the petition is put
into review. The fee waiver review can typically take
2-3 months. To avoid this delay, petitioners can
submit the full fee with the petition and request that
the fee be returned if the Agency agrees with the
applicant that the petition is in the public interest.
The petition can then be put under review while the
refund request is being evaluated.
IMPORTANT NOTE: These fees may change without notice
being published in this manual.
All fees must be paid by money order, bank draft, or
certified check drawn to the order of the Environmental
Protection Agency. All payment of fees must be
forwarded to the following address:
Environmental Protection Agency
Headquarters Accounting Operations Branch
Office of Pesticide Programs
(Tolerance Fees)
P.O. Box 360277M
Pittsburgh, PA 15251
The payments should be specifically labeled "Tolerance
Petition Fees" and should be accompanied only by a copy
of the letter or petition requesting the tolerance.
The actual letter or petition, along with supporting
data should be forwarded within 30 days of payment of the
fee to the following address:
Document Processing Desk (PETN)
Office of Pesticide Programs - H7504C
U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
7-10
-------
A petition will not be accepted for processing until
the required fees have been submitted. A petition for
which a waiver of fees has been requested will not be
accepted for processinq until the fee has been waived,
or if the waiver is denied, the proper fee is
submitted. A request for waiver or refund will not be
accepted after scientific review of a petition has
begun.
Refer to Chapter 8 of this manual for additional information
on tolerance petition fees and other fees.
6. incomplete petitions - Petitions will not be
accepted for processing if the proper fee has not been
submitted, if any of the required data are lacking or
the petition is otherwise determined to be incomplete.
If a petition is not accepted for processing because it
is incomplete, it will be returned. The original fee
amount submitted, less a charge of $1,300 for handling
and initial review, will also be returned.
If a petition is withdrawn by the petitioner after initial
processing but before significant scientific review has
begun, the original fee, less $1,300 for handling and
initial review, will be returned. If an unacceptable
petition is resubmitted, it will require the appropriate fee
that would be required if it were submitted for the first
time.
D. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions concerning 1) whether a petition
for a tolerance is required, 2) the appropriate fee, 3) how to
submit your request for a petition for tolerance and/or
application for product registration, or 4) what data are
required to support your petition for tolerance and/or
application for product registration, please contact the
appropriate Product Manager for the pesticide. If the petition
request involves a new chemical not yet assigned to a Product
Manager, you should contact the appropriate Deputy Branch Chief,
or Branch Chief for a Product Manager assignment. Refer to
Chapter 18 of this manual' for a listing of the various Product
Managers, Deputy Branch Chiefs and Branch Chiefs.
B. REFERENCES CITED IN CHAPTER 7 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 158 - Data requirements for registration.
Part 177 - Issuance of Food Additive Regulations.
7-11
-------
Part 178 - Objections and Requests for Hearings.
Part 179 - Formal Evidentiary Public Hearing.
Part 180 - Tolerances and exemptions from tolerances
for pesticide chemicals in or on rav
agricultural commodities.
Part 185 - Tolerances for pesticides in food
administered by the Environmental Protection
Agency (Prior to June 29, 1988, 40 CFR Part
185 was designated 21 CFR Part 193)
Part 186 - Tolerances for pesticides in animal feeds
administered by the Environmental Protection
Agency (Prior to June 29, 1988, 40 CFR Part
186 was designated 21 CFR Part 561)
2. Federal Food Drug and Cosmetic Act
Section 408 - Tolerance for pesticide chemicals in or
on raw agricultural commodities
Section 409 - Food additives
3. Pesticide Assessment Guidelines, Subdivision D, Product
Chemistry, EPA-540/09-82-018.
4. Pesticide Assessment Guidelines, Subdivision 0, Residue
Chemistry, EPA-540/09-82-023.
5. PR Notice 86-5 - standard Format for data submitted under
the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and certain
provisions of the Federal Food, Drug and
cosmetic Act FFDCA). Issued July 29, 1986.
6. PR Notice 88-5 - Tolerance Enforcement Methods -
Independent Laboratory Confirmation by
Petitioner, Issued July 15, 1988.
7. Federal Register Notice, Regulation of Pesticides in Food:
Addressing the Delaney Paradox - Policy Statement, October
19, 1988 (53 FR 41104).
8. Federal Register Notice, Tolerance Processing Fees,
February 7, 1991 (56 FR 4946).
7-12
-------
CHXVPSR •
* **** FIBS AM REQUIRED FOR MflTflTRATTOM
IMTORKXTIOM
The 1988 amendments to the Federal Insecticide,, Fungicide
and Rodent icide Act (FIFRA) require that annual maintenance fees
be paid by registrants for a period of 9 years beginning March 1,
1989, of pesticide products registered under Section 3 or 24 (c)
of FIFRA, and provide for the collection of a fee for the
reregistration of pesticides. In addition, the Federal Food,
Drug and Cosmetic Act (FFDCA) provides for fees for the
processing and review of tolerance petitions. These fees are
discussed in more detail below.
IMPORTMTT MOTE: Fees are not required for:
Registering a product with a new active
ingredient.
Registering a new use of a previously registered
active ingredient.
Registering a product substantially similar or
identical to a previously registered active
ingredient.
Amending a registered product label.
Obtaining an Experimental Use Permit.
B. ANNUAL REGISTRATION MAINTEHXNCB FEES
Section 4(i}(5) of FIFRA requires each registrant of
pesticide products to pay an annual registration maintenance fee
based on the number of registrations held. The current fee
(January 15, 1992) is $650 for the first registration held by any
registrant and $1300 for each subsequent registration. The
maximum fee for registrants holding 50 or fewer registrations is
$55,000, except for small businesses for which it is $38,500.
The maximum fee for registrants holding more the.n 50
registrations is $95,000, except for small businesses for which
it is $66,500. Registrations for which the fee is not paid by
A "small business" registrant eligible for these lower fee
payment caps is defined as one which employs 150 or fewer people
and, during the three year period prior to the most recent
maintenance fee billing cycle (i.e., December 31, 1990) had average
annual gross revenue from chemical sales not exceeding $40 million,
taking into account any parents' and subsidiaries' employees and
gross revenues.
8-1
-------
January 15, 1992, vill be canceled, by order and without a
hearing, if you do not pay the fee to keep a registration in
effect, you vill be permitted until January 15, 1993, to dispose
of existing stocks of the pesticide, except in special
circumstances when less tine may be granted. You will be billed
by the Agency at the beginning of each calendar year. Zf you
need assistance in interpreting the instructions for filing your
maintenance fee, you can get help from our toll-free maintenance
fee information line at 1-800-444-7255.
IMPORTANT NOTE: 1) FIFRA was amended by a 1991 amendment to the
Food, Agriculture, Conservation, and Trade Act which changed the
due date for paying the maintenance fee from March 1 to January
15 each year. 2) You should also be aware that the annual
maintenance fee may be increased each year as appropriate. 3) Zn
general, there are no provisions for any waiver or refund of
registration maintenance fees. However, the Food, Agriculture,
Conservation, and Trade Act of 1990 did amend FIFRA to allow the
Administrator to reduce or waive maintenance fees for minor
agricultural use registrations, when he determines that the fee
would be likely to cause significant impact on the availability
of the pesticide for the use. This determination will be made
only after all the 1992 maintenance fee responses have been
received. Zf at that time the Agency determines that product
cancellation resulting from nonpayment of the fee would
significantly impact the availability of a particular
pesticide for a specific minor agricultural use, the Agency
will defer cancellation of the registrations in question,
and will provide affected registrants the opportunity to
maintain these registrations by paying a reduced maintenance
fee. 4) Registrations under section 24(c) of FIFRA are deemed
registration under section 3 of FZFRA and thus are subject to
this fee requirement. 5) The maintenance fee requirement does
not apply to supplemental registrations of distributors. Such
supplemental registrations are identified by a three-element
registration number in which your EPA Company Number is the third
element.
C. RBREOIflTRATION FBBB
Section 4(i)(l-4) of FIFRA states that registrants of
pesticides shall collectively pay a fee for the reregistration of
an active ingredient. These fees vary considerably and are based
on among other things, whether the pesticide is an active
ingredient of any pesticide registered for a major food or feed
use, or is registered only for non-food or non-feed uses.
Provisions are made for the reduction or a waiver of fees for
minor use and other pesticides and for small business registrants
of pesticides. Zn accordance with section 4(c) of FZFRA, the
Agency has published lists of active ingredients subject to
reregistration. List A was published in the Federal Register of
February 22, 1989 (54 FR 7740), List B in the Federal Register of
8-2
-------
May 25, 1989 (54 FR 22706), List C in th« Federal Register of
July 24, 1989 (54 FR 30846) and the last list, List D in the
Federal Register of October 24, 1989 (54 FR 43388). In addition,
registrants will be notified of the tine by which they are to
notify the Agency whether or not they intend to seek
reregistration. For a detailed discussion of the .reregistration
of registered pesticides and the fee schedules, you should refer
to section 4 of FIFRA as amended October, 1988.
D. TOLERANCE PETITION FEES
Under section 408 of the Federal Food, Drug and Cosmetic Act
(FFDCA), fees nay be charged to cover the cost of the processing
and review of tolerance petitions. Tolerances are required to be
established for residues of a pesticide whose use nay result in
residues on a food or feed commodity.
Refer to 40 CFR section 180.33 for a detailed discussion of
the various fees required for the type of petition for which you
intend to make application. The fees vary considerably according
to type of petition requested and its complexity and they will be
adjusted annually in accordance with section 180.33(o). You
should refer to the February 7, 1991 Federal Register Notice (56
FR 4946) for a more detailed discussion of the tolerance
processing fee requirements and to Chapter 7 of this manual for a
very brief, general discussion of some of the fees required for
the more frequently requested petitions for tolerance.
E. WHO TO CONTACT TOR ADDITIONAL INFORMATION
If you have any questions concerning 1) whether a petition
for a tolerance is required, 2) the appropriate, fee, 3) how to
submit your application for product registration and/or a
petition for tolerance, or 4) what data are required to support
your application for product registration and/or petition for
tolerance, please contact the appropriate Product Manager for
that pesticide. If the petition for tolerance and/or application
for product registration involves a new chemical not yet assigned
to a Product Manager, you should contact the appropriate Deputy
Branch Chief, or Branch Chief for a Product Manager assignment.
Refer to Chapter 18 of this manual for a listing of the various
Product Managers, Deputy Branch Chiefs and Branch Chiefs.
7* RgFERENCBB CITED ill CHAPTER a - Refer to Chapter 1C for
information OB the source of these documents.
1. Code of Federal Regulations, Title 40
Part 180 - Tolerances and exemptions from tolerances
for pesticide chemicals in or on raw
agricultural commodities
8-3
-------
2. Federal Food, Drug and Cosmetic Act
Section 408 - Tolerances for pesticide chemicals
in or on raw agricultural commodities
3. Federal Register Notices
- Tolerance Processing Fees, February 7, 1991 (56 FR
4946}
- Pesticides For Which Registration Standards Have Been
Issued (List A), February 22, 1989 (54 FR 7740)
- Pesticides Required To Be Reregistered
- (List B), Hay 25, 1989 (54 FR 22706)
. (List C), July 24, 1989 (54 FR 30846)
- (List D), October 24, 1989 (54 FR 43388)
4. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 4 - Reregistration of registered products
5. Food, Agriculture, Conservation, and Trade Act of 1990,
November 28, 1990
Subtitle H - Pesticides - Sections 1493
6. Food, Agriculture, Conservation, and Trade Act
Amendments of 1991, December 13, 1991
Section 1006 - Amendments to FIFRA and Related
Provisions
8-4
-------
m> MOW TO XfPIiT TOR Mf
A. QBHBRAIi IinfORMXTION
Experimental Use Permits (EUPs) are issued under FIFRA
section 5 to allow prospective registrants to generate
information or data necessary to register a pesticide under
section 3 of FIFRA. - You should refer to 40 CFR Part 172 for
detailed information on EUPs. In general EUPs are issued for:
1. A pesticide not registered with the Agency, or
2. A registered pesticide for a use not registered with the
Agency.
Pesticides under experimental use permits may not be sold or
distributed other than through participants in the approved
experimental use program. They may only be used at the
application site of a cooperator in the program, and only in
accordance with the terms and conditions of the experimental use
permit.
B. WHEN IB AH EXPERIMENTAL OB8 PERMIT BBQUIRgD?
1. Generally, an EUP is required before you can conduct
large scale field testing. Large scale field testing
would be any instance other than those described in
item 2 below. However, in certain cases (e.g., "novel"
microbial pesticides -- certain genetically altered and
non-indigenous microbial pest control agents as
discussed in item 3 below) small scale field tests may
require an EUP.
IMPORTANT MOTBt EUPs are required for testing of pesticides
in a comparable indoor situation, for example a pesticide to
control roaches in domestic dwellings, institutions, etc.
and for field testing of swimming pool sanitizers and
disinfectants under actual use conditions.
2. EUPs are generally presumed not to be required for a
substance or mixture of substances being put through
laboratory or greenhouse tests, or limited replicated
field trials, in which the purpose is only to determine
its value for pesticidal purposes or to determine its
toxicity or other properties, under the following
circumstances:
a. Land use - For tests conducted on a cumulative total
of not more than 10 acres involving use of the test
material against a particular pest, provided that any
food or feed crops involved in or affected by the tests
are destroyed or consumed only by experimental animals.
-------
unless a tolerance or exemption fron a tolerance ha»
been established.
b. Aouatie use * For tests conducted on a total of not
•ore than one surface-acre of water involving use of a
test material against a particular pest, provided that
such waters involved in or affected by the tests will
not be used for irrigation, drinking water supplies, or
body contact recreational activities. In addition, no
tests may be conducted in waters that contain, or which
affect any fish, shellfish or other plants or animals
which may be taken and used for food or feed unless a
tolerance or exemption from a tolerance has been
established.
e. Animal treatments - For tests conducted only on
experimental animals. No animal may be tested if it
may be used for food or feed purposes, unless a
tolerance or exemption from a tolerance has been
established.
3. Small scale field testing for "novel" mierobial
pesticides requiring an BUP — Due to concerns about the
capability of microorganisms to reproduce and multiply in
the environment and the potential for these microbials to
cause unforseen adverse impacts, the Agency may require an
EUP for small scale field testing of certain "novel"
microbial pesticides (i.e., genetically-altered and non-
indigenous microbial pest control agents). Refer also to
the section on Application Requirements for an Experimental
Use Permit, C.l.b. below.
C. APPLICATION REQUIREMENTS FOR Alf EXPERIMENTAL USB PERMIT
Your application for an experimental use permit must contain
or address the following:
1. General Requirements
a* Conventional. Biochemicalf and Most Microbial
Pestieides
1) Application for Experimental Use Permit, EPA
Form 8570-17.
2) EPA Registration Number of the product to be
used, if registered.
3) Purpose or objectives of proposed testing.
4) A description in detail of the proposed testing
program including:
9-2
-------
a) Test parameters
b) A designation of the pest organism(s)
involved
c) The amount of pesticide product proposed
for use
d) The crops, fauna, flora, sites, modes,
dosage rates and situations of application on
or in which the pesticide is to be used
e) The states, and counties within the state,
in which the proposed program will be
conducted
f) The number of acres, number of structural
sites, or number of animals by state and
county to be treated or included in the area
of experimental use
g) The proposed dates or period(s) during
which the testing program is to be conducted
h) The manner in which supervision of the
program will be accomplished
IMPORTANT KOTB! It is very helpful in the Agency's review
process if you include a table which indicates the states to
which the product is to be shipped, and the pounds of
product to be shipped to each state for each pest or pest
complex, along with the total pounds of product to be
shipped to each state. For example:
EXPERIMENT USE PERMIT SUMMARY WORKSHEET
COMPOUND: Cryptop
TOTAL ACRES: 700
POUNDS A.I. REQUESTED: 2300
NUMBER OF APPLICATIONS (By Site)
1-Soybeans
S-Cotton
2-Corn
STATE
AL
AR
GA
TOTALS
SITE 1 /
Cotton
ACRES
200
100
100
J: 400
SITE 2 /
Corn
ACRES
100
100
SITE 3 /
Sovbeans
ACRES
50
50
100
200
SITE 4 /
ACRES
TOTAL
ACRES
250
150
300
700
TOTAL
LB. AI
SHIPPED
1050
550
700
2300
A tabular summary of this kind speeds review and processing of
the experimental use permit. (See Appendix 9-1 for blank format)
9-3
-------
5) The name, street address, telephone number, and
qualifications of all participants in the program
(whether or not in the employ of the applicant).
A participant is any person acting as a
representative of the permittee and responsible
for making available for use, or supervising the
use or evaluation of an experimental pesticide to
be applied at a specific application site.
6) The name and street address of all cooperators,
if available at the time the application is
submitted or as soon as possible thereafter.
Cooperators are persons who grant permission for
an experimental use pesticide to be used on
application sites which they own or control.
7) Information on prior testing - a description
and the specific results of any appropriate prior
testing of the product conducted by the applicant
to determine, (a) toxicity and effects in or on
any target organisms at the site of application,
and (b) phytotoxicity and other forms of toxicity
or effects on nontarget plants, animals and
insects, at or near the site of application, or
(c) any adverse effects on the environment.
8) The proposed method of storage and disposition
of any unused experimental pesticide and its
containers.
9) Any other additional pertinent information as
the Agency may require.
b. Small scale field testing - "novel'* micrebial
pesticides (i»e«» genetically altered and POP*"
indigenous microbial pest control agents1
Prior to the initiation of any small scale field
testing which involves genetically altered or non-
indigenous microbial pest control agents, the research
organization, company, or individual must submit a
notification to the Agency so that a determination can
be made as to whether an EUP is required.
You should also refer to Chapter 3 - Biochemical and
Microbial Pesticides, Section D., Small-scale field
testing Level I reporting and Level II notification
requirements, for a more detailed discussion of the
Agency's policy and requirements for small-scale field
testing for microbial pesticides.
9-4
-------
Tolerace
If the proposed experimental use pesticide is to be
used in such a manner that any residue can reasonably
be expected to result in or on food or feed, the
applicant must either 1) submit evidence that a
tolerance or an exemption from the requirement of a
tolerance has been established for residues of the
pesticide in or on such food or feed under section 408
of the Federal Food Drug and Cosmetic Act (FFDCA) , or a
regulation promulgated under section 409 of that Act,
or 2) submit a request proposing establishment of a
tolerance or a temporary tolerance under FFDCA section
408, or a regulation under section 409. Refer to
Chapter 7, for a further discussion of tolerances.
Zn lieu of submitting a request for a tolerance or
temporary tolerance, the applicant may certify that the
food or feed item resulting from the experimental use
program will be destroyed or fed only to experimental
animals to be used only for testing purposes (not for
food or feed) .
3. Data requirements
If the proposed EUP is for an unregistered pesticide, the
following information and/or data are required:
a. Completed Confidential Statement of Formula, EPA
Form 8570-4.
b. Appropriate data in accordance with the data
requirements identified in 40 CFR Part 158 for an
experimental use permit.
c. Reentry data, if available.
d. Submitted data (3 copies) must be bound and
formatted in accordance with the requirements of PR
Notice 86-5.
IMPORTANT NOTE: Each study must be separately bound.
Confidential attachments and supplemental statements of
data confidentiality must be included within the
binding of the body of the study. All bindings must be
secure, but easily removable to permit microfilming.
(See PR Notice 86-5 and PR Notice 89-3 for specific
instructions on binding of studies.)
9-5
-------
All pesticides shipped or used under an experimental
use permit must be labeled with directions and
conditions for use including the following:
a. The prominent statement "For Experimental Use Only"
b. The Experimental Use Permit Number
c. The statement "Not for sale to any person other than
a participant or cooperator of the EPA-approved
Experimental Use Program"
/
d. The name, brand or trademark
e. The name and address of the permittee, producer, or
registrant
f. The net contents
g. An ingredient statement
h. Warning or caution statements
i. Any appropriate limitations on entry of persons into
treated areas
j. The establishment registration number, except in
those cases where application of the pesticide is
made solely by the producer
X. The directions for trial use
IMPORTANT NOTE: Refer to Chapter 2, page 2-16 for
label/labeling format information.
5. Extensions er ren
1 of
erimanfcal Use Permits
Experimental Use Permits and associated temporary
tolerances are usually issued for a period of one or
two years. The permit and any associated temporary
tolerances, may be extended, renewed, or amended upon
written request to the Agency, if circumstances
warrant.
6. Fee Requirements
If your application for an Experimental Use Permit is
accompanied by a petition for a tolerance, temporary
tolerance, an exemption from the requirement of a
tolerance or a temporary tolerance exemption, the
9-6
-------
1
petition is subject to fee requirements as discussed in
Chapters 7 and 8 of this manual. An extension or
renewal request for a temporary tolerance is also
subject to a fee requirement.
IMPORTANT MOTB: 40 CFR 152.55 requires that .inert
ingredients. metabolites, and degradation products, as veil
as active ingredients, be cleared by the Agency if your
product is to be used on food or feed crops. If your
proposed labeling bears instructions for use of the product
on food or feed crops, or if the intended use of the product
results or may be expected to result, directly or
indirectly, in pesticide residues in or on food or feed, you
must submit a statement indicating whether a tolerance,
exemption from the requirement of a tolerance, or a food
additive regulation has been issued by the Agency under
section 408 or 409 of the Federal Food Drug and Cosmetic Act
(FFDCA). If a tolerance, exemption from the requirement of
a tolerance, or a food additive regulation has not been
issued for such residues, your application must be
accompanied by a petition for establishment of appropriate
tolerances, exemptions from the requirement of a tolerance,
or food additive regulation in accordance with 40 CFR 180.
Alternatively you may certify that the food or feed derived
from the experimental program will be destroyed or fed only
to experimental animals for testing purposes, or otherwise
disposed of in a manner which will not endanger man or the
environment.
D. WHO TO COMTACT TOR ADDITIONAL INFORMATION
Please contact the appropriate Product Manager for your
pesticide if you have any questions such as whether an
experimental use permit is required, whether a temporary
tolerance is required for the proposed use, the appropriate fee,
how to submit the application for an experimental use permit, or
data required to support the application. If you have questions
concerning the testing of "novel" microbial pesticides and/or
transgenic plants you should contact Product Manager 18 for
insecticide products and Product Manager 21 for fungicide or
herbicide products. If the EUP is for a new chemical which has
not been assigned to a Product Manager, you should contact the
appropriate Deputy Branch Chief, or Branch Chief for a Product
Manager assignment. Refer to Chapter 18 of this manual for a
listing of the various Product Managers, Deputy Branch chiefs and
Branch Chiefs.
9-7
-------
B. MMMMCM CTTBP TM CHXPTM t - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Fart 152 - Pesticide Registration and Classification
Procedures
Part 158 - Data requirements for registration
Part 172 - Experimental use permits
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988.
Section 3 - Registration of pesticides
3. Federal Food Drug and Cosmetic Act
Section 408 - Tolerances for pesticide chemicals in or
on raw agricultural commodities
Section 409 - Food additives
4. PR Notice 86-5 - standard Format for data submitted under
the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and certain
provisions of the Federal Food, Drug and
Cosmetic Act (FFDCA). Issued July 29,
1986.
5. PR Notice 89-3 - Format standards for Reregistration
Phase 3 summaries and reformatted
versions of studies previously submitted
under the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA) and certain
provisions of the Federal Food, Drug,
and Cosmetic Act (FFDCA). Issued
December 20, 1989.
9*8
-------
EXPERIMENTAL USE PERMIT SUMMARY WORKSHEET
APPENDIX 9-1
COMPOUND:
TOTAL ACRES:
POUNDS A.I. REQUESTED:
NUMBER OF APPLICATIONS (By Sit«):
STATED
AL
AR
AZ
CA
CO
DE
FL
6A
HI
IL
ID
IA
KS
KY
LA
MA
ME
MD
MI
MN
MO
MS
MT
NE
NV
NM
NY
NC
ND
NH
NJ
OH
OX
OR
PA
RI
SC
SD
TN
TX
UT
VA
WA
HI
WV
WY
TOTALS
SITE 1 /
ACRES
•
SITE 2 /
ACRES
-
SITE 3 /
ACRES
SITE 4 /
ACRES
TOTAL
ACRES
TOTAL
LB. AI
SHIPPED
9-9
-------
-------
XRS
BKOITTK
IHTOHKXTIQII
Section 25 (c) (4) of FIFRA provides that the Administrator
nay specify devices which are subject to any provision of FIFRA
section 2(q)(l) or section 7. Devices are defined in FZFRA
Section 2 (h) .
The Agency's policy concerning its authority and activities
with respect to devices was published in the Federal Register of
November 19, 1976 (41 FR 51065).
B. DEFINITION OF DEVICES
/
40 CFR Section 153.240 defines a device as "any instrument
or contrivance (other than a firearm) which is intended for
trapping , destroying, repelling, or mitigating any pest or any
other form of plant or animal life (other than man and other than
bacterium, virus, or other microorganism on or in living man or
other living animals) ; but not including equipment used for the
application of pesticides (such as tamper-resistant bait boxes
for rodenticides) when sold separately therefrom".
In general, if an article uses physical or mechanical means
to trap, destroy, repel, or mitigate any plant or animal life
declared to be a pest at 40 CFR 152.5, it is considered to be a
device, and not subject to registration under FIFRA section 3.
However, if the article incorporates a substance or mixture of
substances intended to prevent, destroy, repel, or mitigate any
pest, it is considered to be a pesticide and as such is subject
to registration under FIFRA section 3.
C. DEVICES SUBJECT TO T»* >g*
The Agency, in the November 19, 1976 Federal Register
Notice, stated that devices subject to FIFRA section 2(q)(l) and
section 7 include but are not limited to:
1. Certain 'ultraviolet light systems, ozone generators,
water filters and air filters (except those containing
substances which are' pesticides) , and ultrasonic devices,
for which claims are made to kill, inactivate, entrap, or
suppress the growth of fungi, bacteria, or viruses in
various sites,
2. Certain high frequency sound generators, carbide cannons,
foils, and rotating devices, for which claims are made to
repel birds,
10-1
-------
3. Black light traps, fly traps, *l*ctronic and heat
screens, fly ribbons, and fly paper for which claims are
made to kill or entrap certain insects, and
4. Hole thumpers, sound repellents, foils and rotating
devices, for which claims are made to repel . certain mammals.
IMPQBTMIT HOTBt Although not specifically mentioned in the
November 19, 1976 Federal Register Notice, the Agency has
determined that electromagnetic devices are also subject to
FIFRA section 2(q)(l) and section 7.
D. DEVICES HOT SUBJECT TO THE ACT
/
The November 19, 1976 Federal Register Notice provided the
following examples of those types of devices that are not subject
to FIFRA:
l. Devices which depend for their effectiveness more upon
the performance of the person using the device than on the
performance of the device itself, and
2. Devices which operate to entrap vertebrate animals.
Products generally falling within these two categories include
rat and mouse traps, fly swatters, tillage equipment for weed
control and fish traps.
E. REQUIREMENTS FOR DEVICES
1. Registration Mot Required
A device is not required to be registered under FIFRA
section 3. However, devices are subject to certain other
requirements of FIFRA as indicated below.
2. Iffl
Recniirement
Devices are subject to the labeling requirements of FIFRA
section 2(q)(l) and 40 CFR Part 156. These requirements
are summarized below.
a. Under FIFRA section 2(q)(l) a device is considered
to be misbranded and subject to enforcement action if:
1) Its labeling bears any statements, designs, or
graphic representations, which are false or
misleading (see 2.b. below for examples of false
or misleading statements) ,
10-2
-------
2} Its packaging or wrapping must conform to
standards established pursuant to FIFRA section
25(c)(3) (as of this date, such standards have yet
to be established for devices),
3) It is an imitation of, or is offered for sale
under the name of another device,
4} It's label fails to bear the establishment
number,
5) Required information is not prominently
displayed on the label,
6) It lacks adequate directions for use, or
7) It lacks an adequate warning or caution
statement.
b. 40 CFR section 156.10 (a)(5) provides the following
examples of labeling statements or representations
which constitute misbranding:
1) A false or misleading statement concerning the
composition of the product,
2) A false or misleading statement concerning the
effectiveness of the product as a pesticide or
device,
3) A false or misleading statement about the value
of the product for purposes other than as a
pesticide or device,
4) A false or misleading comparison with other
pesticides or devices,
5) Any statement directly or indirectly implying
that the pesticide or device is recommended or
endorsed by any agency of the Federal Government,
6) A true statement used in such a way as to give
a false or misleading impression to the purchaser,
7} Label disclaimers which negate or detract from
labeling statements required under the Act and
regulations, and
8) Non-numerical and/or comparative statements on
the safety of the product*
10-3
-------
ifcAl>l.i.AlmAfife KAeri.flfcrAfci.oii And
irfclner. llAAfeM Mi
Devices are subject to the establishment registration and
reporting requirements FZFRA section 7 and Part 40 CFR Part
167. All establishments in which devices subject to the Act
are produced must be registered with the Agency as producing
establishments. This includes foreign establishments in
which devices shipped to the U.S. are produced, as well as
establishments located in the U.S. which produce devices for
export. Refer to Chapter 11 for information on how to
obtain an EPA establishment number.
FIFRA section 8 and 40 CFR 169 provide information on such
records that are required to be maintained by producers of
devices .
4. inspection of Bfft
-------
In addition, devices are subject to the record keeping and
inspection requirements in accordance with section S of
FIFRA.
7. child-resistant Packaging
Refer to FIFRA section 25(c)(3) and 40 CFR section 157.20
for information concerning child-resistant packaging
requirements.
F. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions concerning devices, whether they
are subject to the Act, or establishment registration, please
contact the Office of Compliance Monitoring, Compliance Division
(EN-342), Environmental Protection Agency, 401 M St., S.H.,
Washington, DC, 20460. Telephone (202) 260-7835.
G. REFERENCES CITED III CHAPTER 10 - Refer to Chapter 16 for
information on the source of these documents.
l.Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
Part 153 - Statement of policies and interpretations
Part 156 - Labeling requirements for pesticides and
devices
Part 157 - Packaging requirements for pesticides and
devices
Part 167 - Registration of pesticide-producing
establishments, submission of pesticide
reports, and labeling
Part 169 - Books and records of pesticide production
and distribution
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 2 - Definitions
Section 3 - Registration of pesticides
Section 7 - Registration of establishments
Section 8 - Books and records
Section 12 - Unlawful acts
Section 13 - Stop sale, use, removal, and seizure
Section 14 - Penalties
Section 17 - Imports and exports
Section 25 - Child resistant packaging
3. Federal Register Notice (40 FR 32321), August 1, 1975.
10- 5
-------
4. Federal Register Notice, P««t Control Devices and Device
Producer*, (41 FR 51065), Nov. 19, 1976.
10-6
-------
11 — ROW TO OBYXIlf AH EPA BBVABX.I
AL IlffFORItATIOM
If you produce or formulate your own pesticide, then the
place (s) [or establishment (s) ] in which you produce a pesticide,
or device, is subject to registration. ( Refer to FZFRA section
7) . However, if you produce the pesticide only for application
by yourself and not for sale or distribution, you are not
required to register your establishment.
40 CFR Part 167 entitled "Registration of Pesticide-
Producing Establishments, Submission of Pesticide Reports, and
Labeling1*, provides detailed information concerning definitions,
registration procedures, labeling, and reporting requirements.
An "establishment" is defined as any site where a pesticide
or device is produced, regardless of whether:
1) the site is independently owned or operated, or
2) the site is domestic (located in the U.S.) and is
producing the pesticide or device only for export, or
3) the site is located in a foreign country and is producing
the pesticide or device for importation into the United
States .
The term "produce" is defined as the manufacture, preparation,
propagation, compounding, or processing of any pesticide or
device, (including pesticides produced for use under an
Experimental Use Permit) , or the repackaging or the changing of
the container of any pesticide or device.
You should refer to 40 CFR Part 167 for more detailed
information regarding the registration of your establishment,
labeling and reporting requirements.
B» APPLICATION TOR REOIflTRATIOII OF PBflTICIPB-PRODPCTItQ
BBTABLI8HMB1ITS
1. Complete the application form EPA Form 3540-8,
Application for Registration of Pesticide-Producing
Establishments .
2. Where to submit your application:
•• Domestic B«fclMifhlfB^l - Submit your application
to the EPA Regional Office having jurisdiction over the
State in which the headquarters of your company is
located. Refer to Chapter 18 for a listing of the
various EPA Regional Offices.
ll-l
-------
b« Foreign Establithm.tn.tf - Foreign companies should
submit their application to EPA's headquarters office
at the address listed below:
Environmental Protection Agency
Office of Compliance Monitoring (EN-342)
401 M St., S.W.
Washington, D.C. 20460 U.S.A.
C. INFORMATION REOPIRBD
Your application for the registration of your establishment
requires the following information:
1) The name and address of your company,
2) The type of ownership (individual, partnership,
cooperative association, corporation, or any organized
group of persons whether incorporated or not), and
3) The names and addresses of all producing
establishments.
D.
TO ORT&TM &9PT.TC&TTOM VORMfl
EPA Form 3540-8, Application for the Registration of
Pesticide-Producing Establishments may be obtained from your EPA
Regional Office (see Chapter 18), or from the Office of
Compliance Monitoring (EN-342), Environmental Protection Agency,
401 M Street, S.W., Washington, D.C. 20460.
l. REFERENCES CITED IK CHAPTER ii - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 167 - Registration of pesticide-producing
establishments, submission of pesticide
reports, and labeling
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 7 - Registration of Establishments
11-2
-------
r
12 - HOW TO SUBMIT DATA AND CONFID!
AX. van
A. GENERAL INFORMATION
Some of the information (and data) you must submit to EPA is
protected by FIFRA from disclosure or release to certain persons
under certain circumstances. These protections are found in
FIFRA Section 10. A brief synopsis is given below.
You may also make confidentiality claims covering
information other than that described in FIFRA Section
10(d)(l)(A), (B), or (C). If such claims are made, you will have
to substantiate each claim/ and the EPA General Counsel will rule
on each claim before any disclosure or release of the information
is made. The substantiation process is provided to afford
protection to certain information that is not explicitly
described in FIFRA or EPA Regulations. Consider making claims of
confidentiality only after carefully reading the citations listed
in section B. of this chapter. Normally, we see very few claims
of this type that qualify for confidential treatment.
Data submitted in support of your application for
registration, amendments to a registration, petitions for
tolerance, experimental use permit, etc., must be submitted in a
standard format in accordance with 40 CFR 158.32-33 and PR Notice
86-5. Refer to section C. of this chapter for a general
discussion of these requirements.
B. SYNOPSIS OF FIFRA flBCTIOM 10 - CONFIDENTIAL BUSINESS
INFORMATION
In brief, Section 10 provides that health and safety data on
registered or previously registered pesticides shall be made
available to the public, except that it does not authorize the
release of the following information cannot be released:
1. Information that discloses manufacturing or quality
control processes.
2. Information that discloses testing for and measuring the
quantity of deliberately added inert ingredients, and
3. Information that discloses the identity or percentage
quantity of deliberately added inert ingredients.
When data are submitted, information of the types 1, 2, and 3,
above must be physically separated from the rest of the data
(study) and placed in a confidential attachment to the study.
(See PR Notice 86-5 for specific instructions about study
formatting.)
12-1
-------
FIFRA Section 10(b) protects certain confidential business
information, such as trade secrets and commercial or financial
information.
FIFRA Section 10(e) permits EPA to give confidential
business information (CBI) you submit to its contractors who are
helping to do the work of the Agency. Such contractors are bound
to protect this information to the same extent as EPA staff. We
provide notification to submitters of CBI that their data will be
provided to a contractor. This is usually done by publishing a
Notice in the Federal Register and always precedes giving the CBI
to the contractor.
FIFRA Section 10(g) prohibits the disclosure of information
submitted by an applicant or registrant to any representative of
a multinational pesticide producer or to anybody who intends to
deliver such information to a multinational pesticide producer.
FIFRA provides that in certain circumstances the EPA
Administrator may disclose information that is otherwise
protected. Such action is rare, and is described in FIFRA
Section 10(b), 10(d)(3), and 10(g).
Information about registered pesticide products that can be
released is normally not released until 30 days after the product
is registered. See FIFRA Section 3(c)(2)(A).
This has been a very brief review of certain points about
CBI that may be of special interest to you. Please also see;
FIFRA Section 10, 40 CFR 2.307, and the citations listed in 40
CFR 2.307(c).
IMPORTANT MOTE; Documents containing CBI, i.e., a confidential
Statement of Formula (CSF), should not be transmitted over FAX
machines unless the sender wants to clearly waive his or her CBI
rights and states this on the documents being "FAXed.*
C. HOW TO SUBMIT DATA
The following discussion highlights some of the more
important points that you should follow when submitting data.
You should also refer to 40 CFR 158.32-33 and PR Notice 86-5 for
a more detailed discussion of how to format your data submission
When you submit data, the data will be reviewed to determine
whether it meets the data formatting requirements set forth in PR
Notice 86-5. If major problems are found during this screening
process, the studies will be returned to you for correction.
Studies that meet the formatting requirements will be assigned a
12-2
-------
- rt following individuals in the Information services Branch
of OPP's Program Management and Support Division may be contacted
for assistance in answering questions or to provide guidance
concerning the data formatting procedures as required by PR
i ^
Theresa Downs (703) 305-5363,
Maureen Sherrill (703) 305-5361,
Kris Pappajohn (703) 305-5316.
Master Record Identifier (MRID) number and entered into the
Agency's Pesticide Document Management System. These studies are
then able to be retrieved by the MRID number at any time. You
US!* "£'£? the5e MRID numb«rs in li«u of sending in additional
copies of these data to support additional applications for
registration .
The following diagrams are meant to provide guidance on how
to format your data submission. Again you should refer to PR
Notice 86-5 for more detailed information.
FORMAT OF THE 80BMITTM.
APPLICATION TRANSMITTAL
(submit one copy only)
(submit
3 cop
DATA TRANSMITTAL
<—J
STP
SOCC T
IGLP/FS
BOS
I ATS
(copy #3)
(copy II)
Studies submitted as unique (copy 12)
physical entities, according
to the format below.
MOTE: As indicated in the above illustration, three identical
copies of the data transmittal must be submitted.
LEGENDI
STP •
SOCC -
GLP/FS *
BOS
ATS
* Refer to 40 CFR 158.34
Study title page.
Statement of confidentially claims.
Good Laboratory Practice (GLP) and flagging*.
Body of study, in English.
Appendices to the study.
12-3
-------
OF THE BUBMITTSD STUDIES
Study title page.
Statement of confidentially claims.
Good Laboratory Practice (GLP) and flagging*
statements (as appropriate).
-. Body of study, in English.
Appendices to the study
Title Page of the
Confidential
Attachment.
LEGEND
Confidential Attachment.
-Supplemental Statement
of Confidentiality
Claims.
* Refer to 40 CFR 158.34
Miscellaneous documents submitted
at your option.
Documents which must be submitted as appropriate
to meet established requirements.
1. APPLICATION TRAH8MITTAL
The application transmittal may include any or all of the
following:
a. Application forms
b. Formulator's exemption statements
c. Confidential Statement of Formula
d. Certification with Respect to Citation of Data
e. Data requirement matrices
f. Data waiver request and supporting rationales
g. Labeling
IMPORTAMT NOTEI PR Notice 86-5 does not change the
registration requirements for applications for
registration or amendments as set forth in 40 CFR 152
and elsewhere. PR Notice 86-5 only applies when you
submit data to support the application, and then only
to the data. All of the items listed in this sub-
section address non-data requirements for registration,
and are filed in the Agency's registration jacket
(file) for your product. Thus they need not be
submitted in three copies like the data.
12-4
-------
2* DATA TRAMflMTTTAIi DOCDXBMT
You should provide a copy of the Data Transnittal for
each set of studies. Bind it separately, and be
certain that it itemizes all studies that are
physically included in the submittal. You will be sent
a copy of your data transmittal document with the MRID
numbers assigned to each piece of data or study. Refer
to PR Notice 8*6-5 for a sample transmittal document.
3. BIND STUDIES SEPARATELY
If a study addressed several data requirements, do not
include it in your submittal more than once. Identify
its full subject scope on its title page, and then cite
the same study in your application in all appropriate
contexts .
Each study must be separately bound. Confidential
attachments and supplemental statements of data
confidentially nusi be included within the binding of the
body of the study. All bindings must be secure, but easily
removable to permit microfilming.
4. WHAT TO INCLUDE IN A STUDY
All study-specific supplements, addenda, supporting
analyses, protocols, or correspondence submitted at the
same time as the report of the study itself should be
included within the binding and pagination of the
primary study.
5. IDENTIFYING
TO PREVIOUSLY SUBMITTED STUDIES
Whenever you submit information to supplement a
previously submitted study, whether at your own
initiative or in response to a request by EPA, it must
be prepared in the format required by PR Notice 86-5.
Submit three complete sets under an appropriate
transmittal document, including supplemental
information for only one study in each binding, and
identifying the previously submitted study in
supplements as clearly as possible, i.e., by EPA
Accession Number or (preferably if you know it) the
Master Record Identifier (MRID) number on its title
page.
6. STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Each submitted study must have this Statement. The
exact text of one of the two alternative forms of the
statement (Refer to PR Notice 86*5) must appear on page
12-5
._
-------
2 of the study. You Bay add to the required text a
reference to the proprietary nature of the document,
and you may assert that it may not be copied, quoted,
etc. by any recipients othar thgn gpfr. You may not,
however, assert a right of prior approval for use,
copying, or distribution of the data by EPA, as
required and constrained by Sections 3 and 1*0 of FIFRA.
If there are markings (such as "Company Confidential")
in your study documents, you must add to the required
text an explicit statement that over-rides the implicit
supplemental claims of confidentiality that result from
these markings. This over-ride statement may specify
that it applies only to use of the data by EPA in
connection with the provisions of FIFRA.
IMPORTMTP MOTE: Documents for which a statement of data
confidentiality claim has been made should not be
transmitted over FAX machines unless the sender wants to
clearly waive his or her CBI rights and states this on the
documents being "FAXed."
RlOLTIONz
0. WHO TO COHTACT FOR APDITIOliXL
If you have any questions concerning confidential business
information as it may concern your application or how to format
and submit supporting data, please contact the Information
Resources Development Section, Information Services Branch,
Program Management and support Division. Refer to Chapter 18 of
this manual.
B. RgFEMJMCEB
CITED m
_12, - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 2 - Public information
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 3 - Registration of pesticides
Section 10 - Protection of trade secrets and other
information
3. PR Notice 86-5 - Standard format for data submitted under
the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and certain
provisions of the Federal Food, Drug and
Cosmetic Act (FFDCA) , Issued July 29,
1986.
12-6
-------
4. PR Hotie« 89-3 - Format standard* for Reregistration
Phase 3 summaries and reformatted
versions of studies previously submitted
under the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA) and certain
provisions of the Federal Food, Drug,
and Cosmetic Act (FFDCA). Issued
December 20, 1989.
12-7
-------
-------
13 -
A. GENERAL IMTORMATIOH
40 CFR 152.135 provides information necessary for the
transfer of the registration of a product from one person or
company to another. Applications for the registration of
products which are still pending registration (not registered)
may also be transferred. 40 CFR 152.98 provides information for
the transfer of data rights from one person or company to
another. You should refer to these references for specific
details on the transfer of registrations and/or data rights.
A discussion of transfer requirements is provided below.
*
B. TRANSFER OF PRODUCT RBQIBTRATIpMS
A registrant may transfer the registration of a product to
another person, and the registered product may be distributed and
sold without the requirement of a new application for
registration by that other person, if the parties submit to the
Agency the documents as described in 40 CFR 152.135 and receive
approval by the Agency.
1. Persons seeking approval of a transfer of a product
registration must provide a document (a Transfer Document)
signed by the authorized representative of the registrant
of the product to be transferred (the transferor) and of the
person to whom the product registration is to be transferred
(the transferee) that contains the following information:
a. The name, address, phone number, EPA-assigned
company number, and State of incorporation (if any) of
the transferor,
b. The name, address, phone number, EPA-assigned
company number, and State of incorporation of the
transferee (If the transferee does not have an EPA-
assigned company number, he or she should request that
one be assigned),
c. The product name(s) and EPA registration number(s),
or the EPA File Symbol for pending products, of the
products to be transferred,
d. A statement that the transferor transfers
irrevocably to the transferee all right, title, and
interest in the EPA registration(s) listed by product
name and EPA Registration Number in the document,
13-1
-------
e. A statement that the transferred registration(s)
shall not serve as collateral or otherwise secure any
loan or other payment arrangement or executory promise,
and that the registration(s) shall not revert to the
transferor unless a new transfer agreement is submitted
to and approved by the Agency,
f. A description of the general nature of the
underlying transaction, e.g., merger, spinoff,
bankruptcy transfer (no financial information need be
disclosed),
g. A statement that the transferor and transferee
understand that any false statement may be punishable
under 18 U.S.c: 1001, and
h. An acknowledgement by the transferee that his rights
and duties concerning the registration under FZFRA and
this chapter will be deemed by EPA to be the same as
those of the transferor at the time the transfer is
approved.
2. In addition, the transferor must submit to the Agency as
required by 40 CFR 152.135(c) a notarized statement
affirming that:
a. The person signing the transfer agreement is
authorized by the registrant to bind the transferor,
b. Ho court order prohibits the transfer, and that any
required court approvals have been obtained, and
c. The transfer is authorized under all relevant
Federal, State and local laws and all relevant
corporate charters, bylaws, partnerships, or other
agreements.
IMPORTAMT MOTE; Notary rules do not generally allow a
person to notarize their own signature. Therefore, it is
recommended that the same person not sign both the transfer
document and the notarized statement.
IMPORTXMT MOTBI m the event that the original documents
cannot be submitted for the attachments to the transfer
document, each of the copied documents must be notarized and
certified as a true copy of the originals.
13-2
-------
3. If the required documents are submitted, and no
information available to the Agency indicates that the
information is incorrect, the Agency vill approve the
transfer without requiring that the transferee obtain a new
registration(s). The Agency will notify the transferor and
the transferee of its approval.
4. The transfer will be effective on the date of Agency
approval. Thereafter, the transferee will be regarded as
the registrant for all purposes under FIFRA.
5. The rights to exclusive use of data or data compensation
under FIFRA section 3(c)(l)(D) are separate from the product
registration itself and may be retained by the transferor,
or may be transferred independently in accordance with
40 CFR 152.98. If the registrant as the original data
submitter wishes to transfer data rights at the same time as
he transfers the registration, he may submit a single
transfer document containing the information required by
this section for both the registration and the data.
IMPORTANT NOTBi When product registrations are transferred from
one registrant to another, all restrictions, data requirements,
conditions of registration, including timeframes for the
submittal of data or other information, suspensions or any other
requirements existing on the registration are transferred with
the registration. The new registrant (transferee) is responsible
for adhering to or complying with all such restrictions, data
requirements, conditions of registration, timeframes, suspensions
or any other requirements that have been imposed on the acquired
product registration.
With respect to timeframes for the submittal of data or
other information, the new registrant is responsible for the
submittal of all required data according to the schedules already
established by the Agency as a result of a data call-in under
FIFRA section 3(c)(2)(B), or a condition of the registration
under FIFRA section 6(e), for the acquired product registrations.
Failure to comply with these timeframes, may result in the
issuance of a Notice of Intent to Suspend the registration of the
affected product under FIFRA section 3(c)(2)(B), or a Notice of
Intent to Cancel the registration of the affected product under
FIFRA section 6(e).
Requests for the extension of time to submit required data
or other information from the new registrant, merely because they
acquired the registration after the 3(c)(2)(B) data call-in was
issued, or after the conditions of registration under section
6(e) were imposed will not be granted. If the new registrant has
13-3
-------
other valid reasons for delays in the testing which vere clearly
outside their control, then such a request for tine extensions
will be considered in accordance with established procedures. If
such delays are expected to be encountered, and a time extension
is believed to be necessary, the Agency should be informed as
soon as possible, and in any event prior to the due date.
Transfers that occur while a 3(c)(2)(B) data call-in is
being issued or during the 90 day response time to the data call-
in are subject to the sane conditions expressed above.
C. TRAKSFBR OF DATA RIOHTfl
A person who possesses rights to exclusive use data or data
compensation under FIFRA'section 3(c)(l)(F) nay transfer such
rights to another person in accordance with 40 CFR 152.98. In
order for the Agency to process a request for the transfer of
data rights, certain documentation is required.
1. The original data submitter must submit to the Agency a
transfer document that contains the following information:
a. The name, address, phone number and State of
incorporation (if any) of the original data submitter
(the transferor),
b. The name, address, phone number and State of
incorporation of the person to whom the data rights are
being transferred (the transferee),
c. Identification of each item of data transferred
including:
1) The name of the study or item of data,
2) Whether the study is an exclusive use study,
and, if so, when the period of exclusive use
protection expires,
3) The name of the person or laboratory that
conducted the study,
4) The date the study was submitted to the Agency,
5) The EPA document number assigned to the item of
data [the Master Record Identification Number
(MRID) or Accession Number}, if known. If not
known, the EPA administrative number (such as the
EPA Registration Number, petition number, file
symbol, or permit number) with which the item of
data was submitted, such that the Agency can
identify the item of data.
13-4
-------
6) A statement that the transferor transfers
irrevocably to the transferee all rights, and
interest in the items of data named,
7) A statement that the transferor and transferee
understand that any false statement may be
punishable under 18 U.S.C. 1001, and
8) The names, signatures and titles of the
transferor and transferee, and the date signed.
2. In addition, the transferor must submit to the Agency as
required by 40 CFR 152.98, a notarized statement from a
company official or from the company legal counsel affirming
that:
a. The person signing the transfer agreement is
authorized by the original data submitter to bind the
data submitter,
b. No court order prohibits the transfer, and any
required court approvals have been obtained, and
c. The transfer is authorized under Federal, State and
local lavs and relevant corporate charters, bylaws or
partnership agreements.
IMPORTANT NOTE; Notary rules do not generally allow a
person to notarize their own signature. Therefore, it is
recommended .that the same person not sign both the transfer
document and the notarized statement.
3. The Agency will acknowledge the transfer of the data by
notifying both transferor and transferee, and will state the
effective date of the transfer. Thereafter the transferee
will be considered to be the original data submitter of the
items of data transferred for all purposes under FIFRA
section 3(c)(l)(F), unless a new transfer agreement is
submitted to the Agency.
D. WHO TO CONTACT TOR FURTHER IKTORMATIOHl If yOU have any
questions or require additional information concerning the
transfer of product registrations or data rights please contact
the Administrative Processing Section, Registration Support
Branch. Refer to Chapter 18 of this manual.
13-5
-------
i.
13 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 3 - Registration of pesticides
Section 6 - Administrative review; suspension
13-6
-------
14 -
A* STATB ISSUMtCB Of gXPERIKBlTTAL UflK PERMITS
Section 5 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) authorizes any State to issue an
experimental use permit for a pesticide in accordance with a
State plan approved by the Agency. 40 CFR Part 172, Subpart B -
State Issuance of Experimental Use Permits, provides detailed
information on state experimental use permits. In general,
authorized states can issue experimental use permits for the
purpose of gathering data necessary to support the State
registration of a pesticide to meet special local needs under
FIFRA Section 24(c) and for the purpose of experimentation.
>
To date, Idaho, Florida and Vermont have received
authorization from the Agency to issue state experimental use
permits.
WHO TO CQMTACTi For additional information concerning state
EUPs, you should contact the pesticide regulatory authority in
the state in vhich you wish to obtain a state EUP. A listing of
the state regulatory agencies can be found in Chapter 18.
B. STATE REGISTRATION OF SPECIAL LOCAL ITBgDfl
FIFRA Section 24(c) authorizes a State to provide
registration for additional uses of federally registered
pesticides formulated for distribution and use within that State
to meet special local needs in accordance with the provisions of
the Act. 40 CFR Part 162, Subpart D - Regulations Pertaining to
State Registration of Pesticides to Meet Special Local Needs,
provides detailed information on the scope and authority of the
states to issue registration of pesticide products.
Under FIFRA Section 24(c), states are authorized to register
new end-use products or additional uses of federally registered
pesticides if the following conditions exist:
1. a special local need for that product use,
2. the use, ii' a food or feed use, is covered by an
appropriate tolerance or has been exempted from the
requirement of a tolerance,
3. registration for the same use has not previously been
denied, disapproved, suspended, or canceled by EPA, or
voluntarily canceled by the registrant because of health or
environmental concerns about an ingredient contained in the
product, unless EPA has reversed the original action,
14-1
-------
4. the registration is in accord with the purposes of FIFRA.
24(c)s which amendments federal registrations (new uses).
States may register:
1. subject to the limitations set forth in 40 CFR Part
162, any new use of a federally registered pesticide
product.•
2. any use of a federally registered product for vhich
registration of other uses of the product was denied,
disapproved, suspended, or canceled by the EPA,
provided that the proposed use was not considered by
the EPA in reaching such a determination and only after
the State consults with appropriate EPA personnel on
its acceptability.
3. any use of a federally registered product for which
registration of some or all uses has been voluntarily
canceled by the registrant unless such voluntary
cancellation follows the issuance of an EPA Notice of
Intent to cancel for human health or environmental
reasons. States may only grant 24(c) registrations for
voluntarily canceled uses of products after consulting
with appropriate EPA personnel.
IMPORTANT KOT»» A State may not register an amendment
to a federally registered manufacturing-use product.
24(c)s which are new products (not previously federally
registered). States may register:
1. a product which is identical in composition to a
federally registered product, but which has differences
in packaging, or in the identity of the formulator,
2. a product which contains the same active and inert
ingredients as a federally registered product, but in
different percentages,
3. a product containing a new combination of active,
or active and inert, ingredients only if each of the
active ingredients in the new product is present
because of the use of one or more federally registered
products and if each of the inert ingredients in the
new product is contained in a federally registered
product,
4. a product containing an ingredient that (1) has had
one or more of its formulations or uses denied,
disapproved, suspended, or canceled by EPA because of
. human health or environmental concerns or (2) the
14-2
-------
registrant has voluntarily canceled a formulation or
use following the issuance of an EPA Notice of intent
to Cancel because of health or environmental concerns,
provided the 24(c) formulation and/or use was not
considered in EPA's action and was not included in a
Notice of Intent to Cancel and only after the State
consults with appropriate EPA personnel•regarding the
acceptability of the 24(c) application.
IKPQRTAMT MOTEi A State may not register a new
manufacturing-use product.
Requests for Special Local Need (SLN) registrations are
generally made by pesticide companies to the specific state.
Once a state approves the application, the state then forwards
notification of the SLN registration to EPA for review. Provided
the state has complied with the requirements of FIFRA section
24(c) and 40 CFR Part 162, the registration becomes effective
immediately.
The EPA has 90 days from receipt of the SLN notification
from the state to disapprove the registration. Otherwise it
becomes a Federal registration under FIFRA section 3 for the use
only within the state.
General Disapproval of State Registration
EPA may disapprove any state registration on any reasonable
grounds (excluding solely lack of essentiality), any state
registration which, when compared to a federally registered
product, does not have both a similar composition and use
pattern. Grounds for disapproval may include, but are not
limited to:
1. the 24(c) will probably create an unreasonable
adverse effect upon man and/or the environment;
2. the refusal of the registering State to submit
information supporting the registration, i.e.,
application form (within 10 working days), Labeling for
the 24(c), Confidential Statement of Formula (new
product only), final printed label (within 60 days),
State revocation notice with date of revocation and
reason(s) for revocation, and scientific studies
supporting a "no unreasonable adverse effects" findings
by the State (within 15 working days);
3. Failure of the information submitted by the State
to support the State decision to issue the 24(c);
14-3
-------
Special Disapproval of State Registrations
EPA nay disapprove any SLN registration at any. time
(even beyond the 90 day period) if it is determined
that the 24(c):
(a) would constitute an imminent hazard;
(b) may result in a residue on food or feed
exceeding, or not covered by, a tolerance,
exemption, or other clearance under the FFDCA.
Once the SIN is registered under FIFRA, it is subject to any
additional data requirements that may be required by the EPA
either as the result of a Registration Standard or any other
FIFRA Section 3(c)(2)(B) data call-in.
PEE MOPIREMMTrS FOR BLH * ff
The 1988 amendments to FIFRA requiring that annual
maintenance fees be paid by registrants of pesticide products
apply to registrations under Section 24(c) of FIFRA. You should
refer to Chapter 8 for a discussion of registration maintenance
fees.
C. EMERGENCY EXEMPTIONS
FIFRA section 18 authorizes the Administrator to exempt
State and Federal agencies from any provision of FIFRA, if he
determines that emergency conditions exist which require an
exemption. The regulations in 40 CFR Part 166 establish
procedures by which the Administrator may exempt a Federal or
State agency from the provisions of FIFRA which regulate the
manner in which a pesticide is made available for use or is used.
There are four types of emergency exemptions which may be
authorized:
1. Specific exemption. A specific exemption may be
authorized in an emergency condition to avert a significant
economic loss, or a significant risk to endangered species,
threatened species, beneficial organisms, or the environment.
EPA shall allow the use of a pesticide under a specific exemption
for as long a period as is reasonably expected to be necessary
but in no case for longer than 1 year.
2. Quarantine exemption. A quarantine exemption may be
authorized in an emergency condition to control the introduction
or spread of any pest new to or not theretofore known to be
widely prevalent or distributed within and throughout the United
States and its territories. EPA shall allow use of a pesticide
under a quarantine exemption for as long a period as is deemed
14-4
-------
necessary but in no case for longer than 3 years. Quarantine
exemptions nay be renewed. Interin reports containing the
information specified in 40 CFR 166.32(b) to the extent available
shall be filed annually.
3. Public health exemption. A public health exemption may
be authorized in an emergency condition to control a pest that
will cause a significant risk to human health. EPA shall allow
the use of a pesticide under a public health exemption for as
long a period as is reasonably expected to be necessary but in no
case for longer than 1 year.
\
4. Crisis exemption. A crisis exemption may be utilized in
an emergency condition when the time from discovery of the
emergency to the time when the pesticide use is needed is
insufficient to allow for the authorization of a specific,
quarantine, or public hea'lth exemption. The crisis provisions
may not be utilized to authorize a pesticide use if any of the
following has occurred:
• EPA has informed the head of the Federal or State agency,
the Governor, or their official designee, not to issue
such an exemption;
- The pesticide use has been suspended under section 6(c) of
FIFRA;
- The pesticide use has been canceled following a notice
issued under section 6(b) of FIFRA;
- The pesticide contains a new chemical; or
- The application proposes the first food uae of a
pesticide.
A crisis exemption may be authorized for: (a) only as long
as is necessary to control the pest or conditions causing the
emergency; (b) no longer than 15 days, unless an application
requesting a specific, quarantine, or public health exemption for
this use has been submitted to the Agency.
The documents EMERGENCY EXEMPTIONS ONDER SECTION 18 OF THE
FEDERAL INSECTICIDE, FUNGICIDE, AND RODBNTICIDE ACTl I. Guidance
for State and Federal Agencies, and II. Instructions for
submission of emergency exemption applications can be obtained
from the National Technical Information Service (NTIS) by calling
(703) 487-4650. If you have any questions, or require any
further information, please call the communications Branch in
OPP's Field Operations Division at (703) 305-5017.
WHO TOCONTACTi Additional information concerning applications
for a state special local need registration should be addressed
to the state in which you wish to make an application for a SLN
registration. A listing of the various state pesticide agencies
can be found in Chapter 18 of this manual.
14-5
-------
D. »«y«B«iCBB CITED ffl CHAPTER H - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 162 - State registration of pesticide products
Part 166 - Exemption of Federal and State agencies for
use of pesticides under emergency conditions
Part 172 - Experimental use permits
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 3 - Registration of pesticides
Section 5 - Experimental use permits
Section 18 * Exemption of Federal and State agencies
Section 24 - Authority of states
14-6
-------
CHAPTER IS -
A. OBNBHAL IMTORMATIOK
Although you may have obtained a Federal registration for
your pesticide product, which allows you to distribute and sell
your product in the U.S., there are state regulations that you
nay have to comply with before you can distribute and/or sell the
product within that state.
In addition, there may be other Federal, State, or local
requirements that you must satisfy. The following listing is
intended only to provide general information on some of these
requirements, or to provide a point of contact. It should be
noted that the listing is not all inclusive, nor is it complete.
It is your responsibility to comply with all federal, state or
local regulations.
8. BTATB REGULATION OF FEDERALLY REGISTERED PESTICIDES
FIFRA Section 24(a) states that "A State may regulate the
sale or use of any federally registered pesticide or device in
the State, but only if and to the extent the regulation does not
permit any sale or use prohibited by this Act".
Even though you have obtained a Federal registration for
your pesticide product which allows you to distribute and sell
the product within the U.S., the various states in which you may
wish to distribute and sell your product may have additional
requirements for the regulation of pesticides within the state.
The requirements vary from state to state, and may include
additional data requirements, additional restrictions on
pesticide use within their jurisdiction, and licensing
requirements. You should contact each state in which you intend
to market your product to determine what additional requirements
may affect the sale, distribution or use of your product.
WHO TO CONTACT: For additional information concerning state
registration 'requirements for your Federally registered pesticide
product, you should contact the pesticide regulatory authority in
the state in which you intend to market your product. A listing
of state regulatory authorities can be found in Chapter 18 of
this manual.
C. USE OF PESTICIDES IM MEAT AND POULTRY PLANTS
Federally registered pesticides intended for use in
federally inspected meat and poultry plants must be
appropriately labeled and authorized by the U. S. Department of
Agriculture (USDA).
15-1
-------
The Federal Meat Inspection Act, as amended by the Wholesome
Meat Act of 1967, and the Poultry Products Inspection Act, as
amended by the Wholesome Products Act of 1968, require the
maintenance of safe and sanitary conditions in federally
inspected meat and poultry plants. These Acts are enforced by
the Animal and Plant Health Inspection Service through the Meat
and Poultry Inspection Program (MPIP).
The Inspection Program calls for the authorization of the
use of substances and compounds in the plants, because use of
such materials may result in adulteration or unwholesomeness of
meat and poultry being processed. All chemicals produced in the
U.S. for marketing to federally inspected meat and poultry plants
must be evaluated by the/ USDA in order to provide assurance that
the chemicals used in federally inspected plants are authorized
for use and that their proper use will not result in adulteration
or contamination of food products.
1* Labeling Requirements - Before directions for use in
federally inspected meat and poultry plants can be accepted under
the Federal Insecticide, Fungicide and Rodenticide Act, (FIFRA),
you must obtain authorization from the USDA. Upon receipt of
confirmation of USDA authorization, your product labeling can be
amended to include the following statement:
"Authorized by USDA for use in federally inspected meat and
poultry plants.**
2. Application forUSDA Authorization - If you wish to have
your product approved for use in a federally inspected meat or
poultry plant, you must make an application to obtain
authorization from the USDA.
WHO TO COKTACTI For additional information on the use of
pesticides in federally inspected meat and poultry plants, and
where to obtain application forms for authorization from the
USDA, contact:
Product Assessment Division
Compounds and Packaging Branch
RP, FSIS, U.S. Department of Agriculture
Building 306, BARC-East
Beltsville, MD 20705
(301) 504-8566
D. U8B Of PESTICIDES OK FOOD CONTACT BPRTACBB. Mtt PAPER AMP
PAPERBOARD (FOOD OSES). OK MEDICAL DEVICES* A8 HUMXM AMD ANIMAL
DRPQ8. AMD IK CANE-SUGAR AMD BEET SUGAR MILM
The Food and Drug Administration (FDA) and the Environmental
Protection Agency. (EPA) have several areas of mutual regulatory
15-2
-------
responsibility which nay require review by one or both agencies.
The following is a brief summary of these areas:
1. flanitiier« (pesticides used OP food contact surtaoesi
Any pesticide product intended for sanitizing inanimate food
contact surfaces must be approved by the FDA pursuant to 21
CFR 178.1010. Ingredients in these products are considered
to be Indirect Food Additives. EPA will not register
sanitizer products unless a food additive regulation has
been issued for the active and inert ingredients or the
ingredients are "generally recognized as safe" by FDA.
Persons who wish to obtain FDA approval must submit a Food
Additive Petition or similar request to:
f
Division of Food and Color Additives (KFF-330)
Food and Drug Administration
200 C Street, S.W.
Washington, D.c. 20204
2. Micrcbioeides la paper and paperboard ffoed use)
Other than EPA responsibilities under FFDCA and FIFRA, FDA
evaluates the safety and efficacy of pesticides used in
paper or other materials which are not themselves regulated
as pesticides which come into contact with food. FDA must
approve the ingredients of a pesticide as indirect food
additives under 21 CFR Part 176 before EPA will approve
a registration. Petitions or requests may be sent to the
same address as in 1. above.
3. Antimicrobial pesticides used en medical devices
An antimicrobial agent used on medical devices is considered
by FDA to be an accessory to a medical device. Accordingly,
FDA requires premarket notification under section 510(X) of
the FFDCA for marketing of such agents. FDA reviews the
safety and efficacy of these antimicrobial products.
Approval by both FDA and EPA must be obtained before these
products may be sold or distributed. Section 510(k)
petitions may be submitted to:
Division of Gastroenterology-Urology
and General Use Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration (HFZ-332)
8757 Georgia Avenue
Silver Spring, MD 20910
15-3
-------
4* Hujf
Animal Drugs
FDA and EPA have areas of mutual responsibility with respect
to applications for drugs under FFDCA and for registration
of pesticides under FIFRA. in 1971, FDA and EPA issued a
Memorandum of Agreement stating which agency has primary or
secondary responsibility on specific matters (See Federal
Register Notice, 36 FR 24234). This agreement was updated
in 1973 (38 FR 24233) and in 1979 (44 FR 63749). Briefly,
EPA has primary jurisdiction for disinfectants and
sanitizers, treatments of certain pests on animals, aquatic
treatments solely for algae or bacterial slime, sanitizers
for aquarium equipment, and sanitizers for inanimate
surfaces or drinking water of animals which do not claim
disease control. FDA has primary jurisdiction for new human
or animal drugs, and products which are intended to: control
parasites on humans, relieve the effect of insect bites,
prevent diaper rash through treatment of diapers, treat
athletes foot, treat certain animal diseases and pests,
treat water for fish parasites or diseases, and treat
drinking water to control animal parasites or diseases.
Questions on these areas of jurisdiction may be referred to
the EPA 's Antimicrobial Program Branch. Refer to Chapter
18 of this manual.
5. Cane- sugar
beet^suqar mills
Pesticides used for controlling microorganisms in .cane-sugar
and beet-sugar mills must be approved by the FDA under 21
CFR 173.320. Petitions may be directed to the following
address :
Division of Food and Color Additives (HFF-330)
Food and Drug Administration
200 c street, S.w.
Washington, D.C. 20204
B. ANTIMICROBIAL FUEL ADDITIVES
Any pesticide product intended for use in aviation fuel must
have the approval of the Federal Aviation Administration (FAA)
for use in aircraft engines. Persons who wish to obtain FAA
approval must submit their request to:
FAA Flight Standards Service
Engineering and Manufacturing Division
Federal Aviation Administration
Washington, D.C. 20591
15-4
-------
The U.S. Department of Transportation (DOT) and the
Environmental Protection Agency (EPA) have several areas of
mutual regulatory responsibility which may require review by one
or both agencies.
The Hazardous Material Transportation Uniform Safety Act, as
amended in 1990, requires that pesticides being shipped are
properly packaged, marked and labeled. If the pesticide to be
shipped is considered a hazardous material, it will need to bear
the proper DOT Hazard Warning Labels prominently on the product
labeling. Also, depending upon the size of the shipment, trucks
may need to be placarded.,
If you wish to transport pesticides which may present
physical or chemical hazards, you must obtain shipping papers
from DOT prior to such shipment.
WHO TO COliTACT i
For additional information on the transportation of
pesticides, and how to obtain shipping papers, contact:
Office of Hazardous Material Standards
Department of Transportation
ATTN: Ed Mazzullo
Km. 8100
400 7th St., SW
Washington, DC 20590-0001
Phone: (202) 366-4488
G. HON-INDIGENOUS AMD GEHETICALLY ENQIKBERED MICROBIAL PRODUCTS
INCHTDINQ KILLED MICHOBIATiH
1. Toxic Substances Control Act (TSCA). Products of
recombinant DNA technology are also regulated by EPA
under TSCA by the Office of Pollution Prevention and
Toxics (OPPT) during stages of production before the
products become pesticides (such as during
fermentation). A Pre-Manufacturing Notice (PMN) may be
required for these products. PMNs are not required
while the product is under research and development
(such as under an EUP), and are also not required for
nonindigenous or trans-conjugant organisms. For
information on TSCA requirements related to microbial
pesticide production contact:
15-5
-------
EPA Office of Pollution Prevention and Toxics
Chemical Control Division
Program Development Branch
Kathleen Bailey (202)
David Giamporcaro (202)
260-5591 or
260-6362 .
2. U.S. Department of Agriculture (USDA). Any organism
(including plants) may be considered a potential plant
pest. Such organisms may be regulated under either the
Plant Pest Act and/or the Plant Quarantine Act. Such
organisms may /require a permit for import and/or
introduction testing, and use. For information on
USDA permit requirements contact:
USDA
Animal and Plant Health Inspection Service
Sally McCammon
John Payne
(301) 436-8761
(301) 436-8378
15-6
-------
CHXPTBR 1< - HOW Tp OBTXTM PDHLICATIOIfg
The listing entitled "Availability of OPP Publication
Listings" includes information on various OPP documents that are
available at the National Technical Information Service (NTIS).
The listing includes information on the following:
1. Information for Ordering OPP Publications from the
National Technical Information Service
2. Registration Standards Report (includes Reregistration
Eligibility Documents (REDs)
3. Pesticide Fact Sheets (includes Pesticide R.E.D. Fact
Sheets)
4. Special Review Position Documents
5. Hazard Evaluation Division (HED) - Pesticide Assessment
Guidelines
6. Hazard Evaluation Division (HED) - Standard Evaluation
Procedures
7. Pesticide Product Information
- Compact Label File
8. Miscellaneous Publications/Documents
9. Pesticide Data Submitters List by Chemical (listed under
Miscellaneous Publications/Documents)
Copies of the listing, which includes the NTIS Document order
number, the EPA Document Number and the cost of the document on
either microfiche or hard copy, are available from the following
address:
U.S. EPA
Document Management Section (H7502C)
Information Services Branch, PMSD
Office of Pesticide Programs
401 M Street, S.W.
Washington, D.C. 20460
Telephone: (703) 305-5240
16-1
-------
B.
The following documents are for sale, and are available from
the Superintendent of Documents, U.S. Government Printing Office,
Washington, D.C. 20402.
Code of Federal Regulations, Title 40 (40 CFR)
- 40 CFR, Part 2 - Public information
- 40 CFR, Parts 150 to 189 - Protection of
Environment
The Code of Federal,Regulations is also available for
examination at Government depository libraries and many other
libraries. A complete listing of only Government Depository
Libraries is available without charge from The Library, U.S.
Government Printing Office, 5236 Eisenhower Avenue, Alexandria,
VA 22304. A listing of libraries where the Code of Federal
Regulations is available, which includes both Government
depository libraries and other libraries that maintain copies of
the Code of Federal Regulations can be found in the Federal
Register of April 18, 1989 (54 FR 15608).
EPA Headquarters Telephone Directory
A copy of an order form for ording the EPA Headquarters
Telephone Directory can be found at the end of this chapter.
C. DOCUMENTS AVAILABLE FROM THE BHVIROIIMEKTAL PROTECTION AGENCY
The following documents are available from the Environmental
Protection Agency:
1* Federal Insecticide* Fungicide and Rodenticlde Act, as
amended. Qetebar 1»M. EPA 540/09-89-012.
Copies of the FIFRA are available from the following
address:
Environmental Protection Agency
Office of Pesticide Programs
Registration Division
Registration Support Branch (H7505C)
401 M Street, S.W.
Washington, D.C. 20460
Telephone: (703) 305-7700
16-2
-------
2. Iii«t ot all ff derail v registered pesticide product*
f iMsified ma "»Mtriot«d y «• P««ticid««««
This listing is available through the Pesticide Information
Network (PIN) , an on-line, no cost computer bulletin board
operated by OPP. This system can be reached, with a PC by
data-phone (modem) , similar to many popular PC-to-PC
bulletin boards. Completely menu driven, it is very "user
friendly" and contains several informative data bases, such
as the "Restricted Use Products" file, which is a monthly
updated listing of all RUPs.
Questions about the PIN may be referred to the User Support
Group at 703-305-7499 between the hours of 7:00 AM to 4:00
PM EST. The phone number for accessing the PIN is: 703-305-
5919, 24 hours a day, except for some periods of time
between 1:00 PM to 3:00 PM any weekday for updating and
maintenance.
3* Chemicals for Which Data Waivers Have Been Granted
As outlined in 40 CFR Part 158.45(d), Agency decisions on
data waivers are available to the public at the following
location:
Environmental Protection Agency
Office of Pesticide Programs
Docket Reading Room, Room 1132
Crystal Mall 12
1921 Jefferson Davis Highway
Arlington, VA 22202
Office hours are from 8:00 AM to 4:00 PM, Monday through
Friday, except legal holidays. Telephone: (703) 305-5805
Written Requests; Any person may obtain a copy of any waiver
decision by written request to the following address:
Environmental Protection Agency
Freedom of Information (A-101)
401 M Street, SW
Washington, DC 20460
4. LISTING OF RBQIBTRATION STANDARDS AMD RERgQIBTRATIOM
ELIGIBILITY DQCPMBKTfi ISSPBD
This listing, entitled the "Registration Standard Report"
provides information of all registration standards and
reregistration eligibility documents which have been issued,
is contained in a general listing entitled "OPP Publication
Listings" (see above).
16-3
-------
5.
Pesticides Regulation Notices (PR Notices) are nailed to
registrants of record when issued. Additional copies, or
back copies are available front
U.S. EPA
Document Management Section (H7502C)
Information Services Branch, PMSD
Office of Pesticide Programs
401 M street, s.w.
Washington, D.C. 20460
Telephone: (703) 305-5240
D. FEDERAL REGISTER NOTICES
The Federal Register is available for examination at
Government depository libraries and many other libraries. A
complete listing of only Government Depository Libraries is
available without charge fron The Library, U.S. Government
Printing Office, 5236 Eisenhower Avenue, Alexandria, VA 22304.
A listing of libraries where the Federal Register is available,
which includes both Government depository libraries and other
libraries that maintain copies of the Federal Register, can be
found in the Federal Register of April 18, 1989 (54 FR 15608).
16-4
-------
Superintendent of Documents Subscription* Order Fora
Ordtr ProcMMino Coot:
* 6629
YEB, enter my subscription(s) as follows:
Subscriptions to EPA HEADQUARTERS TELEPHONE
DIRECTORY (EPATD) for $15 per year ($18.75 foreign).
The total cost of my order is $_
Price includes
regular domestic postage and handling and is subject to change.
(Company or Personal Name) (Please type or print)
(Additional address/attention line)
Charge
your
order
It's
Easy
(Street address)
MasterCard
(City, state, ZIP Code)
VISA
(Daytime phone including area code)
(Purchase Order No.)
Nay M Mk« your nM*/*ddrt*« •v»U»blt to oth«r Mli«r«?
YES NO
n n
please Choose Method of Paymenti
L-' Check Payable to the Superintendent of Documents
n
To fax
your orders
(202) 512-2233
GPO Deposit Account
I 1 F I T
VISA or MasterCard Account
i—r~r i i r i i r
TIII r~i~i—i r i
(Credit card expiration date)
Thank you for
your orderI
(Authorizing Signature)
Mall To: Superintendent of Documents,P.O. Box 371954,Pittsburgh, PA 15250-7954
-------
-------
The various forms required to be submitted with various
types of applications for registration, experimental use permits
and distributors are listed below.
Copies of the following forms may be obtained, FREE OF
CHARGE, from the Registration Support Branch, Registration
Division (H7505C), Office of Pesticide Programs, Washington, D.C.
20460. Telephone: (AC 703) 305-7700.
EPA FORM
8570-1
8570-4
8570-5
8570-17
8570-20
8570-25
8570-27
8570-28
8570-29
8570-31
8570-32
TITLE
Application for Pesticide
Registration/Amendment (Revised 12-90,
previous editions are obsolete)
Confidential Statement of Formula (Revised
12-90, previous editions are obsolete)
Notice of Supplemental Registration of
Distributor (Revised 8-91, previous editions
are obsolete)
Application for an Experimental Use Permit to
Ship and Use a Pesticide for Experimental
Purposes Only (Revised 2-91, Previous
editions may be used until supply is
exhausted)
Data Reference Sheet (1-91)
Application for/Notification of State
Registration of a Pesticide to Meet a Special
Local Need (12-87)
Formulator's Exemption Statement (7-91)
Certification of Compliance with Data Gap
Procedures (1-91)
Certification with Respect to citation of
Data (7-91)
Certification With Respect to Data
Compensation Requirements (4-90)
Certification of Offer to Cost Share in the
Development of Data with Other Registrants
(05-91)
17-1
-------
EPA FORM
8580-1
8580-4
TITLE
FIFRA Section 3(c)(2)(B) Summary Sheet
Product Specific Data Report
The following forms nay be obtained, Fuse OP CHARGE, from
the Office of Compliance Monitoring (EN-342), 401 M Street, SW,
Washington DC, 20460, or your EPA regional office. See Chapter
18 for a listing of the Regional Offices.
EPA FORM
3540-1
3540-8
TITLE
Notice of Arrival of Pesticides or Devices
Application for Registration of Pesticide-
Producing Establishments
Qraphio representation copies of tbe above forms are
presented below in Figures 17-1 through 17-15. You should note
that the forms represented below are for ILLUSTRATION* PURPOSES
CULT aad should not be used when submitting an application to the
Agency.
17-2
-------
FZOOIB 17-1. MPRB8HHTATIVB COP* OF IPX FORM 8570-1
Please read inatruetfone on revere* before completing fora Fora Approved CM Ho. 2070-0060, Approval expires 11*90*93
L(A)
United States Environmental hotter Ion Agency
Off fee of Pesticide Programs (H7S05C)
Washington, DC 20460
Application for Pesticide:
Registration
OPP Identifier
1«t*fS
1. Company/Product Nuafcer
4. Company/Product (HtM)
2. EPA Product Manager
3. PropoMd Classification
II Horn I I Restricted
5. MOM and Address of Applicant (include Zfp Cod*)
CtMek If this Is • now oddrou
A. Expedited Review. In occordonco with FlFtA Soctton 3(c)(3)
-------
>
m
1
i
i
s
£4
s
g
N
g
1
O
in
S
g
at
flu
H
8
i
£
H
H
i
u
M
1
IH
•4
O
M
*
c
j
|
I
*
i
i
I
ik
*
*
Ul
j
|
1
|
|
«•
•«
*«
•
S
_c
*•
i
i
|
1
!
••a
I
fltfentlal lutl
i
I
S
1
**
i
-5
1
S |
i 1
i!
DO
«
^
&
• **
« u
S>S •
5C -5
~« I
*~a s
«ll "•
*l* "
1^^. i
K V C 4*
is& i
^!i ?
is 1
Si J
i
a.
IW
|
S
a.
N
1
*k*
|.
|
1
|
{
n!
i
1
^0
g
S
g
N*
!
M
U
I
•8
5
(
-•
_
8
|
^
J
!
•
£
1
I
2
a.
u
|
f
£
S
h*
1
V
S
MM>
i
IM
t
•
I
|
%
X
I
S
I
1
*^
i
L
M
{5
-1
»• M>
• fc- **
i n
j|^J
•-
•
i!5J
rS*
1^
|c|
t ^
5 •'
g
i
Ul
•
j
I
1
S
1
^
^
X X
Ms
S83
S^
•°i
5^1
C *** .If
*j» •» t.
Pi'
£«5
| c|
lllB
sit!
B
1
mr
&
'
*
e
«
9
—
"
^
<*
«^|
^
O
a,
M
9
Ul
m
ui
•c
O
*rt
i
*•
II
*
t
S
^
»•
S
?
i
"o
!
1
^
,
|
i
I
•c
-*
e
e
i
M>
•u
-------
FIGURE
COPT OF IPX FORM §370-5
ILLUSTRATION POMFOffB
Please Reed All Instructions Mfore Coapletlng This Fora (Fen man bo typed)
ONJ NO. 2070-0044
Approval expires 1-31-95
SPA
United States Environmental Protection Agency
Office of Pesticide Freer** (N730SC)
401 N Street W
Washington, DC 20460
Instructions
After e registrant hat obtained finel registration for the bMic product, the regiment my then supplemental ly
distribute his/her product. One fora oust be spitted for each distributor product end sust be signed by the
distributor involved. The besic regtstrstion nueber end the distributor company nueber sust be shewn.
If a registrant hes e potential distributor who does not hove s coapsny nueber assigned, she/he should hove the
distributor apply, on letterhead stationary, to the Registration Division to have a nueber assigned prior to subBlttfng
this fora to the agency.
This Notice of Supplemental Distribution aust be submitted by the basic registrant. The completed fora oust have
the concurrence and sianature of both the registrant and the distributer. .
IPA Registration Number of Product>(Distributor
Coapeny Huaber
Naae of Registered Product
How* Do no
(besic product n
•me accepted by EPA)
Distributor Product Nee*
1
L P
Nam* and Address of Distributor (Type; include ZIP cede)
All Conditions •afore Signing
. The distributor product must have the same composition as the basic product. N
I. The distributor product sust be manufactured end packaged by the earns person uho manufactures and packages the
registered besic product.
3. The labeling for the distributor product sust bear the aame claims as the basic product, provided, however, that
specific claims msy be dsleted if by doing so, no other changes to the label are necessary.
4. The product sust remain in the manufacture's unbroken container.
5. The label must beer the EPA registration number of the basic product, followed by a hyphen and the distributor's
company nuaber.
6. Distributor product labels must bear the name and address of the distributor Qualified by such terms as •packed
for..., "distributed by..."; or sold by..." to show that the name is not that of the amnufacturer.
7. All conditions of the besic registration apply equally to distributor products. It is the responsibility of the besic
registrant to see thet ell distributor labeling la kept in compliance with reauiremanta placed on the besic product.
Distributor
Ve intend to Market our product under the Distributor Product
on this Notice.
Signature and Title of Distributor
specified above, subject to the conditions specified
Date
I egree thet the distributor nested above
conditions specified on this Notice.
Signature and Title of Registrant
•effstrsnt
distribute and sell the Distributor Product specified above, subject to the
Date
form 8570-5 (Rev. 2*92) Previous editions are obsolete.
17-5
-------
PXQURB 17-4. UPBSSXjmVTXVB COPT OF EVA FOBM 9570-17
»Qmt TMiVffTBs\T?°* TIB*08** omil
Please read instructlorn on reverse before completing fora Fora Approved QMS no. 2070-0040, Approval expires 11*30*93
EPA
United Statea invlronssntal Protection Agency
Office of Pesticide Program* (N7SOSC)
Washington, DC 20460
Application for an Experimental Use Perait to tmfp
1. Typt of Application
Q MM dl Mm^onts ($*t Mo. 11)
I I ixtontion CGivt »or*it Hmter boloti}
Idontlfior
002SOS
3. HOJM ond Addrttt of Urm/ftnon to Mmi tho
ExptriMntal UM Ptmit <• To M lo«Nd (ineludt
ZIP Codo)
-------
I
I
i
i
s
*
I
i&
8K> S iu
«J **S M '
O •• O IU '
¥« • 8
li:1:^
^ O **» '
S B *- III
III
SS» ^a
IKS Sc
"g
• S
I
i
I
-
i«
TO
rOR RE6
HER
ain)
8
S.
si
i!
Ii
«^
i
•'
uu
!
!
|
"i
I
if
H
is
y *
-------
17-f RIPMSMTTATIVl COPY Of »A FOBM 8570-25
IU.O8TRATIO1I PtTRPOSES OMT.V
Fora Apprw^d. oM Mo. 2070-0055. Approval expires 6-30-90
EPA
united States Environamtol Protect lor Agency
Off let of Pesticide ProgroM (M7505C)
Washington, DC 20*60
Application for/Notification of State Registration
of a Pesticide To Moat a Spaclal Local Maad
(Pursuant to Section 2*(C) of the Federal Imacticida,
1.
and Address of Applicant for Registration
NO* (not EPA-rogietorod)
_ Attach EPA fora 8570-*, Certified
|_| Stoteaent of Formula, for new product*
1. Active InarnUfnTfll In PmttlfTT
5. If thia ia a foad/faad uaa, a to
Data Regiatration laauad
EPA Registration
EPA Coapeny Nyabar
*. Product Naa*
If thia ia a foad/faad uaa, a tolaranea or other raaidua claaranca
ia raquirad. Cita appropriata regulations in 40 CFR Part 180.
21 en Part 103. and/or 21 CFR Part 861.
6. Typa of Registration (Cfva dataila in lto» 12
or a aaparata page, proparly (dentiflad and
attached to this fora):
.. To pan.it LM* af
b. To aiasnd EPA registrations for ana or
fellowin
of
(1)To parait use on additional crops or
aniaals.
7. Nature of Special Local Need (Check one)
a.[_| There U no pesticide product registered by SPA for such use.
_ There ia no EPA-registered pesticide product uMeh, under the
LI conditions of use within the State, would be as aafe and/or
as'efficacieua for such use within the teraa and conditions
_ of EPA registration.
|_| An appropriata EPA-registered pesticide product ia not
available.
(4)To perait use of
tichniomi or aoui
iH.t addi
addition
tionel application
8. If thia registration ia en eaendMnt to an EPA*registered product,
_ia it for a "chanted use pattern" aa defined In 40 CFt 162.37
_|Yee (discus* In I tea 12 below) |_jNo
9. Has an EP* Registration or Experimental use Perait for uae of thia
chesilcal ever been: (Check applicable bojc(es))
QSought iZllMued ClOenied CI Canceled QSuspended
Previous Perait Action: __
|^|Registr*tion j_|E»perte»ntal uee Perait |_|HO Previous Perait
Action
10. Has a FIFRA Section 24(C) registration for thia
use of the product ever, by another State been
_(Check applicable bailee)) _
|_JSought |_| Issued |_|Doniod |_j*evokod
if any of the above are checked, liat States ln
-------
riant! I?-? BinuunrATXVB COPT or BP& FORM •570-27
For» Approved. CM No. 1070-0060. Approval expires H.jo-93
EPA
United States Environswrtal Protection Agency
Washington. DC 20440
Fonuletor'e Exception stateeent
(40 CFI 152.85)
EPA Ft It Syetool/Registretion NuBtoer
Product (Mat
Date of Confidential Statement
of Forsula
-------
17-• R1PRB8WTATIV* COPY OT BPA TOR* §570-21
EPA
United StatM Environmental Protection Agency
MasMnaton. DC 20*60
Certification of
Midi Beta ta
<*0 CF« 152.96)
CM Ho. 2070-0060
Approval expires 11/30/95
Applicant'* Noam and Addrott
EPA Hit SyBbol/R«g<«tratfon HMter
Product KOM
Dato of Application
1 certify that:
1. I have notlfiad In wftlng oach p*r*en on ttw Poatlcidi Data
tucafttart1 Hit for aach actlv* fnoradiant In tht» product. In
•ccordanca with tha raqulraMnta of 40 CM 152.96; and
2. I havt wltad 60 day* followino audi writ tan notice; and
3. I have rocaiwd no raaponaa indicating that any parson haa
stteittad a valid study that Mould tatUfy any of tha rao^ilra-
•anta for which a data oap la elaiaad, and ttwroforo, I havo no
basis for balfvvlng that such data haw boon subalttad to EPA by
any other person.
I f
C L U
A F L * 0
NO U P H
PI S 0 L
L T S T
E RE
A S
T
I
Signature
Titla
Data
EPA Pom 8570-2* (ftav. 1-91)
17-10
-------
rxatnu i?-» MPRBSWTTATIV* COPT OF m FORM tS70-2t
EPA
United States Efwirenemtal Protection Agency
Washington, PC 204*0
Certification with Respect to Citation of Data
QM lo. 2070-0060
Approval Expires 11*30-93
Applicant's Nan* ana Addrees
S IPO
A f I UN
H 0 L R L
P R U P T
L SO
E T S
• E
A S
EPA Mia SyaMl/Reglstratlon
Product
Data of Application
l-»T I 0 H
•HE: If your product ia a 100X repackaging of another EPA-reglstered product that you purchaaa, and
Is labalad for the sane uaas. you do not nood to sufaartt this fora. Yog oust sutaft the Fonaulator's
Exaction Statement CEPA Pom 8570-27).
1. This application la support** by all data submitted or cltod In tha application. In addition. If clta-atl
options ara Indlcatad. this application is aupportod by all data In tha Agency's filaa that eanearn tha
propartiaa or tfftcts of this product that Is Idantical or substantially similar, and that Is ona of tha typos
of data that would ba required to ba submitted If this application sought tha initial ranistration of a
product of Identical or similar eoaposltlon and Intandad uaas under tha data requirements in affact on
tha data of approval of this application. (Chock tha appropriate bones. In Iteas 2 and 3 btlow, that
pertain to your application.)
2. I certify that, for each study cited In support of this application for registration that is an exclusive use
study,
| | 1 aa> the original submitter*; or
| | 1 have obtained the wit ten emission of the original data submitter to cite that study*
3. I certify that, for each study cited in support of this application for registration that ia not an exclusive u
study:
a. | ] I a* the original data submitter*; or
| | I have obtelned the written permission of the origins! data subsitter to cite that study*; or
b. | | I have notified In writing the coapaniea that have submitted data I have cited to support ttiis
application and have offered to: (a) Pay coapensatlon for those data in accordance with section
3(c)(UD) and 3(c)(2)(0) of the Federal Insecticide, fungicide and Rodent I elds Act (FIFRA);
and (b) Coajsonce negotiations to determine which data ara subject to the eoapenaation
requirement of FIFRA and the amount and tanas of coapensatlon due, if any. The coapaniea I
have notified are: (Check ona)
| | All companies listed on the Pesticide Dsta Subsitters List for alt active ingredients contained
in ay product (cite-all aethod or clte-oll option under Selective Method*). (Also sign the
General offer stateaam below.)
| | Those ccapanles that have auteittad the studies which I have cited (Selective Method*).
* A Data Matrix identifying these studies Is ettachad. (Dote: A Data Matrix is not required under the
cite-all Method.)
Signature
Title
Date
si Offer to Pay: I hereby offer and agree to pay ceapanaation to other
persona, with regard te the approval of this application, to the extant required.
Signature
Title
Date
EPA Fora 8570-29 (Rev. 7-91)
17-11
-------
17-10 BBP1B8BMT**XVI COPY OF BPA VOW §570-31
TT.T.TJflTBK'PTOW PTJBPOflltJ!
United States Environmental Protection Agency
Washington. DC 20460
EPA
CERTIFICATION UITN RESPECT TO
DATA COMPENSATION REQUIREMENTS
OMB No. 2070-0104
ft&srml lwfr*s 12*31
Public reporting burden far this collection of information tt estimated to average tS minutes per response, including
tin for reviewing instructions, scorching witting data sources. gathering and maintaining the data naadsd, and
computing and reviewing the collection «f information. Sand comments regarding the burdan estimate or any other
aapact ef thla collaction of information, Including suggestions for reducing thi» burdan. to Chief, Information Policy
•ranch. PN-2Z3. U.S. Environaanttl Protection Agency, 401 N St.. S.U.. Washington, DC 20*60; and to the Office
of Mann Mint and Budget, Paperwork lodMction Project (2070-0106). Uaanington. OC 20903.
I
Pleaaa fill In Manka balow.
Company Name P SO
L T S
Chemical Name E RE
A S
Company Number
EPA Chemical Number
I Certify that: I
0
N
1. For each study cited in support of registration or reregistratlon under the Federal Insecticide, Fungicide and
•odenticio* Act (FIFRA) that is an exclusive use study, 1 a* the original data auteitter, or 1 have obtained the
written perarfaaien of the original data subaitter to cite that study.
2.
That for each study cited In support of registration or rarest strati en under F1FRA that la NOT an exclusive use
study, 1 sat the original data aubsitter. or I have obtained the written permission of the original data submit tar. or
I have notified In writing the coapanyCies} that submit tad data 1 have cited and have offered to: (e) Pay
compensation for those data in accordance with section 3(e)(1){0) and 3(c)(2)(D) of FIFU; and (b) rommanrs
negotiation to determine which data are subject to the compensation requirement of FIFM and the amount of
compensation due, if any. The companies t hove notified aret (check one)
All companies on the dsta submitters' list for the active Ingredient Hated on this form (Cite-All
Method or Cite-All Option mder the Selective Method). (D) end 3(0>.
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (*-90)
17-t2
-------
17-11 BlPUSBMTAfXTB COPY OF 111 FORM §570-32
FOR ILLU8TRATIOH PTJKPO8E8 O«.T
united Statea Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
DATA
For* Approved
ONI Me. 2070-0106
Public rtportlng burden for this collection of Intonation is estimated to average IS minutes par response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining tht data needed, and
collating and reviewing tha coUaction of information. Sand comments regarding tha burden aatfMta or any other
aapact of this col(action of information. Including suggestions for reducing this burden, to Chief, Infonsetion Policy
•ranch, PN-223, U.S. Environmental Protection Agency, 401 N St., S.W., Washington, DC 20440; and to tha Office
of Management and ludget, Paperwork leductlon Project (2070-0106). Washington, DC 20503.
Pleeee fill In M
Company New
Chemicel Name >
Company Number
EPA Chemical Number
I Certify that:
Hy company is Hilling to develop end submit the data required by EPA under the authority of the federal
insecticide. Fungicide and Rodsnticide Act (FIFIA), if necessary. However, ay company Mould prefer to
enter into an agreement Mith one or more registrants to develop jointly or share in the coat of developing
data.
My firm has offered in writing to enter into such an agreement. Thet offer MBS irrevocable and included en
offer to be bound by arbitration decision under section 3(c)(2)(t)(iii) of FIFU ff final agreement en all
items could not be reached otherwise. This offer IMS mmda to the following firm**) on the following
date:
Kane of FirsKs)
I
I P
F I U 0
* 0 U R N
N R S PL
P TOT
I R S
E A E
T S
I
Date of Offer
Certification;
I certify thet I ma duly outhorized to represent the company name above, and that the statements that I have made on
this form end all attachments therein ere true, eccurate, and complete. I acknowledge thet any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Data
Name and Title CPlease Type or Print)
Form 8570-32 (S-91)
Replaces EPA Form 8580-6, which is obsolete
17-13
-------
FXOURB 17-12 RSPRBBEHTATIVB COPY OF 1PA FORM 8580-1
FOR ILLUSTRATION PURPOSES ONLY
Fora Approved. (Mi Hoi 2070-0057. Approval expires 11-30-19.
FINIA SECTION 3(C)(2)(S) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME
EPA REGISTRATION NO.
DATE GUIDANCE DOCUMENT ISSUED
Vith respect to the requirement to subait "generic" data leposed by the FIFRA section 3(c)(2)(l> notice contained in the
referenced Guidance Docuasnt, 1 am responding in the following earner:
iZl 1. I will submit data in a timely Manner to satisfy the following requirements, if the test procedures t Mill
use deviete from (or ere not specified in) the Registration Guidelines or the Protocols contained In the Report
of Expert Groups to the Chemicals Group, OECD Chemicals Tooting Programme, 1 enclose the protocols that I Mill
use.
. |~| 2. 1 have entered into an agreement with one or more other registrants under FIFRA
satisfy the following dote requirementa. The teata, and any required protocols.
section 3(c)(2)(IXii> to
will be submitted to EPA by:
NAME OF OTHER REGISTRANT
O '• I anclose a completed "Certification of Attempt to Enter Into an Agreement with
Development of Date" with respect to the fol lowing data requirements:
Other Registrants for
Q 4. I request that you emend my registration by deleting the following uses (this option Is not available to
applicants for new products}: I
L
S IP
A F U U 0
M 0 S R N
P R T PL
L ROY
E AS
T E
I S
0
H
|~| 5. I request voluntary cancellation of the registration of this product. (This option is not available to
applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE SIGNATURE
DATE
EPA For* 8580-1 (10-82)
17-U
-------
17-13 RlPRISBMTATrT* COPT Of EPA FORM fjStO-4
VOft TT.X.TIBTR>TTOlf *»•"««•—'—— —.«— —
EPA
US Environmental Protection Agency Registration Standard for:
Washington, DC 20*60
Product Specific
Dote Report
Registration
Guideline Ho.
Sec. 158,120
Product
Chemistry
t
i
.
.;
61-2
62-
62-2
62-3
6
6
6
6
&
4
6.
6,
1
i
i
i
I
6
6.
*
6,
6,
6.
• |
>
i
-4
J
•
-6
-7
-8
-o
•
-'
^
P
1
i
3
S—
f
9
»
-20
-21
Sec. 158.135
Toxicology
,
i
•1
-2
J
-5
-6
Name of Test
Identity of inerediants
Statement of coMoosition
Discussion of formation of inoredienti
Preliminary ana va a
Certification o 1 rnlts
Analytical methods for enforcement limits
Color
Physical state
Odor
Me j_ no DO nt
80 1 no DO nt
Dens tv. bulk-density, or soeeiffc gravity
Solubility
Vaoor oressure
11 ••edition eonatanf
(ctanot/water Dart it ion coefficient
DM
Stab 1 tv
ixid z no/rtduclna ruction
lammabik tv
XDlodacj itv
toraee stability
Viaeoaitv
Hiseibilitv
Corrosion Cisrecteri sties
Dielectric treakdown voltaee
~
Acute oral toxic tv. rat
Acute ^'^"il tgx cltv rehnit
Acute inhslst on toxlcitv. rat
Primery eve irr tation raMrit
Primary dermal rritation
Dermal senaittzatien
Testing not
required for ay
product listed
above
(check below)
s
A
H
P
EPA Registration Number
1 am complying with
Data Reouf rement bv •
Citing
MID Ho. •
I
L
L
t
0
R
e
Submitting
Data
(Attached}
(Check below)
U U
f »
T
R
A
T
1
Form Approved
OM f 2070-0057
Explrea 11-30-89
(For EPA Use
Only)
Accession
numbers
assigned
0
f L
0 1
S
E
*
B
N
Certification
I certify that the statements I have mode on this form and all attachments thereto are
true, accurate, and cesnlete. I acknowledge that any knowingly false or mis leading
statement may be punishable by fine or imprisonment or both under applicable leu.
REGISTRANT'S AUTHORIZED REPRESENTATIVE SIGNATURE
DATE
EPA For* 8580-4 (Rev. 5-88) Previous edition is obsolete.
17-1J
-------
FIGURE 17-14 RBPRB80TATIVB COPY OF IPA FOBM 3540-1
PORPOBBB OMLT
For* Approved. ONI No. 2070-0020. expires 3-31-88
u. S. Environmental Protection Afency
ROUGE OF ARRIVAL OF
PESTICIDES MB DEVICES
MltT I TO U COMPLETED IT
1. MIC MB ADDRESS OF IMPORTER 01 AGENT (Include Zip
Cadi) S I P
A F L U 0
H 0 L • II
P R U P
L SO
E T S
3. NAME MB ADDRESS OF SNIPPER t E
A
T
I
0
7. MAJOR ACTIVE INGREDIENTS MB PERCENTAGE OF EACH
8. (MIT SIZE 9. QUANTITY 10. TOTAL NET MET.
t
12. PORT OF ENTRY
u. EJITIT mtmn ». ENTRY BATE u HMO MB NUMRCIT
17. LOCATION OF flOODS FOB EXAMINATION
NPORTER OR HIS AGENT
2. RWC MB ADDRESS OF CONSIGNEE (Include Zip Code
I
T
4. EM REGISTRATION NO. S. EM PRODUCER ESTARUSNNENT
S NO.
4. DRMB NAPE OF PRODUCT
N
11. COUNTRY OF ORIGIN
IS CARRIER
INVOICE DATA
18. NUMBER 19. DATE 120. PUCE
22. 1 ASSERT THAT INFORMATION CONSTITUTING CONFIDENTIAL
RUS1RESS INFORMATION IS SNOW M THE ABOVE BLOCKS
23. SIGNATURE OF IMPORTER OR AGENT 24. DATE
•ART JJ JO If COMPLETED RT U.S. RWtMH^fTMj fKfTEtTIOf Mtf"el
Action to b» talun an shlpMwtt by U.S. Cuttew:
~ R«t»w« shfpMnt.
_ Bttiin thipMnt for irwpcction by EPA
_ t«l*M« diipMnt to cencignM widvr band. ShipMnt Wit bt held IntKt pending EPA frapaetlen.
_ SMplt dnirad mdtr provisions of ttw Ftdtral InMcticidi, Fwiflcldt, and Rodmticidt Act, M MMnrtnl «nd Cuttov
••fuUtlom 19 CFR 12.116. PtoaM forward • M*>U of th* MrchwdlM IdMttlfiod tbowt, tofithor Mfth «tt
•ccoiponying iatels, circulars, and aoVtrtlting aatttr pertaining to such •archandiM, to th« addrast anoun abov*.
_ If it It nacctury to ttkt subMMpla* frea bulk contalnart, contact the EPA offica for Maplfng imtructiena.
_ Other (Spacffy):
SIGNATURE MB TITLE OF EM OFFICIAL DATE
>ART II mm OMHCTCB p ff,«. tWKMB •EWIS
Th* information »houn In Part I Mas covparad with the entry papers for this shipment and no discrepancies Msre noted. Th*
shipment IMS handled as Instructed by EPA in Part II. Any deviations should be brought to th* attention of EPA before
releasing shipment and also be noted in remarks.
REMra
SIGNATURE OF DISTRICT DIRECTOR OF CUSTOMS DATE
EPA Fora 3540-1 (Rev. $-77) Previous editions are obsolete.
17-16
-------
BI*USI«T*TXYB COPT or
FOBM as4o-t
0. I. ENVIRONMENTAL PROTECTION AGENCY
APPUCATKRI ft* REHSTUTIOM Of PESTICIDE - PRODUCING ESTABUI
(SECTION 7, FEDERAL INSECTICIDE, FUNGICIDE. «MO RODENTICIDE ACT,
M AMENDED, 86 Itit. 973.999)
P
•FAB 411 mSTMJCTlOK REFORt COMPLETING U
For*
OM HO. 2070-0045
ABorovel eraire* 11-30-89
0. TUNS. TYPE (EPA UK ONLY)
1. COMPANY NAME
1
16. EPA REGISTRANT NUMBER
2. STREET ADDRESS
N 0
P R
L
7. COMPANY DUNS MMKR
3. CITY
4. STATE
9. ZIP CODE
11. COMPANY HEADQUARTERS (If different frM Nwfeer 1) 1
8. ENTER APPROPRIATE OWNERSHIP CODE
1 - INDIVIDUAL
2 - PARTNERSHIP
3 - COOPERATIVE ASSOCIATION
4 - CORPORATION
5 - OTHER
12. STREET ADDRESS
9. DATE OF INCORPORATION (Me.Dey.Year)
,1,1,
13. CITY
14. STATE 15. ZIP CODE 10. STATE OF INCORPORATION
JUNE. SITE LOCATION. AND MAIL1N6 ADDRESS OF
EACH PtOBUCINC esTABLlSNMENT
16. NAME OF ESTABLISHMENT
17. ESTAB. NO. (EPA UM Only)
18. DUNS NUMKR
19. LOCATION (StrMt, City)
20. STATE
21. ZIP CODE
22. CUSTOM BLENDER
23. NAILINC ADDRESS OF ESTABLISHMENT (StrMt. City)
24. STATE
25. ZIP CODE
26. SIC CODES
16. NAME OF ESTABLISHMENT
17. ESTAB. NO. (EPA UM Only)
18. DUNS NUMBER
«,
r «
B 19. LOCATION (Strt*t, City)
20. STATE
21. ZIP CODE
22. CUSTOM SLENDER
23. MAILING ADDRESS OF ESTABLISHMENT (Street, City)
24. STATE
29. ZIP CODE
26. SIC CODES
6. NAME OF ESTABLISHMENT
17. ESTAB. NO. (EPA UM Only)
18. DUNS NUMBER
19. LOCATION (StrMt, City)
20. STATE
21. ZIP CODE
22. CUSTOM BLENDER
23. NAILING ADDRESS OF ESTABLISHMENT (StrMt, City)
24. STATE
29. ZIP CODE
26. SIC CODES
16. NAME OF ESTABLISHMENT
17. ESTAB. NO. (EPA UM Only)
18. DUNS NUMBER
19. LOCATION (StrMt, City)
20. STATE
21. ZIP CODE
22. CUSTOM BLENDER
23. NAILING ADDRESS OF ESTABLISHMENT (StrMt, City)
24. STATE
25. ZIP CODE
26. SIC CODES
16. NAME OF ESTABLISHMENT
17. ESTAB. NO. (EPA UM Only)
18. DUNS NUMBER
19. LOCATION (StrMt, City)
20. STATE
21. ZIP CODE
22. CUSTOM BLENDER
23. NAILING ADDRESS OF ESTABLISHMENT (StrMt,-City)
24. STATE
25. ZIP CODE
26. SIC CODES
Q CONTINUED ON ATTACHES MEET
27. SIGNATURE OF COMPANY OFFICER
28. NAME AND TITLE
DATE (No.Oey.Yr)
,1,1,
30. TELEPHONE NUMBER
31. DATE APPLICATION RECEIVED
JURE
THE ESTABLISHMENTS ASSIGNED NUMBERS ABOVE
HAVE BEEN REGISTERED IN ACCORDANCE WITH
SECTION 7, FIFRA AS AMENDED
32. SIGNA
EPA
USE
ONLY
33. EPA REGIONAL OFFICE
34. DATE REVIEWED
M FORM 3540-8 (REV. 10-81)
PREVIOUS EDITIONS ARE OBSOLETE
17-17
-------
-------
CHAPTER 18 - WHO TO
COMTACT
FOR ASSISTANCE AMD WHERE TO SEND
YOUR APPLICATIONS AMD SUBMIflflTOKB
A. GENERAL INFORMATION
The Registration Division, Office of Pesticide Programs,
consists of three pesticide product branches, the Insecticide-
Rodent icide Branch, the Fungicide-Herbicide Branch, the
Antimicrobial Program Branch, and one support branch, the
Registration Support Branch. The pesticide product branches are
further subdivided into Product Manager Teams which are
responsible for the review and processing of applications for
registration, amended registration, petitions for tolerances, and
experimental use permits. ,
B. WHERg TO SUBMIT YOUR APPLICATION
1. Applications for registration, petitions, experimental
use permits, etc., must be mailed to the following address:
Document Processing Desk (Distribution Code) **
Office of Pesticide Programs (H7504C)
U.S. Environmental Protection Agency
401 M street, S.w.
Washington, D.C. 20460
** insert Appropriate Distribution Code identified
below.
2. Hand-delivered applications must be delivered to the
following address:
U.S. Environmental Protection Agency
Crystal Mall, Bldg. #2, Rm. 258
Document Processing Desk (Distribution Code) **
1921 Jefferson Davis Highway
Arlington, VA 22202
** Insert appropriate Distribution Code identified
below.
3. Distribution Codes
When you send mail to either of the above addresses, we will
be able to process your application more expeditiously if you
indicate the type of application you are submitting. The
following Distribution Codes are designed to enable the Agency to
identify, route and process your incoming mail more quickly and
accurately. The Distribution Code should be used as indicated in
the addresses cited above.
18-1
-------
SECTION 3 PRODUCT REGISTRATIONS
DISTRIBUTION
CODE
TYPE OF APPLICATION
APPL Application for Product Registration
AMEND Amendment to Registration
CAN/HD Request to Cancel a Registered Product
or to Withdraw a Pending Registration
CSRT Certifications of Product Registration
LIP Label Improvement Program Response
XFER Transfer Products to a Different Company
OTHER ACTIONS
BIOTECH Biotech Applications and Pre-EUP Notifications
EMEX Emergency Exemption
EUP Experimental Use Permit
ZR4 Minor Use Petition
PETN Petition for Tolerance
SLN Special Local Need Registration
INFORMATION PERTAINING TO ADVERSE EFFECTS
6(a)(2) Unreasonable Adverse Effects Data
COMPANY NAME AND ADDRESS
COADR Company Name and Address Change
DIST Supplemental (Distributor) Registration
NEWCO Request for a Company Number (Register an
Establishment)
DATA CALL-IN RESPONSES (PRODUCT SPECIFIC*
DCI-RD-PMXX
RED-RD-PMXX
Response to a Data Call-in
Response to a Reregistration Eligibility
Document
(xx identifies the PM Team)
DATA CALL-IN RESPONSES (GENERIC 1
DCI-SRRD-XXX
RED-SRRD-XXX
Response to a Data Call-In
Response to a Registration Eligibility
Document
(xxx identifies the regulatory case number or chemical name
as specified in individual OPP instructions)
18-2
-------
OTHER REGULATORY RESPONSES
RS-XXX
Response to a Registration Standard (including
Second Round Reviews)
(xxx identifies the regulatory case number or chemical name as
as specified in individual OPP instructions)
C. ORGANIZATIONAL CHARTS:
TOXIC SUBSTANCES
or PREVENTION, PESTICIDES AND
This section contains organizational charts for the Office
of Prevention, Pesticides,and Toxic Substances, including names
and telephone numbers for the heads of each organization.
Detailed charts are provided for the Office of Pesticide Programs
and the Office of Compliance Monitoring but not for the Office of
Pollution Prevention and Toxics.
OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES
TOXIC
PREVENTION PESTICIDES AND
UKDA J. FISHER, Assistant Administrator (202) 260-2902
VICTOR J. KH4M, Deputy Assistant Administrator (202) 260-2910
QF
PREVENTION
AND TOXICS
MARK A.
Director
(202) 260-3810
JOSEffi S. CARRA
Deputy Director
(202) 260-1815
[No detailed charts
provided for this
organization, j
OFFICE OF Mafi
FKXZAMS
DOUdAS D. OWPT
Director
(703) 305-7090
SUSAN H. WAYLAND
Deputy Director
(703) 305-7092
[Refer to detailed
charts below for
breakdown of this
1
OFFICE o
MICHAEL M. STAHL
Director
(202) 260-3807
CONNIE A. MUSC3OVE
Chief Executive Of f i
(202) 260-7833
[Refer to detailed
charts below for
breakdown of this
CP - ]
18-3
-------
u
i
I!
B
*
ik
t i it
I 1$
8 ill!
II
r«j
!!i
!
X —
!
. «»--*
- <*£*£*
i ilili
f> £ *• • ••
!{il£
«• • ^ • «•
! |iW
«hii?
-«I-
itfjl
Jllft
H|.i
"•?.
W!i
llii-i
i
§
I 111
it:
i
.«
K I U M. { 3 *> «
' Ibhli
u-e- «.
M u-e
*
(8 i «5 ^2
Illssi
i
---
5 ie•£ •»
o » u e
1
-------
w
«
&
IS
s
i
! r:
»• e •< — —
go w u u
**c Iss
s,
Sec
>»
i li!
bl
lo
"g £-?
iu 5 « f —
3 Si*
i! Ill
_. fex°?
I *!i-fl£
1" £S£j|?
11?i^^
5i3z«
tlsii
M S5i .8s
i hllll
-------
i
gg
i
5f«.
ii
t*i
ll*
il
i s*
§y • 5 •
• S x»,i
-------
i
s
>* t >»-»»• O
I ||j]|:!5rk||if.
^ c ** tf ^ jj Qi »«» • • J» v *•
^^ ^ * •» v 5T * B v & *
-------
ss
I
i
i
lit
!l!
I ill
} I lit
K l"|s
*
-------
eg
I t
Si
^ ^
ft
II
h
1
ii
g
is si*
Iw !.«•««
w 6
tf.5
Jlf
•5 £ •*?
w • « £
" 8-IS
• O * • 5
S "HSjf
'lifl
Ilii
§ l!§Jc! !
I
•8 2
;!l|*t
• < S 3 *< C
! «e•u $
5-9-EJ^^*
• :%=-25i
i i
ii
C* •—• • i *^ m
- S* 28 £ i
55-5*'E'52 -•»
*^o«2:-Ba
* £lliMiis;i
6 I:2f5s1=ris
? 55is:«»:^H
I JijfirlMh
* ssils^.i t£
i i-ihsj:^!
i o^Hs-si5:!:
! i
J 6*^76^«»B2
s if Sir g^i^s.
i§ 1111*11
i L*l|lfJJ
- isi!!|!i
i*< g t.2
?!I
>g
i l»!
> ^
if!
P 15
fc s i
« -I* -
§ -•£SS
? i^l
rf; fjj.s
ill If
«Jl|,
8^1^»!
|i|i:i
i Is*!!!
3 ,«!?if
-------
II
l i
S3
S
5
k
B
I1
r
I
1!
'
it
«.«
Zu
1 i -
*• i-E 0
» :±
• . 5 s
if
A
£1
JlilKi.
Is ?!
I* j
>&.u«O>_C*<
if c?£iis~
A. 8-2 £ ». &.•• o
-------
ii
£
u.
a
I h_.ihfli?
Mi
*
I
8
I I
s s
<•» . «%
i g
§
III-
S *
8 lj
** fi«
g g g g g *;*£
w w ** w *"3»'i
S « *
2 \
i*n
-•Hi
*!*!
g^2»
= *|o
*5|^
ihi
I i
• •
§ §
«*» «*
g g
!
i >fi
* IJ-i
a •
-------
I
u
i
- u-6&c5
«*
i
.s**ii"«5ii
»i"*!mii
Ui!i!{i1|i
ililllj1'
*• *»
e •
*=:Sill
S
p KU;i|i|t
-------
•• > tl B * ft 1
isllJlli
ff-2 *l;jfi
!U5liS:il8t!
PS g K
*» *» £ c
?g|! ?l!il Hi!
i'ilii
!»1l!2
s
8
s«=! fIslJ*:-!s£
slit !;f-rt^N
'111 il'ilalhi
**ls sIMs'iist
Mil iHilJiflil
=.-11 li!i!5;M!^
I'frj ?4.l!]!if|!i
! I
§11* Jrllslslsil
i§« S^^l&xiffif
2i&.
' •* *£ ?i
-------
i
i
i
ft
8
i
ii
i
*
I
2-
B •
mi
! jfilil} 81
I" iirf?!* ill
rl-sl
i*«?i=i s:i
|{!|«|| JK
-------
s
o Z
** *•
ii i
J* S I
_ k _ k J. 9
il
It
Is
•*5 — _•<••« — Hfis^o
i*ltll£f=="s
••-i^**^^ _*•*_
i!
!
ji«2?8>8-* -~
iliiiiliiiiiii: in
S
,xl|| SSiiiiaai.
f|i|l § S 5 § £ § § S |j|
l*i:l. Illiliilhi
• f«^*^4i^ *^ ^ v v w ^ ^ •<*
Zsf.j5 l»l
S-8-5fe**£ S5&
i!P i ii«i
cl—Sbv — t^—
Bsrlfi I lt?i
lliiil
?^I='5]
•I 31-
«l*i|l
-------
I
i
i
*
IS
i
g
^
e
Hl.
*Ki
i!
Jl
s-li-i *!
[sjiiiy
**?«Si
filil!
, I«*8"!
8llK"I«
I lM[h
liiiilii
**
!S«"'
§^«
*l^
]l!i
5
*li,i
rf|fr
• — « k. — o.
i!i w
!ih li
I ,i\iiiii!i|!
* !dif!liHli!
-------
D. BBQiaTRATION DIVISION. WASHINGTON B.C.
1. IM8«CTICIPB - RODEKTICIDB BBXMCH
BRANCH CHIEF - Herbert S. Harrison (703) 305-5200
DEPUTY BRANCH CHIEF - Harvey Wamick (703) 305-5200
The various Product Manager Teams that are responsible for
certain types of products are indicated below.
PRODUCT MANAGER 10 - Dick Mountfort (703) 305-6502
TYPE OF PRODUCTSi Pyrethrins, Insect Repellents,
Certain Synthetic Pyrethroids (including
Resmethrin, Allethrin, Tetramethrin,
d-Phenothrin
PRODUCT MANAQER 13 - George LaROCCa (703) 305-6100
TYPE OF PRODUCTS: chlorinated Organic
Insecticides, Drug/Pesticide Combinations,
Dichlorvos, Endosulfan, Fenthion,
Fensulfothion, Disulfoton,
Second Generation Pyrethroids (i.e., Permethrin
and Cypermethrin)
PRODUCT MANAGER 14 - Rob Forrest (703) 305-6600
TYPE oy PRODUCTSi Most Organo-Phosphorus
products i.e., malathion, dimethoate,
except those listed with PMs 13 and 19,
Boric Acid, Vertebrate Pesticides,
Animal and Bird Repellents
PRODUCT MANAGER IB - Phil Hutton (703) 305-7690'
TYPE OF PRODUCTSt Microbials, Biologicals,
Insect Growth Regulators, Most Botanicals
PRODUCT MANAGER 19 - Dennis Edwards (703) 305-6386
TYPE of PRODUCTSi carbemates, Miticides,
Toxaphene, Carbary1, Chlorpyrifos,
Parathion, Azinphos-methyl
18-17
-------
2. FOMQICIDB - HERBICIDE BRANCH
BRANCH CHIEF - Frank Sanders (703) 305-6250
DEPUTY BRANCH CHIEF - Thomas AdamczyX (703) 305-6250
The various Product Manager Teams and their area of
responsibility are listed below.
PRODUCT MANAGER 21 - Susan Lewis (703) 305-6900
mm or PRODUCTS! Fungicides, Nematicides, Wood
Preservatives, Microbials
PRODUCT MANAGER 22 - Cynthia Giles-Parker
(703) 305-5540
TYPE OF PRODUCTS: Fungicides, Herbicides which
include Arsenicals, Copper, and some Plant
Growth Regulators
PRODUCT MANAGER 23 - Joanne Miller (703) 305-7830
TYPE OF PRODUCTS! Herbicides: Phenoxys, Aquatics
PRODUCT MANAGER 25 - Robert Taylor (703) 305-6800
TYPE or PRODUCTS: Herbicides, Plant Growth
Regulators (shared with PM Team 22),
Desiccants, Defoliants
3. ANTIMICROBIAL. PROGRAM, BRANCH
The Antimicrobial Program Branch is responsible for the
registration activities of pesticides used as hospital
sterilants, disinfectants, water treatment products, anti-
foul ing paints, swimming pool chemicals, and fumigants.
BRANCH CHIEF - Juanita Wills (703) 305-6661
DEPUTY BRANCH CHIEF - Walter C. Francis (703) 305-6661
PRODUCT HAMMER 31 - John H. Lee (703) 305-5676
TYPE OF PRODUCTS - Anti-fouling Paints, Quaternary
Ammonium and Water Treatment Compounds, Hospital
sterilants
PRODUCT MANAGER 32 - Ruth G. Douglas (703) 305-7964
TYPE OF PRODUCTS - Hypochorites, Halides,
Chlorophenolics, Swimming Pool Chemicals,
Fumigants
18-18
-------
4.
IKSTflTMTTON SOV9Q99 BIUUfCR
(These telephone numbers will
change)
The Registration Support Branch im responsible for the
processing and review of Section 18 Emergency Exemption
requests, minor use (IR-4) petitions, inert ingredient
clearances, and the review of product chemistry and
precautionary labeling (acute toxicology) data. Additional
responsibilities include tolerance reassessment, policy and
regulation development and Office of Management and Budget (OMB)
clearance, the processing of product registration transfer
requests, and registration cancellation requests, and front-
end application processing.
BRANCH CHIEF - Donald R. Stubbs (703) 305-7700
DEPUTY BRANCH CHIEF - James Tompkins (703) 305-7700
FRONT END PROCESSIKQ STAFF
STAFF LEADER - Edith Minor (703-305-6978)
AREA OF RESPONSIBILITY: Front-end applications
processing. Processing and status of expedited review
applications. When inquiring about the status of your
application, you must be able to provide the red number
in the upper right-hand corner of the Application for
Registration/Amendment form (EPA Form 8570-1).
PRECAUTIONARY REVIEW BECTIOK
SECTION HEAP - Tom Ellwanger (703) 305-7783
AREA OF RESPONSIBILITY! Precautionary labeling
(acute toxicity) reviews.
PRODUCT CHEMISTRY REVIEW SECTION
- Donald R. Stubbs (Acting) (703) 305-7700
AREA OF RESPONSIBILITYI Review Of product
chemistry data.
In late summer or early fall of 1992 all members of the
Registration Support Branch (RSB) will move to Crystal Station
Building 1 (CS-1) and their telephone numbers and room numbers will
change from those listed in this manual. However, you can continue
to call their old telephone number for a period of time after the
move occurs and you will be given the new telephone number.
Otherwise, you may call the EPA's Directory Assistance/Personnel
Locator number (202) 260-2090.
18-19
-------
RESPONSE AMD MTNOtt USE SF.CTTOM
(These telephone
numbers will change)
SECTION HEAP - Rebecca S. Cool (703) 305-5806
AREA OF RESPONSIBILITY! Emergency Exemptions
(Section 18*s) and Minor Use (IR-4)
petitions.
PROJECT COORDINATION SECTION
SECTION HEAD - Tina Levine (703) 305-5179
AREA OF RESPONSIBILITY! Inert clearance requests,
tolerance revocation, regulation and standard
operating procedures development, Office of
Management and Budget (OMB) clearance of programs,
and intra and intercoordination of lab audits and
other media programs within the Agency.
ADMINISTRATIVE PROCESSING SBCTIOII
SECTION HEAP - Donald R. Stubbs, Acting (703) 305-7700
AREA OF RESPQNSiBiLiTYi Product registration
transfers, cancellation requests, program status
and reporting, and ADP processing.
I. OFFICE OF COMPLIANCE MONITORING: POLICY AMD GRANT DIVISION
1. PESTICIDE ENFORCEMENT POLICY BRANCH
BRANCH CHIEF - Phyllis Flaherty (703) 308-8383
The types of functions within the area of responsibility of each
staff person are indicated below:
DAM HELFGOTT (703) 308-8288
FUNCTIONS: FIFRA Section 6(g) Policy; FIFRA ERF;
Labeling, including State-Labeling Issues
Committee; Existing Stocks.
In late summer or early fall of 1992 all members of the
Registration Support Branch (RSB) will move to Crystal Station
Building 1 (CS-l) and their telephone numbers and room numbers will
change from those listed in this manual. However, you can continue
to call their old telephone number for a period of time after the
move occurs and you will be given the new telephone number.
Otherwise, you may call the EPA's Directory Assistance/Personnel
Locator number (202) 260-2090.
18-20
-------
filEEEBLBQIXl (703) 308-8290
FACTIONS: Export and Biotechnology; Policy
Support for Record Keeping Regulations and GLP
Standards.
VIRGINIA LATHROP (703) 308-8292
FUNCTIONS: Pesticides and Groundwater
Coordination; Revised Policy Compendia (5
Volumes); Contract Coordinator; Generic Compliance
Monitoring Strategy for Cancellations/Suspen-
sions; FIFRA section 6(g) Outreach Plan; FIFRA
Policy Search System.
OIHAH MORTEN8EN (703) 308-8293
FUNCTiQNfl! Worker Protection Standards;
Endangered Species.
DAVID BTAHflBL (703) 308-8295
FUNCTIONS; FIFRa section 19/Disposal; Section
19(d)(4)/Primacy; Worker Protection Regulation;
Communication Strategies; State Labeling
Improvement Committee; FIFRA: Contract
Manufacturing and Custom Blending; FIFRA section
6(g) Policy; Special Review Chemical.
BEVERLY PPDIKB (703) 308-8296
FUNCTIONS; Develop Compliance Strategies for
FIFRA Enforcement of Maintenance Fee
Cancellations; Special Review Chemical;
Advertising.
2. GRANTS MID EVALUATION BRANCH
BRANCH CHIEF - Linda Flick (Acting) (202) 260-7841
The types of functions within the area of responsibility of each
staff person are indicated below:
LORILYN MeKAY (202) 260-6733
FUNCTIONS: Regional Liaison: VII, t IX; Asbestos
and Multi-Media Branch Lead; Groundwater Branch
Lead; TSCA Enforcement Decentralization Branch
Lead; Co-lead on State Pesticide-Lab Issues.
18-21
-------
CURTIS TOT
(202) 475-8318
FUKCTIONS: Regional Liaison: IV, VIII, & X;
FOSTTA Work Coordinator; QUIPE (Pesticides
Inspector Newsletter) Editor; Worker Protection
Branch Lead.
SUSAN KAVAHAUqH (202) 475-7008
JUNCTIONS: FIFRA '88; Regional Liaison: I & III;
PCB Branch Lead; Lawn Care Initiative Lead; OCM
Tribal Contact.
M&RY ELLEN FODNTE8NISKI
(202) 382-7422
FUNCTIONS: Regional Liaison: II, V, & VI; EPCRA
Branch Lead; Endangered Species Protection
Program; Hexavalent Chromium; Enforcement
Special Projects; Pesticide Grant Allotments;
Branch Lead on State Pesticide Lab Issue; Branch
Lead for Pesticide Project Officer Oversight
Manual.
3. TOXICS ENFORCEMENT POLICY BRANCH
BRANCH CHIEF - Janet Bearden (202) 260-7832
The types of functions within the area of responsibility of each
staff person are indicated below:
KENNETH QiRBILLY (202) 260-6747
FUNCTIONS; Asbestos Ban and Phase Out Rule; EPA
Asbestos Worker Protection Rule; TSCA Good
Laboratory Practices; TSCA Section 4 and Section
21; Asbestos in Public and Commercial Buildings.
SALLY 8X8NBTT (202) 260-1376
FUMCTIOHfi! Biotechnology (TSCA); AHERA; Pollution
Prevention (ITP); Geographic TSCA; New chemical
Exposure Limits.
GARY SECRE8T (202) 260-8660
FUNCTIONS; PCBs; Manager, Ability to Pay Study;
OCM Representative, PCB Steering Committee; Dioxin
in Sludge.
BRIPQET BULLIVXN (202) 260-8418
FUNCTIONS: EPCRA Section 313; TSCA Section 5 and
Section 8; Hazardous Communications Rule; Lead
Acid Batteries; Pollution Prevention Act.
18-22
-------
PETER PXQMTO (202) 260-4889
FUNCTIONS; Hexavalent Chromium; Lead in Solder,
Lead in Brass Fittings; Clean Air Act Amendments;
Acrylamide; TSCA Export/Import.
P. OFFICl Of COMPLIANCE MONITORING! LABORATORY DATA INTEGRITY
ASSURANCE DIVISION
1. PROGRAM SUPPORT AMD COMPLIANCE REFERRAL BRANCH
BRANCH CHIEF - Robert Zisa (703) 308-8400
The types of functions within the area of responsibility of each
staff person are indicated below:
RAY BRQWM (703) 308-8252
FUNCTIONS; Post-GLP Inspection/Data Audit
Monitoring; Review of GLP Inspection Reports;
Requests to OPP/OPPT for Regulatory Review of
Audited Studies; Response to FOIA Requests.
STEPHEN BRQZENA (703) 308-8267
FUNCTIONS: FIFRA '88 Pesticide Reregistration
Compliance Program; Issuance of Notice of Intent
to Suspend (KOITS) Actions for Non-Compliance with
Pesticide Testing Requirements; Liaison with OGC
and OPP for Settlement of NOITS Actions;
Assistance with GLP Inspection/Data Audit
Targeting.
CAROL BUCKINGHAM (703) 308-8254
FUNCTIONSt Assistance with FIFRA '88 Registration
Compliance Program; Operation of LDIAD Computer
Tracking Systems; Response to FOIA Requests.]
DORIS DYSON (703) 308-8260
FUNCTIONS; Computer contract Administration;
Systems Support.
YVBTTB HELLYER (703) 308-8256
FUNCTIONS; pre-GLP Inspection/data Audit
Activities; GLP Inspection/data Audit Targeting;
OPPT Chemical Testing Monitoring; Memoranda of
Understanding (MOU) with Foreign Governments for
GLP Programs. FDA Liaison for GLP Inspection/
data audit Program.
18-23
-------
FRANKLIN BMITH (703) 308-8273
FUNCTIONS; ADP Systems Support; ADP Extramural
Budget Management; Computer Contract
Administration; Local Area Network (LAN)
Administration.
O. OFFICE Of COMPLIANCE MONITORING: COMPLIANCE DIVISION
1. COMPLIANCE BRANCH
BRANCH CHIEF - Maureen T. Lydon (202) 260-5567
The types of functions within the area of responsibility of each
staff person are indicated below:
MIKE CALHOOH (202) 260-3375
FUNCTIONS; Team Leader for PCBs and Pesticides;
PCB General Information and PCB Natural Gas
Pipelines; Pesticides General Information and
Pesticide Exports; OCM Criminal Liaison.
ANN CLAVIN (202) 260-9438
FUNCTIONS! Mercury in Paints; PCB Co-lead;
Hexavalent Chromium Rule; Enforcement Requests.
KENNETH QDTTERMAN (202) 260-6902
FUNCTIONS: FOIA Coordinator, Credentials Officer,
Regional Review and National Meeting Coordinator,
Inspection Forms Coordinator, Inspection Manual
Custodian.
RICHARD KRATOFIL (202) 382-3487
FUNCTIONS: FIFRA Section 7 Foreign Establishment
Registration and Product Distribution; FIFRA DCO.
TERESA 1TTTI.E
(202) 260-4985
FUNCTIONS: Asbestos (AHERA) Regional Coordinator,
AHERA Compliance Monitoring; OCM TSCA Document
Control Officer.
JOHN MASON (202) 260-2301
FUNCTIONSi FIFRA Related Activities such as
Canceled and Suspended Products and Initiatives
(e.g., Dinoseb, Lawn Care, Malathion); Section
6(g) Compliance; Foreign Purchaser Acknowledgement
Statements tracking; Deliver, Order, Project
Officer.
18-24
-------
DAVID MEREDITH (202) 260-7864
FUNCTIONS; Project Manager for the National
Compliance Database, FIFRA/TSCA Tracking System,
and the EPCRA Targeting System; OCM Coordinator
for Strategically Targeted Activities for Results
System (STARS); Project Officer for CSC Contract
Support to FTTS and SSTS in Regional Offices, AOP
Issues.
PHILIP MILTON (202) 260-8598
FUNCTIONS; TSCA Sections 4,5,8,12 and 13 Regional
Coordinator; Hexavalent Chromium Rule; Asbestos
Ban and Phase out Rule; OCM Enforcement
Coordinator.
PAMELA 8ADNDBR8 (202) 260-1809
FUNCTIONS! Inspector Training; Contract
Management/extramural Funding Support; FZFRA
Section 7 Tracking System Manager; Pesticide
Export (USDA/FDA issues)7 AHERA AARP Inspectors
Grants; Canadian Liaison Issues; Project Officer
for General Programming Support contract (PRC).
AMAR flIKQH (202) 260-3868
FUNCTIONS; FIFRA General, including: Worker
Protection Standards, Endangered Species,
Groundwater, Disinfectants.
JULIE VXNDENB08CH (202) 260-9335
FONCTIONB! EPCRA Compliance Monitoring; EPCRA
Regional Coordinator - all regions; Investiga-
tion Requests under EPCRA; EPCRA AARP Grants for
Inspectors.
2. CA8B SUPPORT BRANCH
BRANCH CHIEF - Gerald StUbbS (202) 260-7861
The types of functions within the area of responsibility of each
staff person are indicated below:
ROSE BUROES8 (202) 260-4328
FUNCTIONS: TSCA Section 5/8 Case Development;
Region IV Coordinator; FIFRA Section 8 - Books and
Records.
18-25
-------
CIKDY COLDIROK (202) 382-3801
FUNCTIONS; Program Attorney - Advisor; General
TSCA Issues (Section 5 PMN, Section 8 NOC, Self
Confessors); FIFRA Section 3 Registration
(3(c)(2)(B)); Region V Coordinator; FIFRA -
Water Purifiers; TSCA Section 5/8 Case
Development; TSCA and FIFRA GLP Case
Review/Enforcement; Multi-media Issues.
BETH CROWIiEY
(202) 260-8464
FONCTIONB! TSCA Section 5/8 Development; Region
II Coordinator; PCB Issues; Contract Issues.
BRIAN DYER
(202) 260-3477
FUNCTION?: FIFRA Devices; FIFRA NOJ; TSCA Section
8(c) and 8(d); FTTS Case Tracking; TSCA Section
5/8 Case Development; Region VII Coordinator.
K. ABBREVIATED
IC8TMTI.E DIRECTORY
Many of the program offices at EPA Headquarters have
purchased facsimile machines and fax users can now send urgent
information directly to the program office. Priority letters,
drawings, charts, forms, labels, and photographs are particularly
appropriate for facsimile communications. However, you are
requested to limit your transmission of information to 12 pages
or less in order to prevent the facsimile machine from being tied
up for long periods of time by a single user. Documents
containing more than 12 pages should be sent to the Agency by
express mail. For best results use only black ink on white
paper.
IMPORTANT KOTEt Confidential Business Information (CBI), i.e.,
Confidential Statement Formula (CSF) should not be transmitted
over the facsimile machine unless the sender wants to clearly
waive his or her CBI rights and states this on the CSF.
If the FAX Number for the office to which you wish to send
information is not listed below, please call the intended
recipient of your document to obtain the appropriate transmission
number.
PROGRAM OFFICE
Office of Pestiei.d
Registration Division
Antimicrobial Proorm Branch
FAX NUMBER
(703) 305-6244
(703) 305-6920
(703) 305-5786
18-26
-------
jide- Herbicide Product Branch
inaeotiaide-Rodentlejde Branch
Registration Support Branch
Special Rev^ey ajid Rerecistration Piviaion
•mm. Management and Support Division
Information Bervieea Bz
(703) 308-1825
(703) 305-6596
(703) 308-1848
(703) 308-8773
(703) 305-7670
(202) 260-0575
Office ofPollution, Prevention and Texiea
Office of Compliance Monitoring (Immediate Office) (202) 260-1474
Coamliance Piviaion (202) 260-0646
Policy and Grants Division (202) 260-0641
Pesticide Enforcement Policy (703) 308-8218
(703) 308-8285
(703) 308-8286
>rv Pata Integrity Assurance
Pivision
UK BiiBBOift and GonBlianca
Referral Branch
Office of General Counsel
Peaticidea and Toxic Substances Ptvision (202) 260-2432
Science Adviaorv Beard
Offlea f nrative Law Judaea
Office of Qreund Water and Drinking Water
Emergency and Remedial Reaponaes (8OPERFOHD)
Aasociate Administrator for
e Affaire
Preaa Relations Division
(202) 260-9232
(202) 260-3720
(202) 260-4383
(202) 260-4386
(202) 260-4309
18-27
-------
REGIONAL OFFICES
HgQTOM 1
Jurisdiction: Connecticut, Maine, Massachusetts, New
Hampshire, Rhode Island, Vermont
Environmental Protection Agency
John F. Kennedy Federal Building, RM 2203
Boston, MA 02203
(617) 565-3420
RgQION 2
Jurisdiction: New Jersey, New York, Puerto Rico, Virgin
Islands
Environmental Protection Agency
26 Federal Plaza
New York, NY 10278
(212) 264-2657
REQIOM 3
Jurisdiction: Delaware, District of Columbia, Maryland,
Pennsylvania, Virginia, West Virginia
Environmental Protection Agency
841 Chestnut Street
Philadelphia, PA 19107
(215) 597-9800
REGION 4
Jurisdiction: Alabama, Florida, Georgia, Kentucky,
Mississippi, North Carolina, .South Carolina,
Tennessee
Environmental Protection Agency
345 courtland Street, N.E.
Atlanta, 6A 30365
(404) 347-4727
REGION S
Jurisdiction: Illinois, Indiana, Michigan, Minnesota, Ohio,
Wisconsin
Environmental Protection Agency
230 South Dearborn Street 5 SPT 7
Chicago, IL 60604
(312) 353-2000
18-28
-------
MOIOM J
Jurisdiction: Arkansas, Louisiana, New Mexico, Oklahoma,
Texas
Environmental Protection Agency
1445 Ross Avenue
12th Floor, Suite 1200
Dallas, TX 75202
(214) 655-6444
RBGIOM 7
Jurisdiction: Iowa, Kansas, Missouri, Nebraska
Environmental Protection Agency
726 Minnesota Avenue
Kansas City, KS 66101
(913) 551-7000
REGION 8
Jurisdiction: Colorado, Montana, North Dakota, South Dakota,
Utah, Wyoming
Environmental Protection Agency
999 18th Street
Suite 500
Denver, CO 80202-1603
(303) 293-1603
REGION 9
Jurisdiction: Arizona, California, Hawaii, Nevada, American
Samoa, Guam
Environmental Protection Agency
215 Fremont Street
San Francisco, CA 94105
(415) 744-1305
REQIOM 10
Jurisdiction: Alaska, Idaho, Oregon, Washington
Environmental Protection Agency
1200 Sixth Avenue
Seattle, WA 98101
(206) 442-1200
18-29
-------
Alaska
American Samoa
Arizona
Arkansas
California
Colorado
Commonwealth of
the Northern
Mariana Islands
Director
Ag Chemistry/Plant Industry Division
Alabama Dept. of Agriculture & Industry
P.O. Box 3336
Montgomery, AL 36193
(205) 242-2631
Pesticide Specialist
Alaska Dept. of Environmental Conservation
500 s. Alaska St., Suite A
Palmer, AK 99645
(907) 745-3236
Director, American Samoa EPA
Office of the Governor
Pago, American Samoa
96799
State Chemist
Office of State Chemist
P.O. Box 1586
Mesa, AZ 85211-1586
(602) 542-3579
Director
Division of Feed, Fertilizer & Pesticides
Arkansas state Plant Board
P.O. Box 1069
Little Rock, AR 72203
(501) 225-1598
Chief, Pesticide Registration Branch
Division of Pest Management
California Dept. of Food & Agriculture
1220 N Street, Room A-447
Sacramento, CA 95814
(916) 322-6315
Chief, Pesticide Applicator Section
Division of Plant Industry
Colorado Dept. of Agriculture
4th Floor, 1525 Sherman Street
Denver, CO 80203
(303) 239-4140
Chief, Division of Environmental Quality
Commonwealth of the Northern Mariana
Islands (CNMI)
P.O. Box 1304
Saipan, MP 96950
18-30
-------
Connecticut
Delaware
District of
Columbia
Florida
Georgia
Gu
Hawaii
Idaho
Senior Environmental Analyst
Pesticide Control Section
Department of Environmental Protection
State Office Building
Hartford, CT 06106
(203) 566-5148
Pesticide Compliance Supervisor
Delaware Dept. of Agriculture .
2320 South DuPont Highway
Dover, DE 19901
(302) 739-4811
Section Chief, Pesticide Section
Environmental Control Division
Dept. of Consumer & Regulatory Affairs
5010 Overlook Avenue, S.W., Room 114
Washington, D.C. 20023
(202) 404-1167
Administrator
Pesticide Registration Section
Bureau of Pesticides
Division of Inspection
Florida Dept. of Agric. & Consumer Services
3125 Doyle Conner Blvd.
Tallahassee, FL 32399-1650
(904) 487-2130
Ag. Manager II
Entomology £ Pesticide Division
Georgia Dept. of Agriculture
Capitol Square
Atlanta, GA 30334
(404) 656-4958
Director, Air & Land Programs Division
Guam Environmental Protection Agency
Harmon Plaza Complex, Unit D-107
130 Rojas St.
Harmon, Guam 96911
Registration Specialist, Pesticides Branch
Plant Industry Division
Hawaii Dept. of Agriculture
1428 South King Street
Honolulu, HI 96814
(808) 548-7119
Supervisor, Pesticide Programs
Division of Plant Industries
Idaho Dept. of Agriculture
P.O. Box 790
Boise, ID 83701-0790
(208) 334-3243
18-31
-------
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Mains
Maryland
Chief, Bureau of Plant & Apiary Protection
Illinois Dept. of Agriculture
State Fairgrounds
Springfield, IL 62791-9281
(217) 782-3817
Pesticide Compliance Officer
Indiana State Chemist Office
Dept. of Biochemistry
Purdue University
West Lafayette, IN 47907
(317) 494-1492
Supervisor, Pesticide Section
Iowa Dept. of Agriculture
Wallace Bldg.
East 7th Street and Court Avenue
Des Koines, IA 50319
(515) 281-8591
Administrator, Pesticide Registration
Plant Health Division
Kansas Dept. of Agriculture
109 S.w. Ninth Street
Topeka, KS 66612-1281
(913) 296-2263
Director
Kentucky Dept. -of Agriculture
Capitol Plaza Tower
Frankfort, KY 40601
(502) 564-7274
Director, Pesticides & Environmental
Programs
Louisiana Dept. of Agriculture
P.O.BOX 44153
Baton Rouge, LA 70804-4153
(504) 925-3763
Pesticides Registrar
Board of Pesticides Control
Maine Dept. of Agriculture
State House Station 128
Augusta, ME 04333
(207) 289-2731
Registrar, State Chemist Section
Plant Industries & Resource Conservation
Maryland Dept. of Agriculture
0233 Chemistry Bldg.
College Park, MD 20742
(301) 841-5710
18-32
-------
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
Manager, Technical Assessment sect.
Pesticides Bureau
Maine Oept. of Food and Agriculture
100 Cambridge Street, 21st Floor
Boston, MA 02202
(617) 727-3020
Supervisor, Product Registration
Pesticide & Plant Management Div.
Michigan Dept. of Agriculture
P.O. Box 30017
Lansing MI 48909
(517) 373-1087
Pesticide Control Specialist
Agronomy Services Division
Minnesota Dept. of Agriculture
90 West Plato Blvd.
St. Paul, MN 55107
(612) 296-1161
Pesticide Registration
Division of Plant Industry
Dept. of Agriculture and Commerce
P.O. Box 5207
Mississippi State, MS 39762
(601) 325-3390
Supervisor, Bureau of Pesticide Control
Plant Industries Division
Missouri Dept. of Agriculture
P.O. Box 630
Jefferson City, MO 65102-0630
(314) 751-2462
Chief, Technical Services Bureau
Environmental Management Division
Montana Dept. of Agriculture
Agriculture-Livestock Bldg.
Capitol Station
Helena, MT 59620-0205
(406) 444-2944
Director, Bureau of Plant Industry
Nebraska Dept. of Agriculture
301 Centennial Mall
Lincoln, NE 68509
(402) 471-2394
Director, Division of Plant Industry
Nevada Dept. of Agriculture
P.O. Box 11100
Reno, NV 89510-1100
(702) 688-1180
18-33
-------
Mew Hampshire
New Jersey
H*v Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Director, Division of Pesticide Control
New Hampshire Dept. of Agriculture
Caller Box 2042
Concord, NH 03301
(603) 271-3550
Chief, Bureau of Pesticide Control
NJ Dept. of Environmental Protection
401 East State street CN 411
Trenton, NJ 08265
(609) 530-4123
Chief, Bureau of Pesticide Management
Division of Agric. & Environmental Sciences
New Mexico Dept of Agriculture
P.O.Box 30005, Dept 3AQ
Las Cruces, NK 88003
(505) 646-2133
Director, Bureau of Pesticide Management
Dept. of Environmental Conservation
Rm. 404, 50 Wolf Road
Albany, NY 12233-7254
(518) 457-7482
Assist. Pesticide Administrator
Food £ Drug Protection Division
North Carolina Dept. of Agriculture
P.O. Box 27647
Raleigh, NC 27611-0647
(919) 733-3556
Director, Registration Division
North Dakota Dept. of Health and
Consolidated Labs
P.O. Box 937
Bismarck, ND 58502
(701) 221-6149
Specialist in Charge
Pesticides Regulation
Ohio Dept. of Agriculture
Division of Plant Industry
8995 East Main Street
Reynoldsburg, OH 43068-3399
(614) 866-6361
Program Manager
Pesticide Registration Program
Oklahoma Dept. of Agriculture
2800 North Lincoln Blvd.
Oklahoma City, OK 73105-4298
(405) 521-3864
18-34
-------
Oregon
Pennsylvania
Puerto Rico
Republic of Palau
Rhode Island
South Carolina
South Dakota
Tennessee
Program Coordinator, Plant Division
Oregon Dept. of Agriculture
635 Capitol Street, N.E.
Salem, OR 97301
(503) 378-3776
Use & Investigation Specialist
Bureau of Plant Industry
Division of Agronomic Services
Penna. Dept. of Agriculture
2301 N. Cameron Street
Harrisburg, PA 17110
(717) 787-4843
Director, Analysis t Registration of
Agricultural Materials
Puerto Rico Dept. of Agriculture
P.O. Box 10163
Santurce, PR 00908
(809) 796-1710, 1735
Executive Officer
Palau Environmental Quality Protection Board
Republic of Palau
P.O. Box 100
Koror, Palau 96940
Senior Plant Pathologist
Division of Agriculture & Marketing
Dept. of Environmental Management
22 Hayes Street
Providence, RI 02908
(401) 277-2782
Department Head
Dept. of Fertilizer £ Pesticide Control
256 Poole Agricultural Center
Clemson, SC 29634-0394
(803) 656-3171
Supervisor, Pesticide Activity
Division of Regulatory Services
South Dakota Dept. of Agriculture
Anderson Bldg., 445 East Capitol
Pierre, SD 57501
(605) 773-3724
Pesticide Registration
Division of Plant Industries
Tennessee Dept. of Agriculture
P.O.Box 40627, Melrose Station
Nashville, TN 37204
(615) 360-0130
18-35
-------
Vermont
Virginia
virgin Islands
Washington
West Virginia
Wisconsin
Director
Texas Dept. of Agriculture
P.O. BOX 12847
Austin, TX 78711
(512) 463-7549
Director, Division of Plant Industry
Utah Dept. of Agriculture
350 North Redwood Road
Salt Lake City, ITT 84116
(801) 538-7180
Director, Plant Industry
Laboratory £ Standards Division
Vermont Dept. of Agriculture
116 State St., State Office Bldg.
Montpelier, VT 05602
(802) 828-2435
Supervisor
Office of Pesticide Regulation
VA Dept. of Agriculture & Consumer Service
P.O. Box 1163
Richmond, VA 23209
(804) 371-6558
Director, Pesticide Programs
Division of Natural Resources Management
Dept. of Conservation and Cultural Affairs
P.O. Box 4340
St. Thomas, VI 00801
(809) 774-6420
Chief, Registrations & Services
Washington Dept. of Agriculture
406 General Administration Bldg. AX-41
Olympia, WA 98504
(206) 735-5062
Administrator
Regulatory £ Inspection Division
W. Va. Dept. of Agriculture
Charleston, WV 25305
(304) 348-2209
Certification & Licensing
Wisconsin Dept. of Agriculture, Trade 6
Consumer Protection
P.O. Box 8911
Madison, WI 53708
(608) 266-7131
18-36
-------
Wyoming Manager, Technical Service*
Wyoming Dept. of Agriculture
2219 Carey Avenue
Cheyenne, wy 82002-0100
(307) 777-6590
THE END
18-37
-------
-------
GLOSSARY 07 SELECTED TERMS, ABBREVIATIONS AMD ACRONYMS
USED XV THE OTTICE Of PESTICIDE PROGRAMS
AA - Assistant Administrator
AAFCO - Association of American Pesticide Control Officials. An
association of state pesticide regulatory officials dedicated to
the effective enforcement of lavs and implementation of programs
that relate to proper and safe use of pesticide chemicals.
ACB - The Analytical Chemistry Branch (ACB) within the Biological
and Economic Analytical Division (BEAD) of the Office of Pesticide
Programs (OPP). ACB provides analytical and environmental
chemistry services in support of pesticide registration, special
review, and tolerance petition programs. ACB also provides support
to the office of General Counsel, the EPA Regional Enforcement
Program, and the National Ground Water Monitoring Program. There
are two laboratories in this branch, one in Beltsville, Maryland
and one in Bay St. Louis, Mississippi.
ACCELERATED REGISTRATION BRANCH - The Accelerated Reregistration
Branch (ARE) within the Special Review and Reregistration Division
(SRRD) of the Office of Pesticide Programs (OPP) is responsible for
the reregistration activities of List B, C, And D Chemicals. ARB
staff manage data requirements, issue Data Call-In Notices, process
industry's data and requests, and coordinate internal
reregistration eligibility decisions.
ACCEPTABLE DAILY INTAKE - ADI. A now defunct term for reference
dose.
ACCESSION NUMBER - An identification number . that used to be
assigned (for cataloging purposes) to physical volumes of studies
submitted to the Office of Pesticide Programs; this numbering
system has been replaced by the Master Record Identification (MRID)
system, which identifies each individual study.
ACTIVE INGREDIENT - In any pesticide product, the active ingredient
is the component which kills, or other wise controls, the target
pests and includes any substance (or group of structurally similar
substances if specified by the Agency) that will prevent, destroy,
repel, or mitigate any pest, or that functions as a plant
regulator, desiccant, or defoliant within the meaning of FIFRA
section 2(a). Pesticides are regulated primarily on the basis of
active ingredients. Abbreviated AI.
G-l
-------
ACUTE TOXICITY - The ability of a substance to cause poisonous
effects resulting in harm or death soon after exposure. Acute
toxicity is established through scientifically verifiable data from
animal or human exposure tests. Values are usually expressed as
LDjo or LCs0 and mg/Jcg. Acute toxicity studies include oral, dermal,
and inhalation studies.
ADZ - See Acceptable Daily Intake.
ADDRESS or RECORD - The applicant's or registrant's United States
address for correspondence purposes. It is the address to which
the Agency will send certain notices (i.e., those imposing legal
requirements) concerning the application and any subsequent
registration information. It is the responsibility of the
applicant or registrant to ensure that the Agency has a current and
accurate address.
ADJUVANT - A subsidiary ingredient or additive in a mixture which
contributes to the effectiveness of the primary ingredient.
Adjuvants are added to pesticides use dilutions in tank mixes by
growers or applicators prior to application to the crop to be
treated. Agricultural chemical adjuvants are grouped according to
their intended purpose in the tank mix and include but are not
limited to the following groups: acidifying agents, buffering
agents, anti-foam agents, defoaming agents, anti-transpirants,
color adjuvants, dyes, brighteners, compatibility agents, crop oil
concentrates, oil surfactants, deposition agents, drift reduction
agents, foam markers, gustatory stimulants, feeding stimulants,
herbicide safeners, spreaders, extenders, adhesive agents,
suspension agents, gelling agents, synergists, tank and equipment
cleaners, neutralizers, water absorbants, and water softeners.
Adjuvants intended for pesticidal use in tank mixes are required to
be cleared under the Federal Food, Drug and Cosmetic Act prior to
being used. Adjuvants intended for non-pesticidal uses are to be
cleared with the FDA prior to being used.
ADMINISTRATIVE PORTION OF APPLICATION FOR REGISTRATION - That
portion of the Application Package comprised of the administrative
paperwork, i.e., the Application for Registration/Amendment (EPA
Form 8570-1); the Confidential Statement of Formula (EPA Form 8570-
4) ; the Certification with Respect to citation of Data (EPA Form
8570-29); the Formulator's Exemption statement (EPA Form 8570-27);
the Draft Labeling; the Statement identifying the "substantially
similar" or "identical" product (if a "me-too" amendment); and the
Data Matrix Chart (if the selective method of support is used).
The administrative documents are ny£ to be bound together.
ADMINISTRATOR - The Administrator of the United States
Environmental Protection Agency or his/her delegate.
AQENCY - The United States Environmental Protection Agency (EPA),
unless otherwise specified.
G- 2
-------
Al - see Active ingredient.
ANALYTICAL CHEMISTRY BRANCH - See ACB.
AOAC - Association of Official Analytical Chemists.
APPLICANT - A pesticide chemical company or person who intends to
or has applied to the Agency (Office of Pesticide Programs,
Registration Division) for a registration, amended registration, or
reregistration for registration of a pesticide product, under FIFRA
section 3.
ARB - See Accelerated Reregistration Branch.
ASTHO - Association of State and Territorial Health Officials.
ASSOCIATION OF AMERICAN PESTICIDE CONTROL OFFICIALS * See AAPCO.
ASSOCIATION 07 OFFICIAL ANALYTICAL CHEMISTS - See AOAC.
AUTHORIZED AGENT - A person residing in the United States who is
designated by an applicant or registrant to act as their agent in
matters pertaining to pesticide registration.
BAB - The Biological Analysis Branch (BAB) within the Biological
and Economic Analysis Division (BEAD) of the Office of Pesticide
Programs (OPP). BAB is responsible for the preparation of use-data
software programs for exposure assessments, qualitative use
assessments, and biological analyses of pesticides.
Bilingual labeling.
BEAD - The Biological and Economic Analysis Division (BEAD) is one
of the seven Divisions that constitutes the Office of Pesticide
Programs (OPP). BEAD conducts analyses on pesticide use and
benefits; acquires, validates, and interprets technical data
relative to pesticide use; conducts economic analyses on the
impacts of regulatory options; and validates analytical chemistry
methods. BEAD is comprised of the Planning and Evaluation Staff,
and three branches: Biological Analysis Branch (BAB), Economic
Analysis Branch (EAB), and Analytical Chemistry Branch (ACB).
BIOCHEMICAL PESTICIDES - Biochemical pesticides include, but are
not limited to, products such as semiochemicals (e.g., insect
pheromones), hormones (e.g., insect juvenile growth hormones),
natural plant and insect growth regulators, and enzymes.
BIOLOGICAL ANALYSIS BRANCH - See BAB.
BIOLOGICAL AND ECONOMIC ANALYSIS DIVISION - See BEAD.
G- 3
-------
CB * Th* Communications Branch (CB) within the Field Operations
Division (FOD) of the Office of Pesticide Programs (OPP) develops
and operates programs that disseminate pesticide and OPP
information to the public. CB also manages the OPP public docket
(see docket file).
CB I - See Chemistry Branch I and II.
CB II - See Chemistry Branch I and II.
CBI - Confidential Business Information - material that contains
trade secrets or commercial or fiancial information that been
claimed as confidential by the submitter (usually the registrant).
Procedures for handling CBI material can be found in the OPP and
the OPTS CBI manuals. CBI material should not be sent over FAX
machines unless the sender wants to clearly waive his or her CBI
rights and so states on the CBI material being FAXed.
CERCLA - The Comprehensive, Environmental, Response, compensation,
and Liability Act (CERCLA). Commonly known as "Superfund," this
statute includes provisions for the cleanup of existing hazardous
waste sites and requires that releases of hazardous substances in
quantities greater than established reportable quantities be
reported to the National Response Center. Under CERCLA section
103, the application of a pesticide product registered under FIFRA
is exempt from regulation. CERCLA in implemented by the Office of
Solid Waste and Emergency Response, Office of Emergency and
Remedial Response. Also see the Superfund Amendments and
Reauthorization Act of 1986 (SARA).
CERTIFICATION AND TRAINING BRANCH - The Certification and Training
Branch (CTB) within the Field Operation Division (FOD) of the
Office of Pesticide Programs (OPP) is responsible for directing and
implementing the Agency's regulatory and non-regulatory pesticide
applicator training and certification activities under section 4
and section 23 of FIFRA. CTB also acts as OPP's liaison to state
governments and tribal governments.
CTR - The Code- of Federal Regulations. A codification of the
general and permanent rules published in the Federal Register by
the Executive departments and agencies of the Federal Government.
The Code is divided into 50 titles which represent broad areas
subject to Federal regulation. Each title is divided into chapters
which usually bear the name of the issuing agency. Each chapter is
further subdivided into parts covering specific regulatory areas.
Regulations that pertain to EPA are at 40 CFR. Thus, 40 CFR 152.40
refers to title 40, part 152, section 40; the section on who may
G-4
-------
apply for new registration of a pesticide product. Each volume of
the code is revised at least once each calendar year and issued on
a quarterly basis approximately as follows:
Title 1 through Title 16 as of January 1
Title 17 through Title 27 as .of April 1
Title 28 through Title 41 as of July 1
Title 42 through Title 50 as of October 1
The appropriate revision date is printed on the cover of each
volume.
CHEMICAL CASE - For purposes of review and regulation, individual
active ingredients that are chemically similar (e.g., salts and
esters of the same chemical) are grouped into chemical cases by the
Agency.
CHEMICAL MANUFACTURERS ASSOCIATION - The Chemical Manufacturers
Association (CMA).
CHEMICAL PESTICIDES - Synthetic or natural occurring chemicals that
exhibit pesticidal properties and are formulated into products
intended for preventing, destroying, repelling, or mitigating a
pest, or intended for use as a plant regulator, defoliant, or
desiccant.
CHEMICAL PRODUCERS AND DISTRIBUTORS ASSOCIATION - The Chemical
Producers and Distributors Association (CPDA).
CHEMICAL SPECIALTIES MANUFACTURERS ASSOCIATION - The Chemical
Specialties Manufacturers Association (CSMA) ; was originally named
the National Association of Insecticide and Disinfectant
Manufacturers.
CHEMISTRY BRANCH I AND II - Chemistry Branch I (CB I) — Tolerance
Support and Chemistry Branch II (CB II) — Reregistration Support
are two branches within the Health Effects Division (HED) of the
Office of Pesticide Programs (OPP) that were formerly known as the
Dietary Exposure Branch (DEB). CB I and CB II evaluate analytical
methods and residue, metabolism, and dietary exposure data. These
an&lyses are used to estimate dietary exposure to pesticides and
may lead to recommendations for or against proposed pesticide
residue tolerances in food or feed, and reassessment of tolerances.
CHILD-RESISTANT PACKAGING * (CRP) - Packaging that is designed and
constructed to be significantly difficult for young children to
open. Registrants of pesticide products required to be in child-
resistant packaging are required to certify to the Agency that the
package meets the standards of 40 CFR 157.32.
CHRONIC TOZICITY - .The capacity of a substance to cause long-term
poisonous human health effects.
G-5
-------
CITE-ALL METHODS OF SUPPORT - one of two methods by which an
applicant for registration may comply with the data compensation
requirements of FIFRA section 3(c)(l)(F). Under this method the
applicant, where "exclusive use" data is involved, cites all
pertinent data in the Agency's files only with the written
permission of the exclusive use data submitter; where there is no
exclusive use data involved, the applicant cites all pertinent data
in the Agency's files with permission of the original data
submitter or by offering to pay compensation for use of the data in
accordance with FIFRA sections 3(c)(l)(F) and submits a general
offer to pay statement to the Agency stating his or her offer and
agreeing to pay compensation to other data submitters t the extent
required by FIFRA section 3(c)(1)(F).
CMA - See Chemical Manufacturers Association.
CODE OF FEDERAL REGULATIONS - See CFR.
COLLATERAL LABELING - Collateral labeling must be submitted along
with the application for registration and includes bulletins,
leaflets, circulars, brochures, data sheets, flyers or other
written, printed or graphic matter which is referred to on the
label or which is to accompany the product.
COMMUNICATIONS BRANCH - See CB.
COMPREHENSIVE ENVIRONMENTAL, RESPONSE, COMPENSATION, AND LIABILITY
ACT - See CERCLA.
CONFIDENTIAL BUSINESS INFORMATION - See CBI.
CONFIDENTIAL STATEMENT OF FORMULA - (CSF) . A list showing the
identity of the ingredients contained in a pesticide formulation.
The list is submitted by a registrant or applicant, on the
Confidential Statement of Formula form (EPA Form 8570-4), at the
time of application for registration or change in formulation.
CORT STUDIES - The set of toxicology studies of chronic feeding,
oncogenicity (which is now referred to as carcinogenicity),
reproduction, and teratology. These studies are required for all
food/feed use pesticides and one or more may also be required for
nonfood/feed use pesticides.
CPDA - See Chemical Producers and Distributors Association.
CRP - See Child-Resistant Packaging.
CSF - See Confidential Statement of Formula.
C8MA - See Chemical Specialties Manufacturers Association.
CTB - See Certification and Training Branch.
G-6
-------
DAA - Deputy Assistant Administrator.
DATA CALL-XM NOTICE - (DCI). As provided by FIPRA section
3(c)(2)(B), data call in is a notice/letter that is issued by the
Reregistration Division and/or Registration Division to pesticide
registrants requiring then to submit specific data or scientific
studies to support the registration of a pesticide. Failure to
submit this data can result in suspension of the registered
products.
DATA GAP - The absence of any valid study or studies in the
Agency's files which would satisfy a specific data requirement for
a particular pesticide product.
DATA MATRIX CHART - A matrix chart showing all of the data required
to support the application for registration. The applicant
indicates on the matrix how he/she is satisfying the data
requirements, i.e., by submitting the actual data or by referencing
EPA's Master Record Identification (MRID) number. The Data Matrix
Chart is required to be submitted only if the applicant elects to
use the Selective Method of Support for his/her application.
DATA PORTION OF APPLICATION FOR REGISTRATION - The portion of the
Application Package comprised of the actual data required to
support your application for registration, i.e., product specific
chemistry data, acute toxicity data, efficacy data, generic data
(if the application is for a new use or a new active ingredient).
Applicants are required to submit three copies of the data,
properly bound and formatted in accordance with PR Notice 86*5.
DATA REVIEW RECORD - A form attached to material (e.g., data
submitted by a registrant) transferred from one Office of Pesticide
Programs (OPP) Division to another for review. The material is
assigned a record number and a bar code which are used to track the
material in the Pesticide Registration Action Tracking System
(PRATS) (formerly the On-Line Tracking System (OLTS)).
DATA SUBMITTER'S LIST - The current Agency list, entitled
Pesticide Data Submitters by Chemical," of persons who have
submitted data to the Agency.
DCI - See Data Call-In Notice.
DEB - See Chemistry Branch I and II.
DESIGNATED U.S. AGENT - See Authorized Agent.
G-7
-------
DEVICE - Any instrument or contrivance (other than a firearm)
intended for trapping, destroying, repelling, or mitigating any
pest or any other form of plant or animal life (other than man and
other than a bacterium, virus, or other microorganism on or in
living man or living animals) but not including equipment used for
the application of pesticides (such as tamper-resistant bait boxes
for rodenticides) when sold separately.
DIETARY EXPOSURE BRANCH - (DEB) - See Chemistry Branch I and IX.
DIETARY RISK EVALUATION SYSTEM - The Dietary Risk Evaluation System
(ORES) is a computerized tool for analyzing human dietary exposures
to individual pesticides and comparing the exposures to known
toxicity levels. The DRES is the responsibility of the Science
Analysis and Coordination Branch (SACB) within the Health Effects
Division (HED) of the Office of Pesticide Programs (OPP). DRES was
formerly known as the Tolerance Assessment System (TAS).
DOCKET FILE - A file maintained in the public docket (Room 1128,
Crystal Mall Building 2 (CM2), for the Office of Pesticide Programs
(OPP)) for materials that pertain to Special Review and
Reregistration of pesticides. Instructions for docketing can be
found in 40 CFR 155. Materials in the docket are available for
public inspection unless they are marked as confidential business
information. It is the responsibility of the OPP product managers
and review managers to submit materials to the docket.
DOMESTIC APPLICATION - Pesticide application in and around houses,
office buildings, motels and other living or working areas; now
termed residential use. See residential use.
DRES - See Dietary Risk Evaluation System.
EAB - The Economic Analysis Branch (EAB) within the Biological and
Economic Analysis Division (BEAD) provides economic analyses for
EPA's pesticide regulatory program, including analyses of economic
impacts of pesticide regulatory policies and of individual program
actions under the various sections of FIFRA.
EC - An Emulsifiable Concentrate (EC) is a type of pesticide
formulation that contains the active ingredient, one or more
petroleum solvents, and an emulsifier that allows the formulation
to be mixed with water. The strength of this concentrate usually
is stated in pounds of active ingredient per gallon of concentrate.
ECOLOGICAL EFFECTS BRANCH - The Ecological Effects Branch (EEB)
within the Environmental Fate and Effects Division (EFED) of the
Office of Pesticide Programs (OPP) is responsible for assessing
pesticide effects on non-target species including fish, birds,
small mammals, beneficial insects, and plants.
ECONOMIC ANALYSIS BRANCH - See EAB.
G-8
-------
EOF - The Environmental Defense Fund (EOF).
ESB - See Ecological Effects Branch.
SEC - Estimated Environmental Concentration. An estimate of the
concentration of a pesticide occurring in or on various media
(i.e., soil, water, air) aftr pesticide application, as determined
from the results of environmental fate or environmental expression
testing.
BFED - The Environmental Fate and Effects Division (EFED) is one of
seven Divisions that constitutes the Office of Pesticide Programs
(OPP) and is responsible for assessment of pesticide effects on
non-target animal and plant species in the natural environment and
groundwater. EFED is made up of the Science Analysis and
Coordination Staff (SACS), the Ecological Effects Branch (EEB), and
the Environmental Fate and Groundwater Branch (EFGWB). This
Division was created by the OPP reorganization of July 1988 when
the Hazard Evaluation Division was split into the Environmental
Fate and Effects Division (EFED) and the Health
Effects Division (HED).
EFFICACY DATA - Data showing that the pesticide is effective in
controlling the pests for which control claims are made on the
product label.
EFGWB - The Environmental Fate and Groundwater Branch (EFGWB)
within the Environmental Fate and Effects Division (EFED) of the
Office of Pesticide Programs reviews and evaluates data on :
pesticide fate and transport; aspects of pesticide leachability;
and ground water effects. EFGWB also manages and coordinates human
and environmental monitoring activities in support of the pesticide
regulatory program.
ELI - The Environmental Law Institute (ELI) conducts research on
current developments in environmental law; publishes the
"Environmental Reporter.1*
EMERGENCY EXEMPTION - A provision in FIFRA (Section 18) which
permits the Administrator to exempt any Federal or State agency
form any of the requirements of FIFRA if emergency conditions
exist. The term "emergency conditions" is defined at 40 CFR
166.3(d). Pursuant to the provisions of FIFRA section 18, EPA has
promulgated regulations at 40 CFR Part 166 under which EPA can
grant an emergency exemption to a state or another federal agency
that allows, subject to certain restrictions, the use for a limited
period (usually one year) of a pesticide product that is not
registered for that particular use.
EMERGENCY SUSPENSION - Suspension of registration under FIFRA
section 6(c) due to an imminent hazard. See Suspension of
Registration also.
G-9
-------
EMULSIFIABLE CONCENTRATE - See EC.
EMUL8IPIER - A chemical that aids in suspending one liquid in
another, usually an organic chemical in an aqueous solution.
END-USE PRODUCT - EP - A pesticide product whose labeling bearing
instructions for using or applying the product (as packaged and
sold, or after dilution by the applicator) for controlling pests or
regulating plant growth. The term excludes products with labeling
wich allows663Xusef the product to formulate other pesticide
products.
ENVIRONMENTAL DEFENSE FUND - See EOF.
ENVIRONMENTAL EXPRESSION - The extent and manner in which a
microorganism establishes and maintains its presence in an
ecological habitat.
ENVIRONMENTAL PATS DATA - Scientific data that characterize a
pesticide's fate in the ecosystem, considering its degradation
inducers (light, water, microbes), pathways, and resultant
degradation products.
ENVIRONMENTAL PATE AND EFFECTS DIVISION - See EFED.
ENVIRONMENTAL PATE AND GROUNDWATER BRANCH - See EFGWB.
ENVIRONMENTAL LAW INSTITUTE - See ELI.
EP - See End-Use Product.
EPA - The Environmental Protection Agency.
EPA COMPENDIUM OP ACCEPTABLE USES - A list of federally registered
pesticides with their uses and approved maximum acceptable
application rates and other use restrictions; this outdated system
was replaced by the use index. The use index has subsequently been
replaced by LUIS. See LUIS.
EPA ENDANGERED SPECIES BULLETIN - A bulletin that contains lists of
endangered species (including birds, fish, mammals, and plants)
which may be exposed to a pesticide or pesticides in a given
county. The bulletin also contains pesticide use information
necessary to protect the species from exposure to pesticides.
G-10
-------
ESTABLISHMENT REGISTRATION - The assignment of a registration
number to a site where a pesticide or device is produced. The
number is a two part hyphenated number referred to as an EPA
Establishment Number. The first part of the number is series of
numerals that identifies the company and the second part is a two
letter code identifying the state or country in which the
establishment is located. The establishment number is required to
be on the product label.
ESTIMATED ENVIRONMENTAL CONCENTRATION - See EEC.
CUP - See Experimental Use Permits.
EXCLUSIVE USB DATA - Beginning September 30, 1978, Exclusive Use
Data pertains to those data that were submitted to the Agency in
support of the registration of a new active ingredient, a new
combination of active ingredients, or an application to amend the
original registration to add a new use, for a period of 10 years
after the initial registration has been issued. In order for the
Agency to consider such data in support of an applicant's
application for registration or amendment, the applicant must
obtain for each data submitter listed on the Data Submitters List,
as an exclusive use data submitter, written authorization
identifying the applicant as the applicant to whom authorization
has been granted to allow the Agency to use all applicable data to
satisfy the data requirements for the application in question.
EXPERIMENTAL USE PERMITS - EUP * A permit authorized under FIFRA,
section 5, which is granted to applicants allowing them to conduct
testing of a new proposed pesticide product and/or use outside of
the laboratory and generally on 10 acres or more of land or water
surface. EUPs are most commonly used for larger scale testing of
efficacy and gathering of crop residue chemistry data. EUPs are
processed by Product Manager (PM) Teams in the Office of Pesticide
Programs1 Registration Division Product Branches.
FACTA - Food, Agriculture, Conservation, and Trade Act of 1990.
FDA - The Food and Drug Administration. This agency is
responsible for carrying out the provisions of the Federal Food,
Drug, and Cosmetic Act (FFDCA), which includes pesticide tolerance
enforcement. See FFDCA.
FEDERAL FOOD, DRUG, AMD COSMETIC ACT - FFDCA - The Federal Food,
Drug and Cosmetic Act. The law which regulates, among other
things, the use of drugs (human and veterinary), chemicals in
cosmetics, and human and animal foods; this includes the legal
requirement of tolerances for pesticide residues (Sections 408 and
409) in or on food and feed items. These tolerances are
established by EPA.
G-ll
-------
FEDERAL INSECTICIDE, FUNGICIDE MID RODBNTICIDE ACT - The Federal
Insecticide, Fungicide And Rodenticide Act. The law which sets
forth the regulation of the sale, distribution and use of
pesticides in the United States.
FEDERAL RECORD CENTER - The Federal Records Center provides
economical storage of and access to noncurrent records. The agency
stores noncurrent, inactive, and permanent records at the Center.
FEDERAL REGISTER - (FR) A daily government publication where all
federal regulatory actions, including proposed rules, final rules,
and notices are published.
FEEDING STIMULANT - When Included in a pesticide formulation,
feeding stimulants are treated as inert ingredients and are
required to go through the same Agency clearance under FIFR2100Xand
the FFDCA that inert ingredients are subject to. When feeding
stimulants are added to a pesticide in a tank mix at a use site
they do not require registration but are subject to the FFDCA.
7FDCA - See Federal Food, Drug, and Cosmetic Act.
FHB - The Fungicide-Herbicide Branch (FHB) within the Registration
Division (RD) of the Office of Pesticide Programs (OPP) carries out
regulatory responsibilities on herbicide and fungicide products.
FHB is responsible for processing applications for registration,
experimental-use permits, and petitions for tolerances for these
classes of pesticides.
FIELD OPERATIONS DIVISION - The Field Operations Division (FOD) is
one of seven Divisions that constitutes the Office of Pesticide
Programs (OPP). It oversees implementation of OPP regulatory
actions, directs pesticide applicator training and certification,
and manages the public docket. Within FOD there are five branches:
the Regional Operations Branch (ROB); the Public Response and
Program Resources Branch (PRPRB); the Communications Branch (CB);
the Occupational Safety Branch (OSB); and the -Certification and
Training Branch (CTB).
FIFRA - See Federal Insecticide, Fungicide and Rodenticide Act.
FIFRA SCIENTIFIC ADVISORY PANEL - The FIFRA Scientific Advisory
Panel (SAP) is an independent group of scientists, authorized under
FIFRA, to comment on notices of intent issued under FIFRA section
6 and final form regulations issued under FIFRA section 25 (a). The
SAP also comments, evaluates, and makes recommendations regarding
the scientific analyses made by the Agency.
FIFRA SECTION is - See Emergency Exemption.
6-12
-------
FIFRA SECTION 24(C) * (Special Local Need (SLN)) - Authorizes a
state lead agency to register additional uses of federally
registered pesticides. Special Local Needs (SLNs) may only be used
in the registering state, but otherwise have full federal
registration status. All SLNs must be submitted to EPA for review
subsequent to registration by a state.
FINAL PRINTED LABELING - The label or labeling which will accompany
the pesticide product when distributed or sold.
FLOWABLE * A formulation in which the active ingredients are finely
ground insoluble solids mixed with a liquid as a suspension.
Flowables are mixed with water for application.
7OD - See Field Operations Division.
FOIA - The Freedom of Information Act (FOIA); legislation that
generally makes available to the public, documents possessed by the
federal government.
FR - See Federal Register.
FREEDOM OF INFORMATION ACT - See FOIA.
FUNGICIDE-HERBICIDE BRANCH - See FHB.
GENETIC ENGINEERING - Directed transfer of permanent genetic
information between species. This may include organisms that the
Agency considers to be microbial pest control agents. Some higher
plants have been "genetically engineered1* to produce a pesticide or
other compound not produced by the native plant.
GENERIC DATA - Generic Data pertain to the properties or effects
of a particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
Generic Data may also be data on a "typical formulation11 of a
product. "Typical formulation" testing is often required for
ecological effects studies and applies to all products having that
formulation type. Any registrant who does not qualify for the
formulator's exemption (FIFRA section 3(c) (2) (D) and 40 CFR 152.85)
is required to submit generic data to support the his/her product
registration.
GLP - Good Laboratory Practices (GLP) are standards established in
40 CFR 160 to assure the quality and integrity of data submitted by
registrants. Provisions of the GLP standards include record
keeping, personnel, and laboratory equipment requirements.
GOOD LABORATORY PRACTICE - See GLP.
GPO - U.S. Government Printing Office, 16-2
G-13
-------
HEALTH imcrs Division - The Health Effects Division (BED) is one
of the seven Divisions that constitutes the Office of Pesticide
Programs (OPP). It is responsible for assessment of pesticide
effects on human health. This Division was created by the OPP
reorganization of July 1988 when the Hazard Evaluation Division was
split into the Environmental Fate and Effects Division (EFED) and
the Health Effects Division (HED). RED is made up of six branches:
the Science Analysis And Coordination Branch (SACB); the Toxicology
— Insecticide and Rodenticide Support Branch; Toxicology —
Herbicide, Fungicide, and Antimicrobial Support Branch; Chemistry
Branch I — Tolerance Support; Chemistry Branch II
Reregistration Support; and the Occupational and Residential
Exposure Branch (ORES).
HED - See Health Effects Division.
ICR - An Information Collection Request (ICR) is prepared pursuant
to the requirements of the Paperwork Reduction Act (PRA) for rules,
proposed rules, surveys, or other documents that contain
information gathering requirements. The ICR is a description of
what information is needed, why the information is needed, how it
will be collected, and how much the information collection will
cost. An ICR is submitted to OMB for approval.
IDS - Incident Data System. A computerized system, currently under
development in the Information Services Branch of the Office of
Pesticide Programs1 Program Management Support Division, for
receiving incident reports.
INCIDENT DATA SYSTEM - See IDS.
IMMINENT HAZARD - A situation that exists when the continued use of
a pesticide during the time required for a cancellation proceeding
would be likely to result in unreasonable adverse effects on humans
or the environment or will involve unreasonable hazard to the
survival of an endangered species.
INDEMNIFICATION - A provision of FIFRA section 15 that requires EPA
to pay certain persons for the cost of stock on hand at the time a
pesticide registration is suspended.
INERT INGREDIENT - Pesticide components such as solvents, carriers,
and surfactants that are not active against target pests and
includes any substance (or group of structurally similar substances
if designated by the Agency), other than an active ingredient,
which is intentionally included in a pesticide product.
Inert ingredients in pesticide product formulations are regulated
under both the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended and the Federal Food, Drug, and Cosmetic Act
(FFDCA).
G-14
-------
INFORMATION COLLECTION REQUEST - See ICR.
INFORMATION SERVICES BRANCH - Th« Information Services Branch (ISB)
within the Program Management and support Division (PMSD) of the
Office of Pesticide Programs (OPP) provides inomation management
support to the OPP regulatory program. These services include
assessing information needs, directing the OPP security program,
and maintaining liaison with information contacts and organizations
outside OPP.
INSECTICIDE-RODENTICIDE BRANCH - The Insecticide-Rodenticide Branch
(ZRB) within the Registration Division (RD) of the Office of
Pesticide Programs is responsible for processing applications for
registration, experimental-use permits, and petitions for
tolerances for pesticides in these use classes.
INSTITUTIONAL USE - Any application of a pesticide in or around any
property or facility that functions to provide a service to the
general public or to public or private organizations, including but
not limited to hospitals and nursing homes; schools other than
preschools and day care facilities; museums and libraries; sports
facilities; and office buildings.
INTEGRATED PEST MANAGEMENT - Integrated Pest Management (IPM) is
the concept and practice of using a variety of methods (cultural,
pesticidal, biological, etc.) to control pests.
INTERMEDIATES: Pesticide intermediates are substances which are
not themselves pesticides, but which undergo chemical reactions
resulting in the formation of a pesticide. Pesticide intermediates
are subject to regulation under TSCA. Pesticide intermediates
include any beginning or intermediate material which is a chemical
precursor to a pesticide active ingredient, whether produced in
situ or obtained from other sources.
INTERREGIONAL RESEARCH PROJECT NO. 4 - The Interregional Research
Project Number 4 (IR-4) is a program sponsored by the U.S.
Department of Agriculture (USDA). IR-4 provides national
leadership and coordination for information on the clearance of
minor use pesticides and generates data to support minor-use
registrations.
INTRASTATE PRODUCT - A pesticide product that was registered by a
state for sale and use only in that state. new intrastate
registrations are no longer permitted, and existing products must
be converted to full federal registration or canceled. Because
these products are not federally (EPA) registered, they may only
distributed or sold in the state of registration. Intrastate
products were identified by a product number greater than 3000
(e.g., 1573-48801.
IPM - See Integrated Pest Management.
G-15
-------
IR-4 - Sea Interregional Research Prct No. 4.
ZRB - See Insecticide-Rodenticide Branch.
IBB - See Information Services Branch.
LABEL USB INFORMATION SYSTEM - See LUIS.
LUIB - The Label Use Information System (LUIS) is a computer data
base of label directions for .pesticide usage. Information
contained in LUIS includes: use sites, application type, timing,
equipment, dosage, application frequency, reentry and preharvest
restrictions, geographic limitations, and selected limitations to
use. Data are extracted by product but may be aggregated by active
ingredient. The system currently focuses on information needed to
support reregistration. Additional information (e.g., pests, more
use limitations) will be added to the system to support special
reviews and other reregistration activities.
MAINTENANCE FEE - An annual fee required of registrants for each
pesticide product retained for registration.
MANUFACTURING-USE PRODUCT - A Manufacturing-Use Product (MP or HUP)
is any product intended (labelled) for formulation or repackaging
into other pesticide products.
MARGIN Or SAFETY/MARGIN OF EXPOSURE - The Margin of Safety/Margin
of Exposure (MOS/MOE) is a numerical value that characterizes the
amount of safety to a toxic chemical — a ratio of exposure to a
toxicological endpoint, usually the NOEL.
MASTER RECORD IDENTIFICATION NUMBER - See MRID Number.
"ME-TOO" PRODUCT - An application for registration of a pesticide
product that is substantially similar or identical in its uses and
formulation to products that are currently registered. See Chapter
6, D., Question 1 of this manual for a more detailed discussion of
a "mertoo" product.
MICROBIAL PESTICIDES - Microbial pesticides are microorganisms and
include but are not limited to bacteria, algae, fungi, viruses, and
protozoa used as pest control agents (40 CFR 152.20).
MI8CIBLB - Capable of being mixed. Often used to describe certain
pesticide formulations.
MOS/MOE - See Margin of Safety/Margin of Exposure.
MP- See Manufacturing-Use Product.
6-16
-------
IQtXD NOMBlft - The Master Record Identification (MRID) Number is a
unique cataloging number assigned to an individual study at the
time of submission to the Agency. It is EPA's system of tracking
studies used in support of pesticide product registration.
NUP - See Manufacturing-Use Product.
MACA - The National Agricultural Chemicals Association (NACA).
KARA - The National Agrichemical Retailers Association.
HAS - The National Academy of Sciences (NAS).
NA8DA - The National Association of State Departments of
Agriculture.
NATIONAL ACADEMY OF SCIENCES - See NAS.
NATIONAL AORICULTURAL CHEMICALS ASSOCIATION - See NACA.
NATIONAL COALITION AGAINST THE MISUSE OF PESTICIDES - The National
Coalition Against the Misuse of Pesticides (NCAMP).
NATIONAL INSTITUTE FOR ENVIRONMENTAL HEALTH SCIENCES - As part of
the National Institute of Health, the National Institute for
Environmental Health Sciences (NIEHS) performs basic research,
including genetic and cancer studies, that relates to environmental
health sciences.
NATIONAL PEST CONTROL ASSOCIATION - The National Pest Control
Association (NPCA).
NATIONAL PESTICIDE INFORMATION RETRIEVAL SYSTEM - The National
Pesticide Information Retrieval System (NPIRS), located at Purdue
University, is the commercially-available version of the Pesticide
Product Information System (PPIS). In addition to PPIS
information, NPIRS also includes Pesticide Document management
System data (e.g., MRID number, study title, title page from
submitted study). Also see Pesticide Product Information System.
NATIONAL PESTICIDE TELECOMMUNICATIONS NETWORK - The National
Pesticide Telecommunications Network (NPTN), located at Texas Tech
University, is a network from which the public can get answers to
their pesticide-related questions by calling a toll-free phone
number (1-800-858-7378) that is funded by EPA.
NATIONAL TECHNICAL INFORMATION SERVICE - (NTIS). An organization
that sells certain government publications including EPA documents
such as testing guidelines. Orders can be placed at NTIS,
Attention: Order Desk, 5285 Port Royal Road, Springfield, VA 22161.
Telephone: (703) 487-4650.
G-17
-------
NATURAL RESOURCES DEFENSE COUNCIL - The Natural Resources Defense
Council (NRDC).
NCAMP - See National Coalition Against the Misuse of Pesticides.
NEW CHEMICAL - An application for registration of a product
containing a new pesticide (active ingredient) that is not an
active ingredient in a product currently registered with the Agency
(40 CFR 152.114).
NEW USE - An application for registration of a use for an active
ingredient(s), or formulation type, not currently included in the
directions for use of any product that contains such active
ingredient(s) or formulation type. When used with respect to a
product containing a particular active ingredient "New Use" means
(1) any proposed use pattern that would require the establishment
of, increase in, or exemption from the requirement of a tolerance
or food additive regulation under section 408 or 409 of the FFDCA;
(2) any aquatic, terrestrial, outdoor, or forestry use pattern, if
no product containing the active ingredient is currently registered
for that use pattern; or (3) any additional use pattern that would
result in a significant increase in the level of exposure, or a
change in the route of exposure, to the active ingredient of man or
other organisms. (See 40 CFR 152.3(p)).
NZEBS - see National Institute for Environmental Health Sciences.
NOAEL - No observable Adverse Effect Level.
NOEC - No Observed Effects Concentration.
NOEL - No Observed Effects Level.
NOIC - The Notice of Intent to Cancel (NOIC).
NOZ8 - The Notice of Intent to Suspend (NOIS).
NOMINAL CONCENTRATION - The amount of an ingredient which is
expected to be present in a typical sample of a pesticide product
at the time the product is produced, expressed as a percentage by
weight.
NO OBSERVED ADVERSE EFFECT LEVEL - See NOAEL.
NO OBSERVED EFFECT CONCENTRATION - See NOEC.
NO OBSERVED EFFECT LEVEL - See NOEL.
NOTICE OF INTENT TO CANCEL - See NOIC.
NOTICE OF INTENT TO SUSPEND - See NOIS.
G-18
-------
NPCA - S*a National Pest Control Association.
NPIRS - See National Pesticide Information Retrieval System.
NPTN - See National Pesticide Telecommunications Network.
NRDC * See Natural Resources Defense Council.
NTIS - See National Technical Information Service.
OCCUPATIONAL AND RESIDENTIAL EXPOSURE BRANCH - The Occupational and
Residential Exposure Branch (OREB), within the Health Effects
Division (HED) of the Office of Pesticide Programs (OPP) is
responsible for review and evaluation of data in the exposure of
people to pesticides.
OCCUPATIONAL SAFETY BRANCH - The Occupational Safety Branch (OSB)
within the Field Operations Division (FOD) of the Office of
Pesticide Programs (OPP) develops and recommends Agency policy and
implements a strategy for pesticide occupational safety programs.
Through cooperative agreements, grants, or contracts, OSB manages
external efforts that contribute to a better understanding of the
phenomena of worker exposure to pesticides, the health problems
created, and identification and demonstration of practicable and
effective means to reduce exposure.
OCM - The Office of Compliance Monitoring.
OD - Office Director.
ODW - Office of Drinking Water (ODW) is the former name of the
Office of Drinking Water and Ground Water. The Office of Drinking
Water and Ground Water promulgates drinking water standards (MCLs)
and/or issues Health Advisories for pesticides known or suspected
to contaminate groundwater.
OECD GUIDELINES - Guidelines prepared by the Organization of
Economic and Cooperative Development of the United Nations; these
guidelines assist in the preparation of protocols for
toxicological, environmental fate, etc. studies.
OES - The Office of Endangered Species (OES) is part of the Fish
and wildlife Service of the Department of Interior.
OFFICE OF DRINKING WATER - See ODW.
OFFICE OF DRINKING WATER AND GROUND WATER - See ODW.
OFFICE OF ENDANGERED SPECIES - See OES.
G-19
-------
OFFICE OF PEBTICIDB PROGRAMS - The Office of Pesticide Programs
(OPP) and the Office of pollution Prevention and Toxics comprise
the two offices within the Office of Prevention, Pesticides, and
Toxic Substances. OPP is comprised of seven Divisions: the
Biological and Economic Analysis Division (BEAD); the
Environmental Fate and Effects Division (EFED); the Field
Operations Division (FOD); the Health Effects Division (HED); the
Program Management and support Division (PMSD); the Registration
Division (RD);and the Special Review and Reregistration Division
(SRRD).
OLTS - The On-Line Tracking System (OLTS) is a computerized
tracking system used to track data review records. OLTS was
replaced by the Pesticide Registration Activity Tracking System
(PRATS). See PRATS also.
OMB - The Office of Management and Budget.
OK-LIKE TRACKING SYSTEM - See OLTS and PRATS.
OPM - The Office of Personnel Management.
OFF - see Office of Pesticide Programs.
OREB - See Occupational and Residential Exposure Branch.
ORGANIZATION OF ECONOMIC AND COOPERATIVE DEVELOPMENT - An
organization of the United Nations that prepares guidelines that
assist in the preparation of protocols for toxicological,
environmental fate, etc. studies. Also see OECD Guidelines.
O8B - See Occupational Safety Branch.
FAQ - Pesticide Assessment Guidelines (PAG) are protocols
referenced in 40 CFR 158 that provide registrants with guidance on
how to conduct required studies. Copies of the Guidelines can be
obtained from the National Technical Information Service.
FAI - A Pure Active Ingredient (PAI) is a test substance required
for certain pesticide studies. PAIs do not have inert ingredients
added.
FBA - A Preliminary Benefit Analysis (PBA) is a summary of a
pesticide's uses and benefits; developed by the Biological and
Economic Analysis Division (BEAD) of the Office of Pesticide
Programs (OPP) for the preliminary determination (PD 2/3) stage of
a Special Review.
G-20
-------
PCO - Past Control Operator. A term not employed by FIFRA which is
often used to describe a person or company that applies pesticides
as a business (e.g., exterminator); often used to describe such a
service for household applications as compared to agricultural
applications.
PDMS - The Pesticide Document Management System (POMS) is a
collection of documents of regulatory significance to pesticides,
including submitted studies, maintained by the Agency. The
documents are microfiched and indexed by an on-line retrieval
system that anyone in the Office of Pesticide Programs (OPP) can
use.
PES - The Planing and Evaluation Staff (PES) within the Biological
and Economic Analysis Division (BEAD) of the Office of Pesticide
Programs (OPP) is primarily responsible for formulating BEAD budgets
and program plans, administrative management, science integration
and program evaluation, and coordination of preparation for
hearings.
PZ8T - any insect, rodent, nematode, fungus, weed, or any other
form of terrestrial or aquatic plant or animal life or virus,
bacteria, or other micro-organism (except viruses, bacteria, or
other micro-organisms on or in living man or other living animals)
that is injurious to health or the environment. (See FIFRA section
2(t) and 25(c)(1).
PEST CONTROL OPERATOR - see PCO.
PESTICIDE - Any substance or mixture of substances intended for
preventing, destroying, repelling, or mitigating any pest, and any
substance or mixture of substances intended for use as a plant
regulator, defoliant, or desiccant.
PS8TZCZDE ASSESSMENT GUIDELINES - see PAG.
PESTICIDE DOCUMENT MANAGEMENT SYSTEM - See PDMS.
PE8TZCZDE INCIDENT MONITORING SYSTEM - The Pesticide Incident
Monitoring System (PIMS) is a collection of human and environmental
poisoning events related to specific pesticides that were reported
to the Office of Pesticide Programs (OPP). PIMS was discontinued
in 1981 due to budgetary constraints and the unverifiable nature of
its data; it was based on volunteered information.
PESTICIDE INTERMEDIATESi See Intermediates.
G-21
-------
PBflTICIDB PRODUCT INFORMATION SYSTEM - The Pesticide Product
Information System (PPZS) is a data base that provides information
on more than 60,000 currently and formerly federally registered
pesticide products and other non-pesticide chemicals. For each
federally registered product, PPZS can provide the product name,
registrant name and address, EPA registration number, type of
formulation, signal word, types of pesticide activity, active
ingredient names and percentages, application sites, and pests
controlled. PPIS also contains information on whether the product
has been classified for restricted or general use.
PESTICIDE REGISTRATION ACTIVITY TRACKING SYSTEM - See PRATS.
PESTICIDE REGULATION NOTICE - See PR Notice.
PHI - The Pre-harvest Interval (PHI) is the time between the last
pesticide application and harvest of the treated crop.
VIMS - See Pesticide Incident Monitoring System.
PLANNING AND EVALUATION STAFF - See PES.
PM - Product Manager. See Product Manager Team.
PMSD - The Program Management and Support Division (PMSD) is one of
the seven Divisions that constitutes the Office of Pesticide
Programs (OPP). PMSD provides administrative support to all OPP
Divisions; prepares program plans and budget proposals; manages the
indemnification process; and provides overall leadership for OPP
management program. PMSD is comprised of four branches: the
Administrative Branch (AB); the Resources Management and Evaluation
Branch (RMEB); the Information Services Branch (ISB); and Systems
Branch (SB).
POLICY AND SPECIAL PROJECTS STAFF - The Policy and Special Projects
Staff (PSPS) within the Office of Pesticide Programs (OPP) serves
as the Office Director's primary means for analyzing and responding
to external critiques of program activities and policies.
PPIS - see Pesticide Product Information system.
PRATS - The Pesticide Registration Activity Tracking System (PRATS)
is an on-line tracking system to monitor the science reviews of
data submissions. PRATS is also used to request actions (e.g.,
risk assessments, DRES runs, etc.) from the science divisions.
PRATS replaced the On-Line Tracking System (OLTS).
PRE-HARVEST INTERVAL - See PHI.
PRELIMINARY BENEFIT ANALYSIS - See PBA.
6-22
-------
Pa NOTICE - A Pesticide Regulation (PR) Notice is a written notice
generally issued by the Registration Division to pesticide
registrants that communicates important changes in regulatory
policy or procedures. Each PR Notice is assigned a two part number
beginning with the year issued and the cardinal number issued
within that year (e.g., 87-1, 87-2, 92-1, etc.)- The name of the
notice derives from the Pesticide Regulation Division, a precursor
organization to the Registration Division of the Office of
Pesticide Programs.
PRODUCT MANAGER TEAM - PM Team - An organizational unit in each
of the three Registration Division Product Branches which is
primarily responsible for processing applications for new and
amended product registration, petitions for tolerances,
experimental use permits, special local need applications, and
reregistration of currently registered pesticides. There are
currently 11 PM Teams, each headed by a product manager and staffed
by 4 - 7 reviewers. Each PM Team has a number (e.g., PM 10; PM 21;
PM 31). There are currently five teams in the Insecticide-
Rodenticide Branch, four teams in the Fungicide-Herbicide Branch,
and two teams in the Antimicrobial Branch.
PROGRAM MANAGEMENT AND SUPPORT DIVISION - see PMSD.
PROTOCOL - A study plan or method.
P8P8 - See Policy and Special Projects Staff.
PURE ACTIVE INGREDIENT - See PAI»
RAC - See Raw Agricultural Commodity.
RAP - See Risk Assessment Forum.
RAW AGRICULTURAL COMMODITY - Raw Agricultural Commodities (RAC)
include, among other things, fresh fruits, whether or not they have
been washed and colored or otherwise treated in their unpeeled
natural form; vegetables in their raw or natural state, whether or
not hey have ben stripped of their outer leaves, waxed, prepared
into fresh green salads, etc.; grains, nuts, eggs, raw milk, meats,
and similar agricultural produce. It does not include foods that
have ben processed, fabricated, or manufactured by cooking,
freezing, dehydrating, or milling.
G-23
-------
IB * The Reregistration Branch (RB) within the Special Review and
Reregistration Division (SRRD) of the Office of Pesticide Programs
(OPP) manages the reregistration process that provides for the
review of all List A pesticides. Management of the process
includes planning, scheduling, and coordinating Health Effects
Division (HID), Environmental Fate and Effects Division (EFED),
Program Management and Support Division (PMSD), arid Biological and
Economic Analysis Division (BEAD) inputs, conducting the
administrative review, and preparing and issuing documents. These
documents include Reregistration Eligibility Documents (REDs) and
Tolerance Reassessments.
RCRA - The Resource conservation and Recovery Act (RCRA) is a law
under which EPA regulates the transportation, storage, and disposal
of hazardous waste, it is implemented by the Office of Solid Waste
and Emergency Response's Office of Solid Waste.
RD - Registration Division of the Office of Pesticide Programs.
The Registration Division is primarily responsible for implementing
the provisions of FIFRA relating to the registration of pesticide
products.
REBDTTABLB PRESUMPTION AGAINST REGISTRATION - Rebuttable
Presumption Against Registration (RPAR) is the former name for
Special Review.
RED - Reregistration Eligibility Document (RED) - A document
issued at the completion of the Agency's reregistration review of
a registered pesticide active ingredient. The RED sets forth the
Agency's decision on whether products containing a pesticide are
eligible for reregistration. The RED also assesses the
acceptability of existing tolerances, and describes the need for
additional data or other information. It is accompanied by a data
call-in if additional data are required.
REENTRY INTERVAL - The Reentry Interval (REI) is t!950Xrequire
has been treated with a pesticide; required in order to reduce or
avoid real or perceived toxicity risks to field workers.
REFERENCE DOSE - The Reference Dose (RfD) is an estimate of the
acceptable daily exposure of humans to a pesticide. RfDs are
derived for the noncarcinogenic effects of substances which may
also be carcinogenic. Formerly called the acceptable daily intake
(ADI).
REGISTRANT - The term given to a person or entity that has
registered a pesticide product under FIFRA.
REGISTRATION DIVISION - See RD.
6-24
-------
REGISTRATION MUMBBR - The EPA registration number is a hyphenated,
two part number assigned by the Registration Division to identify
each product registration (e.g., 1253-79); the first number is the
assigned company number and the second number is the specific
product number. The registration number is required by FIPRA to
appear on the product's label.
REGISTRATION PROCESS - The process and final Agency action
authorizing the legal sale, distribution, and use of a pesticide
product. The process includes OPP's consideration of scientific,
legal, and regulatory requirements of the product and results in
the Agency issuing either a Notice of Registration or a denial to
the applicant.
REGISTRATION STANDARD - Registration Standard (RS) is a document
issued in connection with the Agency's reregistration program prior
to the enactment of FIFRA '88 that characterizes a pesticide's
available scientific data base and the Agency's position on the
registered uses of that pesticide. Registration Standards were
accompanied by data call-ins requiring submission of additional
data. All chemical cases that had Registration Standards issued
prior to the enactment of FIFRA '88 are on reregistration List A.
REGISTRATION SUPPORT BRANCH - The Registration Support Branch (RSB)
within the Registration Division (RD) of the Office of Pesticide
Programs (OPP) is responsible for: the emergency exemption program
under section 18 of FIFRA; review of state issued section 24(c)
special local needs registrations; the clearance requests for
exemption from a tolerance for inert ingredients; the tolerance
revocation program; the management and coordination of minor or
specialty use tolerance petitions submitted under the Federal Food,
Drug, and Cosmetic Act; and child-resistant packaging.
REI - See Reentry Interval.
REREGISTRATION - Section 4 of FIFRA requires EPA to reregister all
pesticides originally registered before 1984 on specified
timetables. Reregistration priority is given to chemicals with the
highest potential for exposure — high-volume and food-use
chemicals (i.e., List A chemicals). Through this priority process,
four lists of pesticides (Lists A, B, C, and D), were established
under FIFRA '88.
The reregistration process consists of: the Agency identifying the
studies necessary to conduct human health and environmental risks
assessments; obtaining and reviewing these studies; and determining
whether the pesticide's uses do not pose unreasonable adverse
risks.
Also see Reregistration Branch; Accelerated Reregistration Branch;
Data Call-in; and List A, B, C, and D Pesticides.
G-25
-------
RBREGIBTRATION BRANCH - See RB.
RBREGISTR&TION ELIGIBILITY DOCUMENT - See RED.
RESIDENTIAL USB - Pesticide application in and around houses,
apartment buildings, motels, and other living areas.
RESOURCE MANAGEMENT AND EVALUATION BRANCH - The Resource Management
and Evaluation Branch within the Program Management and Support
Division (PMSD) of the Office of Pesticide Programs (OPP) provides
overall management, direction, guidance, and support to divisions
and offices on the development and implementation of program and
budget plans.
RESTRICTED USE PESTICIDE - (RUP) - If the Agency determines that a
pesticide, when applied in accordance with its labeling or in
accordance with widespread and generally recognized practices may
generally cause, without additional restrictions, unreasonable
adverse effects on the environment. EPA will classify the
pesticide or the particular use or uses to which the determination
applies for restricted use. Restricted-use pesticides may generally
be applied only by trained, certified applicators or those under
their direct supervision, and may be subject to other regulatory
restrictions.
RESOURCES CONSERVATION AND RECOVERY ACT - See RCRA.
REVIEW MANAGER - A Review Manager (RM) is an employee in the
Special Review Branch (SRB) or Reregistration Branch (RB) of the
Special Review and Reregistration Division (SRRD) whose
responsibility is to coordinate the review process for one or more
pesticide chemicals. This includes leading review teams for
pesticides or issues under review.
RfD - See Reference Dose.
RISK ASSESSMENT - In general, a risk assessment (RA) is a
determination of the likelihood of a hazard to occur from
population exposed to pesticide chemicals. This likelihood may be
expressed as a numerical probability or as a margin of
safety/margin of exposure. Simply stated: RISK - Hazard x
Exposure.
RISK ASSESSMENT COUNCIL - The Risk Assessment Council reviews the
policy and procedural aspects of the Risk Assessment Forum's (RAF)
technical findings. After approval by the RAC and the
Administrator, the Forum's findings become policy.
6-26
-------
RISK ASSESSMENT TORUM - The Risk Assessment Forum (RAF) consists of
Agency risk assessment (RA) expert scientists who study technical
Agency-vide RA issues and refer their findings to the Risk
Assessment Council. The RAF was established to promote consensus
on RA issues within the Agency.
RM - See Review Manager.
RMEB - See Resource Management and Evaluation Branch.
RPAR - See Rebuttable Presumption Against Registration.
RS - See Registration standard.
RSB - See Registration Support Branch.
RUF - See Restricted use Pesticide.
SAB - The Science Advisory Board (SAB) is an Agency-wide series of
committees that advises the Administrator on scientific issues.
8ACB - The Science Analysis and Coordination Branch (SACB) within
the Health Effects Division (HED) of the Office of Pesticide
Programs (OPP) coordinates and integrates human and domestic animal
toxicological data along with dietary and non-dietary exposure to
determine the risk for pesticides.
SACS - The Science Analysis and Coordination Staff (SACS) within
the Environmental Fate and Effects Division (EFED) of the Office of
Pesticide Programs supports the assessment of environmental
pesticide hazards by integrating individual discipline-specific
review components into an overall statement of risk. The SACS also
generally reviews EFED's scientific output, analyzes science policy
issues, and recommends resolution of issues.
SATE DRINKING HATER ACT - The Safe Drinking Water Act (SDWA)
requires the Agency to set health standards for water sources used
for public drinking water systems. It directs the EPA
administrator to develop: (1) National primary drinking water
regulations that incorporate maximum contaminant levels; (2)
Underground Injection Control regulations to protect underground
sources of drinking water; and (3) Groundwater protection grant
programs for the administration of sole source aquifer
demonstration projects and for wellhead protection area programs.
SAP - See FIFRA Scientific Advisory Panel.
SARA - The Superfund Amendments and Reauthorization Act of 1986
(SARA) is the legislation that reauthorized the Superfund program
in 1986. In addition, this law made several amendments to CERCLA
and established the provisions for SARA Title III — Emergency
Planning and Community Right-to-Know.
G-27
-------
SB * The Systems Branch (SB) within the Program Management and
Support Division (PMSD) of the Office of Pesticide Programs (OPP)
is the central point within OPP for automatic data processing
systems analysis and design. Services provided include: Automated
Data Processing (ADP) facilities and hardware, data input, and
retrieval support from the computerized data bases.
SCIENCE ADVISORY BOARD - See SAB.
SCIENCE ANALYSIS AMD COORDINATION BRANCH - See SACB.
8CZENCB ANALYSIS AND COORDINATION STAFF - See SACS.
8DWA - See Safe Drinking Water Act.
SECTION la - See FIFRA Section 18 (Emergency Exemption).
SECTION 24(c) - See FIFRA section 24(c) (special local need).
SELECTIVE METHOD OF SUPPORT - One of two methods by which an
applicant for registration or amended registration may comply with
the data compensation requirements of FIFRA section 3(c)(l)(F).
Under this method the applicant lists the specific data
requirements that apply to his or her product, its active
ingredients, and use patterns, and demonstrates compliance with the
data requirements by either submitting the actual studies, or
citing individual studies, or by demonstrating that no study has
bously submit2OXto the Aency (a datplfiSOXgap).
8ETAC - The Society for Environmental Toxicology and Chemistry
(SETAC) is a professional society for environmental toxicologists
and chemists; publishes a journal entitled Environmental Toxicology
and Chemistry and sponsors symposia on various environmental issues
that relate to toxicology and chemistry.
8FIREO - The State FZFRA Issues, Research Evaluation Group (SFIREG)
is a group of state regulatory officials who work with Office of
Pesticide Programs (OPP) staff to identify and resolve overlapping
state and federal regulatory and research issues.
8LN - See FIFRA Section 24(c).
SMALL BUSINESSES - The ten "small business" in regard to
eligibility for reduced registration maintenance fees means a
business that employees 150 or fewer people and, during the three
year period prior to the most recent maintenance fee billing cycle
(i.e., December 31, 1990) had average annual gross revenue from
chemical sales not exceeding $40 million, taking into account nay
parents' and subsidiaries* employees and gross revenues.
SOCIETY FOR ENVIRONMENTAL TOXICOLOGY AMD CHEMISTRY - see SETAC.
G-28
-------
SOLUTION - A formulation or use dilution of a pesticide that
dissolve* in the carrier liquid or diluent and vill not settle out
or separate in an aqueous medium.
SO? - A Standard Operating Procedure (SOP) is a written procedure
that conveys procedures for various functions performed by Office
of Pesticide Programs (OPP) staff. SOPs address both technical and
administrative matters.
SPECIAL LOCAL MEED - See FIFRA Section 24(C).
SPECIAL REVIEW - The purpose of the Special Review (SR), formerly
known as Rebuttable Presumption Against Registration (RPAR),
process is to help the Agency determine whether to initiate
procedures to cancel, deny, or reclassify registration of a
pesticide product because uses of that product may cause
unreasonable adverse effects on the environment, in accordance with
sections 3(c)(6) and 6 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). The process is intended to ensure that
the Agency assesses risks that may be posed by pesticides, and the
benefits of use of those pesticides, in an open and responsive
manner. The issuance of a Notice of Special Review means that the
Agency has determined that one or more uses of a pesticide may pose
significant risks and that, following completion of the Special
Review process, the Agency expects to initiate formal proceedings
seeking to cancel, deny, reclassify, or require modifications to
the registration of the product(s) in question unless it has been
shown during the Special Review that the Agency's initial
determination was erroneous, that the risks can be reduced to
acceptable levels without the need for formal proceedings, or that
the benefits of the pesticide's use outweigh the risks. Following
completion of the Special Review process, a pesticide in question
may be returned to the registration process. Regulations
pertaining to Special Review procedures are at 40 CFR 154.
SPECIAL REVIEW BRANCH - The Special Review Branch (SRB) within the
Special Review and Reregistration Division (SRRD) of the Office of
Pesticide Programs (OPP) is responsible for managing the Special
Review process for chemicals that have been placed in Special
Review. The Special Review process provides a framework for
risk/benefit reviews of pesticide products and preparation of
documents stating the Agency's position (i.e.. Position Documents).
Subsequent action may include risk reduction measures, cancellation
of some or all uses, emergency suspension/cancellation.
G-29
-------
SPECIAL REVIEW AMD RBREGISTRATION DIVI8IOM - The Special Review and
Reregistration Division (SRRD) is one of the seven Divisions that
constitutes the Office of Pesticide Programs (OPP). It manages
special reviews and reregistration of pesticide products; issues
data call-ins related to the special review and reregistration
processes; and issues position documents and follow-up reports.
This Division is comprised of the immediate office- staff and three
branches: the Special Review Branch (SRB); the Reregistration
Branch (RB); and the Accelerated Reregistration Branch (ARB).
SR - see Special Review.
8KB - See Special Review Branch.
8RRD - See Special Review and Reregistration Division.
STANDARD OPERATING PROCEDURES - See SOP.
STATE PI7RA I8SDES, RESEARCH EVALUATION GROUP - See SFIRE6.
8UPERFDND AMENDMENTS AND RBAUTHORI2ATION ACT O7 1986 - See SARA.
SUPPLEMENTAL REGISTRATION - Common term for a process through which
a registrant may permit the distribution or sale of his or her
registered product under another's name and address. Such
distribution or sale is termed a supplemental distribution under
EPA regulations at 40 CFR 152.132. Also called distributor
registrations/products. A supplemental registration is identified
by a three part number (e.g.,1342-6-2) in which the first and
second numbers make up the primary registrant's registration
number, followed by the third part which is the supplemental
registrant's company number.
SURROGATE DATA - Data from studies which involve test organisms on
a test substance that are used to estimate the characteristics or
effects on another organism or of another substance.
SUSPENSION - Finely divided solid particles mixed in a liquid.
SUSPENSION OP REGISTRATION - An action authorized under FIFRA
section 3(c)(2)(B) or section 4 that temporarily halts further
distribution and sales of a pesticide product, suspension under
3(c)(2){B) or section 4 is imposed because the registrant has
failed to meet data submission requirements. The registrant can
request a hearing to challenge the notice. Suspension can be
lifted when the requirements are met.
A suspension of registration also can be issued under FIFRA section
6(c) due to an imminent hazard. The registrant has the right to an
expedited hearing on the question of whether an imminent hazard
exists. Also see NOIS and Emergency Suspension.
G-30
-------
SYSTEMS BRANCH - See SB.
TECHNICAL GRADE ACTIVE INGREDIENT - A Technical Grade Active
Ingredient (TGAX) is the pesticide chemical in pure form (usually
95 - 100% active ingredient) as it is manufactured by a chemical
company prior to being formulated (i.e., vettable powders,
granules, emulsifiable concentrates).
TECHNICAL GRADE PRODUCT - A registered manufactured-use product
that is composed of technical grade active ingredient.
TEP - A Typical End-use Product (TEP) is a term used in data
requirements to convey direction to a data producer to use a
commonly used end-use product as the test substance.
TGAI - See Technical Grade Active Ingredient.
THE ACT - In this manual this term refers to FIFRA (the Federal
Insecticide, Fungicide, and Rodenticide Act).
THEORETICAL MAXIMUM RESIDUE CONTRIBUTION - The Theoretical Maximum
Residue Contribution (TMRC) is the theoretical maximum amount of a
pesticide in the daily diet of an average human. This theoretical
amount assumes that the diet is composed of all food items for
which there are tolerance-level residues of the pesticide. The
TMRC unit is expressed as mg (of pesticide)/kg (of body
weight)/day.
TMRC - See Theoretical Maximum Residue Contribution.
TOLERANCE - The maximum permissible residue levels for pesticides
in raw agricultural produce and processed foods. Whenever a
pesticide is registered for use on a food or a feed crop, a
tolerance (or exemption from the tolerance requirement) must be
established. EPA establishes the tolerance levels, which are
enforced by the Food and Drug Administration and the Department of
Agriculture. Whenever a pesticide is registered for use on a food
or feed crop, a tolerance or an exemption from the tolerance must
be established. Established tolerances and exemptions from
tolerances for pesticide chemicals in or on raw agricultural
commodities are listed in 40 CFR Section 180; tolerances for food
additives in food for human consumption are listed in 40 CFR
Section 185; and tolerances for feed additives in animal feed are
listed in 40 CFR Section 186.
TOLERANCE PETITION - A formal request to establish a new tolerance
or modify (raise, lower or revoke) existing tolerances.
G-31
-------
TOXIC SUBSTANCES CONTROL ACT - The Toxic Substances Control Act
(TSCA) is a law administered by the Office of Pollution Prevention
and Toxic* that governs the manufacture processing distribution,
use and disposal of chemical substances. Pesticides, tobacco and
tobacco products, nuclear materials, foods, food additives, drugs
and cosmetics are excluded from TSCA's coverage.
TSCA - See Toxic Substances Control Act.
TYPICAL BUD-USE PRODUCT - See TEP.
USE INDEX - A compilation of everything on a label for each
pesticide product including the sites the pesticide is used on and
the application rate. The Use Index is prepared by the Biological
and Economic Analysis Division (BEAD).
VOLTILITY - The property of a substance to become a vapor or gas
without chemical change.
WATER SOLUBLE PACKAGING - Packaging that dissolves in water; this
type of packaging is used to reduce exposure risks to mixers and
loaders.
"WEIGHT OF EVIDENCE" APPROACH - Evaluation based on a qualitative
assessment of the available scientific evidence.
WETTABLB POWDER - Hettable Powder (WP) is a dry formulation
materials that must be mixed with water or other liquid before it
is applied.
WP - See Wettable Powder.
G-32
-------
INDEX
Page
Active Ingredient (AI)
Claiming femulator' s exemption for 6-16
Formulating products with unregistered source of 6-16
Requirement for registration 1-2
Acute toxicity data 2-18;
4-4
Additional brand names
must not be false or misleading 4-13
Address of record 2-2
Adjuvants 1-3
Administrative amendments; types of
Labeling changes 4-2
Formula changes 4-2
Administrative portion of application for registration 2-9
Administrative Processing Section, RSB, RD, OPP 18-20
Agency screening of applications for expedited review 2-17;
4-8
Amendments to product registration 1-8
Not requiring a formal application
Notifications 4-13
Requiring notification but not approval 4-13
Labeling changes 4-13
Additional or substitution of brand names...4-13
Use of bilingual labeling 4-15
Changes in warranty 4-15
Other labeling revisions 4-15
Final printed labeling 4-15
Product chemistry changes 4-17
Active ingredient 4-17
Inert ingredients 4-18
Starting materials for integrated system
products 4-19
Change in formulation process 4-19
Requiring a formal application
"Me-Too" amendments 4-1
New use amendments 4-10
Labeling for 4-22
INDEX-1
-------
INDEX (Continued)
Page
Annual registration maintenance fees 8-1
Antimicrobial fuel additives
Who to contact 15-4
Antimicrobial Program Branch, RD, OPP 18-11;
18-18
Applicant' s name 2-2
Application for Experimental Use Permit
(EPA Form 8570-17) k 9-2
Application for Pesticide Amendment (EPA Form 8570-1) 2-2;
4-2; 4-10; 7-5
Application for Registration of Pesticide-Producing
Establishments (EPA Form 3540-8) 11-1
Application, transmittal of 12-4
Applications which
Do not qualify for expedited reviev 2-14
Qualify for expedited reviev 2-14
Authorized agent 2-3
Bilingual labeling
Use of 2-28
Biochemical pesticides 2-1
Considerations for registration; general information..3-1
Exempt from registration 3-2
Biological control agents
Not subject to FIFRA 1-4
Certification of products as Restricted Use 2-8
Certification with Respect to Citation of Data (EPA Form
8570-29) 2-7 ;
4-4; 4-11
INDEX-2
-------
INDEX (Continued)
Page
Changes that can be made to a registration without notifying the
Agency
Changes in the net contents to accommodate changing
package sizes or contents variability if such
changes do not require changes in the use
directions 4-21
Correction of typographical or printing errors
in labeling 4-21
Use of metric units in addition to standard U.S.
units for net contents, dosages and other
numeric expressions 4-21
Redesign of label format that does not modify
approved label text, consistent with 40 CFR 156.10
format requirements 4-22
Revision, addition, or deletion of non-mandatory
label elements 4-21
Chemical pesticides 2-1
Child-resistant packaging 10-5
Certification relating to 2-7
Cite-all method of support 6-7;
6-14
Comparison with selective method of support 6-23
Claims not allowed to be used on product labeling 4-13
Classification of products as restricted use 2-8
Collateral labeling 2-21
Completeness of applications for registration 2-9
Completeness of applications for petitions for tolerance...7-4
Conditional registration 1-9
Confidential Business Information 12-1
How to submit 12-2
Information that can not be released to the public...12-1
Confidential Statement of Formula (EPA Form 8570-4) 2-3;
4-3
Contact See "Who To Contact" in this Index
INDEX-3
-------
INDEX (Continued)
Page
Contents of an application for registration 2-2
Data
Chemicals for which waivers have been granted 16-3
Compensation charges/payment disputes 6-10
Compensation requirements 2-5;
6-1
In support of products first registered
after 9/30/78 6-2
Regarding data submitted after 12/31/69 6-2
Methods for complying with;
The cite-all method of support 6-7
The selective method of support 6-8
Compensation procedures applicable to
Applications for an amendment of a
registration 6-2
(Also see "Data compensation procedures do not
apply".)
Applications for registration of a new product...6-2
Compensation procedures not applicable to
Applications adding or deleting deliberately
added inert ingredients 6-3
Applications adding or deleting supplemental
registrants (distributors) 6-3
Applications to increase or decrease the
percentage of one or more active ingredients
or deliberately added inert ingredients 6-3
Applications making a change in the package or
container size 6-3
Applications making a change in the product
name, or adding an additional brand name 6-3
Applications making a change in the
registrant' s name and address 6-3
Applications making a change in the source of
supply of active ingredients 6-3
Applications making a change in the warranty,
warranty disclaimer, or liability limitation
statements, or addition or deletion of such
statements 6-3
Applications clarifying the directions for use...6-3
Applications correcting typographical errors 6-3
Applications deleting an active ingredients 6-3
Applications to delete an approved use from
the label 6-3
Applications for experimental use permits 6-3
INDEX-4
-------
INDEX (Continued)
Page
Data (continued)
Applications to redesign the label format,
which involves no substantive changes in
the directions for use, claims,
representations, or precautionary statements..6-3
Applications to revise the identity or amount
of impurities in the product 6-3
Applications for amendment where the Agency
determines that scientific data would not
be needed in order to approve the amendment...6-4
Applications "splitting" the label for the
purpose of marketing the product in different
geographic regions with appropriate labels,
where each amended label will contain
previously approved use instructions
appropriate to a particular geographic
region 6-3
Efficacy data requirements 2-5;
2-11
Format
for data. 2-4
for submittal package 12-3
for submitted studies 12-4
Generic 2-11
How to submit 12-1;
12-2
In support of the petition for tolerance 7-8
Number of copies required 2-4
Portion of Application for registration. 2-11
Requirements for efficacy 2-5
2-11
Requirements for experimental use permits 9-5
Transmittal document 12-4
Data Matrix Chart 4-4;
4-11
Designated U.S. agent 2-3
Devices
Child-resistant packaging for 10-5
Definition of 1-4;
10-1
Establishment registration and reporting, books
and records 10-4
Importation and exportation of 10-4
Inspection of establishments 10-4
Labeling requirements 10-2
INDEX-5
-------
INDEX (Continued)
Page
.1-4;
Devices (continued)
Not subject FIFRA
10-2
Registration requirements for 10-1
Subject to FIFRA. 10-1
Violations, enforcement activities and penalties 10-4
Distributor product
Labeling
Must be sane as basic registered product (see
exceptions also) 5-2
Exceptions to being the same as the basic
registered product 5-2;
5-3
Hay not be repackaged 5-2
Must be produced, packaged, and labeled in a
registered establishment operated by basic
registrant 5-2
Document Management Section, ISB, PMSD, OFF 18-10
Documents
Available from the Environmental Protection Agency...16-2
Available from the National Technical Information
Service 16-1
Available from the U.S. Government Printing Office...16-2
Dosage rate 2-2
Draft labeling 2-4
Efficacy data
Required for pesticide products that control
pests of public health significance. 4-2;
4-4? 4-11
Requirements for 2-5;
2-11
Emergency exemptions 14-4
Emergency Response and Minor Use Section, RSB, RD, OFF....18-11;
18-20
Enforcement 4-23
Environmental Protection Agency (EPA)
Documents available from 16-2
EPA Regional Offices 18-28
INDEX-6
-------
INDEX (Continued)
Page
Establishment number
Application for ...................................... 11-1
How to obtain ........................................ 11-1
Information required ......................... •. ....... 11-2
Where to obtain application forms ....... .... ......... 11-2
Where to submit application:
For Domestic establishments .............. . ...... 11-1
For Foreign establishments . . . ................... 11-2
Establishment of tolerance ...................... . .......... 2-1
Exclusive use data certification ............. .... ....... * . . 6-5
Exemption from requirement of tolerance ...... . ............. 2-1
Expedited review
Agency screening of applications for .................. 4-8
How to submit an application for. . . .-. ................. 4-6
Of "Me-Too" applications for amended registration ..... 2-14 t
4-4
"Me-Too" Applications which do not qualify for ........ 4-5
"Me-Too" Applications which qualify for ............... 4-5
Experimental Use Permits
Application requirements .............................. 9-2
Data requirements for ................................. 9-5
Extension or renewal of ............................ ... 9-6
Fee requirements for .................... . ............. 9-6
How to apply for ....................... . .............. 9-1
Labeling requirements for ............................. 9-6
Required for
Animal treatments ............................... . 9-2
Aquatic use ...................................... 9-2
Before conducting large scale field testing ..... .9-1
Laboratory testing, greenhouse testing, or
limited replicated field trials .............. 9-1
Land use ............................... . ......... 9-1
Small scale fild testing "novel"
pesticides ................................... 9-2
Summary worksheet for ................................. 9-3
State issuance of .................................... 14-1
Tolerance requirements for ............................ 9-5
Exportation
of pesticides .............................. . .......... 1-6
Facsimile directory ....................................... 18-27
FACTA .................................................. ... .2-5?
2-7; 4-rl; 6-1
INDEX-7
-------
INDEX (Continued)
Page
Federal Insecticide, Rodenticide and Fungicide Act
(FIFRA) 16-2
State regulatory authority under 14-1
Federal Register Notices 16-4
Fees
Annual registration maintenance 8-1
For experimental use permits 9-6
Requirements for SLNs 14-2
Reregistration 8-2
Small businesses 8-1
Definition of small business 8-1
Tolerance petition 7-5;
7-6; 7-7; 8-2
Field Operations Division, OFF 18-8
Final printed labels
Submission of 4-22
Food Additive regulation 2-1
Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) 2-5;
2-7; 4-1; 6-1
Foods
Not subject to FIFRA 1-4
Format
For Administrative Portion of Application 2-33
For Data Portion of Application 2-33
For Restricted Use Product Label 2-30;
2-31
For Unrestricted Use Product Label 2-32
Forms
How to obtain them 17-1
Formulator's Exemption Statement (EPA Form 8570-27) 2-10;
4-4; 4-11; 6-4
Front End Processing Staff, RSB, RD, OPP 18-11;
18-19
Fungicide-Herbicide Branch, RD, OPP 18-11;
18-18
INDEX-8
-------
INDEX (Continued)
Page
Generic data 2-11
Government Printing Office (GPO)
Documents available from ; ie-2
Guideline for determining an application's eligibility for
fast trade (expedited) review 2-15;
4-7
How to
Amend the registration of a product 4-1
Apply for an experimental use permit '. 9-1
Apply for registration of a pesticide 2-1
Apply for supplemental registration 5-1
Obtain anA establishment number ll-l
Obtain Forms. 17-1
Obtain publications 16-1
Submit an exemption from the requirement of a
tolerance 7-1
Submit "Me-Too" applications for expedited review 2-15;
4-6
Submit notifications 4-20
Submit petitions for a tolerance 7-1
Human drugs
Not subject FIFRA 1-4
Importation
of pesticides 1-6
Incomplete applications 2-11;
4-21
Incomplete petitions 7-11
Inert ingredients 1-6;
4-17
Information Resources Development Section, ISB, PMSD, OPP.18-10
Information Services Branch, PMSD, OPP 18-10
Insect predators
Not subject FIFRA 1-4
Insecticide-Rodenticide Branch, RD, OPP 18-11;
18-17
Intermediates 1-4
INDEX-9
-------
INDEX (Continued)
Pag*
Labeling
Changes that cannot be submitted as a notification....4-13
Claims not allowed to be used on 4-14
Deletions not permitted by Notification 4-2 ;
4-15
Submission of final printed labeling for
Notifications and non-notifications. 4-22
For amendments requiring a formal application 4-22
Requirements for experimental use permits 9-6
Listing of
Federally registered pesticide products classified
as "Restricted Use Pesticides (RUP) 16-3
Registration Standards issued 16-3
Reregistration Eligibility Documents issued 16-3
Macroscopic parasites
Not subject to FIFRA 1-4
Material Safety Data Sheets (MSDS) 2-29
Matrix format for data requirements listing
Sample of 6-29
"Me-too" registration
Amendments that require supporting data^ 4-3
Applications not qualifying for expedited review 4-5
Applications qualifying for expedited review 4-5
Definition of 2-1
Expedited review of "Me-Too" applications for
amended registration 4-4
How to submit an application for expedited review 4-6
"Me-too product"? ,
What is a 6-11
Methods for complying with the data compensation
requirements of FIFRA 6-7
Cite-all 6-7
Selective 6-8
Microbial pesticides 2-1
Considerations for registration; general information..3-1
considered under Level I reporting 3-3
Considered under Level II notification for
small-scale field testing 3-4
Exempt from registration 3-2
MRID number 12-3
INDEX-10
-------
INDEX (Continued)
Page
National Technical Information Service (NTIS)
Documents available from 16-1
Nematodes
Not subject to PIFRA 1-4
New chemical.
Definition 2-1
New use.
Definition .2-1
Amendments 4-10
Non-indigenous and genetically engineered microbial products
Who to contact 15-5;
15-6
Non-notifications 4-21
Notice of Supplemental Registration of Distributor
(EPA Form 8570-5) 5-1
Notifications
How to submit 4-20
Label deletions not permitted by 4-2;
4-15
Labeling changes that cannot be submitted as
Actions concerning an unregistered product 4-16
Addition of sites or uses 4-16
Deletion of precautionary language or
restrictions 4-16
Deletion of use patterns, pests, claims,
or sites of use 4-16
Submission of final printed labeling for 4-22
Not subject to FIFRA
Biological control agents 1-4
Devices 1-4
Foods. 1-4
Human drugs. 1-
Insect predators 1-
Macroscopic parasites 1-
Nematodes 1-
Pheromones in pheromone traps 1-
Preservatives for biological specimens 1-
Treated articles 1-
Vitamin-hormone horticultural products 1-
INDEX-11
-------
INDX (Continued)
Page
Other types of registrations and/or approvals that nay be
needed from federal or state agencies other than EPA's
pesticides program 15-1
Pest
Definition of 1-1
Pesticide
Definition of 1-1
Labeling requirements
General guidance .2-22
Specific guidance
Child hazard warning statement 2-24
Company name and address 2-23
Directions for use 2-28
Environmental hazard 2-25
EPA establishment number 2-23
EPA registration number 2-23
Hazard to humans and domestic animals 2-25
Inert ingredients reclassified as active
ingredients 2-24
Ingredients statement 2-23
Minimum type size 2-24
Misuse statement 2-27
Name to be used in ingredient statement 2-23
Net contents .2-23
Nominal concentration 2-24
Physical or chemical hazard - flammability..2-26
Pounds per gallon statement. 2-23
Product name 2-22
Reentry statement 2-27
Referral statement 2-25
Restricted use classification 2-26
All uses restricted 2-26
Some but not all uses restricted 2-27
Side/back precautionary labeling. 2-25
Signal word 2-24
Skull 6 crbssbones and word "Poison" 2-25
Statement of practical treatment 2-25
Storage and disposal block ; 2-28
Warnings and precautionary statements 2-24
Registrations/approvals needed from other federal
state agencies 15-1
Shipping (Transportation) of 15-5
State regulation of federally registered. 15-1
INDEX-12
-------
INDEX (Continued)
Page
Pesticide (continued)
Use of in/on
Antimicrobial fuel additives 15-4
Beet sugar mills 15-2 ;
15-4
Cane sugar mills 15-2;
15-4
Food contact surfaces 15-2
Sanitizers 15-3
As Hunan and animal drugs 15-2;
15-3; 15-4
Medical devices 15-3
Antimicrobials 15-3
Microbials
Non-indigenous and genetically engineered..15-5;
15-6
Paper and paperboard (food uses) 15-2
Microbiocides 15-3
Meat and poultry plants 15-1
Pesticide Intermediates 1-4
Petition for a tolerance
How to submit an application to request 7-1
Pheromones
In pheromone traps; not subject to FIFRA 1-4
Precautionary Labeling Review Section, RSB, RD, OPP 18-11;
18-19
Pre-harvest interval (PHI) 2-2
Preservatives
For biological specimens; not subject to FIFRA 1-4
PR Notices 16-4
Product Chemistry Review Section, RSB, RD, OPP 18-11;
18-19
Product Manager Team 10 18-11;
18-17
Product Manager Team 13 18-11;
18-17
Product Manager Team 14 18-11;
18-17
INDEX-13
-------
INDEX (Continued)
Page
Product Manager Team 18 18-11;
18-17
Product Manager Team 19 18-11;
18-17
Product Manager Team 21. 18-11;
18-18
Product Manager Team 22 18-11;
18-18
Product Manager Team 23 18-11;
18-18
Product Manager Team 25 18-11;
18-18
Product Manager Team 31 18-11;
18-18
Product Manager Team 32 18-11;
18-18
Product specific chemistry data 2-11
Project Coordination Section, RSB, RD, OPP 18-20
Publications
How to obtain. 16-1
Public Response and Program Resources Branch, FOD, OPP....18-8
Questions and answers about data compensation 6-11
RED (Registration Eligibility Document) 2-8
Listing of issued 16-3
Regional Offices - EPA 18-28
Region 1 18-28
Region 2 18-28
Region 3 18-28
Region 4 18-28
Region 5 18-28
Region 6 18-29
Region 7 18-29
Region 8 18-29
Region 9 18-29
INDEX-14
-------
INDEX (Continued)
Region 10,
Page
. 18-29
Regional Operations Branch, FOD, OPP 18-8
Registration
Changes allowed without Agency notification
In the net contents to accommodate changing
package sizes or contents variability if
such changes do not require changes in
the use directions 4-21
Correction of typographical or printing
errors in labeling 4-21
Use of metric units in addition to standard
U.S. units for net contents, dosages and
other numeric expressions 4-21
Redesign of label format that does not
modify approved label text, consistent
with 40 CFR 156.10 format requirements 4-22
Revision, addition, or deletion of
non-mandatory label elements 4-21
Of a date that indicates date of
manufacture or label approval 4-22
Addition of State-required analysis of
fertilizer component of pesticide-
fertilizer products.» 4-21
Addition of State-required analysis of
wood-preservative product 4-22
Inclusion of the DOT hazard diamond 4-21
Inclusion of lot or batch codes, or other
production identifiers 4-21
Routine changes in the name and address of the
registrant on the label 4-21
Of your own product 1-7
How to amend the registration of a product ....4-1
Registration Division, OPP 18-11
Registration Standard
Listing of issued 16-3
Registration Support Branch, RD, OPP 18-11;
18-19
Reregistration Eligibility Documents (REDs) 2-6
Listing of issued 16-3
Reregistration Fees. 8-2
INDEX-15
-------
INDEX (Continued)
Page
Restricted use
Classification of products as 2-8
List of 16-3
Screening of applications for expedited review. 4-8
Selective method of support 6-8 J
6-15
Comparison with cite-all method of support 6-23
Who has to cite or submit residue chemistry data? 6-18
Small businesses
Definition of 8-1
Small-scale field testing
Level I reporting requirements for 3-3
Level IZ notification requirements for 3-4
Special Local Needs
Fee requirements for 14-2
State registration of 14-1
State agencies with lead pesticide responsibility 18-30
Alabama 18-30
Alaska 18-30
American Samoa 18-30
Arizona 18-30
Arkansas 18-30
California 18-30
Colorado. 18-30
Commonwealth of the Northern Mariana Islands 18-30
Connecticut. 18-31
Delaware 18-31
District of Columbia 18-31
Florida 18-31
Georgia 18-31
Guam 18-31
Hawaii 18-31
Idaho 18-31
Illinois 18-32
Indiana. 18-32
Iowa 18-32
Kansas 18-32
Kentucky 18-32
Luisiana 18-32
Maine 18-32
Maryland.. * 18-32
Massachusetts 18-33
Michigan 18-33
INDEX-16
-------
INDEX (Continued)
Page
State agencies (Continued)
Minnesota 18-33
Mississippi 18-33
Missouri 18-33
Montana 18-33
Nebraska 18-33
Nevada 18-33
New Hampshire 18-34
New Jersey 18-34
New Mexico 18-34
New York 18-34
North Carolina 18-34
North Dakota 18-34
Ohio 18-34
Oklahoma 18-34
Oregon 18-35
Pennsylvania 18-35
Puerto Rico .18-35
Republic of Palau 18-35
Rhode Island 18-35
South Carolina 18-35
South Dakota 18-35
Tennessee 18-35
Texas 18-36
Utah 18-36
Vermont 18-36
Virginia 18-36
Virgin Islands 18-36
Washington 18-36
West Virginia 18-36
Wisconsin 18-36
Wyoming. 18-37
State issuance of experimental use permits 14-1
State registration of special local needs 14-1
State regulation of federally registered pesticides
Who to contact 15-1
State regulatory authority under FIFRA 14-1
Grounds for EPA disapproval of State registrations...14-3
Shipping (Transportation) of pesticides 15-4
Who to contact 15-5
Statement of data confidentiality claims 12-5
Statement of substantiality, similarity, or identicality...4-3
INDEX-17
-------
-------
INDEX (Continued)
Page
Studies
Bind separately 12-5
Format of 12-3
Identifying supplements to previously submitted......12-5
What to include in 12-5
Submission of final printed labeling
Notifications and non-notifications 4-21
Amendments requiring a formal application 4-22
Supplemental registration 1-8
How to apply for 5-1
Requirements for approval of 5-1
Timeframes for Agency response to expedited "Me-Too"
applications
45 day response 2-18;
4-9
90 day response 2-19;
4-9
Tolerance
Data in support of the petition for 7-8
Establishment of 2-1
Exemption from requirement of 2-1
Fees
Requirements for 7-8;
8-2
Adjusted annually 7-9
For establishment of a new tolerance 7-9
For establishment of a tolerance at a
lower numerical level 7-9
For an exemption from the requirement
of a tolerance 7-9
For a temporary tolerance 7-10
For a temporary tolerance exemption 7-9
For waiver or refund request 7-8
How to submit an exemption from the requirement of
a tolerance 7-1
How to submit a petition for a tolerance 7-1
Incomplete petitions 7-11
Procedures for filing a petition for 7-4
Requirements for experimental use permits 9-5
When required 7-2
Transfer of
Product registrations 13-1
Data rights 13-4
INDEX-18
-------
-------
INDEX (Continued)
Page
Treated articles
Not subject to FIFRA 1-4
Types of pesticide registration
Amendment to your own registration 1-7
To distribute a'product registered by someone else....1-8
Registration of your own product 1-7
Unconditional registration 1-8
Use of bilingual labeling 2-4;
2-28
Use of pesticides in meat and poultry plants 15-1
Application for USDA authorization. 15-2
Labeling requirements 15-2
Who to contact 15-2
Use of pesticides on food contact surfaces, for paper
and paperboard (food uses), on medical devices, as
human and animal drugs, and in cane-sugar and beet
sugar mills 15-2
Sanitizers (pesticides used on food contact
surfaces) is-3
Who to contact 15-3
Microbiocides in paper and paperboard (food use).15-3
Who to contact 15-3
Antimicrobial pesticides used on medical devices.15-3
Who to contact 15-3
Human and animal drugs 15-4
Who to contact 15-4
Cane-sugar and beet-sugar mills 15-4
Who to contact 15-4
Vitamin-hormone horticultural products
Not subject to FIFRA 1-4
What to include in a study , 12-5
When is an experimental use permit required 9-1
When is a petition for tolerance required 7-2
Amended registration for use on food/feed crops 7-2
Experimental use permit for food/feed crops 7-2
Importation of pesticide treated food 7-3
Inerts in products labeled for food use 7-3
Adjuvants for application to food crops 7-4
When must data compensation procedures be complied with....6-2
INDEX-19
-------
INDEX (Continued)
Page
Where to hand deliver applications 18-1
Where to mail applications .' 18-1
Where to obtain application forms 11-2
Where to request a company number and establishment
registration 5-3
Where to submit applications or resubmissions 4-7;
4-8
Where to submit applications for expedited review 2-17;
2-19
Where to submit applications for supplemental registration.5-3
Who must apply for registration of a pesticide 1-1
Who to contact for assistance for:
Antimicrobials (Antimicrobial Program Branch) 18-11
Data formatting requirements (Program Management and
Support Division) 18-10
Disinfectants (Antimicrobial Program Branch) 18-11
Document distribution (Program Management and
Support Division) - • 18-10
Document management (Program Management and Support
Support Division) 18-10
Freedom of Information (Field Operations Division)...18-8
Fumigants (Antimicrobial Program Branch) 18-11
Fungicides (Fungicide-Herbicide Branch) 18-11
Herbicides (Fungicide-Herbicide Branch) 18-11
Inert ingredient clearance (Registration Support
Branch) • . • • 18-11
Insecticides (Insecticide-Rodenticide Branch) 18-11
Minor use petitions (Registration Support Branch)....18-11
Precautionary labeling review (Registration Support
Branch) 18-11
Product chemistry review (Registration Support
Branch) 18-11
Regional Services (Field Operations Division) 18-8
Rodenticides (Insecticide-Rodenticide Branch) 18-11
Section 18 emergency exemptions (Registration
Support Branch) * 18-11
* U.S. GOVERNMENT PRINTING OFFICE: 1992-617-OOM70M INDEX—2 0
-------
-------
« 2
5 5 =
~ g Z«
= ££ m
ri
" w
="
e>
ro
o
o
6
-------
Reference No. 2
-------
-------
1 Pesticides- Regulation Division
I
. .
ut: Status under the Federal Insecticide, Fungicide, and Rodenticide Act
of U.S.P. Products
To:
All Reviewers of Applications far Registration
.All Standards Branch Personnel •
There has been sons confusion relative to the status under the
FIFRA of products bearing the label designation "U.S.P." Until
•you are notified otherwise, the following current registration
policy should be employed:
The label designation "U.S.P." alone is not sufficient to identify a
fr&t/£/''cSatfcjconomic po'son. Unless the Ubel uars specific
economic .poison claims, or directions for use as an economic poison;
or unless the intent of use as an economic poison can be established
.."a«atrtSirated-in some other manner,,the product is not considered
to be an economic poison and is not subject to the provisions of the
FIFRA.
Di rector
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Citation of Claire Manufacturing Company, Chicago,
SUBJECT: Illinois, for non-registration of alleged pesticide
under ID 69160: Opinion on clain on dust-mop treat
ment product
FROM:
Director, Criteria and Evaluation Division
DATE: July 13, 1973
TO: George Marsh
Regional Inspector, Region V
Environmental Protection Agency
On July 9, Mr. Elijah Brown, Chief, Disinfectants Branch called
Gary Bass, C&ED. He stated that the Pesticide Enforcement Division
had formally cited the subject company for non-registration of a
dust-mop treatment product based on the claim "Prevents the spread
of germ-laden dust." He further stated that you had subsequently
informed hip that the subject firm had indicated that they would
litigate the citation, based on their 'legal interpretation that the
claim did not identify the product as a pesticide. He requested the
Division's opinion as to whether or not the claim would identify the
product as a pesticide. Mr. Brown felt that the claira did identify
the product as a pesticide. ,
On July 9 and again on July 11, Aram Beloian of C&ED contacted you
and elicited the following information: (1) that the PRO, over
Alvin Chock's (Acting Chief, Records Control Branch, PRO) signature
had formally informed Region V that the claim identified the product
as a pesticide, (2) that based on this decision a citation was issued
for non-registration under ID "69160, (3) that the claim read "Prevents
germ-filled dust from scattering", (4) that no collateral labeling
appears to exist, and (5) that the citation could be withdrawn without
prejudice to the subject firm.
We deem the claim you have identified does not qualify the product as
a pesticide under the Federal Insecticide, Fungicide and Rodenticide
Act, as amended by the Federal Environmental Pesticide Control Act of
1972.
Leonard R. Axel rod, Ph.D.
«.»)
-------
Chlorine Used 1n Cooling Towers and Sewage Treatment December 10, 797:
Plants
Acting Director, Registration Division
Kenry J. JCoro
Deputy Assistant-Administrator
Pesticide Programs
Chlorine or chlorine containing products used 1n cooling towers and sewage
treatment plants are considered pesticides within the definition of a
pesticide as set forth in Section 2.(u) of the Federal Insecticide, Fungi-
cide, and Rodenticide Act as amended, and the status of products given
under Interpretation Number 3 of the Regulations for the Enforcement of
the Federal Insecticide, Fungicide, "and Rodenticide Act.
Section 2(u) states that The term 'pesticide1 means (1) any substance
or mixture of substances intended for preventing, destroying, repelling,
or mitigating any pest, and (2).any substance or mixture of substances
intended for use as a plant regulator, defoliant, or desiccant."
Paragraph 362.101(b)(/) Status of products as economic poisons, states
"A substance or mixture of substances is or is not an economic coison
depending upon the purposes for which it is intended." ... "In
general, if a product is marketed in a manner that results in its being
used as an economic poison,, it is considered to be the intended use."
Since we know of no purpose for the addition of chlorine to water used
in cooling towers and to raw sewage or sewage effluent at sewage treat-
ment plants other than for antibacterial or antialgal benefits (and
purposes to the contrary are not defined), we conclude that the intent
of use is as a pesticide.
We have for many years taken the same approach to chlorine and chlorine
containing products recoraiended for use in swimming pool water. If the
labels bears a recommendation for such a use, we have deemed the product
to be subject to the Act. It is not necessary that the label bear actual
pesticide claims in such cases.
Charles L. Smith
-------
ENVIRONMENTAL PROTECTION AGENCY
PESTICIDES OFFICE
•WASHINGTON. O.C. 20250
G 72-29
Pesticides Regulation Division
March 1, 1972
Subject: Bleaching and Cleaning Agents
To: Pesticide Officials
The purpose of this communication is to clarify the position of the
Pesticides Regulation Division regarding- the registration status of
bleaching agents. There is some confusion as to whether or not
products represented as household or commercial bleaches are identi-
fiable as economic pcisons, as that term is defined in the Federal
Insecticide, Fungicide, and Rodenticide Act, by virtue of their
concurrent history and identification of use as disinfectants and
sanitizers. * *
Interpretation 3, dated November 1954, of the Regulations for Enforce-
ment of th? Federal Insecticide, Fungicide, and Rodenticide Act,
40 CFR, Chapter I, Part 162.101, states in part: "Products not con-
sidered cccnonic poisons include deodorants, bleaching agents, and
cJeaninn agsntti, which bear no claims for the control of any pests
..." In conformity vith this interpretation, products represented
solely as bleaches, bleaching agents or cleaning Agents shipped in
interstate commerce which bear no claias in labeling or collateral
labeling that would identify them as economic poisons will not
require registration under the Act.
Examples of chemicals that may serve as bleaching or cleaning agents
ate sodium hypochlorite and sodium dichloro-s-triazinecriene.
froid
Director
-------
February 4, 1972
5.25*: Household Bleach
Enforcement Division •
The registration policy-v;1th respect to household bleach is cs
follows:
1. Household bleach is no longer considered subject
to regulation under ti;3 FIFRA.
2, \'.s will disclsi;:; jurisdiction on any household bleach,
unless -
•a. Its 7f:bc-l tsars an v-CMOKic poison clc-.iw.
b. The r,-r.uffiCt.urrr vrfshcs tc obti'* rccistra- '
tion for the nrodiict by piecing c;
rjiniiniw cj'irrriicrjs" for use as c
•
fevy houseiiolti blerch:-:. sr? currently registered. Thc-se
products will rcifafti their registration ststys by-retain-
ing the ecor,i*.nc j.-oisoi; clcin on the Iclxil. If t-ic* niriU-
facfcirer './ishss to rsr-icrs the product fro-is t:;o pwrvi-i:-1
of tha Ace, he Mf.y t!o ss by deleting all ecosss'^'c no'ion
clfiius fr-:;:« tS:o l.'.Li^l to include the rcsisijvii^:; :Vj -t-cr
A cir.clsi-.-?r will nsft f? j^r •'" '
'
. i IT T 5.-
*« • I * W i 4 . . *
fctir.-j Chic;/
-------
-------
Reference No. 3
-------
-------
116 196i
MEMORANDUM
SUBJECT: 1.0. No. 216606 Tri-Bee Bleach/
Status as a Pesticide •
TO: Edward L. Bunch
I.D. Review Team/PCB
Registration Division (TS-767)
The status of a product as a pesticide 1s Determined by the Intended use
of the product. Such Intent may be either expressed or implied. If a
product 1s represented In any manner that results 1n it being used as a
pesticide, It shall be deemed to be a pesticide for the purpose of the
Act. (Sect. 162. 4(a) of the Regulations for the Enforcement of the
FIFRA).
The use of a sodium hypochlorite solution as a terminal rinse for eating
and drinking utensils is well established as a pesticide use. This • '•
intent for the recommended use pattern is established by the Food Service
Sanitation ordinance and Code 1962 Recommendations of the U.S.
Public Health Service (see Item 2 of Section D attached).
The directions for use in restaurants and taverns of a 200 ppm available
chlorine solution for the treatment of eating and drinking utensils Is a
pesticide use making the product subject to the provisions of the FIFRA.
William E. Campbell.
Microbiologist
TSS/Oisinfectants Branch
Registration Division (TS-767C)
TS-767/DIS/WCAMP8ELL?sb,rm-307/CMfa/X77180/4-16-81
-------
Sanitation
INCLUDING
A MODEL
FOOD SERVICE SANITATION ORDINANCE AND CODE
•
1962 Recommendations
of the Public Health Service
$£$'
* ^
*'79»*
U.S. DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE
Public Heollh Service
Consumer Protection and Environmental Health Service
ENVIRONMENTAL CONTROL ADMINISTRATION
Cincinnati, Ohio 45202
-------
s
!!!! 1 f|
* -S « r S Jg s
5"** .S £. 5 s J5 £ 3
S _ "3 •- & iB^S -3 «*
-S1H|I|§
£ a » g *tJ
!«3 llllll
= * = =2-2 " g «
•s i "s tfl-g 5
&
J!
o .•=
.= £ •» «K
^ 60 e -
MHf I
S5 S? £ * = •§
fsflsl^i'I^ ^-55 o-s i v
1582aga^issJig2«fsf.g-s
"= c . 2 a
si > 5 J
s-C'S S =
iil* ^
|UI I
iS8J i
a:17-5 rf^
g g S t1^^
£ " o S & —
= g= g-^ 5
S _5? In Cd L_
IB
-r«2
V «-
g£
gy
& •£
«1
ec
lit
.§-_>..£
§-"5 £
"12
«*. c ,.
a e. ^
•= *
•51
C~-2
" '
II JI^I!=S|5 =< §«'<* • ^*-*T^5 «
Jilliial-
5 E ~ o s S
^•S o> — 2 -
<-•&'— =, £"2 £ ^
C 3 C •-
— e ^. c
,£P
*w
c*f "t?*^
J: _- = ^
_ • E •» t5 u
£?• o £ r .s •"» S
" *• S =• ~ •*• «—
^11 ^n
^
!•!
II
2£-
?«
" 1,
t?="
4
t**
f£
n
=f i u
I! ""
r*c
< S;
il
•= 1
s
«:
.s!
^ <»
S!-
1^
S?
fc'-K
ic ^.£|i
Is s .— i t: =
8?:***
•E ! i :-T
!*JS5
*=g.£-c
,1 g 8 §/&
?«c Fg
-£ cl^
fc o -i
i «^
V C
•£?:.•
c s- 7
OCs
3»l
^^
^ w
*• ±
> - _. - *r. ^- •»•
^ — i £ S fe c
: - s.£ *r .£ «
' ^5 s" x •• jf
£ fe s*. c *.£ t
•s -= s: o -— —
!*!!«!
:*s
E - TJ
> Si
4! S-E
^ *..!
? § •-
"** *~ 5
.r ~ *
~ = s
L1 v - -y «< P
.= » .c J ^ t
—« u fe --* i- *
c: S
4( *
II
'^ =..2 -5
? f ' «. & i T?
-
_' *• — r z _. £. -5 ^ j
- 5 «^
.~ O^ c
« s i
=' r j = j ? i
lilllll
- -" "g.2
r — v: t>
^;&i«i
O .11
•* ^ «c
•f 8 w
2"« 5 ^i.2~ =4
&S*.5Bs?v*
f "•*•«« fe-^S *
g«88^|*sa
= •= s-= - = o s s-"2 " S"5*^ . D^
|=u«.52:5>2-gggss g-^js ?
2'--oj c ~ 5-s-S <^-s.£-e S'S.5 ..^ ^
.= 0c--es:gc!_'5| s S 1 ^ * i
sxS5>'s_0..!a .s
?•« * £ -S i» * > S -
*^"£ Su 2'2~~--o> &»X
^IM
e»
-s
a S o _ „ ^
•~ « •« «e » »2
•t w i- •? C «
"e T- K •« «e '"S
•Il5| 8 g
"^ '= ft o « £ *°
•*• tl1 X _c? o
.. c « o
I jf 1 I E g «
8-S2.S e* =
-------
IO
g £ c.6 S~ g
J •= a ft g g «2
» C- g ** g G.-,
.„ S-f- * g Eg
iofll!:
«Ei|^
J6 J •« 3 » ™ g»
|J »<.Soo I
T-g* ""
I
e r» t c« o •= •
Illtill
§ I -g I -8
Hfltl
si i. — *° •>
£ J g g ^
•-*• |, m.. £»
seclli^EllErfitl
5 Jl-ili § I II fell
s-i&c
"I'ss
Scis *o
IIB
511!
-ill
•" •- u
^ 5
r.
5^5-8 g
£•£^1°
tt-.-s-=£^ ^
- *- ^ g J J -
I?'5 t
•^•S
s
"JS^^I3!**?*.
! «-^«J *~> St6O-._^g_^o
eJ«5|.s^5E|-e:i
• .s -segg-s s i
« ssj-E *
•gj-g« = g. &>
5 o g ^ ^ "• jg
^** o-— 5^J»S
< 1 ^ 11 c S 1
^ M ••• C£ B«M 0} S •*
MJ^llpl
ill
^1
0 i
^
-------
"2 "2
5 5
*a *
|.l
C
G>
si
&K
e c g j=i «- Q
* 8 "5 Sl-s.5
8|SI=!!IIi
c
o
o
K 3
O
2
441 ^'s
s c^. ••$
«s s Is
•^84?^ fe 8.
rt!3N
sellll
t5 C *•• O fe£ C ss c w**— fe *" B X *"* ^ W
8 1^ E
C! OJ
P«M5|
11^11
S e .9 * e
E .=
"O ~= Sfc-y = ,-q CJ
O fc> O »«( O «•£
£ S £ "** *^
l/-£lill
UIMla
l&lfsl8
^IMI^I
J!i ?
^^ *•
— s **
!< £
'-•I
ji;
isf
12?
2^1^
i^ftrlftiJi
'"'e^r'H*
s •i>-si;ili-s^3^i'g:siivill
-------
-------
Reference No. 4
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
JUN13 1983
MEMORANDUM
TO: Bob Kaneahiro
Pesticide* « Toxics Section, T-2-3
EPA Region IX
THRU: Juanita Wills, Chief
Disinfectants Branch
Registration Division (TS-767)
SUBJECT: Status of The Product DAfffOUT Under PIPRA
The requirements for the development of mildew are
high humidities and warmth. Spores of fungi cannot germi-
nate without moisture* Therefore, if the amount moisture
in an area can be kept below a certain critical level,
fungal growthvwi11 be'prevented;' •
The sample label states that the product contains
Calcium chloride, a very hygroscopic chemical used as a
drying or dehydrating agent for organic liquids and gases.
Its function in this product is to remove moisture from
the air in order to keep water, one of the elements neces-
sary for fungal growth, below the critical level. This
dehydration or dehumidification is not considered pesticidal
activity. Only plant desicants (dehydrating agents) as de-
fined in 40 CPR 162.3 (ff) (6) are considered pesticides
under the Act. Therefore the product DAMP OUT is not a
pesticide requiring registration under the ACT.
William E. Campbell, Jr.
Microbiologist
TSS/Disinfectants Branch
Registration Division (TS-767)
CONCURRENCtS
PA P«M 1120.1 (12-70)
OFFICIAL FILE COPY
-------
-------
Reference No. 5
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. B.C. J0«0
APR 21 1963
or PICK or
PKTICIOKI AMD TOXIC *
MEMORANDUM
To: The Record
Thru:
Subject:
Juanita Wills, Cl
Disinfectants Bri
Registration Division (TS-767C)
Aquatic Treatments Intended to Control Parasites
and/or Diseases of Pish in Ponds or Aquariums
While the application of these products is to the inanimate "aquatic
environment' the intent and the function of these products is the control of
parasites and/or diseases in and/or on the fish.
By adding these products to the water, you are indirectly treating the
fish orally and/or topically since the fish are not removed from the treated
water. This indirect method of treatment is used by the general public for
the treatment of fish diseases and/or parasites in aquariums. While there are
specialized methods for the direct treatment of anesthetized fish, these
methods of treatment are reserved for specially trained ichthyologists.
Only those products that are used to sanitize or disinfect aquarium
equipment or to control algae or bacterial slime, which do not include claims
for control of parasites or diseases of fish, are considered pesticides.
Where the only intended use is the control of parasites and/or disease of
fish, these products are considered exempt from the requirements of the Act
pursuant to 40 CPR 162.3(ff)(2}(ii)(A), copy attached.
Jr.
William E. Campbell,
Microbiologist
Technical Support Section
Disinfectants Branch
Attachment
-------
r
28270 .
establishment owned tor the registrant of
the pesticide product or (3> another reg-
istered establishment operate* undtr
contract with the registrant of the pesti-
cide either to package the pesticide prod-
uct «• to ww toe pesticide as a constitu-
ent put of knottier pesticide product.
provided that the final pesticide product
It registered by the transferor establlsh-
saent
The term "pest* mean* (1) any
insect, rodent, namatode. fungus, weed.
or C2> any other form of terrestrial JOT
aquatic plant or animal life or Una, bac-
terial organism or other microorganism
(except viruses, bacteria, or other micro-
organisms on or in living man or other
living •»^m«i«* which the Administrator
declares to be a pest under section 98 (e)
U> of the Act and I18244 as being in-
Juriouf to health or environment.
(ff> The term "pesticide" means any
substance or mixture of substances In-
tended for preventing, destroying, repel-
linr. or mitigating any pest, and any sub-
stance or mixture of substances intended
for use as a plant regulator, defoliant, or
The term •pesticide'' when not specifi-
cally mn^ttl or rtrllmltffd by other
words, shall include any one or combina-
tion of the following aspects of the term*
the active Ingredient (chemical or bio-
logical) : the pesticide formulation; and
the pesticide product.
The following are examples of classes
of pesticides!
Amphibian ••* NptU* poisoM and nptlknu
Antimicrobial ag*att .
VIM]
Drfotunt*
FUb poisons and npelteatt
MUBBMI pettoat
Hi
nal pol
and n
oadi
nptiluns
ttodtattcMw
SlimlcMM
(1) The term "amphibian and reptile
poisons and repellents'* includes all sub-
stances or mixtures of substances in-
tended for preventing, destroying, re-
pelling, or mitigating amphibians and
reptiles declared to be pests under Sec-
tion 162.14 of this Part Amphibian and
reptile poisons and repellents include,
but are not limited to:
(1) Substances or mixtures of cub-
stance* intended for use in baits or sprays
for killing or repelling snakes, frogs, or
lizards: and
Reproductive inhibitors intended
to reduce or otherwise alter the repro-
ductive capacity or potential of amphib-
ian or rrptile pests.
<2> Tiw term "antimicrobial agents"
Includes all substance* or mixtures of
substances, except those defined as fun-
gicides In paragraph iff Mat of this sec-
tion, and slimicide* in paragraph (ff)
(16) of tills section. Intended for inhibit-
ing the growth of, or destroying any
bacteria, fungi pathogenic to man and
RULES AND REGULATIONS
other animals, or viruses declared to be
pests under 1182.14 and existing in any
environment except those excluded in
paragraph (11) (belowK
(1) Antimicrobial agents include, bat
are not limited to:
Disinfectants intended to destroy
or irreversibly inactivate Infectious or
other undesirable bacteria, pathogenic
fungi, or viruses on surfaces or inanimate
objects.
(B) Sanltlzers intended to reduce the
number of living bacteria or viable virus
particles on Inanimate surfaces, in water,
or in air:
Baetertostats intended to inhibit
the growth of bacteria in the presence
of moisture:
SterHtotrs Intended to destroy
viruses and all living bacteria, fungi and
their spores, on Inanimate surfaces*
Fungicides and f unglstate intended
to inhibit the growth of. or destroy fungi
(Including yeasts). pathogenic to man or
other animals on Inanimate surfaces;
aad
(P> Commodity preservatives and pro*
teetants intended to Inhibit the growth
of, or destroy bacteria In or on raw ma-
terials touch as adhearm and plastics)
mcd io irisf THI f si cfrirt ntTi wr BI^ *nrfiirtu pfd
products (such as fuel, textiles, lubri-
cants, and paints).
(U) Antimicrobial agents do not In-
clude those antimicrobial substances or
mixtures of substances subject to the
provisions of the Federal Pood. Drug aad
Cosmetic Act. as amended (21 USC Ml
ft sea) such as:
f (A) Substances or mixtures of sub-
stances intended to Inhibit the growth
of. inactivate or destroy fungi, bacteria,
or viruses in or on living man or other
animals: and
(B) Substances or mixtures of sub-
stances intended to inhibit the growth
of. inactivate or destroy fungi, bacteria.
or viruses in or on processed food, bev-
erages, or Pharmaceuticals including
cosmetics.
(3) The term "attraetants" includes all
substances or mixture! of substances
which, through their property of attract-
big certain animals, are intended to
mitigate a population of. or destroy any
vertebrate or invertebrate animals de-
clared to be pests under i 1*2.14.
Attnctants Include, but are not
limited to: iA> Sensory stimulants isuch
as pheromones. synthetic attractants.
and certain extracts from naturally-oc-
curring- organic materials) when used
alone, or when in combination with tox-
icants that can kill certain vertebrate
or invertebrate animals, that are in-
tended to draw certain animals Into traps
or away from crops or sites: these sensory
stimulants are considered to be active
Ingredients in pesticide products: and
Toxicants intended to kul or de-
stroy certain birds;
(11) Toxicants Intended to cause, by
pharmacological action, repelling of birds
away from certain sites;
(ill) Sensory agents utilizing taste.
sight, touch, or other means, intended to
repel certain bird species or populations
from certain sites, to reduce their pre-
dation of certain seed and crops, or to
protect other organisms or objects from,
injury, soiling, or harassment; and
Repellents Intended to repel species
dangerous to man or Injurious to aquatic
organisms which man wishes to protect;
and
Sex influence agents intended to
control sexual development of fish, such
as to cause young to develop into all-
female populations.
««• The term "fungicides- includes
alt subst.inccs or mixtures of substances
intended for preventing or Inhibiting the
growth of. or destroying any fungi de-
clared to be pesU under f 182.14.. except
thow xubttanrrs defined as slimlcides in
pnrorrnjjh '16> of this wt:on and
those funcicides and funcistats denned
as antimicrobial agents in paragraph iff)
i2iii><£i of this section and tho*o
antimicrobial substances or mixtures of
KOttAl itCimi, VOL 40, NO. »«—THMSOAY, JUUT J. WS
-------
Reference No. 6
-------
-------
ENVlhOi'JMENTAL PROTECTION AGENCY
** MAR i 3 1973 ' .
?*&*
At* if;
S**}«* Implementation of definitions (k) and (n) of the FEPCA^
*w All Branch Chiefs " -
Section 2, Definitions, of the FEPCA became effective upon
enactment. I am particularly concerned that definitions (k) and
(n) be implemented immediately, (k) indicates that fungus en or
in processed food, beverages, or Pharmaceuticals ere exempt from
the provisions of the Act, and thus not subject to registration
by this Division.
Therefore, we must a) cease processing any applications for
products of this type and b) notify registrants who have pending
applications for products of this type that these products are no
longer subject to registration under the FIFRA. In this regard,
. I would also like to know the number of products currently regis-
tered which are no longer subject to the FIFRA because of definition
(^}- After receiving this information, a determination will be
»«de rcgardins the h«*st nsetnoo to ini'vim MIC rsgi-trirt? ?* *****
change.
Regarding definition (n), it is no longer penaissable to accept
an ingredient statement in accordance with option 2 of the old FIFRA.
All products must now conform to FEPCA Section 2, (n). We should be
lenient in implementing the change on products already registered,
and allow time for registrants to dispose of stocks on hand.
_
Acting Assistant Director
-------
-------
Reference No. 7
-------
-------
€T
March 8. 1979
cr. L D. No. 174412 - Oxy-trite Shock .
Treatment
Acting Section Head/TSS/Disinfectants Branch
Registration Division (TS-767)
to< L D. Review Team/Process Coordination Branch
Registration Division (TS-767)
The Administrative Law Judge. Spencer L. Nissen, in his decision in the
matter of Jonas and Company, Inc., (LF.& R Docket No. HI - 121C) dated
27 July 1978, determined that a purpose and effect of superchlorination is
algae control and that the reasonable pool owner or operator would regard
the purpose of superchlorination as, at the very least, including algae con-
troL
Baaed on this decision, the Agency views superchlorination, or any proposed
substitute, as a pesticidal activity.
Superchlorination involves the phenomenon of breakporttt chlorination which
is the point at which chloramines and nitrogenous materials are oxidized or
destroyed. The significant difference between breakpoint chlorination and
"break-through1* oxidation (oxidizing organic molecules irith non-chlorine
products) is that the chlorine available after achieving breakpoint chlorina-
tion is referred to as free available chlorine which is an excellent disin- « ,
fectant and/or algicide. The effectiveness of free available chlorine as a it**
established fact in the industry.
The active oxidizing agent of Oxy-brite, monopotassuim peroxymonosulfate,
is not generally recognized as an algicide or disinfectant for swimming
pool water and the intent for such aa effect cannot be gleaned from the
label. Additionally, most public and private swimming pools are maintained
in accordance with state and/or local codes which are based on Suggested
Ordinance and Regulation's Covering Public Swimming Pools (Prepared by
the joint Committee on swimming pools of the American Public Health
association in cooperation with the U.S.P.H.S. 1964).
Therefore, since the active oxidizing agent of the subject product is not
generally recognized as a swimming pool water disinfectant or algicide,
the average pool owner, operator, or supplier would not likely use or
recommend that this product be used as a pesticide.
CPA POMN IMM IftCV. »»**l
-------
Since the Agency views superchlorination or any proposed substitute as a
pesticidal activity, the claim "Replaces Superchlorination on the label qf
subject product constitutes a pesticidal claim requiring registration pursuant
to the Act.
The term "oxidizing agent" is not generally associated with pesticidal activity.
Therefore, deleting the label claim "Replaces superchlorination" would remove
the pesticidal claim and the requirement for registration of subject product.
It should also be noted that the use of the term "Replaces Superchlorina-
tion" is considered a mionomer for non-halogen products because of the
phenomenon of breakpoint chlorination. It is our considered opinion that
the only way a non-halogen product can be considered a replacement for:
superchlorination is that a measurable pesticide, derived from the product,
be established in the water after achieving "break-through" oxidation.
m reference to the statement in item 24 of the Collection Report, Mr. Brown
recall a general conversation with representatives of the Company. However
no specific labeling and/or claims were accepted as not falling under the
FIFRA.
£> Campbell Jr.
'6
-------
PRODUCT
DATA SHEET
MOftlOPERSULFATE COMPOUND
OXONE* monopersulfate compound (2KHSO«*
KHS04*K)SO«} is a white, granular, free-flowing
powder that is a unique (triple mtt comprised of
two moles of potassium monopersulfate (potas-
sium peroxymonosulfate, KHSO*). one mole of
potassium hydrogen sulfate (KHSO«), and one
mole of potassium sulfate (K, S04 ).~\Potassium
monopersulfete is the active component with a
chemical structure of
O
K-O-S-O-O-H.
0
OXONE is a unique acidic peroxygen compound
that is useful, particularly in specialty formulations,
where an odorless oxidizing agent is desired, such
as in laundry bleaches, scouring powders, denture
cleaners, bowl cleaners, and in the manufacture of
organic compounds.
TABLE 1
SOLUBILITY OF OXONE9
MONOPERSULFATE COMPOUND
IN WATER
Temperature
•C -F
20
27
49
60
L"
68
80
120
140
160
gOXO/Vf/100gH,O
25.6
26.8
30.0
31.5
33.5
PHYSICAL PROPERTIES AND
TYPICAL ANALYSIS
Molecular Weight 614.5
Active Oxygen, % min. . 4.5
% theoretical &2
Bulk density, g/cc * 1.12-1.20
Ib/cu ft 70-75
Particle size
through U.S.S. #20 Sieve. % 100
through U.S.S. #200 Sine, % 10
pH,925*C
1% solution £3
3% solution 2O
Solubility, g/1 QOg H, 0 at 20*C 25.6
Moisture content, % 0.1
Stability, % active oxygen loss/month <1
Standard Electrode Potential (E*), volts -1.44
Heat of decomposition. Btu/ib 33
Thermal conductivity. Btu/(hr) (ft1 H* F/ft) 0.08
Solubility
Relatively concentrated solutions of monoper-
sulfate ion can be prepared because of the unique
solubility of OXONE. A slurry of 40% OXONE in
water at 27*C (80" F) gives a solution of 14% by
weight monopersulfuric acid. Active oxygen
recovery is 90%.
•ftea.US.Pat.Off.
-------
A Shocking Development:
Wtttr MMftrwif cA*mfc*Js using. Du font's "Oxon*" h9lp *t»p poo/ and fcof tub own«n in tfte swrm or" tfi/ngs
help keep hoi
tab and pool
boom in pool construction has grown with
increased attention to physical fitness,
spurred by such medical studies as those
showing swimming to be beneficial to the
heart
To insure that the pool is always ready
tor use requircsa regular chemical mainte-
nance program. A multitude of things can
contaminate a pool, such AS suntan lotion,
cosmetics, hainpray, even the act of swim-
ming itself—an active swimmer will give
off a pint of pcnpintion in an hour.
To sustain a constant tight against pool
contaminants, chlorine is routinely added
to pod water to destroy hactcria and "hum
off" suspended solids through .oxidation.
But this processJorms compounds .called
chloramincs and. while they remain a
form of chlorine, chloramincs arc only one-.
fifteenth as effective as "five chlorine"
By JAMES MOORE
Human nature being what it is, when its
hot we pray for snow and, of course, when
it snows we dream of vacations in the sun.
For some three million American families,
however, summer's heat is beatable with-
out calling in the snow—they lump in their '-.
own swimming pool •»
The number of residential pools has tre- »
bled in the last ten yean, lending credence L
to the U.S. Bureau of Outdoor Recreation r
statement that swinunins is by far the lead- t
ing individual participatory sport. The ?
f
* *
-------
in killing microorganisms and bacteria
which might infect bathcn.
So, ai every pool owner knows, the fight
must fo on. The next maintenance step
required is called a "shock treatment." A
massive dosafe of chlorine is added to the
water about every two weeks to destroy the
eUomnino.
Treating a pool this way is like taking a
pofo stick ride," explains lames F. Stem,
executive vice president of Great Lakes
Biochemical Co., Inc. "First there isn't
enough chlorine, so you add some, and
Whether tt'i to Mtmgt Mnd '
rwtfut deep, or just for fanttv fun. hot tutu aod
ipM DsWt DCCOnM A |Mt|TltisH* IMW IMRW pfOOUCt*
then there's too much aftershock treating
so you can't use the pool for several hours.
Up, down, up, down."
About two yean ago, Great Lakes Bio-
chemical, a Milwaukee producer of spe-
cialty chemicals, introduced a new shock
treatment compound to its line of water
treatment chemicals. Bearing the name
"Oxy-Brite", the granulated oxidircr is de-
signed to slow the "pogo stick" mainte-
nance chore for pool owners by providing
a long lasting residual effect which main*
tainsaclcansing potential in the water and
reduces chlorine demand.
The maior ingredient in "Oxy-Britc" is
"Oxonc" monupcrnulfatc compound, an
odojtsjs oxidizing agent produced by
. Uneful in specialty formulations
' laundry bleaches, scouring pow-
ders, and denture cleaner*, "Oxonc" was
attractive to Great Lakes Biochemical be-
cause is don not contain chlorine.
'The biggest problem with chlorine is the
fact that you can't bank it," continues
Stem. "By that, I mean the chlorine doesn't
fight contaminants in the water ovcralong
period of time, but starts right in forming
chlorsmines. Only a few days after shock
treatment there isn't enough chlorine to
properly fight bacteria."
By usinga chemical which does not con-
ceed without raising the chlorine level so
high that an extended waiting period must
be observed before the pool is usable. "No»
body wants to tit next to a pool full of
chemicals and wait for the chlorine level
to drop," mined Stern,
As required of ashock treatment, "Oxy-
Brite" removes built-up contaminants and
chloramines. But in addition, itaisoacts to
prevent die formation of new chlora-
mines, thereby making the chlorine intro-
duced during *h* regular chlorinatioa ptoc-
ess more "bankable."Tbis assures the pres-
ence in the water of free chlorine residuals
to continually attack bacteria between
shock treatments.
Great Lakes Biochemical's president
and director of research, Dr. Robert M.
Stem, lames' older brother, is also a myth
destroyer. Popular thinking holds that ex-
cessive amounts of chlorine in pool water
cause the infamous eye bum and odor
commonly associated with pools.
"Chloramines are really the bad guys,"
offers Dr. Stern. "They make the water
cloudy and cause eye bum. A pool, particu-
larly one indoors where the air doesn't
circulate as freely, will have an odor when
there are too many chloramines.
"If you can keep the chloramines from
forming in the first place, the water will
sparkle and be clearer. Obviously, it's also
going to be healthier for the swimmers. You
can't do without chlorine because the
water always needs a disinfectant. If you're
able to achieve a more uniform chlorine
level, and let the chlorination process do
its iob, you'll get more use out of the pool."
Doing more swimming in a pool and less
work ha» teen the objective of Dr. Stem's
research for more than 20 yean. As a result.
Great Lakes Biochemical now offer* a
broad line of products to control algae in
swimming pools, lakes, ponds and foun-
tains, as well as nut and corrosion pre-
venters, evaporation inhibitors, anda full
line of cleaners for surfaces which nor-
mally come in contact with water.
"All our research here has been designed
to solve the problems of maintaining clear,
sparkling, estnetically pleasing water," Dr.
Stem said.
Safe and healthful water is even more
critical for « home product that's rapidly
growing in popularity— the hot tab.
Spawned in this county in Southern Cali-
fornia, more than 100,000 tubs are ex-
pected to be sold this year.
Available in many shapes and SOB*, the
hot tubs requite maintenance similar to a
pool only more frequently. Blame the high
water tempestuies and nvinpffr or p^fff
who may cntoy a hot soak in the tub's
limited space for this.
"The hot tubs, or spas, have been around
for some time in health clubs, but all the
attention lately to physical fitness has
made them popular for the home," Dr.
Stem said. "Obviously, if people perspire
in a swimming pool, the problem is only
going to get worse when the water ;
rare is up around 105 degrees. In a health
club, where lots of people are using the
same water, well it sure has got to be clean
or that dub won't be around long. We've
formulated our product specifically for the
higher temperatures."
For hot tub water treatments. Great
Lakes Biochemical often a product called
"Activate". It, too, is based on Du Pom's
"Oxone". A key property of "Oxone", its
dusolvability, produccsa shock treatment
solution which leaves no concentrated un-
dissdved chemicals on the pool or tub floor
to cause scaling or bleaching. Equally im-
portant, there is no chemical residue to
foul the pumping and filtration equipment
necessary for proper hot tub maintenance.
For more information on "Oxy-Britc"
and "Activate" plus a list of distributors of
Great Lakes Biochemical products, write
to: SHOCK TREATMENT. i)u float
tine. Wilmington. DE 19898.
-------
-.* -
13 DEC 1978
Mr. B. Ronald Klasko
Law Off ices
Fourteenth floor
I*od Title Building
100 Sooth Broad Street
Philadelphia, Pennsylvania 19110
to your letter of November 21, 1978, in which
you express the urgency of your belief that OCT-BRIEE should be Ismail
ately removed from the marketplace. Purthersore, yoa request a •status
report* of current and contemplated tfh activities with regard to this
Ibe Regions have all been inf orssd of this issue, ttditionally,
your special concerns have been relayed to Region V, the location of
the QKY-BRITE manufacturer. Region V officials are initiating a prompt
investigation.
Zf I can be of further help to you, please contact me.
Sincerely yours.
A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforoenent Division
PTScD:SSB:P.HJ3SELL:dt:ra.3632:ex.50630:12/11/78
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460 ,
OFFICE OF ENFORCEMENT
MEMORANDA
SUBJECT:
TO:
"Superchlorination"
Enforcement Division Directors
Pesticide Branch Chiefs
The enclosed letter is being sent to you for your information.
M. Jonas, and Co., Inc., was fined for selling SCORCH, an unregistered
product. This product, containing calcium hypochlorite, was sold as a
"superchlorinator". Super chlorination is the addition of extra chlorine to
oxidize the organic matter in the swimning pool. Once the "chlorine demand"
has been satisfied, residual chlorine remains in the pool for antimicrobial
activity. The organic molecules may also be oxidized with non-chlorine
products.
In his decision, the Administrative Law Judge, Spencer T. Nissen,
determined that "superchlorination" is a pesticidal activity. Thus, any
product making a claim to superchlorinate (or to "replace superchlorina-
tion " ) requires registration.
If you have any questions on this matter, please contact Pamela Russell
of my staff (PTS 755-0630).
irector
Substances
Ivision
Enclosures
A. E. Conroy I
Pesticides and
Enforcenen
-------
-------
Reference No. 8
-------
-------
Consolidated StatoEccnt-of Registration Policy .?K^R t977
for Articles and ilaterlals Impregnated with •
Antiniicroblal Pesticides
Acting Director
Registration Division (UH-567)
Deputy Assistant Adtalnlstrator .'
for Pesticide Program (Mf-066)
The'Federal, Insecticide, Fungicide, end Rodentleido Act, as aecnded,
considers any substance or mixture of substances intended for pre-
venting, destroying, repelling, or aitirjating viruses, bacteria, or
other oicroornanis&s (except viruses, bacteria, or otner raicro-
orgaiiisas on or in living nan or other living anioals) to be pa&tlcides.
Such products as disinfectants, sanitlzers, bacteriostats, and
sterilizers are generally referred to as antimicrobials. This tern
also includes fungicides and funci stats which are intended to inhibit
the growth of, or destroy fungi (including yeasts), pathogenic to
•an or other anIra Is on inanimate surfaces* Bacteriostats and fun*
gistats are often Incorporated into fabrics or end-articles to inhi-
bit tte growth of bacteria anil fungi in the presence of adequate
moisture for toe purpose of prolonging the useful life of these
treated substances or preventing the dcvelopnent of undesirable odors
associated with nicrcbial growth and multiplication.
The t-.isic chemical manufacturer or forariator nvst obtain registration
for each specific use of an antimicrobial product intended for in?reo-
nating materials or end-articles before it can be legally offered for
sale. The treated material or end article is then exempted fron the
requirement for registration under the provisions of Section lC2.4{c).
As with other pesticides, products intended for Impregnating materials
or end-articles are registered on the basis of demonstrated efficacy
and safety. The burden of proof in this regard rests with the appli-
cant. As with other antimicrobials, the site-target pest relationship
1s of utmost Importance in demonstrating product efficacy. The Impreg-
nated articles or materials must be tested enploying specific odor-
causing bacterial or fungal Isolates at.concentrations shown to be the
cause of offensive odors or product degradation. Sufficient replication
Is required to demonstrate reproducibility of results and to eliminate
-------
experimental error. Only articles or eatsrials that are Hhely
to becoae moist or vetted during norm! conditions of use will l»e
acceptable uses for registration f0r the inprc'.n.itlnn materials.
Unless 1t can oe demonstrated tnat treated materials that are like-
ly to renal n dry under non.:al coudl liens of use are also a source
of bacterial odors or subject to nicroblal degradation, products
reco-'sraended for impregnating articles or materials in such instances
shall not be considered for registration.
The site- target pest relationship must be Identified in deteminlng
whether the ii.orennatlnn treatment v/ill serve the purpose for which
it is Intanaad. Tne site in such Instances is the treated article
or materials. TKC target pasts are those odor-causing or degrading
Bicrobial Isolates obtained frcw an untreated sarnie of the material
or article to be impregnated. If .the pesticide used in t!ie tipregna-
ting process can be demonstrated to inhibit the oro:th of tha odor-
causing or degrading aicrcbial isolates when incorporated into the
finished article or caterlsl, it will be deemed to be efficacious in
fulfilling the purpose for which the impregnating treatment 1s In-
tended.
Many registrants have sought to amend the registration of existing
products to inclu& uses In iscrognatlnf) footwear such as socks, shoe
linings, and sJws inserts, sn&inq to claim effectiveness for the
treated articles aqaihst athlete's foot fungi. Athlete's foot fungi
(TricJioghyton rantagroahytos) are pathonenic fungi ccsvnonly recog-
ni2C4d by the lay ccnsuisr. Our registration policy for kmrcgnated
Articles and paterials dcss not prrvide for acceptance of the athlete's
foot fungi data based on a "altlaatina." .or funglstatic level of
activity.
Although the registration policy regarding residual antlnlcrobial ac-
tivity of icprcsnatcd articles and naterials has Lsen recently re-
vised, it is ncu: considered sound and workable. This currant policy
also precisely conform with ti;e requ1ren»nts delineated in 162.21
(2) of the Section 3 Regulations.
The requirement that products for which clalos of effectiveness
against pathogenic bacteria and fungi are made In labclino must demon-
strate the ability to eliminate siicroonjMisas or reduce their ncpu-
lation to safe levels (and not narely inhibit their grovitli) is con-
sistent with the overall registration program for antimicrobial pesti-
cides.
Douglas 0. Canpt
cc: Gary Bass
WH-C7:DIS:EFBrowu:bb:HS:JE:JJru 343 XC9458
3-3-77
-------
Reference No. 9
-------
-------
37992 F«d«raJ Register / Vol. 49. No. 188 / Wednesday. September 26. 1884 / Proposed Rules
than cm the performance of the
ice itself, such u nt and mouse
>*> fly swatters, and tillage
pment for weed control.
4 Those that operate only to entrap
vertebrate animal*, such as fish traps.
(c) Required labeling information. The
following information must be included
on each device, its wrapper, or its
package:
(l) Nome, brand or trademark. The
label of a device whose function is not
obvious oust include a name, brand or
trademark, and an indication of the
function of the device.
(2) Name and address of the producer
or distibutor. The name and address of
the producer of the device must be
provided on the label. Refer to f 15&24
for further information on name and
address requirements.
(3) EPA establishment number. The
label of each pest control device must
bear the establishment registration
number assigned under FIFRA section 7.
This number may appear in any location
on the label or on the device itself. If the
device is contained in a wrapper or
outer container through which the
establishment number cannot be dearly
read: the establishment number must
also appear on such outer, container or
wrapper. Refer to 115841 for further
information on the display of the EPA
r. The
! number may not be
or emphasized by size, color
typography to imply Agency approval.
or endorsement
(4) Precautionary statements. The
label must identify any hazards posed in
using the product, and must provide
adequate warnings and use limitations
that if adhered to. will protect against
or ininimJZB such hazards. Hazards may
include, but are not limited to. structural
(such as sharp edges), mechanical (such
as rapidly moving parts), electrical, high
temperature, radiation, chemical, or
noise.
(5) Directions for use. Directions for
use of the product must include, at a
minimim. the following information: .
(i) Site of use. Where the device is
intended to be used, positioned, or
located.
(ii) Activation, instructions on bow to
install or activate, and. if necessary.
deactivate the device if it-would not be
self-explanatory or obvious to the user.
(u'i) Target pest. The pest{s) the device
is intended to destroy, capture, repel or
affect, and the results that may be
expected (death, entrapment repellency.
inactivation).
(iv) Restrictions or limitations on use.
' specific circumstances under which
i should not be used, or that
F limit the effectiveness of the
device. If the duration of the
effectiveness is limited, the length of
time the device can be expected to be
effective must be indicated. If the
product would not be effective in certain
situations that might reasonably be
encountered in use. a statement to this
effect must be included.
(d) False and misleading statements.
The labeling of a pest control device
shall not contain any statement that is
false or misleading in any respect
Examples of false and misleading
statements.may be found in 1150.15.
Product labeling may bear "sterilizer"
or "sporitidar claims It-
fa) The product meets the standard in
paragraph (b) of this ssctiou. when
tasted by at least two laboratories^me
of which is independent of the
registrant and
(b) The product when tasted b)' the
method in { 9i-2(a) of Subdivision C of
the Registration Guideline* or Its
equivalent kills the tast-aporwoa all
720 carriers used to the i
fiMJOS Disinfectants for use on hard
(a) Performance requirement Product
labeling may bear claims as a
"disinfectant" if. when tested by the
appropriate method in section 91-2 (b).
(c). or (d) of Subdivision G of the
Registration Guidelines or its
equivalent kills the-last microorganisms
on M out of 80 carriers of «ach set to
provide significance attbe 96 .percent
confidence level.
(b) Limited efficacy claims. The
labeling of a disinfectant which is
effective against specific
microorganisms only (e.g. Herpes virus,
influenza virus, cold (rhino) viruses)
must clearly denote these limitations.
Furthermore, such limitations must be .
readily understandable and shall not be
misleading to the user.
(c) General or brood-spectrum
efficacy claim*. Labeling claims of
effectiveness-as a "General
Disinfectant" and representations that
the product is effective against a broad
spectrum of microorganisms are
acceptable if the product is effective
against both Gram-positive and Gram-
negative test microorganisms.
(d) Hospital or medical environment
efficacy claims. Labeling claims for use
on surfaces in hospital or medical
environments will be accepted only for
those products that have been
demonstrated to be effective for general
or broad-spectrum disinfection (see
paragraph (c) of this section) and
additionally against Pseudomonas
aeruginosa. Oaims such as "hospital
disinfectant" or "for hospital use" are
acceptable. Claims such as "hospital
grade" or "hospital strength" are not
acceptable. „•
f 1K410
mat
(a) Performance requirement. Product
labeling may bear claims of
effectiveness against pathogenic fungi if
the product kills all fungal spores by one
of the following test methods:
(1) The AOAC Fungicidal Test (see
section 91-2(e)(l) of Subdivision G of
the Registration Guidelines) or its
equivalent or
(2) The AOAC Use Dilution Method or
AOAC Germiciadal Spray Products
Test modified to conform to appropriate
elements of the AOAC Fungicidal Test
(see 191-2(e)(3) of Subdivision G of the
Registration Guidelines) or its
equivalent
(b) Claims against pathogenic fungi.
The statement that a product is effective
against "athlete'a loot" is not
acceptable, ff-the product is effective
against the causative organism
[Trichophyton mentofropfiytes} in
appropriate areas such as shower room
floors, locker room benches, or bath
mats, the label may bear a statement
such as "kills athlete's foot fungi on
inanimate surfaces."
f 1HJ18
(a) Performance requirement. Product
labeling mar bear claims as a "virucide"
against designated human-pathogenic
viruses if. when tested according to the
method in section tt-Zffl of Subdivision
G of the Registration Guidelines or its
equivalent the product:
(1) Inactivates the virus at all dilutions
when no cytotoxicity is observed in the
assay system: or
(2) Reduces the viral tiler by at least a
3-log magnitude when cytotoxicity is
observed in the assay system.
(b) Virucidal claims. The unqualified
claim "viruddal" is not acceptable. The
claim "vinitidal" must be qualified by
designating each specific virus against
which the product has been tested and
shown to be effective, and to indicate
that the activity occurs only on
inanimate surfaces.
Itftao
(a) Performance requirement. Product
labeling may bear claims as a
"tuberculocide" against Mycobacterium
-------
Federal Register / Vol. 49. No. 188 / Wednesday. September 28. 1984 / Proposed Rule*
tuberculosis if. when tested by the
appropriate method in section 91-2(g) of
Subdivision C of the Registration
Guidelines or its equivalent:
(1) The product kills the test
microorganisms on all carriers: and
(2) No growth occurs in eny of the
inoculated tubes of the two edditionel
required media.
|b) Tuberculocidol claims. The
labeling of a product claiming
disinfection of inhalation therapy
equipment and pulmonary diagnostic
equipment but which has not been
tested for effectiveness against
'•tycobacteriam tuberculosis must bear
the following statement: This product
has noi been tested for effectiveness
asainsi .\hcobacttriutn tubercu.Mis.
«nd must not be reii«d upon when a
tuberculocidai product is desired."
§?MJ2S Phenol coefficient
The phenol coefficient, es determined
by the AOAC Phenol Coefficient Teet in
section n-2(h) of Subdivision C of the
Registration Guidelines or its
equivalent is permitted to appear on
labeling only if:
ia) The product is a disinfectant, with
use directions adequate to support a
disinfection level of antimicrobial
Brevity: and
b) The phenol coefficient, when
r.ui::plied by 20. provides me effective
use dilution of the product (as confirmed
by the AOAC Use-Dilution Method (eee
section 91-2 (•). (b). or (c) of Subdivision
G) or its equivalent]; and
(c) The phenol coefficient is
determined on the pesticide es
formulated, rather than the active
ingredient(s).
§11*330 Products for UM
areas and surfaces and thus may
present a potential problem.
(a) Performance requirement. Product
labeling may bear disinfecUntxlaims
against specific microorganisms other
than designated test species if. when
tested by the appropriate method of
section 91-2(i) of Subdivision G of the
Registration Guidelines or its
equivalent:
|l) The product kills the test
microorganism on ail carriers: and
(2) Plate count data on appropriate
culture media demonstrate that a
concentration of at least 10*
microorganisms survived the carrier
drying step in untreated controls.
(b) Claims against other
rr:rrnoreonism. Substantiated claims of
effectiveness of a product against
specific microorganisms other then (he
designated test microorganism^) are
permitted, but not required, provided
that .the target pest is likely to be
present in or on the recommended vise
fa) Performance requirement. Product •
labeling may beer "sanitizing" daims
for use on non-food contact surfaces if.
when tested by the method in section
9l-2(j) of Subdivision G of the
Registration Guidelines or Its
equivalent the product achieves r
reduction of at least 99J percent over
the parallel control count
(b) Claim. The labeling of a product
intended for use on non-food contact
surfaces which does not eliminate, but
significantly reduces, the numbers of
target microorganisms musi be dearly
represented and qualified as being
effective at the sanitizing level only.
Examples of acceptable labeling claims
are: "Sanitizes". "Significantly reduces".
or "Reduce* the number of bacteria by
M4X." Products recommended for use
in critical hospitaJ or medical
environments (hat ere not effective et
the sterilizing or disinfecting level must
bear a labeling disclaimer statement
such as: "This product is not a
disinfectant or sterilizer".
(c) Fogging application*.
Representations such as "gcnnicidai
foggiag" and "dis:nfectam fogging" are
not acceptable. Claims for fogging
applications of disinfectants to sanitize
room surfaces en acceptable.
(d) CircuJote-w-pJoctfClP}
applications. Claims for OP
applications as "germicidal" or
"disinfecting" an set acceptable.
Claims for OP applications to sanitize
the surfaces of the systems are
acceptable.
f is&aeo
(a) Performance requirement—(1}
Halide chemical products. The labeling
of a product formulated with iodophors.
mixed betides, or chlorine-containing
chemicals may beer deims for
"seaitfzlBg" food contact surfaces if.
when tested by the method in section
91-2(k)(l) of Subdivision G of me
Registration Guidelines or its
equivalent the product concentrations
show equivalence of activity to 90.100.
and 200 ppm of available chlorine. (The
test standard is sodium hypochlorile.)
(2) Other chemical product*. The
labeling of a product formulated with
other cnemicals.-such aa quaternary
ammonium compounds, aoionic
detergent-acid compounds, and
chlorinated trisodium phosphate, may
bear daims for "umtizing** food contact
surfaces if. when tasted by the method
in section 9l-«k)(2)-cf Subdivision G of
the Registration Guidelines or its
equivaknt the product achieves*
90.996 percent reduction in the number
of each lest microorganism within 30
[b) Claim*. Claims fora use pattern of
"one-step" deaBme and sanitizing ere
not acceptable for food-contact surfaces.
ff Oil IttHe-
(e) Performance requirement. Product
labeling may beer residual "self-
sanitizing** «>•'•»• (that can be identified
as related to human health) if. when
tested by the criteria in section 91-2{m)
of Subdivison G of the Registration
Guidelines or its eouivalent the product
achieves et iesst a 995 percent
reduction in numbers of lest
microorganisms on the treated
surface(s) over those on the parallel
control surfaced).
(b) Claim*. Label claims pertaining to
residual "aeif-eanitixing- or
"bacterioatatic" surfaces (Le, reduction
In numbers, or inhibition of the growth.
respectively, of specific microorganisms
that may be present or mat may be
subsequently deposited en hard
surfaces) must be related to the
presence of moisture on surfaces net
sre.likeiy to become wet under normal
conditions of use. Lab-jin; must also
indicate the duration of effectiveness of
the treatment Only self-sanitizing
daims can be Identified as related to
htunen health considers
flMJM Laundry
M Disinfecting ore-took— {1}
Performance requirement Product
labeling may bear claims as a
-disinfectant" for pre-eoeking fabrics
prior to laundering if. when tested by the
AOAC Use Dilution Method es
described in section 91-2 (b), (c). or (d)
of Subdivision G of the Registration
Guidelines (modified to include organic
soil es in section 9l-30(e)(4) of
subdivision 5) or its equivalent the
product kills the test microorganisms on
90 out of 60 carriers of each set
(2) Claims* Labeling must distinguish
between products recommended aa
soaking treatments prior to laundering
and products recommended as additives
in actual laundry operations. Pre-
soaktng claims are applicable only to
products which have been shown to be •
effective as "one-step" deaoer-
disinfectanta for hard surfaces in the
presence of moderate amounts of
organic soil (e-g~ "pre-soak diapers for
10 minutes to disinfect").
(b) Non-retiduai iaundry odditiv
(1) Performance requirement, (i) The
labeling of e product intended as a
-------
37994 Federal Register / Vol. 49. No. 1B8 / Wednesday. September 26. 19B4 / Proposed Rules
sundry additive may beir claim* for ~
jiinfection" if, when tested by the
1 in section 91-4(a)(2) Subdivision
•>f the Registration Guidelines or its
.ivalent. the product prevents growth
,. each test microorganism in fabric
subcultures or laundry water
subcultures.
(ii) The labeling of a product intended
as a laundry additive may bear claims
for "sanitizing" if. when tested by the
method in section 9l-4fa}(3) of
Subdivision C of the Registration
Guidelines or its equivalent the product
causes at least 99.9 percent reduction in
numbers of each test microorganism
over.the control count for both fabric
and laundry water.
(2) Claims, The labeling of a product
recommended as a laundry additive
must differentiate between claims to
provide non-residual disinfection and to
sanitize during the laundry operation
(e.g., "disinfects laundry in wash water."
"sanitizes laundry in the final rinse
water").
(c) Residual laundry odditives—{\)
Performance requirement. The labeling
of a product intended as a laundry
additive may bear residual "self-
sanitizing" claims (that can be identified
as related to human health) if. when
tested by the method in section m-
4(e)(4) of Subdivision C of the
«itraiion Guidelines or its
•alert, the product demonstrates a
rtion of at least 99.9 percent in
.mbers of each test microorganism
over the zero-time control and the
parallel untreated control.
(2) Claims. Claims for residual
antimicrobial activity on laundered
materials or articles are acceptable only
when such materials are likely to
become and remain wet (for example,
diapers and bed linens of incontinent
persons) during normal conditions of use
and storage (e.g.. "provides self*
sanitizing residual activity against
pathogenic microorganisms on bed
linens in the presence of wet
contamination").
5156J55 Fabric and textile products.
(a) Carpet sanitizers—performance
requirement. The labeling of a product
intended as a carpet treatment may bear
claims as a "sanitizer" If. when tested
by the method in section 91-4(b) of
Subdivision G of the Registration
Guidelines or its equivalent, the product
demonstrates a 99.9 percent reduction in
numbers of test microorganisms over the
scrubbed control.
(b) Mattrtts and upholstered furniture
treatments—performance requirement.
The labeling of a gas or fumigant
intended for treatment of
s. upholstered furniture.
pillows, and similar objects may bear
claims as a "sterilizer." and
"disinfectant." or "sanitizer" if. when
tested against the criteria in section 91-
4(c) of Subdivision G of the Registration
Guidelines or its equivalent, the product
meets the performance requirement
specified:
(1) In 115&300(a) for sterilizers; or
(2) In i 15&305(a) for disinfectants: or
(3) In {1S&335U) for sanitizer*.
(c) Fabric impregnating treatments—
(1) Performance requirement. The
labeling of a product intended for
impregnating fabrics may bear residual
-self-sanitizing" claims it when tested
by the method in section 91-2(m) of
Subdivision G of the Registntion
Guidelines or its equivalent the product
achieves at least a 99.9 percent
reduction in numbers of test
microorganisms on the treated fabric(s)
over those on the zero-time control and
the parallel untreated control.
(2) Claims. Claims must be limited to
residual self-sanitizing levels of activity
in the presence of moisture. Labeling
must indicate the duration of
effectiveness of the residual activity.
(a) Performance requirement. The
labeling of a product intended for the
treatment of air in enclosed spaces may
bear claims as a "sanitizer" if. when
tested- by the appropriate method in
section 91-5 of Subdivision G of the
Registration Guideline! or its
equivalent the product meets one of the
following standards:
(1) If the product contains glycois. a
vapor concentration of 50 percent
saturation or more in the air of the test
enclosure: or
(2) If the product does not contain
glycois. a reduction of at least 99.9
percent of test microorganisms over the
parallel untreated control in the air of
the test enclosure.
(b) Claims Claims that s product
prevents diseases, or provides any other
health protection, whether expressed or
implied, are not acceptable. Claims must
clearly indicate the mitigating nature of
the activity, such as •Temporarily
reduces the number of airborne
bacteria."
Tenet bowl and urtnal
(a) Surface treatments—(1)
Performance requirement. The labeling
of a product intended for toilet bowl and
urinal surface treatment may bear
"disinfecting" or "sanitizing" claims if.
when tested by the appropriate method
in section 91-2 fb)/(c). (d). or (j) of
Subdivision G of the Registration
Guidelines or its equivalent, the product
meets the performance requirement
specified in:
(i) Section 156.305(a) for disinfectants:
or
(ii) Section 156J35(») for sanitizers.
(2) Claims. Claims for disinfecting or
sanitizing toilet bowl and urinal surfaces
are acceptable. Claims for disinfecting
the hidden trap and claims for solutions
in the tank to disinfect or sanitize the
bowl surface each time the toilet is
flushed are not acceptable.
(b) Water treatments—(1)
Performance requirement The labeling
of a product intended for treating toilet
bow) and urinal water may bear
"sanitizing" claims (that can be
identified as related to human health) if.
when tested by the method in section
91-7(b) of Subdivision G of the
Registration Guidelines or its
equivalent, the product demonstrates at
least a 99.9 percent reduction in
numbers of test microorganisms over the
zero-time control and the parallel
untreated control.
(2) Claims. Claims for products of this
type must cither pertain to sanitizing
activity or aesthetic benefits commonly
associated with control of odor, slime.
.or other aesthetic problems in toilet and
urinal bowl water. Examples of
acceptable claims are: "Inhibits the
production of ammoniacal odors
produced by bacteria in toilet and ur:na!
bowl water" "Controls unsightly slime
formation produced by bacteria in toilet
and urinal bowl water." and "Sanitizes
toilet bowl water." Only sanitizing
claims can be identified as related to
human health considerations.
f 1MJ70. Hu
(a) Emergency water supplies—
performance requirement. The labeling
of a product intended for emergency
treatment of drinking water may bear a
claim as a "disinfectant" if. when tested
by the method in section 91-6!a)(2) of
Subdivision G of the Registration
Guidelines or its equivalent, the product
kills all test microorganisms in the
water
(b) Water purifier u/uts—performance
requirement. The labeling may bear
claims for "purification" of raw water if.
when tested by the method in section
91-fl(a)(3) of Subdivision G of the
Registration Guidelines or its
equivalent, the product eliminates tne
microbial pollution from the water.
•whwtttw pool water
The labeling of a product intenoed for
treatment of swimming pool water may
bear da.ms for "disinfection" if. when
-------
Federal Register / Vol. 49. No. 166 / Wednesday. September 26. 1984 / Proposed Rules 37995
tested according to the laboratory and
field methods in section 91-8(cj|l ) of
Subdivision G of the Registration
C...c .!./:Ci o; ..* equivalent. the product
meets both of (he following criteria:
(«! Laboratory tat. The product meets
or exceeds the performance of the
scd'um hypocblorite control against
each test mjcroorganifm.
•>] Field tent. Not more than 15
percent of the samples collected f«Jii to
!B*e« at! of the following bacterial -
indices:
•I) The standard plate count at 35 *C
does not exceed 200 colonies per 1.0 ml.
J; The most probable number of
•o'rfarm bacteria U less than 2.2
jfiamsms per 100 mi. if :he membrane
• • '-?st is used, iherc *.?.->!! 'j-» no m-.re
r :.-. :,f) cu'form orgdr.:sm per 50 mi.
'3j The ssost probable number of
?n»erococcal organisms is less than 12
organisms per 100 ml. If the membrane
! liter test is used there shall be no more
than 1.0 enterococcal organism per 50
ml.
rviarad claims for antimicrobial products.
The Agency wi!i use the following
criteria :o determine whether or not the
labeling of an antimicrobial agent bears
•:i.i;;«s rjf human health significance:
• -i : Pri/c >c:s bearing labeling c!.i:tr.s to
Control specific microoigdn:«m$
infectious for man. such as
Staphyiococcus ourtota.
\fycobocterium tuberculosis, sand
Psemiomonas aerugtnosa. are
considered to be directly related to
human health.
(b| Ail sterilizers, hospital
disinfectants, swimming pool water
disinfectants, human drinking water
disinfectants and purifiers, and food-
contact surface sanitizers are human
health-related, whether or not control if
infectious microorganisms is specifically
claimed.
|c) Veterinary and animal premise
disinfectants are considered human
health-related if microorganisms that
are infectious for both man and animals
are involved, such as Staphylococeus
aureus and Pseudomonas aeruginosa.
Microorganisms that are solely
pa'hcjsnic far animals (such as canine
d.siemper virus arid hog cholera virus)
die r.r.; c:r.s.;ered human health-
reidted.
(dj Cairns for products as
disinfectants or sanitizers are
considered to include or imply
effectiveness against microorganisms
infectious for man- Such claims must be
expressly qualified (e.g.. "odor-causing
bacteria" or "slime-forming bacteria") in
order to remove implications of human
health significance. In addition, if the
intent of the claim is not cleany defined.
a labeling disclosure of ineffectiveness
of th2 product agains; he.Uh-related
miero-oradnisms may be required (e.g..
"Thr* product hds not b*er.
demonstrated io be e::ectiv« aga:nsi
microorganisms infectious for nun").
(•) Since elimination or significant
reduction in numbers of microorganisms
(sterilization, disinfection, sanitization)
must be demonstrated before a produci
is considered acceptable for claims
against microorganisms infectious for
humans, or for use Jr. medical or
sickroom environments, products
bearing claims for effectiveness at the
bactenostatic (inhibition of growth)
level are not acceptable far such uses.
Brcterfostatic claims are acceptable
only for products expressly
recommended for control of
microorganisms of only economic or
aesthetic significance. e.g.. spoilage
bacteria and ordor-causing bacteria.
(f) Slime ar.d ordor control agents.
preservatives, algicides. and other
products expressly claiming control of
microonanisms of econermc or
«s:h* :~c s:ar.:f;cance are not considered
to be human heai'Weiaisd. but are
neverheiess subject to the requirements
for accurate lab.il claims and adequate
directions for a practical pattern of use.
PART K7-ACQISTRATION OF
PESTICIDE PRODUCING
ESTABLISHMENTS AND SUBMISSION
OF PESTICIDES REPORTS
&a. By revising the heading of Part 167
to read as sat forth above.
I1C7.4
b. Ey remov:na $ 1*57.4
iS«L :. 3. 5. «. • 9. ic :: :• is. «n
-------
Reference No. 10
-------
-------
19270
Federal Register / Vol. 51. No. 102 / Wednesday. May 2B. 1886 / Notices
'•5
EPA hes periodically issued ambient
rater quality criteria beginning in 1073
-ith the publication of the "Blue Book"
rwater Quality Criteria 1072). la 1078.
the lied Book" (Quality Criteria to
Water) wes published. OB November 28.
1080 (45 FR 70318). EPA announced the
publication of 04 wdividtaalambiaat
water quality criteria documents for
pollutants listed as toxic under section
307(e)(l) of the Clean Water Act A '
document addressing 2A7.6-
tetrachlorodibenzo-p-dioxin (TCDD)
was announced on February 15.1064
(FR 40:5631) completing the coverage of
the 65 priority pollutants listed m
307(sHD. Nine ambient water quality
criteria documents, including revision of
seven of the 1080 documents, watt
raieased on fury 20.1005 (50 FR 30704).
A bacteriological ambient water quality
criteria document was published on
March 7.1969 (51 FR 0012).
Today EPA to *H*v**t**$ the
availability for public commaot of a
proposed ambient aquatic lib water
quality criteria document for zinc. This
document, upon fc»»i pubUcation will
update and revise appropriate sections
of the 1000 criteria document
Toe document announced today wul
not contain information OB the effects of
zinc on human health. An adviaory will
issued to update the huBum health
on of the 1000 ambient water
ity criteria docment for abac, tf a
review of the available information
indicates mat each a revision is
necessary. Both the criteria document
announced today and the water quality
advisory addressing human health may
form the basis for enforceable
standards, when published in final form.
Dsttd: May 13. MSB,
i W.I
Acting Auiitont Administrator for Wettr.
Zinc
Freshwater Aquatic Life
The procedures described in the
"Guidelines for Deriving Numerical
National Water Quality Criteria for the
Protection of Aquatic Ortanisms and
Their Uses** indicate that, except
possibly where e locally hnpftrt;*"
species is very sensitive, freshwater
aquatic organisms and their uses should
not be affected unacceptably if the four-
day average concentration (in pg/1) of
zinc does not exceed the numerical
value given by e1**1** **»«•«" »«•»
more than once every three yean on the
average and if the one-hour average
concentration (in «g/l) does not exceed
numerical value given by e1*"*
onet
as CaCot the four-day average
concentrations of zinc are 40,06. and ISO
*§/!, respectively, and the one-hour
average concentre lions an 54.00, and
OTag/1.
Seltwotor Aquatic tife
The procedures described in the
"Guidelines for Deriving Numerical
National Water Quality Criteria for the
Protection of Aquatic Organisms and
Their Uses" indicate that except
possibly where a locally important
species is very senaitive. i
aquatic ffrgftf**""* "^ their i
not be affected naacceptably if the four-
day average concentration of zinc does
axosed 70 pa/I ojore than
every three yean OB the average Bad tf
yean on the average. For example.
at harnesses of SO. 100. and 200 mg/1
not exceed 67 «fl/l more tban <
every three yean on the avenge.
EPA believes that "edd-eolubls" to
probably the best measurement at
present for expressing criteria for metals
and the criteria for zmc wen developed
onthisbasis.However.atthisuma.no
EPA approved method for such a
meaaunmaot to available to impltmtnt
criteria for matala through the regulatory
programs of the Agency and the States.
The Agency to considering development
and approval of a method for a
measurement such as "add-eoluble".
Until one to approved however, EPA
recommends applying crttaria for metals
using the total recoverable method This
has two tmpactsr(l) Cartais apedas of
because the total recoverable method
cannot distinguish between individual
oxidation states, and (2) IB some cases
these criteria might be overly protective
when based on the total recoverable
method
The allowed avenge excursion
frequency of three yean to the Agency's
best scientific Judgment of the average
amount of time it will take an unstrassed
aquatic ecosystem to recover from a
pollution event in which exposun to
zinc exceeds the criterion. Stressed
systems, for example, one in which
several outfalls occur in a limited area,
would be expected to nquira mon time
for recovery. The resiliencies of
ecosystems and their abilities to recover
differ greatly, however, and site-specific
criterie mey be establithed if edequate
justification is provided.
Use of criteria for developing water
quality-baaed permit limits and for
designing waste traetment facilities
requires selection of an appropriate
wasteload allocation modei. Dynamic
models ere preferred for the application
of these criteria. Limited data or other
considerations might make their use
impractical, in which case one must rely
OB a steady-state model. The Agency
recommends interim usewf 1Q5 and
1Q10 far the Criterion Ms
Concentration (CMC) design flow and
7Q5 and 7Q10 for the Criterion
Continuous Concentration (CCC) design
flow in steady-state models for
unstressed and stressed systems.
respectively. These matien are
discussed in mon detail in the
Technical Support Doniment for Water
Quality-Based Toxics Control (US. EPA
106S).
IF* Dec. 0S.1U74 Filed 1-9-40: a*t as]
Activity iOBBiiej
A0J6NCV* Emir
italProti
Agency (EPA).
ACTION: Notice of Policy oa Testing
Methods.
0)t^
ti
StaW
tn
tuberculoddal activity testing options
that will be permitted by the Agency.
Applicants/registrants of all
antimicrobial pesticide* win proposed
or existing tnberculood*! claims for
their stressed (re-used) and/or non-
stressed (discarded dairy} product
solutions must choose one tasting
approach for the development of data to
DATE May 26. 1006.
CONTACT
By nail: 0. lean fenkins. Registration
Division (TS-767Q, Office of Pesticide
Programs. 401M St. SW-
Washington, DC 20400.
Office location and telephone number
Rm. 246. CM 92.1021 Jefferson Dem
Highway, Arlington, Virginia. (703-
557-7443).
0UPK0ja0NTABY BafONSJATlON! Since
1078 the Agency has been advised by
numerous registrants, testing
laboratories, reeearchen. and other
scientific groups that inconsistent test
results wen being obtained when
gluteraldebyde-beaed products wen
tested by the Association of Official
Analytical Chemists (AOAQ
Tuberculotidel Activity Method et 20*C
at 10 minutes exposure. Such findings
wen not reported for other chemical
classes (La., phenolics. Iodine).
Researchen have indicated that
glutaraldehyde-besed products require
longer expoeun times and/or higher
temperatures for tuberculoddal activity
than those specified in the AOAC
Tuberculocidel Activity Method. Similar
-------
Federal Register / Vol. 51. No. 102 / Wednesday. May 26, 1986 / Notices
19271
inconsistencies wire experienced in the
preregisiration tuberculocidal lasting of
antimicrobial pesticides by the EPA
microbiolofial te^iof bdUty in
Belleville. Maryland between lifl and
1179. Advent tubercalocidal data on
glutaraJdehyde-baaad products,
developed by the established AOAC
method. were submitted to A* Agency
under FIFRA section 6M2J in 1878 and
Qua ternary aauBooium compounds
ere generally considered to be MB-'
lubttoiioeid*! However, registrations
neve own iuutd for products in this
chemical class which beer
tobereuloddal efficacy daims. based OB
hibercujoddd date developed by me
AOAC procedure end submitted in
rapport of registration, Hit EPA
tuberatloddeJ testing facility eleo
products in this chemical dees were
tested for tuberculocidal eetivlty by the
AOAC pn '
la SMS, (be AOAC Associate Referee
for the AOAC Tttbercnloddal Activity
Method tabmltted a new quantitative
tuberculocidal procedure for Agency
consideration as an alternative teeting •
method The Agency distributed this
ttnbero
new quantitative f
alodial
on May ZL MM. in
tion with the Label Improvement
* • ••) •«• •«• *vpweja>«ae»« «H
IiBtanldahyoVbaaad boepl tsJ »tarilaat/
duinfectant producu. Tba saw
procedure waa identified aa an option
aitanativa to the AOAC Tubafculoddal
Activity Method for fhitatmldanyda.
based daainieetant product*.
Subaaquantly. eontrovany aroae
concerning tha validity of the naw
Quantitativa procaduia and of tha
establiabad AOAC method In
September 1964. an EPA Scientific
Advisory Panel (SAP) Subpanal was
established to evaluate the naw
procedure. Tha consensus of this
Subpanal waa that the naw procedure
had scientific merit but that more testing
was needed before adoption aa a '
standard method. In Jury SMS. • naw
SAP Subpanal was selected to provide •
comparativa assessment of the existing
AOAC TubarcnJoddal Activity Matbod
and tha naw quantitative nbaVculoeidal
procedure. A public meeting of the SAP
Subpenel was held en September 30.
iW. and comments ware solicited from
the public and interested parties.
Having received the findings of the
Tint and second SAP Subpanal and
Public comments relative to tha
lubereulocidal activity testing methods.
the Agency announces the following
reguletorypolicy:
1. Manufacturers/registrants/
"pplicantr of all antimicrobial pesticides
with proposed or existing tuberculocidal
claims for their stressed (re-used) and/
or BOMtreesad (discarded daily)
product solutions must choaaa ana of
three available Mbamiloddal testing
options to substantiate claims of
tabareuloddal affectivanass. Tha tasting
options ara aa follow:
a. Use of the naw quantitative
tubereuloddal I
glularaldabyda or quaternary
ammonium compounds, using tast
conditions of 10 minutes i
b. Use of toe existing AOAC
.but
with modification of Ike standard tact
Of
and/or temperature that are
endarcaoooWtbetuberaJoddal
afficacy of otherchemicals at SO minutei
exposure end 2UTC be considered
questionable in the future, validation
letting will be required,
4. The oontact/expoeure tnse and
laiBpafatuta naoaaaary to achieve
aifacttv* OH of the product muit be
nflaetad in the direction! lor «aa on the
product kbeL
5. Applicants for ragietration of new
anoaicrobial paattdda prodeuu bearing
cUseoftheaJdrtflfAOAC
Tuberculoddal Activity Matbod
aonloyinitbaataodarataateoaditioai
mtnatas anpaaura tea and gr C far
quasttonabia. aaMetton of option (c)fbr
fjataimldahyda^aaad products moat be
I Dyvalidabo. data, bae«l
araia|aaai ejajj. w MWVeW •wyyvi aaajp
tabercnlodddectMtydainnars
required to provide aupporting
ftabercaloddal data by cae of the three
testing options and any required
validation data prior to issuance of
on the Mine tast ogndltiflftf {SO minft't
at arci from a aacond taanaf facility.
(other than the laboratory that
developed the original data). Ratistraat*
and/or appucanli for nxisltation ara
adviaad that wttbholdiai tastiwaha
«
Jbial
I tVttGft 00 BOt
who wish to amend their product
registration and label to edd a
^^tL^^^^^I^^^JJ^l M^^^^J^^ A!A^^B A^«
iBueiCTiBcioai awit uy uauv. are
required to provide auppui Uiig
tabareuloddal data by one of the three
tasting options and any required
preducta with aatiaHai or propoead
pounds wiO be pamittad to baaa
their taberculoddal datms OP data
davalopad by optional procadnras (a}>
(bj. or (c) above. However, validation
tasting from a diffarant kboratory wffl
be required for any optional procedure
chosen by the registrant/applicant for
thi* chemical class of product*. This
validation tasting raqnlnmant is
considered necessary and warranted
since it is questionable tnat^uatamary
conditions.
I. Registrants or applicants tor
products with costing or proposed
tuberculocidaJ efficacy claims, that ara
formulated with chemical groups other
than ghitaraldehyde or quaternary
this tJme"S baaa their tubereuloddal *
claims on any ana ef tha three optional
tast procedures ((a), (b). or (c)) without
tha required validation tasting.
Validation tasting is net necesaary since
it has bean currently determined that
reliable and reproducible tast results are
obtained for chemicals other than
^^K^ ^t t^^ A^^^KA ^^mU^k^
vafm we Bnw wauug
options end any required validation
data mast provide data by one of the
three options and any required
validation data within SM days ef their
response to a notification under section
9(eH2)|B) of die Federal Insecticide.
Fungicide, and RodanUdda Act (FIFRA)
by the Agency in order to avoid
suspension of their product registration.
0. The Agency will support review and
collaborative testing of the new
quantitative procedure by tha AOAC as
a replacement for the yy*THig AOAC
Tubarcaloddaj Activity Method, or as
an additional alternative procedure.
8. The Agency will notify affected
registrants, under tha authority of FIFRA
section tfcXIXB), ef the epedfie
requirements for compliance with this
announced tuberculocidal testing policy
and the action net will be taken m the
event ef non-compliance
The Agency believes that the validity
of tuberculocidal efficacy claims for
antimicrobial pesticides is a critical
concern due to the public health
implications of environmental
contamination with Mycobocterium
tuberculotit microorganisms. Therefore.
it is for this reason that the Agency
-------
18272
Federal Register / Vol. 51. No. 102 / Wednesday. May 26. 1986 / Notices
•ouffal • scientific oonMuiu on the
oftubtrculoddtlttft -
_, and announces-the
required testing approaches to
documentation of tuberculoddal
effectiveness of antimicrobial
prestitides.
Dated: May 18,1
(PR Doc as-HTM Filed t-P-^tt MS am)
tAL
i of Tim* for
May 8.1
On April 23.1886 (published «t51 FR
18834, Apr. as. 1966) tht Commission
notion tbtfilinf of* petition by tht
National Customs Broken ft Forwarders
Association of America, Inc. requesting
the fotufnittiffn to •*"y*t its nun
pertaining to tiMiicanaiiig of ocean .
freight forwarders. Interested penoai
were fhren until MeyaaiiM. to tabmit
views, arguments or data on the
The Transpacific Westbound Rate
Agreement (TWRA) hu now filed •
request for • three week extension of
time in which to file comments. TWRA
indicates that the current deadline la too
short for its meabers to property
evaluate the petition and formulate an
appropriate response.
Accordingly, for good cause shown,
the Commission will extend the date for
all comments from May 30.1986. to June
23.1988.
By vie ConaissioiL
Iota Robert Cw*n,
Stentary.
IFR Dec eft-tin? Fikd 5-P-id: 8:45 am]
rtgtrtl
Notice to hereby given that the
following persons have filed
applications for licenses as ocean freight
forwarders with the Federal Maritime
Commission pursuant to section IB of
the Shipping Act of 1984 (46U.S.C. app.
1718) and 46 CFR 510.
Persons knowing of any reason why
any of the following persons should not
receive e license are requested to
contact the Office of Freight Forwerders.
Federal Maritime Commission.
Washington. DC 20573.
Amcx International. Inc. 172S K Street
NW. Suite 402, Washington. DC
Officers:
Mamadi Diane. President/Treasurer/
Director
Hee Chang Park, Vice President/
Director
Cynthia Diane, Secretary/Director
Mori Diane, Vice President
Myre Sims, 3226 Talleyrand Avenue.
Jacksonville, PL 32208
Airport Clearance Service. Ine, Cargo
Building 80. JFK International
Airport Jamaica. NY 114*0
Officer!
John J. Emanuale. Vice President
Trion Forwarding Company. lac, 16036
Victory. Suite 200. Houston. TX
77032
Officers:
Robert Wayne Album. President
James Thomas Hanges, Vice President
By the Federal Unite* CononisdoB
Deled: May B. 1888.
Sscretery.
{HI Dec. 88-11918 Filed 1-27-86; MS asij
H-IUHEAL HESUIVE fJYtJTPI
The company listed in this notice has
applied for the Board's approval under
section 3 of the Bank Holding Company
Act (12 ILS.C. 1642) and 1225.14 of the
Board's Regulation Y (12 CFR225J4) to
i bank holding company or to
Kjnlr Af Wafjjr luiUilM
acquire a bank or bai
company. The factors that are*
considered in acting on the applications
are set forth in section 3(c) of the Act (12
U.S.C.1B421C)).
The application is available for
immediate inspection at the Federal
Reserve Bank indicated. Once the
application has been accepted for
processing; it will also be available for
inspection at the offices of the Board of
Governors. Interested persons may
express their views in writing to the
Reserve Bank indicated for that
application or to the offices of the Board
of Governors. Any comment on an
application that requests a hearing must
include a statement of why a written
presentation would not suffice in lieu of
•a hearing, identifying specifically any
questions of fact that are in dispute and
summarizing the evidence that would be
presented el a hearing.
Comments regarding this application
must be received not later than June 18.
A. Federal Reserve Bank of St Louis
(Delmer P. Weisz. Vice President) 411
Locust Street St Louis. Missouri 63168;
1. Oxark BanJafiant, Inc.. Osark.
Arkansas; to acquire at least 80 percent
of the voting shares of Newco
Corporation. Jasper. Arkansas, and
thereby indirectly acquire Newton
County Bank. Jasper. Arkansas, and
Bankttodr Two, he, Pardanelte.
Arkansas, and thereby Indirectly
acquire Arkansas VaUey Bank.
efaw Federal Reserve
•yetsm.MeyZL
fFR Dee. 80-11841 Filed t-V~*k fctt am)
DEPARTMENT Of HEALTH AND
Pood antf Drug
tDoek*tNe.88f-01711
; Food and Drag Admtaii
K The Food and Drug
Administration (FDA) to anneundng
that Oba-Geigy Corp. has filed a
petition proposing mat die food additive
regulations be amended to provide for
the safe use of tfaiodlethylene bis(3.S-di-
f«rf-butyl<4*hydroxyhydrodnnamete) as
an antioxidant for polymers intended to
contact food.
Marvin D. Mack. Center for Food Safety
and Applied Nutrition (HFF-335). Food
and Drug Administration. 200 C St SW»
Washington. DC 20204.202-172-6690.
rAftTMFOMuiMMC Under
the Federal Food. Drag, and Cosmetic
Act (sec. 40B(bMS). 72 Stat 1786 (21
U.S.C. M6(bH9)n. notice is given that a
petition (FAP6B3B26) has been filed by
Ciba«Geigy Corp^ Hum Skyline Dr.
Hawthorne. NY 10S32. proposing that
1178-2010 Afitioaridantt and/or
ttobilamforpolym*!* (21CFR
178J010) be amended to provide for the
safe use of thiodiethylene bis(3^-di-»it-
butyl-4-hydraxyhydrodnnamate) as an
antioxidant for polymers intended to
contact food.
The potential environmental impact of
this action is being reviewed. If the
agency finds that an environmental
-------
-------
Reference No. 11
-------
-------
FIFRA Compliance Monitoring Policy No. 12.5
The Use Of a Diluent Not Specified
On The Product Label
FIFRA Section;
12(a)(2)(G)
Issue:
1 «
Is the use of a diluent not specified on the pesticide label
a violation of FIFRA?
Policy;*
Under FIFRA Section 12(a)(2)(G), 1t 1s unlawful to use any
registered pesticide in a manner inconsistent with Its labeling.
If the label specifies a substance as the product's diluent, the
use of any other substance as a diluent Is considered a use In-
consistent with the label and constitutes a misuse violation under
Section 12(a)(2)(G).
In Instances where no diluent is specified on the label, water
must be used as the diluent.
Discussion;
This policy applies to the use of any substance as a diluent,
which is not specified on the label (e.g. vegetable oil, kerosene,
diesel fuel, fuel oil,). This policy also applies to ultra-low,
low volume, or conventional application systems.
The Agency is Issuing this policy in response to the practice
of some applicators to use diluents not specified on the label.
Specifically, some applicators have used vegetable oil as a
diluent because of Its slow evaporation properties. The Agency
is concerned that this practice may have adverse health effects
if the pesticide does not evaporate at the anticipated rate e.g.
as a result of residues in excess of tolerances or increased farm*
worker esposure to the pesticide. The applicators state that the
use of vegetable oil as the diluent results in a pesticide dosage
less than that specified on the label. In the opinion of the ap-
plicators, the use of vegetable oil as the diluent can therefore
be justified In ultra-low volume (ULV) applications under Section
2(ee)(l) and the March 3, 1981 Advisory Opinion Issued under
Section 2(ee).
* This policy does not supersede or affect existing policies on
tank mixing, or mixing with dry fertilizers or mixing with liquid
fertilizers, nor does this policy address additives, adjuvants or
surfactants.
-------
- 2 -
Section 2(ee)(l) states that applying a pesticide at any
dosage, concentration, or frequency less than that specified on
the labeling is not considered a use inconsistent with the label.
The March, 1981 Advisory Opinion permits the use of a product at
a dosage less than the specified label in ULV applications,
(provided such use -is recommended by an appropriate State or
Federal agency, and the use pattern is submitted to and approved
by EPA).
The provisions of Section 2(ee)(l) and the March, 1981
Advisory Opinion apply only to the use of the diluent specified
on the label. Neither Section 2(ee) nor the March, 1981 Advisory
!FpinTo~n permits a discretionary choice of diluent. The use of a
diluent not specified on the label, regardless of resulting dosage
or application method, constitutes a misuse under Section 12(a)(2)(G)
To determine a legal choice of product diluent, applicators
must consult the pesticide labeling, pesticide exemptions, 24(c)
registrations, or other pertinent EPA policy documents.
See Also:
"Ultra-low Volume or Low Volume Pesticide Application: Issuance
of Advisory Opinion", Federal Register Vol. 46. No. 41, March 3,
1981.
References:
Key Words;
• Ultra-low volume application, low volume applications, diluent,
FIFRA Section 2(ee) , vegetable oil diluent.
A. E. Conroy I K^DTi rector
Compliance Monit^£/ng Staff
Office of Pesticides and Toxic Substances
2( 334
-------
Reference No. 12
-------
-------
»
CERTIFIED MAIL ' |
% •
TOi Registrants of ciutaraldehyde-Based Hospital Sterilant/
Disinfectant products
Dear Registranti '
This letter is to inform you that the labels of pesticide
products containing glutaraldehyde which are registered for
use in hospitals for sterilizing and/or disinfecting critical
instruments and equipment are subject to revision under the
Label improvement Program. PR Notice 80-1, issued June 16,
1980* describes the procedures the Agency is using to upgrade
the labeling of products under this program. A copy of this
notice is attached for your reference.
This letter is also to inform you of the Agency's concern
with regard to tuberculocidal efficacy testing of glutaraldehyde-
based disinfectant products.
Section 1. Label improvement Program.
The following changes should 'be made in the labels of
pesticide products containing glutaraldehyde and registered
for the uses described abovet. •.-.-..
{ar Clarification of directions for use.
(1) A statement.is required to be added to the
label directing the user to discard the used
solution at least daily. A statement similar
to the following would be acceptable! 'Discard
used solution after each day's use*.
(2) As an alternative, efficacy data may be submitted
to support reuse of the solution for a specified
period of time or number of sterilization/
disinfection cycles. if use for a time period
longer than a day is supported by acceptable
'' data, the directions for use should be modified
to reflect the appropriate use period.
(b) Addition of misuse statement.
Immediately below the heading "Directions for Dee",
add the statement 'It is a violation of federal law
to use this product in a manner inconsistent with
its labeling."
-------
Registrants aust submit .an application for amended
registration for product* with labeling which require
revision -in accordance with this no tic* on or before
December 15, 1984. Such application shall incorporate
labeling change* described above.
Any product for which these requirements are applicable
and for which an application for amended registration has
not bean received on or before December 15, 1984, will be
subject to cancellation proceedings under FZFRA Section 6(b),
A list of your affected products is attached, together
with a notation as to which of the requirements, if any, are
applicable to the products.
To satisfy the above requirements which involve labeling
revisions only, i.e., 1 (a)(l) and/or Kb), your application
must include two (2) copies of draft labeling incorporating
the changes specified. Zf you choose to submit final printed
labeling directly, you must assume responsibility for
corrections if the revised labeling is found deficient in any
manner, me requirements of FIFRA Section 3(c)(l)(D) do not
The Agency will respond, --as to the acceptability of
compliance, with the above described changes with a regular
letter. However, you may, if you wish, upgrade your entire
label, provided the label revisions are not. for the purpose
of adding new uses (other than l(a)(2», but are limited to
upgrading, clarifying or bringing the label into compliance
with current regulatory requirements. We will, in this
case, conduct a comprehensive review of the entire label and
either accept the label or notify you of deficiencies. The
deadline for compliance remains as stated above.
Zf you choose the alternative of submitting efficacy
data to support reuse of your product, i.e., 1 (a) (2), in
.lieu of ,the "discard* statement, your application must include
two (2) copies of the supporting efficacy data in addition to
two (2) copies of draft labeling incorporating any specified
changes. The requirements of PR Notice 83-4 and 83-4A issued
June 16 and 24, 1983 respectively, apply.
For guidance in developing a testing protocol for
efficacy data to support reuse of a product, refer to the
attached enclosure "Reuse Testing of Sterilant/Disinfeetant
Solutions.' Before initiation of actual testing, the proposed
protocol should be submitted for review and acceptance by the
Agency.
-------
*• *
If you have products which are subject to these
requirements which are no longer being marketed, you may
wish to submit a request for their voluntary cancellation.
Section 2. Tuberculocidal Efficacy Testing..
This section describes the Agency's concern with regard
to tuberculocidal efficacy testing of glutaraldehyde-based
disinfectant products. No specific response is required to
this part of the letter at this time.
The Agency has received test data derived by a new
quantitative tuberculocidal test method on a number of
glutaraldehyde-based hospital disinfectant products. The
data suggest that this method may provide a more accurate
assessment of the conditions necessary for tuberculocidal
effectiveness of glutaraldehyde-based disinfectants. The
method has been referred to the Association of Official
Analytical Chemists for consideration, and it is expected
that a collaborative study may provide a basis for its
adoption by AOAC as a tuberculocidal test method. At
present* the Agency would consider test data developed
by this method as an optional alternative to the AOAC
Tuberculocidal Activity Method for glutaraldehyde-based
disinfectant products. You should be aware that additional
testing and/or labeling revisions may be required for «'
tuberculocidal efficacy claims, at such time as a scientific
concensus is reached on this methodology. A copy of the
proposed new method is attached for your information.
• if you have any questions concerning this letter, you may
contact John B. Lee at (703) 557-3675.
Sincerely,
Enclosures!
X J)&aniti~Wills, thie
disinfectants Branch
tistration Division"
S-767C)
PR Notice 80-1
List of Affected products for each Registrant
•Reuse Testing of sterilant/Oisinfectant Solutions*
Tuberculocidal Activity Test Method
-------
-------
Reference No. 13
-------
-------
radaral RaHatar / Vol. 84. No. 28 / Thursday. Fabraary «. lt» / Rules, and Regulations
• «ai
i'-limm
tiBBM***
•aM""*
*••••/"»
»MK»*
test (*/*••
Based OB the predicted violations.
USEPA notified tht Govtmor of Ohio OB
December 22.196$. under section
l«XaH2HH) of the draa Air Act 42
USC 7410(«H2KH). thai tht SIP for SO,
is substantially inadequate to attain and
maintain tbeSOiNAAQS in Hamilton
County. The finding of inadequacy and
the call tea SIP revision were generally
issued to accordance with USEPA's
avidance on issuing notice* of 8V
inadequacy.' Under tbii guidance, tba
State would bay* to submit a
xommitment and a schedule for the
development of the SIP reviaioa to
USEPA not more than 00 days bom the
date of notification. A fully adopted pin
for Hamilton County would than have to
be submitted within 1 year of the date of
notification.
However, (t I* USEPA's practice to
consider alternative i
enforceable regulations far HamBtoa
County by no later than June 22, ma*
40 CrU Part 162
warranted. After discussions win the
Ohio Environmental Protection Agency.
USEPA is providing the State with 60
i to submit a commitment and
i for the development of an
" r SIP and vp to 16 months
from the date of notification lor
submission of a fully State adopted SO*
plan for Hamilton County, which
assures the attainment aad maiate
of the SO* NAAQS both in Hamilton
County aad the surroundmg area.
Therefore. Ohio must submit a
schedule for correcting the deficiency by
USEPA notified the Governor of the
State of Ohio by letter that the Ohio SO*
SIP is inadequate teaasuii a*
attetomant and maintenance at the
National Ambient Air Quality
Standards. The notice of deficiency
requires Ohio to submit the SIP
revisions necessary to achieve Iha
standards.
The USEPA considers today's aottaa
to be informational only aad to have an
regulatory effect. H informs the public of
a call for a SIP revision made by USEPA
punuaat to aacttoa 110(aN2)(H) of the
dean Air Act 42 VSJC. 741Q(aNXXH).
Aay final defiaittoo of what would be aa
inadequate response to mis SIP call ay
further USEPA action that would reaolt
from an inadequate Slate raspooae hi
the future, will be effective only alter
CavffleattonofHr¥(AtMV1nia)
:Envb
AfeneyfEPAJ.
•IPi
for antimicrobial pi
of label
tidd
Mlingp
produc
poUey
bearing daims of effectiveness against
MV(AIDS virus).
HIV (AIDS vtrosl efficacy
EPAeonsidenaAbmicroblalpesticidaa
' miqaebaeauae of the critical
> of the threat to public health
iwjuidaa from Imfftcu've use of
tabettngand advartisiiig. EPA has
Air pollution confroL
Oxides.
ftaiasrtj 41 IMC 7401-9M1,
Dated: lamary AlamX
iM.4
develop ftrture Utattvaa desitBed to
upgrade and clarify the labeling of all
anumicrobUlDMticidestoreftect
products. It was not considered
rtoestebUahnewpolici
February 20. I960, and a plan aad
kttaai)
> fS£?A • pudMOi far iMWlMJ
>tOt.M2KH)oot.«» • -
Notinbtr2.lSKI.Fi
USOA br M* a »» •» OM>
revise existing policy in order te
approve fflV efficacy claims. Rather, a
clarification and/or reinforcement of
existing policies as they apply to HV
efficacy daims is needed to serve as
guidance to antimicrobial pesticide
ttduct manufacturers aad registrants.
is for these reasons that the Agency ia
iBOundat a clarification of HIV
policy. Registrants desiring to
Kr
•(MM OMB Air ACT («t nt
Giudane* Docvmm far «w
SITt far NOMIUMMMI Ar*M~
conuuuiawt
•ftts
rmtHKit USEPA f^wtMd. AiVHeai IMS
rtm miiiiH n in iiiiiiit imiinirti n sisJ •!•
WB>MI flMtflMIMl ftOMf WillfliMBV QM*^ tlM MMt
USEPA t ftiMnl ividinet lor WMU« Mtien et HP
_______ _ . _____
register a product or to amend an
existing regtstration to include a HIV
efficacy claim must comply with this
policy. Sterilant products previously
approved by EPA to bear HIV must be
revised to comply with this policy.
•aKatncy tor MM* with •ppf»««e'<]*• e«
coaiiftiMd (or Mwly louod)
By mail D. |aaa lenkiaa (Caaara!
Informatioa). William C Campbett. Jr.
rrech&ical date aad labeling
-------
Fodotal Reftetor / VoL te. No. » / Thursday, February *. HaW/Rule* and Regulation! B2BS
requirements), Jeff Keapter and/or
John LM (Application* far
regsstrattooj. Antimicrobial Program
Branch. Registration Division (TS-
7VCL Office of
Envi
nciaturefor
etton Agency. 401
M Street SW. Washington. DC 20180.
Office of location end telephone
number Room HI. CM «11821
Jefferson Davis Highway. Arlington.
VA. (7U3) SS7-T470.
•UPPUIUNTJUIV iieyeojsjTieiK
In we Federal Register of May 28.188B
(51FR18174). EPA issued a notice
concerning "Advocacy of Pestidde Uses
Which Do Not Appear on f
Pesticide Label*." The mam nruet of
this Notice was to eddress the
unwarranted promotion of efficacy
claim* for antimicrobial pestiddes
against HTV in advertising and other
product related material*. At the time of
this Notice, an acceptable test procedure
was not yet available for evaluating the
efficacy of antimicrobial pesticide*
against WV. and therefore. SPA had not
approved any lebeldaBB* of
effectiveness egainst HTV.
Since May 1988. EPA ha* received
and approved three test procedure*
developed by three different commercial
testing laboratories. The laboratories
developed their test procedure* IB
accordance win those already
employed for testing disinfectants
against other kind* of viruses, except for
die virus-specific boat and essay
procedures. These procedure* were
approved by EPA following consultation
with the Center* for Disease Control
(CDC) and the Food endDng
Administration (FDA). Staff member* of
both CDC and FDA agreed that the
basic parameter* of the three approved
testing protocol* were m egrecment with
these employed for testing disinfectant*
•gainst other kinds of viruses and'
valid test procedures. Baeed on those
three epproved procedures, several
antimicrobial pesticide manufacturer*
tested their product* and submitted data
to EPA in support of proposed label
efficacy claim* against HTV. To data.
data on 88 disinfectant product* have
been evaluated by IPX The data
demonstrate effectiveness of the
product* a* virodde* against HTV-1 oa
hard non-poreu* surface* to the
presence of moderate emounts of
organic soil (S to 10 percent) at the
recommended label dosages in 90
second* to 10 minutes at JO to 28 *C
This demonstration of acceptable
performance against HTV-1 required
that EPA consider approval of
appropriate label claim*. In
consideration of EPA labeling policy for
HIV daima. several labeling element*
terminology/n
designation of target pest the eae of
featured siateeaeaia/phraaes, enlaavd/
emphesixed lettering, special graphic*.
or product names for promotion of HIV
efficacy claims: acceptable we patterns
end required documentation; directions
for use of products egeinst HTV; and eae
end acceptability of supplemental
le beting.
Evaluation of these labeling elements .
indicated that adequate regnletions and
policies existed to address issues that
had *urfeoed or were likely to i
in the registration efanttmioobial
pesticides efficaciou* eajenet HIV.
Therefore. Kt
tee existing policy m order to
regulate HTV efficacy dein ~
only a clarification and/or
reinf orotment of existing policies a*
they epply to HIV efficacy claims is
needed lo serve a* guidance to
registrant* and/or manufectureis of
provided. Soeli claims will b* penmned
ealy under the DireetioiM lor UeeAfim
section of the mbeL ^B
S> The eaiy eee pattens oansideraB
acceptable • cminacttoa wMh HTV
efficacy claims are those that involve
health care settings or other settings in
which there is an expected likelihood of
soiling of inanimate surfecea/ebtecu
with blood or body Quids, end in which
the sarfacea/obiecta likely to be soiled
with blood or body Buids can be
associated with the potential for
MnemiMion of HIV. EPA will require
fee substantiation of efficacy against th<
specific target peat HJV-i. and the
likelihood of blood and body Quid
(oiling and association of coiled
eorface* with the potential
MuuBusaibffityefHIV.
4. Special instructions far use of
antimicrobial ptstiddet against HIV
must be provided in the following
format with each section appropriately
titled and the required use information
The following element*
labeling policy clarification for HIV
l. The only tenninology/nomeadatBre
that i* acceptable for designation of the
ft) " "
tamiBiodeJiciency vim Type 1 (HTV-ir
or "humaa inmunodeficiency vin* Type
2 (HIV-D.- Dther of the above maybe
combined with the parenthetical phreae
-(associated with ADSr or "(AIDS
vim*)."
t. Feetured stetements/phrases.
emphasised/enlarged lettering, special
graphic*, or any product name, that
employ the tern AIDS, are prohibited.
The tern* "AIDS vim* or "Aaeodated
w|*ArpS" may boaee-d for recogBtttaa
pvfpoee*. in ^BTCfltMea*. to accomnany
Feetured ctatementt/phnuea,
emphesiaed/enlarged lettering, or
.•pedal graphic* that are employed for
the primary purpoee of eepeciaBy
promoting or drawing ettaaOon to HIV
efficacy without appropriate uee
information, an enerxeptebU. Per
example, a featured, iacomplet* phreee
each a* WLLS WV-l will not be
permitted. However, a lectured
•tatemeat such a* KILLS HTV-1 ON
PRfrCLEANED ENVIRONMENTAL
SURFACES/OBIECTS PKEVIOU8LY
SOILED WITH BLOOD/BODY FLUIDS
is accept* We if the product is effective
egeitut HTV-I when taetad: the epedBe
surfaces/objects rscomasndsd for
treetment are likely to be eoOedwtth
blood/body fluid* and appropriate
direction* and other me information an
a. Htadiag: Identify a* -SPECIAL
INSTRUCTIONS POR CLEANING AND
DECONTAMINATION AGAINST HTV
OF SURFACES/OBIECTS *r>fl*n
WITH BLOOD/BODY FLUIDS."
b. Pmonal AttfeenteThe specific
barrier protection Hem* to be used whet
handling Items souedwMh blood or
body fluids must be identified, sach es
disposable latex gloves, gown*, i
< »jw «p*r• wvwMggw
c Chaning ftpceoVrr-The >»••• »
dean the specific eurfaces/obiecn pttoi
to disinfection must be identified 04,
"Blood and other body fluid* must be
thoroughly deaned from eurfee** and
obfsctt before application of the
disinfectant (or starHantL"
d. Dtopi*el9f la fiction Atoartolr
The use directton* mo*t state bow and
where to dispose of blood, body fluids.
and dialling material* that are remove
BUB •imacrar ««r»w u. *-g* ' mam mm*
other body fluids should be eutodeved
aad disposed of according to Federal
State, and local regulatioii* for
infectious waste dispose!"
e. Contact TYmr When a contact ta
f or HTV is specified that is shorter than
the contact time specified for other
pathogen*, than It nuat be queUOed wi
a prominent statement such a* this
contact time will not control other
common type* of virus** and bacteria,
* • P*i.*J.u l.iuit&A *^lt 8W
eV* 0tH*s«VKvV*'|PV •VWWMstny WSFSJH «*W
permissible for uee in coniuiictioa win
HTV efficacy claims only if alone, or in
oonKinction with the remainder of the
product lebel text it provide* ail of lh<
; required HTV-related use Information
' (La. use site. surfacM/object*. direetsc
for use. etc): doe* not conflict vjtthjk
rest of the labeling: and I«-*SBB»
-------
Federal
/ Vot S4 No. 28 / Thursday. February 8. 1M» / Rule* and Rewilations
the same lafcf
appiicafale to the rut of the labeling text
(scientific terminology, featured data
etc.). Stteker-type (abating need *oMjr
ft* promotional purpoaee to draw
attention to HIV eflearveaaaa. nther
than for providing valid MM mformatioo.
ia not acceptable.
a. HIV related us* infornatioB may be
presented either on the product
container labal or in accorapanying
technical brocburM or literature.
However, in the Uttar eaaa. the product
container iabal miut specifically
raftranca tha aceompaayinf Utaratura
where such information ia presented.
HLRagiainnMRcojiaioaBaaa
Registrania desiring to register a
product bearing HIV efficacy daim
40 CPU tart an
fP9a>*fia>7i
leartiCaroane:*
to amand an existing regiatrettoo to
iadada a HTV aflieacy daim. must
comply with tha policy announcad in
this notice aad puma EPA approval
through tha required regiatntioB
application procedures.
Tba Federal Register notice of May »
1988 (Si FR 10174). panalttad rafiatraabi .
of •tarUaat producta to daim efficacy
against HIV without additional
documentation of effectiveneea other
than tbaraquirad aporiddaJ data, when
directions for use aa a starilant were
prescribed fop HIV efficacy, and Agency
•ppcoval of labalinf was obtained. EPA
tha ttariltsar uaa bacauaa
n ia aa abaoluta tarm thai
killing of ail micfooftaniama,
induding tha moat raaiatant tpora forma.
against which thaaa predoeta ara laatad
and rha traatmaat rafiniao ia itringaat
(a.g., imowraioa for to houn). Staiilaat
products ragtitarad by EPA with
approval to baar HIV afflcacy claim*
muat alao baar labaliaf thai ia n
complianca with tha labaliaf policy
announcad in thia clarification aotica
(Saa *action 0 abova). Tharafora,
atanlant producta praviooaly approval
by EPA to baar HIV daima ouiat ba
revisad in accordanca with thia
announcamanL and rtgiatraaia
punua EPA approval
raquirad rafiatraiioa appiicaomi
procrdurar within 60 daya ol aW data ol
thi* Notice. EPA will notify thaaa
registrant* of thia (abating darificattoa
policy, tha amandad ngiatratioo
requirement, and tha lima frama (or
responding upon publication of thia
Fadatal Rapatar Notica.
Oaiad; (anuary V.
Diftctof. Qffetoffiu
|FKDecaa-30aaFilad
a:4Saa)
Agency.
AC1
t Eavironmanul Prolacttoa
KUata final rote,
n North Carolina haa applied
for final authorization of revbiona to ita
hasardouawaataprograaiuBdartbe
Raaourea Conaarvatioa and Reeovary
Act (RCRA). EPA haa reviewed North
CaroUna'a application and haa made a
daciaion. aubiad la public review and
comment that North CaroUaa-a
hazardous waste program reviaioa
aaoafiaa all of tha raqniremeata
oacaaaary to qualify for final
authorisation. Thoa, EPA mtaada a*
approve North Carolina's hazardoua
waata ptogfam raviaioaa. North
f^B^^ll^^*^ ** fcj^_~ J»_ ^ia^l^^b^^K
wafDJiaa a apputauuu mr prognm
raviaion ia avaUabie for public review
haaarajoua waata pragnaia la operate lav
the State in bau of the Federal
baaardoua waata prograoi subject aa me
authority tataiaad by EPA in accordance
with the HaxaMoua and Solid Waste
Amandmeata of 19M (HSWAJ. Two
types of authorization may be granted.
The first type, known aa "interim
authorisation," ia a temporary
authorisation which ia granted ff EPA
determines Out me State program ia
"substantially equivalent- to the Federal
program (Section M04(cJ. 42 VSJC.
Hie second type of authorisation ia a
"final" (permanent) authorization that ia
granted by EPA if the Agency finds mat
tha State prognm (I) ia "equivalent" to
tha Federal program. (2) is consistent
with the Federal program and other
State p
i (3) providee for
adequate enforcement (Section amafl
49 u *r Maertiii O>.IM i
42 U3.C agaafb}). Stataa need not have
obtained Interim authorisation in ordea
to qualify far final authorisation. EPA
regulations lor interim or final Stale
authorisation appear at 40 CFR Part ZTL.
•Atw Final authoritaoon for North
Carolina shall ba effective April 10.
19PA unless EPA pubUshes a prior
Federal Registar actioo withdrawing tUa
immediate final rule. Afl comments on
North Carolina a prognm raviaioo
application must ba received by tha
doaa of bvaueaa aa March 13. IMaX
•nniamgi Copies of North Carelina's
fbul authorization application ara
available during ftOO LA. to &00pjn. at
*1 -- ^11 jM.jiAA - tlii.. • • • • * -- i_ -- , „•! -_
ma muowing aonraaaea rar mapecnon
and copying: North Carolina Department
of Human Reaourcea. P.O. Box 2001.
Rataign. North Carolina 27602. Phone:
•U/7&4I7* US. EPA Haadquartara
Ubnry.PM21lA.40tM Sttaat SW,
Waahington. DC »4ea Phone: n2/3aa-
MHtUJ. EPA Region rVUbrary. 341
Courtund Street NK. Atlanta. Georgia
. Written comments ihouldba sent
toMr.Otia)ohnaon.|r,ChiatWasM
Planniag Section RCRA finnckWasto ••n"
—»
Manageneoc Division. U^.
Emrffoamental Protection Agency. 345
Coortland Stree*. NE Atlanta. Georgia
30311 Phone: 404/347-3016.
•en •uamau aafenaurnat cetrrACf?
Mr. Otis Joanaoe. |r. duel Watte
Planning Section. RCRA Branch. Waste
Management Division. UA.
Environmental Protection Agency. 34S
Courtland Street NE, AUanta. Georgia
aOStf. Phone: 404/347-30W.
Section 9008 of the Raaourea
Conaervetion and Recovery Act (RCRA)
ailowa EPA to aulhoriaa State
North Carolina IniOaJly received Baal
autbortsation on December 31.1984.
North Carolina received authorizatioa
for a raviaion to its program on March
23.1090. Car tha Redefinition of Solid
Waata provisions promulgated January.
4,1996. North Carolina haa alao leeatvaaT
authorisation far revisions to Ita^
uiugiam on October 4.1988 far Qoaura
Peat Closure, and Financial
Responsibility Raquiremanta
promulgated May 2.1998. and
• Luting of Spent Pickle Liquor
promuigaMd on May 29.1989. Today.
North Carolina ia seeking approval of Ua
prognm raviaion for the following
authorities promulgated between 1
and 4/23/08.
-------
-------
Reference No. 14
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
SEP 1 4
Policy Statement, Registration Division
Disinfectants Branch
Subject: Label Claims for Control of Legionnaires' Disease
Bacterium in Water Cooling Towers which are Part
of Air Conditioning System for Public Buildings
and Business Establishments.
BACKGROUND;
Although a temporal correlation has been established between
the isolation of Legionnaires1 disease bacterium (LDB) from
cooling towers and the occurence of the disease, it has not
been conclusively demonstrated that the disease organisms
are spread to humans from contaminated air-conditioning
water cooling towers.
The organism has also been isolated from non-epidemic related
habitats such as mud and surface waters. This widespread
distribution of LDB in nature provides opportunity for
frequent human contact, and makes speculations' on epidemio-
logieal relationships questionable.
The Public Health Service officials have recommended that
cooling towers be regularly treated with chemicals that have
been tested and shown to be effective in controlling slime
and high populations of bacteria in cooling tower water.
They have not indicated whether or not chemical treatment of
the environment is necessary to prevent the proliferation
and/or transmission of LDB; nor do they yet have data proving
that any specific treatment will be effective in killing LDB
in water cooling towers.
Because of the limited information currently available on
the autecology and epidemiology of LDB, assessing the relation-
ship of LDB population dynamics and densities in cooling
tower waters to human health is not possible at this time.
If in the future cooling water systems should be unequivocally
identified as an important or the major sources or reservoir
of human disease outbreaks this policy will be adjusted
accordingly and appropriate testing standards will be promul-
gated .
-------
Policy
Carefully weighing the scientific merit of all these facts
it is our conclusion -that to accept label 'claims for
control of Legionnaires' disease bacterium in recircu-
lating water cooling towers would be premature at this
time. Any form of direct claim such as "Controls the
LDB in water .cooling towars" will not be accepted.
*• .
We will review and consider Technical Information
Bulletins for water, cooling tower biocides on a case by
case basis. The text of such bulletins must be in
consort with the scientific facts on LDB and must
reflect the above considerations, especially those by
the PBS, which essentially state that a clean cooling
system is recommended but that no inference can be
drawn on the direct effects on human health.
Example:
Technical Information Bulletin
There is not enough scientific evidence to demonstrate that
controlling the growth of LOB in cooling tower water is a
necessary and/or,adequate step in preventing the spread of
this disease bacterium although this possible mode of trans-
mission cannot be entirely disregarded. Even in the absence
of complete knowledge about LOB disease transmission and
causal relationships of environmental LOB levels and disease
outbreak, it is prudent to minimize slime growth and excessive
bacterial contamination in cooling towers. This precaution
is supported since the limited ecological studies on LOB
have shown that the presence of the organism was usually
associated with heavy fouling of cooling systems. By
reiterating these established recommendations, this does not
imply that any type of chemical treatment of air conditioning
components will control the growth of LOB, reduce transmission
of LOB, or prevent Legionnaires' diesease. Regular treatment
with (product name) following label directions-will control
the growth of fouling organisms in cooling tower water. The
__________ Formulation has not been tested for effectiveness
against LOB.
-------
(Alternative:) In preliminary laboratory teats the
formulation has-been shown to inactivate pure- cultures of
LDB. However, the ability of this formulation to control
the growth of or inactivate LDB in operating water cooling
towers exposed to ultraviolet light, organic material, other
microbial contamination, and aeration, has not been documented,
These preliminary findings also do not address the problem
of long-term preventive maintenance of water cooling towers.
Xeco Engler,
Chief,
Disinfectants Branch
Registration Division (TS-767)
-------
-------
Reference No. 15
-------
-------
t
<*R 14 1983
POLICY MEMORANDA
ID: Disinfectants Branch Personnel
SUBJECT: Claims Against Herpes Simplex Virus Type 2
Background;
As a result of recent widespread publicity and consequent public aware-
ness concerning infections caused by herpes simplex virus type 2 (genital
herpesyirus), there have been an increasing number of inquiries and proposals
regarding amendments to existing registrations and new products -Kith label
claims of effectiveness against this virus. To aid in a consistent'approach
to such claims, the following guidance is provided as to our general policy
and the policy for specific types of products which it is anticipated may
become involved with these claims.
All health-related antimicrobial pesticide products are intended to
reduce or eliminate microbial pathogens in/on the inanimate environment and, '
in so doing, to act as adjuncts to reducing the hazard of transmission of
potentially infectious microorganisms' via fbmites (objects or materials which
may .have been associated with infected persons or animals and which potent-
ially harbor pathogenic microorganisms). By themselves, these products are
not considered agents of prevention, control, or curing disease, but rather
are intended to reduce the potential for transmission of the causative organisms
by only one route - the inanimate environment. Therefore, products intended
for use against genital herpesvirus on environmental surfaces are considered
to provide the same assumed public health benefit, that 'is, reduction or elim-
ination of these organisms on treated surfaces, thereby reducing the potential
hazard of transmission by this one route - inanimate surfaces. It should be
made clear that there is no basic change of policy , but rather an expansion
to provide specific guidance for a subject of increasingly intense interest
and concern.
Guidance:
a. General. Within recent years, it has become possible by more sophisticated
techniques to subdivide the herpes simplex virus group into two serological types
which largely correspond to the site of infection: herpes simplex virus
type 1 (HSV-1; oral herpesvirus) and herpes simplex virus type .2 (HSV-2;
genital herpesvirus). Previous to this, undesignated serotypes of the.
herpesvirus were used in testing for a less specific claim against "herpes
simplex virus". Many older labels bear such a claim. Recently accepted
labels have been required to specify efficacy against HSV-1 and/or HSV-2;
-------
depending on which virus was tested. This requirement is in accordance
with the longstanding policy- that the specific test virus (including the
type or strain) must be named on the label if claims of virucidal effect-
iveness are made. This more recent policy will continue to be in effect
for new products'or products with significant efficacy-related amend-
ments. Thus, all claims for effectiveness against herpesviruses must be
supported by product-specific efficacy data with HSV-1 and/or HSV-2
strains, and the tested type(s) must be specified on the label. Pro-
ducts with the old claim will be updated only if they are re-opened for
review by a significant efficacy-related amendment.
The following
lature should be used in label claims: (1) Herpes
f ' f * * X ^<%% *• % " •
simplex virus type 1 or 2 (name of choice); or (2) Human herpesvirus type 1
or 2; or (3) Herpesvirus hominis type 1 or 2. This name may be followed
by a parenthetical or explanatory phrase such as "oral herpes" or "causa-
tive agent of cold sores in the mouth" (for HSV-1); or "genital herpes" or
"causitive agent of genital herpes infections" (for HSV-2). The claims
must be prominently qualified for efficacy on "environmental surfaces"
or similar wording. .
b. Specific Types of Products.
1. Hard-Surface Disinfectant and Virucide Combinations: For products
with basic bactericidal efficacy claims plus additional virucidal
claim(s) against HSV-2 (and possibly other viruses), the efficacy
data and labeling requirements are the same as current policy as
specified in the guidelines for public health uses.
2.
3.
Hard-Surface Virucides Cfaly; For products bearing only claim(s) for
virucidal efficacy against HSV-2 (and possibly other viruses), the
efficacy data requirements are limited to virucidal testing only in
accordance with the guidelines for public health uses. Label claims
are limited to statements such as "Virucidal only against herpes
simplex type 2 (and possibly other specifically named viruses which
are tested) on environmental surfaces; not a bactericide". General
claims such as "disinfectant" or "germicide" which may imply a
wider spectrum of efficacy apart from viruses are unacceptable for
products in this category.
Food-Contact Hard-Surf ace Sanitizers: This category includes products
intended for sanitizing food-contact surfaces with additional claim (s)
for efficacy against HSV-2 (and possibly other viruses). These pro-
ducts must be demonstrated to be effective sanitizers against bacteria
according to the efficacy data requirements as specified in the guide-
lines for public health uses, and have additional data by analogous
methodology ( a special protocol is required from the applicant) show-
ing the same level of performance against the specific viruses claimed.
Label claims are limited to "sanitizes" or "reduces the number" of
-------
bacteria and the names of the specific viruses tested.
4. Disinfectants for Swimming Pools. Spas, and/or Hot Tubs: This
category includes products intended for treatment of bacteria in
spinning pool, spa, or hot tub water with additional claim(s) for
efficacy against HSV-2 (and possibly other viruses). These pro-
ducts oust be effective as swuming pool water disinfectants
against bacteria in accordance with current criteria, and have
additional data by methodology analogous to the A.O.A.C. Water
Disinfectants For Swimming Pools Method (a special protocol is
required from the applicant) showing the same level of performance
against the specific viruses claimed.
S. Miscellaneous Products: Other types of products which nay be en-
countered with HSV-2 claims will be handled on a case-by-case basis.
Engler
Chief, Disihfi
Branch
Registration Division (TS-767G)
L
-------
-------
Reference No. 16
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
• WASHINGTON, O.C. 20460
of net or
mnriciDcs AND TOXIC MIMTANCO
01 J983
MEMORANDUM
TO:
Disinfectants Branch Personnel
The nemo dated March 14, 1983 provides basic guidance
on how to deal with products claiming to be effective against
Herpes II virus. Some common sense issues concerning use
directions have recently surfaced largely based on documented
misconceptions by the general public. It is, therefore,
important to review the use directions carefully for Herpes
II products.
1. The simplest case is where a Herpes II claim is added
to an existing hospital type disinfectant and simply re-
presents the addition of an additional organism. Even so
the use directions should be checked to allow for the •
proper contact time (10 minutes) and precleaning just in
case we are dealing with an old label which is not explicit.
2. There is a good chance that especially for spray prod-
ucts the registrant is intending to promote the product
for on the spot use, i.e. spray on or wiping a toilet seat
for immediate use. This "intended" use pattern is not com-
mensurate with (1) The requirement for precleaning surfaces
and (2) Contact time of 10 minutes; even for directions such
as "spray until throughly wet and allow to air dry" a 10
minute contact time is implied. In other words the emphasis
should be put on precleaning and contact time to make it
sufficiently clear that the product cannot be relied on to
disinfect a toilet seat immediately before use.
Furthermore, while we generally may allow claims such
as " and thereby reduces the potential transmission
of (herpes virus, etc) from these surfaces", we should
carefully review labels carrying herpes virus claims in
order to make sure that this phrase may not add to the
misconception of the product's performance.
-------
3. There will be legitimate products which can be used on
the spot in toilets. For these the registrant will have to
perform special tests with short contact times and sufficient
soil load to reflect a soiled surface. These products will
be quite distinct from general janitorial or hospital type
products to which simply a Herpes II claims has been added.
BE WATCHFUL.
Dr/ Re to Engler,
Disinfectants Bri
Registration Division TS-767
-------
Reference No. 17
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 204CO
JUL3
or rice, or PCSTICIOCS AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Labeling of "Swimming Pool Kits"
TO: Disinfectants Branch
Personnel
The question comes up occasionally on how to label so called swimming
pool kits. Such kits usually contain one or more pestsicides (microbicides,
algaecides) and other non-pesticidal chemicals such as cleaners, acids,
bases, or cyanuricacid, all contained in a carrying and storage box or
pail.
The regulations 40 CFR 162.10(a)(4) state that the pesticide label must
be attached to the immediate container as well as to any outside wrapper
or container though which the label can not be clearly read. This section,
however, does not actually address the situation where several pesticides
and non-pesticidal chemicals with different use directions, warning
statements, and the like are contained in an opaque outer container. It
would appear illogical and confusing to affix several complete label* to
the outside of a kit of this sort. This would serve no useful purpose
since the user would be confused as to which label applies to which
container on the inside. On the other hand the buyer of a kit (and
inspector) must be made aware that the kit actually contains pesticides.
A corollary situation exists with respect to child resistant packaging
(CRP). It could be argued that in case the kit has a child resistant
closure the individual containers need not be in CRP. Alternatively, if
the individual containers are in CRP the kit itself needs not be child
resistant.
For swimming pool kits the following considerations apply and should be
followed:
A. Labeling
1. Each pesticide product within the kit must be fully labeled. .
The rare occasion .being very small bottles where a complete
label cannot be affixed. In these cases the label must refer
to the place where proper use directions and the like can be
found. The need for basic hazard labeling of each product is
self-evident.
-------
2. The labeling of the kit itself must be sufficient to indicate '
that it contains pesticide chemicals. '
Minimally this would consists of;
(1) Name of pesticide
(2) Ingredient statement
(3) Signal word/child warning and referral to actual
labels on the individual products.
(4) Net weight
(5) Reg. No. Est. No.
(6) Producer
of each pesticide product contained within the kit.
B. Child Resistant Packaging.
40 CFR 162.16 defines package only as the immediate pesticide container
and not as the shipping and distributing container. Also basic
logic dictates that a child resistant closure on the kit would
serve little purpose when the pesticide products are removed and
not always stored in the kit container. Therefore, if CRP is
required for any or all pesticide products in the kit the product
containers themselves must have CRP closures whereas it is not
necessary that the kit container has such a closure.
Reto Engler, Ph.D. '
Disinfectants Branch Chief
Registration Division (TS-767)
cc: S. Harker
J. Ackerman
-------
Reference No. 18
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 20460
nova-
orriex or
PKffTICIDM AND TOXIC lUMTANCK!
MEMORANDUM
SUBJECT:
Policy on X.Quat Formulations Allowed
in Household Products.
BACKGROUND: There seems to be an unwritten policy that household formula-
tions containing more than 10X quat should not be registered. Quats are
probably some of the most corrosive chemicals for the eye (and skin). This
unwritten policy was apparently established in the mid 1970's based on informal
discussions with the Toxicology Branch. Very few products were actually
refused registration because of this policy.
Between 1972 and 1974 several (15) quat formulations varying from 10 to SOX
were tested at Beltsville for oral LDso, eye Irritation and skin irritation
(information from C. -Rodriquez's file). While there was a fair correlation
between concentration and LDc0 (250mg/kg for SOX; 500 mg/kg for 40X, Ig/kg
for 20X and 2-3 g/kg for 10XJ no such correlation for 1rr1tancy was observed.
Although 10X formulations were usually somewhat less Irritating than SOX
formulations, there were some 10X formulations which were as damaging to
eyes and skin as were the higher concentration. Most of the tests were
carried out for only 7 or 14 days, but even so, the color photographs and
draize scores indicate that all formulations essentially caused blindness or
at least irreversible occular distruction.
Although there is a restriction criteria for household products causing
severe eye irritation (CFR 40 162.11) this criterion has never been invoked,
because It was concluded, that proper precautionary labeling (eye and skin
protection) would sufficiently reduce the risk. The hazards from these
products are no more and no less than those from other household items such
as oven cleaners, acids, and the like. Additionally, these products are now
required to be in child-resistant packaging (CRP) thus reducing the risk for
children in the home environment.
-------
The household restriction criterion for oral toxicity is based on the
of the use dilution (1.5 g/kg) and not the formulated product. The effective
use dilution for quats however, is essentially the same whether a 10 or
higher % formulation is used, or e-lse the quat is used directly such as for
a swimming pool algaecide and not further diluted for use. Based on the
oral toxicity of the 80% quat a 1:10 or 1:20 use dilution for example would
be sufficient to remove the product from the oral toxicity restriction criterion.
Such directions for use dilution are practically non existant for Quats,
they are used in much more diluted form.
Summary. Conclusion, and Policy
1. The scientific evidence does not show that a 10* "cut-off" point for
quats used in households is in fact supported.
2. Restriction from household use on eye irritation alone has not been
implemented since simple protective measures will sufficiently
reduce the risk.
3. The products in question are in CRP, thus reducing the risk to children,
for whom 12 above otherwise would not apply.
4. The restriction criterion for o'ral toxicity generally would not apply
since quats are used either sufficiently diluted or by direct appli-
cation of the concentrate to a large volume of water (swimming pool).
Since the unwritten policy was informal and furthermore did not affect more
than 5-20 applications a more formal recision of the informal policy is
neither necessary, desirable, nor cost effective
Policy: Based on these considerations the unwritten policy on quat limita-
tion for household products is not tenable. Quats of any coneertrations can
be registered for home use products, provided they are (1) stringently labeled
to indicate the danger of permanent eye injury and require the use of eye
and skin protection (see PR Notice 81-3 and PCN 2161.2) (2) are packaged in
CRP and (3) the directions for use dilution would not trigger the restriction
criterion for oval toxicity (L5g/kg body weight as diluted for use). This
policy does not affect any other procedures generally applied to amendments
and registration applications. This policy is effective immedicately.
Reto Engler
Chief , „
Disinfectants Branch /
Registration Division (TS-7&7C)
-------
Reference No. 19
-------
-------
SS2;
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
APR I 4 1981
MEMORANDUM
owe* or
PKSTICIOC* AND TOXIC CUMTAMCM
SUBJECT: Substitution of Technical Quais (alternate supplies) in
Disinfectant Type Products.Branch Policy.
TO: Disinfectants Branch Personnel
The supplier of the active ingredient (technical chemical) for a
pesticide formulation can be changed by the registrant, provided that
the alternate technical is registered and the a.i. is identical. In the
case of quaternary amnoniun compounds a special problem has surfaced
because alternate technical grade formulations contain different amounts
of alcohols (ethyl and isopropyl) or in some cases - no alcohol. These
alcohols are added to improve the solubility and to reduce the freezing
point of the concentrated quats. All in all, they have little or no
bacteriocidal activity at the concentration at which they are present in
the formulated products, and at the eventual use dilution of these
products; these alcohol components are largely a part of the solvent
aystem of the technical grade quats. In some formulations the alcohol
contributed from the technical quat has been listed as an "active
ingredient". In summary, when using alternate supplies of quats the
identity of the quat is of primary concern and not the solvent system.
In order to facilitate'the substitution from alternate suppliers the
following policy shall be observed. The "cut-off* criteria described in
this policy should accomodate most cases. These criteria are established
for convenience to address the most common situations. Exceeding the
criteria should not automatically disqualify a substitution, instead it
should trigger a determination by the efficacy review team on a case by
case basis whether the substitution which falls outside the criteria can
be supported.
Criteria for accepting alternate sources of quats.
1. The quartenary ammonium compound in the technical grade compound
has to be identical. The alternate technical grade quat must be
registered.
2. The technical grade quat intended for substitution can contain 0-
20t alcohol (see 14).
3. For public health realted products, the resulting formulation
defacto can contain 0-10% alcohol (see 14). .
For non-public health.related end use products no limitation on
alcohol content, apply.
-------
4. Ethanol and Isopropanol can be interchangeably accepted. Hethanol
substitution at any concentration is not acceptable without
additional review (toxicology).
5. The equivalent of alcohol in the technical grade quats used for
substitution shall be water. The sum total of water and alcohol
shall be made part of the formulations inert portion.
These criteria shall be applied immediately, they also can be used to
reverse prior decisions which were not consistent with these criteria.
// *" ~w //
Ret6 Engler, Chief I/
Disinfectants Branch
Registration Division/(TS-767)
-------
Reference No. 20
-------
-------
UNITED STAItS EN VIR- -i .•**• A^ * :-'J I KlTlON AC.LNCY
WASHING •:>*, O.C 20460
JUN If 067
MEMORANDUM
SUBJECT:
FRoni
or
TO:
THRU;
I AND TOXIC SUMTAMCKS
Use of Iodine for Long-Term Drinking Water Sanitation
iw—_^
Reto Engler, Chief /& s ..'" .s?
Scientific Mission Support Staff
Toxicology Branch/HED (TS-769)
William Campbell, Jr. Head, TSS
Disinfectants Branch
Registration Division (TS-767)
Theodore M. Farber, Ph.D.
Chief, Toxicology Branch
Hazard Evaluation Division (TS-769)
This is in response to your memorandum of May 8, 1987,
concerning "acceptable levels" of iodine due to drinking
water sanitation. The correspondence between Dr. J. Cotruvo
and Halex Inc., (William Gartner) seems pretty much the point;
i.e., since the iodine requirement of the American population
is already exceeded from other sources, chronic or even
subchrpnic (several weeks) exposure to additional iodine must
be avoided (more of a good thing, in this case, is not betterll)
Thus our recommendation is not to allow drinking water
sanitation with iodine on a continuous basis (e.g., home owner
wells, or even mobile homes). Water sanitation with iodine
must remain limited to short term and/or emergency uses (e.g.,
military and private field uses, catastrophes such as floods,
earthquakes and tornados where the water supply might be
temporarily contaminated with sewage). In addition we have
in the past required precautionary labeling (even in the case
of short-term uses) referring to the possible effects of excess
exposure to iodine on pregnant women or .persons having thyroid
problems.
cc: J. Cotruvo
f!3 5/26/87 sp
-------
MEMORANDUM
SUBJECTS Long Tern Us* of Iodine in Drinking Water
FXOMs William Campbell, Jr. Head, TSS
Disinfectants Branch
Registration Division (TS-767C)
TOt Reto Engler, Ph.D.
Toxicology Branch
Hazard Evaluation Division
Attached is a letter from Halex* Inc. which requests
an acceptable limit for iodine in drinkilng water* The
letter was originally sent to ODM who forwarded it to RD.
We request you recommendations in this regard.
TS:767C:DIS:TSS:JWilson:sbi RM-711, 557/7109, 5/8/87
-------
Reference No. 21
-------
-------
y*"<"<
I ^8^ * UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
fl .X? Uf A«-ft^lKl^nii.<«i>«>>B.> ««. ^
WASHINGTON. D.C. 20460
MAR 5 1985
CERTIFIED MAIL
OFFICE OF
'CSTICIOCS ANO TOXIC SUVITAMCI
TO: Registrants of Disinfectants Containing Pine Oil
Dear Registrant:
This letter is to inform you that certain labels of
registered pesticides containing pine oil must be revised
to comply with current requirements.This notice is being
issued in accordance with the Label Improvement Program
which was published in the Federal Register, vol. 45, No. 110,
June 5, 1980, and Pesticide Registration Notice 80-1 of
June 16, 1980.
This notice applies to registrants whose products fall in
any of the following categories:
Category I(A):
Pesticides whose approved labels list pine oil as the
only active ingredient;
Category KB) :
Pesticides whose approved labels list pine oil and
soap, ethanol, and/or isopropanol as active ingredients.
Soap, ethanol, and isopropanol formerly were classified
as active ingredients. As of December 1982, however, they
have been reclassified as inert ingredients. Therefore, the
ingredient statement on the labels for these products will
henceforth declare only pine oil as the active ingredient in
accordance with Section 162.60 of Title 40 of the Code of
Federal Regulations, July 1, 1982.
-------
Category II: •
Pesticides whose approved labels list pine oil as
an active ingredient and one or more other recognized active
ingredients on their approved labels (such as a chlorophenolic
or a quaternary ammonium compound), but whose registrations
have not been or cannot be supported by microbiological
efficacy data against both Salmonella choleraesuis and
Staphylococcus aureus, as specified in the attached DIS/TSS
Enclosure No. 1.
A computer print out of all registered products whose
labels list pine oil as an active ingredient is enclosed as
Appendix A to this notice. Not all products on that list
are affected by this notice. Registrants are responsible
for ascertaining whether their product(s) fall in any of the
three categories listed above; if so the registrant roust
comply with this notice. The list may not be complete and
up to date. Therefore, a registrant who knows that his or
her product falls in any of the three categories listed
above, but whose product does not appear on the list, is
still obligated to comply with this notice.
In any event, all registrants receiving this notice must
complete Appendix B, Notification of Intent to Comply with LIP
Notice for pine Oil, and return it to the Agency within 90 days
of the return receipt of this notice.
Submissions from registrants responding to this notice will
be processed as administrative amendments under Section 152.8Kb)
of 40 CFR, which do not involve consideration of data. In the
event that a particular amendment involves consideration of data
which was not developed with the particular product in question,
and which is not the property of the registrant, the procedures
and compensation requirements appearing in Part 152 of Title 40
of the Code of Federal Regulations must be followed.
I. BACKGROUND INFORMATION
A. Microbiological Efficacy Data Requirements for
Disinfectants
The microbiological efficacy data requirements for the
registration of disinfectants are specified in the at-tached
DIS/TSS Enclosure No. 1. The amount and types of data which
the registrant submits for any given product determine the
uses and claims which can be made on the label. Note that
the data which support a particular disinfectant determine
whether the product will be registered as a limited disinfec-
tant, a general or broad-spectrum disinfectant, or a hospital
disinfectant.
-------
B. Limitations of Disinfectants with Pine oil as the*
On I y Ac t i ve I ng red i enT
It has been established that disinfectants formulated
to contain Pine Oil, Soap and Alcohol, and which do not
contain an effective amount of another fortifying active
ingredient
-------
II. OPTIONS FOR COMPLYING WITH THIS NOTICE
A. Option 1: Limited non-health benefit claims
require no microbiological efficacy data
1. Allowable Claims
Under this option, the product can be labeled
only as a,limited disinfectant for killing odor
causing bacteria in those areas or on those sites
where bacteria normally cause odors. These are
toilet areas, shower stalls, garbage receptacles,
garbage disposals, and similar sites or areas.
The reason no data is required to support these
uses is that they are not intended to provide
health benefits to the user, only aesthetic benefits
by counteracting bad odors. (Refer to the attached
DIS/TSS Enclosure NO. 16 for the criteria used by
the Agency in determining whether or not the
labeling of antimicrobial pesticides bears uses
of human health significance).
2. Registrants' Responsibilities Under This Option
Registrants who propose non-health related
claims for their products should be aware that
although the Agency does not require submission
of efficacy data to support such claims, they are
still responsible for ensuring that these products
perform as intended. The Agency still has the
responsibility of making sure that the use direc-
tions proposed for non-health related claims are
appropriate and adequate. Therefore, the Agency
retains the option of requiring submission of
efficacy data for non-health related claims,
should a product or the use directions on the
proposed label for a product pose reasonable
doubt as to its efficacy as a limited, non-health
related disinfectant.
3. Required" Label Language
BRAND NAME
LIMITED DISINFECTANT TO COMBAT ODORS CAUSED BY BACTERIA
OR
LIMITED DISINFECTANT AGAINST ODOR CAUSING BACTERIA
-------
4. Required Location And Prominence Of The Limiting
Statement
Either one of the two qualifying statements shown
in (3) above must appear on the front panel of the
label, immediately below, and in close proximity
to the brand name, in a type size large enough
and with sufficient contrast, so that the statement
can be easily read by a consumer with normal
vision, when the product is displayed under ordinary
conditions of purchase.
The objects, sites, or areas where the product is
to be used must be incorporated as part of the
use directions. This information may be placed
elsewhere on the label.
Additional optional claims such as "Cleans" and
"Deodorizes" and/or claims against non-health related
microorganisms, e.g. mold and mildew, may be used
in conjunction with the required qualifying state-
ment, on the front panel, but not at the expense
of the space necessary to give the qualifying
statement the required prominence and legibility.
Such claims can not appear in larger type size or
greater prominence or contrast than that of the
required qualifying statement.
B. Option 2; Limited Health-Benefit Claims Requiring
Submission of Efficacy Data
Under this option, registrants must limit the health
benefit uses and claims appearing on the labels of their
products and submit data to support these claims.
1. Required Data
Microbiological Efficacy Data must be submitted
which is developed with the particular product in
question against Salmonella choleraesuis, as
specified in the DIS/TSS Enclosure No. 1. In
certain instances a registrant's product may be
identical to another formulation for which
data has already been developed and submitted by
another company, and which has already been approved
by the Agency and specifically referenced in the
application (a prototype).
If a registrant knows this to be the case, such data
may be specifically cited, provided the procedures
and compensation requirements of P. R. Notice 85-3
-------
(May 14, 1985), are followed. This notice was
mailed to all registrants whose address is on
record with the Agency. In this case the
registrant would still be required to submit
confirmatory data developed with the particular
product in question as specified in the attached
DIS/TSS Enclosure No. 5.
2. Allowable Claims
Under this option, the label must limit the product
as a disinfectant which is effective only against
infectious bacteria commonly associated with the
intestinal tract or human waste. This is the
only health-benefit claim which can be allowed
for the products in the three categories described
in this notice.
3. Required Label Language
BRAND NAME
LIMITED DISINFECTANT AGAINST INTESTINAL BACTERIA
»
OR
LIMITED DISINFECTANT AGAINST BACTERIA OF INTESTINAL
ORIGIN
4. Required Location And prominence Of The Limiting
Statement
This qualifying statement must appear on
the front panel of the label, immediately below,
and in close proximity to the brand name, in type
size large enough and with sufficient contrast,
so that the statement can be easily read by a
consumer with normal vision when the product is
displayed under ordinary conditions of purchase.
The objects or sites to be treated and the areas
in which the product is recommended for use must
be incorporated as part of the use directions.
This information may be placed elsewhere on
the label.
-------
Additional optional claims such as "Cleans" and'
"Deodorizes" and/or claims against non health related
microorganisms, e.g. mold and mildew, may be used
in conjunction with the required qualifying statement:,
on the front panel, but not at the expense of the
space necessary to give the qualifying statement
the required prominence and legibility. Such
claims can not appear in larger type size or
greater prominence, or contrast, than that of the
required qualifying statement.
HI- ADDITIONAL REQUIREMENTS
A. Ingredient Statement
As stated previously in this notice, the ingredient
statement appearing on the labels for these products will
list Pine Oil as the only active ingredient. The Agency
will no longer approve labels listing soap or alcohol as
active ingredients.
1. Ingredient Statement
ACTIVE INGREDIENT
PINE OIL %
INERT INGREDIENTS %
The ingredient statement must comply, to the extent
applicable, with section 162.10(g) of 40 CFR, 7-1-85.
2. Optional Statements with respect to the inert
ingredients.
Registrants who wish to add additional information
about the inert ingredients on the labels for these
products (such as "contains soap, alcohol and/or deter-
gents) may do so, provided these are true statements.
Su.ch information must be printed outside of the in-
gredient statement, immediately below it, and in the
';' minimum type size required by the regulations, or in
the same type size used for the declaration of the
active ingredient.
B. Brand Name
The Brand Name must comply with the general label-
ing requirements applicable to brand names of
Section 162.10(b) of 40 CFR. If in doubt about
the acceptability of a particular brand name
consult the product manager.
-------
2. Unless a product contains 60% Pine Oil (or more)
the product may not be labeled as a PINE OIL
DISINFECTANT. •
3. Names such as "Pine Type Disinfectant", "pine Scent
Disinfectant", and similar names are appropriate and
acceptable for products which contain less than 60%
Pine Oil, as long as these brand names do not include
the term PINE OIL.
C. Additional Claims Against SpecificHealth-Related
Microorganisms
Claims against specific health related microorganisms
can not be made on the labels for pine oil disinfectants
unless they are supported by additional efficacy data .against
the specific microorganism claimed, as specified in the
attached DIS/TSS Enclosure No. 1.
D. Submission of Microbiological Efficacy Data
When submitting microbiological efficacy data the
registrant is responsible for making sure that the laboratory
which conducted the tests reports the results of the tests
in accordance with the attached DIS/TSS Enclosure No. 3.
E. Use Directions
The use directions for all disinfectants must comply with
the specifications and requirements of the DIS/TSS Enclosure
No. 15. A copy is attached for your guidance.
F. One step Cleaning and Disinfecting Claims
If a product's label claims that it is a one step cleaner
disinfectant, meaning that the treated articles or surfaces
need not be pre-cleaned prior to treatment with the product,
the conduct of the supporting data must be modified by the
laboratory doing the tests to incorporate an appropriate
soil load as specified in the attached DIS/TSS Enclosure
No. 2. Similarly, if the product label claims that the
product is effective in hard water, the tests must be
conducted in hard water as specified in this enclosure.
G. Phenol Coefficient Claims
Labels for pine oil containing products bearing phenol
coefficient claims for Salmonella typhi identify the product
as a disinfectant against pathogenic bacteria. The recommended
use-dilution on the product label must not exceed a factor
of 20 multiplied by the phenol coefficient number against
S. typhi claimed. . "•
-------
Since the phenol coefficient claim is for nat.^
it ls not acceptable under option 1 <£r Pathogen1C organisms
permitted labeling ciaims are snecifi^n requirements and
TSS Enclosure No. 6. specified m the attached DIS/
TABLE FOR COMPLYING WITH TUTC
A. Registered Products
1. All registrants receiving this notice must submit
a completed Appendix B (Notification of intent to
Comply with LIP Notice for Pine Oil), no later
than 90 days from the date of certified receipt
of this notice.
2. Labels for the affected products must be revised
to comply with this notice no later than 1 year
from the date of this notice, plus 30 days grace
period for the certified return receipt of the
notice to be received by the Agency. This means
that pesticides which are released for shipment
on or after 13 months of the certified return
receipt of this notice must bear approved labeling
complying with this notice.
B. New products
•
Labels approved for new product registrations must comply
Fwith this notice at the time the registrations are issued.
C. Failure to Comply
Registrants who fail to comply with this notice by the
dates specified above will be issued a Notice of Intent to
Cancel the affected products.
V. INQUIRIES AND RESPONSES TO THIS NOTICE
Castillo, PM 32 or
All responses to this Not ice
Notification of Intent
Pine oil. and
contact:
(?03) 557-3964
Delude a completed
"P
-------
10
Registration Division (TS-767C)
U. S. Environmental Protection Agency
Office of Pesticide Programs
401 M Street, S. W.
Washington, D. C. 20460
Attention: Arturo Castillo - Pine Oil
Sincerely yours,
Enclosures:
Attachment A
Attachment B
Jugiasp. Campt, Directo-,
Registration Division (TSJ767C)
List of Registrant's Products Containing pine
Oil as an Active Ingredient
Notification of Intent to Comply with the LIP
Notice for Pine Oil.
-------
APPENDIX B
NOTIFICATION OF INTENT TO COMPLY WITH LIP NOTICE
FOR PINE OIL PRODUCTS
As a duly authorized representative for the company listed
below, I hereby make the following statements in connection with
the Label Improvement Program Notice for PINE OIL PRODUCTS,
PR Notice.
Company Name
Product Name
EPA Registration No.
| J The product listed above contains only pine oil as a
pesticidally active ingredient, as specified in this notice,
I hereby agree to submit revised labeling limiting the
product to non-health benefit claims (option 1, no data
required) within the time specified.
| | The product listed above contains only pine oil as a
pesticidally active ingredient as specified in the notice.
I hereby agree to submit revised labeling limiting the
product to limited health-benefit claims (option 2) with
the supporting .data within the specified time.
7_'[' The product listed above contains pine oil as the only
pesticidally active ingredient, and in sufficient amount
to support broad spectrum claims. I hereby agree to
submit revised labeling with submission or citation of the
required data to support such claims. I understand that
if the data is found by the Agency not to support the
claims on the proposed label, I must otherwise comply
with option I or II as explained in the notice within
the specified time.
| J The product listed above contains pine oil and other
recognized pesticidally active ingredients and the label
recommends the product as a broad spectrum and/or hospital
disinfectant. However, I have not submitted or cited
data to support those claims. Therefore, I hereby agree
to provide the necessary data to support those claims or
otherwise comply with option I or II as explained in the
notice within the specified time.
-------
J3"[' The product listed above contains pine oil and other
recognized pesticidally active ingredients and the
label recommends the product as a broad spectrum and/or
hospital disinfectant. Efficacy data has been submitted
and the Agency has accepted these data to support the
claims which have been approved Cor the product.
Therefore this statement concludes my obligation under
this notice.
j J The product listed above contains pine oil and it is
registered solely as a manufacturing use pesticide. As such
it does not fall under the reguirements of this notice.
This declaration concludes my obligation under this
notice.
j I Although the product listed above contains pine oil, I do
not intend to comply with PR Notice, 85- / of October , 1985
Therefore, please regard this as a voluntary request for
cancellation of the registration for the product.
Signature
Title
Date
Telephone No. _^
Instructions: A separate Appendix B must be completed for each ,
product containing pine oil and submitted no later than 90 days
front the date of PR Notice 85- , October , 1985. Only one of the
boxes must be checked as appropriate for each product.
-------
Reference No. 22
-------
-------
19174 Federal Regi*ier / Vol SI. Nc. 102 J Wedaeaday. K..iy a. 19M / Rul** and Regulation!
PAPJT 230-AHiiTOS DETECTION
AND CONTROL: LOCAL
JMMOVIDJ
1.94 CFR Pert 2ttu removed.
•ART at1-AStIST08 MCTtCTION
AND STAT1 »UUfc STAtl
IDUCATIONAL AOINOU pfUOVtD]
2. 94 CFR Part 231 unmoved. •
EMVUfONIOMr At PMOnCTION
AGENCY
40 CPU Part 1g*
|Dpei.4ttMaA; put, aoai^j
>•— — — tmfawi^^ f%&
UMV WIHCI! UO
Not
Agency (EPA).
r Notice of eaMndmeat to policy.
! Thi* aottc* amende e policy
ttetemeat pubiiebod in the Fedenl
Regie** or October 22. un (4» FR
5l74lHOctober un policy) and affacta
penoae wbo.dittibute.MlL offer lot
MJe.hctt for eale,ahip. deliver fee
ihipmant, or nweiva tad (baviag w
ncetved) deliver or offer to deliver eny
•BtiHicrobioJ peatieida. If aay *uch
pcnoa malt** aay claim* for an
aattmieobial peitidde product. Urftud
which <
obnl hi
differ from HUM
Bpathogeno.
ouria IB
coaiuactiea with thet prodact'e
refutretion. the EPA will regard thet
penoa ei heviaf vioieted aectioa
12{e){lXB) of the FedereJ laaoctidde.
Fuagjdde, tod Rodeatidde Act (FffRAX
ev«n wbea such daiau en for aeee
allowed by FffRA oocfloB2f.ee).
o*Tt Tfti* policy to effective Jew 27,
IMft.
Deniel A. RellfOR (eaforceaunt
inlDnaetien), Office of Conpitence
Moaitoriaf (E?W42), Office of
Ptittcidet ead Toxic Subeteaces.
Environaentel Protecfioa Afeoey. 401
M SL SW, Weihiapoa. D.C 204«X
(202-MX-7M7).
D. leea }eakiae (tedhaieml iafametioB).
Regiitretiofl Divisioa (TV787CJ.
Office of PtiQcid* Profreau. etn M
^Office locetioa ead telephoae number.
Rm. 248. CM *2. 1921 fcfferaon Divia
Hi|hwey. Arlington. Virfinn. (703-
557-7443).
•un
LPoficy
FffRA etctioa 12(eKl)(B) autee thai it
it oalawfttl for a penoa who diatrihutee.
•elli. offer* for Mia. holdi for Mle.
shipi. deliven for •hipment or receive!
ead (heviai to received) deliven or
offen to deliver a neutered peuitide.
to auke eay daiaa far that product
which differ tubetaabaUy from theee
deiai! made in coaiuoctioa with thet
product'! nfieiratioa. The tena -daiav"
iacittdc!. but ia aet liaiited to, daiau
appeariaf ia advmiaiaa. Uteretun.
lettan. or ether document!, ea well el
oral itaiaawata.
Uader Mtttoa 2(ee) of FffRA It ia aot
eaiiiueto:
1. Apply e peetidde el eay doeege.
coaceaffatioB. or frequescy leaa taaa
that epeciOed oa the labeliaf.
2. Apply a peetidde afaiait aay target
peat aot apedfied aa the. labeliag if the
applicatioa la to the crop, eaiaul or ette
epedfied OB the labeliag (oajeee the
kbel etetei that the peetidde Bey be
uaed oaly agaiaat peeta eped&ed ea the
label).
X Employ any method of apaOeatfoa
aot prohibited by the labeliaf.
la the October IMlpoUey. EPA ttated
In pober that, aiaaa a FIFRA i
2(ee)aMleaetei
mede regirdiag FIPRA aeetfoB Kee>
eeee would aot be treated ea a vtelatiaa
of FffRA eactiov 12(tKlXn ttlttf the
regiatered peetidde'* labeliaf
apedfically prohibit! that aee.
EPA be* ncoaddered Ua policy oa
FffRA aectioB t2(eKl)(B) with reepect to
certaia deima mede for uaee aot oa the
lebeliag. TUe notice iaforw the public
net e penoa with fiaaadal iatereet ia
the UM of aa aatimioobiel peatidde
product targeted agaiait htuaaa
peihogeae. auy aotmaJu aay daiau far
the product which differ from tboee oa
the product'* approved labtling. Thl*
policy doe* sot affect the applicability
of the October leal policy to any
peetidde! other tbaa thoee apoeified la
tttoaotiee.
The Agency bebevee meteffleocr
daiau for eotiBtfoobMl produete that
are aot eupponad by efBeacy dau
aubmitted in conjunction with that
peiticide i ngunnaa may faatat a
fal*e trntt of aecurity tHMf^ heehh
carrprofenionaii relying OB dtal
Bfeduct.Addittoaaily,!iB iheee
mad* ia conjunction with regieireuon
could po*t e **nou* public heelth
ihrtat.
exduded from the October itflt policy.
the Agency will take apprapnit*
enforcement action ponuaat to FffRA.
egainit any penon who diitribute*.
Mil*, offen for Mle. hold* for Hie.
•hip*, deliven for shipment, or receive*
ead (having *o received) deliven or
offen to deliver any antimicrobial
peiitdde if eny claim* made for it e*
part of It* diittibuitoa or M!«.
lubateaiielly differ from thoM med* in
coniunetion with it* reguoetion.
AddfttonmJJy. aay penoa who
temmmenrt! a FffRA aeetiea 2fee) tue
for aa entimicrobtel peeticide nrnani*
liable for peeaibl* dvil damage* erumg
otttofhwowB&egligeac*.
•PAia carnally eoacened about
I claim* far eatimicrobial
pethogeaa, eepeculiy egeiaat hepatia>B
vim (HBV). the eauMtive agent of
ihepetitia.aadl
i type m/
PR!VMH/tAV). the appareat ettologic
rdefldeacy
fndrome (APS). Moat of the incmn**
HBV aad KILV-m/LAV penaia to
r ead diottfeeuat product*.
I to deettoy vtnue* ead ell
living bacteria, fuagjiaad their epocea,
oa iaaaimeie *axfecMM (40 CFR
U24(ffK2XiKDH. Sleriliatioa ia aa
abeelute term aad denote* Itilliag of all
miooorgaaiem*. tBduding the meet
reaiataat epof»lMBa. agaiaai which
BOM producli are leeted. Oiaiafectaati
en eatifflKzooiaJ productt
**. ». iateaded to de*troy or imvenibly
inactivate iafectiou! or other
aadoairaM* becatia. pathogenic fungi.
or virtue* oa nirfece* or iaaaimate
obfeett" (40 CFR 182J (B)(2)(iHA)). la
caataat to iterilian. dtiiafectaati an
mteadeeTfot effecti»eue*« only egaftat
npnentative group* of vegetative
bacteria and pethogeaie fta«J. end
againit rpedfically tMted vlruaei. Some
antimicrobial productt an ngictend
with lebel dlnctiona allowing BM a* •
•terUixerif one tnataent ngimea ii
uaed (*4- immenioa for 10 ioun) or a*
a diunfectaat if e lee* etriageat regimen
1* uaed (e.g, immenrion for 10 miaute*).
FffRA aectiaa 3(c)(S){A) (tele* that
the Admiaiitrator ahall ngiater e
pealicidaifbedetermiaMthet**. .. it*
composition i* euch ea to werraat the
propoeed daima for iL" la addittoa. 40
CFR ISUeOfbHl). publi*hed in the
Fedenl Reguter of November 13.
-------
Federal RcfifWr / Vol 51. No.102 / Wednesday. May 28. 19" / Rule* and Reguiitioni 191-5
(90 PR IfW). states that efficacy data
mreo^indta support all claims"...
toeoBtnlpMtawnaiaaiaaatfeatpoM
a threat IB Jmttaa haalth aad whoaa
presence cannot be nedtty obeorved by
thi user, including bat oat United to.
microorg aaisma infection to man in any
ana of the uuaiaate aariroamant"
EPA nqvina tha fallowing data prior to
registering a product with a vtrueidal
label date (l) Demonstrated recovery
of U>« infective fora of tha particular
virus dried oa aa inaaimata surface, aad
(2) availability and «M of tuitabla aaaay
method* to demoattrale abaaaca of tha
dried virus aftar traatntant of tht surface
with the antimicrobial product (Ptattcid*
AaaaaaaMBt Guideliaea. SubdiviaiOB C—
Product ParfoiBaeca. Saedoa 91-30
(d)(5J. National Technical Information
Service Ordar Number PB S3-1S3824).
To register a product with o labal
claim that the product can be used as a
ttarllixar. EPA nqvtns data abowiaf
that tha product ia tponeidaL (Pesticide
Aaaatamaat Guidelines, aa abort.
Section 9l-«(eHlJ-J Since aporaa an tha
moat nsieuat form of microorganism.
no additional data an aatdad to aupport
virucidal daima for pradueta that an
ainady registered aa sterilisers. Whil*
HBV ia a relatively wall understood
human pathogen, than an only limited
txparimaatal data coaoaniaf viral
racovtry and inaetivation by
disinfectants oa bard surfacee. Tola la
dua to lack of a suitable aaaay aalhod
for daiirmtninc whathar tha infective
vima remain* on hard rarfaees aftar
disinfection, To datarmiaa this, tba
experimenter muat attempt to grow tha
virus ia a boat system.
Tha only known aonhuman host
system is the chimpanzee, and
chimpanzees an practically unavailable
for such experiments. In 1963 the
Center* for Disease Control (CDC]
published findings of a clinical study in
which five chimpanzees wan injected
with dried HBV-infected plasma tnatad
with each of five different ftmieidM Q.
Clinical Microbiology. 1*0): S34-S38,
1983). Though the chimpanzees did not
show evidence of HBV tafaction aftar 9
months, these data an too limited to be
conclusive. Therefore, the data an
inadequate to demonstrate thai
disinfection provides adequate contra)
against HBV contamination when
sterilization may be the only effective
control measure. This discrepancy in
control procedures (U. disinfection
rather than sterilization) could result in
failure to reduce HBV contamination.
(hereby incnastng public haalth risks.
Tha only known routes of
transmission for AIDS virus, which was
isolated and identified in 19M. are
iducta.
through aemal contact, blood pi
or from mother to newborn.
Transmission of APS via caaual
cootact bat aot been demoasmtad
(New England f oumal of Medicine.
314(6)344-340.4988). Recently, data
have become available which indicate
that KILV-m/LAV my be recovered
aftar dryiag OB maaasate turfaee* for
extended periods QounAl of the
American Medical Association.
aSfcltfr-ltfl. 19M). Tbeee flattings
advaaea the poeeibtitty that the vine
nay be transmitted via each surfaces.
Given the Insidious and fatal nature of
AIDS, hospitals aad other health-can
" ' ' ' loan*
ta eaavalUoff the aamd of HTLVJI/
LAV, laoaof c Jan at both CDC Q.
Infectious Diaoaaoa, M2(Z)^00-«9. IMS)
aadthePa«taivbutitttta(LaBcatr«»>
•Ot. UM) ha^a eoBdacttd stadias
demoasMttag that cattaia chemicals
effectivdy Utt HTLV-m/LAV ta Uqald
. .TbaCDCIaaoadanportto
adviaa ntanatod parttea of aair
tnnemiseioe of KTLvS/SvV to the
workplace (Morbidity and Mortality
Weakly lUpott 34<4S)*«-«iS,
NovamborlS.tW).Tbanport
ampbaateaa that tbo ncoowaadatioaa
for pnveattog tnantaeloB of ADS an
be
Mcpoaodtobtoedorl f, ^
paraoaa who may bo landed win
HTLV-ffi/LAV. Tbo report provides
certain broad reeommeVdeflons tot
steriUang or diatnfectin* manimate
surfacta or objacta that have been ia
contact with blood or other body fluids
of aa ADS patient.
If HTLV-m/LAV can be recovered
from inanimate surfaces, it appears that
aa acceptable protocol can be
developed to taet tha efficacy of
antimicrobial predncta (Journal of
Methods
IfitS). However, since no acceptable
protocol baa beta developed, aad no
data submitted ao claims have been
accepted against AIDS viraa for any
product
Given Iha available evidence and
methodology concerning these viruses.
EPA lacks sufficient basis to approve
HBV or HTLV-tn/LAV virucidal claims
lor any disinfectant product This
situation may change aa research on the
AIDS aad HBV viruses continues and
ngiatranta davalop acceptable protocols
to demonstnte vims isolation end
disinfectant product efficacy.
EPA will allow registrants to make
HBV aad HTLV-m/LAV virucidal
claim* for sterilizer products when used
iu accordance with label directions (of
the sterilization procedure, and when
approved ia connection with the specif::
product ngiatnitea.
Deled: May Ilia**
|eaaA.Me«nh
AttatoM AdaunumwforPmuadft end
ITR Oe& ae-UW Filed sXP«4* MS en)
40 CFR Part 1*0
(•* an3»l/M40; «L^OH-ai
Itattiyl
AOisier Environmental Protection
Agency (EPA).
*erte*c Final rule.
t Tbia rule establishes a
lolaraaea for tha combined residues of
tba herbicide dkbfoa-OMthyi and its
metabolite* in or on the nw agHcuiniral
commodity pea seeds (dry). Thi*
regulation to establish a maximum
Mrmissible level for residues of the
wrbfoda ia or on the commodity was
requested ia a petition submitted by ue
Americaa Hooebat Corp.
menvt MTB Effectiva OB May 28.
; Written objections, identified
by tha docoment control number [PP
6F333S/R840). may bo submitted to:
Hearing Clark (A-llO). Eavironmental
Protection Agency, room 370B. 401M St.
SW.. Washington. DC 20400.
PQS) PtMINlll BMPOjMMtlQM CONTACT!
By mail: Richard Mountfort Product
.Manager (PM) 23. Registration
Division (TS-787C), Environmental
Protection Agency 401M SL SWM
Washington. DC 20460.
Office location and telephone number
Rm. 237. CM No. 2,1821 Jefferson
Davis Highway Arlington, VA, (703-
557-1830).
tarfiMummaet sNFOMtATtON: EPA
issued a notice, published in the Federal
Register of Febraury 19.1980 (SI FR
6034). which announced that American
Hoechst Corp.. Agricultural Division.
Rtc. 202-:o6. North SomerviUe. N] 068?*.
had filed pesticide petition 6F3335 to
EPA proposing to amend 40 CFK 160.3SS
by establishing a tolerance for the
combined residues of the herbicide
diclofop-methyl (methyl 2*{4>(2.4.
dichlorophenoxy)phenoxyipropanoate)
and its metabolites 2*t**{2.4-
dichlorophenoxy)phenoxy]propanoi:
acid and 2-(4-(2.4*dichloro-S-
hydroxyphenoxylphcnoxylpropeniic
-------
Reference No. 23
-------
-------
81065
(CBS, eeS-BJ
>£ST CONTRAL DEVICES AND DEVICE
PRODUCERS
. Consolidation and ClerHicstirn *
I.
• Requirements applicable to pest
control devices and device producers
have been set forth In various regula-
tion* promulgated pursuant to the Fed-
eral Insecticide, Fungicide, and Roden»
ttcide Act. as amended <86 But. 0,73; 89
Btal nil 7 U.8.C. 138 et seq.) (TXFRA"
or "the Act") . The purpose of this notice
Is to provide a consolidation and claruV
cation of all such requirements. •
XL DEramrom
At section 2 (4) ) provides that the Adminis-
trator may specify those classes of de-
vices which shall be subject to any pro-
vision of paragraph 2(q>(I> 17 U.S.C.
136(q)(l» or 8*61100 7 <7 ITAC. U6e>
of this Act upon his determination that
application of such provision Is necas-
sary to effectuate the purposes of this
Act. On July 3. 1975. the Administrator
promulgated regulations (40 F.R, 2*242)
amending 40-CFR Part 163 pursuant to
this authority* 40 CFR 162.16 now pro-
vides that devloes as denned la FXFRA
section 2(h) are subject to the require-
ments of FIFRA section 2(cj> (1) CA>-
and to those provisions of FZFRA section
7 which are necessary to effectuate the
purposes of FIFRA with respect to
devices.
The preamble to these regulations at
40 FJL 26366 declared that to effectuate
the purposes of the Act.- devices subject
to sections 2(«> U> and 7 Include but aw
not limited to:
(A) Certain ultraviolet fight sycuns.
OSOM generaton, water alter* ead air Alten
(•sotpt ttao** eeauialBg •ubstsaess or
ainun* of autauaM vueb an ponwM«).
and ultrwoale dttiets. for which elaww am
m*d« to kill, laMUTM*. onwap. or sup-
pru* tb* growtb of t«a|t, baetwu, or trtniM*
w wlou* BUM: (B> ovuia Wga ftooouey
•otiad gtaeraton. OMWd* tunnont, foOs. aa4
muting dtvtof*. for vhlcb etolaw era mart*
to i*p*l birds; (C) MM* light mpt. ay traps.
•tactranlc and btat serttM, fly ribbons, sad
•r paper, for «hich elainu sn sMd* to kill
or entrap ontaia UMCts: and (D) coeM
tbump*n. sound ivptllmts. folkt and tout-
lag devieoi. for which oisisos ara msrtt to
nptl otrtain muaawls.
The preamble further specifies those
instruments declared to be of a character
unnecessary to be subject to this Act la
order to carry out the purposes of the
Act. These Include:
(I) Tnott which depend for their eBw-
tlmiMtt more upon the ptrfgraanet of tb*
pcnoa uciiut the devte* than on tb* per-
formance of tbt de*le* tutu, and
|S| Tboee which operate to entrap *e»-
it, the Agency wffi
ofderloeadeclarec-
to be subject to regulation under •action
» <4> of the Act as subject to regula-
tion under sections • and 17 as well.
XV*. Stnauar or
rroduet* fcaermllr fatUag within tbot*
two eateforle* Include rat and BBOUM traps,
flj iwatten. Ulteg* equipment for weed eon-
trol »ad ftih trap*.
Section 6 Of FIFRA <7 U3.C. 136f>
provides for such record-keeping mad
record Inspection requirements as the
Administrator determines necessary for
effective enforcement of the Act Section
17 specifies the requirement* to be placed
on the import and export of devices. In
neither of these sections Is there a pro-
vision that the Administrator declare
those classes of devices subject to these
sections of the Act; and In the attendant
FZFRA
TO
Any instrument declared to be a device
under 40 CFR 162.16 is. upon introduc-
tion into channels of trade, subject to the
provisions discussed below. Those provi-
sions of the amended FIFRA which per-
tain to devices are in many respects sim-
ilar to those under the 1647 FIFRA (61
Stat 163: 7 U.S.C. 135-13Sk). In both
Acts the Agency Is authorised to inspect
records showing the delivery, movement.
or holding of devices (7 U.S.C. issc.
1361 >; to obtain samples of any device
in the marketplace (7 UJB.C. ISSd. 136g»:
to seize any misbranded device (7 V£.C.
135g. 136k): to initiate criminal proceed-
ings against any permit violating any
provision of the Act <7 O AC. 125f. 12BI);
and. in- cooperation with the Secretary
of the Treasury, to sample, examine, and
detain any Imported device which vio-
lates the provisions of the Act (7 U.8.C.
135b.l36o>.
The dlfferenees la the provisions of tbe
two Acts with respect to requirements
applicable to devices, lie primaruy In the
greater specification of Jurisdiction and
regulatory requirements provided by the
1072 amendments. For example, while a
device, unlike a pesticide, is not subject
to the section 3 registration requirement
of FZFRA, section 12 of the Act makes
clear the Intent of the Act that subject
devices and persons dealing with devices
be held responsible for those obligations,
other than registration, that are Imposed
by the Act. Jurisdiction to regulate de-
vices Is expanded to tntra- as wen as
Interstate commerce (7 U.S.C. 136J(a>
.(!)). Similarly, section 0.).
With respect to affirmative regulatory
requirements, section 2U».
Section 7 of the amended FZFRA is
totally new. requiring the registration
of establishments which produce devices
declared subject to the Act <7 U.E.C.
136e). In addition to the provisions of
tbe Act allowing tbe Inspection of rec-
ords kept by producers and distributors
of devices, section 6 of FIFRA. as
amended, specifically Imposes the aaae
recordkeeping requirements on producers
of devices intended for export by making
such producers subject to the require-
ments of section 6.
KOttAL tfCUTU. VOL 41. NO. «*—MBM.T, NOVtMSIS IV. 1V7*
-------
610UC
V. EMIGRATION or Sricmc REQOUC*
vans ArrLicABU TO Devices
A. Section J(Q) CD. Mttbrandtng Pro-
visions (7 U.S.C. 136Win>. With pro-
mulgation of U>c refutations at 40 CFR
162.15, which invoked the authority of
section 25(c) (4) to specify devices sub-
ject to sections 2 ana 7 of the Act,
the labeling requirements uf the 1947
FXFRA to which devices had been sub-
ject were expanded (7 U.S.C. 135(z) (1)).
Those misbranding provisions ol section
2<3) (Such stand-
ard* Rave not. as of this date, been issued
by the Administrator; at such time as they
•re, the question of their applicability to
device* will be addressed):
3{n)(l)(C): II U an Imitation of. or is
ottered for Mle under the name or another
device;
3(q)(l){D): IU label falls to bear the
•rtabltthmcot number:
2(q)(l)(E): Required Informmtlon Is not
prominently displayed on the label;
3 (1) (A) misbrand-
Jnc:
A false or misleading statement concern-
ing UM composition ol the product:
A fait* or misleading statement concern-
log the cfiectlveucss of the product;
A MM or misleading statement about the
value of the product tor purposes other than
as a device;
A Mle or misleading comparison with
Other devices;
An; statement directly or indirectly Im-
plylup tbat Ui« device in recommended or
endorMHl by any «;tncy of the 1'rUcraJ Gov-
ernment;
A tnte statement used In such a *-r.y as to
give a false or misleading Impression to the
purchaser:
Label disclaimers which negate or detract
from labrMng etniements required under the
Act and regulations: or
Kon-nuinerieal mid/or comparative state-
ments on the safety of the product.
B.Section 7. ReelstraUon of EstabUsh-
mcnis (7 U.S.C. 13Ge>. On November C,
2973, regulations (40 CFR Part 1G7) for
the implementation of section 7. Regis-
tration of Establishments, were published
In the FEDtKAT. REGISTER (38 F.R. 30557).
The scope of. the requirements is set forth
«t 11672(a): "All establishments, as de-
fined in this part, which produce any
pesticide or device subject to the provi-
sions of this section, must be registered
pursuant to the requirements of these
regulations * * *M At I 1C7.K fc> the term
"device" Is defined as "• • • nnr device
or class of devices as defined by the Act
nnd determined by the Administrator
NOTICES
pursuant to section 25(c) to be tubject
to the provisions ol section 7 ol the
Act," '
Section 7 Imposes three basic require-
ments: (1) Registration of device-pro-
ducing establishments. (2i labeling
which reflects the EPA establfchmciit
number assigned to the establishment in
which Uic device was produced, and (3)
•submission of annun! production reports.
All establishments in which devices
subject to the Act nrc produced must be
registered with the Environmental Pro-
tection Agency as producing establish-
ments. This includes foreign establish-
ments hi which devices shipped to the
United States are produced, as well as
establishments located in the United
States which produce devices for export.
To register establishments, producers
should obtain from an EPA regional
office (he Application for Registration
of Pesticide-Producing Establishments
(EPA Form 3540-9). The applications re-
quire such information as the name and
address of the company headquarters
and the names and addresses of nil dc-
Tlce-producing establishments owned
and operated by the company. This ap-
plication must be submitted to the re-
gional office on or before January 18.
1976. Upon receipt of a completed appli-
cation, the regional office shall register
each establishment listed and shall as-
sign each establishment an EPA estab-
lishment number. This EPA establish-
ment number must be displayed on all
devices released for shipment by the es-
tablishment after 90 days after the pro-
ducer is notified of the assigned number.
The production reports (EPA Form
3540-16) must be submitted to the re-
gional office within thirty days after
notification of registration and by Feb-
ruary I each year thereafter.
C. Section t. Books and Records (7
UJ.C, 13CI). On September 18, 1974,
regulations (40 CFR Part 169) for the
implementation of section a. Books and
Records, were published in the FEDERAL
REGISTER (39 F.R, 33512). Pursuant to
the authority of section S(a) of the Act,
these regulations (at 40 CFR 162.2)
specify those records pertaining to de-
velopment, testing, production, holding,
and distribution, which all producers of
devices declared subject to the Act are
required to maintain and submit to in-
spection. These requirements apply to
domestic and foreign persons producing
devices for sale and distribution hi the
United States and to domestic producers
who export devices.
Specifically, producers of devices sub-
ject to the Act arc required to maintain
the following records:
1692 Quantities shipped or delivered for
shipment.
These records shall be retained for two
years.
169.2 (c): Inventory records with re-
spect to Uic types and amounts of de-
vices in stock which he has produced.
These records may be disposed of when
a more current inventory record is pre-
pared,
169.2 (h>: In Uie case of devices in-
tended solely for export to any foreign
country, copies of the specifications or
directions of the foreign purchaser for
the production of the devices. These rec-
ords shall be retained for two years after
expiration of the contract.
Pursuant to the authority of section
8 of
the FIFJtA as amended requires that
such devices must be prepared or packed
in accordance with the specifications or
directions of the foreign purchaser niul
that producers of such devices must
maintain books and records pursuant to
section 8ta).
VI. ENFORCEMENT Avr>ionmr.s
Section 9(a) (7 U.S.C. 13Cia» of
the Act authorizes officers of Uic Agency
to inspect any establishment or other
place where a device is held for distribu-i
tion or sale in order to obtain a sample of'
the device as packaged, labeled ond re-
leased for shipment, and samples of iiny
containers or labeling for Uic device. Of-
ficers of the Agency are also authorl/ed
KOEtAL IEGUKK. VOL 41. NO. J»S—FMOAY, NOVfMKI If. W«
-------
to inspect books and records required to
bo maintained under section Sin) and
copies of records which are available
under section C(b>.
Pursuant to section 13(2><8> of the
Act, H is unlawJiil for any perMin to re-
fuse to keep or to penult inspection of
.books and record*, or to refuse to permit
Inspection of an establishment. Pursuant
to section 12ia> (1) iF> of toe Aet. it is
unlawful to sell or distribute any device
which is misbranded. Finally, pursuant
to section 12 (a) (SHU of the Act. it is
unlavful to violate any provision of sec-
Upon * findinc of any unlawful act '
the Administrator may assess a civil
penalty pursuant to section H«a> of the
Act or Initiate criminal proceedings pur-
suant to section 14 «b> of the Act. If.
upon inspection or testa, a device Is be-
Uevcd to be In violation of the Act. or If
It Is believed that a device is intended to
bo distributed or told in violation ol the
Act. a Stop Sale. Use or Removal Order
may be Issued pursuant to section I3(a).
Additionally, section 13 (b) authorizes In
ran seizure proeeedines In a federal dis-
..triet court against any device which ta
misbranded or which; when used in ac-
cordance with, the requirements imposed
under the Aet causes unreasonable ad-
vene effects upon the environment.
- Finally, the Administrator may seek iu-
junctlve relief pursuant to section 16*c>
to prevent and restrain violations of the
Act.
TO. PUBLIC COMKCKT
Die Administrative Procedure Aet (5 •
TJ.S.C. 533 Q») provides that the solici-
tation of comments Is not required of
•Federal agencies for -interpretative
rules, ceneral statements of policy, or
rales of aceney organization, procedure.
or practice." EPA has determined that
this Kotlce falls within this exemption
from the requirement to solorlt public
• comment. Nonetheless, interested per-
sons mar submit written comments re-
tarding the policy set forth in this
Notice to the Pesticides and Toxic Sub-
stances Enforcement Division (ES-J«).
Ofure of Enforcement. \3& Environ-
mental Protection Agency. 4C1 M St*
6W., lYashhuUon. D.C. 204GO. Three
copies of these comments should be sub-
mitted to facilitate the work of the EPA
fend others interested in inspecting such
Dated: November t. me. •
SIAXIKT W. LCCBO.
Auistant Administrator
tor Enforcement.
XMc.7fr.MUfi Vllcd 11-1*--70:S:*6 MH|
KOitM UBNItt. VOfc 41, NO. MS-niOAr. NOVEMSft It. 1«
. \
-------
OPERATING
Number: 3037.1
Date:OtT19 1977
~rC"WC7' T'n ^-^np;-—pr • •••\rg*""r:
-------
3037.1
f. The name, address and telephone number of their Regional Branch
Chief, to whom they should refer further questions.
g. Any specific questions contained in the letter should be responded to.
4. A copy of the letter should be sent to the Pesticides and Toxic Substances
Enforcement Division (PTSED--EN-342)
IMPLEMENTATION; This procedure is effective immediately.
-------
-------
Reference No. 25
-------
-------
3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 20460
OFFICE or PESTICIDES AND TOXIC SUBSTANCES
DATA REQUIREMENTS
Bacteriostatlc Potable Water Treatment Units
Any unit intended for physical and/or chemical treatment of microbiologically
potable water from a municipal water facility to remove .undesirable tastes,
odors, chemicals or other aesthetically objectionable properties is identi-
fied as a potable water treatment unit. Only potable water treatment units
containing a bacterlostatic agent (e.g. silver) are under the purview of the
Federal Insecticide, Fungicide and Rodenticlde Act (FIFBA). The submission
of supporting efficacy data are not required because the microorganisms caus-
ing aesthetic problems (e.g. objectionable tastes, odors and the like), which
are assumed to be associated with these units, are not microorganisms of
public health significance. However, appropriate data must be submitted
indicating that the pesticide (e.g. silver) and other chemical components
which are incorporated in the unit are not released at levels which exceed the
maximum permitted in the EPA Interim Primary Drinking Water Regulations.
A general procedure for testing 3 units at the recommended flow rate for silver
release is indicated below:
1. Flush the unit with local tap water; then measure the silver release in the
effluent water.
2. After 5 to 10Z of the filter life (measured in gallons), equilibrate the
unit by passing water containing low total dissolved solids (as specified
in the attached publication*) at a volume which is equivalent to 50-100
times the volume capacity of the unit. Shut down the unit for at least
24 hours; then measure the silver release in the stagnant water from the
unit.
3. Resume the challenge of the unit with local tap water until SOZ of the
filter life is reached.
4. At SOZ of the filter life, repeat step 2.
5. Resume the challenge of the unit with local tap water until 9SZ of the
filter life is reached.
6. At 95Z of the filter life, repeat step 2.
s
7. Documentation of the flow rate, cumulative gallonage challenge in each unit,
sampling time and dates, and- the person (s) responsible for the testing are
required Information to be included in the silver release data report.
* "Interim Requirements for Registration of Bacteriostatic Water Treatment Unit
for Home Use", Federal Register, Vol. 41, No. 152-Thursday, August 5. 1976.
This publication also provides the chemical analytical procedures to be
followed in determining the silver release data.
-------
32778
NOflttS
v. The mrpoae of Uito state-
ment to to five notice of Ibc policy of Ute
Environmental Protection Agency (EPA1
with respect to the reftoiratlon under
the Federal Insecticide. Fungicide, and
RodenUelde Act (FIFRAJ. as amended
(M mat. tit. 1 OAC. IM et eoq.t. of
certain bacterieetatle water treatment
unite intended for home (Me. Bpedncally.
to
wnalver whtofc to Intended to prevent
' or mltftmM an? port, and which
* itfettBM tkpmter eapMitr
couM bt txpoetod for
by oet tutty. nut
i tb* dmto wbleh tbt
•a •wiHe«Moa (or
ttM nftetmUoaof tboM ntu. •
Tho Atney to pgbltohftn tbto
4 of UM Admlntotnttv*
Act. 8 VJBJC, MtfblOU. tt to w
tldpBtod thkt UMmotovownta bmta.
tbtnto, wlU bo
tn tte OaldollMi lor
to ttat Oblttd SUteh vHIA ttM,
tton ICe) (8) of FORA. (Be* th
tacana of Jam M. l«i, 40 FB
U. and aeptember 0, ton, 40 FB
417MJ
Thm •!• ttttw fononl typoi of
1. Water treatment units which are not
intended to prevent, destroy, repel or
militate any microorganism or other
past.1 Examples of product* In thto clan
an product* comprised of activated
carbon or eoano filtering material.
which are Intended only to remove un-
desirable chemicals, odon or partlculate
matter, and with respect to which no
•xpWemWd or iftiffiiffd "Ifl^^u ffff pccti*
ddal activity art made. Water traat-
' AttMtim k ia*iud to 40 ent
wbleB prondw as *ouo«: -A subvuao* or
mwtun of mtataaeat is a prartlflOt uadcr
the Act if it is unsafe* for prsvsatiac, e*-
JwfOJIlH. fwyAlUBf ^1* BUwintiBtlAeT
(aw swttea Kui of tb* AS* tot I;
(fr». loch tatsat may a* ettber <
. Zt a aroevct to I'spisssiiiaa la a
that raratts la Us fcwa* vsstf M a
I* stall a* osstae* a pattteUto tor
»of tbs A« • • •."
M0»m. VOL 41, NO. l«—WUtSOAY. AUOim S. 1*f«
-------
NOTICES
32779
moot unite in Uxti class arc not subject
to regulation under FIFRA.
2. Water treatment unite which eon-
stot only of * physical maun to prevent.
destroy or mitlg»ti microorganisms or
other pate in wmttr. 8wn water treat-
ment unite art devices within the mean-
ing or FIFRA Section Sen). While de-
vices arc not subject to the PIFRA
registration requirement, the sale, dis-
tribution or other movement tn com-
merce of a device In this eategory which
i* misbranded within the meaning of
ITFRA Section 2(q> is a violation of
the Act. In addition, the producers of
such devices are subject to the require-
ments of FIFRA Section 7, regarding
reports to the Agency and other matters.
'See 40 CTR 163.15.)
3. Water treatment unite Incorporating
a substance or mixture of substances in-
cluding any chemical antimicrobial
agent, intended to prevent, destroy or
mitigate microorganisms or other pests
in water. Water treatment unite In this
class are pesticides subject to the FIFRA
registration requirement. (See FIFRA
Sections 3(a> aadl2iaHl>'A>.> A pesti-
cide cannot be registered unless the Ad-
ministrator has made the findings set
forth in FIFRA Section 3 .
Among other things. Section 3'c> (S> and
40 CFR l«7.7 <1) require the Adminis-
trator to find that the pesticide is effec-
tive for the uses set forth on the label.
and that the pesticide will not generally
cause unrfft<""Mf adverse effects on the
environment when used as directed. The
applicant has the burden of proof with
respect to each of the required findings-
Home use baetertostatic water treat-
ment units with filtering media Impreg-
nated with silver, which is intended to
prevent, destroy or mitigate any pest are
included in category 3 above and there-
fore are subject to the registration re-
quirements of Section 3 of FIFRA.
Under 40 CFR 141.14 of the National
Interim Primary Drinklntr Water Regu-
lation* -December 24.1975. 40 FR 595«O .
potable water Is permitted a certain
amount of harmless bheteria which Is In-
dieenou* to munlclnally treated water.
Because of the potential for extemive
growth of such bacteria trapped within
the flltcrin* medium, most water treat-
ment units for home ««e contn'n a bac>
teriostatie pesticide. The oetticide in
such units is, of necessity, incorporated
to nevate the potential problem created
by the primarv Intended use of the U> > or labeling
(see FIFRA Section 3(3HiUA>.) Products whose
label or labeling fail to satisfy the re-
quirements of the Act and the regula-
tions are •misbranded" (see FIFRA
Section 2 ) ; the sale, distribution or
other movement in commerce of a mis-
branded pesticide is a violation of the
Act (see FIFRA Section 12(qUI>UHF> and 40
CFR 162.10(1) > and adequate warning
or caution statement* (see FIFRA Sec-
tion 2iq) (1) (O) and 40 CFR 162-lO«h* ) .
Additionally, the labeling mutt not con-
tain any statement design, or graphic
representation thereto which to false or
misleading m any particular (see FIFRA
Section 3iqui)iB> and 40 CFR 103.10
Table V, «pro.) dabns of
cldal action Include dates that the fol-
lowing win be removed from water:
i.
volatile ergaasss (matt k*
Since the basic purpose for the home
use water treatment unite addressed In
this policy statement to to achieve bene-
fits other than pestteldal (anthnfcnbtat>
benefits, the pestlctdal claims permis-
sible on the labeling and/or to advertis-
ing must be quite limited and explicit.
The following pestteldal claims are con-
sidered to be the. maximum warranted
for products of tills type :
1. Inhibit* tee growth of bacteria within
the Alter unit.
!. Contains • bactertovtatic filter.
3. Provide* bacteflostatic activity mUhin
tht Alter unit.
In considering the foregoing allowable
claims. It Is ob«. ioiu that any represen-
tation. either directly or by implication.
of these products as "water purifiers"
constitutes a false or misleading claim.
They may be represented a« "valcr
treatment units", "water clariners".
-water filters", or "water deodorisers".
or similar names which do not in any
way imply water purification. Det*nd-
Ing upon the claim* proposed and sup-
porting evidence submitted, general
claims such as "produces a clear water"
or -improves water quality" mny be ac-
ceptable.
Regulatory jurisdiction under FIFRA
extends to all claims made on a prod-
uct with pcsticidal use. including non-
pesticldal claims. (See 40 CFR I62.10(a*
iS>.) Claims of value which are consid-
ered to be non-pcstlcidal must also be
supported by adequate evidence. ?05. where prr-turin* to etm-
tf urtMl. A sattefactory rr.i*cc of key iter-
ni-tcrtstics to as follows:
MI CnOO — 23 mff. 1 rppmt
Alkalinity M euro —40 mgl (ppm>
Totail t>li»olrv:i»n- thai h.is been artificially coa-
.•.titntcri to the concentration ranges
;» hove f«r the tao water will be
Claims must be ju-stified lor the life
of thi» ttnit. as represented by the Rumu-
farnirrr, and utien ived as directed.
Prc-tcstin? In EPA Laboratories may
be required for any
-------
327*0
NOTICES
BMxntouxuui
A. Challenge three product units, and
three control units without silver, with a
continuous flow of tap water, sampling
in accordance with the format outlined
in Table L
B. Deeblorinated. sterilised (auto-
claved) tap water, seeded with Pseudo-
moos* fluoreseens (ATCC No. 13999)
which te a saprophytlc microorganism
commonly found in the mlerofiora of
water, at a concentration of 900 micro-
organisms per ml. must be employed In
the test as the -artificially contaminated
water. This water should be prepared by
suspension of the organisms from 34-
hour tryptone-glucose extract
all bacterial counts of the test
ilfleanttf lees than the
counts by the end
the test (to Justify the need for the
aertostatlc agent).
Horn—UaloM disposable glostwan to u*«t.
all flttiwBi* mutt te pr*-cl«UM4 M follow*:
(l) AM M ml cone. HKO, to aaflk; (3) Bwirl
•MMiallr or nurmnlrally for * BUB, mit^if
rat»mtti*wttto4*iuf
HMO.:
a«K (•)
<«)
•top 9 two aaatioasi IMMK
la • S* BUD. ooluttOB tor SO sain.: <•> Soak
Book la * J% MH.OH ODluttott for SO Bin.: (7)
~ - la Bobon labofMory Waiter (or
at doiented toy manufacturer.
C. Bach unit mutt be filled to it* ca-
pacity with artificially contaminated wa-
ter, and doted off in auch a manner ae to
retain thte water. A1M ml aaraple of the
artificially contaminated water mot be
retained for M hours, with a «um«l
count reported at the end of thte period.
The efluent from the unit abould be aam-
pled after the proscribed holdlni period
at room temperature, (flee Table J.)
Tlieholdov period li required to stim-
ulate the non-use or "stafnaBon" period
old expect under conditions of ues
A. The flow rate (as recommended).
pH. and tenpsrature of the tap water
must be determined at each i"""p11ng
tnternU: and the water hardness, alka-
linity, and total dissolved solid* of the
water etfuent at fee
tost must be reported.
B. Chemical analysis for silver
ceotratton in the treated drtnkiog water
must be performed by the Atomic Ab-
sorption Method. Duplicate samples for
silver analysis must be taken from the
bacteriological samples as indicated, in
Table tt POT details on sampling and
cleaning of glassware for silvar analysis
see Table It
C. All analytical procedures, unless
otherwise specified will be in accordance
with the "Standard Methods for the
FTsmlfiBtlon of Water and Waatewater."
cited above.
See Taste V for guideline* for develop-
ing data to support non-peetleidal
claims. The test results and information
required during the testing of an units
must be recorded and submitted m the
precise formats outlined in Tables ED
and XV below.
TASU
n H W fHtxmmt n
Ittltanl
before the < .
D. Bacteriological assays should be
conducted on two (». one hundred ml
camples at each prescribed Interval from
each of the she units. Remove samples
f or silver analysis in accordance with Ta-
ble ZL To aO twetvo samples add 14 ml of
a sterile neutralising solution containing
9 percent sodium thtoglyeollate and 74
percent sodium thlosulfate. Plate counts
must be carried out as described in the
Standard Plate Count procedure. •'Stand-
ard Methods for the Examination of
Water and Wastewater," Thirteenth Edi-
tion. 1971. American Public Health Asso-
ciation. Inc., 1740 Broadway, new York
K7 10019 (page 980). The tests should
be performed utilising tryptone-glucose
extract agar. and all plates must be men-
bated at room temperature (20«-W C)
for 49 hours.
A filter unit will be considered to be
effective as a bacteriostatlc filter only
«f tnOeitllr cwumlitMrd w»Ur.
Ciaunm or OLAMWIU FOB AKALT
MM a. Soak IS x ISO
ram tal« MH,OB for SO
b. Vriac t*M rate WMB nek
wft gtttt MM rate
la
i. lamp]* Oelteetioa.
.. _. i-.-.r^a^TiMkll™. - - -— ^^Msrt^1^^ * ttlW •uUBpli) WttbOttt tlM UM fiC BfO.
10 fBi UIO U X leW SUa> OtpptJO MW PMi M-__ **.^ f tijr i ___ ---------- mimtsm *• *iu
twl tub* rim^lirtrf Ihiv* ttopt «€ OOMB* ttM ** n*MlwlI|C pwotaurt pnor CQ UM
t ». «• test tabs wltfc cone. HKO, «ut allow
..»...»- aa^ a^n^i BM O_
e. aanpl*Mao*M«yroruMty«ia,
». neairtng proosduia (only ter t»t tubai e. «opoat»topt tt
vhleb to** torn uaid wttfc HMO, to lablMt «. Tfc« ,« M HH.OK MMk at
A( MtoetpMeB) . • prrrtomly.
MQttAi BMttttl, VOL 41, NO. 1»—tMUUflAV. AUOUsT I,
-------
NOHCB
32781
i
5
i
J '•
-------
32782
1. Mint to tffttfa. I*
••ami and ar« bot allow**. Oaten for
rtaoral of -cbloroforB" or "aldrls" M»
allow**. if •upporwd Of •Mtafaetcry tautjmm.,
i. T*« rraftmd analytical m«ttad* ar*!
JTMAod* /or
nation »r VM*r Mtf BTa*te IPMCr
Public Baaitb AMOC.. 10H tttb ttnvt MW«
Wub. o.C. SOOM) OffleUI tnrtliod* of IM
AoMrtean Bodctj for Twunc Itettruu
(AOTM) and tta ••ncutlea of
(AO4C) Wt I
OJUore^orm
by anoiyMi (or
pntesbtjr itta§ UM
M74.
MttodcBay to acaeptaM* tt dora«!
1 ODd'proved. Th* UBlt Boat to *OB*
t*
Of 14 ppB of Total
(TOO) for tto Ufa of tto
to 10% (or !••> cT
4. AUrto. tnartn, rtc. removal claim* murt
by ajuly**a. Tto preferred
i to Method for Organochlortne P*M-
i bdartrlal CBuantt. MDQAltr. «PA.
ClnelnaatL Ohio. Horambar M. UTS. Tto
unit wtu to eonttauoualy npoart to water*
oaatalnlat t*n ooootntratkmi of tto pwti-
rtdai for wkleb elatmi ar* Ming mad*. Tto
tart watar Btuit atao eontain a tor irtrnmtil,
IOTA of 1JO PPB Total Orfaaic Carbon
-------
Reference No. 26
-------
-------
FIFRA ENFORCEMENT POLICr STATEMENT NO. 3.7
u
Exemption from Registration - Ant i.microb"ials used as
preservatives in medical devices regulated by FOA.
4fc
•fc
Issue;
*
Is an antimicrobial substance intended for use as a preservativ
in fn-vitro diagnostic reagents that are regulated under the Federal
Food. drug, and Cosmetic Act (FFOCA) exempt froo the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration
requireoent? •
-------
- 2 -
requirements of FJFRA
PMt,e,d.
Antiofcrobfal agents
-tn-vitro diagnostic reagents
i";
fe^ta&s-
Substances Enforcement
DEC 8 1331'
-------
Reference No. 27
-------
-------
(Reprinted from Federal Register of December 22, 1971; 36 FR 24234}
AGREEMENT BETWEEN DEPARTMENT
OF HEALTH, EDUCATION. AND
WELFARE AND ENVIRONMENTAL
PROTECTION AGENCY
Notice Rcgording Moi)-t» of Mvhrol
are nther ptoeedures wbtch should
be aeuHtonf*! In eeder to facilitate lit* han-
dling of Biattm which an of direct concent
lo both Apenetet. TOM* matter* Involve Is-
suance of resuSamms under «rtion «oo of the
fTDCA. «Mat):isl>ment of reference stand-
ards, eaehange of Inlormatloa on certain pro*
am lana**a*«*WM*BBV m •aatM^'M t ' *a*) *te ^__^§A *,^ •
V* VTHnPrW* KfrpllwlHaJHi IV OHM* HP I
,JT registration of A product that to b«t
drug •ltd MI ceonofc.tr poteon and ilr:
ml nation hits been made that the prlnc
ctelnis or reprrarntar.an* relate lo an •
nnmie poison. EPA v.lil withhold regturai
..«.• Dctniinirnt of Health. Education.
mid Welfare and the Enrtroomenul
Protection Anncr tia»c drawn BP ai»
unrecment repardtoc matten of mutuaJ
responsibility under the Federal Food.
Drtqr. ««d Cosmetic Act and toe Federal
IhnrUridc. Puncddde. and Rodentleide
Act It reads as follow*:
w lltM.ru. Evtxanox. *J«P
VfOJtU*
ce HOI* Awxcr
or *eananwT acoMtacte suit'
wrvu. acarox>nuurr mnai
rooa.re.axa coaitcnc act AM»
ion PJan No. a of 1V10 pub-
lUbed in the Frssjau. BMMftt of October •.
1*70. seated In «ection 3. pasagnph (41 that
tho runcttons veved hi the Sccreta*T of
Health. Education, and Welfare of eetabltsh-
IDR tolerance* fi* peaUeMo cbecalcal* under
tho Prder.il Fund. Drus. r.nd Caameuc Act. aa
amende. 51 UJJ.C. 349. 34«a. and 946. wete
to tho AdmlnMrator of the
PiotceUon Agency «3ee:lve
mbcr 3. 1070. After considering a!i of tho
17 r.a pnticlde u>*» wiiirh hars been-attb* •
k jSfe to petition procedure ueder tb«re ttre*
Mctions. and e«rtoin oliier econenJc potaon
tiaeti dubjcet lu:h to the Federal fcuectlrtde.
ir. and H.vlcntlrW* Act. T31 U^-C.
and to tlw Federal Pood. Drug, and
Cosmetic Art. lite Adittiiusirai«r of the En-
vlroiuuentat Pro:ec;lt*i Apency and the 6ee-
tviarr of IiRiiiii. tcMcatloii. and Wc^axe
hare oancittrtrd that thtt asrerment ta
needed to provide fur the rocrdtnatien of
•ariritim }«n.ilninp tn rcnnnmie prisons and
to III.'ITT.-. nit concerned = : t» wli!rh aevner
will pmcrse the pe«:tclde petition* for each
typtot uae.
RearnaniMtlnn Plan No. 3 atoo tranvfcrred
to tl>e Adroimstnior of the fi&rirontnental
Proteetiou Arvney the f unctions of Uie sec-
retary (if Apiculture under the Federal lu-
rectlclde. KunclsiUc. and Rodentleide Act.
There are certain preduc(s which are subject
to tlte rrqiiuvment* of both the FedcnU Food,
Drup. and Ckometlc Act iPFDCAl and the
Federal lu->cctlelde. Punrleide. au Hodentl-
.clde Art (FIFP.A). In the past, coufuslen.
niliMitdetftaiidlitc and li:rqtiv«Uenee hare
rrxnlted fmm prccedunn ftdlovred in enn-
iiecilou «->Ui the proposed marketlRg of tuch
product". The Admlnixtraior of the Environ-
mental Protection Acenry lEPA) and the
Secretary of Ilr.MUi. Education, and Welfare
•re agreed that a new proerdure *'.iould be
fitltowed. whereby the manufacturer would
he infnrmed (It of the a;enry exerclUng
primary "Jurisdiction rrfnrClne UU product.
(» that thr matter will Mr referreO to t»e
other ncfiicy for dect<»t>:i u:>der the law el
that atsenrr. and 13) li.a't ni^proral for mar-
the product will m i be pranttd un>
or until fnch aeFricy ?.tu approved the
-eting under lit re.«;<*ctlvc a-Jthorite.
~ . matter *-as the sunset pf a .aropond
mrnt or cenerml pollry and tn:trpm»-
pubti»hed in the FTITPAJ, fucurrn on
pA»cu«t A. 1070.
cwntiica CM avrreuianoe
•eunuts «n pesticide residues In food and
publication of 'he Pesticide Analytical
Manual.
the term -pesticide chemical" to defined la
eecuon 301 (q) of the Federal Pood. Drug.
•nd Cosmetic Act as a substance which M an
-economic poison* under the Federal Insecti-
cide. Pueglcido. and Hodenticld* Aet and
which to need la the production, atoraga. or
transportation of raw agricultural commodl-
Ue*. Eeoaomie polvms used on food owpa be-
fore or after aarratt and OB food animals an
Included la thto catecery. Eeonomie poisons
used on or ooacealnuag la processed foods
are treated la the Federal pood. Drug, and
Coamette Aet aa food additives rather than
pesticide chemical*.
Both agtacto* agree that:
1. The following petition* will be precinea •
by the Enrtronmemal ProteeUon Agency:
a. P«titions requentng toteraDcea or ex-
emption from toiennce* tor restUne* of
pesticide chemkeato on raw agricultural
commodities.
b. Petition* for food additive reculattona
required for restdue* of pesticide chemicals
earryiaz over aad concentrating la processed
food* manufactured from treated raw acri-
eultural oammoditle*.
c. Petitions (or regulation* for residue* of
economie potions from direct treatment
of processed food* with fumtgaata or
lAcretieide*.
d. Petition* for food additive regulations
to permit the safe iwe cf economic potion* to
iruroguate foed-packaglng materials such a*
wrappers or bag* to protect raw agricultural
eommodlUe* from any pest or to protect
preecsoed foods from Insects.
3. The following petition* will be proc-
essed by FDA:
a. Petition* for food additive reRulatlon* to
permit use of • sealtuera aa food-contact
surfaces. • •' •'
b. Petitions for food additive regulations
to permit the rafe use of economic poison*
*« »re*erv»tues in processed food.
c. Petition* for food additive regulation*
to permit the safe UM or economic pouona
in food packaging material when auch use I*
not eevered by i.d.
3. Application* for approval of drugs under
FTDCA and for registration of economic
potions under FIPRA WUI be processed aa
follow*:
a. Whenever a product to submitted to
either FDA or EPA fcr approval aad it to be-
lieved by either agency that the product to
subject to the requirements of both the
FFDCA and the FIFRA. an Intentgency deter-
mination will be made and an agreement
'rmcned with rexpect to (II whether the
product t* subject to the requirement* of
the FFDCA ar.d FIFttA. (9) whether par-
ticular claim* are "economic prison" or
"drug- claims and (3) whether the repre-
sentations made for the product, including
the implicauoas to be drawn tiieref rom. are
primarily "economic poison** or "drug"
rtpre.trnt.it Ions.
by PDA t.-.jr ;j«» pr**;.** eu
pit** With til* provisions Of SIM MVB t
ministered by VDA.
c. Whenever application to made- to F
lor approval of a product that i* both a di
and an economic pol«on and dclftrmlnat-
ha* been made that the principal claim*
representation* relate to • drug. FDA vlll >
approve a new drug application. a new a-
mal drug application. or *n antibiotic apt
eMten without Arm being advised or *
that MM claim* or representation* subject
we provision* of the rrFRA we warrant
»nd that tlte product is eligible for r*gl*t<
Uon under that we.
d. Whenever application s* nude to E:
lor the regtttration ol a product that to ton
• drug end an economic poi*on and deu
in ln»tton b» been made that tho prlnetp
> claims or rvpicaeatatlont nelato to •> drt
the matter will bo referred by EPA to FT.
and the matter will thereafter D« bandit
aa tr the application had been originally mat
to FDA. ., " ' .
e. Whenever application to made to Ft
for approval of a product that to both »
economic poison and a drug and determin.
Men has been made that the principal elaJn
or representations relate to an nroaueitc pa
son. the matter will be referred by . SA i
EPA and the matter will thereafter be hat
died M If the application t»d been originaii
made to EPA.
f. Xettber agency will kpprore the market
ing of a product under the law admiautcre
by It If the product would not be In ft:
compliance with the requirements of a to'
admlnUterad by the other.
4, If the poisonous or deleterious auMene
referred to In section 40* of the PMer*
Pood. Drug, and Cosmetic Act to present I:
food primarily aa a result of it* use as ;
pesildde chemical, or an economic poitm-
anr regulation establishing a tolerance ir>
such substance In food-wilt be promulgate
by the Environmental Protection ARWWV
An? other regulations under accijon 408 wii
be promulgated by FDA.
5. EPA witt have primary re*ponsiblli:<
far maintenance of an analytical reference
standard! repository cf pesticides for whlr^
tolerances are esMbliihcd. FDA will traiun.-r
to EPA those santplca which have been prv>
pared for this purpose. Upon request, por-
tlor* of ti«.-»« sample* wui be made «v^n-
able to thr FDA and local cnforcemetn ai:-
thorine* us nreded for uye In official «ii«ly-.t-
6. Each agency will appoint »,> inrtitld-iat
and alternates who »haU be rc*i-
luh oprnting procedures between the a-rcti-
cies. rrimary functions of the represent .•-
tires are: (I) To asaure adherence to u.t
eenvral prortolons of paneraphs 1-4 abbtf,
inclusire: (ill to promote mutual conrur-
renee on chemical, wxlcolorlc. ai.rt piiarn*.%-
coioglc rtvjutrpmoutu for pesi-lcldc tnlrranr -
(till to provide for complete nnd itm~'v
e»rha»f»of infonnallRit conrrrvii.i; JH.^^. ••;
-------
.'t
•dcoiatMmttf* mtidMtMB, ncth-
otology. MWHcb pToffrmmx BMmltonai. •«?• 4 '.
MillMtco and eafotMHMat profnuaa. MMI :
total MUM: (ivt *» puma* that IB* will
•oatlau* rc*ponaibuity tor afrraMBU wttb
BUMS and lortlf* cmiBttten MB iiirMliiaao*
and «Bforeement aetmtlM an pMtldd* rt«l-
In rood: (») to provido th»t wfter* th»
. dtlcsat* 10 imeromtloMl orfanl-
to Mthcr EPA or FUA thl* wiu not
«utMn»Uckllr pnclvd* rcprcMnutMa by tb*
other iftiMK «nd (vt) 1* proTld* tMt pub-
Uotum of FDA> PntleUe An*iftlad Uuuat
for rutduet la (oodt «td oitttr «nT»n>n-
' meaui tuMtrttt* cut bt eonitnue* M • joint
VDA-EPA cpoMonBip «ntf«r cdttortel mw-
t ooutrttBS «f npmtituuiw of both
______ MMnf mt or tb* kbo*» praH-
•lacu which M« not TMoind sfMr two
muUrlf Khtdultd mMUBC* «h»U b* «nb-
•itud throne^ tb* arcmBlutloasl •traetuM
of oteb *t*acj tor molutioa.
addltlonnl >(rcuMatt eonetrunff UMM wtd
other roftturt •ffteune Inte
of patUddai and tbalr tutduH IB food and
druca. TMa* propoaata aaay ba fotatly ap>
prorcd by tht Deputy AailittBt Admttitttra-
tor for pMUdda ftognat EPA, and tba
OoHaawloaar of rood ana Druga. HEW.
Mr tb* Dipan&wat of Baattb.
J.O.VBrctuir.
fmn 17. U71.
iC.
MAT 11. mi.
"Far uw BaTlr«BBitnui FrotoetloB Agoney.
Effective tf ate. This •.Kieement became
effective on November 10. i»1i.
Dated: December •. 1971.
Ciutus C. EDWUBS.
CommUsioner o/ food end Dm?*.
|FIiDoc.71-l»e9t FU«t J2-ai-71;«:« ami
RDIIAL tCCIJTH, VOL S«. NO. J4fr—WtONESOAY, DECEMOEK 22, 197]
-------
Reference No. 28
-------
-------
NOTICES
21233
AGREEMENT BETWEEN DEPARTMENT OF
HEALTH, EDUCATION, AND WELFARE
AND ENVIRONMENTAL PROTECTION
AGENCY
Notice Regarding Matter* of Mutual
Responsibility; Amendment
On December 22,1971. the Department
of Health. Education, and Welfare. Food
and Drug Administration (FDA) and the
Environmental Protection Agency (EPA)
published In the FEDERAL Rzcnra a
Memorandum of Agreement regarding
matters of mutual responsibility under
the Federal Food, Drug, and Cosmetic
Act and the Federal Insecticide, Fungi-
cide, and Rodenticide Act (36 FR 24234).
Since the publication of that Agreement,
It has become apparent that additional
Information should be Included with re-
spect to the processing of applications for
approval of drugs under the Federal
Food, Drug, and Cosmetic Act and for
registration of pesticides under the Fed-
eral insecticide, Fungicide, and Rodentt-
ddeAct.
In view of the recent amendment of
the Federal Insecticide, Fungicide,
Rodenticide Act , the term
-pesticide" replaces the term "economic
poison" wherever It appears to the
Agreement Item 3 of the Agreement has
also been amended by agreement be-
tween FDA and EPA to add eight addi-
tional paragraphs (par. g through par.
a), to further detail each agency's
responsibilities on the regulation of
drugs and pesticides. The amendment
reads as follows:
PsoncxioN Aonrcr
MEMOSHMWK or ACBSSXCHT BMABmiN MAT-
TERS or snrruAL sssFOnstsdrrr UMOBS. ns*
•SAL FOCO. DBUO. AMO COSUTTIC ACT AND
USMT1C1DB ACT
3. Applications for approral of drug* under
' PFOCA «ad for registration of pesticides
under FIFKA will be processed as follows:
g. Submission* for approval wUl be to
the agency having primary Jurisdiction In
the format required by that agency which
will be considered *cc*pt*ble by the other
agency in lieu of that normally required.
Where specific requirement* of. the two
agenele* conflict In matter* such M manu-
facturlng. formulation, end Ubrtlng. the
requirements of the agency of primary Juris-
diction will apply.
h. The application of a prodoet for any
of, but not necessarily limited to, tbr uses
luted below Is considered to be both » human
drug *nd a pesticide. The agency for primary
Jurisdiction regarding aucb product* will be
FDA and secondarily If A.
(1) Pedlcuueldee and acablddes Intended
to control parasite* on humans.
(U) Product* intended to relieve the effect
of Insect bitea on humans which •*fA
clatan to repel the Insects causing such bite*.
(Ill) Product* intended to prevent diaper
nan by treatment of diapers.
(iv) Fungicides for human use, Le, ath-
lete's foot which also claim to destroy such
fungus on inanimate objects.
L The application of a product for any
of. but not neeeeaarny limited to. the Mat
listed below is eonalderM to be both a
pestttMe and a human drug. The ageaey
tor primary Jurisdiction regarding such prod-
vets wfll he BPA and secondarily FDA.
(I) Disinfectant* and santtisen intended
for use on lnent~T-t» object* but
claims for use on humans.
J. Certain pesticide* subject to the law*
administered by XPA are also deemed to be
aslmai drugs and subject to the laws ad-
ministered by PDA under, but not neoesamruy
limited to, the following conditions:
(I) Products for oral administration such
a* tablets, boluses, drinking water prepara-
tions, medicated blocks, sad medicated
feeds. Including liquid feeds and supple-
ment* (those do not apply to article* solely
for the control of fecal breeding flies, nor
solely for sanitising the drinking water of
(11) products administered pr
rally.
-------
21234
(vl) Treatments that »re administered
topically, for control of ticks except M listed
to lUm k(Tl).
-------
15763
NOTICES
( 6560-01 -M]
ENVIRONMENTAL PROTECTION
AGENCY
IOPP-00086. FRL 1077-2)
FfsnooE USE AMD raooucnoM §Y
VETECtMARIAMS
f P*licy «n Mw
•! «M Moral biMftitU*.
•Ad fc*4««ticM« Ad «• V*l«riiMriM»
AGENCY: Office of Pesticide Pro-
grams/Office of Enforcement, Envi-
ronmental Protection Agency (EPA).
ACTION: Notice of a proposed policy
for implementation of the Federal In*
sectteide, Fungicide, and Rodenticide
Act. as amended, with respect to veter-
inarians.
SUMMARY: This notice explains
EPA's proposed policy for enforce*
mem of various provisions of the Fed-
eral Insecticide. Fungicide, and Roden-
ticide Act. as amended CFXFRA] (7
U.S.C. 136 et seq.). and regulations
thereunder, with regard to Doctors of
Veterinary Medicine (veterinarians]
who use. mix, or prescribe pesticides.
DATES AND ADDRESSES: The Ad-
ministrative Procedure Act IS U.S.C.
553] provides that the solicitation
of comments is not required of federal
agencies for "interpretative rules, gen-
eral statements of policy, or rules of
ae?nrv organization, procedure or
practice." EPA has determined that
this notice falls within this exemption.
Nevertheless, interested persons may
submit written comments regarding
the proposed policy set forth. If possi-
ble. three copies of all comments
should be submitted by April 30. 1979.
to the Federal Register Section of FIFRA
were promulgated on February 7.1979
(44 FR 7695). describing special (chad-
proof) packaging requirements for pes-
ticides, applicable to practicing veter-
inarians under certain circumstances.
Veterinarians who use restricted use
pesticides, or who dispense pesticides
to their clients, are. to some extent.
subject to all these programs. This
notice describes EPA's proposed policy
for applying these regulations to vet-
erinarians. In general, this policy
would allow veterinarians to continue
their usual practices without having to
comply with all the procedural re-
quirements to which they are legally
subject, provided that they comply
with certain minimal safety precau-
tions described in this policy. These
conditions would not extend or aug-
ment in any way the legal responsibil-
ities or liabilities of veterinarians.
Rather, compliance with these precau-
tions would permit EPA to authorize
veterinary practices which may be
technically inconsistent with some
provisions of FIFRA. but which are
wholly consistent with the legislative
intent and purposes of the Act.
Uaz or RESTRICTED Use PESTICIDES
Under Sections 3. 4. and 12
applicators, or engaged in larfe-st-r.:-
use of pesticides" <40 CFH
171.3cb>UKll». Activities such as th'..-v
would not be pan of a "normal prsr-
tice." and veterinarians would have to
be certified to use restricted use p»s;i-
cides for such purposes. Although Un-
meaning of "normal practice" is bro?d
and may vary according to local need-..
some activities clearly do not come
within the scope of that term. For in-
stance, application of pesticides by a
veterinarian as a "principal or regular
occupation" (39 FR 36447), or soiiriu-
tion of pesticide application business
by veterinarians, is not considered
pan of a "normal practice." Veterinar-
ians who use restricted use pesticide*
for such purposes, or in any other
manner which Is not part of their
"normal practice." are required to
become certified under an appropriate
approved State or Federal certification
plan, unless they use such pesticides
under the direct supervision of a certi-
fied applicator.
Although EPA strongly recommends
that veterinarians keep abreast of ad-
vances In pesticide use and technology-
through appropriate professional con-
tinuing education, veterinarians who
do practice within the bounds of 40
CFR 171.4(e) are exempt from the cer-
tification requirement. EPA interprets
this exemption as also extending to
regular employees of a veterinarian
when applying restricted use pesti-
cides "under the direct supervision" of
the veterinarian. Such supervision re-
quires, unless the pesticide labeling
specifies otherwise, that the employ?*-
be a competent Individual, acting
under the supervision and control of a
veterinarian who is available if and
when needed, even Veterinarians, are
not authorized to dispense restricted
use pesticides to. or supervise the use
of restricted use pesticides by. any
other uncertified persons, including
their clients. However. EPA will spe-
cifically consider the need of veterin-
arians to dispense a pesticide to clients
as pan of any future decision on
whether to restrict use of such a pesti-
cide.
The supervising veterinarian is.-of
course, responsible for the actions of
his employees, including any misuse of
a pesticide by an employee. In addi-
tion, veterinarians must use all pesti-
cides. Including those not classified for
restricted use. consistently with then-
registered labeling. As authorized by
Section 2(ee) of FIFRA. this includes
use against a pest not specified on the
labeling as long as the animal or site
treated i* to specified, unless use
tmsm. vot. 44. NO. n—THURSDAY, MARCH is. i*»
-------
against that pest is expressly forbid-
den by the Administrator of EPA.
REPACKAGING tan DZSKNSING or
PESTICIDES
Sections 3 The name Directions for disposal of the pes-
ticide and the package dispensed to
the client: and
,
CO. and (g) above must be physically
attached to the package given to the
client.
(3) The container in which the pesti-
cide is dispensed to the client is a
childproof package as described in 40
CFR 162.16 of the "Special Packag-
ing" rule (44 FR 7695). unless the vet-
erinarian has determined that the
package is not likely to come within
the reach of children.
(4) The pesticide is prescribed and
dispensed to the client for the treat-
ment of a specific pest problem, on a
case-by-case basis, as part of the veter-
inarian's '•normal practice."
In addition to meeting the above re-
quirements, all veterinarians distribut-
ing pesticides are urged to discuss la-
beling directions with tlje client at the
time the pesticide is dispensed.
Any veterinarian who repackages
and dispenses pesticides, and who does
not satisfy conditions (1) through <4>
above, must comply with all federal
registration and recordkeeping re-
quiremenu for "producers." and may
be penalised under Section 14 of
FIFRA for failure to do so.
FKODVCZXC **» Disrotsmc Srecut
Pmiuut FORMULAS
Veterinarians who prepare their own
special products for treatment of
pests—by altering the original formu-
lation of another pesticide (other than
by mere dilution in accordance with
the pesticide labeling), or by combin-
ing ingredients which are not other-
wise considered pesticides may also be
"producers." If the product formulat-
ed by the veterinarian is a "new
animal drug" [as defined in 21 C.S.C.
321(w) and 32I(gKD). the product and
the veterinarian are subject to regula-
tions of the U.S. Food and Drug Ad-
ministration. If. however, the product
is not a "new animal drug," or an
animal feed containing a new animal
drug, and Is intended to prevent, repel
mitigate, or destroy any pest, it is a
pesticide (Section 2(u) of FIFRA] and
is subject to the primary jurisdiction
of EPA. The veterinarian is then con-
sidered a "producer" under FIFRA
Section 2(w).
As described above, "producers" are
ordinarily required to register prod-
ucts and establishments, to keep rec-
ords, and to meet labeling and packag-
ing standards. If. however, the veterin-
arian produces a special pesticide
blend solely for his own use, or use by
persons In his presence and under his
Immediate supervision, then the veter-
, 15769
tnarian is exempt from these require-!
ments (See. e.p.. 40 CFR 162.3rgg);'
l«2.S(a); 167.2U)]. Nevertheless, when
mixing or using special pesticide
blends, veterinarians are still required
to comply with the labeling directions
of any registered pesticides used. In
addition. EPA recommends that label-
ing meeting the minimum standards cf
40 CFR Pan 162 accompany the spe-
cial blend, in order to promote safe
use. storage, and disposal of such pes-
ticides by the veterinarian and his em-
ployees. Also, w hen applying a special
blend which will leave a residue on or
in an animal intended for use as food.
the veterinarian must ensure that the
Ingredients used have been granted
necessary clearances under the Feder-
al Food. Drug, and Cosmetic Act.
On the other hand, veterinarians
who formulate special pesticide mix-
tures for distribution to others are le-
gally subject to all registration, label-
ing, and packaging requirements im-
posed on producers. However, EPA
recognizes the benefit which may be
obtained by allowing veterinarians to
formulate products to meet unusual
cases. Therefore. EPA will not subject
veterinarians who dispense such prod-
ucts to these requirements if:
(1) The special pesticide blend is pro-
duced by mixing two or more pesti-
cides already registered by EPA, or by
altering the composition of an EPA
registered pesticide, provided that spe-
cial blends m&de from registered pesti-
cides classified for restricted use by
EPA are not dispensed to uncertified
clients.
(2) The special blend is formulates
and dispensed in accordance with rec-
ognized clinical practices and not pri-
marily for purposes of experimenta-
tion.
(3) The use prescribed is consistent
with uses authorized by the labeling of
the registered products used «s ingre-
dients, and the use directions in the la-
beling for the registered ingredicnuts)
do not prohibit the mixture or alter-
ation performed by the veterinarian.
(4) The special product is prescribed
and dispensed to individual clients of
the veterinarian on a case-by-case
basis to meet specific pest problems.
(5) The veterinarian supplies the
client with labeling for the special
product which contains:
(a) The name(s) and percentages) of
active ingredient(s):
(b) The EPA registration number for
each registered product used as an in-
gredient;
(c) Use directions for the use pre-
scribed, which are consistent with the
directions found in the original label-
Ing for the registered products used as
ingredients;
(d) Human and environmental safety
precautionary statements;
(e) An antidote statement:
FIKIAl UGlSTtt, VOL 44, HO. Sa—THU*SOAY, MAICH IS, Iff
-------
15770
Directions for disposal of the pes-
ticide and its container, and
The name and address of the vet-
erinarian; provided that (a), (b). (c).
and shall be physically attached to
the container of the special product
sold to the client.
iCi The container In which the spe-
cial product is sold to the client is a
childproof package, as described by
the."Special Packaging" rule, unless
the veterinarian has determined that
the package is not likely to come
vilhin the reach of children.
In addition to meeting the above re-
quirements, all veterinarians distribut-
inc their OWT> special products are en-
couraged to discuss labeling instruc-
tions for the special product with the
client at the time the pesticide is dis-
pensed.
Veterinarians who do not meet these
conditions when distributing specially
formulated pesticides must .comply
with all registration, recordkeeping. la-
beling, and packaging requirements es-
tablished for ••producers." Failure to
comply may result in the imposition of
penalties under Section 14 of FIPRA.
SPECIAL PACKAGING
As mentioned above, It is expected
that veterinarians who "produce- pes-
ticides for their clients' use will fre-
quently be subject to the requirements
of the "Special Packaging" rule That
is. a veterinarian producing a pesticide
which meets the toxicity requirements
of the "Special Packaging" rule must
package the product in a child-resis-
tant container before dispensing it to
the public.
In addition, in those cues when the
rule m-iU not apply by its own terms.
but the prescribed pesticide is likely to .
come within the reach of children, vol-
untary compliance is a prerequisite to
certain exemptions from registration.
recordkeeping. and labeling require-
ments.
These facts, coupled with the practi-
cal difficulty that some veterinarians
may have in determining whether a
prescribed pesticide Is subject to the
terms of the "Special Packaging" rule.
make it to the veterinarians' advan-
tage to comply with the rule whenever
there is a reasonable possibility that a
prescribed pesticide will be bandied by
children. Therefore, voluntary compli-
ance with packaging standards estab-
lished by the rule is strongly encour-
aged for the above reasons, and also to
increase safety in the use by clients of
prescribed pesticides.
STATS RKOIATIOMB or VRZUHAJUAM*.
This proposed policy statement eon-
cerns only EPA policy under FLPKA
and Federal regulations. It does not
apply to State regulatory restrictions
covering veterinarians who deal with
pesticides. Therefore, all veterinarians
NOTICES
should consult their local professional
associations, licensing offices, and
Slate pesticide regulatory agencies for
detailed information on local require-
ments.
Dated: March 2. 1976.
JAMES M. COPLOM.
Associate Deputy Atsiltant
Administrator for Pesticide
Dated: February 36. 1879.
RICHARD D. Wiuox.
Deputy Assistant Administrator
for General Enforcement
tFR Doc. 7B-TMJ FOed 5-14-79: 8:«S «al
ffOHM tfOSTEK, VOL 44, NO. S9—THUtSOAT. MAIO4 IS, t»7*
-------
-------
Reference No. 29
-------
-------
August 7, 1972
MEMORANDUM OF CONFERENCE
BETWEEN: C. E. Gundlach, V.M.D.
H. Meyers, D.V.M.
H. C. Hewitt, D.V.M.
J. II. Mark, V.M.D.
Division of Now Animal Drugs
Bureau of Veterinary Medicine
and
D. D. Campt
E. F. Brown
J. M. Tavano %
J. G. Touhey
Environmental Protection Agency
Pesticide Regulation Division
Approximately- 95 chemicals were found to be associated with fish
culture. Only 3 drugs for fish that are FDA approved, sulfamethazine,
OTC, MS 222 arc the three that we have specific scientific data.
KMNO^ CuSO^, antimycin and aimular drugs are registered by EPA and
which we have a general knowledge.
'<••
» *
Several product5 as reviewed by EPA are for the control of algae and
other water problems. If ether claims arc made as concern fish
diseases, they are submitted to FDA - DVM, DVMR .for review.
Fifih Aqunriums;
Algae, slime, slu^s, etc., should be reviewed and administered by EPA.
FDA will stay in the area of strict drugs for diseases on or in fish. .
Product submit r«/~ to EPA for control of irnf.cr conditions (disinfec-
tants, alitae, etc.) ;iad IU-KC claims. for Jisji j;;.j ,-.:;lt<-D «'nd or dir~-nr.cs
will be referred' to FDA-for comments. .This also holds true, fqr FDA;
Product: submitted for specific control .of algnc and bacterial slime
etc. would be strictly registered by EPA. this would be true of
slugs and snails.
-------
- 2 -
.Product for fish -diseases and parasites will be strictly FDA's concern.
EPA will forward & letter to the manufacturer informing then that
their product is primarily a drug and thus forward their application
to FDA.
Fish Ponds;
EPA will be responsible for products that control slugs, snails,
herbicides, fish depopulation (fish species that are considered
pests) etc.
Disinfectants; ,
Dairy disinfectants, snnitizcrs, etc. Some are used on inanimate
objects and may be applied to animals by drinking water. Sanitizcrs
applied to skin arc exempted from FIERA, thus could be subject to
control by FDA, dependant upon the proposed or implied uses or indications,
Implication of the treatment and control of mastitis is very strong
on many of the labels.
Direct or implied therapeutic claim are under jurisdiction of EDA.
*
« ~
Consensus of opinion is to delay action on disinfectants until such
time that the llat'l Mastitis Council has made its recemendations.
Such copy will be forwarded to EFA.
liexaclorophene products will be handled at present;, claims for odor
control will be reviewed by EPA and parasite control will be reviewed
by FDA. However, until FDA establishes a ruling as. concerns shampoos,
FDA will continue to comment on all labels as now being done.
Disinfectants in poultry drinking water:
Specific disease control will b« subject to I'DA npprovnl.
•. .
Disinfectants in water for drinking water, inanimate-disinfectant,
etc., are the jurisdiction of EPA.
EPA1,s distributor mechanism was mentioned. Regarding distributors,
EPA doesn't require proposed sample labeling, only a statement certify-
ing that the labeling is essentially the same.
-------
N.
f
- 3 •
EPA will endeavor to implement our agreement regarding pesticide /drugs
as discussed in July 24, 1972 as soon as possible and will forward to
us.
It was further noted that EPA does not intend to register those
products that we "approved as drugs and drug indications. Legal
sections of neither agency have as yet not rendered an opinion on
the meetings or agreements to date.
Cnas. E. Gundlach, V.M.D.
cc: CA 226
CA 228 (AF file)
Dr. Mark, VM 300
Dr. Meyers, VII 400
Dr. Hewitt, VM 310
Mr. Csrapt, EPA
Mr. Brown, EPA
Mr. Tavano, EPA
Mr. Touhey, EPA
Mr. Brunk, VM 200
Dr. Rosenberg, VM 330
CEGundlach, VM 330/blb/8/18/72
-------
-------
Reference No. 30
-------
-------
.'MTED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
:•"•'
SEP 17 !982
«*o TOXIC •UMTAMCC*
TO: Disinfectants Branch Personnel
SUBJECT: Biocidal Fuel Additives
Background;
The Disinfectants Branch registers antimicrobial
products which prevent the microbiological deterioration of
fuel oils, diesel oils, gasoline and the like. It just
recently has come to our attention that another segment of
EPA "registers" fuel additives under the authority of the
Clean Air Act. Another agency, the Federal Aviation
Administration (FAA), has jurisdiction over additives to
aviation fuels. The following should serve as a guidance
for processing product intended as biocidal additives to
fuel.
Guidance;
1. Since the two situations decribded above pertain to
specific sub-categories of "fuel", the use direction
of the product should be examined whether or not they
explicity or implicity cover one or both categories.
2. If the category of aviation fuel is included in the
use directions the registrant must be informed that
clearance by the FAA is required or a disclaimer
against use of the product in aviation fuels must
appear on the label. If the registrant wishes to
obtain clearance for use in aviation fuels he should
be referred to : Manager Aircraft Certification
Division (ANE-100)
12 New England Executive Plaza
Burlington, Mass 01803
or contact Mr. Marty Lindenauer
(617) 273-7330
3. If the category of motor vehicle gasoline, diesel fuel
or engine oil is included the registrant must be advised
to register the product with the Office of Fuel and Fuel
Additive Registration, Research Triangel Park, North
Carolina 27711 or revise the label to exclude these
use areas.
-------
A determination whether any one of these conditions
apply should be made early on in the review (review
for completeness or product chemistry review.) This
is especially important for those products which
explicity list uses in aviation fuels or motor vehicle
fules or. oils, since clearance or registration of
these uses require additional time in other segments
of the Federal government.
ft. Reto Englt
Disinfectants
Registration Div/sion (TS-767)
cc: M. Lindenauer, FAA
A. Futrell, EPA
S. Barker, OFF
-------
Reference No. 31
-------
-------
NOTICES
will not bp open to tho public, t
vided by §209.32 of DOE rcciilalions.
IEP requirements and unanticipated
procedural dcla\s in processing this
notice require thr usual 7-day not in*
period to be shortened.
Issued in Washinston. DC. Marrh
8. 1979.
RoBTKT C. GOODWIN. Jr..
Assistant General Counsel. In-
ternational Trade and A>;irr-
Qcncy Preparedness.
UK Dor. 79 S04I Fi!ri1 3 H 71). B 4S am]
[6560 01-M)
ENVIRONMENTAL PROTECTION
AGENCr
' torp OOOHG. nti. 1077 ;)
PtSTICtOI USf AND PRODUCTION Bt
VtTCBtNAKIANS
Propoivd Stot«n*rnt oF Policy on tht Applica-
ility of th» Federal lnt*rticid«, FynpicidB.
and Rad«rtticid« Ad to V«1«nnariont
AGENCY: Office of Pesticide Pro-
r.rams/Office of Enforcement. Envi-
ronmental Protection Agency nre lepally
subject, provided that they comply
uith certain minimal safety precau-
tions described In this policy. These
eondltions would not extend or aug-
ment in any way th'1 II'I;.T| resjjonsib'1 —
(Ties or liabilities "oT "vetennariai".
Rather, compliance with these precau-
tions would permit EPA to authorize
veterinary practices which may be
technically Inconsistent uith some
provisions of FIFRA. but which ere
wholly consistent with the legislative
intent and purposes of the Act.
USE OF RESTRICTED USE PtsTtcinEs
Under Sections 3. 4. and 12(a)(2)(F)
of FIFHA. no Individual may use a re-
stricted use pesticide unless he Is an
applicator certified under a plan HP
proved by EPA. or Is under the direct
supervision of a certified applicator, or
Is expressly exempted from the certl'!
cation requirement. Reflations jjro-
militated under Section 4 In 1974 (39
Fit 3G4-JG) established an exemption
from thi1 certification requirement for
veterinarians who use restricted use
pesticides in "the course of their
normal practice" (40 CFK 171.4(e)).
that this exemption does not apply to
veterinarians who are "In the business
of applying pesticides for hire, public-
ly holding thensehrs out as pesticide
applicators, or enraged* in large scale
use of pesticides" (40 CFR
171 3e of that term. For In
stance, application of pesticides by a
veterinarian as a "principal or regular
occupation" (39 FR 3G447). or solicita
tion of pesticide application business
by veterinarians, is not considered
part of a rhvrmal practice." Veterinar-
ians who use restricted use pesticides
for such purposes, or in any other
manner which Is not part of their
"normal practice." are required to
become certified under an appropriate
' approved State or Federal certification
ptan.^-hnless they use such pesticides
fied applicator.
Although EPA strongly recommends
that veterinarians keep abreast of ad
vances in peMleide use and technology
through appropriate professional con-
tinuing cducnlfon. v'etennanan.s who
do praftiee ttiihin the bounds of 40
CFR I71,4ic> are exempt from the cer-
tification rrqturrmrjit EPA interprets
this exempt ion as also extending to
regular employees of a veterinarian
when applying restricted use pesti-
cides tinder the direct supervision" of
the veterinarian Such supervision re-
quires, unless the pesticide labeling
specifies otherwise, that the employee
be a competent Individual, acting
under the' .supervision and control of a
-veterinarian wtio Ts available If and
when needed^ even Veterinarians a"re
not authorized to dispense restricted
use pesticides to. or supervise the use
of restricted use pesticides by. any
other uncertified persons. Including
their clients However, EPA will spe-
cifically consider the need of veterin-
arians to dispense a pesticide to clients '
as part of any future decision on
whether to restrict use of such a pesti-
cide.
Thr supervising veterinarian Is, of
course, responsible for the nctipns of
hla employees. Including any misuse of
a pesticide, by an employee. In addi-
tion, veterinarians must use all pesti-
cides, including those not classified for
restricted use, consistently with their •
registered labeling. As authorized by
Section 2iee) of FIFRA, this Includes
use against a pest not specified on the
labeling as long as the anlmn! or site
treated is so specified, unless use
fEDEBAl REOtSTH, VOt. 44, NO. 52—THURSDAY, MAECH 15, 1579
-------
NOTICES
15769
ajfBlnst that post Ls expressly forbid
dm by the Administrator of EPA.
REPACKAGING AND DISPENSING or
PtSTIClDtS
Sections 3 of FfFRA. and
regulations thereunder, require every
"producur" of pesticides to register all
pesticides produced by him. and to
register the establishment In ahlch
they arc produced, prior to sale or dis-
tribution of such pesticides. liy rcgula
tion. the term "producer" Includes all
persons who "repackage or otherwise
change the container of any pesticide.
. . ." (40 CFK 167.1 Use directions for the use pre-
scribed.
Human safety precautionary
statements;
(e> An antidote statement;
(f) Directions for disposal of the pes-
ticide and the package dispensed to
the client, and
(K) The name and address of the vet-
erinarian.
If the original labeling Rccornpnny-
tnc the pesticide «t -<^«,i,-w< •-•• «v,-»
veterinarian, would satisfy some of the
above requirements a copy of that la-
beling may be suppll above must be physically
attached to the package given to the
client.
(3> The container in which the pcsll-
cirie Is dispensed to the chrnt Is a
childproof package as desrrit>fd tn 40
CFH 162 IB of the "Special Packag-
ing" rule (44 Fit 7<>95), unless thi1 vet-
erlnnrian lias determined thai the
package l.s not likely to come within
the reach of children.
(4) The pesticide is prescribe
dispensed lo the client for the treat-
ment of a specific pest problem, on a
CA.se by-case basis, as part of the veter-
inarian's "normal practice."
In addition to meeting the above re-
quirements, all veterinarians distribut-
ing pesticides are urged to discuss la-
beling direction;, with the client al the
time the pesticide Is dispensed.
Any veterinarian who repackages
and dispenses pesticides, and who docs
not satiity conditions (1) through <4)
above, must comply with all federal
registration and recordkecping re-
quirements for "producers." and may
be penalized under Section 14 of
FIFRA for failure to do so.
PRODUCING AND DIEPETJSING SPECIAL
PESTICIDE FORMULAS
Veterinarians who prepare their own
Special products for treatment of
pests—by altering the original formu-
lation of another pesticide (other than
by mere dilution in accordance with
the pesticide labeling), or by combin-
ing Ingredients which are not other-
wise considered pesticides may also be
"producers." If the product formulat-
ed by the veterinarian is a "new
animal drug" [as defined In 21 U.S.C.
321(9.) and 321(g)(l)]. the product and
the veterinarian are subject to regula-
tions of the U.S. Food and Drue Ad-
ministration. If. however, the product
is not a "new animal drug." or an
drug, and Is Intended to prevent, repel.
mitigate, or destroy any pest, it is a
pesticide [Section 2;
162 5(8); 167.2(a)I. Nevertheless, when
rnlxinu or using "special pesticide
blends, veterinarians are still required
to comply with the labeling directions
of any registered pesticides used. In
addition. EPA recommends that label-
ing meeting the minimum standards of
40 CFR Part 162 accompany the spe-
cial blend, In order to promote safe
use. storage, and disposal of such pes-
ticides by the veterinarian
ployees. Also, when applyliu.ii special
blend which will leave a re^OUe on or
In an animal Intended for use as food.
the veterinarian must ensure that the
Ingredients used have been granted
necessary clearances under the Feder-
al Food. Drug, and Cosmetic Act.
On the other hand, veterinarians
who formulate special pesticide mix-
tures for distribution to others art le-
gally subject to all registration. label-
Ing. and packaging /rqulrrments im-
posed on producers However. EPA
recognl7.es the benefit which may be
obtained by allowing veterinarians to
formulate products to meet unusual
CASCS. Therefore. EPA will not subject
veterinarians who dispense such prod-
ucts to these requirements if:
(1) The special pesticide blend IE pro-
duced by mixing two or more pesti-
cides already registered by EPA. or by
aJterlnK the composition of an EPA
registered pesticide, provided that spe-
cial blends made from registered pesti-
cides Classified for restricted use by
EPA are not dispensed to uncertified
clients.
<2t The special blend Is formulated
and dispensed In accordance with rec-
ognised cllnicaJ practices and not pri-
marily for purposes of experimenta-
tion.
(3) The use prescribed Is consistent
with uses authorized by the labeling of
the registered products used as ingre-
dients. and the use directions in the la-
beling for the registered inuredlents(s>
do not prohibit, the mixture or alter-
ation performed by the veterinarian.
(4) The special product Is prescribed
and dispensed to Individual clients of
the veterinarian on a case-by-case
basis to meet specific pe^t problems.
(5) The veterinarian supplies the
client with labeling for the special
product which contains:
(a) The name(s) and perccntage(s) of
active Ingredient(s);
each registered product used as an In-
gredient.
(c) Use directions for the use pre-
scribed, which are consistent with the
directions found In the original label-
ing for the registered products used as
Ingredients;
(d) Human and environmental safety
precautionary statements;
(e) An antidote statement;
KDE«At lEGISTIB, VOL 44, NO 57—THUB5DAY, MARCH 15, 1979
-------
15770
NOTICES
shall be physically attached to
the container of the special product
sold to the client.
(6) The container in which the spe-
cial product is sold to the client 4s a
childproof package. a.s described by
the "Special Packaprinp:" rule, unless
the veterinarian has determined that
the packape is not likely to come
• within the reach of children.
In addition to meetlnc the above re
quirements. all veterinarians distribut-
ing their oun special products are en-
couraged to discus.s labelinc instruc-
tions for the special product with the
client at the time the pesticide Is dis-
pensed.
Veterinarians who do not meet these
conditions when distributing specially
formulated pesticides must comply
with all registration, recordkeepinc. la-
beling, and packarfinp requirements es-
tablished for "producers." Failure to
comply may result in the imposition of
penalties under Section 14 of FIFRA.
SPECIAL PACKAGING
As mentioned above. It Is expected
that veterinarians who "produce" pes-
ticides for their clients' use will fre-
quently be subj<-ct to the requirements
of the "Special Packaging" rule. That
is. a veterinarian producing a pesticide
which meets the toxlclty requirements
of the "SpeclaJ Packaging" rule must
package the product in a child resis-
tant contaJner before dispensing It to
the public.
but the prescribed pesticide Is likely to
come within the reach of chlldfcn. vol-
untary compliance Is a prerequisite to
certain exemptions from registration,
recordkecplryj, and labeling require-
ments.
These facts, coupled with the practi-
cal difficulty that some veterinarians
may have In determlninc whether a
prescribed pesticide Is subject to the
terras of the "Special Packaging" rule.
make it to the veterinarians' advan-
tage to comply with tht rule whenever
there Ls B reasonable possibility that a
prescribed pesticide will be handled by.
children Therefore, voluntary compli-
ance with packaging standards estab-
lished by the rule is strongly encouifc
aced for the above reasons, and also to
increase safely In the use by clients of
prescribed pesticides.
STATE R»;GUI-ATIONS or VETERINARIANS.
This proposed policy statement eon-
cerrts only EPA policy untlef, FJFRA
and federal regulations. It ^ctocs not
apply to Stale regulatory restrictions
covering veterinarians who deal with
pesticides. Therefore, all veterinarians
should consult their local professional
associations, licensing offices, and
State pesticide regulatory apencles for
detailed Information on local require-
ments.
Dated March 2, 1979.
JA_VF:S M. CODLON.
Associate Deputy Assistant
Administrator for Pesticide
frograrrts.
Dated. February 26. 1979.
RICHARD D. WILSON.
Jor General Enforcement,
79-7903 Filed 3-14-79. B 45 am)
[6560 01-MJ
:rr7a2ooG/Tis9. FRL 107-31
PtSTiaOE PSOG8AMS
Ext*n»lon of Temporary Tol«?onr»»,
On August 18. 1978. the Environ-
mental Protection Agency (EPA) an-
nounced (43 FR 36684) the establish-
ment of temporary tolerances for
combined residues of the herbicide 4-
amln0-a-(l.l-dlmethyIethyl>-3-
(methyllhlo>-1.2.4-trlazin 5(4//>one
and Its triazlnone metabolites In or on
the raw agricultural commodities
wheat forage at 2 parts per million
(ppm>; barley straw and wheat straw
at 1 ppm. and barley drain and wheat
grain at 075 ppm. Those tolerances
were established tn response to a pesti-
cide petition (PP 7G2006) submitted
by E. I. da Pont de Nemours At. Co..
Inc.. Wilmington. DE 19898. These
temporary tolerances expire April 11.
1979.
E. I. du Pont de Nemours A: Co.,
Inc.. requested a one-year extension of
these temporary tolerances both to
permit continued testing to obtain ad-
ditional data and to permit the mar-
keting of the above raw agricultural
commodities when treated In accord-
ance with the provisions of the experi-
mental use permits 352-EUP-9B and
352-EUP-100 that have been extended
under the Federal Insecticide. Fungl-
clde. and RodenMcide Act (FIFRA). as
amended In 1972. 1875. and 1978 (92
Slat. 819; 7 U.S.C. 138).
The scientific data reported and all
other relevant material were evaluat-
ed. and It was determined that an ex-
tension of the temporary tolerances
would protect the public health.
Therefore, the temporary tolerances
have been extended on condition that
the pesticide be used In accordance
with the experimental use permit with
the following provisions:
1. The total amount of the pesticide
lo be used must not exceed the quanti-
ty authorized by the experimental use
permits.
2. E. I. du Pont de Nemours & Co..
Inc.. must immediately notify the EPA
of any findincs from the experimental
use that have a bearing on safety. The
firm must also keep records of produc-
tion, distribution, and performance
and on request make the records avail-
able to any authorized officer or em-
ployee of the EPA or the Food and
Drug Administration.
These temporary tolerances expire
February 15. 1980. Residues not In
excess of 2 ppm remaining In or on
wheat forace. 1.0 ppm remaining In or
on barley straw and wheat straw, and
0 75 remaining In or on barley grain
and uheat frraln after this expiration
date will not tx- actionable If the pesti-
cide is legally applied during the term
of and in accordance with the provi-
sions of the experimental use permits
and temporary tolerances. These tem-
porary tolerances may be revoked If
the experimental use permits are re-
ricnce with this pesticide Indicate such
revocation Is necessary to protect the
public health. Inquiries concerning
this notice may be directed to Mr.
Robert Taylor. Product Manager 25.
Registration Division (TS-767). Office
of Pesticide Programs. 401 M St.. SW.
Washington. DC 20460 (202/755-7013).
Dated: March 12, 1979..
(Section «0fl(» of thr Frdeml Food. Drug.
and CttsmMIc Act C21 U.SC. 346a!J)]J
DOUGLAS D. CAMPT.
Acting Director,
Registration Division.
[FR Doc. 79 7»05 Flirt! 3-14-78: 815 «ml
[PP5CU593/T190, FRL 1077-41
MST10DJ MtOOtAMS
wal of a Temporary T»l«ranc«; Ititetndiol
On January* *:"1W8l~-lhe Environ"
mental Protection Agency (EPA) an-
nounced (43 FR 1405) a reextension of
a temporary tolerance for combined
residues of the plant growth regulator
ethanediaJ dloxime In or on the raw
atrrlcultura! commodity oranges at 0.1
part per million (ppm). These tiMcr-
ances were established (41 FR 46371 (n
response to a pesticide petition (PP
5O1593) submitted by Clba Oeitjy
Corp . Agricultural Division. P.O. Box
11422. Greensboro. NC 27409. The tol-
erance was subsequently extended for
one year (42 FR 14729). The reexten-
sion expired January 31. 1979.
Clba Oelgy Corp. requested a one-
year renewal of this temporary toler-
ance both to permit continued testing
to obtain additional data and to
permit the marketing of the above raw
agricultural commodity when treated
In accordance with the provisions of
riDEIAl tfOlin*. VOl- 44. NO. 5}-THU«£DAt, MAICH 13, 1P79
-------
-------
Reference No. 32
-------
-------
Monday
July 28, 1980
Part VI
Environmental
Protection Agency
Statement of Policy on the LsbeJing
Requirements for Exported Pesticides,
Devices, and Pesticide Active Ingredients
and the Procedures for Exporting
Unregistered Pesticides
-------
S0274
Federal Register / Vol. 45. No. 1« / Nfonday. luly 28.1980 / Rules and Regwteiiens
ENVIRONMENTAL F
AGENCY
40 CFR Paris 162.163.164, tea, 168,
187,168,1C», 170,171,172.173,174,
175,178,177,178,170, and 180
fFRL 1546-5]
Statement of Policy en the Labeling
Requirements for Exported Pesticides,
Devices, and Pesticide Active
Ingredient* and the Procedures for
Exporting Unregistered Pesticides
AGENCY: Office cf Enforcement
Environmental Protection Agency (EPA
or the Agency).
ACTION; Notice of policy statement
SUIOIAKY: The Federal Insecticide,
Fungicide, and Rodentidde Act (FIFRA
or the Act) was emended by the Federal
Pesticide Act of 1978 on September 30.
KT& Section ITTa] of the Act was
modified so that pesticides, devices, and
active ingredients used in producing
pesticides which are manufactured for
export must now bear certain minimal
labeling, and die producers of seen
products en now subject to the
requirements of ooth FIFRA sedio.is 7
(establishment registration) and 8
'bocks and records), in sdd'Uoc. unless
a pesticide is rssutcred undar section 3
or is being sold uncer section 6(a)(l) It
cannot be lawfully'exported unlua.
prior to export. (1} the foreign purchaser
has signed & statement acknowledging
that the pu. chaser understands that the
pesticide is unregistered and therefore
cannot be sold in the I'ruled Stales, and
(21 a copy of that stetemc'.t has been
trar-smiiicd tc EPA for tnnsmittal to the
appropriate officials o: the importing
country. This foreign narc!.nienu for
exported pesticide*, duvire*. anc
pesticide active uiifr<*d»i»T t» and the
procedures for exporting unregiaten
pesticide are set forth bdow.
D-l«d: j:<\y ia 1930.
cd^Bt^
•Pub. !>
Sreiion 1S|b).
Actii.i Astistaat Admizutretcr (or
Enforcement.
L Sununar}- of Policy
Pesticides, devices, and active
ingredients used in producing pesticides
which are manufactured for export must
now bear labeling which *.vill serve to
both identify the, product and the
producer and to protect persons who
come In contact with the product
Certain of the label items must be
written in both the English languors and
to the language of the importing country.
These bilingual labeling requirements
apply M the product's ingredient
statement end its warning and
precautionary statements. Exporters of
pesticides which are net registered fcr
use in the Untied States (In accordance
with this policy) must obtain a
statement from die foreign purchaser of
the pesticide in which the purchaser
acknowledges the regulation status of
the product The pesticide n::tst slso
bear labeling to indicate Ihst it is nor
registered in the Ubited S:.vc< fur
purposes of this policy an t.sr^i
pesticide is o:.e which (1) ccr>.ai:u
ectlv« ingredient not fcuid in a
federally reg'stered product; cr fl'l '-•ears
labeling fora use which b currc:;tiv
subject to denial or cancan jdon •>(
registitflion; or (3) is nut timilar ii-
composition and use pattern in L
federally regisrered prod-rct
The acknowledt .n-cnt statrn.ent m-..
(1) idenltfv ih» purchaser, tkr *?-p«irt •.-,
the prn'jiici's iH^ntiiy anj tii" pi'jiiu.-i j
•ii.-stinj.ioa: (2} be obt.iir.id fc-i '.!.c Lit
shipment sf a p^rccui;:' pcsticid: tc a
particular t>urch»«cr f-:r or.jh imp>jr;irc
couniry. annually: (J) tic » i.!:«V.a>i i^jvr
cxporlaiion taKc-s pl-itt-: :\i:a (4) bb
transmitted to EPA vvi't.in s-.w (T\
dayji of receipt by the exporter.
H. Labeling Requirement*
Section ir(a) of FIFRA has been
amended to provide as follow s:
(u) Pesticibcs and Devices lr.:rnd?d fur
Export.— nolwilh»'«rdinr jny other prj.i ;i,
of tbi* Act. no p«i>iciuc or J^vicc or au:vc
ingredient used in producing a pc»t:cid«
in:*ndcd fclely for export Ju uny.iurc:;^
country thai! be deeniet! in vicia'iun cf :.-.:$
Ac'—
[l> when prepared or pack -tad i-/ o-.fi.rj
tl» •h'! fjv'i-iiic.iiio-.j or dirv'toii:. 5: !:..-:
foreign rmr;h;isor. exi.cp. ih.u fir-^'u- •
f uch pp*'i<.ides «i«a '•tvir.-.-i »i-.c! k^..v
'i tin 1 in pnniv^ini; W»;UL
to secti-? j» :-i
c:
-. J'P. ftf-HKbia Jft 1S7S,
Jiii). ana !P;. r. i.vJ H u! this Ac!:
I
i
ft
-------
Fede;d !U*!i!«ter / Vo!. 4S. No. 14fi / Monday, Inly 23. 1980 / Hulea and Regulation- 5Q275
y ?xrwi*fi peitiridA device, and
a:;! V- iv«.-3t*:cai Vited in producing a
-;<« '-Ac,-; *rr.f,: but a lab»! cr label :ig.
•: ri jr':j.1 ?«• »n IOP ianj:s.?« of tht
•";•»* cci'ii .v, '»ii;cr. meets the
iii »Jaiiion. t^item informauon which
uiU «Jt!:.^ FIKS/- sections i(nl'l)lE).
(0, *nd (K; Kid 2 (c)(j:f A' trrd (fc) must
'.Iso appaar nn L:« lobe< or lui-eiiag co
s« i" r-rtvif-j hiliinnuJ (In other wordc,
Ir t .isiHslt jail m tlie Jan^un^e of U»
. r;»rrj»i« a- t-y) infarmiti'in ts
•nynr-c v. S.!: > -dies or c joes in en: tec:
kvitr. diet.; p: :iue'.... /uiy lar.£sage in
v./ik1: cfn.:ia. .^".'.rtLceni business iJ
'. :rd .'J*.*«*. in iha r...uniry or which :s .ba
pn* i:?iiii.v teJj rpoknr lanauo^e nf J:e
ngurtr. . is ;.-c<;.:.i¥sas wie secccd
> OQ in« i^Lal.
S.:;;ior. Tfn.VtJ. iii
!- pr.« -. cide . devi-xt. ?nd eo'He
!iw:*t k?fc3 in r-ndudajv *.csti"'d!fi
'j2i;- il>.!sorhi>; *k$w! irJ:
•'tj i'e-1- ."A E; j.-»c;iirr.b'i« fiuubcn:
. 'i, h j- ft i-.i;*r -dit ai rtat?s.«r.ls;
:. > hhtc *''•- itiise and adv'-iifs •)." t:.io
fc«i b -v 4:i.tv:?at i e-f n.
{i » ir H.^r:- !( tic, bos:- jiuli anc
i.-'Wil-o-r.-'i i.-. J »U!«^:t4iU of >rc-j
.:l In •.•acf- 3*TOi; tr.,.'g:
,'!i)':3".j*fl:ika
(hU.t/otte-
fij :•; 'J:e c;iJ s of iry
.csu.-idcv i}?r.* the itaitrnfJi! "Not
:x .Jsf.-rai ?;r L'a* u the I'nilnd Sites
os" *\!ner ca. ' * " «v;h re-;n>rcc
flitanf-n'-sraa.- h* cucjpio: om end
f > 3;!l«<. HFR/. w.tior r^)f*;U~).
*'••: r. :•'.:-;• f.r^osLa.' $.". ftsiH je'u.iv
•.,-•:! « n. •<;-.• i,. tls-'Engh"' i>i fi-::;
: i ,:.» b . •«• / : .?;" : i •: j>;prr! r.;, couatr;.
".E :-sc-.v: •> ML'.ej ii;ul reqi»>n»^
M.-.J.VC: •?? jijs. tTcnr-.pp.ii J "... in
sj-v. !c.r.w as . . f ;-;. U- i' li'teiy «, b«
r>j>; t: c: •.:tidr.-.-!;-jud by li, -• voir.arv
i- J -.H .•'. . . ' Thrrthr?. Shr bitan :r.g
' '
..
., .:-. i iin.'ine J-d ca»;..C'r.
1 1 in th,- ;
V.'"* '••!' vi
.-; %"•' i . .-%: irt c for
. .a s.'.'.*f-.3 «.! .
.v *.• «• r.".«j> I'.-
-/••«
atwherc an the lab?l cr i^
container in accordance v/iiii th^
ejtalilishmen: rejistiation bbel;ne
fequirenenU set forth »
easily identifiable Jcspifr liieir b-'iig
listed in a foreign Ijiijr-.tise.
e. 'Jss Clossifi -a/ic/i SfJ/si-a;:. The
dtstement of tue clasclficdlioi:
(Reslrrteil U*« Pi stidde or Ccneru' U*e
Pet tiddej must cppear o;i the Ubsung of '
the pesticide: hjwevrr, j.i-rmary
Matemctits rega.'iirji the tciint of 'tc
restriction, e^ "For ns'-oil sale lo and -
application only by Certified
ApplicMors . . ." arc nut required.
vntitv o* Parl.'i}< Name ar.d
of tiw ?rohc
" requirements c-f FIFRA. exporters say
use supplemental labe^ir^-. Pesticides.
devices, end active jigrenients used in
f rnd acinf! pest'V.i.-'es may. Ui-re.' re.
beer a label tvith the eppiopriste
iniamintion required by F1FR4 section
-/(«)(!) or m?y be accompanied by
supplemental UH?ling in instances
where FiF!iA required labeling is in
contravention of foreign labeling
requirements. Supplemental labeling
may be attached to or accompany the
product container or shipping container.
IlL Foreign Purchaser Acknowledrmest
Sta lament
Section 17 of FTCA has been further
amended to provide as follow*:
(«) PeitlcidiH «r.d Oevio.J Intended for
bprft— NotwilhifouidLac «ny o'h^
pruvbion of this Ac?. BO pesticide at device
or vcUve iPgrsdiem i*»cd in ft-j iucins a
ptttickuA inten-kd *o>i>lr far export la jny
f artign ewir.tty jiuli IM cmned & violation
cithn Ait—
(2J in tha cart jf any p»»ticid* cUier than a
rc«t!ciJt rtijjti.-.red und sr tecti.ju n or sold
i.na« ». ctlon i fB»|l) cf th - \jt, if. ?::«r t-
ixp-rt the foreign parch- :zt •> •* signed a
siatemeut .icjicwttdjir'j ,n -t :t * purtL*si,-
i:n-j«rstw>.4s U.«t no'Ji priliciJa is oat
reeisUtrcd Tor use in the U.iitttd Sute* aad
ca«tnot be said to the Uni.iM *'*tit undw ifca
Act A Copy if tSs t rateflt' r.i it! be
IranMaitled >9 «n apprupn.-.t« tifiirjal of the
government c; ;?M import'^ u»urnr>'-
This notice tl'o daFncstes v,-h«t
pesticide products ore affected by thu
provision an*i procedures EPA believe*
ivould satisfy the purposes of section
I7(a)(2J.
IV. P.-uductx Subject in the
Requirements for an Acknoiviedgaant
Statement
MSRV
g. Afeit Irfei^- T»*! .V »vni-M n'JSf
anpeor c.i thr Uljclic^ i:: -ilher
i: jr.n.';;iic.uJ ^igliah units or K.^"r.
in •
rip*, i -ro »
utti'.s.
L R\ My Tv.*K?cs;;?i'J*s. li » ••
p.)st»-i.-'«j is highly to.«ic '.li • Auil nn;i
•mssbones. the ivou'. ''Hoiscn", and H
s!a(e.T.*nt of p,-2cnc.B labelir.s. Th3 *-._r-.
'"Poirr-r." »rd ae jib:: m«;nt j' p:-;ict'rril
iteiiU.r.M* sh^li bj jiiiriiiu.'! The <.;••!'
ti^c-i w t!.m c.t i.vt^-o S! i - : !i...ve-cr.
«-..:t-;r. fli^hiiy ::::?.•..-1 p.:.. ur,:..,
^•.••vc1 ine:cd.or.»i jft.i a.. i i!^i
.- jp!: i ut i*a hlwi ^C'-.uii-'ei .ico
C, r-^.- 40 "FR .< 13i :•.' f.,',.
miner inofi-iiiMiiiwR* >:. !•,.• miilu'inr. ar»u
I^nrlin-;. s»ch is u'f'V.vat rtr,terns "f
nm&»t*s •"»;•• it, peils to bi. ••.nr:t:\il!cii
v r-i';Ji firt- {•Il'rrrr.l fj. .•• :•.; >..•• fcr r.Iiica
t'i* -»..:r.i: 3.-3 <:.-.,t!'i- »:•; :- '.^-- ; := .!^,.
. nr- .crl^t
uy. Such i. v.!^::*1-.-!! !m,/i.' ' v.e,
K when; periicid^s art f -CIR
expcitr^l tc J l-.-^tgr, .-jcit.'y vvii.T sir
ol'ier :*< «r> iJ-.sst.sL
s..: «*iRcnl ..hirh r^ ^ppii'.iL'-i »o
this coi.-'"!':/ h;js. !>• •;'". • J 3.-rS p»v -*.v-!
'v.-u. yi-t *-•'!! .uu ; !?••> ''jtc'i- j
pridi-cts 'vhl.li •-:..- ;ri-.i:r •••iH^liiai on
>v •i«*S!«l»>Jv j ir. !~i» «.'• :iea
-------
Federal
/ Vol. "5. NV Ml / Monday. fulv 28, 19^0 / Rules and Regulations
IrMrnPenls which fe f,-j:f!«rtd ia ;hr
Ur.f<« . .'to.:* .'il'i-.-r. i: u !us Agrrey'*
Jo -..p« > r ra»« .:••
USB iC I:.i: r«i»Hirr!-j ;.-. tut oniteu S.sies
hat be-in -.Md*. '«• (:'} no •.•••r'oioa has
bet :i IMC!* • cr.r.sr-Jn!j Jis o? Lie
ptc.'nc •. .V rer,: JremitMt for obtemiog
jr. acJj ,-.; leti£S.'iit-nt solera en I from a
i-iiMfcr. pa/ch'.:;..' • w iil tpr'i *° pejiin'tlc
JMTM:UC:: j H willed:
|_i "ue p-s^r-idc ;.'-.' »'• inpredien! hus
brer, s-ids cd ;"> ,.;•>. -.nr.aswnable
? ';ife;ts ' ;:jlicld« has
been aaue hy EPA (while the pesticide
my have bo.»n -jiiil under limited
experimental or emer^tasy conditions),
(2) the peaticidu ha* r.ever been
rcyisfcreu brdnr w.iloa 9 because
nitration for tne |ir.*b°cid« active
2n^reOMiat has not bnec sou^hl or hai
not y Jt been jjrautt J. or (3) ihe pesticide
>s L .'tow ex;x>rted ior i u«e whidi is
tiibttantietly dJfc:ert (rr-.ra any
cor.*r.!ly regular id uac -*f that pesticide
«t .(•.. & pcs'icide which i» iBfistered in
h:* oiur.Ty for uta » a teiirJlicide is
e.-f^.rted beuiir^ dirKtiuas for usr CL
:oo:i
-.-cti.-'s ir(jji(*:} so -tppsy to:
•'a} /iii 5red;rnt Jhal I» not
JI nd ia 3 L.-c m'uy n^icie.^i oroduch
'
,8 a <
pulcem to a f- j£.-ji y -o^L'.ereo product.
"''o be CTnj-dtitd - ;.n;iiar in
to:i;io:- iioa 4:id usi- .-Mitrorn. a D9sticiil«
prcisrt -lust c*;:;»j;«» ..-.!•/ tSs i«."!ia
'.ig:6ii!«"n? cr ' on'.c:rj\u.' of activ*
:.{r:-i:> :ris am! ir .'•• r.jve ths »?rae
re«! :•'.:: f prr-i.*c:. »i-!-. Jir v»e p; itara
must .e siimiar to iL: us*. p?Mera of Hie
ic*'i»n'Hy n-s'stertJ f««i«:trds ;o wLIch it
is >en 3 ccf^rarsd. Rr^sJriiions
tnv)Wn£ ch&nges >n UK pHtt«!n.t suai
a 3 iUianpf-a toT. rnn-ot>d io food ^ist.
etuis'/a.- to inciiar t tt t:.*res't iel to
«ou«fc UM, or r.nn-c J.T»»I lie to
f'.osj*;?^ use. *rc -tct :'»n5.^ered to
qiiiJi:y oa iiinilar u*t pul.err.s. Pvsiictde
UfcS whi'Ji were never revit rrd dur-ng
a cencrllotiori or dm -.1 of ;u^iitralicn
Jf-terminatirn '*t)n as a pcjticiitr use
in a crop wh:'l. '•• not grown in the
United btatis) also exemption
i Section Ifaj wiil not be considered ad
te&nily rrgirt rod. Nor will a pesticide
prod-jet whose distribution and u« a:e
•t«S*> in intrastate commerce because the
producer has filed an application for
federal registration in accordance with
tta prucediues found in 40 C*H i 182.17.
Technical grad-Ji end nanttfacluring use
pesticides which are not federally
registered will be corsideted as
registered for purposes ci this policy, if
they qualify as being similar in
composition to a registered formulotiori
use pesticide. {i.c- if the product* have
the same active ingredients and
category of acute toxicityj.
V. Procedures
Section ir(*l{£] requires that before a
t»t«tic.'de *,vhi(.r. is col regu.ic.'cd ;*^rnse
in ihe '.'nitcJ S;alcs cnn be >*rpc: Irfd, ihu
foMJjm purchaser if tht pc-»!:iadc r.\us:
e;kno'.vl«djtc ir. vntsng th«il h*
v.2tl> ntar.v.8 ihp .'csi?;.Etur. plains <;f
ihi pcs»: -'du end '!i it i}-e rtt ,.ir.i«l'.«
tanro'. otr sc-id :n lha b'r.lc.l SUi'.os. A:i
*.t.iX>;'lcr of unrcgirirreil ;-.-sUc; J^i n ••»!
aavo rjcrA.: i -a* r«q«i,- oil
:l i! at.itei.itr. tvr.rr li
ct is ul: stt'j for ship!:. • !'ic
.•*'"'r,r;y *cel» Th:!i .f-q'.isi.ij; •••.;.-•>..: :.-• tc
hd'.a :n h:r,vJ lh» purer Js.;r
e'Jir.'ivi'.ndjieffltri s»atr: -..<. .1 'jcfor?
oxportaiioii tiikej p:ace is th-> only tv.-y
..i assure Unit foreign purchusfcra rumrly
wi'.H th«>«i« n.'w FIFRA export
reouirrir.e. 'Is. "i"he Agenr.y recsjjsir-*
tha: Ini? rtquirrment may cnust «ums
du.mption in Ihe expon. nf pe«ticid'.o.
Howi-ve., anv such Jeliiy* -vitl bt
visitrd only upon ex;rir9{|ijtei*cu pcsticidev, jr.ti then only
for -ht /f'.v/ ? hipricnt »o a foreign
p-j-cnesfcr. in a paitir.jlur courtry.
annually. The information rcv|tiircd or.
the Acknowledgement statement, aiong
with a certification signed by the
e.xportrr. must be transmitted to the
Environmental Protftctio-i As>:rcy wi'.rin
seven d..ys of receipt l-y tiwledgcmcr,t statement must still
M transmitted to EPA within seven
Jays of rrneipt or by the date cf export
vhichcver occur* Srst.
Acknowledgement statements may Lie
acquired at any limit in advance of
shipment for example, an exporter that
shim to the same foreign purchasers
year after year may acquire at the
banning of a year all of the
acknowledgement statements which an
anticipated to be needed.
The Agency will transmit the
acknowledgement statements to
appropriate foreign officials through the
Deportment of State, Statements will be
irnn&mittcd promptly after receipt.
The Agency believes that the purpose
of the pure! jser acknowledgement
statement is '.o advise foreign
g'jwrnments that pesticides which have
been judged by ihe United States to be
hazardous to human health or the
environment, or pesticides for which
hezard assessment has been aade. a
! exported by U.S. producers to
h- country. Foreign govemmenU may
li.^ii use such information as they
«l-,ire. perhaps, for example, in
i -..iIjitiRg the risk of continued use of
if.': pesticide in that country versu* tha
btat'ity that pc'ticide provides. The
.•\^.--; does not «.or.sider that the
a k.nuwkvt'jKNrmi statement is pricuril)
i i-i-n ':•! to ser.-e --i preshipm«c'
{•••:.!•! ..j* '.}.ty m;iy ii.-.{-i»-.'jit ship™i'nij
t.j-. • .is: M» »:-.• A:;f ..^y'd -.'mcera tl *t
.'."c ;t s jvt.T>r:eni> in & timely aauer,
tk: inf^riutition cor'air.eU in th;
«r.! i: ,"vnrdi?"T.ent statement nviil be
it- vvnracj to foreign governments
:; v*.ip.ly upon receipt by EPA.
A
-------
Federal Register / Vol. 45. No. 146 / Monday. July 28. I960 / Rules' and Regulations 502T,
complete utd have signed • purchaser -
acknowledgement statement for the
first shipment of « particular product to
a particular purchaser for each
importing country, annually. A shipment
of the MOM product to a different
purchaser or to the sane purchaser for
disposition to a different importing
country would also trigger the
requirement for obtaining a signed
acknowledgement statement from the
foreign purchaser. A second shipment.
during the same calendai year, involving
the aune product, purchaser, and
importing country would not trigger this
requirement. Any change in the
variables—different purchaser, different
will result in the need for obtaining a
new purchaser acknowledgement
statement
In summary, the procedure* that an
exporter of unregistered pesticides must
follow in obtaining •*"* transmitting
foreign purchaser ackaowledgcnimt
statements are:
(a) The exporter must provide Die
foreign purchaser with instructions
about the required information on an
acknowledgement statement and inform
the foreign purchaser that shipment of
the pesticide cannot be undertaken
unless the exporter has received from
ths foreign purchaser a propi Hy
completed, signed, and dated
acknowledgement statement;
(b) The exporter must secure. pHor to
• shipment an acknowledgement
statement which contains the
information outlined in the Required
Information section of this notioe. Such
a statement must be secured for the first
purchase each year of a particular
pesticide product by a foreign purchaser
destined for a particular country;
(c) The exporter must fcnva.d the
information required on the
acknowledgement statement along with
the certification that export ption did net
take place until a signed
acknowledgement statement was
received, within seven (7) days of
receipt or by the dUe of exportation.
whichever occurs Crst to the foUov/ing
addrbsr;: Eavironau..ual Protection
Agency, Pesticides and Toxic
Substances. Enfwrceroert Di\ri-ion (EN-
342). 40} M Street S V\L Washington.
D.C. 20460.
Attention: Export Acknowledgement
Statement
VI Ra^tira^ Information
*» fi*+tmi*if M«M
-------
50=78
Federal Biraistar / Vol. 43. No. 146 */ Monday, fitly 28, ISSfl / Rules and
for Government ofTit'^lf: II If BO» Ihr
lira! authority on the «ntus cf a givea
pesticide. It is the Intent of CcrT*is
that the procedures thst «n> followed for
notifying foreign governments of the
suspension or cancellation of pesticides
be tho*e which ire also need to inform
them that an unregistered pesticide will
be entering their country. Therefore, inn
channel of communication described la
this policy is derived from the
procedures already used to notify
foreign governments of major
suspension or cancellation actions.
Comment No. 3. Scope of the F1FRA
Suction 17 Requirements. A number of
commenters addressed the definition
contained in this policy slatemen* of an
unregistered pesticide. The Agency
agrees mat clarification on this point is
necessary. It Is not EPA's intent to limit
export of a chemical if it !« properly
labeled and the exporter compile* with
the procedures for obtaining and
transmitting to SPA a properly executed
acknowledgement statement A more
detailed explanation of which products
will be regarded a* unregistered lor the
purposes of Ibis policy ha; been given.
One commenter objected to including
m products with denied or cancelled uses
* and products with different competition
or use patterns with products w&cb
contained no registered active
ingredient. In oratting this policy
statement EPA adopted a broad
interpretation of the registration status
of a pesticide.
The Agency could hav« required
exporter* of all pesticide products that
w«* -ot r*sist»red a;.der section 3 to
acquire an acknowledgement atata.nor.t
frcin the foreign purchaser. The effect of
this would b* Uut an acknowlecjecunt
fitiiemimt wr.uld hew btr?n rcou-reti for
the jiverv.-heL'sinii wnjorit/ uf exported
pesticides since n>ost expa.;s diifar
tlijhtiy in formulilion or directions for
cse from the Ui. .-entered produce or
the iabeis are written !n a foreign
language. The EPA clearly staled i.i the
proposed policy statement «het in its
view Congress did not intend that
exported products w;ia miner venations
from EPA rtf istcred pesticides b«>
subject to teh export notification
procedures. However, products with
cancelled tries er with substantial
differences Jn compositirn or use
wiin minor variations. The Apcncy aust
therefore. reject this comment
Comment No. 4. Status of Cirtain
Unregistered Pesticides. G»i« cofnir.piit--r
suggested that experimental u*c
pruducta 1» treated as registered
products: another corsmcntcr thought
that products with temporary toleiances
ihculd be considered as I* they w*:«s
ri-eiytered. Since: j-jist-j'.ion data f«r
such products an not complete, il ha',
consistently beer. Agency policy to t." at
experimental use products and products
wiih temporary tolerance as
unregistered products, itoducts xvhidi
bear registrations under section Z4(c\ of
nFRA will, however, bi treated as
registered products. Products undergoing
. Rebuttable Presumption Against
Registration will be considered in
accordance with their registration stilus
at the time of export It was suggested
by one commenter that those pesticides
which were registered by a foreign
country should not be rubject to the
requirement for an acknowledgement
statement In order to adequately
enforce a policy which tool? this
approach, the EPA would have to
evaluate the internal registration
procedures conducted by other countries
and to regulate export! based npoo the
policies of the /nywrt/V? country. Thus.
EPA policy would be ilifirrrni for
similar shipments going to different
countries. The Agency mj jct» this
comment Not only would it he
administrative]v difficult to operate «uch
an export prngranu but tuch a policy
fails tc recognise the pi'ini cf hrvii.g »he
asknoxvledgeount sitfcaent: To inforn
foreijRi gov«>mmefitA of the U.S.
isgistrdtion status of a pesticide.
Comment No. 5. Non.v>.^injcrci?!
ExporUt'oo. Anothnr commcntfir
requested cUrifiratiun c a the ~
application of the icltc; provision to
pesticide* which are -x nortc-J wiihoui j
commercial IranV*?OP. Tt:ers .:rc two
pcirsible cate^oribA si; rcdur';: Vj which
this rummi-nt r.:^!it a^ipiy: the fir?!
\*cu!'J IK; small zir.0';i»* of pesticide
exported for re^nrch purposes on'y: thi*
second wuuld be isr^t shipments
exported ;o a (orei^a establishment cf
the donibZlit. cccipany which
manufactures it Research quam iilcs are
subject to ih»,- labeling ruins of this
policy but rot to the acknowledgement
statement nquiremsnl. La-g« shipments
transferred fioro a domestic facility to a
foreign facility of Ute same company will
tw ir;8trd in accor Jance with their U.S.
registration status. That is. if the product
is registered (in accoidance with the use
of that term in this policy}, no
acknoMlcdgvmeni statement if required;
if the product is not registered. :m
e-krowledjismcn* ktaleracnt \vi!l be
requirad.
Comment Na.A. Tf d.r:i'-.'il; nil
Multiple Tsc Chemical". S=T-e
cnrmcnteu o.«kid fcr cl-"'.1c;a;_«R of
lite impact of this pc»Hcy i.pop
fcnnulated and !*.cr-n:.*^: Srj.co ,•; ";i:r's
and multi-use pr>idi>t*ts. I'oi.tuji.iii i and
technical grade pror!::cti which are
ncbject la FIFRA ats subject to this
policy. Tie kibe! oa the exported
product must ccinpiy with sectton 1? ol
FIFRA. A r"ul'i-use product for .vhich no
pesticide ciiiints art n;:me aid .vhich is
not En ac;ive inprflJierit in any pesticide
product in the United States is no;
subject to this policy, ever, if it is
subsequently processed into a pesticide
in another country.
Labeling Comments
Comment No. 7. L'« of Bilingual
Labeling. A number of commenters
sttted that the law did no: require
bilingual labeling. The law state* that an
exported pesticides, device, or pesticide
active ingredient must bear labeling in
cooformance with FIFRA section
2{q)(l)(E}. The fIFRA slates in section
2(q)(lJiC) that a pesticide is izUbruuied
ii:
ABV word. sUterawt or oilier i&forauiHoa
required t«y or under Authority of this Act to
•nponr oa the Uutl ur Luelitig 4 not
prominently placed 'hr. .-».n ... in such
terms as to rcrde.- i: likefy if> Ita nodaitd
undent&Mt by :he ontir,»ry indi>'f.aso cnt! use.
(En>phn>is acUcd.)
The EPA lnl*:rcrr>9 (H.s passr.jte to
apply to orUioary :r.t';viduals in the
imp-vtin; country as wc-M uj >r. ;'^c
l.'aiicd St »«cs. Thus, th^ i.il;.-. j.si
seme bajir infonnation jLr.vt 'he
product to >.s many har.UI: .s uf J;r
pesticide as pcss:b!c. Inturni.tional
fynboh. s'tcQcstod by ar.t» co:rjnsalcr.
could net S'^viu i^iy comrr.i.1.! -at-1 ail
they may he 'i v'irtsier.t
imoortir-g country h...i sr-» .< il c>i.;ci<»l
(JiiilecU. or wbc:i Er.i.>!ir'i is ;ui tjfncial
jjovernr.-.ent '.anjiui.^e. Any iiimtuacc ir.
uh.ich oif-cml guvernmont basir^ss is
cornnonly condurteo Li l?° cftRtry. or
which is the pr«il-.ijn;rt.'.i .•!>' t; ckf-r,
language o> th« cwiilry. is .-rctpuMc as
the second h;ntfu:ige on d.u !:.' ol. if
English is one ol ihirw l..r, •.. ?i-s than a
bilingual label is optional. «\r< :.t as
may be rc^utreu by the irt;p:.n.na
cona'.ry. One fif.r< ••«»» -:r !•«£>:«' :f a
translctior: of t'.v U.S. I..!..•; • . J-j tt
snt:ufnctr.ry. S«»rfc a LL".;«- ,:?' be
iu'.vs uf «iu iiri c-t-
-------
• Federal Register / Vol. 45. No. 146 / Monday. July 28. 1900 / Rules and Regulations " 50279
the intention of this pjbry to supersede
use labeling rrquircmuuls of foreign
govwctnenu. However. Fir RA now
requires that expo, lad pesticides.
devices, and pesticide aci've ingredients
bear certain minima? labeling. If the
labeling whi^Ii c-jr.-cntly appears os:
axported pesticide:: uoss nut meet the
minimum rffKA rsqi-irerif nts", even
though it may meet the fcrcigr country's
retiutreraenfch eddi'iwiiai u baling must
be added te saurfy U.S. law.
Comment Nt». &. Supplemental
LfH-lins. L-ne/aJ cujsravutcrs suggested
Ui<:t ^cpplemer.t-41 kbeling be liberally .
allowed. The Agency intends io be as
fio« cle as possible in this respect.
Exporters wiil'be permitted to use a
variety of types of :abc!fpg tc ccmply
with the FIFHA expert requirements.
The Ageacj 'j principal interest will be
to esurtsin thtU products to whlidt this
policy apptiM bear labels or labeling
which, taken togelher. conform to the
F1FRA section IT^aKl) ntouirenunta.
Comment Mo. 10. Establishmeat
Numbers. One inmmcnter requested the
option of substituting cnother code for
the EPA Establishment Number on the
label. The Act dearly requires that an
Establishment Numoer appear on the
label The Agency roust reject this
suggestion sire* peroK'lng other means
of id«*nUfyias ih* p'odvction
establishment wa::!J negate the
usefuuess of such numbers.
Comment No. 11. Restricted Use
Pesticides. Several ccaeicniars
requested gt'idaccs en label
requirements fcr exppiled restricted use
pesticides. If the pruduc! i* a restricted
use pftiiicibc, then !h: «tatement
"R.'str /.PI! Uss ?esUjiri«" must appear
?i! tlte labs! o: -abi-iirg. Die
supplerjenib -.• staicr.cn- of the te:ms
i-.d conuitiuns cf rr *! i-iior. is r.i:
•tnirired.
Conmpn! Ni,. 12 r« ior Pcssc«s:on of
Acknowicd«S!ncn: b'atenierls. A
number of cosuQii.-.U rs questioned the
roquirfc.runt that 'h«t icknowJeJgement
s(8'tmen!i be in the e.\};:>rt«»r's
pcsjejjicn b«fc-rc kftlp* irm of Ihe
pc»ticide can tai.e ^tccs. Other
comnienters staled lli..t in their or/talon
foreign importrN. throe?.1: oversight or
bureaucratic ineui.-irncy. will not
comply wi^h the ackiov.-ledgement
statement requirement. In the proposed
policy statement, the Agency clearly
MMfnimd lh» pralilcm of lion*
compliance by foreign importers. For
thi* precise roescn. ETA imui reject the
contention that ackn^tviQtigonsent
s^temunts xhculd net be reouirrd to be
in the exporter*s control iw/l/r shipment
lake place. A more liberal
interpretation cf what constitutes
receipt of the acknotrkd-jcmcnt
statements bits been ptmdcd in th«
final policy sulenient tu facililatc
compliaricii. Onr conmenter su^^sted
that a sijjmcd ai:knowIedgickr.owledgement
statement should be tied to the data of
shipment The Agntcy disagrees. Where
possible, acknowledgement statements
will be sent to foreign governments a*
far in advance of shipment as possible.
This will provide the government some
Uroe to review the information received."
The Agency feels aore timely
notification will occur if Iransmittal of
the acknowledgement statement is tied
to date of receipt.
Comment No. 13. Certifications. Some
commenicrs objected to filing, along
with ^.acknowledgement statement, a
certification that the order was not
•hipped before the acknowletigautont
statement was received. The Agency
believes that a certification statement is
necessary. While some monitoring of
compliance will be through in«p3ction of
required hooks and records, •
ccrtuication requir-r^nt wit! j-.-v.. M
remind cvportcri that i Jirm -nt nt!i.U
ivait ur'.il the acknow)r:'2«mcnt
stuleTrnt has L-CI n r . jhin*
Continent No. ::. L';.*sr-i,i«ion cf
Shipment One cr>.i;?i^n-'jr s-j^'-s ;\j
tftr.t there wus no r ned to inch:-.: > :-t die
acknavicdgnraer.! si^i .-mom the
destination of tht- • xcort .'hipff.cn', if
different than the pu.-r!%<*cr» e'idrvu.
This conurenl is rc-jrclid uewure
without thin inionr.atinn th* Ag^r.cy
would be unable *o ">tprr,:i',c if thr
labeling complied wth tii«> biH.iK.jjl
requirements nor woul.1 it krtw ihe
proper place to send the
acknowledgement statement
Comment Nn. t5. Ann-Mi Ktf|vti'ing.
Several commtnters ttnicd lhat the
requirement shut a mw
acknpwledsement sl;.t» menl be
acquired each yjar :h;«t a particular
product is •x;:.>ru. i.,w
requires an acknowledgement
only cnce ser cour.tr}'. iial once per
country, per >csr. Thej Agency must
i-.-jcct thi* coramiMt XlthaughJ^FiuVis
no: clrnr or. this pji.it. the law seems to
ir'iicaie that an ackn'j%vied.^efnent
rlrttc^ient sliuuld be arquift J for each
nvjort shipment M f.r. unregistered
p«*3ticidtt. it .s the A.2e^^,•:.•'s posiiior. that
impoiiiiif; scrji a rcrtuiremcn( would be a
burden for all particc concerned—
eyponer*, Liiportcrs. and tne U.S.
Coveron^ut. u* weil a foreign
Bovonunerto— beyond any regulatary
purpose it may serve. The requirentent
to send an acknowledgement statement
once per yaor, which is similar to that
being ccn.idered undci- the Toxic
Substances Control Act is not overly
burdensome- and yet ucccsiplishe* the
purpose of regular naliflcctlan to toreign
goveracifRts.
Comment N:'. IB. Notifies lion of
Fo.-eign Governments. S-veral
commcnten uueslion^d the procedure
for notifying foreign governments, it was
. suggested that cither the foreign
purchaser or Art exporter should
directly notify the foreign government.
The EPA rejects this proposal First u
would be difficult, if hot impossible, for
the Ag?ucy to monitor compliance under
such a procedure. Second, as previously
exptair.cd. :he procedure fur
transmitting acknowledgement
statement* prra'1«l» that of the
notification of foreign Bnvernments of
suspended or cancelled registrations. It
is the understanding of Ihe Agency that
such a procedure, namely government-
to-sovernaicnt contact was the intent of
Congress.
Comment N'o. 17. Problems with
Irrpc?!: :g Countries. Two commenters
siic,7cstt>u :na: the policy b-; different for
Scdoifci or r',r"*iun:s'. cour.tiies. These
commantc.-sc^td Iheii KX{/sriznce
c\.r»or.tnj( |H->!!':li!e:s to Shew coaf?trie<
v.-s«. c the "i.rpe*i£r " . . ai .! ft tiie
g-'-wnimc'it Tr;jSf inr- ).-{ ;.;;». ic:t-S trs
bai'i by :i.c c:-;.inii:r.(.T^ to be s!nffed ;.y
vt'y cor.sc. -.4tujcldr.: in <:,,"! tjr.^ssu! r?4Uv5li. t\s
!i«s L»siui di..'-::- s'-d fiiacr. it is nni the
intent of tfc:4 .Vj;;Try i-j tvrilf a d'fhrcnt
erpwrt pt'licy :'^r diiferrr.; uo-ialri'-.s.
W. should n:imi;fou.-> pwl'icnu
th any f»Tlic:i!ar cm-ntfy. the
-ncy will ivcrk with industry m:d the
Department jt S::itc to solve them.
eiU
-------
-------
-------
------- |