TABLE OF CONTENTS
Introduction
1. Organizational Contacts
2. Product Registration Process
3. Establishment Registration Process
4. Laboratory Tests
5. The ID Jacket and Its Contents
6. Enforcement Criteria
7. Civil Proceedings
8. Notices of Contemplated Criminal Proceedings
9. Notices of Warning
10. Other types of Initial Actions
11. Explanatory Narratives Used in Initial Actions
12. Recall
13. Stop Sale, Use or Removal Orders and Seizures
14. Disposal
15. Replies
16. Criminal Prosecution
17. Witness Instructions
18. Injunctive Authority
19. Notices of Judgment
20. Notices of Detention
21. General Procedures
22. Case Status and File Procedures
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23. Pesticides Enforcement Management System
24. Interagency Cooperation
25. State Cooperation
26. Appendix
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PESTICIDES ENFORCEMENT CASE
PROCEEDINGS MANUAL
INTRODUCTION
The Pesticides Enforcement Case Proceedings Manual has been
prepared to serve as a training guide and as a day to day working
tool for persons involved in the preparation of enforcement actions.
It is difficult to make a manual of this sort entirely satis-
factory to all potential users. This manual is designed to bring
together the essential information needed to prepare enforcement
cases and to familiarize the user with the different types of
pesticides enforcement actions.
It is hoped that it will be useful to the experienced pesticide
enforcement worker as well as the person just starting out in
enforcement work and that it may serve as a useful reference in
all pesticides enforcement activities.
Whenever possible, the reader is referred to other publications
for additional information. In many cases, the procedures used in
this manual are outlined in considerable detail. Therefore, it
may not be necessary to refer back to these other publications.
The method of presentation is varied according to the subject
under consideration. Most of the procedures are outlined in sequen-
tial order, so that they can be followed step by step.
Numerous exhibits have been included in the manual to facil-
itate the writing of various enforcement actions. While the exhibits
and narrations provide the basic materials for the preparation of an
enforcement case, they can never replace good judgment in evaluating
individual cases.
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SECTION 1
ORGANIZATIONAL CONTACTS
-------
ENVIRONMENTAL PROTECTION AGENCY
PLANNING
§
MANAGEMENT
Administrator
CONGRESSIONAL
AFFAIRS
STj
EQUAL
OPPORTUNITY
\FI
OFFICES
I
INTERNATIONAL
AFFAIRS
ENFORCEMENT
§ GENERAL
COUNSEL
MEDIA
PROGRAMS
CATEGORICAL
PROGRAMS
10 REGIONAL OFFICES
PUBLIC
AFFAIRS
RESEARCH
§
MONITORING
-------
OFFICE OF THE ASSISTANT ADMINISTRATOR
FOR
ENFORCEMENT AND GENERAL COUNSEL
ASSISTANT ADMINISTRATOR
FOR ENFORCEMENT
AND nF.NF.RAT. rniJNSF.T.
DEPUTY GENERAL COUNSEL
DEPUTY ASSISTANT
ADMINISTRATOR FOR
WATER ENFORCEMENT
DEPUTY ASSISTANT
ADMINISTRATOR FOR
GENERAL ENFORCEMENT
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OFFICE OF GENERAL COUNSEL
The Office of General Counsel has the following functions
and responsibilities:
a. To provide legal services to all of the organizational
elements of EPA with respect to all programs and
activities.
b. To provide legal opinions and legal counsel.
c. To prepare, review, and obtain clearance of proposed
legislation and report on legislation, perform
drafting services, coordinate preparation of testimony,
and review transcripts of hearings.
d. In its capacity as the Administrator's legal advisor,
to assist in the formulation and administration of EPA's
policies and programs.
e. To provide functional supervision of performance'
of assigned functions at EPA field offices.
1-3
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OFFICE OF GENERAL COUNSEL
WATER QUALITY
DIVISION
DEPUTY GENERAL COUNSEL
PESTICIDES AND
SOLID WASTE MANAGEMENT
DIVISION
OFFICES OF
REGIONAL COUNSEL
AIR QUALITY AND
RADIATION DIVISION
GRANTS AND
PROCUREMENT DIVISION
-------
Office of General Counsel
Pesticides and Solid Waste Management Division
Anson Keller - Assistant General Counsel
George Robertson - Attorney
Tom Kemp - Attorney
Blaine Fielding - Attorney
John Kolojeski - Attorney
Timothy Marker - Attorney
Edward Lyle - Attorney
1-5
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OFFICE OF DEPUTY ASSISTANT ADMINISTRATOR
FOR GENERAL ENFORCEMENT
DEPUTY ASSISTANT ADMINISTRATOR
FOR GENERAL ENFORCEMENT
MOBILE SOURCE
ENFORCEMENT
DIVISION
STATIONARY SOURCE
ENFORCEMENT
DIVISION
PESTICIDES ENFORCEMENT
DIVISION
-------
PESTICIDES ENFORCEMENT DIVISION
The Pesticides Enforcement Division (PED) operates under
the Deputy Assistant Administrator for General Enforcement
in a staff capacity and is responsible for planning, directing,
and coordinating the enforcement programs conducted within each
EPA region.
In connection with its operating functions, PED coordinates
enforcement actions with the Registration Division (RD) in order
to determine possible violations of the Act.
In order to accomplish its functions, PED is divided into
three branches: a Program Operations Branch, a Programs Appraisals
Branch, and a Pesticides Enforcement Management Systems Branch.
The Program Operations Branch is responsible for maintaining
liaison with RD and for reviewing RD's scientific analyses of
product samples. This branch also coordinates all regional pesti-
cides enforcement activities.
The Program Appraisals Branch reviews enforcement and inspec-
tional activities and publishes information relating to PED actions
and policies.
The Pesticides Enforcement Management Systems Branch processes
all data and mail relating to Pesticides Enforcement activities.
1-7
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PESTICIDES ENFORCEMENT DIVISION
Office of the Director
Program Appraisals
Branch
Pesticides Enforcement
Management Systems Branch
Program Operations
Branch
Inspectional
Proceedings
Section
Enforcement
Proceedings
Section
Data
Processing
Section
Regional
Distribution
Mail Unit
Regional
Coordination
Section
Publications §
Information Section
Establishment
Registration
Section
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PESTICIDES ENFORCEMENT DIVISION
Name
A. E. Conroy, II
Title
Division Director
Mailing Address
Pesticides Enforcement
Division
EPA
401 M Street S.W.
Washington, D.C. 20460
Ralph Turpin Associate Director
Anthony Dellavecchia Program Operations Branch Chief
John Martin Program Appraisals Branch Chief
Ken Shiroishi Pesticides Enforcement Management
Systems Branch Chief
Region No.
I § II
III $ IV
V $ VII
VI § VIII
IX $ X
KEY PED CONTACTS
Coordinator/Program Specialist
John Love
John Seitz/Tom Morgan
John Foley/Ron DeBerry
Darl Mount
Mary McDonnell
Unit
A
C
B
D
E
NOTE:
ALL CONTACTS ARE TO BE MADE THROUGH YOUR REGIONAL
COORDINATOR IN PEP, WASHINGTON, D.C.
1-9
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OFFICE OF CATEGORICAL PROGRAMS
OFFICE OF
CATEGORICAL PROGRAMS
OFFICE OF
PESTICIDE
PROGRAMS
OFFICE OF
SOLID
WASTE
MANAGEMENT
PROGRAMS
OFFICE OF
TOXIC
SUBSTANCES
OFFICE OF
RADIATION
PROGRAMS
OFFICE OF
NOISE
ABATEMENT §
CONTROL
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OFFICE OF PESTICIDE PROGRAMS
OFFICE OF
PESTICIDE PROGRAMS
.
OPERATIONS
DIVISION
REGISTRATION
DIVISION
CRITERIA § EVALUATION
DIVISION
TECHNICAL SERVICES
DIVISION
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REGISTRATION DIVISION
The Registration Division, under the supervision of a
Director, is responsible for the registration of pesticides
and the establishment of experimental permits to assure
human safety as well as the protection of environmental
quality. Makes recommendations to the Office of General
Enforcement with respect to enforcement actions, provides
technical support for such actions, and coordinates certain
cancellation and suspension actions with the Office of General
Enforcement. Works closely with the Criteria and Evaluation
Division in identifying the need for new standards and guide-
lines applicable to the registration process, and in identifying
the need for conducting reviews of registered products.
1-12
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Registration^Pfvision
Petitions for
New Chemicals
New Uses
Temporary Permits
Tolerances
Office of Director
Coordination
i Branch
I ^
New Products (Old Chemicals)
Amendments
Supplemental
Renewals
Chemistry
Branch
Toxicology
Branch
\ __.
Ecological
Effects Branch
I
Applications/
Records Control
Branch
Disinfectants
Branch
1
Herbicides/Fungicides
Branch
Insecticides/
Rodenticides Branch
J
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Registration Division
Division Director - John B. Ritch Jr.
Chemistry Branch - Carroll W. Collier
Toxicology Branch - Dr. Orville Paynter
Ecological Effects Branch - Dr. William Welles
Applications/Records Control Branch - Alvin Chock
Disinfectants Branch - Elijah F. Brown
Herbicides/Fungicides Branch - Thomas E. Adamczyk
Insecticides/Rodenticides Branch - Herbert S. Harrison
Coordination Branch - Lee Terbush
1-14
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OPERATIONS DIVISION
The Operations Division, under the supervision of a
Director, is responsible for the development of programs to
enhance the effectiveness of governmental activities in the
pesticide area. Provides program policy direction to tech-
nical assistance and training programs in the pesticide area.
Develops and recommends program content and model legislation
for states and, through the EPA Regional Offices, assists states
in developing and enhancing their programs along recommended
lines. Participates in Federal interagency activities in
the pesticide area. Conducts investigations of pesticides
accidents and incidents.
1-15
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OPERATIONS DIVISION
OFFICE OF DIRECTOR
STATE SERVICES BRANCH
ADMINISTRATIVE STAFF
PUBLICATION BRANCH
ACCIDENT INVESTIGATION
BRANCH
OFFICE OF DIRECTOR
STATE AND REGIONAL
PROGRAM DEVELOPMENT
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Operations Division
Dr. John Osmun - Division Director
Accident Investigation Branch
Charles Mitchell - Program Management Officer
Dennis McLane - Wildlife Biologist
Frank Davido - Biologist
Walt Waldrop - Chemist
1-17
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TECHNICAL SERVICES DIVISION
The Technical Services Division, under the supervision
of a Director, is responsible for providing technical data
and information to support the work of other Divisions concerned
with pesticides activities. Plans, directs, and operates, within
the framework of the overall Agency information system, computer
data systems designed to meet the operating needs of EPA and to
provide routine information on accepted uses and tolerances to
states and other agencies on a timely basis. Provides statistical
analysis, decision modeling, and computer programming support
to the other Divisions of the Office of Pesticide Programs.
Conducts monitoring programs to assess pesticide residue
levels in air, water, soil, crops, livestock, aquatic and
land animals, and the effects of human exposure to pesticides.
Develops or provides for the development of scientific publica-
tions related to the pesticides program, and provides library
and reference services of a highly specialized nature. Provides
policy, technical, and program guidance and supervision to the
laboratory operations conducted by the Office of Pesticides
Programs. Develops and maintains analytical reference standards
for pesticides to support research and regulatory activities.
1-18
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TECHNICAL SERVICES DIVISION
TECHNICAL SERVICES
DIVISION
HUMAN
EFFECTS
BRANCH
ECOLOGICAL
MONITORING
BRANCH
CHEMICAL, BIOLOGICAL
INVESTIGATION
BRANCH
SYSTEMS
INFORMATION
BRANCH
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TECHNICAL SERVICES DIVISION - LABORATORY SERVICES BRANCH
AND OTHER EPA LABORATORIES
HEADQUARTERS OFFICE PERSONNEL
Environmental Protection Agency
Building 402, ARC
Beltsville, Maryland 20705
FTS § Local Tel: 301-344-2487
Dr. Ronald A. Davis Branch Chief
Section Heads
Dr. Robert L. Jasper Biological § Safety Section
FTS § Local Tel: 301-344-2443
Dr. Bruce G. Wiersma Monitoring Section
FTS § Local Tel: 301-344-2156 or 2069
Coleman Hall Analytical Section
FTS 5 Local Tel: 301-344-2232
Coordination Staff
Kenneth F. Kissler Program Coordinator
EPA
Building 402, ARC
Beltsville, Md. 20705
FTS § Local Tel: 301-344-2443
A. J. Culver, Jr. Biological Methods Coordinator
EPA Plant Biology Lab
3320 Orchard Street
Corvallis, Oregon 97331
FTS § Local Tel: 503-752-4337
J. Dean Hansen Biological Methods Coordinator
EPA
Sample Storage Building 409-1
ARC
Beltsville, Md. 20705
FTS f, Local Tel: 301-344-2015
1-20
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TECHNICAL SERVICES DIVISION - LABORATORY SERVICES BRANCH
EPA - ANIMAL BIOLOGY LAB
Building 288, ARC
Beltsville, Md. 20705
FTS 5 Local Tel: 301-344-2576
EPA - CHEMISTRY LAB
Room 101, S. Lab Bldg. 306, ARC
Beltsville, Md. 20705
FTS 5 Local Tel: 301-344-2233/2246/2266
EPA - ENTOMOLOGY LAB
Building 402, ARC
Beltsville, Md. 20705
FTS 5 Local Tel: 301-344-2292
EPA - MICROBIOLOGY LAB
Building 406, ARC
Beltsville, Md. 20705
FTS 5 Local Tel: 301-344-2563 or 2564
EPA - MONITORING LAB
Building 402, ARC
Beltsville, Md. 20705
FTS § Local Tel: 301-344-2156 or 2069
EPA - PHARMACOLOGY LAB
Building 225, ARC
Beltsville, Md. 20705
FTS t, Local Tel: 301-344-2058 or 2055
EPA - PLANT BIOLOGY LAB
Building 402, ARC
Beltsville, Md. 20705
FTS 5 Local Tel: 301-344-2221
EPA - CHEMISTRY LAB
MTF, Building 1105
Bay St. Louis, Mississippi 39520
FTS Tel: 601 -688-3252
Local Tel: 601-688-2211, Ext. 3252
EPA - PLANT BIOLOGY LAB
3320 Orchard Street
Corvaliis, Oregon 97331
FTS $ Local Tel: 503-752-4277 or 4278
1-21
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EPA - CHEMISTRY LAB
Blclg. 45-C, Federal Center
Denver, Colorado 80225
FTS $ Local Tel: 303-234-3751
EPA - CHEMISTRY LAB
Room 1000, 201 Varick Street
New York, New York 10014
FTS $ Local Tel: 212-620-3474/3475/3476
EPA - CHEMISTRY LAB
Room 545, Federal Office Bldg.
50 Fulton Street
San Francisco, California 94102
FTS 5 Local Tel: 415-556-6805
EPA - MONITORING LAB
MTF, NASA
Building 1105
Bay St. Louis, Miss. 39520
FTS § Local Tel: 601-688-3170/3171/3172/3212/3292
1-22
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Regional Enforcement Contacts
EPA, Region I
Mr. Richard H. Johnson
Director, Enforcement Division
John F. Kennedy Federal Building
Room 2303
Boston, Massachusetts 02203
EPA, Region II
Mr. Weems Clevenger
Director, Categorical Progs. Div,
26 Federal Plaza
New York, New York 10007
EPA, Region III
Mr. William Riley
Director, Enforcement Division
6th § Walnut Streets
Philadelphia, Pa. 19106
EPA, Region IV
Mr. Roy P. Clark
Chief, Pesticides Branch
1421 Peachtree Street NE.
2nd Floor
Atlanta, Georgia 30309
EPA, Region V
Mr. James 0. McDonald
Mr. James 0. i'i^i^uncu.u
Enforcement Division
ic^1/-£i-y» T\ -v* T -\ r a
Director, jtnrorcemen
1 North Wacker Drive
Chicago, Illinois fi
EPA, Region VI
Mr. Thomas P. Harrison II
Director, Enforcement Division
1600 Patterson Street
Dallas, Texas 75201
EPA, Region VII
Mr . John Wicklund
Chief, Pesticides Prog. Branch
1735 Baltimore Avenue Rm. 249
Kansas City, Missouri 64106
EPA, Region VIII
Mr. Irwin L. Dickstein
Director, Enforcement Division
1860 Lincoln Street
Denver, Colorado 80203
EPA, Region IX
Mr. Richard L. O'Connell
Director, Enforcement Division
100 California Street
San Francisco, Calif. 94111
EPA, Region X
Mr. Leonard A. Miller
Director, Enforcement Division
1200 Sixth Avenue
Seattle, Washington 98101
60606
1-23
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SECTION 2
PRODUCT REGISTRATION PROCESS
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REGISTRATION PROCESS
A. New Registration (Authority) Sec. 4. (a) of the old FIFRA*
When applying for a new registration of a product, the
following forms should be submitted to the Registration Division:
1) 5 draft copies of the proposed labeling including
brochures and additional directions
2) completed PR Form 9-199 (application) (Exhibit 1)
3) completed PR Form 9-196 (confidential formula) (Exhibit 2)
NOTE: AN APPLICATION DOES NOT CONSTITUTE REGISTRATION
The company, upon filing an initial application, is assigned
a permanent registrant number. This number followed by a hyphen
and letters is the file symbol. This file symbol will translate
into the product registration number when the product is accepted
for registration.
Ex: Before Acceptance After Acceptance
File Symbol Registration Number
339-R 339-1
B. Amended Registration
When a change in claims or directions for use is desired,
the following should be submitted:
1) 5 draft copies of the amended labeling
2) PR Form 9-198 (application for amended registration)
(Exhibit 3)
* The term new FIFRA refers to the 1947 FIFRA as amended by
P.L. 92-516, dated October 21, 1972. The term old FIFRA refers
to the 1947 FIFRA as amended prior to P.L. 92-516.
2-1
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When a minor change in the product's formula is desired,
the following form should also be submitted:
PR Form 9-196 (confidential formula)
NOTE: A NEW PRODUCT REGISTRATION IS REQUIRED WHEN THERE
IS A MAJOR CHANGE IN THE PRODUCT'S FORMULA. (See
PR Notice 70-20) (Exhibit 4)
After the effective date of a change in labeling or formula
(the date of acceptance), the product may be marketed only under
the new claims or formula. However, the Director may permit a
reasonable time for the disposition of stocks of the discontinued
product. - Paragraph 362.10 (g) (2) of the Regulations.
C. Supplemental Registration (Authority) Sec. 4. (a) of the old
FIFRA.
When a company other than the registrant wishes to distribute
a basic registrant's product under his distributor label, the
following application must be submitted by the registrant.
PR Form 9-1 (Exhibit 5)
NOTE: AN_APPLICATIONJDOES NOT CONSTITUTE ACCEPTANCE OF THE
DISTRIBUTOR. A COPY OF THE ACCEPTED 9-1 FORM MUST BE RECEIVED
3Y_THE'_RE'GISTRANT_B'EFO'RE'_THE_DI'STRIBUTOR__PRODUCT CAN BE LEGALLY
MARKETED*
* The term, marketed, means: To distribute, sell, offer for
sale, ship deliver for shipment, or receive and (having so
received) deliver or offer to deliver.
2-2
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D. Rejection
When an application for new registration or amended registra-
tion is unacceptable, the firm receives a rejection on either:
PR Form 9-14 (rejection-labeling) (Exhibit 6)
PR Form 9-24 (rejection-labeling and data) (Exhibit 7)
NOTE: THE NEW PRODUCT OR THE PRODUCT WITH THE AMENDED
LABELING MAY NOT YET BE LEGALLY MARKETED.
E. Acceptance
When a product is accepted for new or amended registration,
the firm receives a notice and a stamped accepted label. These
notices are listed below:
PR Form 9-25 - Minor corrections are listed which are required
(Exhibit 8) to be incorporated in the label at its next
printing. However, in the interim, the firm
may legally market the product without incor-
porating the minor corrections in the label.
PR Form 9-26 - Major corrections are listed. These corrections
(Exhibit 9) must be incorporated into the labeling before
the product can be legally marketed.
PR Form 9-225 - A combined form listing the 9-25 and 9-26
(Exhibit 10) paragraphs. This form is issued only when the
product is initially registered.
PR Form 9-265 - No corrections are requested, the product may
(Exhibit 11) be legally marketed bearing the accepted label.
2-3
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Cancellation (Authority) Sec. 6.(a) (b) of the new FIFRA
Unless revised labeling is submitted or a hearing is
requested, a cancellation of registration is effective 30 days
after the receipt of a notice of intent to cancel. These
notices include:
1. PR Form 9-289 - Notice of five year renewal (Exhibit 12)
2. PR Notice
3. Letter of Intent to Cancel (evidence from samples of
continued product failure)
In each case, the notice of intent to cancel is sent be
certified mail and the certified receipt is filed by RD as evidence
that the notice was received by the firm.
A final notice of cancellation, PR Form 9-288, is often sent
to the firm several months after the actual date of cancellation.
However, the effective date of cancellation is 30 days after receipt
of the notice of intent to cancel. (Exhibit 13)
Suspension (Authority) Sec. 6.(c) of the new FIFRA
The registration of a pesticide is suspended if it is
determined that such action is necessary to prevent an imminent
hazard during the time required for cancellation or change in
classification proceedings. The order of suspension may not be issued
unless a notice of intention to cancel or to change the classi-
fication of the pesticide is also issued.
2-4
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The registrant has the opportunity to appeal the suspension
order by requesting an expedited hearing before the Agency on
the question of whether an imminent hazard exists. The registrant
may not market the product in question while the suspension order
is in effect even though he has requested a hearing.
NOTE: TOR FURTHER INFORMATION ON THE REGISTRATION PROCESS,
CONSULT THE "GUIDELINES FOR REGISTERING PESTICIDES IN
THE UNITED STATES."
2-5
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ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D. C. 20250
APPLICATION FOR |NEW| REGISTRATION OF ECONOMIC POISONS
(Under the Federal Insecticide, Fungicide, and Rodenricide Act)
FORM APPROVED: BUDGET BUREAU NO. 4O-RI74S
IMPORTANT: READ INSTRUCTIONS ON REVERSE
1. DATE OF APPLICATION
2. NAME OF ECONOMIC POISON (Must be same product name as
on label-do not list active ingredients)
3. TYPE OF PESTICIDE (Check each applicable item for combination products)
INSECTICIDE^ FUNGICIDEQ HERBICIDE! 1
OTHER (Specify)
RODENTIClDEfI
GERMICIDE-DISINFECTANT!^)
4. NAME & MAILING ADDRESS OF FIRM TO WHOM REGISTRATION IS TO BE ISSUED
(Include Zip Code)
5. IS THE REGISTRANT SHOWN IN
ITEM 4 THE MANUFACTURER?
YES I I
(If "No ", see instruction 5 on
reverse)
NO I I
6. TYPE OF FORMULATION
DUSTl I WETTABLE POWDER I I
GRANULAR [~~|
PRESSURIZED PRODUCT l"~)
EMULSIFIABLE LIOUID[^] BAITl I
OTHER (Specify)
7. TYPE OF CONTAINER
METAL^I GLASSC
PLASTIC! 1
9. MANNER IN WHICH LABEL
LITHOGRAPHEDQ
I OTHER (Specify)
PAPER | |
8. NET CONTENTS OR CONTAINER SIZES
IS AFFIXED TO PRODUCT OTHER (Specify)
PAPER. GLUEDQ3 STENCILEDfl
10. PLACE WHERE DIRECTIONS FOR USE APPEAR
ON LABEL j^J IN PRINTED MATTER ACCOMPANYING PRODUCT^]
II. DATA SUBMITTED WITH THIS APPLICATION (Identify and submit in triplicate)
EFFICACY DATAQ TOXICOLOGY DATA CZ) RESIDUE DATAl~~l
OTHER (Specify) i
PETITION FOR TOLERANCE I I
12. ANY ADDITIONAL PERTINENT INFORMATION (Do not enter confidential formula here-see item 13, below)
13. THE FOLLOWING MUST BE SUBMITTED WITH APPLICATION
• Five (5) copies of proposed labeling, including all printed or graphic matter which
may accompany the sale of this product. Copies must be clearly legible and identical,
• Five (5) copies of the complete formula, showing the precise name and percentage
of each active and each inert ingredient. (This information is treated confidentiallyj
14. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE
16. DATE SIGNED
17. RECEIVED BY USDA - PESTICIDES REGULATION
DIVISION, WASHINGTON, D. C.
IN ANY CORRESPONDENCE ON THIS PRODUCT.
REFER TO THIS FILE SYMBOL NO.:
PR FORM 9-199
MAY 1969
EXISTING STOCK OF PRFORM 9-199 (JULY 1968)
WILL BE USED UNTIL EXHAUSTED
Exhibit la
2-6
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FORM APPROVED: BUDGET BUREAU NO. 4O-R1746
U.S. DEPARTMENT OF AGRICULTURE
AGRICULTURAL RESEARCH SERVICE
PESTICIDES REGULATION DIVISION
WASHINGTON. D. C. 2O25O
APPLICATION FOR | NEW | REGISTRATION OF ECONOMIC POISONS
(Under the Federal Insecticide. Fungicide, and Rodenticide Act/
IMPORTANT: READ INSTRUCTIONS ON REVERSE
3. TYPE OF pESTiciDEfC/iec* each applicable item for combination products)
INSECTICIDE O FUNGICIDEO HERBlCIDEl 1
RODENTICIDE d] GERMICIDE-DISINFECTANT 1 1
1. DATE OF APPLICATION
2. NAME OF ECONOMIC POISON (Must be same produc t name as
on label-do not list active ingredients)
OTHER (Specify}
4. NAME ft MAILING ADDRESS OF FIRM TO WHOM REGISTRATION IS TO BE ISSUED 5. IS THE REGISTRANT SHOWN IN
(Include Zip Code) ITEM A THE MANUFACTURER?
YES I I
(If "No ", see instruction 5 on
reverse)
NO I I
6. TYPE OF FORMULATION
DUSTED WETTABLE POWDER O PRESSURIZED PRODUCTQ
OTHER (Specify)
GRANULAR!|
EMULSIF1ABLE LIQUID! |
HAITI I
7. TYPE OF CONTAINER
METAL Q GLASS I I
PLASTIC | 1 PAPER I 3
OTHER (Specify!
8. NET CONTENTS OR CONTAINER SIZES
9. MANNER IN WHICH LABEL IS AFFIXED TO PRODUCT
LITHOGRAPHED!^] PAPER. GLUED! I
I OTHER (Specify)
STENC1LEDO
10. PLACE WHERE DIRECTIONS FOR USE APPEAR
ON LABEL] 1
IN PRINTED MATTER ACCOMPANYING PRODUCT I I
II.DATA SUBMITTED WITH THIS APPLICATION (Identify and submit in triplicate)
EFFICACY DATACU TOXICOLOGY DATA O RESIDUE
OTHER (Specify):
PETITION FOR TOLERANCE I I
12. ANY ADDITIONAL PERTINENT INFORMATION (Do not enter confidential formula here-see item 13, below)
13. THE FOLLOWING MUST BE SUBMITTED WITH APPLICATION
• Five (5) copies of proposed labeling, including all printed or graphic matter which
may accompany the sale of this product. Copies must be clearly legible and identical.
• Five (5) copies of the complete formula, showing the precise name and percentage
of each active and each inert ingredient. (This information is treated confidentially.!
14. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE
S. TITLE
16. DATE SIGNED
PR FORM 9—199
MAY 1969
EXISTING STOCK OF PRFORM 9-199 (JULY 1968)
WILL BE USED UNTIL EXHAUSTED
Exhibit Ib
2-7
APPLICANT'S COPY
-------
ENVIRONMENTAL PROTECTION AGENCY
PESTICIDES REGULATION DIVISION
WASHINGTON, D. C. 20250
CONFIDENTIAL STATEMENT OF FORMULA
(Under the Federal Insecticide, Fungicide, and Rodenticide Act)
^•^^•^^ IMPORTANT: Read instructions on reverse before completing
ff^F^ form. All information will be treated confidentially.
FORM APPROVED
BUDGET BUREAU NO. 40-R1746
l. PAGE NO. This Formula!
OF
2. DATE OF APPLICATION
3. REASON FOR SUBMISSION (Check one)
SUBMITTED BY
BASIC SUPPLIER
APPLICATION FOR I 1 APPLICATION FOR AMENDED 1 — 1 ^e instruction C I — 1
NEW REGISTRATION 1 1 OR RENEWAL REGISTRATION 1 1 on reverse) \ 1
4. NAME & MAILING ADDRESS OF APPLICANT OR REGISTRANT
(Include Zip Code)
7. NAME & MAILING ADDRESS OF BASIC SUPPLIER (If applicable)
(Include zip code)
9. IS THE INGREDIENT (PRODUCT) NAMED TM ITEM 8 REGISTERED
WITH THE EPA.? 1 1 i 1
YES 1 1 NO 1 1
6. REGISTRATION NO. OR FILE SYMBOL (If known)
8. NAME OF INGREDIENT (PRODUCT) PROVIDED BY BASIC
SUPPLIER FOR WHICH FORMULATION IS UNKNOWN
(If any)
10. IF "YES" IN ITEM 9, GIVE REGISTRATION NO.
11. NAME OF EACH ACTIVE AND EACH INERT INGREDIENT USED IN THE FORMULATION **£ |ACHENT
(List both the common name and the precise chemical name of each) BY WEIGHT
5. NAME OF ECONOMIC POISON (Must be same product name
as on label-do not list active ingredients!
D
CONTINUED ON ATTACHMENT(S)
All ingredients listed in item 11 above and on
additional pages must total
100%
13. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE
15. DATE SIGNED
16. RECEIVED BY EPA -PESTICIDES REGULATION
DIVISION, WASHINGTON, D. C.
PR FORM 9-196
(MAY 1970)
Exhibit 2a
2-8
-------
INSTRUCTIONS FOR PR FORM 9-196
A. The complete chemical composition of each economic poison must be known so it can be evaluated for registration
under the Federal Insecticide, Fungicide, and Rodenticide Act. This information is also necessary to determine the
status of ingredients, both active and inert, under the Pesticide Chemicals Amendment to the Federal Food, Drug, and
Cosmetic Act.
B. This form is designed for reporting the ingredients used in the formulation of an economic poison. Its use will speed the
review. It must be completed and submitted with each "Application for New Registration of Economic Poisons"
(PR Form 9-199), or with each "Application for Amended Registration of Economic Poisons" (PR Form 9-198)
if revision involves a formula change, or with each "Application for Renewal Registration of Economic Poisons"
(PR Form 9-197).
C. If the complete chemical composition of formulated ingredients, either active or inert, used in this product's formulation
is not known to you, send a separate set of these forms for each such ingredient to your Basic Supplier. When you do
this, it is important that you first fill in items 2 thru 8 so that we may positively identify the supplier's product with your
economic poison. The Basic Supplier is then requested to complete item 1, and items 9 thru 15, and submit the form
to this Division. This Statement is treated confidentially. It cannot be used to support a customer's (formulator's)
application for subsequent registration without written authorization from the Basic Supplier.
ITEM NO.
1. PAGES OF THIS FORMULA. Show "1 of 1", "1 of 2", etc. If space on this form is insufficient to list all ingredients,
continue on additional sheets and number in sequence.
2. DATE OF APPLICATION. Enter the same date as the related application form.
3. REASON FOR SUBMISSION. Read instruction B above.
4. NAME AND MAILING ADDRESS OF APPLICANT OR REGISTRANT. Enter the name and mailing address of your
firm.
5. NAME OF ECONOMIC POISON. Enter the product name of this economic poison as it will appear on the finished label.
6. REGISTRATION NO. OR FILE SYMBOL. These reference items are assigned by the PR Division. If unknown, leave
blank.
7. NAME AND MAILING ADDRESS OF BASIC SUPPLIER. } _ . , . ., . ,
I Complete only if required
8. NAME OF INGREDIENT (PRODUCT) PROVIDED BY BASIC | by Instruction C above.
SUPPLIER FOR WHICH FORMULATION IS UNKNOWN J
9. IS THE INGREDIENT (PRODUCT) NAMED IN ITEM 8 \
REGISTERED WITH EPA ? "YES" or "NO". I Completed only by the
/ Basic Supplier.
10. IF "YES IN ITEM 9, GIVE REGISTRATION NO. K
Self-Explanatory. /
11. NAME OF EACH ACTIVE AND EACH INERT INGREDIENT USED IN THE FORMULATION. List both the common
name and the precise chemical name of each active and each inert ingredient used in formulating this product.
a. First list the active ingredients. List them in the very same order as they appear or will appear in the ingredient state-
ment on the finished label.
b. Next, list the name of each inert ingredient.
c. When a formulated product is listed in the formula, name its basic manufacturer and give its EPA
Registration Number, if known, in parenthesis following the name of the product. (Also see Instruction C above).
d. The trade name and manufacturer of surfactants and other adjuvants (dyes, emulsifiers, solvents, perfumes) must be
listed. The complete chemical composition of emulsifiers and surfactants must be listed. Enclose the manufacturer's
name in parenthesis following the product listed by trade name. (Also see Instructions C above).
e. If a dye or other coloring material is used, state the color.
12. PERCENTOF EACH BY WEIGHT. Enter in this column the percentage by weight of each active and each inert ingredient
listed in item 11. Each entry must be opposite that ingredient to which it applies. The percentages by weight for the active
ingredients must agree with those appearing in the ingredient statement on the label. The sum of all the percentages listed
must equal 100 percent.
13. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE. When completed, the authorized representative of the firm
must sign this form.
14. TITLE. Self-explanatory.
15. DATE SIGN ED. Self-explanatory.
Exhibit 2b
2-9
-------
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION DIVISION
WASHINGTON. D. C. 20250
APPLICATION FOR | AM ENDED] REGISTRATION OF ECONOMIC POISONS
(Under the Federal Insecticide, Fungicide, and Rodenticide Act)
^MPORTANTt READ INSTRUCTIONS Oh REVERSE
FORM APPROVED
BUDGET BUREAU NO. 4O-R1746
1. DATE OF APPLICATION
2. NAME OF ECONOMIC POISON fj^ust oe same product name as on label-do not list active ingredients)
3. NAME ft MAILING ADDRESS OF REGISTRANT (Include Zip Code)
4, REGISTRATION NO.
(PROPOSED EFFECTIVE DATE
OF CHANGE
6. NATURE OF «EvisioN (Check applicable item and give details in item 7, when required )
GENERAL REVISION OF LABELING I I
CHANGE IN FORMULATION [~~)
(Give description of exact change
in item 7)
OTHER rn
(Specify in item 7)
ADDITIONAL USES ADDED TO LABELING JT~\
(List new recommendations in item 7)
CHANGE IN PRODUCT NAME I I
(Give old name and new name
in item 7)
7. DETAILS REQUIRED BY REVISION CHECKED IN ITEMS (Attach additional sheets if more space is needed)
I I CONTINUED ON ATTACHMENT
8. THE FOLLOWING MUST \BE SUBMITTED WITH THIS APPLICATION
• Five (5) copies of revised labeling, including any printed or graphic matter
which may accompany the sale of this product. Copies must be clearEy
legible and identical.
• If a change in formulation is involved, five (5) copies of a statement of
revised formula showing the precise name and precentage of 4fl_c_h active
and each inert ingredient.
(This infnrmation is treated confidentially)
•When appropriate, three (3) copies of Supporting Data.
9. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE
TITLE
f 11. DATE SIGNED
12. RECEIVED BY USDA-PESTIC1DES REGULATION
DIVISION, WASHINGTON, D. C.
IN ANY CORRESPONDENCE ON THIS PRODUCT REFER TO
REGISTRATION NO. IN ITEM 4, ABOVE.
PR FORM 9-198
MAY 1969
EXISTING STOCK OF PR FORM 9-'«8 (AUG. 1968)
WILL BE USED UNTIL EXHAUSTED
Exhibit 3a
2-10
-------
INSTRUCTIONS FOR. PR FORM 9-198
1. Applications should be submitted as
-------
PR Notice 70-20
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D. C. 20250
September 14, 1970
NOTICE TO MANUFACTURERS, FORMULATORS, DISTRIBUTORS,
AND REGISTRANTS OF ECONOMIC POISONS
Attention: Person Responsible For Federal Registration of Economic
Poisons
APPLICATION FOR CHANGE IN FORMULA FOR REGISTERED
PRODUCTS
Section 362.10 (g)(l) of the Regulations for the Enforcement of the
Federal Insecticide, Fungicide, and Rodenticide Act provides for
limited changes in the formula of a registered economic poison.
In the past, rather extensive changes in formula have been accepted as
amended registration. This has often led to administrative difficulties
in record keeping and confusion for registrants of economic poisons.
Therefore, future applications for amended registration involving a
formula change will be considered only if the change in percentage of
active ingredient(s) or changes in inerts will not result in a need
for modifying the required precautionary labeling or directions.
Changes in formulation which involve the addition or removal of an
active ingredient(s) or which do not meet the requirements listed above
will be considered as new products. Such submissions should include a
completed PR Form 9-199 (Application For New Registration). If you
intend to discontinue marketing of the original product, please inform
this Division so that cancellation procedures may be instituted.
i •%<-« '-•y-'i 's'j f-
iarold G} Alfort
Assistant Director
Exhibit 4
2-12
-------
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D. C. 20250
APPLICATION FOR
SUPPLEMENTAL REGISTRATION FOR DISTRIBUTORS
(Under Section 4 of the Federal Insecticide, Fungicide,
and Rodenticide Act)
FORM APPROVED: BUDGET BUREAU NO. 4O-R3580
1. DATE OF APPLICATION
2. REGISTRATION NO.
3. DATE LABELING OF THIS PRODUCT ACCEPTED BY USDA
4. NAME OF REGISTERED PRODUCT
5. NAME AND ADDRESS OF REGISTRANT (Include Zip Code-)
r
L_
J
It is requested lhat the registration record under the Federal Insecticide, Fungicide and Rodenticide Act of the product named above
be amended to include the labels for each distributor listed below:
6. DISTRIBUTOR
(Name anil Address-include /ip Code)
/.DISTRIBUTOR'S PRODUCT NAME
(Show complete product name as it will appear on the distributor's label)
CONTINUATION SHEET ATTACHED (If checked, submit 2 copies)
CERTIFICATION
This is to certify that the distributor(s) product has the same formula as that of the registrant, is manufactured by the same person,
and the labeling oj which contains the same claims and registration number as the registered product named above. The labeling of
this registered product •was accepted by the Department of Agriculture by correspondence on the date shown in item 3 above. The
product remains in the manufacturer's original unbroken package until it is sold to the user.
8.SIGNATURE OF FIRM REPRESENTATIVE
9.TITLE
10. DATE SIGNED
FOR PESTICIDES REGULATION DIVISION USE ONLY - The registration record under the Federal Insecticide, Fungicide, and Rodenticide
f Act of the product named above has been amended to include the labels for the distribulor(s) listed above.
BTcr^
(SIGNATURE
PR FORM 9-1
MAY 1969
EXISTING STOCK OF PR FORM 9-1 (JULY I960).
WILL BE USED UNTIL EXHAUSTED.
Exhibit 5a
2-13
-------
Conditions for listing Distributors
A. After a manufacturer (formulalor) submits acceptable labeling and obtains regis-
tration for a basic product, he may list distributors by submitting the name and
address of the distributor and the product name to be used on the distributor's label.
This request must be submitted by the registrant; such request from the distributor
is not acceptable. The product may then be legally shipped in interstate commerce
under the distributor's label under the following conditions.
1. The distributor's label does not differ in substance from the basic label accepted
for the manufacturer, except;
a. The product name may differ so long as it is not misleading,
b. The name and address of the distributor must be preceded by a qualifying
phrase such as, "distributed by," "sold by," or "manufactured for,"
c. If the basic label bears directions for use on a number of crops or sites, the
distributor's label may bear directions for use on only a part of the crops or
sites, provided such directions are complete.
2. The distributor's label must bear the USDA Registration Number assigned to the
manufacturer's product.
3. The distributor's product must remain in the manufacturer's original unbroken
container as long as it is in the channels of trade. (Products purchased by the
distributor in bulk lots and repacked cannot be legally shipped in interstate
commerce without a separate registration.) Also, the immediate container of
products shipped from the manufacturer to the distributor must bear registered
labeling.
B. Any change in the registration status of the manufacturer's or registrant's basic
product or its labeling applies equally to all distributor's products listed under the
registration. It is the responsibility of the manufacturer or registrant to see that
all distributor's labeling complies with the currently accepted labeling for the basic
product.
C. It is not necessary to submit copies of distributor's labeling.
Exhibit 5b
2-14
-------
FORM APPROVED: BUDGET BUREAU NO. 4O-R1746
U.S. DEPARTMENT OF AGRICULTURE
AGRICULTURAL RESEARCH SERVICE
PESTICIDES REGULATION DIVISION
WASHINGTON. D. C. 2O25O
APPLICATION FOR [NEW | REGISTRATION OF ECONOMIC POISONS
(Under the Federal Insecticide, Fungicide, and Rodenticide Act)
•IMPORTANT: READ INSTRUCTIONS ON REVERSE
3. TYPE OF pESTiciDEfOiec/fc each applicable item for combination products}
INSECTICIDEd) FUNGICIDEO HERBICIDEl 1
RODENTICIDEn GERM ICI DE-DISINFECT ANT Q
1. DATE OF APPLICATION
2. NAM EOF ECONOMIC POISON (Must be same product name as
on label-do not list active ingredients}
OTHER (Specify}
4. NAME ft MAILING ADDRESS OF FIRM TO WHOM REGISTRATION 13 TO BE 186UED 5. IS THE REGISTRANT SHOWN IN
(Include Zip Code! ITEM 4 THE MANUFACTURER?
YES I I
(If "i\'o ", see instruction 5 on
reverse)
NOl I
6. TYPE OF FORMULATION
DUSTQ WETTABLE POWDER
GRANULAR!|
PRESSURIZED PRODUCT I I
EMULSIF1ABLE LIQUIDdl BAITl I
OTHER (Specify)
7. TYPE OF CONTAINER
METAL dl GLASS | I
PLASTIC r~l PAPER r~~3
OTHER (Specify 1
8. NET CONTENTS OR CONTAINER SIZES
9. MANNER IN WHICH LABEL IS AFFIXED TO PRODUCT OTHER (Specify}
LlTHOGRAPHEDdl PAPER. GLUEDdl STENCILEPl 1
10. PLACE WHERE DIRECTIONS FOR USE APPEAR
ON LABEL dJ
IN PRINTED MATTER ACCOMPANYING PRODUCT I 1
II. DATA SUBMITTED WITH THIS APPLICATION (Identify and submit in triplicate)
EFFICACY DATAO TOXICOLOGY DATA dl RESIDUE DATAQ
OTHER (Specify):
PETITION FOR TOLERANCE I I
Ta. ANY ADDITIONAL PERTINENT INFORMATION (Do not enter confidential formula here-see item 13, below)
13. THE FOLLOWING MUST BE SUBMITTED WITH APPLICATION
• Five (5) copies of proposed labeling, including all printed or graphic matter which
may accompany the sale of this product. Copies must be clearly legible and identical.
• Five (5) copies of the complete formula, showing the precise name and percentage
of each active and each inert ingredient. (This information is treated confidentially.)
14. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE
t. TITLE
16. DATE SIGNED
PR FORM 9-199
MAY 1969
EXISTING STOCK OF PRFORM 9-199 (JULY 1968)
WILL BE USED UNTIL EXHAUSTED
Exhibit Ib
2-7
APPLICANT'S COPY
-------
ENVIRONMENTAL PROTECTION AGENCY
PESTICIDES REGULATION DIVISION
WASHINGTON, D. C. 20250
CONFIDENTIAL STATEMENT OF FORMULA
(Under the Federal Insecticide, Fungicide, and Rodenticide Act)
ll^^B^h IMPORTANT: Read instructions on reverse before completing
Jf^F^ form. All information will be treated confidentially.
FORM APPROVED
BUDGET BUREAU NO. 40-R1746
1. PAGE NO. This Formula)
OF
2. DATE OF APPLICATION
3. REASON FOR SUBMISSION (Check one)
APPLICATION FOR I 1
NEW REGISTRATION I 1
APPLICATION FOR AMENDED I I
OR RENEWAL REGISTRATION I I
SUBMITTED BY
BASIC SUPPLIER
(See instruction C i—i
on reverse) I I
4. NAME & MAILING ADDRESS OF APPLICANT OR REGISTRANT
(Include Zip Code)
7. NAME & MAILING ADDRESS OF BASIC SUPPLIER
(Include zip code)
9. IS THE INGREDIENT
WITH THE EPA,?
(If applicable)
(PRODUCT) NAMED fn ITEM 8 REGISTERED
YES 1 1 NO [~]
6. REGISTRATION NO. OR FILE SYMBOL (If known)
B. NAME OF INGREDIENT (PRODUCT) PROVIDED BY BASIC
SUPPLIER FOR WHICH FORMULATION IS UNKNOWN
(If any)
10. IF "YES" IN ITEM 9, GIVE REGISTRATION NO.
15 PPRPFNT
11. NAME OF EACH ACTIVE AND EACH INERT INGREDIENT USED IN THE FORMULATION ££ EACH
(List both the common name and the precise chemical name of each) 8Y WEIGHT
5. NAME OF ECONOMIC POISON (Must be same product name
as on label-do not list active ingredients)
D
CONTINUED ON ATTACHMENT(S)
All ingredients listed in item 11 above and on
additional pages must total
100%
13. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE
14. TITLE
15. DATE SIGNED
16. RECEIVED BY EPA -PESTICIDES REGULATION
DIVISION, WASHINGTON, D. C.
PR FORM 9-196
(MAY 1970)
Exhibit. 2a
2-8
-------
INSTRUCTIONS FOR PR FORM 9-196
A. The complete chemical composition of each economic poison must be known so it can be evaluated for registration
under the Federal Insecticide, Fungicide, and Rodenticide Act. This information is also necessary to determine the
status of ingredients, both active and inert, under the Pesticide Chemicals Amendment to the Federal Food, Drug, and
Cosmetic Act.
B. This form is designed for reporting the ingredients used in the formulation of an economic poison. Its use will speed the
review. It must be completed and submitted with each "Application for New Registration of Economic Poisons"
(PR Form 9-199), or with each "Application for Amended Registration of Economic Poisons" (PR Form 9-198)
if revision involves a formula change, or with each "Application for Renewal Registration of Economic Poisons"
(PR Form 9-197).
C. If the complete chemical composition of formulated ingredients, either active or inert, used in this product's formulation
is not known to you, send a separate set of these forms for each such ingredient to your Basic Supplier. When you do
this, it is important that you first fill in items 2 thru 8 so that we may positively identify the supplier's product with your
economic poison. The Basic Supplier is then requested to complete item 1, and items 9 thru 15, and submit the form
to this Division. This Statement is treated confidentially. It cannot be used to support a customer's (formulator's)
application for subsequent registration without written authorization from the Basic Supplier.
ITEM NO.
1. PAGES OF THIS FORMULA. Show "1 of 1", "1 of 2", etc. If space on this form is insufficient to list all ingredients,
continue on additional sheets and number in sequence.
2. DATE OF APPLICATION. Enter the same date as the related application form.
3. REASON FOR SUBMISSION. Read instruction B above.
4. NAME AND MAILING ADDRESS OF APPLICANT OR REGISTRANT. Enter the name and mailing address of your
firm.
5. NAME OF ECONOMIC POISON. Enter the product name of this economic poison as it will appear on the finished label.
6. REGISTRATION NO. OR FILE SYMBOL. These reference items are assigned by the PR Division. If unknown, leave
blank.
7. NAME AND MAILING ADDRESS OF BASIC SUPPLIER. \ Complete only if required
8. NAME OF INGREDIENT (PRODUCT) PROVIDED BY BASIC [ by Instruction C above.
SUPPLIER FOR WHICH FORMULATION IS UNKNOWN J
9. IS THE INGREDIENT (PRODUCT) NAMED IN ITEM 8 \
REGISTERED WITH EPA ? "YES" or "NO". I Completed only by the
( Basic Supplier.
10. IF "YES IN ITEM 9, GIVE REGISTRATION NO.
Self-Explanatory. /
11. NAME OF EACH ACTIVE AND EACH INERT INGREDIENT USED IN THE FORMULATION. List both the common
name and the precise chemical name of each active and each inert ingredient used in formulating this product.
a. First list the active ingredients. List them in the very same order as they appear or will appear in the ingredient state-
ment on the finished label.
b. Next, list the name of each inert ingredient.
c. When a formulated product is listed in the formula, name its basic manufacturer and give its EPA
Registration Number, if known, in parenthesis following the name of the product. (Also see Instruction C above).
d. The trade name and manufacturer of surfactants and other adjuvants (dyes, emulsifiers, solvents, perfumes) must be
listed. The complete chemical composition of emulsifiers and surfactants must be listed. Enclose the manufacturer's
name in parenthesis following the product listed by trade name. (Also see Instructions C above).
e. If a dye or other coloring material is used, state the color.
12. PERCENT OF EACH BY WEIGHT. Enter in this column the percentage by weight of each active and each inert ingredient
listed in item 11. Each entry must be opposite that ingredient to which it applies. The percentages by weight for the active
ingredients must agree with those appearing in the ingredient statement on the label. The sum of all the percentages listed
must equal 100 percent.
13. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE. When completed, the authorized representative of the firm
must sign this form.
14. TITLE. Self-explanatory.
15. DATE SIGNED. Self-explanatory.
Exhibit 2b
2-9
-------
OFFICE OF PESTICIDES PROGRAMS "
REGISTRATION DIVISION
WASHINGTON. D. C. 20250
APPLICATION FORlAMENDEPl REGISTRATION OF ECONOMIC POISONS
(Under the Federal Insecticide, Fungicide, and Rodenticide Act)
MPORTANTl READ INSTRUCTIONS ON REVERSE
FORM APPROVED
BUDGET BUREAU NO. 4O-R1746
1. DATE OF APPLICATION
2, NAME OF ECONOMIC POISON (^ust oe same proauct name as on label-do not list active ingredients)
NAME t MAILING ADDRESS OP REGISTRANT
(Include Zip Code)
I
4. REGISTRATION NO.
(PROPOSED EFFECTIVE DAT!
OF CHANGE
6. NATURE OF ^VISION (Check applicable item and give details in item 7, when required)
GENERAL REVISION OF LABELING I I
CHANGE IN FORMULATION [~~1
(Give description of exact change
in item 7)
OTHER f~n
(Specify in item 7)
ADDITIONAL uses ADDED TO LABELING J~~l
(List new recommendations in item 7)
CHANGE IN PRODUCT NAME I I
(Give old name and new name
in item 7)
7. DETAILS REQUIRED BY REVISION CHECKED IN ITEMS (Attach additional sheets if more space is needed)
I I CONTINUED ON ATTACHMENT
8. THE FOLLOWING MUST \BE SUBMITTED WITH THIS APPLICATION
• Five (5) copies of revised labeling, including any printed or graphic matter
which may accompany the sale of this product. Copies must be clearly
legible and identical.
• If a change in formulation is involved, five (5) copies of a statement of
revised formula showing the precise name and precentage of each active
and eoch inert ingredient.
(This information is treated confidentially)
• When appropriate, three (3) copies of Supporting Data.
9. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE
TITLE
(11. DATE SIGNED
12. RECEIVED BY USDA-PESTICIDES REGULATION
DIVISION, WASHINGTON, D. C.
PR FORM 9-198
MAY 1969
IN ANY CORRESPONDENCE ON THIS PRODUCT REFER TO
REGISTRATION NO. IN ITEM 4, ABOVE.
EXISTING STOCK OF PR FORM 9-'«8 (AUG. T968)
WILL BE USED UNTIL EXHAUSTED
Exhibit 3a
2-10
-------
INSTRUCTIONS FOR. PR FORM 9-198
1. Applications should be submitted as
-------
PR Notice 70-20
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D. C. 20250
September 14, 1970
NOTICE TO MANUFACTURERS, FORMULATORS, DISTRIBUTORS,
AND REGISTRANTS OF ECONOMIC POISONS
Attention: Person Responsible For Federal Registration of Economic
Poisons
APPLICATION FOR CHANGE IN FORMULA FOR REGISTERED
PRODUCTS
Section 362.10 (g)(l) of the Regulations for the Enforcement of the
Federal Insecticide, Fungicide, and Rodenticide Act provides for
limited changes in the formula of a registered economic poison.
In the past, rather extensive changes in formula have been accepted as
amended registration. This has often led to administrative difficulties
in record keeping and confusion for registrants of economic poisons.
Therefore, future applications for amended registration involving a
formula change will be considered only if the change in percentage of
active ingredient(s) or changes in inerts will not result in a need
for modifying the required precautionary labeling or directions.
Changes in formulation which involve the addition or removal of an
active ingredient(s) or which do not meet the requirements listed above
will be considered as new products. Such submissions should include a
completed PR Form 9-199 (Application For New Registration). If you
intend to discontinue marketing of the original product, please inform
this Division so that cancellation procedures may be instituted.
Assistant Director
Exhibit 4
2-12
-------
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D. C. 20250
APPLICATION FOR
SUPPLEMENTAL REGISTRATION FOR DISTRIBUTORS
(Under Section 4 of the Federal Insecticide, Fungicide,
and Rodenticide Act)
FORM APPROVED: BUDGET BUREAU NO. 4O-R35BO
1. DATE OF APPLICATION
2. REGISTRATION NO.
3. DATE LABELING OF THIS PRODUCT ACCEPTED BY USDA
4. NAME OF REGISTERED PRODUCT
5. NAME AND ADDRESS OF REGISTRANT (Include Zip Code)
r
J
It is requested that the registration record under the Federal Insecticide, Fungicide and Rodenticide Act of the product named above
be amended to include the labels for each distributor listed below:
6. DISTRIBUTOR
INume and Address-include Xip Coda)
7.DISTRIBUTOR'S PRODUCT NAME
(Show complete product name as it will appear on the distributor's label)
D
CONTINUATION SHEET ATTACHED (// checked, submit 2 copies)
CERTIFICATION
This is to certify that the distributor(s) product has the same formula as that of the registrant, is manufactured by the same person.
and the labeling of which contains the same claims and registration number as the registered product named above. The labeling of
this registered product was accepted by the Department of Agriculture by correspondence on the date shown in item 3 above. The
product remains in the manufacturer's original unbroken package until it is sold to the user.
8.SIGNATURE OF FIRM REPRESENTATIVE
9.TITLE
10. DATE SIGNED
FOR PESTICIDES REGULATION DIVISION USE ONLY - The registration record under the Federal Insecticide, Fungicide, and Rodenticide
Act of the product named above has been amended to include the labels for the distributor(s) listed above.
SIGNATURE
TITLE
PR FORM 9-1 EXISTING STOCK OF PR FORM 9.1 (JULY 19601,
MAY 1969 WILL BE USED UNTIL EXHAUSTED.
Exhibit Sa
2-13
-------
Conditions for listing Distributors
A. After a manufacturer (formulator) submits acceptable labeling and obtains regis-
tration for a basic product, he may list distributors by submitting the name and
address of the distributor and the product name to be used on (he distributor's label.
This request must be submitted by the registrant; such request from the distributor
is not acceptable. The product may then be legally shipped in interstate commerce
under the distributor's label under the following conditions.
1. The distributor's label does not differ in substance from the basic label accepted
for the manufacturer, except;
a. The product name may differ so long as it is not misleading,
b. The name and address of the distributor must be preceded by a qualifying
phrase such as, "distributed by," "sold by," or "manufactured for,"
c. If the basic label bears directions for use on a number of crops or sites, the
distributor's label may bear directions for use on only a part of the crops or
sites, provided such directions are complete.
2. The distributor's label must bear the USDA Registration Number assigned to the
manufacturer's product.
3. The distributor's product must remain in the manufacturer's original unbroken
container as long as it is in the channels of trade. (Products purchased by the
distributor in bulk lots and repacked cannot be legally shipped in interstate
commerce without a separate registration.) Also, the immediate container of
products shipped from the manufacturer to the distributor must bear registered
labeling.
B. Any change in the registration status of the manufacturer's or registrant's basic
product or its labeling applies equally to all distributor's products listed under the
registration. It is the responsibility of the manufacturer or registrant to see that
all distributor's labeling complies with the currently accepted labeling for the basic
product.
C. It is not necessary to submit copies of distributor's labeling.
Exhibit 5b
2-14
-------
ENVIRONMENTAL PROTECTION AOENCY
PESTICIDES REGULATION DIVISION
WASHINGTON. 0. C. 20tM
Gentlemen:
Subject
The labeling referred to above submitted in connection vith registration under the Federal
Insecticide, Fungicide, and Rodenticide Act, is not acceptable for the reason* given below.
It should be corrected or amended in accordance with these consents and resubsiitted in
quintuplicate.
P"r°*"U BKISTIN* STOCK Of fit rOMM «-«4. S«PT 1MI. WILL •• USKO UNTIC IHMAUiTBD
Exhibit 6
2-15
-------
ENVIRONMENTAL PROTECTION AGENCY
Pesticides Regulation Division
Washington, D. C. 20250
Gentlemen:
Subject :
The labeling referred to above, submitted in connection with registration
under the Federal Insecticide, Fungicide, and Rodenticide Act, is not accept-
able for the reasons given below. Please furnish the requested information
together with five copies of corrected labeling.
PR Form 9-24
Exhibit 7
2-16
-------
ENVIRONMENTAL PROTECTION AGENCY
PESTICIDES REGULATION DIVISION
WASHINGTON. D. C. 202*0
"I
Gentlemen:
Subject :
The labeling referred to .ibove, submitted in connection with registration under the Federal
Insecticide, Fungicide and Rodenticide Act, is being accepted at this time; and a stamped copy
i* enclosed for your records. However, it is subject to the comment(s) listed below. The corrcc-
lion(s) should b« made when new labeling is printed.
PR FORM ^ 25 PBEVIOU3EOITION SOP THIS FORM »RE
°CT"6' Exhibit 8
2-17
-------
CNVIRONMKNTAL PROTECTION AGENCY
PESTICIDES REGULATION DIVISION
WASHINGTON. D. C. 20ZBO
Gentlemen:
Subject:
The subject labeling, submitted in connection with registration under
the Federal Insecticide, Fungicide, and Rodenticide Act, is being ac-
cepted at this time. To expedite registration, this acceptance is be-
ing made on the basis of the draft submitted with the application.
Certain defects, given below, have been noted. These corrections must
be incorporated when the finished labeling is prepared. Five copies
of the finished labeling must be submitted.
I'H i'-OKM 9-26
Exhibit 9
2-18
-------
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D. C. 20250
NOTICE OF REGISTRATION UNDER THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT
REGISTRATION NO.
DATE OF ISSUANCE
NAME OF ECONOMIC POISON
NAME AND ADDRESS OF REGISTRANT
r
NOTE: Changes in labeling of formula differing in substance from that accepted in connection with this registration must be submit-
ted to and accepted by the Pesticides Regulation Division prior to use of the label in interstate commerce. In any correspondence on
this product always refer to the above registration number.
On the basis of the information furnished by the registrant, the above named economic poison is hereby registered under
Section 4 of the Federal Insecticide, Fungicide, and Rodenticidc Act.
A copy of the labeling accepted in connection with this registration is returned herewith.
Registration is in no way to be construed as an endorsement or approval of this product by this Department. In order
to protect the public, the Se.cretary, on his own motion, may at any time cancel the registration of an economic poison in
accordance with Section 4 (c) of the Act. The acceptance of any name in connection with the registration of a product
under this Act is not to be construed as giving the registrant a right to exclusive use of the name or to its use if it
has been covered by a trademark held by others.
The following paragraphs are applicable only when checked:
I I To expedite registration, this notice is being issued on the basis of the draft submitted with the application. Certain
defects, given below, have been noted. These corrections must be incorporated when the printed labeling is
prepared. Five copies of the printed labeling must be submitted to complete the file on this product.
LJ The registration for this product is being issued with the understanding that certain defects in the labeling which
are noted below will be corrected as soon as possible. Objection is not raised to the use of the present labeling
for a reasonable period of time while fully corrected labeling is being prepared. Five copies of the corrected
labeling must be submitted.
D
L"_J Attachment is applicable.
HEAD. REGISTRATION SECTION
PESTICIDES REGULATION DIVISION
FORM 9-225 EXISTING STOCK OF PR FORM 9-225. MAR. 1962. WILL D£ USED UNTIL EXHAUSTED
OCT. 1964
Exhibit 10
2-19
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(ENVIRONMENTAL PROTECTION AOENCY
OCSTICIOCS REGULATION DIVKION
WASHINGTON. D. C. 202M
J
Gentlemen:
Subject :
The labeling referred to above, submitted in connection with registration under the Federal
Insecticide, Fungicide, aod Rodenticide Act, is acceptable and a stamped copy is enclosed for
your records.
Very truly yours,
Enclosure
PR FORM 9-268 f»n«VIOU« COITIONS OF THI» FORM ARC OBSOLETE.
SEP 1967
Exhibit 11
2-20
-------
tNVIRUNMtNIAL KKUItCUUN
nFFICE OF PESTICIDES PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D. C. 20250
NOTICE OF INTENT TO CANCEL REGISTRATION OF ECONOMIC POISONS
UNDER THE FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT
DATE OF NOTICE:
CERTIFIED MAIL
r i
IN REPLY REFER TO:
9-RC-5R
L J
ATTENTION: Person Responsible for Registration of Economic Poisons
In accordance with section 4 f. of the Act (7 USC 135 b. (f)) and section 362.10 (i) and (j) of the Regulations notice is hereby
given that the five year registration period for the economic poisons identified by the registration numbers listed hereon has
expired. These registrations will be canceled effective 30 days from the receipt of this notice unless you take the following
steps to renew them.
1. Place a "/" at the left of each registration number you wish renewed.
2. For each product checked, submit a separate PR Form 9-197. Application for Renewal Registration of Economic Poisons.
3. Sign the statement below.
4. Return the original copy of this notice to the Division at the address shown above. (Keep the carbon for your files.)
It will be necessary that fully acceptable labeling be submitted before reregistration can be issued. You will be advised if
changes in labeling are required and given an opportunity to make the necessary corrections as provided in Section 4 c. of the
Act.
If registration of products is canceled, any further shipment in interstate commerce will be in violation of the Federal Insec-
ticide, Fungicide, and Rodenticide Act.
USDA REG. NO. PRODUCT NAME
SIGNATURE
Assistant Director
REQUEST FOR CONTINUED REGISTRATION
// is requested that registration under the Federal Insecticide, Fungicide and Rodenticide Act be continued for the product(s)
registered under the number(s) checked above. A separate PR Form 9-197 with required supporting material is enclosed for
each product checked. It is understood that the registration of the product(s) not checked will be canceled.
BY (Signature)
TITLE
DATE
PR FORM 9-289 REPLACES PR FORM 9-289, FEB. 1966 WHICH IS OBSOLETE ORIGINAL (To be returned)
MAY 197° T- i • i - ^ -• i
Exhibit 12
2-21
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ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION DIVISION
WASHINGTON, D. C. 20250
NOTICE OF CANCELLATION OF REGISTRATION
UNDER THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT
EFFECTIVE DATE OF CANCELLATION
REASON FOR CANCELLATION
CERTIFIED MAIL
NAME AND ADDRESS OF REGISTRANT (Include Zip Code)
l_ J
As provided in section 4.c. of the Act and in accordance with the provisions of the regulations for its enforcement, the
economic poison registration(s) designated below is fare; cancelled. Any further shipment in interstate commerce of the
"products under this (these) registration(s) will be in violation of the Federal Insecticide, Fungicide, and Rodenticide
Act.
USDA REG. NO. PRODUCT NAME
I I Attachment is applicable.
SIGNATURE
ASSISTANT-DIRECTOR FOR REGISTRATION
PR FORM 9-288 REPLACES PR FORM 9-288, JAN. 1968, WHICH is OBSOLETE
FEB. 1970
Exhibit 13
2-22
-------
-------
SECTION 3
ESTABLISHMENT REGISTRATION PROCESS
-------
ESTABLISHMENT REGISTRATION PROCESS
This chapter will be written when the establishment
registration process is finalized. The chapter will only
cover those establishment registration requirements which
directly relate to the development of enforcement cases
and will not provide detailed, step-by-step procedures re-
garding the registration of establishments.
3-1
-------
-------
SECTION 4
LABORATORY TESTS
-------
LABORATORY TESTS
Tests methods employed in the analysis of ID samples fall
into two categories, official and unofficial.
1. Official Test Method - Refers to a test method accepted
by a recognized standard setting organization, such as
the Association of Official Analytical Chemists (AOAC)
and the American Society for Testing and Materials (ASTM).
2. Unofficial Test Method - Refers to a method which has
not as yet been accepted as a standard method but is
employed by EPA in the analysis of a sample because
other reliable test methods are not available.
Extreme care and judgement should be exercised in preparing
enforcement cases when unofficial test methods are used as the basis
for evidence of a violation of the FIFRA. Consultations with Regional
Coordinators are strongly recommended before proceeding with enforce-
ment actions in these cases.
The following manuals on test methods are available and should
be kept in the office for reference.
1. Official Methods of Analysis of the Association
of Official Analytical Chemists.
2. EPA Chemists Manual.
The above two manuals may be obtained by writing:
4-1
-------
Attention: Mr. Warren Bontoyan
Environmental Protection Agency
Office of Pesticides Programs
Technical Services Division
Chemistry Laboratory
ARC Room 101 South Building 306
Beltsville, Maryland 20705
3. EPA Manual of Biological Testing Methods for Pesticides
and Devices.
This manual may be obtained by writing:
Attention: A. J. Culver, Jr.
EPA-PR Plant Biology Lab
3320 Orchard Street
Corvallis, Oregon 97331
4-2
TRANSMITTAL NO. 74-1 (2-8-74)
-------
-------
SECTION 5
THE ID JACKET AND ITS CONTENTS
-------
THE ID JACKET AND ITS CONTENTS
An ID Jacket is prepared for every sample that is collected.
The jacket contains the labeling, documents, test results, ID reviews,
and the enforcement actions pertaining to the official sample.
A. Labeling -
The labeling contained in the ID jacket may be
the actual labeling, a picture of the actual labeling,
a Xerox copy or a typewritten copy of the labeling.
The labeling should be identified by ID number, date
of collection, and the inspector's initials or name.
Sub-sample labels should also be appropriately
identified with their sub-sample numbers.
B. Documentation -
1. Producer Establishment
Copies of the Notice of Inspection and Receipt for
Samples may or may not be in the ID folder of sampled
products. Copies of these forms are attached to the
Inspector's Establishment Inspection Report which are
turned in to the Regional office.
If enforcement action is being considered, the
Inspector's Establishment Inspection Report should be
investigated to ensure that a copy of the Notice of
Inspection and a copy of the Receipt for Sample exists.
5-1
-------
Intra/interstate shipments
The documents listed below are the best sources for
the determination of the actual shipping date. Since
all of these documents may not be available, the documents
are listed in their order of preferable use.
a. Bill of Lading(E/L) - This is the best evidence of
shipment.
b. Freight Bill (F/B) or Waybill - The second best
document. The connecting line reference (C/L)
shows the actual date of shipment by a previous
carrier.
c. Parcel Post Cancellation Stamp - Evidence of the
shipment date by the U. S. Postal Service.
d. Invoice - In addition to the shipping date, this
document usually contains a description of the
products being shipped.
e. Packing Slip - This document usually contains a
description of the products being shipped.
f. Purchase Order - When this is the only available
document, the date of receipt from the dealers,
jobbers, warehouseman's statement or the affidavit
should be used as the date of shipment.
g. Receiving Report - This document usually contains a
description of the products shipped.
5-2
-------
3. Any one of the following statements will certify that
the preceding documents pertain to the shipment of the sample
a. Dealer's Statement
b. Jobber's Statement
c. Warehouseman's Statement
d. Affidavit - When this is the only available document,
the date of receipt should be used as the shipping date.
4. Notice of Inspection - A written statement as to the
reason for the inspection.
5. Receipt of Samples - A written receipt describing the
sample obtained by the inspector and verifying that
the owner of the establishment was given an equal portion
of the sample, if he so requested.
Collection Report - An official report of the collection, but
not a document to be used as evidence of intra/interstate
shipment.
The following items appearing on the Collection Report should
be examined carefully before taking any enforcement action.
!• ID No. - The ID number appearing on the jacket folder
must agree with the ID number on the collection report.
a. Documentary samples will have the notation "DOC"
after the ID number. A documentary sample is an
official sample but only the labeling is obtained
or reported with the documentary evidence of the
shipment. No physical sample is collected.
5-3
-------
b. Investigational samples will have the notation
"INV" after the ID number. These are samples
collected for special investigation or informa-
tional purposes and need not be collected from
lots in interstate commerce or under Federal
jurisdiction.
2. Date of Shipment - For the official date, refer to the
transportation records
3. Amount before sampling - The amount on hand must be
less than or equal to the amount shipped.
4. Description - Indicates the number of subsamples collected,
5. Shipper - For the actual shipper, refer to the transpor-
tation records.
6. Reason for collection - This should be noted because:
a. It may indicate a suspected violation.
b. It may indicate the sample was collected in a
Market Basket Survey. A Market Basket Survey is
a sampling of products from the market place with-
out accompanying documentation.
D. History of Official Sample - This document indicates that the
integrity of the sample has been maintained. Each time the
seal is broken and resealed it must be noted on the form.
5-4
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Laboratory Test Results - The following are the three types
of laboratory reports:
1. Sample Analytical Report - relates to the chemical com-
position of the product.
2. Efficacy Test - relates to the effectiveness of the
product.
3. Toxicity Report - relates to the category of toxicity of
the product. This report is primarily used by the
Registration Division.
Statements by the Registration Division's I.D. reviewers
1. Enforcement Case Review - Determines the registration
status of the product and its status as a pesticide or
device. The review also shows the product's accepted name
and the name and address of the registrant.
2. Review by the ID Control Officer - Determines if there
are any significant composition, efficacy or labeling
defects.
3. Scientific Review - If product defects are found the
ID jacket is routed to one or more of the following
reviewers -- Chemistry, Efficacy, and Safety. (The
term NAG is an abbreviation used by the ID reviewers
to indicate no adverse comment.)
5-5
-------
6
-------
SECTION 6
ENFORCEMENT CRITERIA
-------
ENFORCEMENT CRITERIA
A. Once the ID jacket and its contents have been received,
the following points must be considered for official
s amp1e s :
1. The adequacy of the documentation
2. The significance which the reviewer attaches to the
violation
3. The violative history of the firm in relation to the
type of action, i.e., notice of warning or notice of
contemplated civil or criminal proceedings. (Data
regarding a firm's violative history may be obtained
by utilizing the Pesticide Enforcement Management
System (PEMS).)
NOTE: ONLY ONE TYPE OF INITIAL NOTICE (NOTICE OF CONTEMPLATED
PROCEEDINGS, NOTICE OF WARNING, ETC.) MAY BE TAKEN
ON EACH CASE.
If more than one defect in the product's labeling or
formula is noted in the ID jacket, the highest level
of action warranted by one or more of the defects is
the level of action taken on the entire ID case. When
a particular violation warrants a notice of contemplated
proceedings and the product has additional minor defects
6-1
-------
which are unrelated to any charge, these minor
defects may be mentioned in the narrative of the
notice.
Once the above points have been considered, the following
determinations can be made.
Registration Status
These determinations are based on the comments section of the
Enforcement Case Review Form (EPA HQ Form 8500-7 (2-73)).
1. New Registration
The product is not now or has not previously been
registered.
A. If pesticide claims are made on the label or in
collateral literature accompanying the product
during interstate distribution and sale.
Level of action - Notice of contemplated proceedings
B. If a file symbol appears in the comments section,
it will indicate that an application is pending for
the product; however, such an application does not
constitute registration of the product.
Level of action - notice of contemplated proceedings
6-2
-------
C. If the reviewer notes PR notice 70-20, then the
chemical analysis must verify that the sample product
is different from the accepted one and as such
constitutes a different product requiring a separate
registration.
Level of action - notice of contemplated proceedings
D. If pesticide claims are made for the product and
these types of claims were not previously considered
as statements identifying the product as a pesticide.
Level of action - notice of warning
E. If pesticide claims are made in collateral literature
and there is no evidence that the literature accompanied
the product during its interstate distribution and
sale.
Level of action - advertising letter
(If the consignee supplies the literature, send
the action to the consignee. If the source of the
literature is unknown, send the action to the
manufacturer.)
Cancellation
The product was previously registered, but the
registration has been cancelled.
6-3
-------
A. Renewal was not requested by the registrant
(PR form 9-289) at the end of the five-year
registration period.
Level of action - notice of contemplated proceedings
B. Cancellation at the request of registrant
Level of action - notice of contemplated proceedings
C. Cancellation by a PR notice because the product's
uses are no longer acceptable.
Level of action - notice of contemplated proceedings
D. Cancellation by a PR notice because the product's uses
are no longer acceptable and potentially hazardous.
Level of action - notice of contemplated proceedings with
higher level of action such as a stop sale, use or removal
order, a recall and/or seizure.
NOTE: QUESTIONS CONCERNING HIGHER LEVELS OF ACTION SHOULD
BE DIRECTED TO THE APPROPRIATE REGIONAL COORDINATOR.
E. Cancellation letter resulting from samples exhibiting
continued product failure.
Level of action - notice of contemplated proceedings with
higher level of action
3. Non-registerable products.
These are pesticides, which because of their ingredients
and/or recommended uses, are not registerable.
Level of action - notice of contemplated proceedings with
higher level of action
6-4
-------
4. Supplemental Registration
The distributor's product is not supplementally registered.
Level of action - notice of warning to the registrant
II. Labeling
1. Precautionary statements.
The following determinations are based on the safety
reviewer's comments.
A. Does not bear a signal word and/or the statement
"keep out of reach of children" on the front panel.
Level of action - notice of contemplated proceedings
B. Lacks required precautionary statements which:
1. Could result in hazards to the user.
Level of action - notice of contemplated proceedings
with higher level of action
2. Would not likely result in hazards to the user.
Level of action - notice of contemplated proceedings
C. Label does not bear symbols and/or statements required
for highly toxic substances.
Level of action - notice of contemplated proceedings
D. Does not bear required precautions, but they are
implied by other precautionary statements on the label.
Level of action - notice of warning
E. Bears precautionary statements of a higher category of
toxicity than those required for the product.
Level of action - notice of warning
F. Precautionary statements are not prominently placed.
Level of action - notice of warning
6-5
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2. Unwarranted statements with respect to the product's
safety. The following determinations are based on the
safety reviewer's comments.
A. May result in the mishandling or misuse of the product.
Level of action - notice of contemplated proceedings
B. Not likely to result in the mishandling or misuse of
the product.
Level of action - notice of warning
3. Directions for use.
The following determinations are based on the efficacy re-
viewer's and pesticide residue chemist's comments.
A. Does not bear required directions for use which:
1. Could result in misuse, illegal residues, or
lesser effectiveness.
Level of action - notice of contemplated proceedings
with higher level of action
2. No adverse effects anticipated.
Level of action - notice of warning
B. Directions for use differ in substance from those
accepted in connection with the registration of the
product.
1. Major
Level of action - notice of contemplated proceedings
2. Minor
Level of action - notice of warning
6-6
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Claims.
The following determinations are based on comments by the
efficacy reviewer and residue chemist.
A. Bears claims that have not been accepted in connection
with the product's registration.
1. Those claims which would not be acceptable for
the product by the Registration Division.
a. Could be hazardous.
Level of action - notice of contemplated
proceedings with higher level of action
b. No hazard would be expected.
Level of action - notice of contemplated
proceedings
c. Unwarranted claims regarding the product's
ingredients, ex: CONTAINS NO DDT.
Level of action - notice of warning.
2. Those claims which would be accepted by the
Registration Division if submitted.
Level of action - notice of contemplated
proceedings
B. Bears claims which have been accepted by the
Registration Division, but were reworded by the
registrant in such a way that they may mislead
the consumer.
Level of action - notice of warning
6-7
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5. Ingredient Statement
The following determinations are based on comments by the
Chemistry reviewer
A. Ingredient statement as declared on the sample
product's label differs from that which was accepted
in connection with the product's registration.
Level of action - notice of contemplated proceedings,
charging composition differs if new registration is
not required pursuant to PR notice 70-20.
B. Totally lacks any ingredient statement.
Level of action - notice of contemplated proceedings
C. Present, but not in prescribed format.
Level of action - notice of warning
D. Not on the front panel when required.
Level of action - notice of warning.
E. Term "inert ingredients" less prominent than the
term "active ingredient."
Level of action - notice of warning
F. Misspelling or typographical errors.
Level of action - notice of warning
6. Other label omissions
A. Product or establishment registration numbers
B. Statement of net weight (should be verified by
the inspector on the collection report)
C. Name and address of manufacturer or registrant
D. Brand name of product
Level of action - notice of warning
6-8
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NOTE: THE LEVEL OF ACTION SHOULD BE RAISED TO A NOTICE OF
CONTEMPLATED PROCEEDINGS WHEN THERE ARE THREE OR MORE
LABELING ERRORS AT THE NOTICE OF WARNING LEVEL ON ONE
SAMPLE.
7. Collateral literature
If unaccepted statements are found only in collateral
literature and the source of the literature is unknown.
Level of action - advertising letter to the registrant
III. Analytical test results
The following determinations are based on the chemistry reviewer's
comments regarding the tests' reliability and the significance of
the results.
1. Deficiency
A. Deficiency is 10% or greater
1. Affects the product effectiveness
Level of action - notice of contemplated
proceedings with higher level of action
2. Not likely to affect the product's effec-
tiveness .
Level of action - notice of contemplated
proceedings
B. Deficiency is less than ten percent.
1. Likely to affect the product's effectiveness.
Level of action - notice of contemplated
proceedings with higher level of action
2. Not likely to affect the product effectiveness
Level of action - notice of warning
6-9
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Contamination
The following determinations are based on comments by the
chemistry, pesticide residue, safety, and efficacy reviewers.
A. Contamination could be hazardous
Level of action - notice of contemplated proceedings
with higher level of action
B. Contamination is not likely to be hazardous
1. Significant level of contamination, but posing
no hazard
Level of action - notice of contemplated proceedings
2. Trace amounts which are not included in the
products's confidential formula statement.
Level of action - notice of warning
Overformulation
A. Hazardous
Level of action - notice of contemplated proceedings
with higher level of action
B. Not hazardous
Level of action - notice of warning
Net Weight Deficiency
If a deficiency is reported by the laboratory but is not
supported by a field weighing, no action can be taken
unless at least six units have been weighed by the
laboratory.
6-10
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A. 3% deficiency or less
Level of action - none
B. 3% to less than 10%
Level of action - notice of warning
C. 10% to less than 20%
Level of action - notice of contemplated proceedings
D. 20% or greater
Level of action - notice of contemplated proceedings
with higher level of action
NOTE: A HIGHER LEVEL OF ACTION MUST BE SUPPORTED BY A FIELD
WEIGHING
IV. Efficacy Tests
The following determinations are based on the efficacy reviewers
comments regarding the reliability and significance of the
tests.
1. Disinfectants (tests are conducted with the following
standard organisms).
A. Staphylococcus aureus and/or Salmonella choleraesuis
1. Hospital use - Kills neither organism
Level of action - notice of contemplated proceedings
with highest level of action
2. Hospital use - Kills only one organism
Level of action - notice of contemplated proceedings
with higher leyel of action
3. Non-hospital use - Kills neither organism
Level of action - notice of contemplated proceedings
with higher leyel of action
6-11
-------
4. Non-hospital use - Kills only one organism
Level of action - notice of contemplated pro-
ceedings
B. Trichophyton interdigitale - fails to kill
Level of action - notice of contemplated proceedings
C. Pseudomonas aeruginosa - fails to kill
Level of action - notice of warning
2. Rodenticides
A. Single Dose - the current acceptable minimum standard
is 90% mortality after 8 days in order for the product
to be considered effective in a commensal rodent
population.
SINGLE DOSE RODENTICIDE
Standard Mortality - 901 after 8 days
Mortality Level of Action
0 - 80% Notice of contemplated proceedings
81 - 85% Notice of warning
B. Multiple Dose
1. Cereal or water baits - the current acceptable
minimum standard is 33 1/3% acceptance and 90%
mortality in order for the product to be considered
effective in a commensal rodent population.
6-12
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Acceptance
0-19.7
19.8-26.41
19.8-26.4%
0-100%
Mortality Level of Action
and/or 0-80 Notice of contemplated proceedings
and 81-85% Notice of contemplated proceedings
81-85% Notice of warning
100% Notice of warning
NOTE: WHEN THE MORTALITY IS EXTREMELY LOW, A HIGHER LEVEL OF
ACTION MAY BE WARRANTED.
2. Paraffin Blocks - the current acceptable
minimum standard is 25% acceptance and 80%
mortality in order for the product to be con-
sidered effective in a commensal rodent
population.
PARAFFIN BLOCK
Standard Acceptance - 25%
Standard Mortality - 80%
Acceptance
0 - 14.9% and/or
15 - 20% and
15 - 20% or
0 - 100%
Mortality Level of Action
0 - 71% Notice of contemplated proceedings
72 - 76% Notice of contemplated proceedings
72 - 76% Notice of warning
100% Notice of warning
6-13
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3. Insecticides and Fungicides
Due to the number and variability of insecticide
and fungicide efficacy tests, determinations must
be done on an individual basis - consult your
regional coordinator.
V. Pharmacology - Enforcement actions are usually not based on
these tests.
B. Market Basket Surveys (Refer to VI (c) (6) of this manual.)
1. Prepare enforcement correspondence when inor labeling
or chemical problems are found.
2. Prepare a sample request when major violations are found,
3. Prepare recall when hazardous or ineffective conditions
are found. Issue sample request concurrently.
6-14
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-------
SECTION 7
CIVIL PROCEEDINGS
-------
CIVIL PROCEEDINGS
I. Authorities
The Act authorizes the Administrator to give notice to any
person against whom civil proceedings are contemplated [Sec. 14 (a)]
Such notice will infrom the person cited that:
(1) the Agency proposes to assess a civil penalty in conse-
quence of a stated violation of the Act, and
(2) he has the right to request a hearing, open to the public,
on the matter.
Authority to take action and to initiate any proceedings
required in the assessment of a civil penalty is vested concurrently
in the Assistant Administrator for Enforcement and General Counsel,
and to the Regional Administrators.
Authority to conduct hearings requested in the assessment of
a civil penalty under Sec. 14(a) is vested in the Administrator
and in his designated Administrative Law Judge.
Authority to direct all matters at all pre-hearing and post-
hearing stages of the proceeding is vested in the Regional Adminis-
trator. Under the authority of the Regional Administrator, the
Regional Enforcement Division will:
a. issue an initial Complaint and Notice of Opportunity for
a Hearing,
b. conduct all settlement conferences,
c. prepare stipulations and issure consent decrees, and
d. prepare evidence for use at hearings where such hearings
are requested.
7-1
-------
The Regional Administrator shall in every proceeding issue
a final order, conduct the Administrative review of the proceedings
if the final order is appealed, and refer the case to the U.S.
Attorney for collection if the Respondent fails to pay the full
amount of the penalty.
II. Basis
The Act provides for six general categories of enforcement
responses to evidence of violations. However, it is the intention
of the Agency to utilize the civil penalties provision of the Act
in the vast majority of its enforcement actions.
A Complaint imposing a civil penalty may be issued by the
Regional Enforcement Division where the violation:
1. involves a first offense under the Act by any pesticide
registrant, commercial applicator, wholesaler, dealer,
retailer, distributor,
2. involves any user [other than a first-offense by a party
outside of the scope of Sec. 14(a) (1)],
3. has presented a real (but not an extreme and unreasonable)
risk to man or to the environment, or
4. is likely to be an isolated occurrence.
The civil penalties complaint can, except as noted above, be
issued against any person in response to a violation of any pro-
vision of the Act.
Ill. Procedure for the Assessment of a Civil Penalty
7-2
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A. Complaint and Notice of Opportunity for Hearing (Exhibit l~]
Proceedings to assess a civil penalty under the Act shall
start with the issuance of a Complaint by the Regional Enforce-
ment Division. The Complaint shall state specifically the
factual basis constituting the alleged violation of specific
provisions of the Act. This Notice shall contain a precise
statement of the amount of the civil penalty proposed to be
assessed.
It will inform the person cited that he may, within twenty (20)
days, request a hearing for the purpose of determining:
1. Whether the alleged violations occurred as set
forth in the Complaint, or
2. Whether the proposed penalty is appropriate to the
alleged violations.
The Notice will likewise invite the person cited to confer
informally with the Regional Enforcement Division to pursue the
possibilities of settling the matter. A person so cited may request
a hearing by notifying the Regional Hearing Clerk, Environmental
Protection Agency, in writing by certified mail of his desire to
exercise his right thereto.
In cases of higher levels of action an additional statement
is attached to the Complaint and Notice of Opportunity for
Hearing. These statements warn the firm that two separate actions
are being taken for the violation. The statements are: (Exhibit 2)
7-3
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1. E-66 (Seizure)
2. E-67 (Stop Sale, Use, and Removal Order)
3. E-68 (Recall)
B. Request for a Hearing
Upon receipt of a request for a hearing, the Regional Hearing
Clerk shall assign an I. F. § R. Docket Number and shall notify
the Regional Enforcement Division that such request has been
received. The Regional Enforcement Division shall, upon receipt
of such notice, forward to the Regional Hearing Clerk the complete
file of the case. All further communications and filings by any
party to the proceedings shall be with the Regional Hearing Clerk.
For the Agency to have adequate record and notification to
proceed with requested hearings, the Regional Hearing Clerk must
promptly receive copies of each motion, pleading or transaction in
the proceedings.
Once the person cited has requested a hearing, the proceedings
become an adversary proceedings. There shall be no ex parte communi-
cations with the Administrative Law Judge, the Regional Administrator
or with Regional Judicial Officer. The parties or their representa-
tives may, however, confer informally to explore the possibilities
of settlement of the matter at any stage in the proceedings.
The conduct of the hearing will be governed by Rules of
Practice for the Assessment of a Civil Penalty promulgated to
implement Section 14(a) of the Act. A copy of these rules of
practice shall be forwarded by the Regional Hearing Clerk to
any party requesting a hearing upon receipt of such request.
7-4
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C. Answer
Any person who requests a hearing must, within twenty (20)
days of the filing of such request, file with the Regional
Hearing Clerk an answer which directly and clearly admits, denies
or explains each of the factual allegations set forth in the
Complaint with regard to which he has any knowledge. The answer
shall likewise contain a definite statement of the facts
constituting the grounds of defense.
A denial of any material fact alleged in the Complaint
shall be construed by the Agency as a request for a hearing
and an answer.
Upon receipt of such answer, the Regional Enforcement Division
shall evaluate any information contained therein which may tend
to relieve the person cited of liability. If, upon examination
of the answer, it is determined that no violation of the Act
has occurred, the person cited shall be so informed. The case
shall be closed upon the issuance by the Regional Administrator
of a final order reflecting the Agency's view that no violation
of the Act has occurred.
D. Default Order (Exhibit 3)
Failure of the person cited to make a timely request for a
hearing shall constitute a waiver of the right to such a hearing.
In this event, a Default Order shall be issued by the Regional
Administrator. This Default Order shall be considered to be a
final order of the Regional Administrator. Upon the issuance of
7-5
-------
a Default Order, the proposed penalty becomes due without further
proceedings. Any penalty so assessed shall be paid within
twenty (20) days of receipt of the Default Order.
E. Settlement Conference
It is the express policy of the Agency to encourage settlemeng
where such settlement is consistent with the provisions and objectives
of the Act. Whether or not the person cited requests a public
hearing, he may confer informally with the Regional Enforcement
Division regarding the facts alleged in the Complaint or the
amount of the proposed penalty. The written consent agreement
shall constitute a memorandum of any settlement agreement which
results from such informal conferences.
The consent agreement shall contain stipulations and admissions
regarding all factual alle_ga±inns nnt dismissed from the complaint,
conclusions of law, and an order that the party shall pay a given
civil penalty. To become binding, the Consent Agreement must be
accompanied by a final order of the Regional Administrator approving
the stipulations of facts and the assessment of a civil penalty
in the agreed amount. Once so approved, the Consent Agreement
shall be dispositive of the proceeding. The signing of a Consent
Agreement shall constitute a waiver of the Respondent's right to
request a hearing on any matter therein settled. (Exhibit 4)
7-6
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F. Hearing Procedures
If the party requests a hearing and subsequent attempts at
settlement of the matter fail to achieve agreement, a hearing
shall be held in accordance with the provisions of the Rules of
Practice Governing Hearings Conducted in the Assessment of a Civil
Penalty.
The Regional Enforcement Division will be a party in the
proceedings and shall, by its attorneys, prosecute the case.
The Regional Administrator and the Office of Regional Counsel
shall adjudicate the proceedings and issue the final findings of
fact, conclusion of law and final order.
The Administrative Law Judge shall try the case, make preliminary
findings of fact, conclusions of law and shall prepare an initial
decision.
It is essential to the judicial propriety of the civil penalties
provision that the separation of the prosecutory and adjudicatory
functions be maintained in the Regional Offices.
G. Post Hearing Procedures
If the Regional Administrator finds in his final order that the
person charged is not liable for the violation alleged in the
Complaint, the Regional Office shall order dismissal. It shall
inform the person charged and close the case. If the Regional
Administrator finds in his final order that the person charged
is liable for the violation and orders payment of a civil penalty,
7-7
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the Regional Office shall assess the penalty. The party may
appeal the findings of the final order to the U. S. Court of
Appeals pursuant to the provisions of Section 16 (b). Obligation
to pay the civil penalty does not fall due until the party has
exhausted all appeals.
H. Payment of the Final Penalty
A civil penalty assessed as a consequence of the issuance of
a Complaint may become due and payable upon the issuance by the
Regional Administrator of (1) a Default Order upon the failure
of the party to request a hearing or to submit a timely answer,
(2) an approved Consent Agreement and final order, following an
informal settlement of the case, or (3) a final order following
a hearing.
Payment shall be made by forwarding to the Regional Hearing
Clerk a cashier's or certified check for the full dollar amount
of the assessed penalty payable to the Treasurer, United States of
America. The Hearing Clerk shall forward this check to the Financial
Management Branch for deposit in the appropriate account. (Exhibit 5)
Any penalty assessed by any means outlined above shall be
referred to the U. S. Attorney for collection if full payment has
not been received within twenty (20) days after the issuance of
the final document or within twenty (20) days after a terminal
appeal from such document has upheld the party's liability. When
the penalty is paid to the Agency or is collected by the court,
the case will be closed.
7-8
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UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY
Environmental Protection Agency
Complainant
v.
John Doe
Respondent
ID No.
COMPLAINT
AND
NOTICE OF OPPORTUNITY
FOR HEARING
Complaint
This is to notify you that there is reason to believe that you
have violated Section of the Federal Insecticide, Fungicide,
and Rodenticide Act as amended (86 Stat. 973), hereinafter referred
to as the Act, by (producing, distributing, holding for sale, using,
etc.) the pesticide or device ___ •
The pesticide or device (produced, held for sale or distribution,
shipped from to
was used, etc~on or about
) was not in
compliance with the provisions of the Act as specified below:
1.
2.
3.
Charges
(Explanation of charges if required)
Proposed Civil Penalty
In view of the above, pursuant to Section 14(a) of the Act, the
United States Environmental Protection Agency, hereinafter referred
to as EPA, proposes to assess a civil penalty of ($ )
dollars against (name of respondent) .
Exhibit la
7-9
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Opportunity to Request a Hearing
You have the right to request a hearing, open to the public,
to be held in the county or city where you or your company reside.
At such hearing you may present evidence regarding 1) whether the
alleged violation in fact occurred as set forth in the complaint,
or 2) whether the proposed penalty is appropriate to the violation
cited. You must request a hearing within twenty (20) days of
receipt of this notice unless such period is extended by the
Regional Administrator, EPA Region . Address any request for
a hearing to Regional Hearing Clerk, EPA Region ,
(address of Regional Office) .
The hearings held in the assessment of these civil penalties
will be conducted in accordance with the provisions of the Adminis-
trative Procedure Act (5 U.S.C. 552 et seq.). The Rules of Practice
governing these hearings provide that any person requesting a
hearing with respect to a proposed civil penalty shall, within
twenty (20) days of the filing of such request, file with the
Regional Hearing Clerk, EPA Region , a written answer which
clearly and directly admits, denies or explains each of the factual
allegations contained in the complaint. A copy of these Rules of
Practice shall be forwarded to you by the Regional Hearing Clerk,
EPA Region , upon receipt of your request for a hearing.
If you do not request a hearing within the time allowed by
this notice, the above penalty will be assessed without further
proceedings and you will be so notified.
Settlement Conference
Whether or not you request a hearing, you may confer informally
with us, concerning the alleged violation or the amount of the
proposed penalty. We have authority to modify the amount of the
proposed penalty to reflect any settlement agreement reached with
you in any such conference. EPA encourages all parties against whom
a civil penalty is proposed to be assessed to pursue the possibilities
of settlement as a result of informal conferences. Any such settle-
ment shall be finalized by the issuance of a written Consent Agree-
ment by the Regional Administrator, EPA Region The issuance
of such Consent Agreement shall constitute a waiver of your right to
request a hearing on any matter stipulated to therein.
To explore the possibility of settlement in this matter contact
(.name pf responsible enforcement officer) , EPA Region , (address
of Regional 'Office)~ telephone ~ .
Director Enforcement Division, EPA Region
Date At
Exhibit Ib
7-10
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E-66. This notice is given pursuant to Section 9 of the
Act. It is separate from and should not be confused
with any seizure action which may have been instituted
in any United States District Court.
E-67. This notice is given pursuant to Section 9 of the
Act. It is separate from and should not be confused
with stop sale, use, or removal order which may have
been issued by this Agency.
E-68. This notice is given pursuant to Section 9 of the Act.
It is separate from and should not be confused with any
request for recall involving this product.
Exhibit 2
7-11
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UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY
Environmental Protection Agency ) ID No.
Complainant )
v. )
)
)
John Doe )
Respondent ) DEFAULT ORDER
Notice is hereby given that in connection with the enforce-
ment of the Federal Insecticide, Fungicide, and Rodenticide Act,
CP.L. 92-516; 7 U.S.C. 136 et seq.) as amended, hereinafter,
FIFRA, a civil penalty is herewith assessed against you, _
_ in the amount of _ ($ _ ) dollars. In
determining the above penalty EPA has considered the size of
your business, the effect of the penalty on your ability to
continue in business, and the gravity of the violation. This
sum must be paid in full within twenty (20) days of your receipt
of this notice. Payment may be made by forwarding to the Regional
Hearing Clerk (address, Regional Office) by certified mail a
cashier's or certified check for the above sum, payable to the
United States of America.
This penalty is assessed pursuant to the provisions of Section
14 Ca) of FIFRA (1 U.S.C. 136(1)). Your liability for the payment
of the above amount arises out of the facts and circumstances set
forth in complaint, ID No. _ , dated _ , a copy of which
is attached. These facts constitute a violation of Section _
of FIFRA and give rise to a civil penalty of the magnitude
assessed herein.
You are ordered to pay the above penalty as a consequence of
the violation of FIFRA noted in the complaint, ID No. _ and
your subsequent failure to respond within twenty (20) days to such
factual allegations, as provided for in the Complaint and Notice of
Opportunity for Hearing.
If you fail to pay the assessed sum in full within twenty (20)
days of your receipt of this notice, the matter will be referred
to the Attorney General for collection of this civil penalty by
action of the appropriate U.S. district court as provided in Section
14 Ca) C4) of FIFRA.
Attachment
Regional Administrator
Date At
Exhibit 3
7-12
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UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY
Environmental Protection Agency ) ID No.
Complainant )
v.
John Doe ) CONSENT AGREEMENT AND
Respondent ) FINAL ORDER
Preliminary Statement
1. This civil proceeding for the assessment of a penalty was
initiated pursuant to Section 14 (a) of the Federal Insecticide,
Fungicide, and Rodenticide Act (P.L. 92-516; 7 U.S.C. 136 et seq.),
as amended, hereinafter FIFRA. The action was instituted by a
Complaint and Notice of Opportunity for Hearing, filed upon
Respondent pursuant to FIFRA charging _
2. Respondent filed an answer in which he admits the jurisdic-
tional allegation of the Complaint,
admits
and explains[neither admits nor denies)
3. Respondent hereby explicitly waives his right to request a
hearing on any issue consented to herein.
4. Respondent consents to the issuance of the order hereinafter
recited, with the stipulations and admissions of facts and con-
clusions of law for the purposes of this proceeding only Respondent
consents to the payment of a civil penalty of the amount hereinafter
stipulated.
Findings of Fact
JThe "Findings of Fact" section shall state with particularity all
findings of fact with respect to each material allegation noted in
the Complaint.3
Conclusions of Law
By reason of the facts set forth in the "Findings of Facts," it is
concluded that respondent has violated Section of FIFRA.
Exhibit 4
7-13
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Respondent hereby consents to the issuance of the following order,
The Enforcement Division, EPA Region_ hereby recommends that
the Regional Administrator issue the following order:
Order
Respondent shall within twenty (20) days of his receipt of
this Consent Agreement and Final Order, pay by cashier's or
certified check a civil penalty in the amount of ($ ) dollars.
(Respondent)
(jEnforcement Division, EPA, Region
Date: At:
It is so ordered. This order shall become effective immediately,
(Regional Administrator, EPA Region
Date: At:
Exhibit 4
7-14
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Washington, B.C. 20460
To: Financial Management Branch
From:
Subject: Check in settlement of a civil penalty case.
Attached is a check received in settlement of a civil penalty
case under the Federal Insecticide, Fungicide, and Rodenticide
Act, as amended.
Case ID No.
Firm:
Amount:
Please deposit the check in Miscellaneous Fines, Account No.
681099.
Exhibit 5
7-15
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8
-------
SECTION 8
NOTICES OF CONTEMPLATED CRIMINAL PROCEEDINGS
-------
NOTICES OF CONTEMPLATED CRIMINAL PROCEEDINGS
Citations are notices of contemplated criminal proceedings
in accordance with Section 9. (c) (1) of the Act as
amended.
Each citation is composed of a cover letter and a separate
charge sheet for each Sample ID. (Exhibit 1)
A. There are several cover letter formats for the citation.
These formats are based on samples collected:
1. From interstate shipments before October 22, 1972
[Exhibit 2 a,b).
2. From intra/interstate shipments on or after October
22, 1972 (Exhibit 3).
3. From a producer establishment (Exhibit 4 a,b).
4. For evidence of misuse (See Exhibit 5).
B. The citation charge sheet is composed of several sections:
1. The Heading Section - this section will differ
according to the cover letter used (See Exhibits 1-5).
There are several types of headings:
a. If the sample is collected from an intra/interstate
shipment (Exhibit 6).
b. If the sample is collected from a producer
establishment (Exhibit 7) .
c. If the sample is collected in connection with
misuse (Exhibit 8).
8-1
-------
2. The Charge Section - depending upon the type of
violation the following charges must be used:
E201-250 for shipments before October 22, 1972
(Exhibit 9). El-50 for shipments on or after
October 22, 1972 (Exhibit 10).
3. The Narrative - the charges are explained in the narrative
section which is enclosed in parentheses. See Section 11
of this manual for a detailed discussion of each charge
and explanation.
C. In cases of higher levels of action, an additional statement
is attached to the citation. These statements warn the firm
that two separate actions are being taken for the violation.
The statements are: (Exhibit 11)
1. E-66 or E-266 (Seizure).
2. E-67 or E-267 (Stop sale, use and removal order).
3. E-68 or E-268 (Recall).
D. All citations are sent by certified mail. For record keeping
purposes, the following information must appear in the upper
margin of the return receipt:
1. Type of action.
2. Sample ID Number.
Your return address must be on the reverse side of the return
receipt card. When the receipt is returned, it is retained
in the ID jacket. (Exhibit 12)
8-2
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Pesticides Enforcement Division
ID No. 10000
CERTIFIED MAIL
Norfolk Distributors, Inc.
10 Return Avenue
Norfolk, Virginia 283711
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal Environ-
mental Pesticide Control Act of 1972), it has been disclosed that
on or about December 7, 1981, you delivered for shipment from
Norfolk, Virginia, to Columbus, Ohio, a product called GOPHER GETTER,
consigned to Kill 'Em Dead, Inc. We have obtained a sample from
this shipment which, upon examination, was found not to be in
compliance with the provisions of the statute, as specified in the
accompanying charge sheet. Accordingly, it appears that your action
in making this shipment constituted a violation of said act.
This letter is to notify you that criminal proceedings are con-
templated, looking toward further action as provided by the statute.
Before further action is taken, however, you are hereby afforded an
opportunity to offer such explanation as you wish for consideration
by the Agency. Your answer, in duplicate, signed by you or your
attorney, should be filed with this office within 20 days after the
receipt of this notice. Should you desire to present your views
orally, in addition to filing a written reply, you should so advise
in your answer in order that a date may be set for such presentation,
which would be held here.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 1
8-3
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ID No. 10000 - GOPHER GETTER
Shipper: Norfolk Distributors, Inc.
Norfolk, Virginia
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL INSECTICIDE,
FUNGICIDE, AND RODENTICIDE ACT IN THAT THE PESTICIDE WAS:
1. Misbranded in that the label did not bear on the front panel
or the part of the label displayed under customary conditions
of purchase the warning or caution statement "Keep out of
reach of children," and a signal word such as "Caution."
[12 (a) (1) (E), 86 Stat. 990; 2(q) (1) (G), 86 Stat. 977]
2. Misbranded in that the label borne by the product failed to
bear the registration number assigned. [12 (a) (1) (E), 86
Stat. 990; 2(q) (1) (C) (v), 86 Stat. 978]
(The product failed to bear the required front panel pre-
cautionary labeling and the assigned registration number
755-100.)
Exhibit 1
8-4
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NOTICE OF CONTEMPLATED CRIMINAL PROCEEDINGS
INTERSTATE SHIPMENTS BEFORE OCTOBER 22, 1972
ID No.
ID No.
ID No.
CERTIFIED MAIL
Company
Street
City
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, it has been disclosed that on
or about
you delivered for shipment from
to
a (the) product(s) called
consigned to
We have obtained a sample(s) from this (these) shipment(s)
which, upon examination, was (were) found not to be in
compliance with the provisions of the statute, as specified
in the accompanying charge sheet(s). Accordingly, it appears
that your action in making this (these) shipment(s) constituted
a violation of said act.
This letter is to notify you . . . etc.
Sincerely yours,
Name
Title
Enclosures
Exhibit 2a
t-5
-------
ID No. 71739
CERTIFIED MAIL
McDonnell Enterprises
300 South Third Street
Kansas City, Missouri 66118
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, it has been disclosed that on
or about August 19, 1907, you delivered for shipment from Kansas
City, Missouri, to Chicago, Illinois, a product called MCDONNELL
GRUB DUST, consigned to United Pharmaceutical Company, Inc.
We have obtained a sample from this shipment which, upon
examination, was found not to be in compliance with the provisions
of the statute, as specified in the accompanying charge sheet.
Accordingly, it appears that your action in making this shipment
constituted a violation of said Act.
This letter is to notify you that criminal proceedings are con-
templated* looking toward further action as provided by the statute
Before further action is taken, however, you are hereby afforded
an opportunity to offer such explanation as you wish for consider-
ation by the Agency. Your answer, in duplicate, signed by you or
your attorney, should be filed with this office within 20 days
after the receipt of this notice. Should you desire to present
your "views orally, in addition to filing a written reply, you
should so advise in your answer in order that a date may be set
for such presentation, which would be held here.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 2b
8-6
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NOTICE OF CONTEMPLATED CRIMINAL PROCEEDINGS
INTRA/INTERSTATE SHIPMENTS ON OR AFTER OCTOBER 22, 1972
ID No.
ID No.
ID No.
CERTIFIED MAIL
Company
Street
City
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal
Environmental Pesticide Control Act of 1972), it has been
disclosed that on or about
you delivered for shipment from
to
a (the) product(s) called
consigned to
We have obtained a sample(s) from this (these) shipment(s)
which, upon examination, was (were) found not to be in com-
pliance with the provisions of the statute, as specified in
the accompanying charge sheet(s). Accordingly, it appears
that your action in making this (these) shipment(s) constituted
a violation of said act.
This letter is to notify you . . . etc.
Sincerely yours,
Name
Title
Enclosures
Exhibit 3
8-7
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NOTICE OF CONTEMPLATED CRIMINAL PROCEEDINGS
PRODUCER ESTABLISHMENT
ID No.
ID No.
ID No.
CERTIFIED MAIL
Company
Street
City
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal
Environmental Pesticide Control Act of 1972), a sample of a
(the) product (s)
was obtained on
The product(s) had been released for shipment by your
producer establishment in
This (These) sample(s), upon examination, was (were) found
not to be in compliance with the provisions of the statute,
as specified in the accompanying charge sheet(s). Accordingly,
it appears that your action in marketing this (these) product(s)
consituted a violation of said act.
This letter is to notify you . . . etc.
Sincerely yours,
Name
Title
Exhibit 4a
8-8
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Pesticides Enforcement Division
ID No. 88888
CERTIFIED MAIL
A. J. Dudley § Sons
2 Market Place
Baltimore, Maryland 62971
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal Environ-
mental Pesticide Control Act of 1972), a sample of the product,
DUDLEY'S DISINFECTANT, was obtained on January 1, 1980. The
product had been released for shipment by your producer establishment
in Baltimore, Maryland. This sample, upon examination, was found
not to be in compliance with the provisions of the statute, as
specified in the accompanying charge sheet. Accordingly, it appears
that your action in marketing this product constituted a violation
of said act.
This letter is to notify you that criminal proceedings are con-
templated, looking toward further action as provided by the statute.
Before further action is taken, however, you are hereby afforded an
opportunity to offer such explanation as you wish for consideration
by the Agency. Your answer, in duplicate, signed by you or your
attorney, should be filed with this office within 20 days after the
leceipt of this notice. Should you desire to present your views
orally, in addition to filing a written reply, you should so advise
in your answer in order that a date may be set for such presentation,
which would be held here.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 4b
8-9
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NO EXHIBIT 5
HAS BEEN PREPARED
8-10
-------
INTRA/INTERSTATE SHIPMENT
ID No.
ID No.
ID No.
NAME OF PRODUCT:
DATE OF SHIPMENT(S):
SHIPPER:
CONSIGNEE:
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
(ECONOMIC POISON/PESTICIDE) WAS:
Exhibit 6
8-11
-------
PRODUCER ESTABLISHMENT
ID No.
ID No.
ID No.
NAME OF PRODUCT:
DATE OF COLLECTION:
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
or
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE DEVICE
WAS:
or
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT:
Exhibit 7
1-12
-------
NO EXHIBIT 8
HAS BEEN PREPARED
i-13
-------
CITATION CHARGES FOR VIOLATIONS
OCCURING BEFORE OCTOBER 22, 1972
PRODUCT FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT:
201. In that the product was not registered under Section 4 of
the Act. 17 U.S.C. 135a(a) (1); 135b)
202. Misbranded in that the label did not bear on the front panel
or the part of the label displayed under customary conditions
of purchase the warning or caution statement "Keep out of
reach of children" and a signal word such as "Caution."
17 U.S.C. 135aCa) (5); 135(z) (2) (d) ; 40 CFR 162.9]
203. Misbranded in that the label did not bear a warning or
caution statement which is necessary and, if complied with,
adequate to prevent injury to living man and other vertebrate
animals, vegtation, and useful invertebrate animals. [ 7 U.S.C
135a(a) (5); 135(z) (2) (d)]
204. Misbranded in that the labeling accompanying the product did
not contain directions for use which are necessary and, if
complied with, adequate for the protection of the public.
17 U.S.C. 135a(a) (5); 135 (z) (2) (c)]
205. Misbranded in that when used as directed or in accordance
with commonly recognized practice, the product would be
injurious to living man or other vertebrate animals.
17 U.S.C. 135a(a) (5); 135(z) (2) (g)]
206. Misbranded in that the label borne by the product did not
bear an ingredient statement giving the name and percentage
of each of the active ingredients , together with the total
percentage of the inert ingredients, or an ingredient state-
ment giving the names of each of the active and each of the
inert ingredients in the descending order with the total
percentage of the inert ingredients. [7 U.S.C. 135a(a) (5);
135(z) (2) (e); 135(o)]
207. Misbranded in that the ingredient statement did not appear
on that part of the immediate container of the retail
package (front panel) which is presented or displayed under
customary conditions of purchase. [7 U.S.C. 135a(a) (5);
135 (z) (2) (e)]
208. Misbranded in that the term "Inert Ingredients" appeared in
smaller sized type and was less prominent than the term,
"Active Ingredients." [7 U.S.C. 135a(a) (5) 135(z) (2) (e) ;
135(o) ; 40 CFR 162.7(d)J
Exhibit 9
8-14
-------
209. Misbranded in that the label stated in part: [7 U.S.C.
135a(a) (5); 135(z) (1)]
210. Adulterated in that its strength or purity fell below the
professed standard or quality under which it was sold.
[7 U.S.C. 13Sa(a) (5) ; 135(y)]
211. Adulterated in that another substance, namely (Name of
Substance) , had been substituted wholly or in part for the
article. [7 U.S.C. 135a(a) (5) 135(y)]
212. In that the label borne by the product failed to bear the
registration number assigned. [7 U.S.C. 135a(a) (2) (d) ;
40 CFR 162. 6(f)]
213. In that the label borne by the product did not bear a state-
ment of net weight or measure of content. [7 U.S.C. 135a(a)
(2) (c)]
214. In that the net weight or measure of content was not stated
in terms of the largest unit present. [7 U.S.C. 135a(a) (2)
(c) ; 40 CFR 162. 6(e)]
215. In that the claims made for the product and the directions
for its use differed in substance from the representations
made in connection with its registration . [7 U.S.C. 135a(a)
CD]
216. In that the claims made for the product differed in substance
from the representations made in connection with its regis-
tration. [7 U.S.C. 135a(a) (1)J
217. In that the composition of the product differed from the com-
position as represented in connection with its registration.
17 U.S.C. 135a(a) (1)]
218. In that the label borne by the product did not bear a state-
ment giving the name and address of the manufacturer, regis-
trant, or person for whom manufactured. [7 U.S.C. 135a(a) (1)]
219. In that the label borne by the product did not bear a state-
ment giving the name, brand, or trademark under which the
product was sold. [ 7 U.S.C. 135a(2) (b)]
220. Misbranded in that the label bore a statement as to the
safety of the product which is false or misleading.
17 U.S.C. 135(a) (5); 135(z) (1); 40 CFR 162.14(a) (5)]
221. Misbranded in that the precautionary labeling on the front
panel was not prominently placed thereon with such conspic-
uousness as to render it likely to be read under customary
conditions of purchase. {7 U.S.C. 135a(a) (5) 135(z) (2)
Exhibit 9
8-15
-------
CITATION CHARGES FOR VIOLATIONS
OCCURING ON OR AFTER OCTOBER 22, 1972
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL INSEC-
TICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE PESTICIDE WAS:
El. Not registered under Section 4 of the Act. [7 U.S.C. 135a(a)
(1), 135b]
E2. Misbranded in that the label did not bear on the front panel
or the part of the label displayed under customary conditions
of purchase the warning or caution statement "Keep out of
reach of children," and a signal word such as "Caution."
[12(a) (1) (E), 86 Stat. 990; 2(q) (1) (G), 86 Stat. 977]
E3. Misbranded in that the label did not bear a warning or
caution statement which is necessary and, if complied with,
adequate to protect health and the environment. [12(a) (1) (E) ,
86 Stat. 990; 2 (q) (1) (G), 86 Stat. 977]
E4. Misbranded in that the labeling accompanying the product did
not contain directions for use which are necessary and, if
complied with, adequate to protect health and the environment.
[12(a) (1) (E), 86 Stat. 990; 2(q) (1) (F), 86 Stat. 977]
E5. Misbranded in that the label borne by the product did not
bear an ingredient statement giving the name and percentage
of each of the active ingredients, together with the total
percentage of the inert ingredients, or an ingredient state-
ment giving the names of each of the active and each of the
inert ingredients in the descending order of the percentage
of each present in each classification, together with the
total percentage of the inert ingredients. [12(a) (1) (E),
86 Stat. 990; 2(q) (2) (A), 86 Stat. 977; 7 U.S.C. 135(o)]
E6. Misbranded in that the ingredient statement did not appear
on that part of the immediate container of the retail package
(front panel) which is presented or displayed under customary
conditions of purchase. [12(a) (1) (E), 86 Stat. 990; 2 (q)
(2) (A), 86 Stat. 977]
E7. Misbranded in that the term "Inert Ingredients" appeared in
smaller sized type and was less prominent than the term,
"Active Ingredients." [12(a) (1) (E), 86 Stat. 990; 2(q) (2)
(A), 86 Stat. 977]
E8. Misbranded in that the label stated in part: (particular
false or misleading claims). [12(a) (1) (E), 86 Stat. 990;
2 (q) (1) (A), 86 Stat. 977]
Exhibit 10
8-16
-------
-2-
E9. Misbranded in that the label borne by the product failed to
bear the registration number assigned. [I2(a) (1) (E), 86
Stat. 990; 2(q) (1) (C) (v) , 86 Stat. 978]
E10. Misbranded in that the label borne by the product did not
bear the required statement of net weight or measure of
content. [12(a) (1) (E), 86 Stat. 990; 2(q) (2) (C) (iii), 86
Stat. 978]
Ell. Misbranded in that the label borne by the product did not
bear a statement giving the name and address of the
producer, registrant, or person for whom manufactured.
[12(a) (1) (E), 86 Stat. 990; 2(q) (2) (C) (i), 86 Stat. 978]
E12. Misbranded in that the label borne by the product did not
bear a statement giving the name, brand, or trademark under
which the product was sold. [I2(a) (1) (E), 86 Stat. 990;
2(q) (2) (C) (ii), 86 Stat. 978]
E13. Misbranded in that the labeling bore a statement as to the
safety of the product which is false or misleading.
[12(a) (1) (E), 86 Stat. 990; 2(q) (1) (A), 86 Stat. 977]
E14. Misbranded in that the precautionary labeling on the front
panel was not prominently placed theron with such conspic-
uousness as to render it likely to be read under customary
conditions of purchase. [12(a) (1) (E), 86 Stat. 990;
2(q) (1) (E), 86 Stat. 977]
E15. Misbranded in that the product is an imitation of, or is
offered for sale under the name of, another pesticide.
[12(a) (1) (E), 86 Stat. 990; 2(q) (1) (C), 86 Stat. 977]
E16. Misbranded in that the product contains a substance in
quantities highly toxic to man and the label fails to bear
required symbols or statements. [I2(a) (1) (E), 86 Stat. 990;
2(q) (2) (D), 86 Stat. 978]
E17. In violation in that the claims made for the product (and/or
where appropriate the directions for its use) differed in
substance from the representations made in connection with
its registration. [7 U.S.C. 135a(a) (1)]
E.8. In violation in that the composition of the product differed
from the composition as represented in connection with its
registration. [7 U.S.C. 135a(a) (1)]
E19. Adulterated in that its strength or purity fell below the
professed standard or quality under which it was sold.
[12(a) Cl) CE), 86 Stat. 990; 2(c) (1), 86 Stat. 975]
Exhibit 10
8-17
-------
-3-
E20. Adulterated in that another substance, namely (name of
substance), had been substituted wholly or in part for the
article. [12(a) (1) (E) , 86 Stat. 990; 2(c) (2), 86 Stat. 975]
E21. Adulterated in that valuable constituent of the pesticide
had been wholly or in part abstracted. [12(a) (1) (E), 86
Stat. 990; 2(c) (3), 86 Stat. 975]
E22. Not colored or discolored as required. [12(a) (1) (D), 86
Stat. 990]
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL INSEC-
TICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE DEVICE WAS:
E23. Misbranded in that its labeling bore a statement which was
false or misleading. [7 U.S.C. 135a(a) (5), 135(z) (1)]
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL INSEC-
TICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT:
E24. Detached, altered, defaced, or destroyed, in whole or in
part, labeling required under the Act. [12(a) (2) (A), 86
Stat. 990]
E25. Refused to furnish or permit access to records as authorized
by Section 5 of the Act. [7 U.S.C. 135a(c) (2)]
E26. Refused to allow inspection of establishment or refused to
allow the sampling of a pesticide (or device). [12(a) (2) (B),
86 Stat. 990]
E27. Gave a guaranty or undertaking which was false. [12(a) (2) (C),
86 Stat. 990]
E28. Used a registered pesticide in a manner inconsistent with
its labeling. [12(a) (2) (G), 86 Stat. 990]
E29. Used a pesticide which was under an experimental use permit
contary to the provisions of the permit. [12(a) (2) (H),
86 Stat. 990]
E30. Violated a "stop sale, use, or removal" order. [I2(a) (2) (I),
86 Stat. 990]
E31. Violated a suspension order. [12(a) (2) (J), 86 Stat. 990]
E32. Violated a cancellation of registration. [12(a) (2) (K),
86 Stat. 990]
Exhibit 10
8-18
-------
-4-
E33. Violated a provision of Section 7 of the Act in that the
establishment where the pesticide was produced was not
registered. 112(a) (1) (L), 86 Stat. 991]
E34. Knowingly falsified all or part of an application for
registration, an application for experimental use permit,
or other information marked as confidential and submitted
to the Administrator. [12(a) (2) (M), 86 Stat. 991]
E35. Added a substance to, or took a substance from, a pesticide
in a manner defeating the purpose of the Act. [12(a) (2)
(0), 86 Stat. 991]
E36. Used a pesticide in tests on human beings in violation of
the Act. [12(a) (2) (P), 86 Stat. 991]
Exhibit 10
8-19
-------
E-66. This notice is given pursuant to Section 9 of the
Act. It is separate from and should not be confused
with any seizure action which may have been instituted
in any United States District Court.
E-67. This notice is given pursuant to Section 9 of the
Act. It is separate from and should not be confused
with any stop, sale, use, or removal order which may
have been issued by this Agency.
E-68. This notice is given pursuant to Section 9 of the Act.
It is separate from and should not be confused with any
request for recall involving this product.
E-266. This notice is given pursuant to Section 6 of the Act
(7 U.S.C. 135d). It is separate from and should not be
confused with any seizure action which may have been
instituted in any United States District Court.
E-267. This notice is given pursuant to Section 6 of the Act.
It is separate from and should not be confused with any
stop sale, use, or removal order which may have been
issued by this Agency.
Exhibit 11
8-20
-------
E-268. This notice is given pursuant to Section 6 of the Act
(7 U.S.C. 135d). It is separate from and should not
be confused with any request for recall involving
this product
Exhibit 11
8-21
-------
-------
SECTION 9
NOTICES OF WARNING
-------
NOTICES OF WARNING
This type of action is issued for minor violations in
accordance with Section 9.(c) (3) of the Act as amended.
The Notice of Warning is composed of three parts.
A. The first part identifies the sample:
1. Samples collected from intra/interstate shipments
(Exhibit la,b).
2. Samples collected at the producer establishment
(Exhibit 2a,b).
3. Samples collected in a Market Basket Survey (Exhibit 3a,b)
B. The second part identifies and explains the alleged violation
(for instructions on how to write an explanation of a
violation refer to Section XI of this manual).
C. The third part is the closing paragraph. This paragraph
indicates the expected response from the firm. There are
several closing paragraphs: (Exhibit 4)
E86. Since most of these violations are of a minor nature,
this is the most common closing. The firm may submit
additional information at its option.
E87. This closing is used only when the previous violation was
minor and resulted in only a notice of warning. The firm
is not requested to make a reply.
E88. Since a written reply is seldom required for a minor
violation, this closing is not frequently used.
9-1
-------
NOTICE OF WARNING - INTRA/INTERSTATE SHIPMENT
ID No.
ID No.
ID No.
Company
Street
City
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal
Environmental Pesticide Control Act of 1972) , there (is/are)
under consideration (a) sample(s) of
which (was/were) obtained from (a) shipment(s) made from
to
on or about
(This/These) shipment(s) did not comply with the provisions of
the Act in that
Sincerely yours,
Name
Title
Exhibit la
9-2
-------
ID No. 50297
William Cosby and Associates
Post Office Box 22222
Punxsutawney, Pennsylvania 10630
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal
Environmental Pesticide Control Act of 1972), there is under
consideration a sample of CAPTAIN BILL'S BARNACLE BLASTER,
which was obtained from a shipment made from Punxsutawney,
Pennsylvania, to the U. S. Naval Academy, Annapolis, Maryland,
on or about February 2, 1978.
This shipment did not comply with the provisions of the Act in
that the product failed to bear a complete statement of net
contents. The label of the five gallon container bore the
statement, "NET CONTENTS: GALLONS." However, the exact
volume was not stamped in the space provided.
You should assure yourself that all necessary corrections are
made and that any further marketing of this product is in full
compliance with the provisions of the Act. Any additional
information that you wish to submit will be included in the
file regarding this matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit Ib
9-3
-------
NOTICE OF WARNING - PRODUCER ESTABLISHMENT
ID No.
ID No.
ID No.
Company
Street
City
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal
Environmental Pesticide Control Act of 1972) , there (is/are)
under consideration (a) sample(s) of
which (was/were) obtained on
(This/These) product(s) had been released for shipment by your
producer establishment in
(This/These) product (s) did not comply with the provisions of
the Act in that
Sincerely yours,
Name
Title
Exhibit 2a
9-4
-------
ID No. 50298
Trouble, Inc.
One Blue Chip Way
Zap, North Dakota
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal
Environmental Pesticide Control Act of 1972), there is under
consideration a sample of TROUBLE'S TOXIC TERMITE KILLER, which
was obtained on October 31, 1978. This product had been
released for shipment by your producer establishment in Zap,
North Dakota.
This product did not comply with the provisions of the Act
in that the label bore the registration number, "EPA Reg. No.
2001-711." However, the registration number assigned to this
product is EPA Reg. No. 2001-701.
You should assure yourself that all necessary corrections are
jnade and that any further marketing of this product is in full
compliance with the provisions of the Act. Any additional
information that you wish to submit will be included in the
file regarding this matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 2b
9-5
-------
NOTICE OF WARNING - MARKET BASKET SURVEY
ID No.
ID No.
ID No.
Company
Street
City
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal
Environmental Pesticide Control Act of 1972), there (is/are)
under consideration (a) sample(s) of the product(s)
(This/These) product(s) did not comply with the provisions
of the Act in that
Sincerely yours,
Name
Title
Exhibit 3a
9-6
-------
ID No. 98765
P. J. Bogdonovich Corporation
4 Circle Drive
Lubbock, Texas 73211
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal
Environmental Pesticide Control Act of 1972), there is under
consideration a sample of the product STERLING PARK LAWN
GROOMER.
This product did not comply with the provisions of the Act
in that the label failed to bear the precaution, "This product
is to^cic to toads." This precaution was on the label accepted
in connection with the product's registration on June 6, 1974,
under the registration number 755-0297.
You should assure yourself that all necessary corrections are
made and that any further marketing of this product is in full
compliance with the provisions of the Act. Any additional
information that you wish to submit will be included in the file
regarding this matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 3b
9-7
-------
E86. You should assure yourself that all necessary corrections
are made and that any further marketing of (a. this product)
(b. these products) is in full compliance with the provisions
of the Act. Any additional information that you wish to
submit will be included in the file regarding this matter.
E87. Since your company has taken action to correct (a. this type
of violation) (b. these types of violations), we do not
contemplate further proceedings at this time. You should
assure yourself that any further marketing of (a. this product)
(b. these products) complies with all provisions of the Act.
E88. Please inform us of the action you will take in this matter.
Exhibit 4
9-8
-------
10
-------
SECTION 10
OTHER TYPES OF INITIAL ACTION
-------
OTHER TYPES OF INITIAL ACTION
A. Advertising Letter - The advertising letter is issued when
only the collateral literature bears unaccepted statements
or pesticide claims. Refer to Section 6, (I) (1) (A) and
(II) (7) of this manual regarding determinations.
The letter is divided into three parts, just as the notice
of warning.
1. The first part identifies the collateral literature.
2. When pesticide claims are made for an unregistered
product, the second part identifies the claims which
bring the product under the purview of the Act.
(Exhibit la,b) When unaccepted statements are made
for a registered product, the second part specifies
the unaccepted statements. (Exhibit 2a,b)
3. In both cases, the third part, the closing, usually
requests a written reply from the firm.
B. Trade Complaints - In response to a trade complaint, a reply
is made to the complainant (Exhibit 3a,b) and a sample
request is issued.
10-1
-------
Company
Street
City
Subject: ID NO. 00000 - BRAND NAME
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, there have been brought to our
attention copies of
This literature makes statements regarding the product
such as
These statements identify the product as a pesticide within the
meaning of the Act. Refer to Section of the Act,
enclosed. The use of these statements in connection with the inter-
state distribution and sale of the product would constitute a viola-
tion of the Act. Therefore, these statements should be deleted or
an application for the registration of the product should be submitted,
Please inform us of the action you will take in this matter.
Sincerely yours,
Name
Title
Exhibit la
10-2
-------
Foley Jon Company
2141 Sagr
Washington, B.C. 20250
Subject: ID No. 54321 - SUPER JON
Gentlemen:
In connection with the enforcement of the Federal
Insecticide, Fungicide, and Rodenticide Act, there
have been brought to our attention copies of "The
Janitor's Guide."
This literature makes statements regarding the product,
SUPER-JON, such as, "Sanitize the bowl with Super-Jon."
These statements identify the product as a pesticide
within the meaning of the Act. Refer to Section 2 of the
Act, enclosed. The use of these statements in connection
with the interstate distribution and sale of the product
would constitute a violation of the Act. Therefore, these
statements should be deleted or an application for the.
registration of the product should be submitted.
Please inform us of the action you will take in this
matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit Ib
10-3
-------
Company
Street
City
Subject: ID No. 00000 - BRAND NAME
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal
Environmental Pesticide Control Act of 1972) , there have been
brought to our attention copies of
This literature makes statements regarding the product
such as
Statements such as these were never accepted in connection with
the registration of the product. Use of these statements in
connection with the marketing of the product would constitute a
violation of the Act, a copy of which is enclosed. Therefore,
such statements should be removed from all literature advertising
this product or data submitted to support them.
Please inform us of the action you will take in this matter.
Sincerely yours,
Name
Title
Exhibit 2a
10-4
-------
Dexol Company
5021 Seminary Road
Alexandria, Virginia
Subject: ID No. 12345 - DEXOL SEVIN 5% DUST
Gentlemen:
In connection with the enforcement of the Federal Insect-
icide, Fungicide, and Rodenticide Act (as amended by the
Federal Environmental Pesticide Control Act of 1972) , there
have been brought to our attention copies of the "Dexol
1971 Dealer Price List."
This literature makes statements regarding the product,
DEXOL SEVIN 5% DUST, such as, "For use on chickens. Dust
chickens by placing 1 Ib. of the product in a duster
box ..." Statements such as these were never accepted
in connection with the registraton of the product. Use
of these statements in connection with the marketing of
the product would constitute a violation of the Act, a
copy of which is enclosed. Therefore, such statements
should be removed from all literature advertising the
product or data submitted to support them.
Please inform us of the action you will take in this
matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 2b
10-5
-------
Company
Street
City
Gentlemen:
We wish to thank you for the information contained in your
letter of
(An) official sample(s) of the product(s),
(has/have) been requested, including all collateral literature.
Appropriate action will be initiated if the product (s) (is/are)
found in violation of the Federal Insecticide, Fungicide, and
Rodenticide Act.
Your concern in this matter is appreciated.
Sincerely yours,
Name
Title
Exhibit 3a
10-6
-------
Sidney 0. Smith and Company
4908 Fran Place
Alexandria, Virginia 22304
Gentlemen:
We wish to thank you for the information contained in your
letter of April 1, 1984. An official sample of the product,
MIGHTY MOUSE MASHERS, has been requested, including all
collateral literature. Appropriate action will be initiated
if the product is found in violation of the Federal Insecticide,
Fungicide, and Rodenticide Act.
Your concern in this matter is appreciated.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 3b
10-7
-------
11
-------
SECTION 11
EXPLANATORY NARRATIVES USED IN INITIAL ACTIONS
-------
EXPLANATORY NARRATIVES USED IN INITIAL ACTIONS
Charges E1-E50 are used for registered products marketed
on or after October 22, 1972, and also when specifically authorized
for certain unregistered products.
Charges E201-E250 are used for all products shipped in inter-
state commerce before October 22, 1972, and when proof of interstate
shipment is required for a non-registered product shipped after
October 22, 1972.
All charges are quotations taken directly from the Act or the
Act as amended. Except for charges E8 and E210, the wording of
most of these charges never varies. The exceptions, charges E8
and E210, are based on the definition of misbranding contained in
the Act and the Act as amended which states: ". . . if its labeling
bears any statement, design, or graphic representation relative
thereto or to its ingredients which is false or misleading in any
particular ..."
The E8 or E210 charge is divided into two sections:
1. The first section makes the statement, "Misbranded in
that the label stated in part:" and quotes only the
part of the label which is to be negated or falsified.
2. The second section is the "whereas" statement. This
statement only negates what is stated on the product's
label. It does not state the evidence on which the
charge is based. The statutory reference for the charge
immediately follows the "whereas" statement.
11-1
-------
All evidence on which the charge is drawn is presented in
the narrative of the notice of contemplated proceedings.
The narrative section of the notices of contemplated pro-
ceedings explains the charges and additional minor defects which
are unrelated to any charge. Since there are no charges in the
notice of warning and other types of initial actions, the nar-
rative of these types of action states both the product or
label defect and the explanation.
Certain statements regarding devices, product and establishment
registrations, and repeated violations, are frequently used in the
narrative of notices of contemplated proceedings. These statements
are E51-E56 and E251-E253. (Exhibit 50)
Certain statements regarding distributor product registration
and initiation of corrective action are usually placed in the
narrative of the notice of warning or other types of initial action.
These statements are E76, E77 and E276. (Exhibit 51)
A. Registration Status
1. New Registration - product has never been registered
A. There is no indication that the firm is aware of
the registration requirements for the product.
Charges - El or E201
Format - see Exhibit 1
11-2
-------
B. An application has been submitted for the product's
registration
1. A file symbol appears in the comments section of
the Enforcement Case Review Form
Charges - El or E201
Format - see Exhibit 2
2. A file symbol appears on the product's label
Charges_ - El or E201 and E8 or E210
format - see Exhibit 3
C. The product is not registered pursuant to PR
Notice 70-20.
Charges - El or E201 and E8 or E210
Format - see Exhibit 4
D. The product is not registered and bears certain types
of statements which were not previously considered
to be pesticide claims.
Format - see Exhibit 5
2. Cancellation of Registration
A. Renewal not requested.
Charges - El or E201 and when applicable, E8 or E210
Format - see Exhibit 6
B. Cancellation at request of registrant.
Charges - El or 201 and when applicable, E8 or E210
Format - see Exhibit 6
C. Cancellation by a PR notice.
Charges - El or E201 and when applicable, E8 or E210
Format - see Exhibit 7
11-3
-------
D. Cancellation by a PR notice because the product's
use is potentially hazardous.
Charges - El or E201 and E4 or E204 and when applicable,
E8 or E210
Format - see Exhibit 8
E. Cancellation resulting from samples showing
continued product failure.
Charges - *E1 or E201 and when applicable, E8 or E210
Pormat - see Exhibit 9
3. Non-Registerable Products
Charges - El or E201 and E4 or E204
Pormat - see Exhibit 10
4. Supplemental Registration
Format - see Exhibit 11
B. Labeling
1. Precautionary Statements.
A. Does not bear signal word and/or "KOOROC" statement
Charges - E2 or E202
Format - no explanation required in the narrative
B. Lacks required precautionary statements.
Charges - E3 or E203
Format - see Exhibit 12
C. Label does not bear required symbols and/or
statements for highly toxic substances.
Charges - E16 or E203
Pormat - see Exhibit 13
11-4
-------
D. Does not bear required precautions, but they
are implied by other precautionary statements
on the label.
Format - see Exhibit 14
E. Bears precautionary statements of a higher
category of toxicity than those required for
the product.
Format - see Exhibit 15
F. Precautionary statements are not prominently placed,
Format - see Exhibit 16
Unwarranted statements with respect to the product's
safety.
A. May result in the mishandling or misuse of
the product.
Charges - E13 or E222
Format - see Exhibit 17
B. Not likely to result in the mishandling or misuse
of the product.
Format - see Exhibit 18
Directions for Use
A. Does not bear required directions for use.
1. Could result in misuse, illegal residues, or
lesser effectiveness
Charges - E4 or E204
Format - see Exhibit 19
11-5
-------
2. No adverse effects anticipated.
Format - see Exhibit 20
B. Directions for use differ in substance from those
accepted in connection with the registration of
the product.
1. Major
Charges - E17 or E218
Format - see Exhibit 21
2. Minor
Format - see Exhibit 22
Claims
A. Bears claims that have not been accepted in
connection with the product's registration.
1. Those claims which would not be acceptable
for the product by the Registration Division.
a. Could be hazardous.
Charges - E4 or E204 and E17 or E217
Format - see Exhibit 23
b. No hazard would be expected.
Charges - E17 or E217
Format - see Exhibit 24
c. Unwarranted claims regarding the product's
ingredients, ex: Contains NO DDT.
Format - see Exhibit 25
11-6
-------
2. Those claims which would be accepted by the
Registration Division if submitted.
Charges - E17 or E217
Format - see Exhibit 26
B. Bears claims which have been accepted by the
Registration Division, but were reworded by the
registrant in such a way that they may mislead the
customer.
Pormat - see Exhibit 27
Ingredient Statement
A. Ingredient statement as declared on the sample
product's label differs from that which was
accepted in connection with the product's
registration.
Charges - E18 or E219
Format - see Exhibit 28
B. Totally lacks any ingredient statement
Charges - E5 or E207
Format - see Exhibit 29
C. Present, but not in prescribed format.
Charges - when other citation charges are drawn
E5 or E207
Format - see Exhibit 30
D. Not on the front panel when required
Charges - when other citation charges are drawn
E6 or E208
Format - see Exhibit 31
11-7
-------
E. The term "inert ingredients" is less prominent than
the term "active ingredient"
Charges - when other citation charges are drawn
E7 or E209
Format - see Exhibit 32
F. Misspelling or typographical error.
Format - see Exhibit 33
6. Other label omissions.
A. Product or establishment registration numbers.
Charges - when other citation charges are drawn
E9 or E213
Format - see Exhibit 34
B. Statement of net weight
Charges - when other citation charges are drawn
E10 or E214
Format - see Exhibit 35
C. Name and address of manufacturer
Charges - when other citation charges are drawn
Ell or E220
Format - see Exhibit 36
D. Brand name of product
Charges - when other citation charges are drawn
E12 or E221
Format - see Exhibit 37
11-8
-------
C. Analytical Test
When a violation is based on a chemical analysis of the
product, two items must be considered:
[1] The contamination or deficiency must be reported
for each unit of the product which was sampled.
The unit should not be confused with a subsample.
A unit is considered to be a sample from one
container regardless of the number of the
subsamples involved. Therefore, each product
container is equivalent to one unit. If two subsamples
are taken from one drum, the sample consisted of one
unit. If two subsamples are taken from two drums
of the product, the sample consists of two units.
[2] The batch code of each unit which is analyzed must
be reported in conjunction with the respective
analytical result. When the product is not coded,
this fact should also be stated.
1. Deficiency
When a product is found to be deficient in an ingredient,
the highest percent of that ingredient found in each unit
jnust be determined. These percentages are then reported
in conjunction with their respective batch codes. Depending
on the method of analysis and the type of ingredient
statement on the product's label, one of the following
formats for reporting a chemical deficiency may be used:
11-9
-------
A. When the percentages of each active ingredient are
declared on the product's label and the analysis
specifically determines the amount of the ingredient
found in the product.
Charges - E8 or E210 and E19 or E211
Format - See Exhibit 38
B. When the percentages of each active ingredient are
declared on the product's label, but the analysis is
based on one common chemical which is found in two
or more of the ingredients.
Charges - E8 or E210 and E19 or E211
Format - see Exhibit 39
C. When the percentages of each active ingredient are
not declared on the product's label.
Charges - E21 and E18 or E219
Format - see Exhibit 40
D. When the product would not be fully effective because
of a chemical deficiancy
Charges - E8 or E210 and E19 or E211
Format - see Exhibit 41
Contamination
When the product contains an additional ingredient which
has not been declared on the product's label, the lowest
percent of that ingredient found in each unit must be
11-10
-------
determined. These percentages are then reported in
conjunction with their respective batch codes.
A. When contamination could be hazardous
Charge - E8 or E210 and E20 or E212 and E4 or E204
Format - see Exhibit 42
B. Contamination not likely to be hazardous
Charge - E8 or E210 and E20 or E212
Format - see Exhibit 43
3. Overformulation
When the product contains an overformulation in any
ingredient, the lowest percent of this ingredient found
in each unit must be determined. These percentages
are then reported in conjunction with their respective
batch codes. When interpreting the analytical report
and the reviewer's comments, do not confuse the terms
"overage" and "average."
A. Hazardous
Charge - E4 or E204 and E8 or E210
Format - see Exhibit 44
B. Not hazardous
Format - see Exhibit 44
D. Efficacy Tests
When the violation is based on ineffectiveness, the charge
E8 or E210 is drawn. Only the false or misleading statements
regarding the product's effectiveness are quoted.
11-11
-------
Disinfectant
Report only those test results on each organism where the
product failed the test. Total the results of all units
of each batch code. Do not report tests that the product
passes.
Format - see Exhibit 45 (Staphylococcus aureus,
Salmonella choleraesuis, and
Trichophyton interdigitale)
- see Exhibit 46 (Pseudomonas aeruginosa)
Rodenticides
A. Single Dose
Format see Exhibit 47
B. Multiple Dose
1. Cereal or water baits - Both results, acceptance
and mortality, are always reported even though
the product is below the minimum standard in
only one of these criteria. When reporting
the test results, the number of test animals
and the time span of the test can vary. The
test results should be checked in order to
report these figures correctly.
Format - see Exhibit 48
2. Paraffin Block
Format - see Exhibit 49
11-12
-------
I.D. No. 101611 - BREATH OF PINE ALL PURPOSE CLEANER
Brondow, Inc.
Mt. Vernon, New York
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
ECONOMIC POISON WAS:
In that the product was not registered under Section 4 of the
act. [7 U.S.C. 135a(a)(l), 135b]
(The product is an economic poison within the meaning of the
Federal Insecticide, Fungicide, and Rodenticide Act, a marked
copy of which is enclosed. Please refer to Sec. 2a, 2d, and
2n of the act, and Paragraphs 362.2(c) and 362.2(d) of the
regulations. Claims such as "***DISINFECTS***" are economic
poison claims and bring the product within the purview of the
act.
Interstate shipments of this product without benefit of
registration are in violation of the act. We are enclosing
PR Form 9-199 for use in application for registration of the
product.)
EXHIBIT 1
11-13
-------
I.D. No. 103264 - SCHERING 224 HERBICIDE
Sobering Corporation
Bloomfield, New Jersey
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
ECONOMIC POISON WAS:
In that the product was not registered under Section 4 of
the act. [7 U.S.C. 135a(a)(l), 135b]
(An application for registration of the product was sub-
mitted October 14, 1972, and assigned file symbol 3204-RO.
However, registration has not been issued. The assigning
of a file symbol does not constitute registration.
Interstate shipments of this product without benefit of
registration are in violation of the act.)
Exhibit 2
11-14
-------
I.D. No. 101880 - SCHERING 601 INSECTICIDE
Schering Corporation
Bloomfield, New Jersey
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
ECONOMIC POISON WAS:
1. In that the product was not registered under Section 4
of the act. [7 USC 135a(a)(l), 135b]
2. Misbranded in that the label stated in part:
I I 'A' * A
SCHERING
601
INSECTICIDE
A A *
EPA Reg. No. 3204-EI
whereas the product was not registered under registration
number 3204-EI. [12 (a) (1) (E) , 86 Stat. 990; 2(q)(l)(A),
86 Stat. 977]
(An application for registration of the product was sub-
mitted August 18, 1972, and assigned file symbol 3204-EI.
However, registration has not been issued. The assigning
of a file symbol does not constitute registration.
Interstate shipments of this product without benefit of
registration are in violation of the act.)
Exhibit 3
11-15
-------
I.D. No. 9782 - PARSONS 3 -WAY DUST
Parsons Chemical Works, Inc.
Grand Ledge, Michigan
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
ECONOMIC POISON WAS:
1. In that the product was not registered under Section 4
of the act. [7 U.S.C. 135a(a)(l), 135b]
2. Misbranded in that the label stated in part:
"ft ft ft
PARSONS
3 - WAY
DUST
ft A ft
ACTIVE INGREDIENTS
Sulfur ........................................ 20.001
Cap tan* ....................................... 1.181
*N-trichloromethyl-mercapto-4-
cyclohexene-1 ,1-dicarboxmide
Rotenone ...................................... 1.00%
INERT INGREDIENTS ............................... 77.78%
ft ft ft
USDA REG. NO. 1969-86
whereas the product with this formulation is not registered
under registration number 1969-86. [12 (a) (1) (E) , 86 Stat .
990; 2(q)(l)(A), 86 Stat. 977]
(The formulation of the product accepted under Reg. No. 1969-
86 was declared as: ACTIVE INGREDIENTS Sulfur 8.00%, Copper
oxide 6.70%, Rotenone 1.00%. Other Derris Resins 0.04% and
INERT INGREDIENTS 84.26%. Since the formulation of the
product in question differs significantly from the formulation
of the product accepted under Reg. No. 1969-86, the product
in question would be considered a different product and as
such require separate registration. Please refer to PR
Notice 70-20, enclosed.
Interstate shipments of this product \vithout benefit of
registration are in violation of the act. We are enclosing
PR Form 9-199 for use in application for registration of the
product.)
Exhibit 4
11-16
-------
ID No. 102203
The Sta-Dri Company
1572 Annapolis Road
Odenton, Maryland 21113
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal Environ-
mental Pesticide Control Act of 1972), there is under consideration
a sample of STA-DRI MASONRY PAINT, which was obtained from a ship-
ment made from Odenton, Maryland, to Builders Supply Company,
Jonesboro, West Virginia on or about November 17, 1972.
This shipment did not comply with the provisions of the act
in that the product was not registered under Section 4 of the act.
The product bore the economic poison claim "INHIBITS MOLD AND
MILDEW." Not withstanding previous actions and determinations
regarding this matter, it is the position of the Registration
Division that this product as represented by the sample label is
subject to the act. Continued interstate shipments of this
unregistered product would be in violation of the act. We are
enclosing PR Form 9-199 for use in applying for registration if
you so desire.
In order to remove the product from the purview of the act,
the claim inhibits mold and mildew must be deleted from all labeling
and advertising literature or revised somewhat as follows: "Sta-
Dri Masonry Paint eliminates a source of moisture which encourages
the growth of mold and mildew that discolors and stains most surfaces
If you intend to take this course of action, a copy of the revised
label should be submitted for our review.
Please inform us of the action you will take in this matter.
Sincerely yours,
A. E. Conroy II
Director
Enclosure
Exhibit 5
11-17
-------
I.D. No. 101663 - METHOXYCHLOR 280
Baird § McGuire, Inc.
Holbrook, Massachusetts
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
ECONOMIC POISON WAS:
1. In that the product was not registered under Section 4
of the act. [7 U.S.C. 135a(a)(l), 135b]
2. Misbranded in that the label stated in part:
METHOXYCHLOR 280
ft ft ft
USDA Reg. No. 551-62
* ft ft i '
whereas the product was not registered under registration
number 551-62. [ 12 (a) (1) (E) , 86 Stat. 990; 2 (q) (1) (A) , 86
Stat. 977]
(Registration for the product under registration number
551-62 was cancelled effective June 3, 1972, as a request
for renewal of registration was not received by the Registration
Division pursuant to their letter of May 3, 1972.
Interstate shipments of this product without benefit of
registration are in violation of the act. We are en-
closing PR Form 9-199 for use in application for registration
of the product.)
Exhibit 6
11-18
-------
I.D. No. 89496 - CHIPCO PMA 10 LIQUID TURF FUNGICIDE
SHIPPER: Rhodia, Inc.
Chipman Division
New Brunswick, New Jersey
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
ECONOMIC POISON WAS:
1. In that the product was not registered under Section 4
of the act. [7 U.S.C. 135a(a)(l), 135b]
2. Misbranded in that the label stated in part:
it & A *
CHIPCO PMA 10
LIQUID TURF FUNGICIDE
USDA Reg.
No. 2079-32
whereas the product was not registered under registration
number 2079-32. [12 (a) (1) (E) , 86 Stat . 990; 2(q)(l)(A),
86 Stat. 977]
(Registration for the product under 2079-32 was cancelled
effective May 12, 1972, pursuant to PR Notice 72-5, a copy
of which is enclosed. Interstate shipments of this product
without benefit of registration are in violation of the
act .)
Exhibit 7
11-19
-------
I.D No. 99078 - ATM 2,4,5-T LAWN AND GARDEN HERBICIDE
ATM Company, Inc.
Lumbar, Montana
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
ECONOMIC POISON WAS:
1. In that the product was not registered under Section 4 of
the Act. [7 U.S.C. 13Sa(a)(l), 135b]
2. Misbranded in that the labeling accompanying the product
did not contain directions for use which are necessary and,
if complied with, adequate to protect health and the environ-
ment. [12(a)(1)(E), 86 Stat. 990; 2(q)(l)(F), 86 Stat. 977]
3. Misbranded in that the label stated in part:
ii A A A
ATM
2,4,5-T LAWN AND
GARDEN
HERBICIDE
A A *
REG. NO. 2234-78
A A A it
whereas the product was not registered under Reg. No. 2234-78
[12(a)(1)(E) , 86 Stat. 990; 2(q)(l)(A), 86 Stat. 977]
(The registration of this product was cancelled effective
May 1, 1970, pursuant to PR Notice 70-13, enclosed. This
product was subject to PR Notice 70-13, which cancelled
registrations of all granular 2,4,5-T formulations bearing
directions for use around the home.
Interstate shipments of this product without benefit of
registration are in violation of the Act.)
Exhibit 8
11-20
-------
I.D. No. 98675 - H.J.S. RAT KILLER
SHIPPER H.J.S Company
Elm, Nevada
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE ECONOMIC
POISON WAS:
1. In that the product was not registered under Section 4 of
the Act. [7 U.S.C. 135a(a)(l), 135b]
2. Misbranded in that the label stated in part:
11 A A A
H.J.S. Rat-Killer
A A A
EPA REG NO 897-42
TO KILL RATS: Place baits where rats have been seen. (Baits
may be mixed with foods for which rats have shown a preference.)
Repeat until all rodent signs disappear.
A A A »
whereas the product was not registered under Reg. No. 897-42,
and when used as directed would not be effective in killing rats.
[12(A)(1)(E) , 86 Stat. 990; 2(G)(1)(A), 86 Stat. 997]
(Registration for this product was cancelled effective June 6, 1971,
after repeated demonstrations of ineffectiveness.
During a fifteen day feeding study involving 20 albino rats, the
test animals consumed by choice only 2\ of the bait in their
total diet resulting in only a 5% mortality. An acceptance of 331
and a mortality of 901 are considered necessary for the product
to be effective in the commensal rodents environment.
Interstate shipments of this product without benefit of registration
are in violation of the Act.)
Exhibit 9
11-21
-------
I.D. No. 95867 - PQR MARINE ANTI-FOULING PAINT
SHIPPER: PQR Company
New York, New York
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
ECONOMIC POISON WAS:
1. In that the product was not registered under Section 4 of
the Act. [7 U.S.C. 135a(a)(l), 135b]
2. Misbranded in that the labeling accompanying the product
did not contain directions for use which are necessary
and, if complied with, adequate to protect health and the
environment. [12(a)(1)(E), 86 Stat. 990; 2(q)(l)(F), 86
Stat. 977]
(Registration of products containing mercury for use as
anti-fouling paints were suspended and cancelled effective
March 22, 1972, pursuant to PR Notice 72-5, copy enclosed.
Interstate shipments of this product without benefit of
registration are in violation of the Act.)
Exhibit 10
-------
April 17, 1973
Conskill Poisons
1911 Elm Street
Slagg, New Jersey 54321
Gentlemen:
Subject: I.D. No. 66876 - DEWITT INSECT BOMB
In connection with the enforcement of the Federal Insecti-
cide, Fungicide, and Rodenticide Act, there is under consideration
a sample of DEWITT INSECT BOMB, which was obtained from a ship-
ment made from Slagg, New Jersey, to Dewitt Products, Inc.,
Columbis, Missouri, on or about August 9. 1972.
This shipment did not comply with the provisions of the Act
in that the product was not supplementally registered for the
distributor, Dewitt Products, Inc. The marketing of this pro-
duct without benefit of supplemental registration for the
distributor is in violation of the Act. An application for
supplemental registration, PR form 9-1, is enclosed.
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is in
full compliance with the provisions of the Act. Any additional
information that you wish to submit will be included in the file
regarding this matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 11
11-23
-------
ID No. 83144 - ABC 10% CHLORDANE DUST
SHIPPER: ABC Company
San Antonio, Texas
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
Misbranded in that the label did not bear a warning or caution
statement which is necessary and, if complied with, adequate to
protect health and the environment. [12(a) (1) (E), 86 Stat.
990; 2(q) (1) (G), 86 Stat. 977]
(The label of the product did not bear the caution statement
"Keep children and pets off treated areas until the insecticide
has been washed into the soil and treated areas have dried com-
pletely." This caution did appear on the label accepted April 21,
1966, in connection with registration of the product under
registration number 623-12.)
Exhibit 12
11-24
-------
I.D. No. 96660 - ABC BRAND 2LB. EPN EC
SHIPPER: ABC Company
San Antonio, Texas
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
Misbrande'd in that the product contains a substance in quanti-
ties highly toxic to man and the label fails to bear required
symbols or statements. [12(a) (1)(E) , 86 Stat. 990; 2(q)(D),
86 Stat. 978]
(The label of the product failed to bear on the front panel
the word "Poison" in red, the skull and crossbones, and the
statement "See antidote and other warnings on side panel."
These items were on the label accepted April 9, 1979, in
connection \vith the registration of the product under the
registration number 623-23.)
Exhibit 13
11-25
-------
Pesticides Enforcement Divisions
ID No. 103394
ABC Company
1313 Main Street
San Antonio, Texas 78209
Gentlemen:
In connection with the enforcement of the Federal
Insecticide, Fungicide, and Rodenticide Act, (as amended
by the Federal Environmental Pesticide Control Act of 1972) ,
there is under consideration a sample of ABC SURFACE
DISINFECTANT which was obtained from a shipment made from
San Antonio, Texas, to XYZ Supply Company, Nashville,
Tennessee, on or about January 3, 1973.
This shipment did not comply with the provisions of the
act in that the label of the product failed to bear the
required precaution, "Causes eye irritation." The label
accepted October 19, 1971, in connection with registration
of the product under registration number 632-420 did bear
this statement.
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is
in full compliance with the provisions of the act. Any
additional information that you wish to submit will be
included in the file regarding this matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 14
11-26
-------
Pesticides Enforcement Division
I.D. No. 90604
ABC Company
1313 Main Street
San Antonio, Texas 78209
Gentlemen:
In connection with the enforcement of the Federal
Insecticide, Fungicide, and Rodenticide Act, (as amended
by the Federal Environmental Pesticide Control Act of 1972) ,
there is under consideration a sample of ABC MALATHION GARDEN
SPRAY which was obtained from a shipment made from San Antonio
Texas, to XYZ Supply Company, Nashville, Tennessee, on or
about January 12, 1973.
This shipment did not comply with the provisions of the
act in that the label of the product bore the words "DANGER"
and "POISON", and the skull and crossbones. These did not
appear on the label accepted September 10, 1968, in connection
with registration of the product under registration number
442-23. The category of toxicity of this product requires
only the signal word "Caution" in conjunction with the state-
ment "Keep out of reach of children" on the front panel.
You should assure yourself that all necessary corrections
are made and that any further marketing o.f this product is
in full compliance with the provisions of the act. Any
additional information that you wish to submit will be
included in the file regarding this matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 15
11-27
-------
Pesticides Enforcement Division
I.D. No. 103395
ABC Company
1313 Main Street
San Antonio, Texas 78209
Gentlemen:
In connection with the enforcement of the Federal
Insecticide, Fungicide, and Rodenticide Act, (as amended
by the Federal Environmental Pesticide Control Act of
1972), there is under consideration a sample of ABC MALA-
THION GARDEN SPRAY which was obtained from a shipment
made from San Antonio, Texas, to XYZ Supply Company, Nashville
Tennessee, on or about February 6, 1973.
This shipment did not comply with the provisions of
the Act in that the precautionary statement, "Caution:
Keep out of reach of children", on the front panel of the
label of the product was not sufficiently prominent as
to render it likely to be read under customary conditions
of purchase. This statement immediately followed the list
of product uses and was in the same type size. Please
refer to the enclosed notice of September 1, 1966, regarding
the correct type size.
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is
in full compliance with the provisions of the act. Any
additional information that you wish to submit will be
included in the file regarding this matter.
Sincerely yours,
A. E. Conroy 11
Director
Exhibit 16
11-28
-------
I.D. No. 103396 - ABC DISINFECTANT 100% HCL
SHIPPER: ABC Company
San Antonio, Texas
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
Misbranded in that the labeling bore a statement as to the
safety of the product which is false or misleading. [12(a)
(1)(E), 86 Stat. 990; 2(q)(l)(A), 86 Stat. 977]
(The label of the product bore the claim, "Safe to Hands."
This is an unwarranted claim as to the safety of the product
and this claim did not appear on the label accepted July 10,
1971, in connection with registration of the product under
registration number 5-5. This claim is inconsistent with
the direction, "Wear Gloves", and the precaution, "Avoid
Contact With Skin" .)
Exhibit 17
11-29
-------
I.D. No. 90607
ABC Company
1313 Main Street
San Antonio, Texas 78209
Gentlemen:
In connection with the enforcement of the Federal Insecti-
cide, Fungicide, and Rodenticide Act, (as amended by the Federal
Environmental Pesticide Control Act of 1972), there is under
consideration a sample of ABC SANITIZING CLEANER which was
obtained from a shipment made from San Antonio, Texas, to XYZ
Supply Company, Nashville, Tennessee, on or about February
20, 1973.
This shipment did not comply with the provisions of the
Act in that the label of the product bore the unwarranted
safety claim, "Non-irritating if used according to label
directions." This claim was not on the label accepted August
8, 1971, in connection with registration of the product under
registration number 5-5.
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is in
full compliance with the provisions of the act. Any additional
information that you wish to submit will be included in the
file regarding this matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 18
11-30
-------
I.D. No. 69634
SANA CAGE WASH
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
Misbranded in that the labeling accompanying the product
did not contain directions for use which are necessary and,
if complied with, adequate to protect health and the en-
vironment. [12(a) (1) (E) , 86 Stat. 990; 2(q)(l)(G), 86 Stat.
977]
(The product's label failed to bear directions indicating the
areas to be treated and the proper use dilutions. These
directions were borne on the label accepted on April 4, 1972,
in connection with the product's registration under Reg. No.
55-5.)
Exhibit 19
11-31
-------
I.D. No. 5000
Pesticide Chemical Company
1600 Pennsylvania Avenue
New York, New York
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, as amended by the Federal
Environmental Pesticide Control Act of 1972, there is under
consideration a sample of PESTO INSECTICIDE SPRAY, which was
obtained from a shipment made from New York, New York, to
Ace Hardware Store, Catalina, California, on or about February
14, 1973.
This shipment did not comply with the provisions of the Act
in that the product's label failed to bear the required directions
for use, "xxx spray the area continuously for 90 seconds."
These directions were borne on the label accepted on April 4,
1972, in connection with the product's registration under
Reg. No. 5-5.
You should assure yourself that all necessary corrections are
made and that any further marketing of this product is in full
compliance with the provisions of the act. Any additional
information that you wish to submit will be included in the
file regarding this matter.
Sincerely yours ,
A. E. Conroy II
Director
Exhibit 20
11-32
-------
I .D No. 96058
Blue Cross Chlor Granules
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
In violation in that the claims for the product differed in
substance from the representations made in connection with
its registration. [7 U.S.C. 135a(a)(l)]
[The sample product's label bore the directions, "For proper
pool water sanitation maintain a chlorine residual of 0.6
to 1.0 parts per million (PPM)". However, the label accepted
in connection with the product's registration on February 26,
1971, under Reg. No. 6991-1 bore the following directions for
use, "Maintain a chlorine residual of 1.6 to 2.0 parts per
million (PPM) and a 7.2 - 7.6 pH range".)
Exhibit 21
11-33
-------
I.D No. 96058
Blue Cross Chlor Granules
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
In violation in that the claims for the product differed in
substance from the representations made in connection with
its registration. [7 U.S.C. 13Sa(a)(l)]
(The sample product's label bore the directions, "For proper
pool water sanitation maintain a chlorine residual of 0.6
to 1.0 parts per million (PPM)". However, the label accepted
in connection with the product's registration on February 26,
1971, under Reg. No. 6991-1 bore the following directions for
use, "Maintain a chlorine residual of 1.6 to 2.0 parts per
million (PPM) and a 7.2 - 7.6 pH range".)
Exhibit 21
11-33
-------
I.D. No. 4000
Pesticide Chemical Company
1600 Pennsylvania Avenue
New York, New York
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, (as amended by the Federal
Environmental Pesticide Control Act of 1972) , there is under
consideration a sample of PRESTO SHARK REPELLANT, which was
obtained from a shipment made from New York, New York, to
Marineland Supplies, Naggshead, North Carolina on or about
July 4, 1972.
This shipment did not comply with the provisions of the Act
in that the product's label bore directions for use of the
product in swimming pools. These directions were not accepted
in connection with the product's registration on April 1,
1971, under EPA Reg. No. 99-2.
You should assure yourself that all necessary corrections are
made and that any further marketing of this product is in
full compliance with the provisions of the Act. Any additional
information that you wish to submit will be included in the
file regarding this matter.
Exhibit 22
11-34
-------
I.D. No. 1000
CHLORDANE IOWP
Pesticide Chemical Company
New York, New York
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
1. Misbranded in that the labeling accompanying the product
did not contain directions for use which are necessary
and, if complied with, adequate to protect health and the
environment. [12(a)(1)(E) , 86 Stat. 990, 2(q)(1)(F),
86 Stat. 977]
2. In violation in that the claims made for the product
differed in substance from the representations made in
connection with its registration. [7 U.S.C. 135a(a)(l)]
(The sample product's label bore claims for use of the product
on sugarcane and buckwheat. However, these claims were not
on the label accepted in connection with the product's regis-
tration on June 18, 1972, under EPA Reg. No. 260-1. In
addition, use of the product on sugarcane and buckwheat would
likely result in illegal residues in or on these harvested
crops. These uses were prohibited pursuant PR Notice 71-3
enclosed .)
Exhibit 23
11-35
-------
I.D. No. 2000 PEDIGREE FLEA COLLAR FOR DOGS
Pesticide Chemical Company
New York, New York
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
In violation in that the claims made for the product differed
in substance from the representations made in connection
with its registration (7 U.S.C. 135(a)(l))
(The sample product's label bore the claim "KILLSxxxTICKS"
which was not accepted in connection ivith the product's
registration on April 5, 1972, under EPA Reg. No. 5988-1.)
Exhibit 24
11-36
-------
I.D. No. 3000
Pesticide Chemical Company
1000 Pennsylvania Avenue
New York, New York
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (as amended by the Federal
Environmental Pesticide Act of 1972), there is under consideration
a sample of PESTO MOSQUITO REPELLANT SPRAY, which was obtained
from a shipment made from New York, New York, to Pesticide
Retail Company, Dallas, Texas, on or about January 1, 1973.
This shipment did not comply with the provisions of the Act in
that the product's label bore the claim "Contains No DDT"
which was not accepted in connection with the product's
registration on December 2, 1972, under EPA Reg. No. 999-1.
This is an unwarranted claim concerning the product's safety.
You should assure yourself that all necessary corrections are
made and that any further marketing of this product is in full
compliance with the provisions of the Act. Any additional
information that you wic.h to submit will be included in the
file regarding this matter.
Sincerely yours ,
A. E. Conroy II
Director
Exhibit 25
11-37
-------
I.D. No. 87023 - HOPKINS FRUIT TREE SPRAY
Jo Blow Company
Zilch, New Mexico
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
In violation in that the claims made for the product differed
in substance from the representations made in connection
with its registration. [7 U.S.C. 135a(a)(l)]
(The labeling on the product bore claims for use of the
product against "aphid", "bud moth", "leaf roller" and
"apple maggot" xvhich were not accepted in connection with
the registration of the product, May 5, 1968, under EPA
Reg. No. 2393-170.)
Exhibit 26
11-38
-------
Pesticides Enforcement Division
April 13, 1973
I.D. No. 88001
Mysan Corporation
919 West 38th Street
Chicago, Illinois 60609
Gentlemen:
In connection with enforcement of the Federal Insecti-
cide, Fungicide, and Rodenticide Act, as amended, there is
under consideration a sample of OXFORD SPRAY AND WIPE SPOT
CLEANER, which was obtained from a shipment made from Oxford
Chemicals, Atlanta, Georgia, to Leeds Hospital, Leeds, Alabama,
on or about May 31, 1972.
This shipment did not comply with the provisions of the
act in that the product's label bore the statement, "Use this
unique no rinsing cleaner for cleaning and sanitizing Counter
Tops, Table Tops, and other surfaces where food is served and
processed. However, the label accepted in connection with
the product's registration on March 6, 1972 limited the "NO
RINSE" claim to non-food contact surfaces. This request was
made in letters from Registration Division to your firm on
May 6, 1971, and March 9, 1972. Further interstate shipments
of this product bearing the improper label will be in vio-
lation of the act.
You should assure yourself that all necessary corrections
are made and that future shipments of this product are in full
compliance with the provisions of the act. Any additional in-
formation that you wish to submit will be included in the file
regarding this matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 27
11-39
-------
I.D. No. 37023 - HOPKINS FRUIT TREE SPRAY
Date of Shipment:June 8, 1972
Shipper: Cole Chemical Supply
Division Hopkins Agricultural
Madison, Wisconsin
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
In violation in that the composition of the product differed
from the composition as represented in connection with its
registration. [7 U.S.C. 135a(a)(l)]
(The ingredient statement on the labeling of the product
represented the product to contain 10% captan, 101 malathion
and 10% technical methoxychlor as the active ingredients,
and 70% inert ingredient; whereas the formulation accepted
in connection with registration of the product, May 5, 1968,
under USDA Reg. No. 2393-170 was represented as containing
10% captan, 5% malathion, 5% technical methoxychlor as the
active ingredients, and 80% inert ingredients.)*
*NOTE
If the discrepancy in the labeled ingredient statement cannot
be clearly explained by paraphrase, the labeled ingredient
statement may be quoted.
Exhibit 28
11-40
-------
I.D. No. 1000 - HELP'S DISINFECTANT
ABC Company
Anywhere, U.S.A.
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
Misbranded in that the label borne by the product did not
bear an ingredient statement giving the name and percentage
of each of the active ingredients, together with the total
percentage of the inert ingredients, or an ingredient state-
ment giving the names of each of the active and each of the
inert ingredients in the descending order of the percentage
of each present in each classification, together with the
total percentage of the inert ingredients. [12(a)(1)(E),
86 Stat. 990; 2(q)(2)(A), 86 Stat. 977; 7 U.S.C. 135(0)]
Exhibit 29
11-41
-------
Pesticides Enforcement Division
I.D. No. 100158
August 16, 1972
Vestal Laboratories
Division of Chemed Corporation
4963 Manchester Avenue
Saint Louis, Missouri 63110
Gentlemen:
In connection with the enforcement of the Federal Insecticide;
Fungicide, and Rodenticide Act, there is under consideration
a sample of VESTAL LPH GERMICIDAL DETERGENT 1 STROKE SYSTEM,
which was obtained from a shipment made from Saint Louis,
Missouri, to Veterans Administration Hospital, Muskogee,
Oklahoma, on or about January 6, 1972.
This shipment did not comply with the provisions of the act
in that the ingredient statement failed to separate the inert
ingredients from the active ingredients. The label
accepted in connection with the product's registration under
registration number 5-3 bore the ingredient statement in the
proper format.*
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is
in full compliance with the provisions of the act. Any
additional information that you wish to submit will be
included in the file regarding this matter.
Sincerely,
A. E. Conroy II
Director
*NOTE
Thistype of narrative may be used in notices of contemplated
proceedings.
Exhibit 30
11-42
-------
Pesticides Enforcement Division
I.D. No. 00000
XYZ Pesticides Company, Inc.
00000 Zero Street
Maryland, Ohio 00000
Gentlemen:
In connection with the enforcement of the Federal Insecti-
cide, Fungicide, and Rodenticide Act, as amended, there is
under consideration a sample of KILL A BUG TODAY, which was
obtained from a shipment made from Maryland, Ohio, to Kill A
Bug Company, Saint Charles, New York, on or about January 1,
1980.
This shipment did not comply with the provisions of the
Act in that the product's label bore the ingredient statement
on the back panel. The label accepted in connection with the
product's registration on January 15, 1978, under registration
number 682-817, bore the ingredient statement on the front
panel.*
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is in
full compliance with the provisions of the act. Any additional
information that you wish to submit will be included in the
file regarding this matter.
Sincerely yours,
Mr. John Doe
Director
'"NOTE
This type of narrative may be used in notices of contemplated
proceedings.
Exhibit 31
11-43
-------
Pesticides Enforcement Division
I.D. No. 00000
XYZ Pesticides Company, Inc.
00000 Zero Street
Maryland, Ohio 00000
Gentlemen:
In connection with the enforcement of the Federal Insecti-
cide, Fungicide, and Rodenticide Act, as amended, there is
under consideration a sample of KILL A BUG TODAY, which was
obtained from a shipment made from Maryland, Ohio, to Kill A
Bug Company, Saint Charles, New York, on or about January 1,
1980.
This shipment did not comply with the provisions of the
Act in that the term, "inert ingredients" was in smaller sized
type and was less prominent than the term "active ingredients".
These terms were given equal prominence in the ingredient
statement on the label accepted in connection with the product's
registration on May 12, 1978, under registration number 820-12.*
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is in
full compliance with the provisions of the Act. Any additional
information that you wish to submit will be included in the
file regarding this matter.
Sincerely yours,
Mr. John Doe
Director
*NOTE
This type of narrative may be used in notices of contemplated
proceedings.
Exhibit 32
11-44
-------
Pesticides Enforcement Division
I.D. No. 00000
XYZ Pesticides Company, Inc.
00000 Zero Street
Maryland, Ohio 00000
Gentlemen:
In connection with the enforcement of the Federal In-
secticide, Fungicide, and Rodenticide Act, as amended there
is under consideration a sample of KILL A BUG TODAY, which
was obtained from a shipment made from Maryland, Ohio, to
Kill A Bug Company, Saint Charles, New YOrk, on or about
January 1, 1980.
This shipment did not comply with the provisions of
the Act in that the ingredient statement, appearing on the
product's label, bore the statement, "Seven 50.0%.
However, the proper spelling of this chemical name is Sevin.*
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is
in full compliance with the provisions of the act. Any
additional information that you wish to submit will be in-
cluded in the file regarding this matter.
Sincerely yours ,
Mr. John Doe
Director
*NOTE
This type of narrative may be used in notices of contemplated
proceedings, although there is no related charge.
Exhibit 33
11-45
-------
Pesticides Enforcement Division
I.D. No. 00000
XYZ Pesticides Company, Inc.
00000 Zero Street
Maryland, Ohio 00000
Gentlemen:
In connection with the enforcement of the Federal In-
secticide, Fungicide, and Rodenticide Act, as amended there
is under consideration a sample of KILL A BUG TODAY, which
was obtained from a shipment made from Maryland, Ohio, to
Kill A Bug Company, Saint Charles, New York, on or about
January 1, 1980.
This shipment did not comply with the provisions of
the Act in that the label failed to bear the product's
registration number. The product is registered under
registration number 1234-56.*
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is
in full compliance with the provisions of the act. Any
additional inforamtion that you wish to submit will be in-
cluded in the file regarding this matter.
Sincerely yours,
Mr. John Doe
Director
'"NOTE
This type of narrative may be used in notices of contemplated
proceedings.
Exhibit 34
11-46
-------
Pesticides Enforcement Division
I.D. No. 00000
XYZ Pesticides Company, Inc.
00000 Zero Street
Maryland, Ohio 00000
Gentlemen:
In connection with the enforcement of the Federal In-
secticide, Fungicide, and Rodenticide Act, as amended, there
is under consideration a sample of KILL A BUG TODAY, which
was obtained from a shipment made from Maryland, Ohio, to
Kill A Bug Company, Saint Charles, New York, on or about
January 1, 1980.
This shipment did not comply with the provisions of the
Act in that the product's label failed to bear a statement
of net weight or measure of content. The product was in-
voiced as containing five gallons.*
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is
in full compliance with the provisions of the act. Any
additional information that you wish to submit will be in-
cluded in the file regarding this matter.
Sincerely yours,
Mr. John Doe
Director
*NOTE
This type of narrative may be used in notices of contemplated
proceedings.
Exhibit 35
11-47
-------
Pesticides Enforcement Division
I.D. No. 00000
XYZ Pesticides Company, Inc.
00000 Zero Street
Maryland, Ohio 00000
Gentlemen:
In connection with the enforcement of the Federal In-
secticide, Fungicide, and Rodenticide Act, as amended, there
is under consideration a sample of KILL A BUG TODAY, which
was obtained from a shipment made from Maryland, Ohio, to
Kill A Bug Company, Saint Charles, New York, on or about
January 1, 1980.
This shipment did not comply with the provisions of the
Act in that the product's label failed to bear the name and
address of the manufacturer, registrant, or person for whom
manufactured. The address of your firm was on the label
accepted in connection with the product's registration on
April 15, 1976, under registration number 830-16.*
You should assure yourself that all necessary corrections
are made and that further marketing of this product is in
full compliance with the provisions of the act. Any additional
information that you wish to submit will be included in the
file regarding this matter.
Sincerely yours,
Mr. John Doe
Director
This type of narrative may be used in notices of contemplated
proceedings.
Exhibit 36
11-48
-------
Pesticides Enforcement Division
I.D. No. 00000
XYZ Pesticides Company, Inc.
00000 Zero Street
Maryland, Ohio 00000
Gentlemen:
In connection with the enforcement of the Federal In-
secticide, Fungicide, and Rodenticide Act, there is under
consideration a sample of a product invoiced as BUG KILLER,
which was obtained from a shipment made from Maryland, Ohio,
to Kill A Bug Company, Saint Charles, New York on or about
January 1, 1900.
This shipment did not comply with the provisions of
the Act in that the product's label failed to bear the name,
brand or trade-mark under which the product is sold. The
label accepted in connection with the product's registration
on May 5, 1977, under the registration 386-10, bore the
brand name KILL A BUG TODAY.*
You should assure yourself that all necessary corrections
are made and that any further marketing of this product is
in full compliance with the provisions of the act. Any
additional information that you wish to submit will be in-
cluded in the file regarding this matter.
Sincerely yours,
Mr. John Doe
Director
*NOTE
This type of narrative may be used in notices of contemplated
proceedings.
-------
I.D. No. 88048 - PEARSON'S 1.5% ROTENONE POWDER
Pearson Chemicals, Inc.
Willowtree, South Carolina
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
1. Misbranded in that the label stated in part:
ii ft ft ft
PEARSON'S 1.5% ROTENONE
POWDER
Active Ingredients:
Rotenone .................. 1.501
Other Cube Resins ......... 3.00%
Inert Ingredients ........... 95.50%
Total Ingredients ....... 100.00%
ivhereas the product contained less than 1.501 rotenone.
[12(a) (1) (E) , 86 Stat. 990; 2(q)(l)(A), 86 Stat. 977]-
Adulterated in that its strength or purity fell below the
professed standard or quality under which it was sold.
[12(a) (1) (E) , 86 Stat. 990; 2(C)(1), 86 Stat. 975]
(When tested two units of the product coded "176" and
"186" were found to conatin only 0.59% and 0.61%
retonone, respectively.)
Exhibit 38
11-50
-------
ENFORCEMENT CASE REVIEW
(Test and Label)
ID NUMBER
88048
EPA REGISTRATION NUMBER
55-4800
TYPE OF REVIEW
CHEMISTRY
EFFICACY
SAFETY
OTHER (Specify)
TEST RESULTS AND SIGNIFICANCE
A deficiency was found in the active ingredient: Rotenone. The
analysis was by an acceptable procedure. Rotenone was determined
by appropriate infrared methods, Virginia Department of Agriculture,
and "Methods of Analysis-AOAC llth ed., 6.109-6.110." A "Total
Ether Extraction of Rotenone and Other Cube Resins" (AOAC 6.111)*
further confirmed the deficiency.
Analyst
First
Second
Second
Ingredient(Method)
Rotenone(VDA-IR)
Rotenone(AOAC-IR)
Sub
0.59% Aug.
0.571
2.89%
Sub $2
0.61%
Rotenone(AOAC-Ether Ext.)* 2.89% 2.97%
§ other cube
The chemical deficiency is definite and well established.
Claim
1.5%
1.5%
4.5%
LABELING REVIEW
IDATE OF ACCEPTANCE OF
APPLICABLE LABELING
2-24-72
ARE THERE ANY SIGNIFICANT LABELING DEFECTS?
I YES (If yes, list substantial discrepancies and significances below)
SUBSTANTIAL DISCREPANCIES AND SIG NIF 1C ANCES
E. B. Brittin
Chemist
Exhibit 38
EPA Hq Form 8SOO-7A (2-73)
11-51
-------
Sub. 1
(1.0 .b)
.45 Kg
.57%
.61%
Sub. 2
(1.0 Ib)
.45 Kg
.61%
Claimed
(1.0 Ib)
.45 Kg
1.5%
SAMPLE SUMMARY ANALYTICAL REPORT
Sample No.: 88048
Product: Pearson's 1.5% Rotenone
Analyst: Danny McDaniel
Date Analyzed: 2-16-73
Description: 2 - 1 Ib cartons
Appearance beige dust
Seal Broken 2-7-73
Net Weight
Rotenone (VDA 621.1 I.R.)
Avg. .59%
TLC (920.0 A§B)
No contamination detected
Resealed ID No. 88048 2-16-73 Danny McDaniel
Sample remaining approx (2 Ib) .90 Kg
Check Analysis 2-23-73 Robert R. Robertson
Sample sealed ID No. 88048 2-23-73 Danny McDaniel
Sub No. 2
Rotenone (AOAC XI 6.109 IR) 0.57%
Soxhlet extraction with acetone
Resealed ID No. 88048 2-23-73 Robert R. Robertson
Sample remaining Approximately 0.91 Kg
LABORATORY REMARKS: Rotenone is 60% deficient in both subs.
Exhibit 38
11-52
-------
SAMPLE SUMMARY ANALYTICAL REPORT CON'T
Sample No.: 88048
Product: Pearson's 1.5% Rotenone
Additional Analysis 4-12-73 Robert R. Robertson
Sample Sealed ID No. 88048 2-23-73 Robert R. Robertson
Sub No. 1 Sub No. 2 Claim
Total Ether Extract
(AOAC XI 6.111) 2.89% 2.97% 4.5%
Resealed ID No. 88048 4-12-73 Robert R. Robertson
Sample remaining Approximately 0.9 Kg
Exhibit 38
11-53
-------
I.D. No. 97342 - SABAN'S INSECT DUST
Saban Insect Control Company
Worthington, Virginia
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
1. Misbranded in that the label stated in part:
n A A A
SABAN'S
Insect Spray
A A A
ACTIVE INGREDIENTS
Carbaryl 3%
Malathion 31
Diazinon 2%
INERT INGREDIENTS 921
A A An
whereas the product contained less than 31 malathion and
2% Diazinon.
[12(a)(1) (E) , 86 Stat. 990; 2(q)(l)(A), 86 Stat. 977]
2. Adulterated in that its strength or purity fell below the
professed standard or quality under which it was sold.
[12(a) (1) (E) , 86 Stat. 990; 2(c)(l), 86 Stat. 975]
(The product was represented to contain 3% malathion
and 2% Diazinon which are equivalent to 0.86% total
phosphorus. However, when tested, the product, coded
"936", was found to contain only 0.52% total phosphorus.)
Exhibit 39
11-54
-------
I.D. No. 110000 - SANI-CLEAN DISINFECTANT
Sani-Clean, Inc.
Washington, D. C.
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
1. Adulterated in that a valuable constituent of the pesti-
cide had been wholly or in part abstracted.
[12(a) (1)(E) , 86 Stat. 990; 2(c)(3), 86 Stat. 975]
2. In violation in that the composition of the product
differed from the composition as represented in con-
nection with its registration.
[7 U.S.C. 135a(a) (1)]
(When analyzed, the product, coded "A-593", was found to
contain 23% less chlorine than the amount declared in
connection with registration on June 21, 1969, under
registration number 1000-500.)
Exhibit 40
11-55
-------
I.D. No. 102936 - MILLONE INSECT CONTROL
Millone , Inc .
Wilson, Alabama
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
1. Misbranded in that the label stated in part:
it* A *
Millone
Insect Control
Active Ingredients
Clobber .................... 62%
Malathion .................. 1%
Inert Ingredients ............ 37%
* * AH
whereas the product contained less than 62% clobber.
[12(a) (1) (E) , 86 Stat. 990; 2(q)(l)(A), 86 Stat. 977]
Adulterated in that its strength or purity fell below
the professed standard or quality under which it was
sold. [12(a) (1) (E) , 86 Stat. 990; 2(c)(l), 86 Stat. 975]
(The uncoded product was found to contain only 5.3%
clobber. Due to this deficiency the product would not
be fully effective in controlling insects.)
Exhibit 41
11-56
-------
ID No. 100506 - FORD'S HOUSEHOLD INSECTICIDE
Ford Chemical
Westwood, Tennessee
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
1. Misbranded in that the labeling accompanying the product
did not contain directions for use which are necessary
and, if complied with, adequate to protect health and the
environment. [12 (a) (1) (E) , 86 Stat. 990; 2 (q) (1)
(F) , 86 Stat. 977]
2. Misbranded in that the label stated in part:
FORD'S
Household Insecticide
* * *
Active Ingredients:
Sodium Fluoride ....... 59.00%
Sodium Flurosilicate .... 19.00%
Pyrethrins .......... 18%
Inert Ingredients ........ 21.82%
* * *'T
whereas the product contained an additional active
ingredient, namely methyl parathion, which was not
listed in the ingredient statement. [12 (a) (1) (E) ,
86 Stat. 990; 2 (q) (1) (A), 86 Stat. 977]
3. Adulterated in that another substance, namely methyl
parathion, had been substituted wholly or in part for the
article. [12 (a) (1) (E) , 86 Stat. 990; 2 (c) (2), 86
Stat. 975]
(The product coded "CB-798" was found to contain 0.08% methyl
parathion. The use of this product as directed would pose a
potential hazard to the user.)
Exhibit 42
11-57
-------
I.D. No. 101342 - 2-20 CABBAGE DUST
Southern Chemicals, Inc.
Columbia, South Carolina
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
1. Misbranded in that the label stated in part:
it* * *
2-20
CABBAGE DUST
Active Ingredients:
Toxaphene ................. 20%
Parathion ................. 2%
Inert Ingredients ........... 78%
whereas the product contained additional active ingre-
dients, namely strobane and maneb , which were not listed
in the ingredient statement. [12 (a) (1) (E) , 86 Stat. 990;
2(q)(l) (A) , 86 Stat. 977]
2. Adulterated in that other substances, namely strobane
and maneb, had been substituted wholly or in part for
the article. [] 2 (a) (1) (E) , 86 Stat. 990; 2(c)(2), 86
Stat. 975]
(Two units of the product coded "CD 0042" were found to
contain 0.77% and 0.75% maneb and 0.80% and 0.75% strobane,
respectively . )
*NOTE
This type of narrative may be used in a notice of warning.
Exhibit 43
11-58
-------
ENFORCEMENT CASE REVIEW
(Test and Label)
ID NUMBER
101342
EPA REGISTRATION NUMBER
10536-2
TYPE OF REVIEW
CHEMISTRY
XX)
EFFICACY
SAFETY
OTHER (Specily)
TEST RESULTS AND SIGNIFICANCE
The sample was found to contain undeclared pesticides:
Terpene polychlorinates [consists of chlorinated camphene pinene and rela-
ted polychlorinates (65-66% chlorine)]*
Maneb (manganese ethylenebisdithiocarbamate)
The analysis \vas by acceptable procedures :
*Strobane was identified by GLC and infrared procedures and calculated
from chlorine content determined by an appropriate sodium reduction
method (AOAC 10th ed., 4.188) Maneb was calculated from carbon dis-
ulfide content-EPA PR Method (765.1) and was found to contain manganese
on the basis of the contamination found.
Analyst Contaminant (Method) Sub #1
first Strobane (GLC)pos.
second Strobane (GLC) pos.
second Strobane (infrared) pos.
first Maneb (EPA-PR 765.1) 0.77%
Sub #2
pos .
pos.
pos.
0.75%
Claim
none
none
none
none
The chemical contamination is well established. Toxaphene the claimed
(ingredient (20.0%) doesn't contain the chlorinated pinene.
iStrobane calculated from chlorine - 18.2% (Sub #1) 18.9% (Sub #2)
i
ITE:
!fer
Sub #3 and
to chemical
Sub #4 are not
residue review
contaminated
LABELING REVIEW
ARE THERE ANY SIGNIFICANT LABELING DEFECTS?
I J YES (It yes, list substantial discrepancies end significances below)
DATE OF ACCEPTANCE OF
APPLICABLE LABELING
10-15-71
SUBSTANTIAL DISCREPANCIES AND S IG NIF 1C ANCES
E. Brittin
Chemist
Exhibit 43
EPA Hq Form 8500-7A (2-73)
11-59
-------
ENFORCEMENT CASE REVIEW
(Test and Label)
ID NUMBER
EPA REGISTRATION
101342
NUMBER
TYPE OF REVIEW
CHEMISTRY
residue
EFFICACY
SAFETY
OTHER (Specify)
TEST RESULTS AND SIGNIFICANCE
Claim toxaphene 20.0%
Found Strobane in Sub 1
toxaphene in Sub 3
It is difficult to distinguish toxaphene and Strobane, but this was done
by GLC and mass spectrometry (from R. Thomas). Residues of goxaphene
and Strobane are not distinguishable. Illegal residues of Strobane
are unlikely.
Contaminant maneb 0.77%, 0.75%
Use on cabbage - Tolerance 10 ppm
Illegal residues of maneb are unlikely.
NOTE: Strobane and maneb probably were deliberately used.
R. Caswell
Pesticide Residue Chemist
LABELING REVIEW
ARE THERE ANY SIGNIFICANT LABELING DEFECTS?
f 1 YES (It yes, list substantial discrepancies and significances belowf)
DATE OF ACCEPTANCE OF
APPLICABLE LABELING
SUBSTANTIAL DISCREPANCIES AND SIGNIF 1CANCES
Exhibit 43
EPA Hq Form 8500-7A (2-73)
11-60
-------
I.D. No. 123456789
SUDDEN DEATH BUG SPRAY
Sudden Death, Inc.
Tombstone, Arizona
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT IN THAT THE PESTICIDE
WAS:
1. Misbranded in that the labeling accompanying the product
did not contain directions for use which are necessary, and,
if complied with, adequate to protect health and the environ-
ment. [12(a)(1)(E), 86 Stat. 990; 2(q)(l)(F), 86 Stat. 977]
2. Misbranded in that the label stated in part:
HA A A
SUDDEN DEATH BUG SPRAY
* * A
Active Ingredient
Diazionon* 0.5%
Inert Ingredients 99.51
*0,0-Diethyl 0-(2 isopropyl-6-methyl-4-
pyrimidinyj) phosphoroioate
A A A li
whereas, the product contained more than 0.5% Diazinon.
[12(a) (1)(E), 86 Stat. 990; 2(q)(l)(2), 86 Stat. 977]
(The product \vas found to contain 1.2% Diazinon. Diazinon
is not accepted for household use at concentrations above
0.5%, refer to PR Notice 78-3, enclosed)*
*NOTE
The narrative regarding the overformulation may be used in
a notice of warning.
Exhibit 44
11-61
-------
I.D. No. 10987654321
DR. JEKYLL'S PATENTED TWOINONE SNAKE OIL DISINFECTANT
AND ATHLETE'S FEET REMEDY
Fred Hyde and Associates
Deadwood, California
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
Misbranded in that the label stated in part:
i'A A A
Dr. Jekyll's Pattented Twoinone
SNAKE OIL
Disinfectant
and Athletes Feet Remedy
A A A
To disinfect your hospital, scrub the floors, walls,
ceilings, windows, doors and interns with one gallon
of Dr. Jekyll's Snake Oil to 20 gallons of water.
A A A
For athletic feet, use one gallon of Dr. Jekyll's Snake
Oil to 20 gallons of water on the affected feet. They
will never be the same again.
A A AH
whereas, when used as directed, the product would not act as an
effective disinfectant or athlete's foot remedy. [12(a)(1)(E),
86 Stat. 990; 2(q)(l)(a), 86 Stat. 977]
(When tested by the AOAC Use Dilution Test at a dilution of 1-20
samples of the product coded "eyE deR" failed to kill Staphylococcus
aureus in 25 out of 30 trials, and Salmonella choleraesuis in 12
out of 20 trials. The product also failed to kill Trichophyton
interdigitale within fifteen minutes at a dilution of 1-20 in
the AOAC Fungicide Test.)
Exhibit 45
11-62
-------
I.D. No. MCDCVXIII
Cleanliness Company, Division of Godliness Enterprises, Ltd.
Number One Peter's Lane
Heavenly Valley, California
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide and Rodenticide Act (as amended by the Federal En-
vironmental Pesticide Control Act of 1972), there is under
consideration a sample of ANGEL FRESH GERM KILLER, which was
obtained from a shipment made from Sacramento, California, to
Purity Corporation, Las Vegas, Nevada, on or about April 1,
1976.
This shipment did not comply with the provisions of the act in
that the product failed to kill Psuedomonas aeruginosa in 2
out of 20 trials when tested by the AOAC Use Dilution Test
at a dilution of 1-20.
You should assure yourself that all necessary corrections are
made, and that any further marketing of this product is in full
compliance with the provisions of the act. Any additional
information that you wish to submit will be included in the
file on this matter.
Sincerely yours,
A. E. Conroy II
Director
Exhibit 46
11-63
-------
I.D. No. 4567890 - SMILODON RAT GETTER
Smiling Don Division of Felix Enterprizes
La Brea, California
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
Misbranded in that the label stated in part:
n* A A
SMILODON RAT GETTER
makes you smile
KILLS RATS
OVERNIGHT IN HOURS
A A A
To kill rats overnight: Place baits in afternoon or evening
in areas where rats have been seen. Repeat until all
rodent signs disappear.
A A A it
whereas, when used as directed, the product would not
effectively kill rats overnight.
[2(a)(1) (E) , 86 Stat. 990; 2(q)(l)(2), 86 Stat. 977]
(During an eight-day feeding study involving 20 albino
rats, only 60% of the test animals were killed. A mor-
tality of 90% is considered necessary for the product to
be effective in the commensal rodent environment.)
Exhibit 47
11-64
-------
I.D. No. 123456 - KILZEM DED RAT AND MOUSE BAITS
Kilzem Company
Kalamazoo, Michigan
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
Misbranded in that the label stated in part:
ii A * A
Kilzem Ded Rat and Mouse Baits
A A A
Directions for mice: Scatter several spoonfulls of Kilzem
baits around areas where you know that these beady-eyed
little rodents live.
Directions for rats: Same as for mice, only use a larger
spoon.
A A A
KILZEM DED kills them dead!
A A AH
whereas the product would not be effective in killing rats
and mice.
[12(2)(1)(E), 86 Stat. 990; 2(q)(l)(2), 86 Stat. 977]
(During a fifteen-day feeding study involving ten house mice,
the test animals consumed by choice only 6.4% of the bait in
their total diet resulting in only a 20% mortality. In a
similar test involving twenty albino rats, the test animals
consumed by choice only 21.2% of the bait in their total
diet resulting in a mortality of only 15%. An acceptance of
33% and mortality of 90% are necessary to consider a product
effective in the commensal rodent environment.)
Exhibit 48
11-65
-------
I.D. No. 100000945 - RAT AND MOUSE BLOCKS
Disney Manufacturing Company
Anaheim, California
CHARGE SHEET
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL
INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT IN THAT THE
PESTICIDE WAS:
Misbranded in that the label stated in part:
it A A A
Let Disney
RAT AND MOUSE BLOCKS
Block for You
A A A
To Use: Place blocks near runs or other infested areas.
Repeat as necessary until rodent signs are no
longer evident.
A A All
whereas, when used as directed, the product would not be
effective in killing rats and mice. [12 (a) (1)(E), 86 Stat. 990;
2(q) (1)(2), 86 Stat. 977]
(During a fifteen-day feeding study involving ten house mice,
the test animals consumed by choice only 6.4% of the bait
resulting in only a 201 mortality. In a similar test
involving twenty albino rats, the test animals consumed
by choice only 21.2%, and the result was only a 15% mor-
tality. An acceptance rate of 25% and mortality of 801
are necessary to consider the product effective in the
commensal rodent environment.)
Exhibit 49
11-66
-------
E-51. The product is a pesticide within the meaning of the
Federal Insecticide, Fungicide, and Rodenticide Act,
a marked copy of which is enclosed. Please refer to
(Insecticide) (1) Sec. 2 (o), 2(t), and 2(u) of the Act.
(Fungicide
Bactericide) (2) Sec. 2(k), 2 (t), and 2(u) of the Act.
(Rodenticide) (3) Sec. 2(t) and 2(u) of the Act.
(Herbicide) (4) Sec. 2(t), 2(u), and 2 (cc) of the Act.
(Insecticide
and
Fungicide) (5) Sec. 2(k), 2(o), 2(t), and 2(u) of the Act,
(Algaecide) (6) Sec. 2(t) and 2(u) of the Act.
(Animal
Repellents) (7) Sec. 2(d), 2 (t), and 2(u) of the Act.
(Nematocide) (8) Sec. 2 (r), 2(t), and 2(u) of the Act.
E-52. The product is a device within the meaning of the
Federal Insecticide, Fungicide, and Rodenticide Act,
a marked copy of which is enclosed. Please refer to:
(Device) Sec. 2(h) of the Act.
Exhibit 50
11-67
-------
E-251. The product is an economic poison within the meaning
of the Federal Insecticide, Fungicide, and Rodenticide
Act, a marked copy of which is enclosed. Please refer
to:
(Insecticide
§ Fungicide)
(Algaecide)
(Animal
Repellents)
(Nematocide)
(Insecticide) (1)
CFungicide
Bactericide
(Rodenticide)
(Herbicide)
(3)
(4)
(5)
(6)
(7)
(8)
Sec. 2a, 2c, and 2m of the Act, and Paragraph
362.2(c) of the Regulations.
Sec. 2a, 2d, and 2n of the Act, and Paragraphs
362. 2 (c) and 362.2(d) of the Regulations.
Sec. 2a and 2c of the Act, and Paragraph 362.2
(c) of the Regulations.
Sec. 2a, 2f, and 21 of the Act, and Paragraphs
362.2(c) and 362. 2 (e) of the Regulations.
Sec. 2a, 2c, 2d, 2m, and 2n of the Act and Para-
graphs 362.2 (c) and 362.2(d) of the Regulations.
Sec. 2a of the Act and Paragraphs 362.2 (c) and
362.2 (e) of the Regulations.
Sec. 2a of the Act and Paragraph 362.2 (c) of the
Regulations.
Sec. 2a, 2g, and 2k of the Act and Paragraphs
362. 2 (c) and 362.2(f) of the Regulations.
E-252. The product is a device within the meaning of the Federal
Insecticide, Fungicide, and Rodenticide Act, a marked
copy of which is enclosed. Please refer to:
(Device)
Sec. 2(b) of the Act and Paragraph
362.14(a) of the Regulations.
E-253. (a) Interstate shipments of this product without benefit
of registration are in violation of the Act. (b) We are
enclosing PR Form (9-I99~) for use in application for
registration of the product.
Exhibit 50
11-68
-------
E-53. The violation alleged herein constitutes a repeated
violation by your company. It is emphasized that
in our further consideration of this matter, particular
attention will be given to (1) the explanation for the
alleged violation, and (2) the assurances which may be
given that the alleged violation will not recur.
E-54. (a) The marketing of this product without benefit of
registration is in violation of the Act. (b) We are
enclosing PR Form 9-199 for use in application for
registration of the product.
E-55. The establishment is a producer within the meaning of
the Federal Insecticide, Fungicide, and Rodenticide Act,
a marked copy of which is enclosed. Please refer to
Sec. 2(s), 2(w), and 2 (dd) of the Act.
E-56. (a) The production of a pesticide in an establishment
which is not registered pursuant to Section 7 of the
Act is in violation of the Act. (b) Enclosed is an
application for registration of the establishment.
Exhibit 50
11-69
-------
E-76. The marketing of (a. this product) (b. these products)
without benefit of registration for the distributor
(is/are) in violation of the Act. We are enclosing
PR Form 9-1 for use in application for supplemental
registration for the distributor (s).
E-77. This letter is being sent to you since you are the
^registrant/manufacturer) of the (a. product) (b. products)
and therefore in the best position to initiate corrective
action.
E-276. Interstate shipments of (a. this product) (b. these
products) without benefit of supplemental registration
for the distributor are in violation of the Act. An
application for supplemental registration, PR Form
9-1, is enclosed.
Exhibit 51
11-70
-------
12
-------
Section 12
RECALL
-------
RECALL
I. Authority
The recall of a defective product by the manufacturer or
shipper is the most effective and efficient means of
removing such product from the market.
The act contains no authority for the recall of products;
therefore, the effective recall of a product depends upon
the cooperation of the company to which the recall request
is made. A recall action is viewed as a serious and extra-
ordinary matter, and a request for the recall of a product
cannot arbitrarily or capriciously be made. The effectiveness
of a recall program depends upon (a) knowledge on the part
of industry that a recall request will be made only
in those cases where there is a likelihood of injury --
physical or economic -- from the use of a product as directed
(b) knowledge on the part of industry that the Agency will use
all legal means available to it under the statute to support
any recall request and (c) knowledge on the part of industry
that state officials are cooperating with the Agency in the
removal of such products.
II. Basis
There are three types of recall action:
1. National recall in connection with a suspension and/or
cancellation.
12-1
-------
2. National recall in connection with a notice of contemplated
proceedings.
3. Informal recall.
In all three cases, the initial decision that a product should
be withdrawn from the market will be based upon the information
contained in the file, including Office of Pesticides staff
evaluations and opinions, and such other information as may
be available and relevant. All information upon which a
recall decision is based shall be included in the official
file.
Recalls will be initiated in all cases where the available
information indicates that the product is (a) potentially
hazardous when used as directed or (b) ineffective for the
purposes claimed. A product will be considered in the potentially
hazardous category when, among other things, its use as directed
is likely to result in:
1. Injury to the user or handler of the product;
2. Injury to animals where direct application is made;
3. Injury to plants;
4. Injury to consumers due to residues;
5. Economic injury to growers due to actionable residues;
6. Injury to fish or wildlife; or
7. Identifiable adverse effect on the environment.
12-2
-------
An informal recall may be issued in lieu of a national
recall in cases where, among other things:
1. The level of potential hazard is not believed to
be great, but where action in addition to a citation
should be taken;
2. The evidence is insufficient to back up the recall
request with appropriate legal action, including
multiple seizures, stop sale, use or removal orders,
etc.
3. It is doubtful that any additional amounts of the
product remain on the market, but where a quick check
should be made by the company.
Ill. Procedures
A. National Recall in connection with a suspension and/or
cancellation.
1. The Office of Pesticides Programs will determine
when a product's registration should be suspended
and cancelled due to a hazard or when a product's
registration should be cancelled due to ineffect-
iveness. In either case, a national recall will be
issued by the region where the firm is headquartered.
2. PED will send to the region:
a. The date of the suspension order or cancellation
notice .
b. The reason for the cancellation.
c. The names of the product or products to be
recalled for each registrant.
12-3
-------
B. National or informal recall in connection with a notice of
contemplated proceedings.
1. When a gross violation is noted by the region and
recall level of action is anticipated:
a. Contact the regional coordinator.
b. Telecopy the label to Washington, B.C.
c. Concurrence for recall will be otained by
FED from: [1] OPP, [2] The region where the firm
is headquartered, [3] In the case of an informal
recall, from the region in which the shipper
or producer establishment is located.
d. If concurrence for a national recall is obtained,
the region where the product was sampled:
1. Telecopies the original records and label
to the region where the firm is headquartered
for initiation of the recall.
2. Forwards the original label and records to
the region where the shipper or producer
establishment is located for initiation of
contemplated proceedings.
e. If concurrence for an informal recall is obtained,
the region where the product was sampled forwards
the original records and label to the region where
the shipper or producer establishment is located
12-4
-------
for initiation of contemplated proceedings and
informal recall.
NOTE: SAMPLES OF THE PRODUCT MAY BE FORWARDED TO THE LABORATORY
AT THE REGION'S DISCRETION.
2. When a recall situation is identified on a sample
which has been routed through Washington, B.C.,
FED will obtain concurrence from: [I] OPP, [2] The
region where the firm is headquartered, [3] In the
case of an informal recall, the region where the
shipper or producer establishment is located.
a. If concurrence for a national recall is obtained:
1. Regional coordinator will telecopy label
and records to the region where the firm is
headquartered for initiation of the recall.
2. Regional coordinator will forward the orig-
inal label, records, etc. to the region
where the shipper or producer establishment
is located for initiation of contemplated
proceedings.
b. If concurrence for an informal recall is obtained:
Regional coordinator will telecopy the label
and records to the region where the shipper or
producer establishment is located for initiation
of contemplated proceedings and informal recall.
The orginals will be mailed to this region.
12-5
-------
IV. Format
A. National recall in connection with suspension and/or
cancellation.
The standard recall request is sent by certified
mail and notifies the firm of the reason for recall,
the products to be recalled, the procedures to be
followed, and the personnel in the region to be
contacted regarding the recall request. (See Exhibit
la,b) .
B. National recall in connection with notice of contemplated
proceedings.
The recall notice will identify (1) the product,
(2) shipment or producer establishment, (3) the
violation (batch codes if there is an ineffective
or misformulated product), (4) the procedures to
recall the product and (5) the regional personnel
who will supervise the action. (See Exhibit 2a,b,c).
C. Informal Recall
The recall note is always on a page separate from the
notice of contemplated proceedings. The recall note:
1. Names the product,
2. Identifies the hazards and the batch codes of an
improperly formulated or ineffective product,
3. Requests the removal of the product from the market.
12-6
-------
Depending on the amount of detail needed to identify the
hazard, one of the formats exhibited may be used.
(See Exhibit 3a,b).
NOTE: WHEN A PRODUCT IS FOUND HAZARDOUS, AND IS NOT CONNECTED
WITH VIOLATIONS OF THE ACT OR A SUSPENSION AND/OR
CANCELLATION, A RECALL MAY BE REQUESTED BY INITIAL
CORRESPONDENCE WITH THE REGISTRANT. (See Exhibit 4).
12-7
-------
NATIONAL RECALL IN CONNECTION WITH A
SUSPENSION AND/OR CANCELLATION
CERTIFIED MAIL
Company Name
Address
Gentlemen:
Subject: ID No.
EPA Reg. No.
There has been sent to you on a letter notifying you
that registration under the Federal Insecticide, Fungicide, and
Rodenticide Act for, EPA Reg. No. , is suspended.
As set forth in the letter of suspension,
Therefore, it is requested that your company take immediate steps
to withdraw this product from the market. Specifically, it is
requested:
1. That your company initiate procedures to determine the
locations of all quantities of this product and the
amount of such product at each such product location.
2. That the product be returned to your company from all
such product locations, and
3. That you inform us of (a) all steps taken by your company
in connection with the recall of this product and (b) the
completeness of the recall action.
This action will be supervised through the Office of
, telephone number .Mr. , or a representative
of his office, will contact you on the matter.
Thank you for your cooperation.
Sincerely yours,
Name
Title
Exhibit la
12-8
-------
CERTIFIED MAIL
No-Bug Agricultural Products, Inc.
Research § Development Center
11710 Lake Avenue
Woodstock, Illinois 60098
Gentlemen:
Subject: ID No. 73618 - PANOGEN 42 LIQUID SEED DISINFECTANT
EPA Reg. No. 2139-5
There has been sent to you on February 19, 1970, a letter notifying
you that registration under the Federal Insecticide, Fungicide, and
Rodenticide Act for PANOGEN 42 LIQUID SEED DISINFECTANT, EPA Reg.
No. 2139-5, is suspended.
As set forth in the letter of suspension, it has been determined
that directions on products containing alkyl mercury for seed
treatment purposes are inadequate to prevent treated seeds from
being fed to livestock or disposed of in a manner that results in
wildlife feeding on them. Therefore, it is requested that your
company take immediate steps to withdraw this product from the
market. Specifically, it is requested:
1. That your company initiate procedures to determine the
locations of all quantities of this product and the
amount of such product at each such product location.
2. That the product be returned to your company from all
such product locations, and
3. That you inform us of (a) all steps taken by your company
in connection with the recall of this product and (b) the
completeness of the recall action.
This action will be supervised through the office of Mr. K. H.
Kaneshiro, Supervisory Inspector, 610 South Canal Street, Room 815,
Chicago, Illinois 60607, telephone number 312-353-6219. Mr. Kaneshiro,
or a representative of his office, will contact you on the matter.
Thank you for your cooperation.
Sincerely yours,
Exhibit Ib
12-9
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NATIONAL RECALL
SAMPLE COLLECTED AFTER SHIPMENT
ID. No.
CERTIFIED MAIL
Company Name
Address
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, as amended by the Federal
Environmental Pesticide Control Act of 1972 ( ),
we have obtained and tested a sample of the product
This sample was obtained from a shipment made by you on ,
from to
In view of the intended uses of the product it is requested that
your company take immediate steps to withdraw this product from
the market. Specifically, it is requested:
1. That your company make a complete record check to
identify the consignees of the product;
2. That such consignees be requested to return this
product to your company; and
3. That you inform us of (a) the steps taken by your
company to recall the product and (b) the completeness
of the recall action.
This action will be supervised through the Office of Mr.
, telephone number
or a representative of his office, will contact you on the matter,
Thank you for your cooperation.
Sincerely yours,
Exhibit 2a
12-10
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NATIONAL RECALL
SAMPLE COLLECTED AT PRODUCER ESTABLISHMENT
ID No.
CERTIFIED MAIL
Company Name
Address
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, as amended by the Federal
Environmental Pesticide Control Act of 1972 ( ),
we have obtained and tested a sample of the product
This sample was obtained on
from your producer establishment in
In view of the intended uses of the product, it is requested
that your company take immediate steps to withdraw this product
from the market. Specifically, it is requested:
1, That your company make a complete record check to
identify the consignees of the product;
2. That such consignees be requested to return this
product to your company; and
3. That you inform us of (a) the steps taken by your
company to recall the product and (b) the completeness
of the recall action.
This action will be supervised through the Office of Mr.
, telephone number
Mr. , or a representative of his office, will contact
you on the matter.
Thank you for your cooperation.
Sincerely -yours,
Exhibit 2b
12-11
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Pesticides Enforcement Division
ID No. 95968
CERTIFIED MAIL
Hub States Corporation
2000 North Illinois Street
Indianapolis, Indiana 46202
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 135-135k), we have
obtained and tested a sample of the product, HUB STATES FORMULA
40. This sample was obtained from a shipment made by you on
December 1, 1971, from Indianapolis, Indiana, to Darbco, Inc.,
East Providence, Rhode Island.
Tests of the sample coded "7040" showed the product to be so
deficient in 0,0,0,0-Tetraethyl dithiopyrophosphate that it would
be ineffective for the purpose of insect control as set forth on
its label.
In view of the intended uses of the product, it is requested that
your company take immediate steps to withdraw this product from
the market. Specifically, it is requested:
1. That your company make a complete record check to
identify the consignees of the project;
2. That such consignees be requested to return this product
to your company; and
3. That you inform us of (a) the steps taken by your company
to recall the product and (b) the completeness of the
recall action.
This action will be supervised through the office of Mr. George J.
Marsh, Regional Supervisor, Environmental Protection Agency, One
North Wacker Drive, Chicago, Illinois 60606, telephone number
312-353-6219. Mr. Marsh, or a representative of his office, will
contact you on this matter.
Sincerely yours,
Exhibit 2c
12-12
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I.D. No. 72846 - SUPER SLUG BAIT
NOTE:
It is requested that you take steps to determine if any
additional amounts of this ineffective product remain
in channels of trade. If so, it is further requested
that all such lots of the product, coded B1234, be
removed from the market
Exhibit 3a
12-13
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I.D. No. - PEARSON'S GREEN DEVIL DUST CONTAINING 5% MALATHION
NOTE:
In view of the possibility of illegal residues, it is
requested that you take steps to determine if any add
itional amounts of this deficient and contaminated
product remain in channels of trade. If so, it is
further requested that all such lots of the uncoded
product be removed from the market.
Exhibit 3b
12-14
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ID No. 82162
National Laboratories
Lehn § Fink Industrial Products
Division of Sterling Drug, Inc.
225 Summit Avenue
Montvale, New Jersey 07645
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, there is under consideration a
sample of AMPHYL DISINFECTANT ANTISEPTIC DEODRANT DETERGENT
(EPA Reg. No. 77-3) which was obtained from shipments made
to Lehn § Fink Industrial Products in care of Hartford Warehouse,
Hartford, Connecticut, on or about February 13 and 17, and
March 4, 1969.
The label of this sample fails to bear adequate precautionary
labeling for a product being classed as a severe irritant (refer
to EPA Reg. No. 675-21).
In view of the lack of adequate precautionary labeling, the
product is potentially hazardous. Therefore, it is requested
that you take steps to determine if any additional amounts of
this improperly labeled product remain in channels of trade.
If so, it is further requested that all such lots of the product
be removed from the market.
Please inform us of the action you have taken with respect to
this matter.
Sincerely yours,
Exhibit 4
12-15
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13
-------
SECTION 13
STOP SALE, USE OR REMOVAL ORDERS AND SEIZURES
-------
STOP SALE, USE OR REMOVAL ORDERS AND SEIZURES
I. Authority
Section 13 (a) authorizes the Administrator to issue a
written or printed 'Stop Sale, Use, or Removal1 Order
to any person who owns, controls, or has custody of any
pesticide or device which is found in violation of any
of the provisions of the Act.
Section 13(b) authorizes in rem (seizure) proceedings againsu
any pesticide or device being transported or, having been
transported, remains unsold or in the original unbroken
packages, or that is sold or offered for sale in any state,
or that is imported from a foreign country, which is in
violation of the provisons of the Act listed in 13(b)
d) C2) C3).
Regional Administrators are authorized to initiate all
actions under Sections 13(a) and 13(b) after obtaining
advance concurrence from the Pesticides Enforcement Division.
II. Guidelines
While Stop Sale, Etc., Orders and Seizures may be used to
accomplish the same objectives, their differences must be
understood. Section 13(b) states that a pesticide or device
"--be proceeded against -- and seized -- by a process in
rem --."
13-1
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Section 13(a) states "-- may issue a written or printed --
order to any person who owns, controls, or has custody --."
Seizures are instituted by asserting (in rem) jurisdiction
over the product; Stop Sale, Etc. Orders are initiated by
asserting (in personam) jurisdiction over the person who
owns, controls, or has custody of the product.
product.
Therefore, a Stop Sale, Etc., Order must be issued to the
person. The Order must be as specific as possible in
identifying the pesticide or device, the violation, and
the amount of the pesticide or device. However, it should
be written to cover all amounts of the violative pesticide
or device owned or controlled by, or in custody of, the
person receiving the Order.
The effect of the Order will be reinforced if copies of the
Order are physically attached to all stocks of the violative
pesticide within the dominion, control, or custody of the
person cited, wherever those stocks may be located.
Stop Sale, Etc., Orders may be used at the producer level to
prevent violative pesticides or devices from entering the
market. Orders may also be issued to quickly cover identified
amounts of violative pesticides or devices already
distributed.
13-2
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Since the Agency will probably have adequate control over
products at the producer level, Seizures will be useful
against products already distributed and as a back-up
for Stop Sale, Etc., Orders when the provisions of such
orders are not being complied with. Consider the following
factors in deciding which action to initiate:
1. Timeliness - Does the situation allow the additional
time (usually several days) required to initiate seizure
rather than a Stop Sale, Etc., Order?
2. Convenience - Is the EPA Inspector or the U. S. Marshal
best located to carry out an agency or a court order?
3. Disposition - Can disposition of the matter best be
handled by the Agency or does the situation call for a
court ordered disposition 13(c) (d)?
Ill. Procedures
A. Action initiated by the region.
1. When a stop sale, use, or removal or seizure
level action is anticipated by the region:
a. Contact the regional coordinator
b. Telecopy the label to Washington, D.C.
2. When the label is received by PED:
a. The coordinator of the region where the product
was sampled notifies the coordinators of the
region where the firm is headquartered and the
region where the shipper is located.
13-3
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b. Concurrence for all stop sale, use, or removal
or seizure actions is obtained from FED.
c. If the region where the firm is headquartered
and/or the region where the shipper is located
also wishes to issue a Stop Sale, Use or Removal
Order at the producer and/or shipper level, the
region where the product was sampled will
forward copies of all necessary information to
the other regions.
d. The region where the sample was collected will
mail the originals to the region where the shipper/
producer establishment is located in order to
initiate contemplated proceedings.
NOTE: SAMPLES OF THE PRODUCT MAY BE FORWARDED TO THE LABORATORY
AT THE REGION'S DISCRETION.
B. Action initiated by headquarters.
When a stop sale, use, or removal or seizure level action
is identified on a sample which has been routed through
Washington, D.C., the regional coordinator will: [1]
Contact the region or regions in which the registrant/
manufacturer, shipper, and consignee are located and seek
concurrence on the level of action from that region or
regions. [2] Telecopies of the label and other pertinent
parts of the file will be sent to the regions involved.
At the same time, the complete ID file will be mailed to
the region where the shipper or producer establishment is
located in order to initiate contemplated proceedings.
13-4
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C. Format
1. Stop Sale, Use or Removal Order.
The person who owns, controls, or has custody of
the violative pesticide or device will be served
a written or printed Stop Sale, Use, or Removal
Order. The Order will name the person being served,
identify the pesticide or device by name, package
size and type, batch code, etc., and the terms
and scope of the order. The Order will cite the
applicable sections of the Act, the nature of the
violation, and the consequences for violating
the terms of the Order.
The original copy of the order will be served
(delivered by hand) by an authorized Agency employee
who will acknowledge the service by signing the order
in the space provided, and entering his title, the
time, and the date of the service.
The person served should acknowledge receipt of the
order by signing the order in the space provided,
and entering his title.
Contact information should be provided to the person
being cited, including the name and address of a person
in the Regional office with knowledge of and authority
to proceed with a satisfactory method of disposition
of pesticide or device affected by the Stop Sale, Etc.,
Order. [Exhibit 1)
13-5
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2. Seizures.
The Regional office will prepare a proposed
'complaint in rem1 and refer it by transmittal
letter directly to the appropriate U. S. Attorney.
Sending a prepared document should expedite filing
and subsequent court ordered seizure by the U. S.
Marshal. (Exhibit 2 a,b)
D. Disposition
1. Stop Sale, Etc., Orders.
Any pesticide or device under a Stop Sale, Etc.,
Order, should not be disposed of in any manner
contrary to the terms of the order or any Federal,
state, or local laws. The Agency must determine
that proper disposition is made of the pesticide or
device in each case.
Disposition can usually be accomplished through
one, or a combination, of the following actions:
-- Obtain registration
-- Recondition to bring into compliance with the
Act by relabeling and/or reformulating
-- Recondition to remove from the purview of the
Act by relabeling
-- Institutional uses which do not constitute use
violations
-- Detoxification
-- Destruction
13-6
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When the Regional Office determines proper disposition
has been made, the method of disposition and amount
of pesticide or devices will be recorded. The matter
will be terminated by issuing a final order which
vacates the Stop Sale, Etc., Order. (Exhibit 3 and 4)
Seizures.
While pesticides or devices under seizure are in the
control of the court, the Regional Office will usually
be called upon to recommend or approve the method
of disposition, and may be directed to supervise the
court ordered action in decrees of condemnation.
When agreeable to the U. S. Attorney, the Regional
Office should prepare the proposed consent or default
decree to be filed by the U. S. Attorney. (Exhibit
5 a,b)
The person supervising reconditioning under a consent
decree should report the method of reconditioning,
what examinations or tests were made, and whether the
pesticide or device is now in compliance with the
provisions of the Act. (Use report of disposition
format).
13-7
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The Agency will be reimbursed by the claimant for
expenses incurred in supervising the reconditioning.
The schedule of expenses should be attached to the
report of supervision and presented to the U. S.
Attorney for collection concurrent with payment of
court costs. (Exhibit 6)
E. Noncompliance With Orders or Seizures
If the terms of a Stop Sale, Etc., Order are not being
complied with, the Regional Administrator may request a
warrant from the Federal district court authorizing
agency representatives to seize the pesticide or device.
(Section 9(b) (3)).
It is a prohibited act to violate any order issued under
Section 13. When evidence of violation of an order is
found, initiation of civil or criminal proceedings with
appropriate penalty may be warranted.
Violation of a court ordered seizure or decree constitutes
contempt of court. When any such violation is found it
should be reported promptly to the U. S. Attorney who filed
the proceedings.
F. Records
An ID File will be maintained for each Stop Sale, Etc.,
Order and Seizure action. Copies of each order, complaint,
letter, memorandum of meeting, agreement, decree, super-
vision of disposition, final order, etc., will be kept in
the ID Files.
13-8
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UNITED STATES ti.'VlflG.'.r.r.UTAL PI'OTLCTIO:! AGENCY
STOP SAIL, USE, OP cr.y.ovAi. op.ni'K
(Date)
l.D. No.(s)
(Name of Cc;::pai7yl
(Address)
By the'authority vested in nr_> pursuant to Section 13(o) of The Federal
Insecticide, Funo icicle, end Roclenticide Act, as amended by the Federal Environ-
mental Pesticide Control Act of 1972, you are hereby ordered not to sell, use,
or remove the pesticide or device
OTaine of pesticice(s) or ccvice(s), bitch Code(s) .Other Identification)
Based upon inspection or tests, there-is reason to believe that the
pesticide or device is in violation of the provision(s) of Section
of the Act in that the pesticide or device is
(Nature of the Violation)
This order shall pertain to all quantities of the above named pesticide or
device within the ov/nership, control or custody of the above named person,
wherever located. Said pesticide or device shall not be sold, used, or
removed other than in accordance v:ith the provisions of this order or of
such further orders as may be issued in connection with the pesticide or
device.
Any person violating the terms or provisions of this order shall be subject
to the penalties prescribed in Section 14 of the Act.
(Authorized EFA Official)
Order served by
(Signature and Title of EPA Enoloveo. Time, Date)
Order received by
(Signature and Title of Person i.'amed Above)
For infcr:v;ition concern inn this iloi; Sale, Use, or Hcir.ovd i Orocr, contact:
Naii'.e and fide
Phone No.
Address (Regional Office)
Exhibit i
13-9
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IN THE UNITED STATES DISTRICT COURT FOR THE
DISTRICT OF
United States of America
v.
Complaint In Rera
TO THE HONORABLE JUDGE OF SAID COURT:
This is a complaint in rem filed in behalf of the United States of
America by the United States Attorney for this District, who represents
as follows:
I
This complaint prays the seizure for condemnation and confiscation
in accordance with the provisions of the Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. 135-135k) of (CAPTION OF COMPLAINT), a
product intended to be used as an economic poison within the meaning of
the act.
Exhibit 2a
13-10
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II
On or about , 19_
the product was transported by
from
to
and the product remains unsold or in the original unbroken packages
and is now in the possession of
or elsewhere within the jurisdiction of this Honorable Court.
Ill
The product is labeled, marked, and branded (in part) as follows:
Exhibit 2a
13-11
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WHEREFORE, in consideration of the premises, your complainant
prays:
(a) That the product be proceeded against and seized for con-
demnation and confiscation, and that it be disposed of as the Court
may direct in accordance with the provisions of section 9 of the act
(7 U.S.C. 135g) and in conformity with the practice of this Court, and
that the parties specified in paragraph II of this complaint and any
and all other persons having or pretending to have any right, title
or interest in and to the product be notified to appear herein in or-
der that they may answer all and singular the allegations herein set
forth.
(b) That this Honorable Court may enter all such orders, decrees,
and judgments as may be necessary in the premises to grant further re-
lief to your complainant and for the costs of this proceeding should
such costs not be satisfied out of the proceeds of the sale of the prod-
uct, if this Honorable Court should decree the same to be sold.
(c) That your complainant may have such other and further relief
as the nature of the case may require.
United States Attorney for the
District of
Exhibit 2a
-------
Office of the General Counsel
Honorable David J. Cannon
United States Attorney
390 Federal Building
517 East Wisconsin Avenue
Milwaukee, Wisconsin 53202
Dear Mr. Cannon:
Subject: United States of America v. 229 containers, more or less,
each containing 5 units, of a product labeled in part
"HARRIS1 ORIGINAL GENUINE 'ANT BUTTONS'"
I.F.&R. No. 1303
There are transmitted herewith the original and copies of a proposed
complaint under .the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 135-135K) with the request that the complaint be filed
by you in the subject matter.
The subject product is an economic poison within the meaning of the
Act and fails to comply with the provisions of the Act as is speci-
fically set forth in the proposed complaint. The date of shipment
and the shipper and receiver of said product are also specified
in the complaint.
It is respectfully requested that this office be informed of all
the actions taken in this case. It is particularly important that
we be informed of the date of the filing of the complaint and fur-
nished with two copies of the final decree since the Act requires
that this Agency publish a notice of judgment in these cases.
Upon request from you, we will be glad to render such assistance
as you may desire in the preparation and prosecution of this case.
Please feel free to contact me with respect to any questions or
requests for information.
If it appears that the case will be contested, we will furnish you
with the evidence necessary to prove the allegations set forth in
the complaint.
Sincerely,
Assistant General Counsel
Exhibit 2b
13-13
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IN THE UNITED STATES DISTRICT COURT FOR THE
EASTERN DISTRICT OF WISCONSIN
United States of America )
v .
containers, more or less
229
containing 5 units, of a
labeled in part "HARRIS*
GENUINE 'ANT BUTTONS'"
each)
product )
ORIGINAL )
TO THE HONORABLE JUDGE OF SAID COURT
Complaint In Rem
This is a complaint in rem filed in behalf of the United States
of America by the United States Attorney for this District, who
represents as follows:
This complaint prays the seizure for condemnation and con-
fiscation in accordance with the provisions of the Federal In-
secticide, Fungicide, and Rodenticide Act (7 U.S.C. 135-135k) of
229 containers, more or less, each containing 5 units, of a
product labeled in part "Harris* Original Genuine 'Ant Buttons'",
a product intended to be used as an economic poison within the
meaning of the Act.
II
On or about August 10 and 16, 1971, the product was trans-
ported by Harris Products Company from Miami Beach, Florida, to
Yahr-Lange Incorporated, 800 Wall Street, Elm Grove, Wisconsin,
and the product remains unsold or in the original unbroken
packages and is now in the possession of Yahr-Lange Incorporated,
800 Wall Street, Elm Grove, Wisconsin, or elsewhere within the
jurisdiction of this Honorable Court.
The product
follows :
III
is labeled, marked, and branded (in part) as
Exhibit 2b
13-14
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HARRIS1 ORIGINAL GENUINE
"ANT BUTTONS"
KILLS ANTS
CERTAIN
WATERBUGS, FLIES, ROACHES, INSECTS, SIVLERFISH
* * *
IV
The product is an economic poison within the meaning of the
Act and it is not registered pursuant to the provisions of Section
4 of the Act (7 U.S.C. 135b).
WHEREFORE, in consideration of the premises, your complainant
prays;
(a) That the product be proceeded against and seized for
condemnation and confiscation, and that it be disposed of as the
Court may direct in accordance with the provisions of Section
9 of the Act (7 U.S.C. 135g) and in conformity with the practice
of this Court, and that the parties specified in paragraph II
of this complaint and any and all other persons having or pre-
tending to have any right, title or interest in and to the
product be notified to appear herein in order that they may answer
all and singular the allegations herein set forth.
(b) That this Honorable Court may enter all such orders,
decrees, and judgments as may be necessary in the premises to
grant further relief to your complainant and for the costs of
this proceeding should such costs not be satisfied out of the
proceeds of the sale of the product, if this Honorable Court
should decree the same to be sold.
(c) That your complainant may have such other and further
relief as the nature of the case may require.
United States Attorney for the
Eastern District of Wisconsin
Exhibit 2b
13-15
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
REPORT OF SUPERVISION OF DISPOSITION OF PESTICIDE OR DEVICE
Pesticide or Device Detained Under
(Stop Sale, Etc., Order; Seizure by Marshal;
(EPA Seizure (warrant); Voluntary Recall; Give Place and Date of Detention)
ID No., IF&R No., Court No.
Name of Pesticide or Device
Amount of Pesticide or Device
Nature of Violation
Type of Disposition Order or Agreement
(Consent Decree; Voluntary Reconditioning;
Court Ordered Destruetion; EtcTj
Method of Disposition
(Reformulate; Relabel; Destroy; Etc.)
Results of Disposition Action
(IN COMPLIANCE - Relabeled; Etc., NOT IN
COMPLIANCE - Ineffective- by Test; Etc.; Give Test Results, Etc.)
Further Action Required
(NONE or, Further Reformulation; Relabeling; Etc.)
Remarks
(Signature and Title of EPA EmployeeJ
(PIace and Date)
Exhibit 3
13-16
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
VACATION OF STOP SALE, USE, OR REMOVAL ORDER
(DATE)
PERSON ORDERED} I. D. NO. (S)
("NAME OF~C~OI-;PANY)
(ADDRESS)
It has been determined that ___^ of the pesticide or device
[Amount)
named in the Stop Sale, Use, or Removal Order dated
has been
(Method of disposition, ie., Registered, Relabeled, Destroyed, etc.]
as of . Therefore, the Stop Sale, Use, or Removal
" (Date of Disposition)
Order is vacated concerning the amount of the pesticide or device stated
above. Any other 'amounts of the pesticide or device affected by the order
shall remain under the effect of the order until disposed of in the manner
described above.
(AUTHORIZED EPA OFFICIAL)
TTITLET
Exhibit 4
13-17
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HI Effi UJintD STATES DISTRICT COUI
SOUIHLRN ounicr or MISSISSIPPI
FILED
OCT4 1971
ROBERT C. THOMAS. CLERK
FOR TUB SOUmOUI DISTRICT OF MISSICSII'IT
JAC120IJ DIVISION
CIVIL ACHOH 110. U?77
UHTJED MATES OF Al-ffiRICA,
Plaintiff
vs.
72 FIVE-CALLOU CMS, MORE OR LESS,
OF A 1T.OSUCT LABELCD TJ7 PART "DCVJ
E01TRON 2^5 O.G. BRUSH Ai!D WEiiD
KIIJU3R
CQNSEi--?T DECREE
It appoarinc unto the Court that tlie nbovc descrited respon-
dent property has been relabeled since the commencement or this action
and has been brought into compliance vith the provisions of the Federal
Insecticide, Funcicide and Hodenticide Act; and that but one claimant,
Bow Chemical Company, lias appeared in this action within the time
provided in the notice of action and arrest published pursuant to the
order of this Court and it further appearing unto the Court that the
United States of America and said claimant have consented to the entry
of this decree;
It is Ordered and Adjudged that the above described property
bo and is hereby forfeited to the uce of the United States.
It ic' further Ordered that said property having now been
brought into compliance vith said act that said forfeiture be remitted
and that the United States Marshal do deliver said property unto the
Bow Chemical Company upon the payment by the Dow Chemical Company of
the costs of this action v/hich are hereby fixed in the sum of $35.20
•which CUQ includes tho fee for executing this order.
Exhibit 5a
13-18
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/ -
ORDERED AND ADJUDGED thic ^ i' day of September, 1971.
s/ Don .'.'. Russell, Jr.
tlHITZD i/IATjJiJ DIGIJUCT JUDGE"
Approved:
U1II1ID STATES OF AMERICA
Plaintiff
nODERT E. IIAUliERG
United States Attoniey
;. JJRC-JH, Ji
Aeoictajit United States Attorney
HIE DCT-J C1IE.5ICAL COMPAIIY
Claimant
By;
Attorney
W. A. Groenins, Jr.
Vice President and
Assistant Secretary
Exhibit 5a
13-19
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UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF WISCONSIN
UNITED STATES OF AMERICA,
Complainant, Case No. 72-C-178
-x-
vs
229 containers, more or less, each DEFAULT DECREE OF
containing 5 units, of a product *
labeled in part "HARRIS1 ORIGINAL CONDEMNATION
GENUINE "MIT BUTTONS" *
On March 28, 1972, a Complaint against the above described
article of hazardous substance was filed on behalf of the United
States of America, the Complaint alleges that the aforesaid article
of hazardous substance was a product intended to be used as an
economic poison within the meaning of the Federal Insecticide, Fungicide,
and RodeAticide Act. Pursuant to monition issued by this
Court, the United States Marshal for this district seized said article
on March 30, 1972.
It appearing that process was duly served herein and
returned according to law; that notice of the seizure of the above
described article was given according to law; and that no persons have
appeared or interposed a claim before the return day named in said
process;
NOW, THEREFORE, on motion of David J. Cannon, United
States Attorney for the Eastern District of Wisconsin, by David B.
Bukey, Assistant United States Attorney in said district, for a
Default Decree of Condemnation, the Court being fully advised in the
prera£ses§> it is:
Exhibit Sb
13-20
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ORDERED, ADJUDGED AND DECREED, that the default of all
persons be and the same are entered herein; and it is further
ORDERED, ADJUDGED AND DECREED, that the article so seized
was a product intended to be used as an economic poison within the
meaning of the Federal Insecticide, Fungicide, and Rodenticide Act,
and is condemned and forfeited to the United States; and it is further
ORDERED, ADJUDGED AND DECREED, that the United States
Marshal in and for the Eastern District of Wisconsin do forthwith
destroy the seized article and make return to this Court.
Dated at Milwaukee, Wisconsin, this 2kth day of May, 1972.
United States District Judge
Exhibit 5b
13-21
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
CHARGES FOR SUPERVISION OF DISPOSITION OF PESTICIDE OR DEVICE
[Attach to Report of Supervis'ionT
ID No., IF&R No., Court No.
Name of Pesticide or Device
Amount of Pesticide or Device
Method of Disposition
Type of Charges
Inspector Time
Analyst Time
Inspector Per Diem
Analyst Per Diem
Inspector Automobile Use
Analyst Automobile Use
Other Transportation or
Miscellaneous Expenses
(itemize)
Sub-Totals
Grand Total
Unit
Hours
^_-__^
"^\
>\N
t\ - . . f.
uays
^^^
\j
^--^
Miles
\^
^
"^-^
^-^
^\
Charge
Per Unit
^"^\^
^^-__
Total
Charge
Remarks:
Exhibit 6
13-22
(Signature of Inspector or Analyst)
-------
14
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SECTION 14
DISPOSAL
-------
DISPOSAL
Authority Sec. 19 of the Act as amended.
EPA, in cooperation with other interested Federal agencies,
establishes procedures and regulations for the disposal or
storage of packages and containers of pesticides and for dis-
posal or storage of ejccess amounts of such pesticides, and will
accept at convenient locations for safe disposal, a pesticide
whose registration has been cancelled, if requested by the owner
of the pesticide.
Inquiries concerning disposal of pesticides should be
referred to the Office of Categorical Programs.
14-1
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15
-------
SECTION 15
REPLIES
-------
REPLIES
I. Authority
Section 9(c) authorizes that any person notified of a
violation shall be given an opportunity to present his
views, either orally or in writing. However, the Agency
is not obliged to respond to this person's reply.
II. Procedure
A. Firm's reply to a notice of contemplated criminal
proceedings
If the reply does not refute the allegations, does not
ask any questions, 01 does not make incorrect state-
ments or assumptions, no response to the letter is
required. The letter is placed in the ID jacket for
future consideration with other evidence contained in
the file.
B. Firm's reply to a notice of contemplated civil
proceedings
The "Rules of Practice Governing Hearings in the
Assessment of Civil Penalties Under the FIFRA" should
be followed in all civil proceedings.
If a firm denies an allegation, a hearing will be
scheduled. However, it may be desirable to make a
reply to the firm's denial in addition to preparing
for a hearing.
15-1
-------
In cases where a firm denies a charge of the complaint
and it is determined that the charge is inaccurate,
the firm may be notified in writing and by telephone
that the charge will be dropped and that a settlement
may still be reached on the other charges prior to a
hearing.
In cases where the firm does not fully understand the
allegations and denies them, a reply may be made to
the firm explaining the charges in further detail.
In any discussions: the opportunity for a hearing should
be emphasized, the information concerning the conduct
of the hearing should be provided, and the possibility
of settlement without a hearing, with approval of the
Administrative Law Judge if a hearing is scheduled,
should be stressed. Refer to Section 7 of this manual
for further information regarding Civil Proceedings.
C. Firm's reply to a notice of warning
If the reply does not refute the allegations, does not
ask any questions, or does not make incorrect statements,
no response to this letter is required. This letter
is included in the file and the case is placed in
permanent abeyance without further notification to the
firm.
15 - 2
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III. Format
When the firm's reply to the Agency's initial action does
refute the allegations, does ask questions, or does make
incorrect statements, the Agency should respond to that
reply.
The Agency's written response to a firm's reply consists
of three parts:
A. The first part, the heading, includes the subject ID
number as well as the usual letter heading information
B. The second part, the body of the letter, includes an
acknowledgement of any comments made by the firm
and a response to the refutations, questions, or in-
correct statements. See Exhibit 1 for commonly used
statements.
C. The third part, the ending, will indicate the status
of the case. The following statements are the commonly
used endings: (Exhibit 2)
1. The endings E126 or E127, will place the notice
of contemplated proceedings in abeyance for
further consideration.
2. The endings E128 or E129 will place the notice of
contemplated proceedings in permanent abeyance.
3. The endings E151 or E152 will place the notice of
warning in permanent abeyance.
15-3
-------
NOTE: AGENCY RESPONSES SHOULD BE LIMITED TO THE ALLEGED
VIOLATION AND SHOULD NOT BE CONCERNED WITH EXPLANATIONS
OF REGISTRATION POLICIES.
IV. Examples of Agency Responses
Some questions are frequently asked in connection with our
enforcement actions. The following exhibits are some
examples of our responses to the questions regarding:
A. Registration
1. Registration/non-registration options (Exhibit 3)
2. Removal of a product from the purview of the Act
(Exhibit 4)
3. Private consultant services and disposal of improperly
labeled material (Exhibit 5)
4. Amended registration procedures (Exhibit 6)
5. Distributor registration procedures (Exhibit 7)
6. Effective date of cancellation (Exhibit 8)
7. Procedures for transfer of registration (Exhibit 9)
B. Labeling
1. New unaccepted claims and directions (Exhibit 10)
2. Disposition of material bearing old claims and
directions which are no longer acceptable (Exhibit 11)
C. Analytical Test
Products which decompose (Exhibit 12)
15-4
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D. Efficacy Tests
1. Independent laboratory test results which differ from
those of EPA (Exhibit 13)
2. The Agency's policy on testing unofficial samples
(Exhibit 14)
E. Samples
The availibility of a portion of the official sample for
independent testing (Exhibit 15)
F. Sampling
The evidence of a violation (Exhibit 16)
G. Guaranty
1. The responsibility of the shipper (Exhibit 17)
2. The validity of a guaranty (Exhibit 18 a,b)
15 - 5
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V. MEMOS OF INFORMAL CONFERENCES/TELEPHONE CONVERSATIONS
A. Informal Conferences
As specified in Sec. 9.c. of the Act, the firm may
wish to present its views orally. If so, the person
who initiated the action as well as other appropriate
officials in the regional office should attend this
informal conference with representatives of the firm.
Notes taken of the proceedings at this informal confer-
ence should be incorporated into a memo, usually written
by the person who initiated the enforcement action. This
should be placed in the ID jacket.
B. Telephone Conversations
Notes should be made of all telephone conversations
with the firm. The note will identify the appropriate
ID No. and relate the substance of the conversation. The
firjm should be asked to confirm in writing any corrective
action which they plan to take.
15 - 6
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E-101. Any further correspondance relating to registration and
labeling for (this/these) product(s) should refer to
- , and be addressed to Mr. Alvin K.
Chock,Chief, Application/Records Control Branch,
Registration Division, Environmental Protection Agency,
Washington, B.C. 20250.
E-102. We note the steps taken by your company to withdraw this
lot of material from the market. When your recall action
is completed, please inform us of the amount and disposition
of any material returned.
E-103. A seized product may be disposed of only in accordance
with Section 13 (c) of the Act. This section authorizes
release of a seized product to its owner after condemnation
of the product and upon payment of court costs and delivery
of a bond conditioned that the product shall n.ot be sold
or otherwise disposed of contrary to the provisions of the
Act. We would not object to release of the compliance with
the Act. Such procedure must be agreeable to the United
States Attorney and Court.
Exhibit 1
15 - 7
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E-126. The Agency has decided to hold this case open for
further consideration.
E-127. Your comments concerning the violation of the Act
have been made a part of the official file for your
company and will be considered in our further review
of this matter.
E-128. The Agency has decided to take no further action in
this case. This decision relates to the specific case
in question and does not bar action on other cases
should circumstances warrant.
This letter is intended to serve as a notice of warning
within the meaning of Section 9 of the Act.
E-129. The Agency has decided to take no further action in
these cases. This decision relates to the specific
cases in question and does not bar action on other
cases should circumstances warrant.
This letter is intended to serve as a notice of warning
within the meaning of Section 9 of the Act.
E-151. We have decided to take no further action in (a. this
case) (b. these cases). This decision relates to the
specific (c. case) (d. cases) in question and does not
bar action on other cases should circumstances warrant.
E-152. We have closed our files in (a. this case) (b. these
cases).
Exhibit 2
15 - 8
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Chemical Associates, Inc.
Attention: Mr. George Warren
Post Office Box 1876
Houston, Texas 77001
Gentlemen:
Subject: ID No. 80397 - HOMCARE SWIPE BRITE TOILET BOWL CLEANER
This will acknowledge your letter of May 13, 1971.
Interstate shipments of this unregistered product bearing economic
poison claims would be in violation of the Act. If you do not
wish to register the product, the economic poison claims listed in
our notice of November 13, 1970, should be deleted and copies of
the revised label should be submitted for review in connection
with this case. However, if you wish to ship the product in
interstate commerce as an economic poison, the applications enclosed
with our notice of November 13, 1970, should be submitted to the
Registration Division, Office of Pesticides Programs.
Please inform us of your decision regarding registration of this
product and the action you are taking to insure that no further
interstate shipments of this product are made before the product
is registered or the economic poison claims are deleted from its
1 ab e 1.
We will hold this case open pending your reply.
Sincerely yours,
Exhibit 3
15 - 9
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Champion Product's, Inc.
Attention: Mr. H. H.
4939 South Austin Avenue
Chicago, Illinois 60638
Gentlemen:
Subject: ID No. 68277 - WEATHERMASTER WATER REPELLENT AND
MILDEW RESISTANT COMPOUND FOR HEAVY
DUTY CANVAS
This will acknowledge comments made in your letter of March 23, 1971
The revised label enclosed with your letter bears no claims which
would identify the product as an economic poison. Unless economic
poison claims are made elsewhere either orally or in writing, the
product would no longer be subject to the provisions of the Act.
The Agency has decided to hold this case open for further consider-
ation .
Sincerely yours,
Exhibit 4
15 - 10
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Lystads, Inc.
Attention: Mr. R. G. Miner
901 University Avenue
Grand Fords, North Dakota 58201
Gentlemen:
Subject: I..D. No. 74484 - LYSTADS GRAIN FUMIGANT 73
Reference is made to your letter of November 10, 1970. The
application for registration and labeling enclosed with your
letter are being forwarded to the Registration Division for
review.
Further interstate shipments of this unregistered product
would be in violation of the Act. Therefore, it is suggested
that no relabeling of your present stocks be made until the
finished label has been accepted. When registration has been
completed, a paper label which conforms to the one accepted,
could be glued over the labeling which is lithographed on
your present stocks of this material.
With respect to reviewing and registering products, we are
not familiar with any firms which provide such a service.
However, the Registration Division Office of Pesticides
Programs is available to answer any questions which you
have regarding product registration. Any further correspon-
dence should be addressed to Mr. Alvin K. Chock, Chief
Application Records Control Branch, Registration Division,
Environmental Protection Agency, Washington, D. C., 20250.
The Agency has decided to hold this case oper for further
consideration.
Sincerely yours,
Exhibit 5
15 - 11
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National Laboratories
Attention: Mr. Michael I. Gastman
Lehn § Fink Industrial Products
Division of Sterling Drug, Inc.
225 Summit Avenue
Montvale, New Jersey 07645
Gentlemen
Subject:
I.D.
I.D.
I.D.
I .D.
I .D.
No.
No.
No.
No.
No.
62053
63195
66589
73186
78836
- DUEL
- DUEL
- DUEL
- DUEL
- DUEL
DISINFECTANT
DISINFECTANT
DISINFECTANT
DISINFECTANT
DISINFECTANT
DEODORANT
DEODORANT
DEODORANT
DEODORANT
DEODORANT
This will acknowledge comments made
17, 1970.
in your letter of March
Draft copies of the label bearing the proposed changes should
be submitted to the Registration Division Office of Pesti-
cides Programs for review. We are enclosing PR Form 9-198,
for use in application for amended registration of the pro-
duct .
Any further correspondence relating to registration and
labeling for this product should be addressed to Mr. Alvin
K. Chock, Chief Application Records Control Branch, Registration
Division, Environmental Protection Agency, Washington, D. C.,
20250.
The Agency has decided
consideration.
to hold this case open for further
Sincerely yours,
Exhibit 6
15 - 12
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Hart - Dalta, Inc.
Attention: Mr. William H. Lockard
Post Office Drawer 340
Zachary, Louisiana 70791
Gentlemen:
Subject: I.D. No. 75528 - RICHEY ANIMAL HOSPITAL PET SPRAY
This will acknowledge comments made in your letter of May
19, 1971, with enclosures.
If your firm wi
ANIMAL HOSPITAL
application for
for your firm.
from the label.
Animal Hospital
such as "Packed
labels enclosed
shes to be listed as a distributor of RICHEY
PET SPRAY, the registrant should submit an
distributor registration of this product
Otherwise, your firm's name should be deleted
In addition, the distributor's name, Richey
, should be qualified by appropriate wording
for", "Distributed by", or "Sold by" on the
with your letter.
We have decided to take no further action in this case. This
decision relates to the specific case in question and does
not bar action on other cases should circumstances warrant.
Sincerely yours,
Exhibit 7
15 - 13
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Crown Chemicals
Attention: Mr. M. G. Stack
4995 North Main Street
Rockford, Illinois 61101
Gentlemen:
Subject: I.D. No. 99231 - CROWN VAPONA SPRAY SOLUTION
This will acknowledge your letter of May 10, 1972 with
enclosures .
We note your comments regarding the receipt of the Notice of
Cancellation for Reg. No. 7273-25. However, in accordance
with the act, cancellation procedures are invoked thirty
days after receipt of the notice of intent to cancel unless
the procedures set forth in Section 4.c. are initiated. PR
notices serve as this notice of intent to cancel. Please
refer to the underlined section of the enclosed PR Notice
71-3. It is the responsibility of the registrant either to
invoke one of the procedures specified in the notice of in-
tent to cancel or to cease interstate shipments of the pro-
duct within thirty days after receipt of this notice.
You should assure yourself that the product with the label
bearing Reg. No. 7273-25 is no longer shipped in interstate
commerce.
Your comments concerning the violation of the Act have been
made a part of the official file for your company and will
be considered in our further review of this matter.
Sincerely yours,
Exhibit 8
15 - 14
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Grain's Manufacturing § Distributing Company
Attention: Mr. Harold Grain
P. 0. Box 9309
Houston, Texas 77011
Gentlemen:
Subject: I.D. No. 84168 - PERFUMED MOTH $ MILDEW BLOCK
This will acknowledge comments made in your letter of June
29, 1971.
The registration of this product has not been transferred
from McCreight Products Company to Grain's Manufacturing
and Distributing Company. To effect the transfer, it is
required that a notorized certificate of assignement be
submitted to the Registration Branch indicating the terms of
the sale and the extent to which we may have in our files.
Interstate shipments of the product without benefit of
registration for your company would be in violation of the
Act.
Your comments concerning the violation of the Act have been
made a part of the official file for your company and will
be considered in our further review of this matter.
Sincerely yours,
Exhibit 9
15 - 15
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Nationwide Chemical Corporation
Attention: Mr. W. T. Wright
P.O. Box 775
Fort Meyers, Florida 33902
Gentlemen:
Subject: ID No. 74084 - ISOBAC 20 LIQUID SOIL FUNGICIDE
This will acknowledge comments made in your letter of June
5, 1970, with photocopy enclosed.
A product may not bear claims and directions for use which
differ in substance from the representations made in connection
with its registration, regardless of the acceptance of the use
in the "Annotated Index of Registered Fungicides and Nemati-
cides." Since the claim was not accepted in connection with
the product's amended registration on December 5, 1966, any
marketing of this product bearing this claim and direction
is in violation of the Act. The label and accompanying
literature bearing the claim and direction for use of the
produce against boll-rot should be submitted for amended
registration of the product or this claim and direction
should be deleted.
Please inform us of the action you will take in this matter.
Sincerely yours,
Exhibit 10
15 - 16
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Chevron Chemical Company
Ortho Division
Attention: Mr. R. D. Wessel
940 Hensley Street
Richmond, California 94804
Gentlemen:
Subject: ID No. 83549 - ORTHOCIDE 50 WRITABLE
This will acknowledge comments made in your letters of
February 9 and 24, 1971.
After the effective date of change in labeling or formula,
a product may only be shipped under the new claims or formula.
However, a registrant may request an extension for a specific
time period for disposition of the remaining stocks under
the old formula or labeling. Since no extension was requested
by your firm, the deletion of the claim for use of the product
on potatoes was effective on the date that the amended labeling
was accepted.
Your comments concerning the violation of the Act have been made
a part of the official file for your company and will be considered
in our further review of this matter.
Sincerely yours,
Exhibit 11
15 - 17
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ABC Company
Attention: Mr. Edward Edwards
5 North Street
Onalaska, Wisconsin 52407
Gentlemen:
Subject: ID No. 45 - MALATHION 101
This will acknowledge your letter of May 2, 1971.
We understand that malathion decomposes. However, it is your
responsibility to insure that a product contains the composition
represented on its label. We would have no objection to an
overformulation of malathion. However, the Registration Division,
Office of Pesticides Programs, should be contacted for the
acceptable rate of overformulation for this type of product.
The Agency has decided to hold this case open for further
consideration.
Sincerely yours,
Exhibit 12
15 - 18
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Peterson Filling § Packaging Company
Attention: Mr. Montfort A. Johnsen
Hegeler Lane
Danville, Illinois 61832
Gentlemen:
Subject: ID No. 66474 - HUNTOLENE BACTERIOSTATIC DUST CONTROL
This will acknowledge your communications of July 15 and August
7, 1969, in reply to our certified letter of July 10. The
"Mixing Instructions" and the Huntington Laboratory reports
enclosed have been noted.
We do not question your contention that Huntington Laboratories
is a capable and quality-conscious company. However, the efficacy
data reported in their laboratory evaluations of July 16, are
opposed to the findings in the Agency's laboratory and we do not
believe that they provide an accurate index to the practical
bacteriostatic benefits claimed. We note that in the absence of
added moisture, no measurable zones of inhibition were obtained
with either the aerosol or liquid concentrate. The Agency's
tests were conducted with samples of the aerosol and the only
moisture present was that furnished by the seeded agar and room
humidity. This, we believe, represents "use as directed."
Even so, the moisture in the seeded agar plate should provide a
more favorable situation than could be expected in actual use.
We fail to see any justification for testing with added water
since this would not represent realistic application.
Your comments concerning the violation of the Act have been made
a part of the official file for your company and will be considered
in our further review of this matter.
Sincerely yours,
Exhibit 13
15 - 19
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Motomco, Inc.
Attention: Mr. W. H. Dollen
89 Terminal Avenue
Clark, New Jersey 07066
Gentlemen:
Subject: ID No. 70486 - MOTOMCO WARFARIN - S CONCENTRATE
This will acknowledge comments made in your letter of June 9, 1970,
The Agency does not conduct tests on independent samples supplied
by the manufacturer. However, a copy of the test method used to
evaluate rodenticide concentrates is enclosed for your own use in
testing this product. The standard laboratory diet referred to in
this test method consists of 65% corn meal, 25% rolled oats, 5%
sugar, and 5% vegetable oil. Only table grade raw ingredients
are used. An acceptance of 33% and mortality of 95% would be
expected in order to consider the product effective in the
commensal rats' environment. In our testing, no difference
in acceptance or mortality has been found between warfarin and
prolin.
The Agency had decided to hold this case open for fur-ther
consideration.
Sincerely yours,
Exhibit 14
15 - 20
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Nu-Tone Products Company, Inc.
Attention: Mr. E. W. Hayes
P. 0. Box 5668
Terminal Annex Station
Denver, Colorado 80217
Gentlemen:
Subject: ID No. 74381 - HEXACLEAN CONCENTRATE CLEANER
Reference is made to your letter of May 18, 1971.
A portion of the sample of HEXACLEAN CONCENTRATE CLEANER which
was collected by our Inspector on January 15, 1971, is being
sent to you for analysis. A copy of our analytical procedure
is enclosed. A second procedure was taken from the Official
Methods of Analysis of the AOAC, 10th edition, paragraph 4.188
(1965). When your analysis of the sample is completed, please
inform us of your results.
Sincerely yours,
Exhibit 15
15 - 21
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Vylon
Attention: Mr. Howard W. Joplin
Post Office Box 1552
Dallas, Texas 78421
Gentlemen:
Subject: I.D. No. 99337 - VYLON BUG KILLING COMPOUND
This will acknowledge comments made in your letter of
November 9, 1971.
Upon advisement of the State of Nebraska, the product was
sampled by an inspector of the Environmental Protection
Agency. An affadavit signed by Mr. Willard B. Wilson of
McCool Locker and Cafe and the cancelled check #1808,
endorsed by you, indicate that you shipped the product in
interstate commerce. Since the product is an economic
poison within the meaning of the Act, it has been alleged
that the interstate shipment was in violation of the Act
as specified in our notice of contemplated criminal pro-
ceedings of October 21, 1971.
The Agency has decided to hold this case open for further
consideration.
Sincerely yours,
Exhibit 16
15 - 22
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Pesticides Enforcement Division
AIR MAIL
Fuller-O'Brien Corporation
Attention: Mr. N. J. Hartzer
450 East Grand Avenue
South San Francisco, California
Gentlemen:
94080
Subject: I.D. No. 98586 - WILLARD QUALITY PRODUCTS CREOSOTE
Reference is made to your letter of September 26, 1972, with
enclosures.
As the shipper of this product in interstate commerce, you are
responsible for the violation which occured. In the future,
you may wish to establish a guaranty as provided in Sec. 7(a)(l)
of the act, Paragraph 362.11 of the regulations, and Inter-
pretation Number 11, copies enclosed. When a guaranty is
established, the guarantor is subject to the penalties which
would otherwise attach to the person holding the guaranty.
The Agency has decided to hold this case open for further
consideration.
Sincerely yours,
A. E. Conroy
Director
II
3 Enclosures
Exhibit 17
15 - 23
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Western Ogden Purifier Corporation
Attention: Mr. George S. Baker, Jr.
7063 Vineland Avenue
North Hollywood, California 96605
Gentlemen:
Subject: I.D. No. 72331 - OGDEN WATER PURIFIER MODEL "A"
SERIES REPLACEMENT CARTRIDGE
TYPE SMI
Reference is made to your letter of February 15, 1971.
The guaranty dated February 8, 1971, which was enclosed
with your letter, is not valid. To be valid, a guaranty
must: (1) be signed and contain the name and address of
the person giving it; and (2) state that the economic
poison was lawfully registered at the time of sale and
delivery and that it complies with all other requirements
of the Federal Insecticide, Fungicide, and Rodenticide
Act (362.11(c) of the Regulations). Please refer to the
enclosed marked copy of the Regulations (362 .11(f)(2)
which provides for a general and continuing guaranty.
Since the guaranty is not valid, your firm is responsible
for the violation which occured. We again request that
you inform us of the action you are taking to insure that
no further interstate shipments of this unregistered pro-
duct will be made.
We will hold this case open pending your reply.
Sincerely yours,
Exhibit 18a
15 - 24
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Law Offices
Attention: Mr. Ivon B. Blum
Blum and Propper
United California Bank Building
9601 Wilshire Boulevard
Suite 409
Beverly Hills, California 90210
Gentlemen:
Subject: I.D. No. 75925 - ANT JEX REDWOOD ANT STAKES
Sunset House
Beverly Hills, California
Reference is made to your letter of March 23, 1971 with
enclosures.
In order that we may complete our evaluation of this matter,
it will be necessary that the guarantee form submitted
with your letter be dated. It is noted that Mr. Richard
P. Cooley of General Pest Service Co. signed the form
regarding Registration No. 3324-3. However, he failed
to state the date such guaranty was undertaken.
We will hold this case open pending receipt pf the completed
guarantee form.
Sincerely yours,
Exhibit 18b
15 - 25
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16
-------
SECTION 16
CRIMINAL PROSECUTION
-------
CRIMINAL PROSECUTION
A. Authority and Basis
Section 14(b)authorizes the institution of criminal prosecution
against any person who knowingly violates any provisions of this
Act. Criminal proceedings will be instituted when the
circumstances surrounding an alleged violation indicate that
(1) the person cited has a history of flagrant violations of
the Act, (2) the acts cited constitute an extreme and unreason-
able risk to man or to the environment, or (3) the violation
is of a type which is likely to be continuous or repeated.
Criminal proceedings may be initiated in response to virtually
any violation of the Act. The Agency intends, however, to
use criminal prosecutions only in instances of aggravated
violations of the Act.
B. Preparation
The notice of contemplated criminal proceedings is the
first step in the criminal prosecution process. However,
it should be noted that Section 9(c) (2) of the Act
specifies that this notice is not a prerequisite to the
institution of criminal proceedings.
After all correspondence appears to be completed one or
more notices of contemplated criminal proceedings, the
evidence in these ID jackets is reviewed. If this review
shows that criminal prosecution is still warranted, the
prosecution file may be compiled in the following manner:
16-1
-------
Documentary evidence
This section exhibits all evidence from each ID jacket
which is needed to prove the alleged violation. The
evidence from each ID jacket is arranged in a prescribed
order to form the ID case. (Exhibit 1) The ID
cases are placed in the prosecution file by chronological
sequence beginning with the ID case having the earliest
date of shipment or producer establishment inspection.
This sequence is used so that the U. S. Attorney will
note the progressive history of the violations.
Dun § Bradstreet Report
This report is included in the prosecution file to
show the financial status of the firm. This infor-
mation may become relevant in determining a fine.
Case Summary
por each ID case there may be prepared a summary of
the information included in the case. The summary is
divided into three separate parts:
a. a list of the relevant facts (optional)
b. a list of the alleged violations (optional)
c. a list of the documentary evidence.
(Exhibits 2a,b,c.)
Recommendation for Prosecution
A brief statement titled "Recommendation For Prosecution"
may be prepared which factually and reliably presents
the reasons for recommending prosecution. These
16-2
-------
reasons may include those associated with alleged
violative shipments which have been PA'd. Items such
as the following, may be included in the "Recommendation
For Prosecution" statement:
a. Date(s) on which registration was issued for the
firm's first and most recent product(s).
b. Number of products registered.
c. Approximate length of time since first written
notice of violation was issued.
d. Number of seizures instituted.
e. Number of formal recalls requested.
f. Number of written notices of violation issued during
a recent specified period of time.
g. Number of samples collected with percentage of
violations during a recent specified period of
time.
h. Statement regarding repeated violations.
i. Statement regarding serious violations with the
likely or probable consequence to the public and/
or environment.
j. Statement regarding failure by defendant to promptly
initiate corrective measures.
16-3
-------
The "Rec9mmendation for Prosecution" statement may be
concluded with the following: "Members of our staff are
prepared to assist you in the preparation and prosecution
of this case." (Exhibit 3)
5. Proposed Information
This document is prepared for the U. S. Attorney by this
Agency in order to expedite the filing of the prosecution
case. (Exhibit 4)
6. Transmittal Letter
The prosecution case will be referred directly to the
U. S. Attorney with a transmittal letter. (Exhibit 5)
NOTE: AFTER A CRIMINAL ACTION HAS BEEN TAKEN AGAINST A FIRM,
NO FURTHER CIVIL OR CRIMINAL ACTION WILL BE TAKEN ON
SAMPLES WHICH WERE SHIPPED OR COLLECTED BEFORE THE
INFORMATION WAS FILED. HOWEVER, IN CASES WHERE A HAZARD
OR INEFFECTIVENESS EXISTS, A RECALL, SEIZURE, OR STOP
SALE, USE OR REMOVAL ACTION MAY BE TAKEN.
16-4
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Exhibit 1.
Exhibit 2.
Exhibit 3.
Exhibit 4.
Exhibit 5.
Exhibit 6.
Exhibit 7.
Exhibit 8.
Exhibit 9.
Exhibit 10
Exhibit 11
Exhibit 12
Exhibit 13
Label of product
Labeling of product
Document(s) showing intra/interstate shipment(s)
of the product
Invoice(s)
Packing Slip(s)
Dealer's statement that sample was collected from
intra/interstate shipment(s) of the product
Dealer's affidavit that sample was collected
from intra/interstate shipment(s) of the product
Warehouseman's statement that sample was collected
from intra/interstate shipment(s) of the product
Affidavit that sample was collected from intra/
interstate shipment(s) of the product
Notice of inspection
Receipt of samples
Inspector's report of collection of
sample from shipment (s)
History of official sample report
Summary analytical report showing results of
chemical analysis of the sample
Report by chemistry reviewer
Report showing results of microbiological
testing of the sample
Report by disinfectants reviewer with PR Notice 70-12
Report by scientific staff specialist
(Insert title of ID reviewer)
Report by safety reviewer
Report by efficacy reviewer with references
CReferences may include acceptable label or PRO
objection to registration letter, etc.)
Exhibit 1
16-5
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Exhibit 14.
Exhibit 15.
Exhibit 16.
Exhibit 17.
Exhibit 18.
Exhibit 19.
Exhibit 20.
Report by Chief, Records Control Branch, verifying
nonregistration of an economic poison
Memorandum to Office of the General Counsel
recommending seizure
Proposed Complaint In Rem
(Include cover letter if available)
Written notice of violation of July 18, 1969,
with references and certified receipt
Reply of August 3, 1968, from firm
Reply of August 3, 1968, from firm's attorney
Enforcement Division letter of August 25, 1971
Enforcement Division no reply follow-up letter of
October 1, 1971
ADDITIONAL MISCELLANEOUS EXHIBIT STATEMENTS
Purchase Order which also serves as receiving
record
Memorandum of October 28, 1968, from Inspector
who collected the sample
Written request for product recall of July 18, 1968,
with certified receipt
Written notice of determination to cancel registration
of August 10, 1968, with certified receipt
Written notice of suspension of August 10, 1968, with
enclosure and certified receipt
Written notice of Cancellation of Registration of
August 10, 1968, with certified receipt
United States Marshal's Return with attachment
Return Of Service Of Writ
Stop Sale, Use or Removal Order
Memorandum of telephone call on August 1, 1968,
from firm's attorney, requesting a conference
Exhibit 1
16-6
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Memorandum of conference on August 10, 1968, between
firm's attorney and Enforcement Division representatives
Reply of August 3, 1968, with (label, testing report,
Status of Firm) attachment, from firm
Reply of August 3, 1968, with (label, referenced
letter(s)) enclosure, from firm
Enforcement Division letter of August 25, 1968, with
references
Letter of August 5, 1968, from firm to state of
Nebraska with copy to consignee
Label accepted in connection with termination of
suspension of the product, with associated application
from firm, and letter of acceptance from Pesticides
Regulation Division
Statement of December 7, 1968, from Standards Branch
nullifying charge 2 of written notice of violation
Exhibit 1
16-7
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ID No. 86420
P Relevant Facts
1. Shipper
2. Legal status
3. Najne of produce
4. Amount on hand
5. Shipped on
6. Shipped from
7. Shipped to
8. Transported by
Swift Agricultural Chemicals Corp
National Stockyards
East Saint Louis, Illinois 62071
A Delaware Corporation
Joseph P. Sullivan, President
Howard G. Gould, Vice President
Edward R. Vrablik, Vice President
Earl J. Grimm, Jr., Secretary
Paul N. Steinbrink, Treasurer
SWIFT LAWN WEEDER $ FEEDER
300 twenty-pound containers
February 11, 1971
East Saint Louis, Illinois
Janesville, Wisconsin
Delivered by Consignee
Exhibit 2a
16-8
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ID No. 86420
B. Alleged Violations:
1. Stated in part:
SWIFT
LAWN
WEEDER
§ FEEDER
* * * »
Herbicide:
ACTIVE INGREDIENT:
**Dimethyamine salts of
2,4-dichlorophenozyacetic acid 1.221
INERT INGREDIENTS: 98.78%
TOTAL 100.00%
^Equivalent to 2,4-dichlorophenozyacetic acid 1.01%
* * * It
whereas the product contained an additional active ingredient,
namely, 2,4,5-trichlorophenoxyacetic acid, which was not named
in the ingredient statement. [12(a) (1) (E), 86 Stat. 990,
2(q) CO C.A) ; 86 Stat. 977]
2. Adulterated in that another substance, namely, 2,4,5-trichloro-
phenoxyacetic acid, had been substituted wholly or in part for
the article. I12(a) (l) (E), 86 Stat. 990; 2(c) (2), 86 Stat.
97 5J
Exhibit 2b
16-9
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Documentary Material
Copies of the follwing documents are attached in the folder marked
for identification as ID No. 86450.
Exhibit 1.
Exhibit 2.
Exhibit 3.
Exhibit 4.
Exhibit 5.
Exhibit 6.
Exhibit 7.
Exhibit 8.
Exhibit 9.
Exhibit 10
Exhibit 11
Label of product
Document showing interstate shipment of
product
Invoice
Dealer's statement that sample was collected
from interstate shipment of product
Inspector report of collection of sample
from shipment
History of official sample report
Summary analytical report of sample
showing chemical analysis of the product
Report of chemistry reviewer
Written notice of violation of August 3, 1971
Reply of August 17, 1971, from firm
Enforcement Division reply of October 6, 1971
Exhibit 2c
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IN THE UNITED STATES DISTRICT COURT FOR THE
EASTERN DISTRICT OF ILLINOIS
United States of America )
) No.
v. ) Violation: Title 7,
) United States Code,
Swift Agricultural Chemicals Corporation) Section 135 thru 135k
The United States Attorney charges:
Count 1
1. On or about February 11, 1971, the defendant, Swift
Agricultural Chemicals Corporation, shipped in interstate
commerce from East St. Louis, Illinois, within the Eastern
District of Illinois, to Jamesville, Wisconsin, 410 twenty-
pound containers of "Vigoro Rid Crabgrass Preventer", an eco-
nomic poison within the meaning of 7 U.S.C. 135(a).
2. Said economic poison was misbranded in that its
label bore the statement that it contained as an active
ingredient 2.3 percent Dacthal (Dimethyl ester of
tetrachloroterephthalic acid), and such statement was false
and misleading since, in truth and in fact, the economic
poison contained more than 2.3 percent Dacthal (Dimathyl
ester of tetrachloroterephthalic acid), in violation of 7
U.S.C. 135(a)(5), 135(z)(l) and 135f.
Count II
1. On or about February 11, 1971, the defendant,
Swift Agricultural Chemicals Corporation, shipped in inter-
state commerce from East St. Louis, Illinois, within the
Exhibit 4
16-11
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Eastern District of Illinois, to Jamesville, Wisconsin,
300 twenty-pound containers of "Swift Lawn Weeder and Feeder",
an economic poison within the meaning of 7 U.S.C. 135(a).
2. Said economic poison was misbranded in that its
label bore the statement that it contained only a single
active ingredient (Dimethyamine salts of 2,4-dichlorophenoxy-
acetic acid), and such statement was false and misleading
since, in truth and in fact, the economic poison contained
an additional active ingredient, namely, 2,4,5-trichlor-
ophenoxyacetic acid, in violation of 7 U.S.C. 135a(a)(5),
135(z)(1) and 13Sf.
Count III
1. Each allegation contained in paragraph 1 of Count
II is realleged, reaffirmed and incorporated herein.
2. Said economic poison was adulterated in that another
substance, namely, 2,4,5-trichlorophenoxyacetic acid, had
been substituted, in part, for the article, in violation of
7 U.S.C. 135a(a)(5); 135(y) and 135f.
United States Attorney for the
Eastern District of Illinois
Exhibit 4
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RECOMMENDATION FOR PROSECUTION
Parsons Chemical Works, Inc. has had many years of experience with the
Federal Insecticide, Fungicide, and Rodenticide Act. The firm was
issued its first registration of an economic poison on September 1,
1948; its most recent registration-the 96th-was granted on July 21,
1972. The company currently has thirty-one products registered under
the act.
Moreover, the firm has a history of alleged violations involving
various provisions of the act. From November, 1967 to October,
1972, approximately twenty-one samples were collected from the
firm's interstate shipments of economic poisons. Of these twenty-
one samples collected, thirteen resulted in notices of contemplated
criminal proceedings. In effect, approximately 621 of the samples
collected during this five-year period were so seriously violative
that criminal proceedings were warranted. As early as May 7, 1951,
the firm was notified of their interstate shipment of an economic
poison which was not in compliance with the act.
The violations alleged in this file are based on six samples. Five
of these samples were allegedly shipped in interstate commerce without
benefit of registration and its premarket clearance. Yet, the
firm has been aware of the registration provisions of the act since
1948. The nonregistration charge under ID No. 97782 resulted from a
label which declared a chemical composition that had not been accepted
in connection with the product's registration. However, ten months
before this shipment under ID No. 97782, we informed the firm that
the subject label was not consistent with current accepted labeling
for this product (Refer to ID No. 84000). The fact that different
charges were drawn under ID No. 84000 and ID No. 97782 for the same
noncompliant aspect of this label should not overshadow the fact
that the firm had been notified of this apparent noncompliance ten
months previous to this second shipment. The primary concern is
that Parsons Chemical Works, Inc. shipped the product bearing this
noncompliant label knowing that such shipment would be in violation
of the act.
Violations alleged on two of the six samples included in this file
resulted from the firm's inadequate formulating procedures and are
indicative of the firm's apparent disregard for consumer protection.
These samples were found to be contaminated to the extent that when
used as recommended they would possibly result in illegal residues in
food. Because of the seriousness of these violations, we requested
the firm to withdraw the contaminated products from channels of trade.
In view of the apparent disregard for the protection of the consumer
as well as for compliance with the provisions of the act, it is recom-
mended that Parsons Chemical Works, Inc. be prosecuted. Members of
our staff are prepared to assist you in the preparation and prosecu-
tion of this case.
Exhibit 3
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Mr. Frederick M. Coleman
United States Attorney
Cleveland, Ohio
Re: Spartan Chemical Co., Federal Insecticide, Fungicide,
and Rodenticide Act, 7 U.S.C. 135 et seq.
Dear Mr. Coleman:
Enclosed is a copy of a letter, with enclosures, to the
Criminal Division from Anson M. Keller, Assistant General Counsel,
Environmental Protection Agency, requesting the institution of
criminal proceedings against the captioned subject for violations of
the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C.
135 et
Spartan Chemical Co., is an Ohio corporation with its offices
and principal place of business at Toledo, Ohio. It has had con-
siderable experience with the requirements of the Act. It registered
its first economic poison (defined in 7 U.S.C. 135(a)) in 1957; its
most recent registration - the 8th - was granted on August 27, 1950.
It currently has five products registered under the Act.
Despite Spartan's obvious familiarity with the Act, 9 of 36
samples collected from interstate shipments between July, 1969 and
April, 1972, were found to so seriously violate the provisions
of the Act that citation action was talcen. In several cases, product
recalls were requested. The Environmental Protection Agency informs
us that it has repeatedly had difficulty with this manufacturer with
respect to effectiveness of products . In reporting on the violation
charged in Count V, the Environmental Protection Agency's product
reviewer reflected on this problem when she stated "The capability
of this manufacturer to produce a consistently effective product
would appear to be questionable." The five violative shipments
cited in information involved a disinfectant which in laboratory tests
was found to be substantially less effective than the consumer on the
basis of the claims made on the label was led to expect. As such the
product was misbranded. These serious and repeated violations as
documented in the file, deprive the public of the safeguards provided
by the Act with respect to the strength and reliability of the
economic poisons they use.
For general information on Spartan, we direct your attention to
the Dun § Bradstreet Business Information Report included in the file.
Exhibit 5
16-14
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To help you assimilate the file, the violations charged in
each of the counts are documented under the following "ID" numbers
of the file:
Counts ID No.
I 67366
II, III 67426
IV 85981
V 99249
All of the violations invlove the same product, Spartan Steri-
Phene Disinfectant Deodorant.
An essential element of each offense is the shipment of the
economic poison in interstate commerce. Information pertaining to
the quantity of the economic poison shipped, the date of shipment,
and the destination is included under the appropriate ID No. The
quantity of the economic poison shipped in violation of the Act is
derived from the shipping documents and the document captioned
"Collection Report." For example, Count I alleges the shipment of
"48 seventeen and one-half ounce containers" of the economic poison
on November 5, 1970. Under item 9 of the Collection Report (ID
No. 67366), the "amount before sampling," that is, the amount on
hand when the inspector arrived and from which the sample was taken,
was "4 master, 4 subs per master, 6/1 Ib. 1 1/2 oz. cans per subs,"
(i.e., at the time of sampling there were 4 cartons on hand each of
which contained 4 sub-cartons of six containers each; although the
total number of containers on hand was 96, only 48 were alleged
because the amount on hand was evenly divided between two lots of
the product and only one of those lots was found to be understrength)
Item 10 of the Collection Report indicates the number and size of
the samples that were taken.
Copies of chemical analytical reports, the micorobiology
laboratory report and the report of the disinfectant reviewer are
also included under each ID No. These reports reveal that some lots
of the involved disinfectant were seriously understrength and when
used as directed could not be relied on to fulfill the claims made
with respect thereto.
In the case of the shipments charged in Counts I, II, and V,
the amount alleged in the information to have been shipped does not
conform to the amount actually shipped as indicated by the shipping
documents. Rather, it corresponds to the amount on hand at the time
of the inspection. Although this is sufficient to sustain to con-
viction, you may wish to consider revising the information to reflect
the full amount shipped in each instance; however, we believe that
in the case of Count I such revisions would be inadvisable because
as noted above only one of the two lots of the product shipped was
Exhibit 5
16-15
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understrength and it is impossible to determine from the documentation
in ID No. 67366 how much of the understrength lot was actually shipped.
In amplification of the third paragraph of the Assistant General
Counsel's letter, all of the counts carry a maximum penalty of $500
per count.
In view of the flagrant disregard of the statutory requirements
by Spartan despite its familiarity with those requirements, we re-
commend that criminal proceedings be instituted. In recent months,
the Environmental Protection Agency has referred many files documenting
serious violations of the Act to this office. This may indicate that
the insecticide industry is of the impression that failures to comply
with the Act will not be discovered or made subjects of enforcement
proceedings. We believe that vigorous prosecution of these violations
will serve to discourage this impression and to inform the industry
that neither the Environmental Protection Agency nor the Department of
Justice takes lightly its responsibility to enforce this important
piece of legislation, which affords virtually the only source of
protection to the consumer and to the environment from the dangers
of defective and improperly labelled economic poisions, against those
who are indifferent to its requirements.
Please keep us advised of all developments, and if we can be of
any assistance to you, feel free to call on us.
Sincerely,
JOHN L. MURPHY, Chief
Government Regulations Section
Criminal Division
By: RICHARD I. CHAIFETZ
Attorney
Exhibit 5
16-16
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17
-------
SECTION 17
WITNESS INSTRUCTIONS
-------
WITNESS INSTRUCTIONS
Introduction
A witness whose appearance and conduct commands the respect
of a jury will find his testimony to be highly regarded. His
perception of what happened will be considered most objective,
and closest to the truth.
Justice may be blind, but a judge and jury are not. Try
as they may to be objective, a judge and jury will favor the
testimony of a witness who is properly dressed, who sits with
propriety, and who speaks clearly.
The purpose of this guide, then, is to point out some of
the things a witness can do to make a better impression on the
judge and jury. Although some may sound pretty far-fetched, they
are all based on actual courtroom experience.
There is also included a section called "Proper Technique
on the Witness Stand." This will give you some idea of what
happens when a witness takes the stand.
A. "Testimony before Juries and Grand Juries"
1. PREPARATION FOR GOOD PERSONAL APPEARANCE
A. You should be clean shaven, and have fingernails
trimmed and clean and hair trimmed and combed.
B. You should be dressed in a conservative, well-
fitted business suit.
C. Have clothes clean, pressed and neat, and shoes shined,
17-1
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D. Do not wear loudly colored shoes, socks, shirt,
tie, etc.
E. Do not wear unusual finger rings or other unusual
adornments.
2. GENERAL CONDUCT IN COURT ROOM AND VICINITY
A. Don't be noisy in the halls in greeting fellow
inspectors or old friends.
B. Don't talk to the defendant or his attorney in or
near the court room.
C. Do not whisper or cause disturbances in the court room.
D. Do not talk to the jurors or discuss the case within
their hearing.
E. Do not sit within the enclosure unless invited.
F. Do not bring magazines or newspapers into the court
room.
G. Be on time when court opens and be available
immediately when called to testify.
B. 1. While sitting in the courtroom, either as a prospective
witness or as an assistant to one of the members of the
Agency, United States Attorney, or General
Counsel's Office, make yourself as inconspicuous as
possible. Facial grimaces at testimony thought adverse
to Government's case, or nods of approbation or approval
17-2
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at testimony particularly favoring the case should be
avoided. They could result in censure from the court
if observed. Attracting attention to yourself by
talking in the courtroom during the proceedings; reading
reports, newspapers, and the like; passing notes;
rustling papers; passing comments, jokes, or snide
remarks about the judge or this or that juryman, or
witness, has its perils. You may impress some but
with others you may be less fortunate. You may
prejudice yourself or the Government if you focus
attention upon yourself. Do not sit in groups of
more than two or three. Spread out in the courtroom.
Don't be an "impetuous prompter" a person who sits in the
courtroom and hears testimony which he believes erroneous
and refutable and who rushes through the rail to the United
States Attorney, the General Counsel's representative, or
the EPA representative at counsel's table to convey
his thoughts on the erroneous testimony. While you may have
a contribution to make, hold your suggestions until recess
or for some other suitable time to transmit them. Even at
recess, wait until judge and jury have left before
approaching counsel. Remember that if you have found
flaws in the opposing case, our lawyers most likely
have found them too. It is disconcerting to those at
17-3
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counsel's table to have interruptions by witnesses and
others in the courtroom who bombard them with suggestions
on strategy, etc. In addition to making you conspicuous,
it shows you are strongly partisan and does not contribute
to the building of a good impression. Jot your ideas
down so you will not forget them when you have an oppor-
tunity to confer with the U. S. Attorney, member of
General Counsel's Office, or others who are directing
the case.
Avoid conversations with principals of or witnesses for
the opposing side during trial. You never can predict
when your statements will be distorted to your disadvan-
tage and perhaps the Government's too. If you cannot
avoid conversation with them, confine your remarks to
matters other than the trial.
During periods of recess keep your guard up. Don't
engage in horseplay, wisecracking, or,loud conversation,
especially about the case. You never know when you are
under the observation of the judge or members of the jury.
Many a Government witness has found himself embarrassed
after making an indiscreet remark in the halls of the
courthouse, or in the elevator, or in a nearby lunchroom,
or men's room, to learn that the judge or a juryman or
17-4
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opposing counsel has been in the same hall, elevator,
or lunchroom and had seen and heard him. Save your
wisecracks for a time and place where the humor in them
can be enjoyed without threat of embarrassment to you or
the Government. Do not hold loud conversations in the
corridor outside of the courtroom while court is in
session.
Do not rush up to congratulate a Government witness when
he steps down from the witness stand. Wait until court
has adjourned. Avoid expressing any approval or disapproval
of his testimony by glance, nod, or otherwise until leaving
the courtroom.
Avoid legal arguments with United States Attorney and
with General Counsel's representative in presence of United
States Attorney. Save your suggestions on legal points
involved until they can be informally discussed with
General Counsel's representative or with United States
Attorney if no General Counsel representative is on the
case. While you may be 100% right as to the law, your
suggestions will be more favorably received if not stated
as dicta, and if suggested rather than propounded.
17-5
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Don't lose your patience or temper while testifying.
A cross-examining attorney often deliberately baits
an irascible witness to anger him. Don't let it happen
to you. Keep calm and unruffled. Neither your thinking
nor your appearance improves with rising ire. Be polite
and courteous to everyone, including opposing counsel
even if he is insulting.
Attorneys questioning you on cross-examination will often
try to force a categorical answer out of you, i.e., a
"yes" or "no" answer. There is some justification for
such attempts because the cross-examiner is permitted
to ask "leading questions." If a simple "yes" or "no"
answer does not bring out the whole truth, it is your
duty to inform the cross-examiner that the question
can't be answered "yes" or "no." If you do this, the
court may insist on a "yes" or "no" but invariably will
allow the whole truth and if a "yes" or "no" answer
doesn't do just that, the court will afford protection
when it understands the situation because it would not
have you violate the oath you took.
Do not insist on sitting at counsel's table or inside
rail. Wait to be asked. While everyone having knowledge
of case could probably be of assistance during trial, the
extent of such assistance must be weighed against the
impression created by five or six persons sitting and
17-6
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working at Government's table while only the defendant
and his counsel are at defendant's table.
10. Don't be an "eager beaver." Don't appear to be over-
anxious to get something into the evidence that the
attorney has not asked for. To do that may suggest
that you have a stake in the outcome of the trial.
11. Don't be afraid to admit that you discussed your testimony
with representatives of the U. S. Attorney's Office, the
General Counsel's Office, or the Environmental Protection
Agency. If you are asked the question, state the truth.
There is nothing improper in a practical discussion of your
testimony with the U. S. Attorney or his Assistant handling
the case. Remember that the opposing attorney ordinarily
asks the question hoping to catch you swearing falsely.
12. Don't spar with the questioning attorney. Answer his
questions frankly, factually, and confidently. Don't
engage in a wit-matching contest. Sparring by a witness
may suggest that he is evading the question and often
detracts from his credibility.
13. Wait for the question to be asked in its entirety before you
reply. Make certain that you understand it, never attempt
to answer a question that you do not fully understand. To
do otherwise may lead to trouble and embarrassment. If
17-7
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witness does not understand all or any part of a
question, he may do one or both of the following.
He may state, in substance, as follows:
(a) I am sorry, but I do not understand /_or, I am
not sure that I understand/" the question, could
you rephrase it?
or
(b) If you mean /_state what you think the question is_7",
then my answer is ...
or
combine (a) and (b) as
(c) I am sorry but I am not sure that I understand
the question, but if you mean . . . then my
answer is ...
14. Don't be afraid or ashamed to admit "I don't know." If
you don't know the answer to a question, say so. Don't
try to cover up ignorance of some fact or set of facts.
If you do, it may suggest evasion on your part.
15. Wait several seconds before you answer a question put to
you in cross-examination in order to give the U. S. Attorney
an opportunity to object if he regards the question as
improper. But avoid undue delays in replying. These
delays, particularly with side glances at the U. S. Attorney,
may give the impression you are being evasive. Try to speak
with the same speed and use the same phraseology on cross-
ejxamination as on direct.
17-8
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16. Don't answer any question objected to by either side
until the court has ruled on the objection. If the
witness has started his answer, he is to stop if any
objection is raised by either side and is not to continue
until the judge or either counsel indicates that it is
proper to continue his response.
17. Answer each question by spoken words. Don't nod assent
or shake your head in dissent. The court reporter is
not watching you but is concentrating on his shorthand
and notebook. He cannot hear a nod or a gesture. The
record of your testimony may be incomplete unless you
answer each question with spoken words.
18. Speak as clearly and distinctly as you can. Use simple
language. Remember you defeat your purpose if you are
not understood, so don't try to impress anyone with a
vocabulary of infrequently used words. If the subject
is technical and scientific, reduce the terminology you
use to an understandable level. If technical words must
be used or are used for any reason, the witness should
define them as he uses them.
19. Don't hesitate to ask permission to refer to your notes to
refresh your recollection in testifying provided your notes
were made at the time of or immediately after the event
about which you are testifying. The fact that you cannot
recall exact details without notes should not be embarassing
and, in fact can be used to the advantage of the Government
when it is shown that the opposing party does not have a
written record of the transaction. Do not read verbatim
long passages from your notes.
17-9
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20. Come into the courtroom prepared. Know your facts.
All pertinent dates and times should be checked. Arrange
all documents and exhibits in order so that the testimony
will be presented without fumbling.
21. Testify only as to facts about which you have first-
hand knowledge. In most instances you cannot testify
about what someone told you. That would be hearsay.
You can testify about what the defendant told you, if
what he told you is relevant to the case.
22. In testifying, keep your voice up. Too often judges have
to admonish witnesses to speak up. Save him the trouble
by striving to have the judge and the whole jury hear
what you have to say.
23. Answer only the question asked, but answer it fully and
to the point. Don't volunteer unnecessary information.
Remember the more you say unnecessarily, the more you
suggest to opposing counsel for cross-examination.
24. Unless you are testifying as an expert, don't express
opinions or conclusions. State only facts. Don't
assume expert knowledge in a field unless you are in
fact an expert by reason of your training and experience.
Reading an article on a subject does not make you an expert
in that subject.
17-10
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25. Don't exaggerate. State the facts accurately and don't
embellish them. Don't be disappointed if the facts
about which you are to testify are not as dramatic as
you would like to have them. The court and jury are
interested only in getting the unvarnished truth, so
give them only that.
26. Be careful when the opposing lawyer reads from a book
or document and questions you about what he read. Before
answering, ask to see the document he read from. He
might be engaging in such deceptive practice as misquoting
or only partially quoting.
27. Never bring to the stand notes, files, or other material
for help in your testimony unless you are willing to
have the opposing side see them. He has a right to see
them.
28. In cross-examination opposing counsel may use the oft
employed technique of asking you whether you regard certain
persons in the field about which you are testifying as
recognized authorities. This is preparatory to asking
you whether you agree with certain statements which those
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authorities made in writings, etc. If your answer is
no--that you don't recognize them as authorities, that
line of cross-examination cannot be pursued. Unless you
definitely have heard of the named persons and are
familiar with their works and do recognize them as
authorities, don't expose yourself by saying that you
so recognize them.
C. Proper Technique On the Witness Stand
1. When called to the witness stand, unless previously
sworn, go directly to the desk of the clerk of the
court to be sworn.
2. Take the oath in a reverent manner. Then proceed to the
witness chair. If you have a long or difficult name,
give a card or paper with the correct spelling to the
court stenographer.
3. Assume proper posture, bearing and demeanor.
a. Sit erectly, but don't appear stiff or tense.
b. Always be courteous, say "Yes Sir" and "No Sir."
c. Speak in a clear, distinct and well'modulated voice
d. Look at and speak distinctly to the jury. Speak
plainly enough so the farthest juror can hear you.
e. Do not speak to the judge unless he asks you a
question.
f. Do not appear eager to convict.
g. Do not show hatred toward the defendant.
17-12
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h. Do not use idioms or language peculiar to the
enforcement profession.
i. Be well poised and under self control.
j. In your effort to appear impartial and unbiased,
do not become listless or "dead pan." Be natural,
candid, frank, and "alive."
k. Do not appear impatient or overly anxious to testify.
1. Do not have anything in your mouth. This includes
gum, toothpick, tobacco, candy or food.
m. Keep your hands away from your mouth, face and head.
n. Do not exhibit nervous tendencies, such as arranging
clothes, tie, etc.
The direct examination.
a. Personal identification questions will be asked
you first.
b. Next type of questions are preliminary to setting
up the body of your testimony.
c. The next or direct question will usually be, "Now
begin right there and tell what you have seen or
heard in connection with this matter." Always tell the
truth.
d. Try to give testimony in chronological order, if
possible.
a. Reveal your first connection with the case.
b. Then give facts in the order they occur.
17-13
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e. Do not give information that has not been asked
for. This is particularly important with respect
to previous criminal records, or other current
crimes of the defendant, now pending.
f. Do not give opinions or hearsay testimony.
g. The district attorney will likely ask more questions
to bring out details and other information to
complete your testimony.
h. Your testimony should be memorized, if possible.
i. You may use your contemporaneous notes to refresh
your memory, and should do so in cases of complicated
figures, dates, etc.
j. If you do refresh your memory from your notes, the
defense has the right to examine them and make them
an exhibit in the case.
k. Do not unnecessarily try to help the district attorney
as he is likely to know just exactly what he is doing.
1. If the defense objects to a question, do not try to
get in an anwswer before the judge has ruled whether
the question is proper.
m. Be able to identify the defendant.
The cross-examination.
a. In the face of skillful and smart defense attorneys, the
task of testifying is not simple or easy.
17-14
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b. Do not be particularly afraid of the defense
attorney. He likely is equally concerned about you.
c. The defense attorney will not question you, unless
he hopes to gain something for his side.
d. Listen carefully to his questions, then reply.
e. There are usually two types of cross-examiners:
1. The bullying, browbeating and aggressive fellow:
A. He is the easier type to contend with.
B. He usually hopes to make you angry and get
your "goat."
1. By casting aspersions at your veracity,
integrity, etc.
2. By nasty references to your service.
3. By magnifying any errors you have made.
C. Don't let him worry you. He likely is
stalling and has nothing much to go on.
D. He may ask rapid fire questions.
1. Give him deliberate answers and don't
let him speed you up.
2. If you do not understand the question
clearly, ask him to repeat or restate it
3. Do not let him interrupt an unfavorable
reply by cutting in with another
question.
17-15
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4. If he asks a long and meaningless
question, ask him to restate it.
E. He may ask a double or two pronged question.
ask him to restate it or carefully answer
each part separately.
F. Answer any question promptly and whole-
heartedly which might reflect credit to
the accused.
G. Beware of questions to which he demands
"Yes" or "No" answers. If a defense attorney
demands a "yes" or "no" answer and neither
"yes" or "no" is the proper answer, a
witness on the stand cannot be required to
answer "yes" or "no" and the judge will not
compel him to do so. He can answer, "neither
yes or no," and usually the judge will let
him explain why it is neither "yes" or "no"
or will request the attorney to reframe his
question. ILLUSTRATION: "Have you quit
beating your wife? Answer "yes" or "no."
H. He may deliberately misquote you.
I. If you do not know the correct answer, say so,
J. If you make an error while testifying,
correct it at the first opportunity.
17-16
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K. He may attempt to try a prosecution witness.
Many defense attorneys try to make an issue
of the actions of inspectors or other prose-
cution witnesses rather than the criminal actions
of the defendant as charged in the indictment.
The witness is not standing trial and
insofar as he is concerned, his best demeanor
is to display no emotion whatever. The
witness should calmly look at the jury and
answer any questions he may be asked. Thus
will the attorney lose more than he gains.
2. The smooth, suave, slick or sneaky type.
a. Fear him more than the other type. He
usually has some definite plan or scheme
for gaining something of value from you.
b. He tends to ask innocent questions for a
while, then asks the catch or trap question,
hoping that you are napping.
c. He may appeal to your vanity and try to get
you to tell how good you are.
d. If you are caught in an error, be frank to
admit it, and explain it if possible.
6. Re-direct and re-cross examination. Same principles apply
as before.
17-17
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D. Proper Conduct After Verdict
1. If the defendant is acquitted.
a. Do not quarrel with or berate him, claiming justice
has been thwarted or miscarried.
b. Be courteous to the jurors. You may seek what factors
caused the acquittal. But do not heckle or embarrass
them.
c. You should compliment and thank the district attorney,
and get his opinion as to the jury's verdict and what
caused it.
2. If the defendant is convicted.
a. Do not rush up to the jurors and shake hands with
them. You might tell them that you are certain their
judgment was right.
b. Congratulate the district attorney, and thank him
for his handling of the case. But, do not gleefully
shake hands with him in the court room or where the
general public would see such action.
c. Do not make any public display of elation over the
outcome of the case.
d. Do not tell the convicted person you finally "got
him." Be courteous if you talk to him. He may be
upset and bitter toward you.
17-11
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SECTION 18
INJUNCTIVE AUTHORITY
-------
INJUNCTIVE AUTHORITY
An injunction is a writ issued by a court; it forbids or
commands a person to perform a particular act.
EPA has the authority to initiate action for an injunction
under Section 16. (c) of the Federal Insecticide, Fungicide, and
Rodenticide Act as amended October 21, 1972, which states that the
"district courts of the United States are vested with jurisdiction
specifically to enforce, and to prevent and restrain violations
of, this Act."
In Pesticides Enforcement, an action for an injunction is
to be initiated only when all other enforcement remedies have
been exhausted. Before initiating such action, headquarters
will be consulted through the Regional Coordinator. The action is
usually commenced with the filing of a complaint in the office of
the clerk of the court. However, since procedural matters vary
greatly among the Federal Districts the procedural routine of the
jurisdiction where the action is being taken should be ascertained
and followed.
18-1
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19
-------
SECTION 19
NOTICES OF JUDGMENT
-------
NOTICES OF JUDGMENT
1. General. The Administrator of the Environmental Protection
Agency is required to publish all court decisions and actions
instituted under the Federal Insecticide, Fungicide, and
Rodenticide Act. (Section 16. (d), Federal Insecticide, Fungicide,
and Rodenticide Act as amended) The purpose of this
publication is to disseminate to the public - principally
through libraries - the results of court decisions involving
pesticide products and the shipment of pesticide products.
The following information will be included: the specific
violations, dates of legal actions, the court decisions, and
the penalty imposed on the violator.
2. Responsibility. The Pesticides Enforcement Division will
publish and distribute all notices of judgement that fall
under the Federal Insecticide, Fungicide, and Rodenticide
Act. The responsibility within the Division is assigned to
the Chief, Program Appraisals Branch (PAB). When a number of
notices of judgment have been sufficiently researched, they will
be sent (under the signature of the Assistant Administrator for
Enforcement and General Counsel) by PED to the printer.
3. Procedure. Each case will be reviewed after it is adjudicated
to determine if all necessary information is present in the file.
19 - 1
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A. Each EPA region will maintain a record of all
seizure and criminal actions referred for legal
action. Once an action has been completed, the
region will prepare a draft of the notice of judgment
and forward it to the FED regional coordinator who,
will check for accuracy and then refer it to the
Publication and Information Section (PIS) of PED for
publication.
The following information will be included in the
record: the name of the case, the identification
number, the date referred, the date of the intitation
of action, and the date of the final decree or
judgment. (Exhibits 1 through 5)
B. The information needed to prepare notices of judgment
will be furnished by the regions in accordance with
already established procedures. It is contemplated
that the regions will promptly inform the Program
Operations Branch (POB) of the termination of each
seizure, criminal action and civil proceeding.
C. The Program Operations Branch will, in turn, promptly
inform the PAB of the termination of each seizure
and criminal action recorded in PED records.
19 - 2
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D. When a seizure or criminal action has been
terminated, a copy of the legal file for the
case will be sent to the FOB. Also, copies
of legal files originating in the regions will be
promptly forwarded to the FOB. Before printing,
the notice of judgment in each case will be forwarded
for review to the Director, Pesticides Enforcement
Division.
E. The FOB will request a status report from the regions
on each case which is not reported closed within six
months after referral for legal action.
Schedule. The Pesticides Enforcement Division will publish
notices of judgment at reasonable intervals in groups of fifty.
Distribution. Distribution of notices of judgment is made
by the Pesticides Enforcement Division. FED will compile a
mailing list of recipients desiring to receive the notices on
a regular basis. Such recipients normally are libraries,
universities, certain civic groups, private citizens, etc.
Other distribution is by special request for certain issues
of the notices.
19 - 3
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1001. U.S. vs. Black Leaf Products Company, No. 71CR501,
N. Dist. 111., District Judge Hubert L. Will, October
4, 1971. (I.F.SR. No. 1229, I.D. Nos. 62460, 62615,
65077, 66997, 68133, 77196 and 77669.)
This is a criminal action in which the defendant is charged
in a seventeen count information filed on May 10, 1971, with
various violations of 7 U.S.C. 135a(a)(2) and (a)(5) which
prohibits the shipment of misbranded and adulterated economic
poisons and economic poisons failing to bear required label
statements.
The company was arraigned in the U.S. District Court, Northern
District of Illinois, Eastern Division, on May 26, 1971,
and pleaded not guilty. On October 4, the company changed its
plea to guilty to 15 counts of the information and was fined
a total of $2,850. Judge Hubert L. Will levied fines of $100
each on counts 2, 6, 8, 10, 14, and 16 and fines of $250
each on counts 1, 3, 4, 7, 9, 11, 13, 15, and 17. Counts 5
and 12 were dismissed on motion by the U.S. The Court ordered
that the fines be paid by October 8, 1971.
Products involved in the case were: BLACK LEAF CHLORDANE
DUST, SHEEN GARDEN FUNGICIDE, NICO-FUME PRESSURE FUMIGATOR,
GRANULAR CURB 5% DIELDRIN LAWN INSECT CONTROL, BLACK LEAF
40 THE ORIGINAL NICOTINE SULPHATE, MR. GARDEN MULTIPURPOSE
ROSE $ GARDEN SPRAY, NEW WARF PELLETS KILLS RATS AND MICE
and BLACK LEAF CRAB GRASS KILLER. Violations of the Federal
Insecticide, Fungicide, and Rodenticide Act included chemical
deficiencies, failure to include required warning and caution
statements on product labels, and failure of labels to bear
the assigned registration number.
Exhibit 1
19 - 4
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1008. U.S. vs. 520 twenty-five pound containers, more or
less of a product labeled in part "GREEN VALLEY
20-10-5 HI-LIGHT FEED § WEED." (I.F.§R. No. 1154,
I.D. No. 63645.)
SHIPPED: 2-28-68, from North Surrey, British Columbia, Canada
by Green Valley Fertilizer and Chemical Company, Ltd.
LIBELED: 5-28-68, Dist. Oreg.
CHARGE: Nonregistration; misbranded--lack of adequate
warning or caution statement on labels, and lack of in-
gredient statement on labels.
FINAL DECREE: 12-11-68. Consent --product released to
claimant for purpose of returning product to Canada.
Exhibit 2
19-5
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1013. U.S. vs. 22 two-pound containers, more or less, of
a product labeled in part "ferti-lome TOMATO AND
VEGETABLE DUST AND SPRAY." (I.F.§R. No. 1227,
I.D. No. 76766.)
SHIPPED: 12-11-68, from Bonham, Texas, by Voluntary Pur-
chasing Groups, Inc.
LIBELED: 2-16-70, S. Dist. Ind.
CHARGE: Misbranded--product contained less than 4.501
zineb as represented in labeling and contained additional
active ingredients, namely, kelthane and methoxychlor not
specified in labeling; adulterated --strength or purity
below standard or quality represented in labeling and
substances namely, kelthane and methoxychlor, substituted
in part for article.
FINAL DECREE: 5-9-70. Default--destruction .
Exhibit 3
19 - 6
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1026. U.S. vs. 1,488 unlabeled containers, more or less,
each containing an insecticide identified as "PET
SPRAY NEW FLEA, TICK AND ODOR CONTROL SPRAY." (I.F.f,R
No. 1279^, I.D. Nos. 84140 and 84141.)
SHIPPED: 6-4-70, from Memphis, Tenn., by Morton Pharma-
ceuticals , Inc .
LIBELED: 5-24-71, E. Dist. La.
CHARGE: Misbranded- - lack of adequate warning or caution
statement on labels, inadequate directions for use, lack
of proper ingredient statement on label, and lack of regi-
stration number on label.
FINAL DECREE: 6-11-71. Consent--claimed by shipper for
relabeling.
Exhibit 4
19 - 7
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1028. U.S. vs. 73 fifty-pound bags, more or less, of a
product labeled in part "HELENA BRAND TOXAPHENE
10% GRANULAR INSECTICIDE," 1,623 fifty-pound bags,
more or less of a product labeled in part "HELENA
BRAND 21 EPN INSECTICIDE GRANULES," and 740 forty-
pound bags, more or less, of a product labeled in
part "HELENA BRAND 21 EPN INSECTICIDE GRANULES."
(I.F.5R. No. 1286, I.D. Nos . 99368, 99369, and 99370.)
SHIPPED: 6-27-71, 6-29-71, 7-8-71, 7-16-71, and 7-17-71
from Des Moines, Iowa, by Helena Chemical Company.
LIBELED: 8-20-71, Dist. Neb.
CHARGE: Nonregistration; product "HELENA BRAND TOXAPHENE
10% GRANULAR INSECTICIDE" misbranded--inadequate direction
for use .
FINAL DECREE: 11-10 71. Consent --products brought into
compliance and released to shipper.
Exhibit 5
19 - 8
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20
-------
SECTION 20
NOTICES OF DETENTION
-------
NOTICES OF DETENTION
A. Authority
Section 17 of the Act as amended authorizes the Administrator
to refuse admission of a pesticide or device if he determines
that such pesticide or device being imported into the United
States violates the provisions of the Act, The Secretary of
the Treasury shall refuse delivery to the consignee and shall
cause the destruction of any pesticide or device refused
delivery which shall not be exported by the consignee within
90 days from the date of notice of such refusal under such
regulations as the Secretary of the Treasury may prescribe.
Under the customs Regulations for the enforcement of Section
17(c) of the FIFRA as amended, the District Director of
Customs may, however, release shipments to the importer or
his agent prior to examination of the shipment by the Admin-
istrator. This is done under a customs bond in the amount and
under the terms prescribed in Section 17 (c) of the Act. Such
shipments released to the importer under bond shall not be
used or otherwise disposed of until determination is made by
the Administrator.
B. Detention Procedure
When, on the basis of available information or actual examina-
tion, it is determined that a shipment should be detained
because of nonregistration or obvious labeling violations,
20-1
-------
the region shall prepare and issue to the, importer a Notice
of Detention and Hearing (Exhibit 1). A copy of this Notice
should be sent to the District Director of Customs at the
port of entry.
NOTE: AN EFFORT SHOULD BE MADE TO DETERMINE THE NAMES AND
ADDRESSES OF THE CUSTOMS IMPORT COMPLIANCE OFFICERS OR
COMMODITY SPECIALISTS WHO DEAL WITH EPA AT EACH PORT OF
ENTRY.
C. Disposition Procedures
If through examination of the product or otherwise, it can
be determined that the product has been brought into com-
pliance with the Act, a Release Notice should be issued to
the importer with a copy sent to the District Director of
Customs of the port of entry. (Exhibit 2)
If the product has not been brought into compliance with
the Act, a Notice of Refusal of Admission should be issued
to the importer with a copy sent to the District Director
of Customs at the port of entry. The District Director of
Customs shall refuse entry of the product and shall cause
the destruction of the product if not exported by the importer
within 90 days from the date of such Notice of Refusal of
Admissions. (Exhibit 3) If the product has been released to
20-2
-------
the importer under bond, the District Director of Customs
shall take action to enforce the terms of the bond.
If the District Director of Customs finds it necessary to
request forfeiture of an importer's bond because the product
was not held intact as required, he may ask EPA to determine
the amount to be levied against the importer's bond. Penalties
should be determined according to the severity of the violations
and the reasons why the product was not available for redelivery,
20-3
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NOTICE OF DETENTION AND HEARING
I.D. No.
Company
Street
City
Gentlemen:
In connection with the enforcement of the Federal Insecti
cide, Fungicide, and Rodenticide Act as amended, examination
of samples or other evidence indicates that the following
shipment is in violation of the Act. The merchandise should
continue to be held intact pending a final decision as to
whether it shall be admitted or refused admission.
Pursuant to Section 17(c) of the Act, you are hereby
afforded an opportunity to offer such explanation as you wish
for consideration by this Agency. Your answer, in duplicate,
signed by you or your attorney, should be filed with this
office within 20 days after the receipt of this notice.
Should you desire to present your views orally, in addition
to filing a written reply, you should so advise in your
answer in order that a date may be set for such presentation,
which would be held here.
I. D. No(s) . Product Name(s)
Date of Importation
Consignee
Shipper/Manufacturer
Entry No. Date Port of Entry
Upon examination it appears that the product(s) failed to
comply with the provisions of the Act, a copy of which is
enclosed.
Sincerely yours,
Name
Title
Exhibit 1
20-4
-------
RELEASE NOTICE
I. D. No.
Company
Street
City
Gentlemen:
In connection with the enforcement of the Federal Insecti-
cide,. Fungicide, and Rodenticide Act as amended, consideration
of the following shipment has been completed. Based on the
examination of samples or other evidence, it is concluded
that pursuant to Section 17(c) of the Act the merchandise need
not be further detained.
I. D. No(s). Product Name(s)
Shipper/Manufacturer
Consignee
Entry No. Date Port of Entry
Amount
This notice does not constitute assurance that the mer-
chandise involved complies with all provisions of the Federal
Insecticide, Fungicide, and Rodenticide Act as amended, and
in no way precludes future action should it be determined that
the merchandise is violative.
Sincerely yours,
Name
Title
Exhibit 2
20-5
-------
NOTICE OF REFUSAL OF ADMISSION
I. D. No.
Company
Street
City
Gentlemen:
In connection with the enforcement of the Federal In-
secticide, Fungicide, and Rodenticide Act as amended, examina-
tion of samples or other evidence has been made with respect
to the following shipment and an opportunity for a hearing
has been granted you:
I. D. No(s). Product Name(s)
Date of Importation
Shipper/Manufacturer
Consignee
Entry No. Date Port of Entry
It appears that the product(s) is (are) not in compliance
with the Act and is (are) subject to refusal of admission due
to the following violations:
You are hereby notified that admission of the merchandise
is refused. This merchandise must be exported under Customs'
supervision within 90 days from the date of this notice or
within such additional time as the District Director of Customs
specifies. Failure to do so may result in destruction of the
merchandise as authorized by the statute; or if the shipment
has been released to you under bond, any action necessary
to enforce the terms of said bond.
Sincerely yours,
Name
Title
Exhibit 3
20-6
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21
-------
SECTION 21
GENERAL PROCEDURES
-------
GENERAL PROCEDURES
I. Carbon copies
A. Distribution
Carbon copies of all enforcement actions should
be distributed to the:
1. ID file
2. Reader's file
3. Company file
4. Sampling inspector
5. Sampling inspector's supervisor
6. Regional coordinator, who will forward the
copy to the Registration Division
B. The following items should be typed at the bottom
of all carbon copies: (Exhibit 1)
1. The distribution list
2. The sample's project code
3. The product registration number or File
Symbol
II. Newsletter Items
The Regional Coordinator will prepare Newsletter Items when
civil or criminal proceedings are completed. The Region will
furnish the Regional Coordinator with all necessary
information.
21-1
-------
III. Press Releases
Once a region has prepared a press release for local
distribution, the press release should be telecopied
to the Regional Coordinator. The Regional Coordinator
will forward the press release to the Publication
and Information Section for national publication.
IV. Request for Portion of the Official Sample
When a firm makes a request, in writing, by telephone,
or conference, for a portion of the official sample for
analytical and/or efficacy testing, the laboratory
where the sample is being stored must be notified of
this request. The Region will forward a completed
"Request for Portion of the Official Sample" along
with a copy of the letter or telephone memorandum to
the Director of the appropriate laboratory. (Exhibits
2a,b). A copy of this completed "Reguest for Portion
of the Official Sample" will also be sent to the Regional
Coordinator. Another copy should be placed in the ID
j acket.
21-2
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Pesticides Enforcement Division
Cenol Company, Inc.
Attention: Mr. James 'A Kocinski
3240 West Chicago Avenue
Chicago, Illinois 60651
Gentlemen:
Subject: ID No. 103228 - NEW! CENOL PRESSURIZED SELF-SPRAYING
FOR HOUSEHOLD USE ANT AND ROACH KILLER
Reference is made to your letters of December 26 and 27, 1972.
As requested, we have instructed our laboratory to send you a
portion of the official sample in question for your individual
testing. The portion of the official sample has been forwarded
to your company on January 29, 1973, under separate cover.
The Agency has decided to hold this case open for further
consideration.
Sincerely yours,
A. E. Conroy II
Director
cc:
ID file
Reader's file
Company file
Sampling inspector
Sampling inspector's supervisor
Reg. No. 524-34
Project code: M-3
Exhibit 1
21-3
-------
REQUEST FOR PORTION OF THE OFFICIAL SAMPLE
Date:
Subject: ID
(Number) (Name of Product)
To: Director
Please ask the Laboratory
(Location) (Discipline)
to send a portion of above-named official sample to:
(Name)
(Company)
(Address)
This sample was requested by
(Name) (Company)
for use in ^ testing,
(analytical,effectiveness, phototoxicity,etc.)
as noted on the attached copy of the letter/telephone
memorandum.
Exhibit 2 a
21-4
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REQUEST FOR PORTION OF THE OFFICIAL SAMPLE
Date: January 1, 1973
Subject: ID 98006 , Malathion 10%
(Number) (Name of Product)
To: Herbert S. Hoover Director
Please ask the Beltsville Chemistry Laboratory
(Location) (Discipline)
to send a portion of above-named official sample to:
James E. Varle
Two's Analytical Laboratory
(Company)
2407 Eighth Avenue, Once, MN 42073
(Address)
This sample was requested by Donald White White's Chemical Com.
(Name)(Company)
for use in analytical testing,
(analytical, effectiveness, phototoxicity, etc.
as noted on the attached copy of the letter/telephone
memorandum.
John Lundy,
Chief, Pesticides Branch - EPA Region XII
Exhibit 2b
21-5
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Lystads, Inc.
Attention: Mr. R. G. Miner
901 University Avenue
Grand Forks, North Dakota 58201
Gentlemen:
Subject: I.D. No. 74484 - LYSTADS GRAIN FUMIGANT 73
Reference is made to your letter of November 10, 1970.
The application for registration and labeling enclosed
with your letter are being forwarded to the Registration
Branch for reviexv.
Further interstate shipments of this unregistered product
would be in violation of the Act. Therefore, it is suggested
that no relabeling of your present stocks be made until the
finished label has been' accepted. When registration has
been completed, a paper label which conforms to the one
accepted, could be glued over the labeling which is
lithographed on your present stocks of this material.
With respect to reviewing and registering products, we are
not familiar with any firms which provide such a service.
However, the Registration Division Office of Pesticides
Programs is available to answer any questions which you
have regarding product registration. Any further correspon-
dence should be addressed to Mr. Alvin K. Chock, Chief
Application Records Control Branch, Registration Division,
Environmental Protection Agency, Washington, D. C., 20250.
Sincerely yours,
Exhibit 5
21-6
-------
National Laboratories
Attention: Mr. Michael I. GAstman
Lehn 6j Fink Industrial Products
Division of Sterling Drug, Inc.
225 Summit Avenue
Montvale, New Jersey 07645
Gentlemen :
Subj ect :
I.D
I.D
I.D
I .D
I.D.
I.D.
I.D.
I .D.
I .D.
No.
No.
No.
No.
No.
62053
63195
66589
73186
78836
DUEL DISINFECTANT
DUEL DISINFECTANT
DUEL DISINFECTANT
DUEL DISINFECTANT
DUEL DISINFECTANT
DEODORANT
DEODORANT
DEODORANT
DEODORANT
DEODORANT
Whis will acknoxvledge comments made in your letter of March
17, 1970.
Draft copies of the label bearing the proposed changes should
be submitted to the Registration Division Office of Pesti-
cides Programs for review. We are enclosing PR Form 9-198,
for use in application for amended registration of the pro-
duct .
Any further correspondence relating to registration and
labeling for this product should be addressed to Mr. Alvin
K. Chock, Chief Application Records Control Branch, Registration
Division, Environmental Protection Agency, Washington, D. C.,
20250.
Sincerely yours,
Exhibit 6
21-7
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22
-------
SECTION 22
SAMPLE RECORD STATUS AND PERMANENT ABEYANCE PROCEDURES
22A SAMPLE RECORD STATUS
1. Active
2. Abeyance
3. Permanent Abeyance
22B PERMANENT ABEYANCE (PA) PROCEDURES
1. Types of PA
2. PA Procedure
a. PA without action
b. PA with action
22C RECORDS RETIREMENT AND RETRIEVAL
TN 74-2 (6-14-74) Case Proceedings Manual
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SECTION 22
SAMPLE RECORD STATUS AND PERMANENT ABEYANCE PROCEDURES
The purpose of this section is to set forth guidelines for
placing sample records in different categories of activity.
It also gives guidance on retiring inactive records.
22A SAMPLE RECORD STATUS
For Record Management purposes, sample record cases are
placed in three categories.
1. Active
A sample record file is considered active through-
out the testing and review period and until it is
determined that no enforcement action is indicated
or until all enforcement actions and correspondence
have been concluded.
2. Abeyance
After it has been determined that no enforcement
action is indicated or after all enforcement actions
and correspondence have been concluded, but the file
needs to be retained for reference, the sample record
is considered to be in an abeyance status.
3. Permanent Abeyance (PA)
When correspondence is no longer being carried on
with the firm, no further action is expected or
possible, and the case is closed, the case is then
placed in permanent abeyance.
In the instance of notice of warning letters, if no
reply from the firm is received within 90 days, the
sample record is removed from the active file and
permanent abeyance procedures are initiated.
22B PERMANENT ABEYANCE (PA) PROCEDURES
1. Types of PA
a. PA without action - Refers to the placing of a
sample record in permanent abeyance because the
sample is chemically and biologically satisfactory
and meets all the labeling requirements of the Act.
TN 74-2 (6-14-74) Case Proceedings Manual
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Section 22: SAMPLE RECORD STATUS AND PERMANENT ABEYANCE PROCEDURES 22B Ib
b. PA with action - Refers to the placing of a sample
record in permanent abeyance after enforcement action
has been concluded.
2. PA Procedure
a. PA without action - If examination of the sample
record reveals that no enforcement action is
warranted:
(1) Mark "PA" and the date on the face of the Sample
Record Jacket.
(2) Prepare Pesticides Enforcement Management Sustem
(PEMS) PA Form. Enter the sample number, date
the.sample was put into permanent abeyance and
the file location. Enter data into PEMS.
(3) Printouts listing samples that have been put
in permanent abeyance will be made available
to the Regional Offices through PEMS on a
monthly basis. The Regional Offices will
supply the laboratories that analyzed the
sample with a copy of the PA listing. THIS IS
IMPORTANT - It notifies the respective labora-
tories that the file has been closed and that
the sample can be disposed of in accordance
with the appropriate disposal method.
b. PA with action - When it is determined that no further
action is necessary after an enforcement action and
subsequent followup then:
Follow steps (1), (2), and (3) as outlined above under
PA without action.
22C RECORDS RETIREMENT AND RETRIEVAL
The EPA records disposition program is designed to provide
for the regular removal from valuable office space of all
records and nonrecord materials which are-no longer essential
for current operations, and for the systematic release of filing
equipment for reuse. At regular intervals PA'ed Sample Records
be transferred to the appropriate federal records center.
TN 74-2 (6-14-74) Case Proceedings Manual
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23
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24
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SECTION 24
INTERAGENCY COOPERATION
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INTERAGENCY COOPERATION
In pursuing pesticides enforcement activities, pesticides
personnel come in contact with other government agencies which
are directly or indirectly involved with pesticides. Cooperation
with these agencies will aid pesticides personnel in areas where
they will not be able to act alone. Needless to say, all activities
conducted with personnel from these agencies should be handled
with courtesy, tact, diplomacy, and good judgment. The agencies
most often consulted and/or contacted are the following:
1. United States Department of Justice - All criminal cases
and seizure actions must be filed by the U. S. Attorney
in the appropriate District Court. EPA will assist the
U. S. Attorney as necessary in the preparation and
prosecution of criminal cases. Close liaison with the
U. S. Attorney should be maintained in order to keep
informed of the status of all court actions.
2. United States Bureau of Customs - To make for more
effective enforcement of the FIFRA at ports of entry
with a minimum of cost and duplication of effort, EPA
and the Bureau of Customs operate under a working
arrangement whereby better protection is achieved than
by the two agencies operating separately. The Bureau
of Customs notifies the appropriate regional pesticides
personnel of pesticides and devices being imported into
24-1
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the United States and detains all such shipments until
notified by pesticides personnel that the shipment may
be released.
3. Federal Trade Commission - Liaison has been established
between EPA and the FTC in order to avoid possible
conflict or duplication of efforts in the adminis-
tration of the FIFRA and the Federal Trade Commission
Act as they apply to pesticides. In general, pesticide
advertising, other than labeling, in periodicals and
by television or radio is handled by the Federal Trade
Commission. However, both agencies reserve the right to
fully use their respective regulatory powers when
necessary to protect the public interest.
4. Food and Drug Administration - FDA grants a tolerance or
an exemption on all pesticide products proposed for use
in a manner which is likely to result in residues in or
on food or feed. FDA surveillance programs include the
collection and examination of samples as well as such
inspections as are necessary in the growing areas. With
the addition of the "misuse" provisions to the amended
FIFRA, closer coordination and cooperation will be
necessary between EPA and FDA to gather information to
enforce this part of the Act.
24-2
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25
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SECTION 25
STATE COOPERATION
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STATE COOPERATION
Section 23 of the FIFRA as amended October 21, 1972,
authorizes EPA to enter into cooperative agreements with States.
Authority may be delegated through the Administrator to cooperate
in the enforcement of the Act through the use of its personnel or
facilities, to train State personnel to cooperate in the enforce-
ment of the FIFRA, and to assist States in implementing cooperative
enforcement programs through grants-in-aid. State agencies may
also be assisted in developing and administering their own programs
for the training and certification of applicators consistent with
EPA standards.
EPA also has the authority to enter into contracts with
Federal or State agencies for the purpose of encouraging the
training of certified applicators. EPA may a'lso, in cooperation
with the Secretary of Agriculture, utilize the services of the
Cooperative State Extension Services for informing farmers of
accepted uses and other regulations made pursuant to FIFRA as
amended.
25-1
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26
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APPENDIX
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REFERENCE LIST FOR REGIONAL OFFICES
1. THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT
(61 STAT. 163; 7 U.S.C. 135-135R)
OCTOBER 1, 1964
2. REGULATIONS FOR THE ENFORCEMENT OF THE FEDERAL INSECTICIDE,
FUNGICIDE AND RODENTICIDE ACT
(TITLE 7, CH. Ill, PT. 362 OF THE CODE OF FEDERAL
REGULATIONS) AS AMENDED AUGUST 29, 1964
3. FEDERAL ENVIRONMENTAL PESTICIDE CONTROL ACT OF 1972
PUBLIC LAW 92-516
4. INSPECTORS MANUAL
5. MANUAL OF BIOLOGICAL TESTING METHODS FOR PESTICIDES AND DEVICES
6. ACCEPTABLE COMMON NAMES AND CHEMICAL NAMES FOR THE INGREDIENT
STATEMENT ON PESTICIDE LABELS
SECOND EDITION JUNE, 1972
7. GUIDELINES FOR REGISTERING PESTICIDES IN THE UNITED STATES
SECOND PRELIMINARY EDITION AUGUST, 1972
8. EPA COMPENDIUM OF REGISTERED PESTICIDES
5 VOLUMES
A-l
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TABLE FOR NUMBERING SYSTEM
E 1- 50 Notice of Contemplated Proceedings charges for
violations on or after 10/22/72
E 51- 65 Statements included in Notices of Contemplated
Proceedings
E 66- 75 Statements included with Notices of Contemplated
Proceedings
E 76- 85 Statements included in Notices of Warning
E 86-100 Closings for Notices of Warning
E 101-125 Statements included in correspondence
E 126-150 Closings for correspondence following Notices of
Contemplated Proceedings
E 151-175 Closings for correspondence following Notice of
Warning
E 201-250 Citation charges for violations prior to 10/22/72
E 251-265 Statements included in old citation
E 266-275 Statements included with old citation on attached
sheets
E 276- Statements included in Notice of Warning under the
registration provisions of the old FIFRA
A-2
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CITATION CHARGES FOR VIOLATIONS
OCCURING ON OR AFTER OCTOBER 22, 1972
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL INSEC-
TICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE PESTICIDE WAS:
El. Not registered under Section 4 of the Act. [7 U.S.C. 135a(a)
Cl), 135b]
E2. Misbranded in that the label did not bear on the front panel
or the part of the label displayed under customary conditions
of purchase the warning or caution statement "Keep out of
reach of children," and a signal word such as "Caution."
[12 (a) (1) (E), 86 Stat. 990; 2(q) (1) (G), 86 Stat. 977]
E3. Misbranded in that the label did not bear a warning or
caution statement which is necessary and, if complied with,
adequate to protect health and the environment. [12(a) (1) (E),
86 Stat. 990; 2 (q) (1) (G), 86 Stat. 977]
E4. Misbranded in that the labeling accompanying the product did
not contain directions for use which are necessary and, if
complied with, adequate to protect health and the environment.
[12(.a) Q.) (E) , 86 Stat. 990; 2 (q) (1) (F) , 86 Stat. 977]
E5. Misbranded in that the label borne by the product did not
bear an ingredient statement giving the name and percentage
of each of the active ingredients, together with the total
percentage of the inert ingredients, or an ingredient state-
ment giving the names of each of the active and each of the
inert ingredients in the descending order of the percentage
of each present in each classification, together with the
total percentage of the inert ingredients. [12 (a) (1) (E) ,
86 Stat. 990; 2(q) (2) (A), 86 Stat. 977; 7 U.S.C. 135(o)j
E6. Misbranded in that the ingredient statement did not appear
on that part of the immediate container of the retail package
[front panel) which is presented or displayed under customary
conditions of purchase. [12(a) (1) (E), 86 Stat. 990; 2 (q)
C2) (A), 86 Stat. 977]
E7. Misbranded in that the term "Inert Ingredients" appeared in
smaller sized type and was less prominent than the term,
"Active Ingredients." [12(a) (1) (E), 86 Stat. 990; 2(q) (2)
CA), 86 Stat. 977]
E8. Misbranded in that the label stated in part: (particular
false or misleading claims). [12(a) (1) (E), 86 Stat. 990;
2 (q) Cl) CA), 86 Stat. 977]
A-3
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E9. Misbranded in that the label borne by the product failed to
bear the registration number assigned. [12(a) (1) (E), 86
Stat. 990; 2(q) (1) (C) (v), 86 Stat. 978]
E10. Misbranded in that the label borne by the product did not
bear the required statement of net weight or measure of
content. [12(a) (1) (E), 86 Stat. 990; 2 (q) (2) (C) (iii), 86
Stat. 978]
Ell. Misbranded in that the label borne by the product did not
bear a statement giving the name and address of the
producer, registrant, or person for whom manufactured.
[12(a) (1) (E), 86 Stat. 990; 2(q) (2) (C) (i) , 86 Stat. 978]
E12. Misbranded in that the label borne by the product did not
bear a statement giving the name, brand, or trademark under
which the product was sold. [12 (a) (1) (E), 86 Stat. 990;
2Cq) (2) (C) (ii), 86 Stat. 978]
E13. Misbranded in that the labeling bore a statement as to the
safety of the product which-is false or misleading.
[12Ca) (.1) (E), 86 Stat. 990; 2 (q) (1) (A), 86 Stat. 977]
E14. Misbranded in that the precautionary labeling on the front
panel was not prominently placed theron with such conspic-
uousness as to render it likely to be read under customary
conditions of purchase. [12(a) (1) (E), 86 Stat. 990;
2(q) (1) (E), 86 Stat. 977]
E15. Misbranded in that the product is an imitation of, or is
offered for sale under the name of, another pesticide.
[12(a) 00 CE), 86 Stat. 990; 2(q) (1) (C), 86 Stat. 977]
E16. Misbranded in that the product contains a substance in
quantities highly toxic to man and the label fails to bear
required symbols or statements. [12(a) (1) (E), 86 Stat. 990;
2(q) (2) CD) , 86 Stat. 978]
E17. In violation in that the claims made for the product (and/or
where appropriate the directions for its use) differed in
substance from the representations made in connection with
its registration.[ 7 U.S.C. 135a(a) (1)]
E.8. In violation in that the composition of the product differed
from the composition as represented in connection with its
registration. [7 U.S.C. 135a(a) (1)]
E19. Adulterated in that its strength or purity fell below the
professed standard or quality under which it was sold.
[12Ca) Cl) CE), 86 Stat. 990; 2(c) (1) , 86 Stat. 975]
A-4
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E20. Adulterated in that another substance, namely (name of
substance), had been substituted wholly or in part for the
article. [12(a) (1) (E), 86 Stat. 990; 2(c) (2), 86 Stat. 975]
E21. Adulterated in that valuable constituent of the pesticide
had been wholly or in part abstracted. [12(a) (1) (E), 86
Stat. 990; 2(c) (3), 86 Stat. 975]
E22. Not colored or discolored as required. [12(a) (1) (D), 86
Stat. 990]
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL INSEC-
TICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT THE DEVICE WAS:
E23. Misbranded in that its labeling bore a statement which was
false or misleading. [7 U.S.C. 135a(a) (5), 135(z) (1)]
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE FEDERAL INSEC-
TICIDE, FUNGICIDE, AND RODENTICIDE ACT IN THAT:
E24. Detached, altered, defaced, or destroyed, in whole or in
part, labeling required under the Act. [12(a) (2) (A), 86
Stat. 990J
E25. Refused to furnish or permit access to records as authorized
by Section 5 of the Act. [7 U.S.C. 135a(c) (2)]
E26. Refused to allow inspection of establishment or refused to
allow the sampling of a pesticide (or device). [12(a) (2) (B) ,
86 Stat. 990]
E27. Gave a guaranty or undertaking which was false. [12(a) (2) (C),
86 Stat. 990]
E28. Used aregistered pesticide in a manner inconsistent with
its labeling. [12(a) (2) (G), 86 Stat. 990]
E29. Used a pesticide which was under an experimental use permit
contary to the provisions of the permit. [12(a) (2) (H),
86 Stat. 990]
E30. Violated a "stop sale, use, or removal" order. [12(a) (2) (I),
86 Stat. 990]
E31. Violated a suspension order. [12(a) (2) (J), 86 Stat. 990]
E32. Violated a cancellation of registration. [12(a) (2) (K),
86 Stat. 990]
A-5
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E33. Violated a provision of Section 7 of the Act in that the
establishment where the pesticide was produced was not
registered. [12(a) (1) (L), 86 Stat. 991]
E34. Knowingly falsified all or part of an application for regis-
tration, an application for experimental use permit, or
other information marked as confidential and submitted to
the Administrator. [12(a) (2) (M), 86 Stat. 991]
E35. Added a substance to, or took a substance from, a pesticide
in a manner defeating the purpose of the Act. [12(a) (2)
(0), 86 Stat. 991]
E36. Used a pesticide in tests on human beings in violation of
the Act. [12(a) (2) (P), 86 Stat. 991]
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E-51. The product is a pesticide within the meaning of the
Federal Insecticide, Fungicide, and Rodenticide Act,
a marked copy of which is enclosed. Please refer to:
(Insecticide) (1) Sec. 2(o), 2(t), and 2(u) of the Act.
(Fungicide
Bactericide) (2) Sec. 2 (k), 2 (t) , and 2(u) of the Act.
(Rodenticide) (3) Sec. 2(t) and 2(u) of the Act.
(Herbicide) (4) Sec. 2 (t) , 2(u), and 2 (cc) of the Act.
(Insecticide
and
Fungicide) (5) Sec. 2 (k), 2 (o), 2(t), and 2(u) of the Act,
(Algaecide) (6) Sec. 2(t) and 2(u) of the Act.
(Animal
Repellents) (7) Sec. 2(d), 2(t), and 2(u) of the Act.
(Nematocide) (8) Sec. 2(r), 2(t), and 2(u) of the Act.
E-52. The product is a device within the' meaning of the
Federal Insecticide, Fungicide, and Rodenticide Act,
a marked copy of which is enclosed. Please refer to
(Device) Sec. 2(h) of the Act.
A-7
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E-53. The violation alleged herein constitutes a repeated
violation by your company. It is emphasized that
in our further consideration of this matter, particular
attention will be given to (1) the explanation for the
alleged violation, and (2) the assurances which may be
given that the alleged violation will not recur.
E-54. (a) The marketing of this product without benefit of
registration is in violation of the Act. (b) We are
enclosing PR Form 9-199 for use in application for
registration of the product.
E-55. The establishment is a producer within the meaning of
the Federal Insecticide, Fungicide, and Rodenticide Act,
a marked copy of which is enclosed. Please refer to
Sec. 2(s), 2(w), and 2 (dd) of the Act.
E-56. (a) The production of a pesticide in an establishment
which is not registered pursuant to Section 7 of the
Act is in violation of the Act. (b) Enclosed is an
application for registration of the establishment.
A-8
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E-66. This notice is given pursuant to Section 9 of the
Act. It is separate from and should not be confused
with any seizure action which may have been instituted
in any United States District Court.
E-67. This notice is given pursuant to Section 9 of the
Act. It is separate from and should not be confused
with any stop, sale, use, or removal order which may
have been issued by this Agency.
E-68. This notice is given pursuant to Section 9 of the Act.
It is separate from and should not be confused with any
request for recall involving this product.
A-9
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E-76. The marketing of (a. this product) (b. these products)
without benefit of registration for the distributor
(is/are) in violation of the Act. We are enclosing
PR Form 9-1 for use in application for supplemental
registration for the distributor(s).
E-77. This letter is being sent to you since you are the
(registrant/manufacturer) of the (a. product) (b. products)
and therefore in the best position to initiate corrective
action.
A-10
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E-86. You should assure yourself that all necessary corrections
are made and that any further marketing of (a. this
product) (b. these products) is in full compliance with
the provisions of the Act. Any additional information
that you wish to submit will be included in the file
regarding this matter.
E-87. Since your company has taken action to correct (a. this
type of violation) (b. these types of violations), we do
not contemplate further proceedings at this time. You
should assure yourself that any further marketing of
(a. this product) (b. these products) complies with all
provisions of the Act.
E-88. Please inform us of the action you will take in this
matter.
A-11
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E-101. A seized product may be disposed of only in accordance
with Section 13 (c) of the Act. This section authorizes
release of a seized product to its owner after condem-
nation of the product and upon payment of court costs and
delivery of a bond conditioned that the product shall
not be sold or otherwise disposed of contrary to the
provisions of the Act. We would not object to release
of the compliance with the Act. Such procedure must be
agreeable to the United States Attorney and Court.
E-102. We note the steps taken by your company to withdraw this
lot of material from the market. When your recall action
is completed, please inform us of the amount and disposition
of any material returned.
E-103. Any further correspondance relating to registration and
labeling for (this/these) product(s) should refer to
- , and be addressed to
Mr. Alvin K. Chock, Chief, Application/Records Control
Branch, Registration Division, Environmental Protection
Agency, Washington, D. C. 20250.
A-12
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E-126. The Agency has decided to hold this case open for
further consideration.
E-127. Your comments concerning the violation of the Act have
been made a part of the official file for your company
and will be considered in our further review of this
matter.
E-128. The Agency has decided to take no further action in
this case. This decision relates to the specific case
in question and does not bar action on other cases
should circumstances warrant.
This letter is intended to serve as a notice of warning
within the meaning of Section 9 of the Act.
E-129. The Agency has decided to take no further action in these
cases. This decision relates to the specific cases in
question and does not bar action on other cases should
circumstances warrant.
This letter is intended to serve as a notice of warning
within the meaning of Section 9 of the Act.
A-13
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E-151 We have decided to take no further action in (a. this
case) (b. these cases). This decision relates to the
specific (c. case) (d. cases) in question and does not
bar action on other cases should circumstances warrant
E-152. We have closed our files in (a. this case) (b. these
cases).
A-14
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201. In that the'product- was not registered under Section 4 of
the Act. [7,U.S.C. }>35a(a) (1); 135b]
202. Misbranded in that the label did not bear on the front panel
or the part of the label displayed under customary conditions
of purchase the warning or caution statement "Keep out of
reach of children" and a signal word such as "Caution."
17 U.S.C. 135aCa) C5); 135(z) (2) (d); 40 CFR 162.9]
203. Misbranded in that the label did not bear a warning or
caution statement which is necessary and, if complied with,
adequate to prevent injury to living man and other vertebrate
animals, vegtation, and useful invertebrate animals. [ 7 U.S.C
135(a) C5); 13S(z) (2) (d)]
204. Misbranded in that the labeling accompanying the product did
not contain directions for use which are necessary and, if
complied with, adequate for the protection of the public.
17 U.S.C. 135a(a) (5); 135(z) (2) (c)]
205. Misbranded in that when used as directed or in accordance
with commonly recognized practice, the product would be
injurious to living man or other vertebrate animals.
17 U.S.C. 135a(a) (5); 135(z) (2) (g)J
206. Misbranded in that the label borne by the product did not
bear an ingredient statement giving the name and percentage
of each of the active ingredients, together with the total
percentage of the inert ingredients. [7 U.S.C. 135a(a) (5);
135(z) (2) (e); 135(0)]
207. Misbranded in that the ingredient statement did not appear
on that part of the immediate container of the retail
package (front panel) which is presented or displayed under
customary conditions of purchase. [7 U.S.C. 135a(a) (5);
135(z) (2) (e)]
208. Misbranded in that the term "Inert Ingredients" appeared in
smaller sized type and was less prominent than the term,
"Active Ingredients." [7 U.S.C. 135a(a) (5) 135(z) (2) (e);
135(o) ; 40 CFR 162.7(d)]
209. Misbranded in that the label stated in part: [7 U.S.C.
135a(a) (5); 135(z) (1)]
210. Adulterated in that its strength or purity fell below the
professed standard or quality under which it was sold.
17 U.S.C. 135a(a) (5); 135(y)]
A-15
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211. Adulterated in that another substance, namely (Name of
Substance), had been substituted wholly or in part for the
article. [7 U.S.C. 135a(a) (5) 135(y)]
212. In that the label borne by the product failed to bear the
registration number assigned. [7 U.S.C. 135a(a) (2) (d);
40 CFR 162.6(£)]
213. In that the label borne by the product did not bear a state-
ment of net weight or measure of content. [7 U.S.C. 135a(a)
(2) (c)]
214. In that the net weight or measure of content was not stated
in terms of the largest unit present. [7 U.S.C. 135a(a) (2)
(c); 40 CFR 162.6(e)]
215. In that the claims made for the product and the directions
for its use differed in substance from the representations
made in connection with its registration. [7 U.S.C. 135a(a)
d)]
216. In that the claims made for the product differed in substance
from the representations made in connection with its regis-
tration. (7 U.S.C. 135a(a) (1)]
217. In that the composition of the product differed from the com-
position as represented in connection with its registration.
[7 U.S.C. 135a(a) (1)]
218. In that the label borne by the product did not bear a state-
ment giving the name and address of the raanfacturer, regis-
trant, or person for whom manufactured. [7 U.S.C. 135a(a) (1)]
219. In that the label borne by the product did not bear a state-
ment giving the name, brand, or trademark under which the
product was sold. [7 U.S.C. 135a(2) (b)]
220. Misbranded in that the label bore a statement as to the
safety of the product which is false or misleading.
J7 U.S.C. 135Ca) [5); 135(z) (1); 40 CFR 162.14(a) (5)]
221. Misbranded in that the precautionary labeling on the front
panel was not prominently placed thereon with such conspic-
uousness as to render it likely to be read under customary
conditions of purchase. [7 U.S.C. 135a(a) (5) 135(z) (2)
Cf)J
A-16
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E-251. The product is an economic poison within the meaning
of the Federal Insecticide, Fungicide, and Rodenticide
Act, a marked copy of which is enclosed. Please refer
to:
(Insecticide) (1)
(Fungicide (2)
Bactericide
(Rodenticide) (3)
(Herbicide) (4)
(Insecticide (5)
§ Fungicide)
(Algaecide) (6)
(Animal (7)
Repellents)
(Nematocide) (8)
Sec. 2a, 2c, and 2m of the Act, and Paragraph
362. 2 (c) of the Regulations.
Sec. 2a, 2d, and 2n of the Act, and Paragraphs
362.2 (c) and 362.2(d) of the Regulations.
Sec. 2a and 2c of the Act, and Paragraph 362.2
(c) of the Regulations.
Sec. 2a, 2f, and 21 of the Act, and Paragraphs
362.2(c) and 362.2(e) of the Regulations.
Sec. 2a, 2c, 2d, 2m, and 2n of the Act and Para-
graphs 362.2 (c) and 362. 2 (d) of the Regulations.
Sec. 2a of the Act and Paragraphs 362.2 (c) and
362.2(e) of the Regulations.
Sec. 2a of the Act and Paragraph 362.2(c) of the
Regulations.
Sec. 2a, 2g, and 2k of the Act and Paragraphs
362.2(c) and 362.2(f) of the Regulations.
E-252. The product is a device within the meaning of the Federal
Insecticide, Fungicide, and Rodenticide Act, a marked
copy of which is enclosed. Please refer to:
(Device)
Sec. 2(b) of the Act and Paragraph
362.14(a) of the Regulations.
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E-253. (a) Interstate shipments of this product without benefit
of registration are in violation of the Act. (b) We are
enclosing PR Form (9-199) for use in application for
registration of the product.
A-18
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E-266 This notice is given pursuant to Section 6 of the
Act (7 U.S.C. 135d). It is separate from and should
not be confused with any seizure action which may
have been instituted in any United States District
Court.
E-267 This notice is given pursuant to Section 6 of the
Act. It is separate from and should not be con-
fused with any stop sale, use, or removal order
which may have been issued by this Agency.
E-268 This notice is given pursuant to Section 6 of the
Act (7 U.S.C. 135d) . It is separate from and should
not be confused \vith any request for recall involving
this product.
A-19
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E-276 Interstate shipments of (a, this product) (b. these
products) without benefit of supplemental registration
for the distributor are in violation of the Act. An
application for supplemental registration, PR Form
901, is enclosed.
A-20
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E-126. The Agency has decided to hold this case open for
further consideration.
E-127. Your comments concerning the violation of the Act have
been made a part of the official file for your company
and will be considered in our further review of this
matter.
E-128. The Agency has decided to take no further action in
this case. This decision relates to the specific case
in question and does not bar action on other cases
should circumstances warrant.
This letter is intended to serve as a notice of warning
within the meaning of Section 9 of the Act.
E-129. The Agency has decided to take no further action in these
cases. This decision relates to the specific cases in
question and does not bar action on other cases should
circumstances warrant.
This letter is intended to serve as a notice of warning
within the meaning of Section 9 of the Act.
A-13
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E-151 We have decided to take no further action in (a. this
case) (b. these cases). This decision relates to the
specific (c. case) (d. cases) in question and does not
bar action on other cases should circumstances warrant
E-152. We have closed our files in (a. this case) (b. these
cases) .
A-14
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201. In that the product- was not registered under Section 4 of
the Act. [7,U.S.C. 3>35a(a) (1); 135bj
202. Misbranded in that the label did not bear on the front panel
or the part of the label displayed under customary conditions
of purchase the warning or caution statement "Keep out of
reach of children" and a signal word such as "Caution."
17 U.S.C. 135aCa) C5) ; 135(z) (2) (d) ; 40 CFR 162.9]
203. Misbranded in that the label did not bear a warning or
caution statement which is necessary and, if complied with,
adequate to prevent injury to living man and other vertebrate
animals, vegtation, and useful invertebrate animals. [ 7 U.S.C
135Ca) C5); 135(z) (2) (d)]
204. Misbranded in that the labeling accompanying the product did
not contain directions for use which are necessary and, if
complied with, adequate for the protection of the public.
17 U.S.C. 13Sa(a) (5); 135(z) (2) (c)]
205. Misbranded in that when used as directed or in accordance
with commonly recognized practice, the product would be
injurious to living man or other vertebrate animals.
17 U.S.C. 13Sa(a) (5); 13S(z) (2) (g)J
206. Misbranded in that the label borne by the product did not
bear an ingredient statement giving the name and percentage
of each of the active ingredients, together with the total
percentage of the inert ingredients. [7 U.S.C. 135a(a) (5);
135(2) (2) (e); 135(o)]
207. Misbranded in that the ingredient statement did not appear
on that part of the immediate container of the retail
package (front panel) which is presented or displayed under
customary conditions of purchase. [7 U.S.C. 135a(a) (5);
135(z) (2) (e)]
208. Misbranded in that the term "Inert Ingredients" appeared in
smaller sized type and was less prominent than the term,
"Active Ingredients." [7 U.S.C. 135a(a) (5) 135(z) (2) (e) ;
135 Co); 40 CFR 162.7(d)]
209. Misbranded in that the label stated in part: [7 U.S.C.
135a(a) (5); 135(z) (1)]
210. Adulterated in that its strength or purity fell below the
professed standard or quality under which it was sold.
[7 U.S.C. 135a(a) (5); 135(y)]
A-15
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211. Adulterated in that another substance, namely (Name of
Substance) , had been substituted wholly or in part for the
article. [7 U.S.C. 135a(a) (5) 135(y)]
212. In that the label borne by the product failed to bear the
registration number assigned. [7 U.S.C. 135a(a) (2) (d) ;
40 CFR 162. 6(f)]
213. In that the label borne by the product did not bear a state-
ment of net weight or measure of content. [7 U.S.C. 135a(a)
(2) (c)]
214. In that the net weight or measure of content was not stated
in terms of the largest unit present. [7 U.S.C. 135a(a) (2)
(c) ; 40 CFR 162. 6(e)]
215. In that the claims made for the product and the directions
for its use differed in substance from the representations
made in connection with its registration. [7 U.S.C. 135a(a)
(1)]
216. In that the claims made for the product differed in substance
from the representations made in connection with its regis-
tration. (7 U.S.C. 135a(a) (1)]
217. In that the composition of the product differed from the com-
position as represented in connection with its registration.
[7 U.S.C. 135a(a) (1)]
218. In that the label borne by the product did not bear a state-
ment giving the name and address of the manfacturer, regis-
trant, or person for whom manufactured. [7 U.S.C. 135a(a) (1)]
219. In that the label borne by the product did not bear a state-
ment giving the name, brand, or trademark under which the
product was sold. [7 U.S.C. 135a(2) (b)]
220. Misbranded in that the label bore a statement as to the
safety of the product which is false or misleading.
J7 U.S.C. 135(a) (5); 135(z) (1) ; 40 CFR 162.14(a) (5)]
221. Misbranded in that the precautionary labeling on the front
panel was not prominently placed thereon with such conspic-
uousness as to render it likely to be read under customary
conditions of purchase. [7 U.S.C. 135a(a) (5) 135(z) (2)
Cf)J
A-16
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E-251. The product is an economic poison within the meaning
of the Federal Insecticide, Fungicide, and Rodenticide
Act, a marked copy of which is enclosed. Please refer
to:
(Insecticide) (1)
(Fungicide (2)
Bactericide
(Rodenticide) (3)
(Herbicide) (4)
(Insecticide (5)
§ Fungicide)
(Algaecide) (6)
(Animal (7)
Repellents)
(Nematocide) (8)
Sec. 2a, 2c, and 2m of the Act, and Paragraph
362.2 (c) of the Regulations.
Sec. 2a, 2d, and 2n of the Act, and Paragraphs
362.2(c) and 362.2 (d) of the Regulations.
Sec. 2a and 2c of the Act, and Paragraph 362.2
(c) of the Regulations.
Sec. 2a, 2f, and 21 of the Act, and Paragraphs
362.2(c) and 362.2(e) of the Regulations.
Sec. 2a, 2c, 2d, 2m, and 2n of the Act and Para-
graphs 362.2 (c) and 362.2 (d) of the Regulations.
Sec. 2a of the Act and Paragraphs 362.2 (c) and
362. 2 (e) of the Regulations.
Sec. 2a of the Act and Paragraph 362.2(c) of the
Regulations.
Sec. 2a, 2g, and 2k of the Act and Paragraphs
362.2(c) and 362.2(f) of the Regulations.
E-252. The product is a device within the meaning of the Federal
Insecticide, Fungicide, and Rodenticide Act, a marked
copy of which is enclosed. Please refer to:
(Device)
Sec. 2(b) of the Act and Paragraph
362.14(a) of the Regulations.
A-17
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E-253. (a) Interstate shipments of this product without benefit
of registration are in violation of the Act. (b) We are
enclosing PR Form (9-199) for use in application for
registration of the product.
A-18
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E-266 This notice is given pursuant to Section 6 of the
Act (7 U.S.C. 135d). It is separate from and should
not be confused with any seizure action which may
have been instituted in any United States District
Court.
E-267 This notice is given pursuant to Section 6 of the
Act. It is separate from and should not be con-
fused with any stop sale, use, or removal order
which may have been issued by this Agency.
E-268 This notice is given pursuant to Section 6 of the
Act (7 U.S.C. 135d) . It is separate from and should
not be confused with any request for recall involving
this product.
A-19
-------
E-276 Interstate shipments of (a. this product) (b. these
products) without benefit of supplemental registration
for the distributor are in violation of the Act. An
application for supplemental registration, PR Form
901, is enclosed.
A-20
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27
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28
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29
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30
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31
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I PESTICIDES ENFORCEFIENTDIVISIO
v
I/=I4,
CASE PROCEEDINGS MANUAL
DATE: February 8, 1974
TRANSMITTAL 74-1
MTERIAL TRANSMITTED
Guidance Regarding Laboratory Tests
MANUAL MAINTENANCE
Remove Insert
Old Page 4-2 New Page 4-2
EXPLANATION
This transmittal updates the original page 4-2, by providing a new address
for obtaining the EPA Manual of. Biological Testing Methods for Pesticides
and Devices.
A. E. Conroy
Director
DISTRIBUTION: All holders of the Case Proceedings Manual.
-------
? mrm -o
<• - - - ^' _ *-.
PESTICII1ES ENFORCEMENT DIVISION
CASE PROCEEDINGS MANUAL
DATE: June 14, 1974 TRANSMITTAL 74-2
MATERIAL TRANSMITTED
Sample Record Status And Permanent Abeyance Procedures
MANUAL MAINTENANCE
Remove insert
Old Section 22 New Section 22
EXPLANATION
This transmittal revises and updates the entire Section 22. The revised
portion sets forth .new procedures for placing sample records in
permanent abeyance.
7
A. E. Conroy IF/
Director
DISTRIBUTION; All holders of the Case Proceedings Manual7
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